Active ingredients: Diclofenac
Voltfast 50 mg granules for oral solution
Voltfast package inserts are available for pack sizes:- Voltfast 50 mg granules for oral solution
- VOLTFAST 25 mg coated tablets, VOLTFAST 50 mg coated tablets
Indications Why is Voltfast used? What is it for?
Pharmacotherapeutic group
Anti-inflammatory, non-steroidal antirheumatic, acetic acid derivatives and related substances.
Therapeutic indications
In the short-term treatment of post-traumatic painful states, post-operative inflammatory states, menstrual pains. Treatment of exacerbations of osteo-articular rheumatic pain of such intensity as to require prompt alleviation.
Voltfast sachets of granules for oral solution are characterized by their rapidity of action, which makes them particularly suitable for the short-term treatment of painful states and acute inflammatory processes.
Contraindications When Voltfast should not be used
- Hypersensitivity to the active substance or to any of the excipients.
- Hypersensitivity to acetylsalicylic acid and in general to other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.
- Active gastrointestinal ulcer, bleeding or perforation.
- Last trimester of pregnancy and during lactation (see "Special warnings").
- History of gastrointestinal bleeding or relative perforation from previous NSAID treatment or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
- Severe hepatic insufficiency.
- Severe renal insufficiency.
- Overt congestive heart failure (class II-IVdell "NYHA), ischemic heart disease, peripheral arterial disease and cerebral ovasculopathy.
- Previous liver disease.
- Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltfast is contraindicated in patients who have worsened asthma attacks, urticaria or acute rhinitis following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.
- During intensive diuretic therapy.
- In case of alterations in hematopoiesis.
- Voltfast is also contraindicated in pediatric age (
- Due to the presence of aspartame, Voltfast granules for oral solution is contraindicated in patients with phenylketonuria.
Precautions for use What you need to know before taking Voltfast
General informations
Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see "Dose, method and time of administration" and the paragraphs below on gastrointestinal and cardiovascular risks).
The concomitant use of diclofenac with other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of any evidence showing synergistic benefits and based on potential additive side effects.
Elderly: On a basic medical level, caution is required in the elderly. In particular, in frail elderly patients or those with a low body weight, the use of the lowest effective dose is recommended. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see "Side Effects").
As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may also occur in rare cases, even without prior exposure to diclofenac.
Like other NSAIDs, Voltfast may mask the signs and symptoms of infections due to its pharmacodynamic properties.
Gastrointestinal effects
During treatment with all NSAIDs, including diclofenac, they have been reported and may occur, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation, which can be fatal. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be discontinued.
As with all NSAIDs, including diclofenac, close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders or with a history indicative of gastric or intestinal ulceration, bleeding or perforation ( see "Undesirable Effects").
The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation. The elderly have a higher frequency of adverse reactions, especially gastrointestinal bleeding and perforation which can be fatal. To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid ASA / aspirin or other drugs that may increase the risk of gastrointestinal events (see below and "Interactions").
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the early stages of treatment.
Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as "aspirin" (see "Interactions").
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease, as these conditions may be exacerbated (see "Undesirable Effects").
Hepatic effects
Close medical surveillance is required when prescribing diclofenac to patients with hepatic insufficiency as the condition may be exacerbated.
As with other NSAIDs, including diclofenac, the values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular checks of liver function are indicated as a precautionary measure.
If liver function parameters are persistently altered or worsened, if clinical signs or consistent symptoms of liver disease develop, or if other manifestations (eg eosinophilia, rash) occur, diclofenac should be discontinued. A "hepatitis with the use of diclofenac" can occur without prodromal symptoms. Particular caution should be exercised in the use of diclofenac in patients with hepatic porphyria, as it could trigger an attack.
Kidney effects
Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, particular caution is required in case of cardiac and renal failure, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medicinal products that may significantly affect renal function and in those patients with substantial extracellular volume depletion from any cause (eg, before or after major surgery) (see "Contraindications"). In such cases, when administering diclofenac, monitoring of renal function is recommended as a precaution.
Discontinuation of therapy is usually followed by a return to pre-treatment conditions.
Skin effects
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see "Undesirable Effects"). Patients in the early stages of therapy they appear to be at higher risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Voltfast should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Cardiovascular and cerebrovascular effects
Adequate monitoring and instruction are required in patients with a history of hypertension and / or congestive heart failure (NYHA class I) as fluid retention and edema have been reported in association with NSAID treatment. Clinical trials and epidemiological data consistently indicate an increased risk of arterial thrombotic events (eg, myocardial infarction or stroke) associated with the use of diclofenac, especially at high doses (150 mg / day) and with long-term treatment. Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
Since the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest possible duration and the lowest effective daily dose should be used. The response to therapy and the need for symptom improvement should be reassessed periodically. patients with congestive heart failure (NYHA class I), established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with diclofenac after careful consideration.
Patients should be alert for signs and symptoms of serious atherothrombotic events (e.g. chest pain, shortness of breath, weakness, slurred speech), which can occur without warning. Patients should be instructed to contact a physician immediately if any of these events occur.
Hematological effects
The use of Voltfast granules for oral solution is only recommended for short-term treatment.
During prolonged treatment with diclofenac, as with other NSAIDs, blood count checks are recommended.
Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with haemostatic defects should be carefully monitored.
Pre-existing asthma
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (eg, nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to allergic rhinitis), are more common than in others patients reactions to NSAIDs such as asthma exacerbations (so-called analgesic intolerance / analgesic asthma), Quincke's edema or urticaria. Special precaution is therefore recommended in such patients (preparing for emergency). This also applies to patients allergic to other substances, eg. with skin reactions, itching or hives.
Interactions What medications or foods may change the effect of Voltfast
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The following interactions include those seen with diclofenac gastro-resistant tablets and / or other pharmaceutical forms of diclofenac.
Lithium: when administered together with preparations containing lithium, diclofenac can raise its plasma concentration. Monitoring of serum lithium levels is recommended.
Digoxin: when administered with preparations containing digoxin, diclofenac can increase their concentrations in plasma. Monitoring of serum digoxin levels is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (eg beta blockers, angiotensin converting enzyme (ACE) inhibitors may cause a decrease in their antihypertensive effect. The combination should be taken with caution and patients, especially the elderly, should receive periodic monitoring of their blood pressure.
In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking Voltfast concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and renal function monitoring should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity.
Concomitant treatment with potassium-sparing diuretic drugs, cyclosporine, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently (see "Precautions for use").
Other NSAIDs and corticosteroids: Concomitant use of diclofenac and other systemic non-steroidal anti-inflammatory drugs or corticosteroids may increase the incidence of gastrointestinal side effects (see "Precautions for use").
Anticoagulants and antiplatelet agents: Caution is recommended as concomitant administration may increase the risk of bleeding (see "Precautions for use").
Although there is no indication from clinical trial data of an "influence on diclofenac on the anticoagulant effect", there have been isolated reports of an increased risk of haemorrhage with concomitant use of diclofenac and anticoagulant therapy.Careful monitoring is recommended for these patients.
Selective Serotonin Reuptake Inhibitors (SSRIs): Co-administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see "Precautions for use").
Antidiabetics: Clinical studies have shown that diclofenac can be administered together with oral antidiabetic agents without affecting their clinical effect. However, isolated cases of both hypo- and hyperglycemic effects have been reported, with the need to adjust the dosage of the agents. antidiabetics administered during treatment with diclofenac For this reason, monitoring of blood glucose levels is recommended as a precautionary measure in case of concomitant therapy.
Methotrexate: diclofenac can inhibit renal tubular release of methotrexate by increasing its levels. Caution is advised when administering NSAIDs, including diclofenac, 24 hours before or after treatment with methotrexate, as blood concentrations of methotrexate and consequently the toxicity of this substance may increase.
Ciclosporin: Diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine due to its effect on renal prostaglandins. Therefore, diclofenac should be administered at lower doses than would be used in patients not on cyclosporine therapy.
Quinolone antibacterials: isolated cases of convulsions have been reported, probably due to the concomitant use of quinolones and NSAIDs.
Colestipol and cholestyramine: These agents may induce a delay or decrease in the absorption of diclofenac. Therefore, it is recommended that diclofenac be administered at least one hour before or 4-6 hours after colestipol / cholestyramine administration.
Potent CYP2C9 inhibitors: Caution is advised when prescribing diclofenac together with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole); this could lead to a significant increase in peak plasma concentrations and exposure to diclofenac, due to inhibition of its metabolism.
Phenytoin: When using phenytoin together with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in phenytoin exposure.
Warnings It is important to know that:
Medicines such as Voltfast may be associated with a modest increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatments. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or smoke) you should discuss your treatment with your doctor or pharmacist.
Fertility, pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
As with other NSAIDs, the use of Voltfast may impair female fertility and is not recommended in women wishing to conceive. Discontinuation of diclofenac should be considered in women who have difficulty conceiving or who are undergoing investigation of infertility.
Pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals administered prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases.
If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose
the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, diclofenac is contraindicated during the third trimester of pregnancy.
Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. It is therefore recommended not to administer Voltfast during breastfeeding to avoid undesirable effects in the infant.
Effects on ability to drive and use machines
Patients who have experienced disturbed vision, dizziness, vertigo, somnolence or other central nervous system disorders with the use of diclofenac should refrain from driving or operating machinery.
Important information about some of the excipients
Voltfast granules for oral solution contains aspartame, a source of phenylalanine. It can be harmful to patients with phenylketonuria (see "Contraindications").
Dosage and method of use How to use Voltfast: Dosage
Undesirable effects can be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see "Precautions for use").
The contents of the sachet should be dissolved in half a glass of plain water. Any opalescence of the solution does not affect the effectiveness of the preparation.
General population
In post-traumatic pain, in post-operative states and in the treatment of exacerbations of rheumatic osteo-articular pain, the attack dose in adults is 100-150 mg per day, divided into 2-3 administrations. In milder cases, a daily dose of 50-100 mg is usually sufficient.
In primary dysmenorrhea the daily dose, which must be individually adjusted, is generally 50-150 mg and, if necessary, can be increased during other menstrual cycles up to a maximum of 200 mg / day. It is advisable to start the treatment when the first symptoms appear and, depending on the symptoms, continue it for a few days.
Special populations
Pediatric patients
Voltfast should not be used in children and adolescents under the age of 14.
For adolescents aged 14 and over, a daily dose of 50-100 mg is usually sufficient. The total daily dose should generally be divided into 2-3 administrations.
Do not exceed the maximum daily dose of 150 mg.
Senior citizens
No starting dose adjustment is required in elderly patients.
Patients with congestive heart failure (NYHA 1) or significant cardiovascular risk factors
Patients with significant risk factors for cardiovascular disease should only be treated with diclofenac after careful consideration (see "Precautions for use").
Renal impairment
Voltfast is contraindicated in patients with severe renal insufficiency (see "Contraindications").
Caution is recommended when administering Voltfast to patients with mild to moderate renal impairment (see also "Precautions for use").
Hepatic impairment
Voltfast is contraindicated in patients with severe hepatic insufficiency (see "Contraindications").
Caution is recommended when administering Voltfast to patients with mild to moderate hepatic impairment (see also "Precautions for use").
Overdose What to do if you have taken too much Voltfast
Symptoms
There is no typical clinical picture resulting from diclofenac overdose.
Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In the case of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures
Treatment of acute NSAID poisoning, including diclofenac, essentially consists of supportive measures and symptomatic treatment.
In case of complications such as hypotension, renal insufficiency, convulsions, gastrointestinal disorders and respiratory depression, supportive measures and symptomatic treatment should be adopted.
Specific therapies, such as forced diuresis, dialysis or haemoperfusion, are unlikely to help eliminate NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism.
After ingestion of a potentially toxic overdose, the use of activated charcoal may be considered, while gastric emptying (eg vomiting, gastric lavage) may be considered after ingestion of a potentially life-threatening overdose.
In case of accidental ingestion / intake of an excessive dose of Voltfast, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Voltfast ask your doctor or pharmacist.
Side Effects What are the side effects of Voltfast
Like all medicines, Voltfast can cause side effects, although not everybody gets them.
Adverse reactions are listed by frequency, most frequent first, using the following convention: common (≥ 1/100 to <1/10); uncommon (≥ 1 / 1,000 to <1/100); rare (≥ 1 / 10,000, <1 / 1,000); very rare (<1 / 10,000), not known (cannot be estimated from the available data).
The following side effects include those reported with short or long term use.
Disorders of the blood and lymphatic system
Very rare: thrombocytopenia, leukopenia, anemia (including haemolytic and aplastic anemia), agranulocytosis.
Disorders of the immune system
Rare: hypersensitivity, anaphylactic and anaphylactoid reactions (including hypotension and shock).
Very rare: angioneurotic edema (including face edema).
Psychiatric disorders
Very rare: disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.
Nervous system disorders
Common: headache, dizziness.
Rare: somnolence.
Very rare: paraesthesia, memory impairment, convulsions, anxiety, tremors, aseptic meningitis, taste disturbances, cerebrovascular accidents.
Eye disorders
Very rare: visual disturbances, blurred vision, diplopia.
Ear and labyrinth disorders
Common: dizziness.
Very rare: tinnitus, hearing impairment.
Cardiac pathologies
Uncommon *: myocardial infarction, heart failure, palpitations, chest pain.
Vascular pathologies
Very rare: hypertension, vasculitis.
Respiratory, thoracic and mediastinal disorders
Rare: asthma (including dyspnoea).
Very rare: pneumonia.
Gastrointestinal disorders
Common: nausea, vomiting, diarrhea, dyspepsia, abdominal pain, flatulence, decreased appetite.
Rare: gastritis, gastrointestinal haemorrhage, haematemesis, haemorrhagic diarrhea, melaena, gastric or intestinal ulcer (with or without bleeding or perforation).
Very rare: colitis (including haemorrhagic colitis and exacerbation of ulcerative ulcerative disease or Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorders, diaphragm-like intestinal stenosis, pancreatitis.
Hepatobiliary disorders
Common: increased transaminases.
Rare: hepatitis, jaundice, liver disorders.
Very rare: fulminant hepatitis, hepatic necrosis, hepatic failure.
Skin and subcutaneous tissue disorders
Common: rash.
Rare: urticaria.
Very rare: Bullous dermatitis, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, hair loss, photosensitivity reaction, purpura, SchonleinHenoch purpura, pruritus.
Renal and urinary disorders
Very rare: acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.
General disorders and administration site conditions
Rare: edema.
* Frequency reflects high dose long-term treatment data (150 mg / day).
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Undesirable effects can also be reported directly via the national reporting system at “www.agenziafarmaco.gov.it/it/responsabili.” By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Expiry: see the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date indicated on the package.
Conservation conditions
Do not store above 25 ° C. Keep the sachets in the outer packaging to protect the medicine from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment. Keep this medicine out of the sight and reach of children.
Composition and pharmaceutical form
Composition
One sachet contains: Active ingredient: diclofenac potassium 50 mg.
Excipients: Aspartame; potassium bicarbonate; pulvaroma anise; pulvaroma mint; mannitol; sodium saccharin, glycerol dibeenate.
Pharmaceutical form and content
Granules for oral solution
Pack of 30 sachets
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
VOLTFAST 50 MG GRANULATE FOR ORAL SOLUTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: diclofenac potassium 50 mg.
Excipients: aspartame.
For the full list of excipients see section 6.1.
03.0 PHARMACEUTICAL FORM
Granules for oral solution
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
In the short-term treatment of post-traumatic painful states, post-operative inflammatory states, menstrual pains. Treatment of exacerbations of osteo-articular rheumatic pain of such intensity as to require prompt alleviation.
04.2 Posology and method of administration
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.4).
Adults
In post-traumatic pain, in post-operative states and in the treatment of exacerbations of rheumatic osteo-articular pain, the attack dose in adults is 100-150 mg per day, divided into 2-3 administrations. In milder cases, a daily dose of 50-100 mg is usually sufficient.
In primary dysmenorrhea the daily dose, which must be individually adjusted, is generally 50-150 mg and, if necessary, can be increased during other menstrual cycles up to a maximum of 200 mg / day. It is advisable to start the treatment when the first symptoms appear and, depending on the symptoms, continue it for a few days.
The contents of the sachet should be dissolved in half a glass of plain water. Any opalescence of the solution does not affect the effectiveness of the preparation.
Children and adolescents
Voltfast should not be used in children and adolescents under the age of 14.
For adolescents aged 14 and over, a daily dose of 50-100 mg is usually sufficient. The total daily dose should generally be divided into 2-3 administrations.
Do not exceed the maximum daily dose of 150 mg.
04.3 Contraindications
Active gastrointestinal ulcer, bleeding or perforation.
Last trimester of pregnancy and during lactation (see section 4.6).
History of gastrointestinal bleeding or perforation related to previous NSAID treatment or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe cardiac, hepatic or renal failure (see section 4.4). Known hypersensitivity to the active substance or to any of the excipients, in particular towards acetylsalicylic acid and in general towards other analgesics, antipyretics, non-steroidal anti-inflammatory drugs.
Like other non-steroidal anti-inflammatory drugs (NSAIDs), Voltfast is contraindicated in patients who, following the administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs, have had a worsening of asthma attacks, urticaria or acute rhinitis.
During intensive diuretic therapy. In case of alterations in hematopoiesis.
Voltfast is also contraindicated in children (14 years).
Due to the presence of aspartame Voltfast granules for oral solution it is contraindicated in subjects suffering from phenylketonuria.
04.4 Special warnings and appropriate precautions for use
General informations
Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the paragraphs below on gastrointestinal and cardiovascular risks).
The concomitant use of diclofenac with other systemic NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided due to the lack of any evidence showing synergistic benefits and based on potential additive side effects.
Elderly: On a basic medical level, caution is required in the elderly. In particular, in frail elderly patients or those with a low body weight, the use of the lowest effective dose is recommended. Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 4.8) As with other NSAIDs, allergic reactions, including anaphylactic / anaphylactoid reactions, may also occur in rare cases, even without prior exposure to diclofenac.
Like other NSAIDs, Voltfast may mask the signs and symptoms of infections due to its pharmacodynamic properties.
Information important on some excipients: Voltfast granules for oral solution contain a source of phenylalanine and can therefore be> harmful for patients with phenylketonuria.
Gastrointestinal effects
During treatment with all NSAIDs, including diclofenac, they have been reported and may occur, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding, ulceration and perforation, which can be fatal. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the medicinal product should be discontinued.
As with all NSAIDs, including diclofenac, close medical surveillance is mandatory and particular caution should be used when prescribing diclofenac to patients with symptoms indicative of gastrointestinal (GI) disorders or with a history indicative of gastric or intestinal ulceration, bleeding or perforation ( see section 4.8).
The risk of GI bleeding is higher with increased doses of NSAIDs and in patients with a history of ulcer, especially if complicated with haemorrhage or perforation. The elderly have a higher frequency of adverse reactions, especially gastrointestinal bleeding and perforation which can be fatal.
To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, treatment should be initiated and maintained at the lowest effective dose.
Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking low doses of acetylsalicylic acid ASA / aspirin or other drugs that may increase the risk of gastrointestinal events (see below and paragraph 4.5).
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the early stages of treatment. Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).
Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease, as these conditions may be exacerbated (see section 4.8).
Hepatic effects
Close medical surveillance is required when prescribing diclofenac to patients with hepatic insufficiency, as the condition may be exacerbated.
As with other NSAIDs, including diclofenac, the values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, regular checks of liver function are indicated as a precautionary measure.
If liver function parameters are persistently altered or worsened, if clinical signs or consistent symptoms of liver disease develop, or if other manifestations (eg, eosinophilia, rash) occur, diclofenac should be discontinued. A "hepatitis with the use of diclofenac" can occur without prodromal symptoms.
Particular caution should be exercised in the use of diclofenac in patients with hepatic porphyria, as it could trigger an attack.
Kidney effects
Since fluid retention and edema have been reported in association with NSAID therapy, including diclofenac, particular caution is required in case of cardiac or renal failure, history of hypertension, in the elderly, in patients receiving concomitant diuretics or medicinal products that may significantly affect renal function and in those patients with substantial extracellular volume depletion from any cause (eg, before or after major surgery (see section 4.3)). In such cases, when administering diclofenac, monitoring of renal function is recommended as a precaution. Discontinuation of therapy is usually followed by a return to pre-treatment conditions.
Skin effects
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). In the early stages of therapy, patients appear to be at highest risk for these reactions: the onset of the reaction occurs in most cases within the first month of treatment. Voltfast should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
Cardiovascular and cerebrovascular effects
Adequate monitoring and instruction are required in patients with a history of mild to moderate hypertension and / or congestive heart failure as fluid retention and edema have been reported in association with NSAID treatment.
Clinical studies and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg / day) and in long-term treatments, may be associated with a modest increased risk of arterial thrombotic events (eg. myocardium or stroke).
Patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with diclofenac after careful consideration. Similar considerations should be made before initiating long-term treatment in patients with risk factors for cardiovascular events (eg, hypertension, hyperlipidaemia, diabetes mellitus, smoking).
Hematological effects
The use of Voltfast granules for oral solution is only recommended for short-term treatment.
During prolonged treatment with diclofenac, as with other NSAIDs, blood count checks are recommended.
Like other NSAIDs, diclofenac may temporarily inhibit platelet aggregation. Patients with haemostatic defects should be carefully monitored.
Pre-existing asthma
In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (eg, nasal polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections (especially when linked to symptoms similar to allergic rhinitis), are more common than in others patients reactions to NSAIDs such as asthma exacerbations (so-called analgesic intolerance / analgesic asthma), Quincke's edema or urticaria. Special precaution is therefore recommended in such patients (preparing for emergency). This also applies to patients allergic to other substances, eg. with skin reactions, itching or hives.
04.5 Interactions with other medicinal products and other forms of interaction
The following interactions include those seen with diclofenac gastro-resistant tablets and / or other pharmaceutical forms of diclofenac.
Lithium: when administered together with lithium-containing preparations, diclofenac can raise its plasma concentration. Monitoring of serum lithium levels is recommended.
Digoxin: when administered with digoxin-containing preparations, diclofenac may increase their plasma concentrations. Monitoring of serum digoxin levels is recommended.
Diuretics and antihypertensive agents: Like other NSAIDs, concomitant use of diclofenac with diuretics or antihypertensive agents (eg beta blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect. Therefore, the combination must be taken with caution and patients, especially the elderly, should receive periodic monitoring of their blood pressure.
In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) the co-administration of an ACE inhibitor or angiotensin II antagonist and agents that inhibit the cyclo-oxygenase system may lead to further deterioration of renal function, including possible acute renal failure, usually reversible. These interactions should be considered in patients taking Voltfast concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in elderly patients.
Patients should be adequately hydrated and renal function monitoring should be considered after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to an increased risk of nephrotoxicity.
Concomitant treatment with potassium-sparing drugs may be associated with an increase in serum potassium levels, which should therefore be monitored frequently (see section 4.4).
Other NSAIDs and corticosteroids: Concomitant use of diclofenac and other systemic non-steroidal anti-inflammatory drugs or corticosteroids may increase the incidence of gastrointestinal side effects (see section 4.4).
Anticoagulants and antiplatelet agents: Caution is recommended as co-administration may increase the risk of bleeding (see section 4.4). Although there is no indication from clinical trial data of an "influence of diclofenac on the anticoagulant effect", there have been isolated reports of an increased risk of haemorrhage with concomitant use of diclofenac and anticoagulant therapy. For these patients it is recommended. careful monitoring.
Selective Serotonin Reuptake Inhibitors (SSRIs): Co-administration of systemic NSAIDs, including diclofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4).
Antidiabetics: clinical studies have shown that diclofenac can be administered together with oral antidiabetic agents without affecting their clinical effect. However, isolated cases of both hypo- and hyperglycaemic effects have been reported, with the need to adjust the dosage of the antidiabetic agents administered during treatment with diclofenac For this reason, monitoring of blood glucose levels is recommended as a precautionary measure in case of concomitant therapy.
Methotrexate: Diclofenac can inhibit renal tubular release of methotrexate by increasing its levels. Caution is advised when administering NSAIDs, including diclofenac, 24 hours before or after treatment with methotrexate, as blood concentrations of methotrexate and consequently the toxicity of this substance may increase.
Ciclosporin: due to its effect on renal prostaglandins, diclofenac, like other NSAIDs, may increase the nephrotoxicity of cyclosporine. Therefore, diclofenac should be administered at lower doses than would be used in patients not on cyclosporine therapy.
Quinolone antibacterials: There have been isolated reports of seizures, probably due to the concomitant use of quinolones and NSAIDs.
Colestipol and cholestyramine: these agents may induce a delay or decrease in the absorption of diclofenac. Therefore, it is recommended that diclofenac be administered at least one hour before or 4-6 hours after colestipol / cholestyramine administration.
Potent CYP2C9 inhibitors: Caution is advised when prescribing diclofenac together with potent inhibitors of CYP2C9 (such as sulfinpyrazone and voriconazole); this could lead to a significant increase in peak plasma concentrations and exposure to diclofenac, due to inhibition of its metabolism.
Phenytoin: When using phenytoin together with diclofenac, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in phenytoin exposure.
04.6 Pregnancy and breastfeeding
Pregnancy
Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development.
Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk has been considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased loss of pre- and post-implantation and embryo-fetal mortality.
In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period.
During the first and second trimester of pregnancy, diclofenac should not be administered except in strictly necessary cases.
If diclofenac is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose and duration of treatment should be kept as low as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose
the fetus to:
- cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension);
- renal dysfunction, which can progress to renal failure with oligo-hydroamnios;
the mother and the newborn, at the end of pregnancy, to:
- possible prolongation of bleeding time, and antiplatelet effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labor.
Consequently, diclofenac is contraindicated during the third trimester of pregnancy.
Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. It is therefore recommended not to administer Voltfast during breastfeeding to avoid undesirable effects in the infant.
Fertility
C.As with other NSAIDs, the use of Voltfast may impair female fertility and is not recommended in women wishing to conceive. Discontinuation of diclofenac in women who have difficulty conceiving or who are undergoing infertility testing should be considered.
04.7 Effects on ability to drive and use machines
Patients who have experienced visual disturbances, dizziness, vertigo, somnolence or other central nervous system disorders with the use of diclofenac should refrain from driving or> using machines.
04.8 Undesirable effects
Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: common (≥ 1/100,
The following side effects include those reported with short or long term use.
Table 1
Clinical studies and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg / day) and for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (eg. myocardium or stroke) (see Section 4.4).
04.9 Overdose
Symptoms
There is no typical clinical picture resulting from diclofenac overdose.
Overdose can cause symptoms such as vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus or convulsions. In the case of significant poisoning, acute renal failure and liver damage are possible.
Therapeutic measures
Treatment of acute NSAID poisoning, including diclofenac, essentially consists of supportive measures and symptomatic treatment.
In case of complications such as hypotension, renal insufficiency, convulsions, gastrointestinal disorders and respiratory depression, supportive measures and symptomatic treatment should be adopted.
Specific therapies, such as forced diuresis, dialysis or haemoperfusion, are unlikely to help eliminate NSAIDs, including diclofenac, due to their high plasma protein binding and extensive metabolism.
After ingestion of a potentially toxic overdose, the use of activated charcoal may be considered, while gastric emptying (eg vomiting, gastric lavage) may be considered after ingestion of a potentially life-threatening overdose.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: non-steroidal anti-inflammatory and antirheumatic, derivatives of acetic acid and related substances.
ATC code: M01A B05.
Mechanism of action
Voltfast contains, as the active ingredient, the potassium salt of diclofenac, a non-steroidal molecule with marked analgesic, anti-inflammatory and antipyretic characteristics. Voltfast sachets of granules for oral solution perform their action quickly, which makes them particularly suitable for the treatment of acute painful and inflammatory states.
The inhibition of prostaglandin biosynthesis, experimentally demonstrated, plays a fundamental role for its mechanism of action as prostaglandins are among the main causes of inflammation, pain and fever.
Diclofenac potassium, in vitro, at concentrations equivalent to those reached in man, does not inhibit the biosynthesis of proteoglycans in cartilage.
Pharmacodynamic effects
Voltfast demonstrated a pronounced analgesic effect in moderate and severe painful states. In the presence of inflammation, for example due to trauma or following surgery, it quickly resolves both pain at rest and movement, inflammatory swelling and wound edema decreases. Clinical studies have shown that the active ingredient of Voltfast resolves the pain and the extent of bleeding in primary dysmenorrhea.
05.2 Pharmacokinetic properties
Absorption
The diclofenac solution obtained from the granules sachets is rapidly and predominantly absorbed in the stomach. With the solution, the peak plasma concentration occurs 10-15 minutes after ingestion.
The difference between the> coated tablet formulation and that in granules for oral solution is not in the amount of active ingredient absorbed, which is the same, but in the absorption rate of diclofenac, which is faster in the granules formulation for oral solution.
Since approximately half of the active substance is metabolised in the liver by first pass effect, the area under the curve (AUC) after oral or rectal administration is approximately half that observed after an equivalent parenteral dose. .
The pharmacokinetic profile remains unchanged even after repeated administration. No accumulation phenomena occur if the recommended intervals between one dose and the next are respected.
Distribution
99.7% of diclofenac is bound to plasma proteins, mainly albumin (99.4%). The calculated apparent volume of distribution is 0.12-0.17 l / kg.
Diclofenac penetrates the synovial fluid, where maximum concentrations are measured 2-4 hours after reaching the plasma peak. The apparent half-life for elimination from the synovial fluid is 3-6 hours. 2 hours after reaching peak plasma values, the concentrations of the active substance are already higher in the synovial fluid than in the plasma and remain so for up to 12 hours.
Biotransformation
The biotransformation of diclofenac occurs partially by glucuronidation of the molecule as such but mainly by hydroxylation and single and multiple methoxylation giving rise to phenolic metabolites (diclofenac 3 "-hydroxy-, 4" -hydroxy-, 5 & nd ash; hydroxy-, 4 ", 5 - dihydroxy and 3 "-hydroxy-4" -methoxy-diclof enac), most of which are converted to glucuronic conjugates.Two of these phenolic metabolites are biologically active, but to a much lesser extent than diclofenac.
Elimination
Total systemic clearance of diclofenac from plasma is 263 ± 56 ml / min (mean value ± standard deviation); the terminal plasma half-life is 1-2 hours.
Four of the metabolites, including the two pharmacologically active, have a "short plasma half-life of 1-3 hours. One metabolite, 3" - hydroxy-4 "-methoxy-diclofenac, has a much longer" plasma half-life; however, this metabolite is virtually inactive.
About 60% of the administered dose is excreted in the urine in the form of glucuronic conjugate of the intact molecule and as metabolites, most of which are also converted to glucuronic conjugates; less than 1% is excreted as unchanged substance. The remainder of the administered dose is excreted as metabolites with the bile in the faeces.
Characteristics in patients
No relevant differences in drug absorption, metabolism or excretion related to age were observed.
Using the usual dosing regimen, there was no accumulation of unchanged active substance after administration of a single dose in patients with renal insufficiency. For creatinine clearance values, the theoretical plasma levels of the hydroxylated metabolites at steady state are approximately 4 times higher than in normal subjects. However, the metabolites are eventually excreted via the bile.
In patients with chronic hepatitis or non-decompensated cirrhosis, the kinetics and metabolism of diclofenac are the same as in subjects without liver disease.
05.3 Preclinical safety data
Diclofenac
Preclinical data from acute and repeated dose toxicity studies as well as those from genotoxicity, mutagenicity and carcinogenicity studies with diclofenac showed no specific risk for humans at usual therapeutic doses.
Inhibitors of prostaglandin synthesis
There is no further information on clinical data other than that already reported in> other parts of this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Aspartame; potassium bicarbonate; pulvaroma anise; pulvaroma mint, mannitol; sodium saccharin, glycerol dibeenate.
06.2 Incompatibility
Not relevant
06.3 Period of validity
2 years.
06.4 Special precautions for storage
Do not store above 25 ° C.
Keep the sachets in the outer carton to protect the medicine from moisture. Voltfast 50 mg granules for oral solution must be kept out of the reach and sight of children.
06.5 Nature of the immediate packaging and contents of the package
Paper / alu / LD-PE bag. Box of 30 sachets.
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
NOVARTIS FARMA S.p.A.
Largo Umberto Boccioni, 1 - 21040 Origgio (VA)
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 028945032
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
First authorization: 10.02.99
Renewal: 16.05.2011
10.0 DATE OF REVISION OF THE TEXT
AlFA Determination of July 2011
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