Active ingredients: Diclofenac
FASTUM ANTI-PAIN 1% GEL
Why is Fastum Painkiller used? What is it for?
Fastum Pain Relief gel belongs to the category of non-steroidal anti-inflammatory drugs for topical use.
Fastum Pain Relief gel is used for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
Contraindications When Fastum Painkiller should not be used
Hypersensitivity to diclofenac or to any of the excipients.
Hypersensitivity to other non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid.
To avoid any phenomena of hypersensitivity or photosensitization, avoid exposure to direct sunlight including the solarium during the treatment and in the following two weeks.
Due to the possibility of cross-sensitization, the product should not be used by patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
Fastum Painkiller gel should not be used during the third trimester of pregnancy and / or breastfeeding.
Its use should also be avoided if you suspect a pregnancy or wish to plan a maternity leave.
Children: Use in children under the age of 14 is contraindicated.
Precautions for use What you need to know before taking Fastum Painkiller
The use, especially if prolonged, of products for topical use, can give rise to sensitization phenomena or local irritation. In this case it is necessary to interrupt the treatment and consult the doctor to establish a suitable therapy.
The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period.
To avoid any phenomena of hypersensitivity or photosensitization, avoid exposure to direct sunlight including the solarium during the treatment and in the following two weeks.
Discontinue treatment if skin rash, mucosal lesions or any other signs of hypersensitivity develop after application of the product.
Fastum Pain Relief can be used with non-occlusive bandages, but must not be used with an occlusive bandage that does not allow air to pass.
Interactions Which drugs or foods can modify the effect of Fastum Painkiller
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Since the systemic absorption of Fastum Painkiller gel following a topical application is very low, interactions with other drugs given systemically are very unlikely.
However, in high-dose and protracted treatments, the possibility of competition between Fastum Pain Relief gel absorbed and other drugs with high plasma protein binding should be borne in mind.
Warnings It is important to know that:
The concomitant use of systemic anti-inflammatory drugs in elderly and / or gastric patients is not recommended. No.
do not use for prolonged treatments. After a short period of treatment without noticeable results, consult your doctor.
Fastum Painkiller gel should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions.
It must not be allowed to come into contact with the eyes or mucous membranes and must not be ingested.
When it can be used only after consulting your doctor
They should consult their doctor before using Fastum Pain Relief gel: Patients who have or have had photosensitization reactions after exposure to sunlight.
Patients with chronic obstructive diseases of the bronchi, inflammation of the nasal mucosa (nasal polyp) who react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs.
It is advisable to consult the doctor even in cases where these disorders have occurred in the past.
Pregnancy and breastfeeding (see What to do during pregnancy and breastfeeding)
What to do during pregnancy and breastfeeding Pregnancy Ask your doctor or pharmacist for advice before taking any medicine. Like other NSAIDs, Fastum Painkiller gel should not be administered in the third trimester of pregnancy and during breastfeeding.
Consult your doctor if you suspect pregnancy or wish to plan a maternity leave.
The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended:
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 was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular malformations, 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 should be kept as low as possible and the duration of treatment as short 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 oligohydroamnios;
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, Fastum Painkiller is contraindicated during the third trimester of pregnancy. The use of Fastum Painkiller gel, as well as any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant.
Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Fastum Painkiller no effects on the infant are expected. Due to the lack of controlled studies in breastfeeding women, the product should only be used during lactation under the advice of a healthcare professional. In this circumstance, Fastum Pain Relief should not be applied to the breasts of nursing mothers, nor elsewhere on areas of skin or for an extended period of time (see Precautions for use).
Effects on ability to drive or use machines
Fastum Painkiller gel does not affect the ability to drive or use machines. Important information about some of the ingredients
The medicine contains methyl hydroxybenzoate which can cause allergic reactions (including delayed).
Doping warning
Not relevant
Dosage and method of use How to use Fastum Painkiller: Dosage
How many
Depending on the extent of the painful areas or surfaces, 2 - 4 g of Fastum Painkiller gel will be applied. Warning: do not exceed the indicated doses.
When and for how long
Three or four times a day. Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent changes in its characteristics.
Warning: use only for short periods of treatment.
Adults over 18 years:
Apply Fastum Painkiller gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of Fastum Painkiller gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated. with gel Warning: use only for short periods of treatment.
Teenagers aged 14 to 18
Apply Fastum Painkiller gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of Fastum Painkiller gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm2. After application, wash your hands, otherwise they will also be treated. with gel.If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.
Children under 14:
Insufficient data are available on efficacy and safety in children below 14 years (see also When it should not be used). Therefore, the use of Fastum Pain Relief gel is contraindicated in children below 14 years of age.
Senior citizens:
The usual adult dosage can be used.
Like
Apply the gel and rub lightly.
Overdose What to do if you have taken too much Fastum Painkiller
The low systemic absorption of topical diclofenac makes an overdose very unlikely.
However, undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 mg of diclofenac sodium).
In the event of accidental ingestion resulting in significant systemic effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs must be taken. They must be considered, especially within a short time of ingestion. gastric decontamination and the use of activated charcoal.
In case of accidental ingestion / intake of an excessive dose of Fastum Painkiller gel, notify your doctor immediately or go to the nearest hospital.
IF YOU HAVE ANY DOUBTS ABOUT USING FASTUM ANTI-PAIN GEL, PLEASE ASK YOUR DOCTOR OR PHARMACIST.
Side Effects What are the side effects of Fastum Pain Relief
Like all medicines, Fastum Pain Relief gel can cause side effects, although not everybody gets them. Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms.
Fastum Pain Relief gel is generally well tolerated.
Local applications of diclofenac-based preparations are well tolerated. Skin redness, itching, burning or rash have been reported.
The use of Fastum Painkiller gel, in combination with other medications containing diclofenac, can give rise to sensitization phenomena to light (photosensitivity), skin rash with blistering, eczema, erythema and skin reactions that may even be severe (Stevens syndrome -Johnson, Lyell's syndrome).
If Fastum Pain Relief gel is applied to relatively large areas of the skin and for a prolonged period, the possibility of systemic side effects cannot be completely excluded.
Adverse reactions (Table 1) 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.
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Request and fill in the undesirable effects report form available at the pharmacy (form B).
Expiry and Retention
Expiry: see the expiry date printed on the package
The expiry date refers to the product in intact packaging, correctly stored.
Do not store above 30 ° C
Warning: do not use the medicine after the expiry date shown on the package. After opening the tube, the validity is 6 months.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
It is important to always have the information on the medicine available, so keep both the box and the package leaflet.
Composition
100 g of gel contain: Active ingredient: diclofenac diethylammonium 1.16 g (equal to 1 g of diclofenac sodium). Excipients: carbomers, methyl parahydroxybenzoate (E218), 96% ethyl alcohol, trolamine, lavender essential oil, purified water.
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
FASTUM ANTI-PAIN 1% GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 g of gel contain:
Active ingredient: DICLOFENAC DIETILAMMONIUM 1.16 g
(equal to 1 g of Dec | ofenac sodium).
Excipients: methyl parahydroxybenzoate (E218)
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Gel
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Fastum Pain reliever gel is indicated for the local treatment of painful and inflammatory conditions of a rheumatic or traumatic nature of the joints, muscles, tendons and ligaments.
04.2 Posology and method of administration
Depending on the extent of the painful areas or surfaces, 2-4 g of Fastum Painkiller gel will be applied 3-4 times a day and rubbed lightly.
Adults over 18 years:
Apply Fastum Painkiller gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of Fastum Painkiller gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated. with gel.
Warning: use only for short periods of treatment.
Teenagers aged 14 to 18:
Apply Fastum Painkiller gel 3 or 4 times a day on the area to be treated, rubbing lightly. The amount to be applied depends on the size of the affected part. For example, 2-4 g of Fastum Painkiller gel (quantity of variable size between a cherry and a walnut) are sufficient to treat an area of 400-800 cm². After application, wash your hands, otherwise they will also be treated. with gel.
If this product is needed for more than 7 days to relieve pain or if symptoms worsen, consult a doctor.
Children under 14:
Insufficient data are available on efficacy and safety in children below 14 years (see also section 4.3 Contraindications).
Therefore, the use of Fastum Painkiller gel is contraindicated in children under 14 years of age.
Senior citizens:
The usual adult dosage can be used.
04.3 Contraindications
Hypersensitivity to diclofenac or to any of the excipients.
Hypersensitivity to other non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid.
Patients who have experienced asthma attacks, urticaria or acute rhinitis after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
Third trimester of pregnancy and lactation (see section 4.6).
Children:
use in children under the age of 14 is contraindicated.
04.4 Special warnings and appropriate precautions for use
Do not use for prolonged treatments.
The possibility of systemic adverse events with the application of topical diclofenac cannot be excluded if the preparation is used on large skin areas and for a prolonged period (see the summary of product characteristics of the systemic forms of diclofenac).
Topical diclofenac should only be applied to intact, non-diseased skin, and not to skin wounds or open lesions. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.
Discontinue treatment if skin rash develops after application of the product.
Concomitant use is not recommended in elderly and / or gastric patients
of systemic anti-inflammatory drugs.
Patients with asthma, chronic obstructive diseases of the bronchi, allergic rhinitis or inflammation of the nasal mucosa (nasal polyp) react with asthma attacks, local inflammation of the skin or mucosa (Quincke's edema) or urticaria to antirheumatic treatment with NSAIDs more often than other patients.
The use, especially if prolonged, of other products for topical use, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
To avoid any phenomena of hypersensitivity or photosensitization, avoid exposure to direct sunlight including the solarium during the treatment and in the following two weeks.
The administration of Fastum Pain Relief gel should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
Topical diclofenac can be used with non-occlusive dressings, but should not be used with an occlusive dressing that does not allow air to pass.
Cutaneous use.
04.5 Interactions with other medicinal products and other forms of interaction
Since the systemic absorption of diclofenac following topical application is very low, such interactions are very unlikely.
In high-dose and protracted treatments, the possibility of competition between absorbed diclofenac and other drugs with high plasma protein binding power should be borne in mind.
04.6 Pregnancy and lactation
Pregnancy
Like other NSAIDs, Fastum Painkiller gel should not be administered in the third trimester of pregnancy and during breastfeeding.
The systemic concentration of diclofenac, compared with oral formulations, is lower after topical administration. Referring to experience with NSAID treatment for systemic administration, the following is recommended:
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 was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality.
Furthermore, an increased incidence of various malformations, including cardiovascular malformations, 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 should be kept as low as possible and the duration of treatment as short 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.
The use of Fastum Painkiller gel, as well as any drug that inhibits the synthesis of prostaglandins and cyclooxygenase, is not recommended in women who intend to become pregnant.
Feeding time
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of Fastum Painkiller no effects on the infant are expected. Due to the lack of controlled studies in breastfeeding women, the product should only be used during lactation under the advice of a healthcare professional. In this circumstance, Fastum Pain Relief should not be applied to the breasts of nursing mothers, nor elsewhere on areas of the skin or for a prolonged period of time (see section 4.4).
04.7 Effects on ability to drive and use machines
The cutaneous application of topical diclofenac does not affect the ability to drive or use machines.
04.8 Undesirable effects
Fastum Pain Relief gel is generally well tolerated.
Itching, redness, burning of the skin or rashes may occur.
The use of Fastum Painkiller gel, in combination with other medications containing diclofenac, can give rise to sensitization phenomena to light (photosensitivity), skin rash with blistering, eczema, erythema and skin reactions that may even be severe (Stevens syndrome -Johnson, Lyell's syndrome).
If Fastum Pain Relief gel is applied to relatively large areas of the skin and for a prolonged period, the possibility of systemic side effects cannot be completely excluded.
Adverse reactions (Table 1) are listed by frequency, most frequent first, using the following convention: common (≥ 1/100,
Table 1
04.9 Overdose
Topical overdose: the low systemic absorption of topical diclofenac makes an overdose very unlikely; however, in this case, it is recommended to wash the affected skin area with water.
A specific antidote is not available.
Undesirable effects similar to those seen after an overdose of diclofenac tablets may be expected if topical diclofenac is inadvertently ingested (1 tube of 100 g contains the equivalent of 1000 mg of diclofenac sodium).
In the event of accidental ingestion resulting in significant systemic side effects, general therapeutic measures normally taken to treat poisoning with non-steroidal anti-inflammatory drugs should be taken. These should be considered, especially within a short time of ingestion. , gastric decontamination and the use of activated charcoal.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group : non-steroidal anti-inflammatory drugs for topical use.
ATC code: M02AA 15
The mechanism of action is expressed in the competitive inhibition of the biosynthesis of prostaglandins and in the inhibition of lysosomal enzymes.
Diclofenac diethylammonium salt has analgesic and anti-inflammatory properties.
100 mg inhibited carrageenan edema in rats by 25.6% at the 3rd hour and 33.6% at the 5th hour.
100 mg inhibited edema by 30.1% after 20 minutes in vascular permeability tests in rats.
5O mg administered before and after the irradiation of ultraviolet rays in the guinea pig prevented the induction of erythema.
100 mg produced an increase in the pain threshold of 56.9% in the Randall test in rats.
50 mg was found to be effective in the prevention and treatment of adjuvant arthritis in rats.
05.2 "Pharmacokinetic properties
In healthy volunteers, the amount of active substance absorbed through the skin after local application determined on the basis of urinary excretion of diclofenac and its hydroxylated metabolites is equivalent to approximately 6% of the administered dose.
This share can increase in the course of inflammatory affections.
After skin application, rapid absorption and rapid passage into liquids and synovial tissues is obtained. Skin thickness, subcutaneous fat and vascularity influence the kinetics of the drug.
05.3 Preclinical safety data
The cutaneous absorption of diclofenac sodium gel varies from species to species. In male rabbits it is 16%, in female rabbits 40%, in baboons 27%.
In the guinea pig, the percutaneous absorption of a single dose was found to be of constant proportion (equal to 8%);
systemic absorption was proportional to the dose (dosage range 0.19-0.72 mg of diclofenac diethylammonium salt per kg of weight).
After removal of the stratum corneum, percutaneous absorption was more rapid and can increase up to tenfold.
After repeated topical applications (400 mg / kg), the steady state blood concentration is reached after 3 days.The concentrations in the muscle tissues underlying the application area were 4 times higher than in the remaining body areas.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Carbomers, methyl parahydroxybenzoate (E218), 96% ethyl alcohol, trolamine, lavender essential oil, purified water.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
Validity of the product after opening: 6 months.
06.4 Special precautions for storage
Do not store above 30 ° C
06.5 Nature of the immediate packaging and contents of the package
Aluminum tube.
Packs containing 50 g and 100 g of gel.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Via Sette Santi, 3
50131 Florence
08.0 MARKETING AUTHORIZATION NUMBER
FASTUM ANTIDOLORIFICO 1% GEL - 50 g tube - A.I.C. n. 040657013
FASTUM ANTIDOLORIFICO 1% GEL - 100 g tube - A.I.C. n. 040657025
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 05/03/1993
Date of last renewal: 31/05/2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Resolution of June 2014
