Active ingredients: Diclofenac, Misoprostol
Artrotec 50 mg + 200 mcg tablets
Artrotec package inserts are available for pack sizes:- Artrotec 50 mg + 200 mcg tablets
- Atrotec 75 modified-release tablets
Why is Artrotec used? What is it for?
Artrotec contains the active substances diclofenac and misoprostol. Diclofenac belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) and works by reducing inflammation and pain. "intestine from possible problems caused by diclofenac.
Artrotec is used in the treatment of:
- rheumatoid arthritis and osteoarthritis (chronic inflammatory rheumatic diseases of the joints);
- ankylosing spondylitis (rheumatism of the spine);
- inflammations of non-rheumatic origin or resulting from trauma.
Artrotec is indicated in patients with stomach or intestinal problems (eg gastritis with erosion of the inner wall of the stomach, previous episodes of injury (ulcer) of the stomach or intestine, bleeding from the esophagus, stomach and / or or the first part of the intestine (small intestine), previous stomach problems due to the use of this type of medicines (NSAIDs)), in which it is considered essential to use non-steroidal anti-inflammatory drugs (NSAIDs), such as diclonefac.
Contraindications When Artrotec should not be used
Do not take Artrotec
- if you are allergic to diclofenac or other non-steroidal anti-inflammatory drugs (e.g. acetylsalicylic acid), misoprostol or other prostaglandins, or any of the other ingredients of this medicine;
- if you have ever had episodes of bleeding or perforation in the stomach or intestines caused by previous NSAID treatment, or if you have suffered in the past from recurrent episodes of bleeding or injury to the stomach or bowel wall (peptic ulcer) ( i.e. if you have suffered from two or more distinct episodes of ulceration or bleeding as determined by a doctor);
- if you have heart disease, that is, if your heart is unable to pump an adequate amount of blood to your body (overt congestive heart failure), or if you have blocked blood vessels to the heart or have had a heart attack (ischemic heart disease) and / or have problems with blood circulation in the brain or have had a stroke (cerebral vascular disease);
- if you suffer from blood circulation problems in the body (peripheral arterial disease);
- if you are or think you are pregnant;
- if you are breast-feeding.
Precautions for use What you need to know before taking Artrotec
Talk to your doctor or pharmacist before taking Artrotec if any of the following apply to you:
- suffer from chronic inflammation of the intestine (ulcerative colitis or Crohn's disease);
- have heart problems or think you are at risk for these conditions (e.g. have high blood pressure, elevated cholesterol and / or triglycerides, diabetes, blood clots in the blood vessels (thrombi) which can lead to heart attack or stroke, chest pain (angina) or smoking). If you have high blood pressure, your doctor will closely monitor your blood pressure throughout the duration of the treatment;
- are easily prone to bleeding or bruising;
- have liver or kidney problems. If your liver or kidney problems get worse, stop taking this medicine;
Artrotec can cause:
- bleeding, sores (ulcers) or perforations in the stomach and / or intestines, even without warning symptoms or previous serious stomach or bowel problems, which can be life-threatening. In this case, contact your doctor and stop the treatment. If you have suffered from these problems in the past or suffer from cardiovascular problems, if you are taking aspirin, corticosteroids, medicines that counteract blood clotting (anticoagulants), medicines for anxiety and depression (called selective inhibitors of the reuptake of serotonin) (see "Other medicines and Artrotec), if you are over 65 or if you drink alcohol, you have an increased risk of experiencing these side effects. If you are over 65 (elderly) or have had gastrointestinal ulcers in the past (see "Do not take Artrotec"), your doctor will tell you to start treatment with the lowest available dose;
- small increased risk of heart attack (myocardial infarction) or stroke. The risk increases with high doses and prolonged treatments. Never exceed the recommended dose or duration of treatment;
- increased blood pressure and therefore your doctor may ask you to check your blood pressure regularly;
- fluid retention in the body and swelling, especially in the legs and feet;
- severe, sometimes fatal skin reactions characterized by blisters, lesions and peeling of the skin (such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis). Stop taking this medicine immediately if you get a rash, lesions or any other skin problems.
If you have heart, liver, kidney problems or if you are over 65, your doctor will check your kidney function periodically and prescribe the lowest possible dose (see section 3 "How to take Artrotec").
If you are on long-term treatment, your doctor will have periodic checks (for example of kidney function, liver function and blood tests).
Side effects caused by Artrotec can be minimized by using the lowest effective dose for the shortest period of time necessary.
Children
The safety and efficacy of this medicine have not been established in children.
Senior citizens
If you are over 65 you will be more likely to experience side effects during treatment with Artrotec, in particular bleeding and perforation of the stomach and / or intestines, which can be fatal (see section 3 "How to take Artrotec"). Your doctor will prescribe the lowest possible dose and will check you regularly during treatment.
Interactions Which drugs or foods may change the effect of Artrotec
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicinal products may affect the efficacy and / or toxicity of Artrotec or Artrotec may affect the efficacy and / or toxicity of the following medicinal products:
- corticosteroids, medicines used for inflammation;
- acetylsalicylic acid (aspirin);
- other non-steroidal anti-inflammatory drugs (NSAIDs) including selective COX-2 inhibitors;
- oral anticoagulants (e.g. warfarin, apixaban, dabigatran and rivaroxaban), medicines that reduce blood clotting;
- antiplatelet agents, medicines used to reduce / inhibit platelet aggregation;
- selective serotonin reuptake inhibitors (SSRIs), medicines used to treat anxiety and depression .;
- diuretics, medicines used to increase urine production;
- ACE inhibitors, angiotensin II antagonists and beta-blockers, medicines used to lower blood pressure. Your doctor will carefully consider whether to prescribe these medicines together with Artrotec, especially if you are an elderly patient or if you have kidney problems;
- ciclosporin or tacrolimus, medicines used to reduce the activity of the immune system, for example after organ transplantation. If you need to take these medicines at the same time as Artrotec, your doctor will closely monitor your kidney function. taking Artrotec and cyclosporine at the same time, your doctor may decide to prescribe the lower dose of Artrotec;
- digoxin, a medicine used for irregular heartbeat and / or heart failure;
- oral hypoglycaemics, medicines used to lower blood sugar levels;
- lithium, a medicine used to treat some types of depression;
- methotrexate, a medicine used to treat rheumatoid arthritis, psoriasis and leukemia;
- voriconazole, sulfinpyrazone, or other medicines that reduce the metabolism of diclofenac (the active substance in Artrotec) in the body, as they can lead to an increase in the effects of the medicine. Your doctor will prescribe the lowest recommended dose of Artrotec.
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Artrotec if you are or think you are pregnant (see section 2 "Do not take Artrotec"), as it may endanger pregnancy (increased risk of miscarriage), development of the fetus (increased risk of birth defects ) and your health (delayed or prolonged labor and increased risk of prolonged bleeding at the time of delivery). If you are a woman of childbearing potential, you must use effective contraceptive methods to avoid becoming pregnant while being treated with this medicine.
Do not take Artrotec if you are breast-feeding as the active substances contained in Artrotec pass into breast milk. Artrotec can cause reversible infertility.
Do not take this medicine if you are planning to become pregnant, have fertility problems or are undergoing fertility tests.
Driving and using machines
It is not known whether Artrotec affects the ability to drive or use machines.
Artrotec contains lactose
Artrotec contains lactose, a type of sugar.If you have been told by your doctor that you have "intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Artrotec: Posology
Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Adults: the recommended dose is 1 tablet 2-3 times a day. Artrotec tablets should be swallowed whole with a glass of water (not chewed) with a meal. If you are over 65 (elderly) or have kidney or liver problems: you do not need to take a dose. other than that recommended for an adult. However, your doctor may decide to start therapy with the lowest possible dose for you. If you have severe kidney or liver problems, your doctor will monitor you closely (see section Undesirable effects).
Use in children
The safety and efficacy of ARTROTEC in children have not been established.
Side effects can be minimized if you take the lowest possible dose for the shortest possible time in which you can control your symptoms (see "Precautions for use").
If you forget to take Artrotec
Do not take a double dose to make up for a forgotten dose.
If you stop using Artrotec
Do not stop taking Artrotec unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Artrotec
If you accidentally swallow / take too much Artrotec, notify your doctor immediately or go to the nearest hospital.
Symptoms may be sleepiness, tremor, convulsions, difficulty breathing, abdominal pain, diarrhea, fever, palpitations, low blood pressure, slow heart beat.
Side Effects What are the side effects of Artrotec
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Artrotec and tell your doctor immediately if you experience:
- severe stomach pain or any sign of bleeding, injury (ulcer) or perforation in the stomach or intestines, such as black stools, blood in stools or vomit. Gastrointestinal perforation and bleeding can sometimes be fatal, especially in the elderly ( see "Warnings and Precautions");
- severe skin reaction such as rash, blistering or peeling of the skin, mucosal lesions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis, mucocutaneous reactions);
- worsening of ulcerative colitis or Crohn's disease (inflammation of the intestine);
- severe allergic reaction such as skin rash, swelling of the face, wheezing or difficulty in breathing (anaphylactic shock and angioedema);
- heart attack;
- kidney problems (renal failure or impairment, renal papillary necrosis, nephrotic syndrome, interstitial tubular nephritis, membranous glomerulonephritis, minimal change glomerulopathy);
- stroke;
- jaundice (yellow / yellow discoloration of the skin and the white part of the eye).
Contact your doctor if you experience the following side effects:
Very common (may affect more than 1 in 10 people):
- pain in the abdomen, diarrhea, nausea and digestive problems.
You can reduce the likelihood of diarrhea by taking Artrotec with meals and by not taking antacids (substances used to reduce stomach acid) that contain magnesium at the same time.
Common (may affect up to 1 in 10 people):
- difficulty falling asleep
- headache, dizziness
- inflammation of the duodenum (a portion of the intestine), gastritis, inflammation of the esophagus
- inflammation of the stomach and intestines
- vomiting, constipation, flatulence, belching
- rash, itching
- changes in blood tests related to liver function
- reduction in hematocrit (blood test that determines the percentage of blood volume made up of red blood cells)
Uncommon (may affect up to 1 in 100 people):
- inflammation of the vagina
- reduction in the number of platelets in the blood (thrombocytopenia) blurred vision
- heart failure
- high blood pressure
- difficulty in breathing (dyspnoea)
- mouth ulcers (stomatitis)
- hives, purpura (brownish-red spots on the skin)
- very heavy menstruation (menorrhagia), or heavy bleeding between one menstruation and the next (metrorrhagia), vaginal bleeding (which can also occur after menopause), menstrual disorders,
- fever
- swelling (edema)
- chills
- increased aspartate aminotransferase, a value in blood tests related to liver function
Rare (may affect up to 1 in 1,000 people):
- nightmare
- inflammation of the pancreas (pancreatitis)
- inflammation of the liver (hepatitis)
- rash characterized by blistering (bullous rash)
- breast pain
- increased pain accompanying menstruation
- birth defects
Frequency not known (frequency cannot be estimated from the available data):
- anemia
- reduction in the number of white blood cells
- inhibition of platelet aggregation with consequent increase in the possibility of bleeding and its duration
- accumulation of fluid in the body, which can cause swelling of the ankles and legs
- mood alteration
- inflammation of the membranes that line the brain (aseptic meningitis)
- inflammation of blood vessels
- liver failure
- fetal death, a life-threatening reaction to the mother due to the passage of amniotic fluid (the fluid surrounding the fetus) or other fetal material into the maternal bloodstream (anaphylactoid syndrome of pregnancy), miscarriage, premature birth, abnormal contractions of the " uterus, retention of the placenta or membranes
- bleeding in the uterus, uterine cramps
- infertility or reduced fertility in women
- rupture / perforation of the uterus
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. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not store above 25 ° C.
Store in the original package to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other information
What Artrotec contains
The active ingredients are diclofenac and misoprostol. Each tablet contains 50 mg of diclofenac and 200 mcg of misoprostol.
The other ingredients are: lactose, microcrystalline cellulose, maize starch, polyvinylpyrrolidone K-30, magnesium stearate, methacrylic acid copolymer C, sodium hydroxide, talc, triethyl citrate, methylhydroxypropyl cellulose, insoluble polyvinylpyrrolidone, colloidal anhydrous silica and castor oil.
What Artrotec looks like and contents of the pack
Artrotec tablets are packaged in Al / PVC blisters contained in boxes of 10, 30 and 60 tablets. Not all pack sizes may be marketed.
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
ARTROTEC 50 MG + 200 MCG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet consists of a gastro-resistant inner core, containing 50 mg of diclofenac, coated with an outer layer containing 200 mcg of misoprostol.
Excipients: lactose.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Round, white, biconvex tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Treatment of inflammatory and degenerative rheumatic diseases: rheumatoid arthritis, ankylosing spondylitis, arthrosis, painful states of inflammation of extra-rheumatic or post-traumatic origin.
ARTROTEC is indicated in patients with known gastrointestinal pathology from peptic disease or from non-steroidal anti-inflammatory drugs (NSAIDs) (erosive gastritis, previous peptic ulcer, previous upper gastrointestinal bleeding, previous NSAID gastropathy), in which treatment with NSAIDs.
04.2 Posology and method of administration
Adults
One tablet 2-3 times a day during meals, to be swallowed whole with a little liquid.
Elderly, impaired kidney or liver function
No dosage modifications are required in the elderly or in patients with impaired hepatic function or with mild or moderate renal impairment, as the pharmacokinetic parameters are not clinically relevant.
However, it is recommended to initiate therapy with the lowest dose and to closely monitor patients with severe renal or hepatic impairment (see section 4.8).
Children
The safety and efficacy of ARTROTEC in children have not been established.
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).
04.3 Contraindications
Known hypersensitivity to the active substances, to acetylsalicylic acid or other NSAIDs, to other prostaglandins or to any of the excipients.
History of gastrointestinal bleeding or perforation related to previous active treatments or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or bleeding).
Severe heart failure.
Known or suspected pregnancy, as the misoprostol component, by increasing the amplitude and frequency of uterine contractions, can endanger pregnancy. ARTROTEC can also induce premature closure of the arterial duct. Breastfeeding.
04.4 Special warnings and appropriate precautions for use
Warnings
The use of ARTROTEC in women of childbearing age is allowed only if suitable contraceptive measures are taken at the same time and if the patient has been warned of the risks that the product entails, if administered during pregnancy (see Contraindications).
Precautions
The use of ARTROTEC should be avoided in conjunction with NSAIDs, including selective COX-2 inhibitors.
Undesirable effects can be minimized with the use of 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).
Elderly: Elderly patients have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2).
Gastrointestinal effects
Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. Gastro-duodenal ulcers can also occur during treatment with ARTROTEC, although with a significantly lower frequency than with diclofenac; the clinical evolution of patients should therefore be monitored carefully.
In the elderly and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest available dose.
Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual gastrointestinal symptoms (especially gastrointestinal bleeding) particularly in the initial stages of treatment.
Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).
When gastrointestinal bleeding or ulceration occurs in patients taking ARTROTEC, the treatment should be discontinued.
NSAIDs should be administered with caution to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).
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.
Like other NSAIDs, the combination of diclofenac / misoprostol can lead to the onset of hypertension or worsening of pre-existing hypertension, both of which may contribute to a higher incidence of cardiovascular events. NSAIDs, including the combination diclofenac / misoprostol, should be used with caution in hypertensive patients. Blood pressure should be carefully monitored during the initiation of diclofenac / misoprostol therapy and throughout the course of treatment.
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).
Like other NSAIDs, ARTROTEC can reduce platelet aggregation and prolong bleeding time. This effect should be considered when determining bleeding times.
Clinical studies and epidemiological data suggest that the use of diclofenac, especially at high doses (150 mg / day) and for long-term treatments, may be associated with a modest increased risk of arterial thrombotic events (eg. myocardium or stroke).
Caution is warranted in patients with impaired renal, cardiac or hepatic function, as the use of NSAIDs may lead to worsening of renal function. The lowest possible dose should be used and renal function monitored.
As a precautionary measure, all patients on long-term treatment with NSAIDs should be monitored (e.g. renal, hepatic and haematological function).
In a large study in which patients took diclofenac for an average of 18 months, elevations in transaminases (ALT / AST) were observed in 3.1% of patients. Elevations in transaminases (ALT / AST) generally occur over a period of 1 to 6 months. In clinical trials, patients taking diclofenac experienced hepatitis, and cases of other hepatic reactions including jaundice and hepatic failure have been reported in post-marketing experience. Liver function should be monitored periodically during diclofenac / misoprostol therapy. . Careful monitoring is required if diclofenac / misoprostol is used in patients with impaired liver function. Treatment with diclofenac should be discontinued if liver function test abnormalities persist or worsen, if any signs or symptoms that fall into the picture occur. liver disease or if systemic manifestations occur.
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 higher risk: the onset of the reaction occurs in most cases within the first month of treatment. ARTROTEC should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.
The medicine contains lactose, therefore patients with rare hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4)
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4).
Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).
Diuretics, ACE inhibitors and angiotensin II antagonists
NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
In some patients with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function), 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 ARTROTEC 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 monitoring of renal function should be considered after initiation of concomitant therapy.
NSAIDs may reduce the natriuretic effect of diuretics by inhibiting the intrarenal synthesis of prostaglandins. Concomitant administration of potassium-sparing diuretics may lead to an increase in serum potassium and therefore potassium levels should be monitored.
Steady-state plasma concentrations of lithium and digoxin may be increased.
Pharmacodynamic studies with diclofenac have not shown an enhancement of the activity of oral hypoglycemic agents and anticoagulant drugs; despite this, since interactions with other NSAIDs have been reported, caution and adequate monitoring should be adopted in case of concomitant treatment.
Particular caution is necessary during co-administration of methotrexate and NSAIDs, as these can induce an increase in plasma concentrations of methotrexate, increasing its toxicity.
04.6 Pregnancy and breastfeeding
ARTROTEC is contraindicated in cases of confirmed or suspected pregnancy and must not be administered during lactation.
Fertility
The use of ARTROTEC, like any drug that inhibits prostaglandin synthesis and cyclooxygenase, is not recommended in women intending to become pregnant.
Administration of ARTROTEC should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
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 of 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 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.
Feeding time
In the mother, misoprostol is rapidly transformed into its acid metabolite, which is biologically active and excreted in breast milk. Diclofenac is excreted in breast milk in minimal quantities. Generally, the potential effects on the infant from any exposure to misoprostol and its metabolites through breastfeeding are unknown. However, diarrhea is a recognized undesirable effect of misoprostol and can occur in breastfed infants.
ARTROTEC 50 should therefore not be administered to nursing mothers.
04.7 Effects on ability to drive and use machines
You don't notice.
04.8 Undesirable effects
Gastrointestinal disorders: the most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or haemorrhage, sometimes fatal, may occur, particularly in the elderly (see section 4.4).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported following administration of ARTROTEC (see section 4.4). Diarrhea is usually mild or moderate and transient; it can be minimized by administering ARTROTEC with food and avoiding the concomitant use of magnesium-based antacids. Belching has also been reported.
Gastritis has been observed less frequently.
Cardiac pathologies: Edema, hypertension and heart failure 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 for long-term treatment, may be associated with a modest increased risk of arterial thrombotic events (eg. myocardium or stroke) (see section 4.4).
Hepatobiliary disorders: liver failure, hepatitis, jaundice.
Diagnostic tests: increased liver function indices: alanine aminotranferrase (ALT), aspartate aminotransferrase (AST), alkaline phosphatase and bilirubin.
Renal and urinary disorders: NSAIDs, as a pharmacological class, have been associated with renal disease, such as papillary necrosis, interstitial nephritis, nephrotic syndrome and renal failure.
Diseases of the reproductive system and breast: menorrhagia, intermenstrual bleeding and vaginal bleeding have been reported in premenopausal women; Vaginal bleeding has been reported in postmenopausal women.
Other side effects: headache, dizziness, rash. Rarely, allergic reactions including anaphylaxis may occur with NSAIDs; bullous reactions including Stevens Johnson syndrome and toxic epidermal necrolysis (very rarely).
04.9 Overdose
The toxic dose of ARTROTEC has not been determined and there is no experience of overdose. An increase in pharmacological effects may occur in the event of an overdose.
Treatment of acute NSAID poisoning is essentially based on systemic and symptomatic supportive measures. The absorption of the drug should be reduced as soon as possible by induction of vomiting, or gastric lavage or treatment with activated charcoal.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: anti-inflammatory and antirheumatic drugs.
ATC code: M01AB55.
ARTROTEC is a non-steroidal anti-inflammatory drug effective in the treatment of signs and symptoms of arthritic diseases.
This activity is due to the active ingredient diclofenac, which has an anti-inflammatory and analgesic action.
ARTROTEC also contains a protective component for the gastroduodenal mucosa, consisting of misoprostol, a synthetic analogue of prostaglandin E1, which increases the production of various factors that maintain the integrity of the gastro-duodenal mucosa.
05.2 Pharmacokinetic properties
The pharmacokinetic profiles of diclofenac and misoprostol administered in the form of ARTROTEC are similar to the profiles obtained when the drugs are taken separately. No pharmacokinetic interactions were observed between the two drugs following multiple doses.
05.3 Preclinical safety data
In animal co-administration studies misoprostol did not enhance the toxic effects of diclofenac. The individual components did not show carcinogenic potential. The combination was also shown not to have mutagenic effects.
Misoprostol administered in animals at doses many times higher than the recommended therapeutic dose caused hyperplasia of the gastric mucosa. This effect, characteristic of type E prostaglandins, is reversible upon discontinuation of treatment.
There is no further information on preclinical data other than that already reported elsewhere in this Summary of Product Characteristics (see section 4.6).
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose, microcrystalline cellulose, corn starch, polyvinylpyrrolidone K-30, magnesium stearate, methacrylic acid copolymer C, sodium hydroxide, talc, triethyl citrate, methylhydroxypropyl cellulose, insoluble polyvinylpyrrolidone, colloidal anhydrous silica, hydrogenated castor oil.
06.2 Incompatibility
Not known.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
Store in a dry place at a temperature not exceeding 25 ° C.
06.5 Nature of the immediate packaging and contents of the package
Aluminum / PVC blister.
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
PFIZER ITALIA S.r.l.
Via Isonzo, 71 - 04100 Latina
08.0 MARKETING AUTHORIZATION NUMBER
AIC n. 029757022 - Box of 10 tablets 50 mg + 200 mg
AIC n. 029757010 - Box of 30 tablets 50 mg + 200 mg
AIC n. 029757034 - Box of 60 tablets 50 mg + 200 mg
Not all pack sizes may be marketed.
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
May 1996 / June 2006
10.0 DATE OF REVISION OF THE TEXT
June 2012
