NOTICE
ANSM - Updated on : 20/11/2023
Product name
RESITUNE 75 mg, gastro-resistant tablet
Acetylsalicylic acid
Sidebar
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as it is prescribed by your doctor, pharmacist or nurse.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist for advice and information.
- If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. See section 4.
- You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this leaflet contain?
1. What is RESITUNE 75 mg, gastro-resistant tablet and what is it used for?
2. What do I need to know before taking RESITUNE 75 mg, gastro-resistant tablet?
3. How do I take RESITUNE 75 mg gastro-resistant tablet?
4. What are the possible side effects?
5. How should RESITUNE 75 mg gastro-resistant tablet be stored?
6. Package contents and otherinformation.
1. WHAT IS RESITUNE 75 mg, gastro-resistant tablet AND WHAT IS IT USED FOR?
Pharmacotherapeutic class: antithrombotics: platelet antiaggregants excluding heparin - ATC code: B01AC06
RESITUNE contains acetylsalicylic acid, which at low doses belongs to the group of drugs known as antiplatelet agents. Platelets are small blood cells that cause blood clotting and are involved in thrombosis. When a blood clot forms in an artery, it blocks blood flow and oxygen supply. In the heart, this can lead to a heart attack or angina pectoris; in the brain, it can cause a stroke.
RESITUNE is used to reduce the risk of blood clots and thus prevent the occurrence of :
- heart attacks (in patients who have had a heart attack in the past),
- strokes (in patients who have had a stroke in the past),
- cardiovascular problems in patients with stable angina (a type of chest pain),
- cardiovascular problems in patients with a history of unstable angina (a type of chest pain), other than in a recent acute phase.
RESITUNE is also used to prevent the formation of blood clots in patients who have undergone certain types of heart surgery designed to widen or unblock blood vessels.
2. WHAT DO I HAVE TO KNOW BEFORE TAKING RESITUNE 75 mg, gastro-resistant tablet?
Never take RESITUNE 75 mg, gastro-resistant tablet:
- if you are allergic to acetylsalicylic acid or to any of the other components of this medicine listed in section 6,
- if you are allergic to other salicylates or non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs are often used to treat arthritis, rheumatism and pain,
- if you have had an asthma attack or swelling of the face, lips, throat or tongue (angioedema) after taking salicylates or NSAIDs,
- if you have or have had a stomach or duodenal ulcer, or any other type of bleeding such as a stroke,
- if you suffer from blood clotting problems,
- if you have severe liver or kidney disease,
- if you are currently in the third trimester of pregnancy, you should not use doses higher than 100 mg/day (see "Pregnancy, breast-feeding and fertility"),
- if you are taking a drug called methotrexate (e.g. for cancer or rheumatoid arthritis) at doses higher than 15 mg/week.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking RESITUNE :
- if you have kidney, liver or heart problems,
- if you have or have had stomach or intestinal problems,
- if you have high blood pressure,
- if you suffer from asthma, hay fever, nasal polyps or other chronic respiratory diseases; acetylsalicylic acid can provoke an asthma attack,
- if you suffer or have suffered from gout,
- if you have heavy periods.
You should seek medical advice immediately if your symptoms worsen or if you experience any serious or unexpected side effects, such as unusual bleeding, severe skin reactions or any other signs of severe allergy (see "Possible side effects").
Inform your doctor if you plan to undergo an operation (even a minor one, such as a tooth extraction) as acetylsalicylic acid is a blood thinner, there may be an increased risk of bleeding.
You must take care not to become dehydrated (you may feel thirsty, have a dry mouth), as the use of acetylsalicylic acid can lead to deterioration in kidney function.
This drug cannot be used as an analgesic or antipyretic.
If any of these situations apply to you, or if you're not sure, talk to your doctor or pharmacist.
Children and adolescents
Acetylsalicylic acid may cause Reye's syndrome when administered to children. Reye's syndrome is a very rare, life-threatening disease affecting the brain and liver. For this reason, RESITUNE should not be given to children under 16 years of age, except on the advice of a doctor.
Other medicinal products and RESITUNE 75 mg, gastro-resistant tablet
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines.
The effect of treatment may be influenced if acetylsalicylic acid is taken at the same time as other medicines used to :
- thin the blood/ prevent clots (such as warfarin, heparin, clopidogrel),
- prevent organ rejection after transplantation (e.g. ciclosporin, tacrolimus),
- treat arterial hypertension (such as diuretics and ACE inhibitors),
- regulate heartbeat (such as digoxin),
- treat manic-depressive illnesses (such as lithium),
- treat pain and inflammation (such as NSAIDs like ibuprofen, or steroids),
- treat gout (such as probenecid),
- treat epilepsy (such as valproate, phenytoin),
- to treat cancer or rheumatoid arthritis (such as methotrexate),
- treat diabetes (such as glibenclamide),
- treat depression (selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine),
- or drugs used as hormone replacement therapy when the adrenal glands or pituitary gland have been destroyed, or to treat inflammation including rheumatic diseases or inflammation of the intestine (such as corticosteroids),
- to treat changes in blood lipid levels (nicotinic acid),
- metamizole (a substance which reduces pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells sticking together and forming a blood clot), when taken at the same time. Consequently, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection.
RESITUNE 75 mg, gastro-resistant tablet with alcohol
Alcohol consumption may increase the risk of gastrointestinal bleeding and prolong bleeding time.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not take acetylsalicylic acid during pregnancy unless advised to do so by their doctor.
You should not take RESITUNE during the last 3 months of your pregnancy, unless your doctor advises otherwise. The daily dose should not exceed 100 mg(see "Never take RESITUNE"). Taking usual or higher doses of this medicine in late pregnancy can cause serious complications for both mother and baby.
Women who are breast-feeding should not take acetylsalicylic acid unless advised to do so by their doctor.
Driving and using machines
RESITUNE may cause dizziness. You should not drive or operate machinery until you know whether this drug affects your ability to do so.
RESITUNE 75 mg, gastro-resistant tablet contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially "sodium-free".
3. HOW DO I TAKE RESITUNE 75 mg gastro-resistant tablet?
Always take this medicine exactly as instructed in this leaflet, or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults
- Prevention of heart attacks:
The recommended dose is 75 mg to 150 mg once a day.
- Stroke prevention:
The recommended dose is 75 mg to 300 mg once a day.
- Prevention of cardiovascular problems in patients with stable or unstable coronary artery disease (a type of chest pain):
The recommended dose is 75 mg to 150 mg once daily.
- Prevention of blood clots after certain types of heart surgery:
The recommended dose is 75 mg to 150 mg once a day.
Elderly
As for adults. In general, acetylsalicylic acid should be used with caution in the elderly, who are more sensitive to adverse effects. Treatment should be reviewed regularly.
Use in children and adolescents
Acetylsalicylic acid should not be administered to children and adolescents under 16 years of age, unless prescribed by a physician (see "Children and adolescents").
Method of administration
Oral administration.
Tablets should be swallowed whole with sufficient liquid (1/2 glass of water). The tablets have a gastro-resistant coating which protects the stomach from irritation; they must not be crushed, broken or chewed. Do not take the tablets with antacids (drugs used to relieve heartburn or indigestion), as they destroy the gastro-resistant coating of the tablets and may cause stomach irritation.
As the gastro-resistant coating slows absorption, RESITUNE is not recommended for patients with acute myocardial infarction (treatment of heart attack). However, if necessary, tablets may be crushed or chewed to accelerate absorption of acetylsalicylic acid.
If you have taken more RESITUNE 75 mg gastro-resistant tablet than you should have
Consult your doctor or pharmacist immediately.
If you have accidentally taken too many tablets, contact your doctor immediately or go to the nearest emergency department. Show any remaining tablets or the empty box to your doctor.
Symptoms of overdose may include ringing in the ears, hearing problems, headache, dizziness, confusion, nausea, vomiting and abdominal pain. Severe overdose may cause rapid breathing (hyperventilation), fever, excessive sweating, restlessness, convulsions, hallucinations, hypoglycemia, coma and shock.
If you forget to take RESITUNE 75 mg, gastro-resistant tablet
If you miss a dose, wait until your next dose is due, then continue as usual.
Do not take a double dose to make up for the one you missed.
If you stop taking RESITUNE 75 mg, gastro-resistant tablet
If you stop taking RESITUNE, contact your doctor or pharmacist.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this drug may cause undesirable effects, but they do not occur systematically in everyone.
If you notice any of the following serious side effects, stop taking RESITUNE and contact a doctor immediately:
- sudden wheezing, swelling of the lips, face or body, rash, fainting, difficulty swallowing or shock (severe allergic reaction or hypersensitivity reaction). (May affect up to 1 in 1,000 people),
- redness, blistering or peeling of the skin, which may be associated with high fever and joint pain. This can lead to erythema multiforme, Stevens-Johnson syndrome or Lyell syndrome (affecting up to 1 in 1,000 people),
- unusual bleeding into your brain (intracranial haemorrhage) which can cause disorders such as severe headaches accompanied by drowsiness, confusion, loss of consciousness. (May affect up to 1 in 1,000 people),
- a syndrome usually manifested by fever, rash, facial swelling and/or enlarged lymph nodes (drug hypersensitivity syndrome with eosinophilia and systemic symptoms (DRESS syndrome)). (Frequency cannot be estimated on the basis of available data),
- unusual bleeding: blood found in sputum, vomit, urine and stools (black stools). (Frequency cannot be estimated on the basis of available data).
Other adverse reactions
Common adverse reactions (affecting up to 1 in 10 people):
- indigestion,
- increased tendency to bleed.
Uncommon side effects (may affect up to 1 in 100 people):
- urticaria,
- nasal irritation,
- difficulty breathing.
Rare adverse reactions (which may affect up to 1 in 1,000 people):
- severe bleeding from the stomach or intestines, change in blood cell count,
- nausea and vomiting,
- cramps in the lower respiratory tract, asthma attack,
- inflammation of blood vessels,
- bruising with purple patches (skin bleeding),
- abnormal, heavy or prolonged menstrual bleeding.
Undesirable effects of undetermined frequency (frequency cannot be estimated on the basis of available data):
- ringing in the ears (tinnitus) or impaired hearing,
- headaches,
- dizziness (lightheadedness),
- stomach or small intestine ulcers and perforation,
- prolonged bleeding time,
- kidney disease,
- liver disease,
- high blood uric acid levels.
Reporting side effects
If you experience any side effects, please tell your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Centres Régionaux de Pharmacovigilance - Website: https://signalement.social-sante.gouv.fr/
By reporting adverse reactions, you are helping to provide more information on drug safety.
5. HOW TO CONSERVE RESITUNE 75 mg, gastro-resistant tablet?
Keep out of sight and reach of children.
Blisters: Store in original, moisture-resistant packaging.
Bottle: Store tightly closed, protected from moisture.
Store at temperatures not exceeding 30°C.
Do not use this medicine after the expiration date indicated onthe box or bottle/blister after EXP. The expiration date refers to the last day of that month.
Do not dispose of any medicine down the drain or in the household waste. Ask your pharmacist to identify any medicines you no longer use. These measures will help protect the environment.
6. CONTENTS AND OTHER INFORMATION
What RESITUNE 75 mg gastro-resistant tablet contains
- The active substance is :
Acetylsalicylic acid........................................................................................................... 75 mg
For one gastro-resistant tablet.
- The other components are :
Microcrystalline cellulose, corn starch, colloidal anhydrous silica, talc, gelatin, heavy magnesium oxide (tablet core) ; copolymer of methacrylic acid and ethyl dacrylate type A, polysorbate 80, titanium dioxide, red iron oxide (E172), black iron oxide (E172), sodium lauryl sulfate, anhydrous colloidal silica, sodium bicarbonate, triethyl citrate, talc (tablet coating).
What RESITUNE 75 mg gastro-resistant tablet is and what it contains
This medicine comes as pink, heart-shaped, biconvex, unmarked tablets in blister packs of 28 or 50 gastro-resistant tablets, or in bottles of 30, 50, 60, 90 or 100 gastro-resistant tablets.
Each bottle contains a desiccant silica gel which must be kept in the bottle to help protect your tablets. The silica gel desiccant is contained in a separate sachet or cartridge and must not be swallowed.
Not all presentations may be marketed.
Marketing authorization holder
PFIZER HOLDING FRANCE
23-25, AVENUE DU DOCTEUR LANNELONGUE
75014 PARIS
Marketing authorization holder
PFIZER
23-25, AVENUE DU DOCTEUR LANNELONGUE
75014 PARIS
Manufacturer
PFIZER ITALIA S.R.L.
LOCALITA MARINO DEL TRONTO
63100 ASCOLI PICENO
ITALY
Product names in member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with current regulations.
[To be completed subsequently by the holder].
The last date on which this leaflet was revised was :
[To becompletedlater by the holder]
< {MM/YYYY}>< {month/YYYY}.>
Other
Detailed information on this drug is available on the ANSM (France) website.