Sopharma – Acetylin Protect 100 mg (30 tablets)
| Form | TABLETS |
|---|---|
| Content | 30 tablets |
€3,69
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Acetylin Protect of the pharmaceutical company Sopharma is a medicinal product containing acetylsalicylic acid, which in high doses lowers elevated body temperature and relieves pain and reduces inflammation. It has an analgesic, anti-inflammatory, antipyretic and anti-aggregate effect. Applicable to the treatment of unstable angina and acute myocardial infarction as often as standard therapy. The product is suitable for prophylaxis in: repeated myocardial infarction, after surgical and other interventions of arterial blood vessels such as aortocoronary venous bypass (ACVB), percutaneous transluminal coronary angioplasty (PTCA); transient ischemic attacks and cerebral infarction after the manifestation of prodromal symptoms; suitable for reducing the risk of a first myocardial infarction in persons with cardiovascular risk: Diabetes mellitus type, hyperlipidemia, hypertension, obesity, smoking, advanced age. Available in a pack of 30 tablets.
| Composition | in 1 tablet: |
| Acetylsalicylic acid | 100 mg |
| Excipients: cellulose powder, corn starch, ethyl acrylate, polysorbate 80, sodium lauryl sulfate, talc, triethyl citrate. | |
Usage
Intended for oral administration. Tablets are taken before meals with a large amount of liquid.
Recommended daily dose is 1 tablet. To prevent a repeat heart attack, it is recommended to take 3 tablets daily.
It is necessary to know that your doctor may in some cases consider that it is necessary to take a higher or slightly lower dose depending on the disease.
More Information
Do not use if:
- you are allergic to acetylsalicylic acid, salicylates or any of the other ingredients of the product;
- you have stomach or duodenal ulcers or have recently had bleeding from the digestive system;
- you suffer from hemophilia, have a reduced number of blood platelets or
- another disease in which there is a tendency to hemorrhage;
you have bronchial asthma, especially if it is triggered by taking - salicylates, drugs for the treatment of rheumatic diseases, others
- medicines to treat pain and fever;
- you are currently being treated with high-dose methotrexate.
This product should not be used during the first and last three months of pregnancy, as well as in children under 12 years of age, unless your doctor has prescribed treatment with this product.
Pay special attention:
if you are taking drugs to reduce blood clotting, as the risk of bleeding increases;
you have had stomach and duodenal ulcers or bleeding from the digestive system;
you suffer from an allergy, incl. and to medicines;
you have kidney or liver disease.
Taking other medicines:
This product should not be used when you are being treated with high-dose methotrexate. It should be used with caution during simultaneous treatment with products that reduce blood clotting, drugs containing acetylsalicylic acid or other salicylates because of the higher risk of bleeding.
Acetylsalicylic acid can change the effects of medicines for the treatment of gout, some products for the treatment of heart disease, glucocorticoids, valproic acid.
If you take medicines for the treatment of diabetes mellitus, incl. insulin it is necessary to know that it is possible that the blood sugar level will decrease, therefore it is advisable to consult a doctor who will assess whether a change in the dosage of these drugs is necessary.
Intake with food and drink:
When taking this product you should not consume alcohol, as the risk of damage to the stomach and intestines is higher.
Pregnancy and breast-feeding:
The product should not be used in the first three months of pregnancy because it may cause damage to the fetus. If it is applied in the last three months, the risk of delay in childbirth, as well as of hemorrhages in the mother and the newborn, increases.
Acetylsalicylic acid is excreted in breast milk. If it is necessary to take the product for a longer time or in higher doses, it is recommended to stop breastfeeding for the time of treatment with the product.
Adverse reactions:
Gastrointestinal disorders:
Common – abdominal pain, heartburn, belching and burning behind the sternum, nausea, vomiting, swelling and discomfort in the abdomen.
Uncommon – vomiting of blood, presence of blood in the stool, ulcers of the stomach and duodenum.
Biliary-hepatic disorders:
Isolated cases of liver function disorders when using Acetylin Protect.
Nervous system disorders:
Uncommon – dizziness, tinnitus, headache, drowsiness.
Blood and lymphatic system disorders:
Common – decrease in the number of platelets, which increases the risk of bleeding or bruising.
Kidney and urinary tract disorders:
Rare – suppression of kidney functions
Unknown – damage to kidney tissues.
Immune system disorders:
Common – hives, skin rash and itching, asthma, severe allergic reaction that causes swelling of the face or throat
Laboratory tests:
Very rare – increased values of uric acid and urea.
Patient Leaflet
ACETYLIN PROTECT tablets 100 mg * 30 SOPHARMA
Package leaflet: patient information
Acetylin Protect 100 mg gastro-resistant tablets Acetylin® Protect 100 mg gastro-resistant tablets
acetylsalicylic acid
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
- Keep this leaflet. You may have to read it again.
- If you need further information or advice, ask your pharmacist.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better or your condition worsens, you should seek medical attention.
What is in this leaflet
1. What Acetylin Protect is and what it is used
for 2. What you need to know before you use Acetylin Protect
3. How to take Acetylin Protect
4. Possible side effects
5. How to store Acetylin Protect
6. Contents of the pack and other information
1. What Acetylin Protect is and what it is used for
Acetylin Protect is a medicinal product that contains acetylsalicylic acid. In high doses, it relieves pain and reduces inflammation, lowers increased body temperature. Given in lower doses, it reduces the ability of blood plates (platelets) to stick together and to the walls of blood vessels, resulting in a decrease in the risk of blood clots (thrombi).
Acetylin Protect is used to treat acute heart attack and certain types of angina simultaneously with other medicinal products.
It is used to prevent recurrence of heart attack, stroke (stroke) due to insufficient blood supply to the brain, as well as to reduce the risk of blood clots during operations and blood vessel tests.
It is suitable for persons at high risk of heart attack, e.g. patients with high blood pressure, diabetes mellitus, high cholesterol, obesity, as well as in smokers and the elderly.
2. What you need to know before you use Acetylin Protect
Do not use Acetylln Protect:
- If you are allergic (hypersensitive) to acetylsalicylic acid, salicylates or any of the other ingredients of this medicine (listed in section 6).
- If you have a stomach or duodenal ulcer or have recently had bleeding from your digestive system.
- If you suffer from haemophilia (an inherited disease in which there is a blood clotting disorder), have a reduced number of blood platelets (platelets) or any other condition that has a tendency to hemorrhage.
- If you have bronchial asthma (shortness of breath, cough), especially if it is caused by salicylates, medicines to treat rheumatic diseases, other medicines to treat pain and fever.
- If you are currently being treated with methotrexate in high doses.
- In the last three months of pregnancy.
- In children under 12 years of age.
Warnings and precautions
- Talk to your doctor, pharmacist or nurse before using Acetylin Protect:
- If you are taking medicines to reduce blood clotting (the so-called anticoagulants), as the risk of bleeding increases.
- If you have had an ulcer of the stomach and duodenum or hemorrhages from the digestive system.
- If you are allergic to non-steroidal anti-inflammatory drugs (indomethacin, ibuprofen, ketoprofen, diclofenac) or other atopies,
- If you have kidney or liver disease.
You should always pay attention to whether other drugs you are currently using contain acetylsalicylic acid, because it is possible that the total amount of all products taken may be higher than the recommended dose. This is especially important when the product is administered in childhood,Acetylsalicylic acid can cause difficulty breathing as a result of spasm of the bronchi, accompanied by cough, itching, skin rash or other allergic reactions. In these cases or if you suspect that an allergic reaction is developing,
you should stop taking the product and see a doctor. This risk is greater in people suffering from asthma, hay fever, those who have polyps in the nose or some chronic lung diseases, as well as in individuals suffering from hives (urticaria) or other allergic skin diseases. Acetylsalicylic acid may lead to increased bleeding and bleeding during and after surgery, incl. when extracting a tooth. If you suffer from gout, the product can provoke a crisis, because it reduces the excretion of uric acid from the body.
Children and adolescents
The product should be used with caution in children as it may cause Reye’s syndrome (a very rare disease with vomiting, somnolence, loss of consciousness and coma).
Other medicines and Acetyline Protect
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This product should not be used when treated with methotrexate in high doses. Caution should be exercised when co-administered with products that reduce blood clotting (coumarin anticoagulants, heparin), medicines containing acetylsalicylic acid or other salicylates because of the higher risk of bleeding Metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and blood clotting), when taken at the same time. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection (prevention).
Acetylsalicylic acid may alter the effects of medicines to treat gout, some products to treat heart disease (e.g. digoxin), glucocorticoids (synthetic analogues of hormones secreted by the adrenal gland), valproic acid (to treat epilepsy).
If you are taking medicines to treat diabetes mellitus, incl. insulin, it is necessary to know that it is possible to lower the blood sugar level, therefore it is desirable to consult a doctor who will decide whether a change in the dosage of these drugs is required,
Acetylin Protect with food, beverages and alcohol
When taking this product, you should not consume alcohol, as the risk of damage to the stomach and intestines is higher.
Fertility, pregnancy and breast-feeding
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.
Pregnancy
Acetylin Protect should not be used in the first three months of pregnancy because it can lead to damage to the fetus.
Acetylin Protect should not be used in the last three months of pregnancy as it increases the risk of delayed labor as well as bleeding in the mother and newborn.
Lactation
Acetylsalicylic acid is excreted with breast milk. If it is necessary to take the product for a longer time or in higher doses, it is advisable to discontinue breast-feeding for the duration of treatment with the product.
Driving and using machines
There is no evidence of adverse influence of the product on the ability to drive and use machines.
Acetylin Protect contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor for advice before taking this product.
3. How to take Acetylin Protect
Always use this medicine exactly as described in this leaflet or as you have told your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.
The product is intended for oral administration. Tablets are taken before meals with a larger amount of liquid.
The recommended daily dose is 1 tablet.
To prevent a second heart attack, it is recommended to take 3 tablets daily.
You should know that your doctor may in some cases consider that you need to take a higher or slightly lower dose depending on the disease.
If you use more Acetyline Protect than you should
If you have used more than this dose, you should contact your doctor or pharmacist for advice.
Overdose (by treatment or accidentally) with acetylsalicylic acid can lead to intoxication that can be serious in the elderly and young children, and in some cases may have a fatal outcome. Most often, tinnitus, hearing disorders, headaches, dizziness, confusion occur.
If in the course of treatment the body temperature rises significantly, rapid breathing occurs, there is a significant decrease in blood pressure, breathing becomes difficult, it is necessary to immediately seek the advice of a doctor or visit the nearest medical institution. In case of overdose, the product should be stopped immediately, vomiting should be induced, activated carbon and other appropriate agents should be administered, as well as water-salt solutions.
If you forget to take Acetylnn Protect
If you forget to take a dose, do so as soon as possible after remembering so that the medicine can have the expected effect. Take the next regular dose at the usual time.
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse,
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Acetylin Protect is generally well tolerated.
Adverse reactions are classified by frequency as follows:
- Common (may affect up to 1 in 10 people): abdominal pain* heartburn, belching and burning behind the sternum, nausea, vomiting, bloating and malaise in the abdomen, decrease in the number of platelets (blood platelets), which increases the risk of bleeding or bruising, hives (hives), skin rashes and itching, severe allergic reaction that causes difficulty breathing or dizziness, asthma, a severe allergic reaction that causes swelling of the face or throat.
- Uncommon (may affect up to 1 in 100 people): vomiting of blood, presence of blood in the stool, ulcers of the stomach and duodenum (more common when taking high doses), dizziness, tinnitus, headache, drowsiness (usually seen with overdose).
- Rare (may affect up to 1 in 1,000 people): suppression of kidney function.
- Very rare (may affect up to 1 in 10,000 people): increased uric acid and urea.
- Not known (frequency cannot be determined from available data): isolated cases of liver function disorders, renal tissue damage.
Reporting of adverse reactions
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Acetylin Protect
Store in the original package at a temperature below 25°C. Keep out of the reach of children.
Do not use Acetylin Protect after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
The product should not be used if you detect changes in the appearance of the tablets.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Acetylin Protect contains
- Active substance in one tablet: acetylsalicylic acid 100 mg.
- The other ingredients are:
Tablet core – lactose monohydrate; microcrystalline cellulose; silica, colloidal, anhydrous; potato starch.
Gastro-resistant shell – talc; triacetin; methacrylic acid copolymer -ethylacrylate (1:1); purified water.
What Acetylin Protect looks like and contents of the pack
Acetylin Protect gastro-resistant tablets are round, biconvex white tablets.
10 (ten) gastro-resistant tablets are packed in PVC / Al blisters.
3 (three) blisters of 10 gastro-resistant tablets and a leaflet are placed in a box made of cardboard.
Marketing Authorisation Holder and Manufacturer
Sopharma AD, Bulgaria
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