Bioplak 250 mg tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Bioplak 250 mg tablets
Acetylsalicylic Acid
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents:
- What Bioplak 250 mg is and what it is used for
- What you need to know before taking Bioplak 250 mg
- How to take Bioplak 250 mg
- Possible adverse effects
- How to store Bioplak 250 mg
- Contents of the pack and other information
1. What Bioplak 250 mg is and what it is used for
Acetylsalicylic acid, at the dose present in this medicine, belongs to a group of medicines known as antiplatelet agents. Platelets are components of the blood, smaller than red and white blood cells, which aggregate when blood clots. By preventing this aggregation, antiplatelet agents reduce the likelihood of blood clots (thrombi) forming.
Your doctor has prescribed Bioplak 250 mg to prevent the formation of blood clots and to reduce the risk of blockage of your arteries, because:
- You have previously had a myocardial infarction or angina pectoris.
- You have had a non-hemorrhagic transient or permanent stroke.
- You have undergone a surgical procedure such as coronary angioplasty or coronary bypass.
2. What you need to know before taking Bioplak 250 mg
Do not take Bioplak 250 mg
- If you are allergic to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).
- If you have or have had gastric, duodenal ulcers or recurrent stomach discomfort.
- If you have experienced allergic reactions of an asthmatic type (difficulty breathing, suffocation, bronchospasms and in some cases coughing or wheezing) when taking anti-inflammatory drugs, acetylsalicylic acid, analgesics, or tartrazine dye.
- If you have or have had asthma, rhinitis, or urticaria.
- If you have haemophilia or other blood coagulation disorders that predispose you to internal bleeding.
- If you have kidney and/or liver disease (renal and/or hepatic insufficiency).
- If you are in the third trimester of pregnancy.
Warnings and precautions
Consult your doctor before starting to take Bioplak 250 mg, especially if you are in any of the following situations:
- You have recently undergone surgery, including dental surgery.
- You are scheduled to undergo surgery, including dental surgery, within the next seven days.
- You are taking anti-inflammatory drugs or other medications, as certain medicines may interact with Bioplak 250 mg and cause undesirable effects (see “Taking Bioplak 250 mg with other medicines”).
- You have hypertension, impaired kidney, heart or liver function, blood coagulation disorders, or are being treated with anticoagulants.
- You are allergic to other anti-inflammatory or antirheumatic drugs.
- You have glucose-6-phosphate dehydrogenase deficiency.
- You have rhinitis and/or urticaria.
- After receiving a vaccine.
Children and adolescents
Bioplak 250 mg is contraindicated in children and adolescents under 16 years of age, as the use of acetylsalicylic acid has been associated with Reye's syndrome, a rare but serious illness.
Elderly patients
Elderly individuals are more likely to experience adverse effects.
Taking Bioplak 250 mg with other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.
This is particularly important in the case of:
- Other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation).
- Metamizole (a substance used to reduce pain and fever); if administered concomitantly, it may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clumping together to form a blood clot). Therefore, this combination should be used with caution in patients taking low-dose acetylsalicylic acid as a cardioprotective agent.
- Anticoagulants (medicines used to "thin" the blood and prevent blood clots), such as warfarin.
- Medicines to lower blood sugar levels (oral antidiabetics).
- High blood pressure medications (diuretics and ACE inhibitors).
- Barbiturates (medicines used to treat seizures).
- Certain antidepressants, such as selective serotonin reuptake inhibitors, as they increase the risk of bleeding.
- Corticosteroids, as they may enhance the risk of gastrointestinal bleeding.
- Cimetidine and ranitidine (used for stomach acidity).
- Digoxin (a heart medication).
- Phenytoin and valproic acid (antiepileptics).
- Lithium (used for depression).
- Methotrexate (used in the treatment of cancer and rheumatoid arthritis).
- Medicines used to treat gout (probenecid).
- The antibiotic vancomycin and sulfonamides (used for infections).
- Zidovudine (used in the treatment of HIV infections).
- Medicines used to prevent transplant rejection (cyclosporine and tacrolimus).
- Interferon alfa.
Taking Bioplak 250 mg with food, drinks and alcohol
Take this medicine after meals or with food.
If you regularly consume alcohol (three or more alcoholic drinks—beer, wine, spirits—per day), taking Bioplak 250 mg may cause gastric bleeding.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Use of this medicine during the first and second trimesters of pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.
You must not take Bioplak 250 mg during the third trimester of pregnancy.
Bioplak 250 mg is excreted in breast milk; therefore, this medicine should not be taken during breastfeeding.
Driving and using machines
No effects on the ability to drive vehicles or operate machinery have been observed.
3. How to take Bioplak 250 mg
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will tell you how long to take Bioplak 250 mg. Do not stop treatment without first consulting your doctor.
Bioplak 250 mg is administered orally.
The recommended dose is:
Adults and children over 16 years of age
The dosage will be determined by your doctor according to your individual needs. Administration of 1 to 3 tablets every 24 hours is recommended.
The tablets should be swallowed whole with a sufficient amount of liquid, preferably with food, and ideally at the same time each day.
If you feel that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Bioplak 250 mg than you should
The main symptoms of overdose are: headache, dizziness, tinnitus, blurred vision, drowsiness, sweating, nausea, vomiting, and occasionally diarrhea.
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. Take this leaflet, any remaining tablets, and the packaging with you to the hospital or doctor so they know which tablets you have taken.
If you forget to take Bioplak 250 mg
If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding.
Common adverse effects (may affect up to 1 in 10 people):
- Gastrointestinal disorders, such as gastric ulcer, duodenal ulcer, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
- Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.
- Urticaria, skin rashes, angioedema.
- Hypoprothrombinemia (with high doses).
Uncommon adverse effects (may affect up to 1 in 100 people):
- Reye's syndrome in patients under 16 years of age with febrile illness, influenza, or varicella (see “What you need to know before taking Bioplak 250 mg”).
- Hepatic disorders, especially in patients with juvenile arthritis.
During long-term treatment and with high doses, dizziness, tinnitus, hearing loss, sweating, headache, confusion, and kidney problems may occur.
Treatment must be stopped immediately if the patient experiences any episode of hearing loss, tinnitus, or dizziness.
In patients who have previously experienced an allergic reaction to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity to these drugs.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es
5. Storage of Bioplak 250 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container following EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bioplak 250 mg
- The active substance is acetylsalicylic acid. Each tablet contains 250 mg of acetylsalicylic acid.
- The other components are microcrystalline cellulose, talc, pregelatinized corn starch, lemon flavour, and sodium saccharin.
Appearance of the product and contents of the pack
White, round, scored tablets. The tablet can be divided into equal doses.
Packaged in blister packs made of polyvinyl chloride (PVC), sealed with a heat-sealable aluminium foil, in packs of 30 tablets.
Marketing Authorisation Holder
Laboratorios ERN S.A.
Perú, 228 – 08020 Barcelona. Spain.
Manufacturers
Laboratorios ERN, S.A.
Gorcs i Lladó, 188 – 08210 Barberà del Vallès. Barcelona. Spain.
Date of the most recent review of this leaflet: April 2019
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/