Bioplak 125 mg tablets
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Bioplak 125 mg tablets
Acetylsalicylic Acid
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor, pharmacist or nurse.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
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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 125 mg is and what it is used for
- What you need to know before taking Bioplak 125 mg
- How to take Bioplak 125 mg
- Possible side effects
- How to store Bioplak 125 mg
- Contents of the pack and other information
1. What Bioplak 125 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 125 mg to help prevent the formation of blood clots and reduce the risk of blockage in 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 125 mg
Do not take Bioplak 125 mg
- If you are allergic to acetylsalicylic acid or to any of the other components of this medicine (listed in section 6).
- If you currently 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 the tartrazine dye.
- If you currently have or have had asthma, rhinitis, or urticaria.
- If you have hemophilia 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
Talk to your doctor before starting to take Bioplak 125 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 125 mg and cause unwanted effects (see "Taking Bioplak 125 mg with other medicines").
- You have high blood pressure, reduced kidney, heart, or liver function, blood coagulation disorders, or are being treated with anticoagulants.
- You are allergic to other anti-inflammatory or anti-rheumatic drugs.
- You have glucose-6-phosphate dehydrogenase deficiency.
- You have rhinitis and/or urticaria.
- After receiving a vaccine.
Children and adolescents
Bioplak 125 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 125 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 together, 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 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 increase 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 125 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, etc.—per day), taking Bioplak 125 mg may cause gastrointestinal bleeding.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you might be pregnant, or plan 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 125 mg during the third trimester of pregnancy.
Bioplak 125 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 or operate machinery have been observed.
3. How to take Bioplak 125 mg
Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will determine the duration of your treatment with Bioplak 125 mg. Do not stop treatment without first consulting your doctor.
Bioplak 125 mg is administered orally.
Recommended dose:
Adults and children over 16 years of age
The dosage will be determined by your doctor according to your individual needs. The recommended administration is 1 to 3 tablets every 24 hours.
The tablets should be swallowed whole with a sufficient amount of liquid, preferably with food and, if possible, at the same time each day.
If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
More Bioplak 125 mg than you should have taken
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, contact your doctor or pharmacist immediately, go to a medical center, or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount taken. Take this leaflet, any remaining tablets, and the packaging with you to the hospital or your doctor so they know which tablets you have taken.
If you forget to take Bioplak 125 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 a missed dose.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Due to its effect on platelet aggregation, acetylsalicylic acid can 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 children under 16 years of age with febrile conditions, influenza or varicella (see “What you need to know before taking Bioplak 125 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.
Anaphylactic or anaphylactoid reactions may occur in patients who have previously shown an allergic reaction to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. This could also occur 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.
5. Storage of Bioplak 125 mg
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 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. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Bioplak 125 mg
- The active substance is acetylsalicylic acid. Each tablet contains 125 mg of acetylsalicylic acid.
- The other components are microcrystalline cellulose, talc, pregelatinized corn starch, lemon flavor, and sodium saccharin.
Appearance of the product and contents of the pack
White, round, scored tablets. The tablet can be divided into equal doses.
Presented in blisters of polyvinyl chloride (PVC) sealed with a heat-sealable aluminum foil, in packs of 30 tablets and 500 tablets (hospital pack).
Marketing Authorization 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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/