BIOPLAK 125 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bioplak 125 mg Tablets

Acetylsalicylic Acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• 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.

Contents of the Package Leaflet

1. What is Bioplak 125 mg and what is it used for
2. What you need to know before you take Bioplak 125 mg
3. How to take Bioplak 125 mg
4. Possible side effects
5. Storage of Bioplak 125 mg
6. Contents of the pack and further information

1. What is Bioplak 125 mg and what is it used for

Acetylsalicylic acid, at the dose present in this medicine, belongs to a group of medicines called antiplatelet agents. Platelets are components of the blood, smaller than red and white blood cells, that clump together when the blood clots. By preventing this clumping, antiplatelet agents reduce the possibility of blood clots (thrombi) forming.

Your doctor has prescribed Bioplak 125 mg to prevent the formation of thrombi and reduce the risk of obstruction of your arteries, since:

• You have previously suffered a heart attack or angina pectoris.
• You have suffered a non-hemorrhagic transient or permanent stroke.
• You have undergone surgical intervention, such as coronary angioplasty or coronary bypass.

2. What you need to know before you take Bioplak 125 mg

Do not take Bioplak 125 mg

• If you are allergic to acetylsalicylic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had stomach ulcers, duodenal ulcers, or recurring stomach discomfort.
• If you have had allergic reactions of an asthmatic type (difficulty breathing, shortness of breath, bronchospasm, and in some cases cough or wheezing) when taking non-steroidal anti-inflammatory drugs, acetylsalicylic acid, analgesics, as well as the dye tartrazine.
• If you have or have had asthma, rhinitis, or urticaria.
• If you have hemophilia or other blood coagulation problems that predispose you to internal bleeding.
• If you have kidney and/or liver problems (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 125 mg, particularly if you are in any of the situations described below:

• You have recently undergone surgical intervention, including dental surgery.
• If you are to undergo surgical intervention, including dental surgery, in the next seven days.
• If you are taking non-steroidal anti-inflammatory drugs or other types of medications, as certain medications can interact with Bioplak 125 mg and produce unwanted effects (see "Taking Bioplak 125 mg with other medicines").
• If you have high blood pressure, have reduced kidney, heart, or liver function, have blood coagulation disorders, or are being treated with anticoagulants.
• If you are allergic to other non-steroidal anti-inflammatory drugs or antirheumatics.
• If you have a deficiency of glucose-6-phosphate dehydrogenase.
• If you have rhinitis and/or urticaria.
• After administration of 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 linked to Reye's syndrome, a rare but serious disease.

Elderly patients

Elderly people are more likely to experience side effects.

Taking Bioplak 125 mg with other medicines

Tell your doctor or pharmacist if you are taking, or have recently taken, other medicines, including those obtained without a prescription, homeopathic medicines, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them.

This is especially important in the case of:

• Other analgesics or non-steroidal anti-inflammatory drugs (medicines used to treat pain and/or muscle inflammation).
• Metamizole (substance to reduce pain and fever), if administered together, may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump together and form a blood clot). Therefore, this combination should be used with caution in patients taking low doses of acetylsalicylic acid as a cardioprotector.
• Anticoagulants (medicines used to "thin" the blood and prevent the formation of blood clots) such as warfarin.
• Medicines to lower blood sugar levels (oral antidiabetics).
• High blood pressure (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 (heart medicine).
• Phenytoin and valproic acid (antiepileptics).
• Lithium (used for depression).
• Methotrexate (used for cancer and rheumatoid arthritis treatment).
• Medicines used to treat gout (probenecid).
• The antibiotic vancomycin and sulfonamides (used for infections).
• Zidovudine (used in HIV infection treatment).
• 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 some food.

If you regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor ... - per day), taking Bioplak 125 mg may cause gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Taking this medicine during the first and second trimester of pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

You should not take Bioplak 125 mg during the third trimester of pregnancy.

Bioplak 125 mg is excreted in breast milk, so you should not take this medicine during breastfeeding.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

3. How to take Bioplak 125 mg

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Bioplak 125 mg. Do not stop treatment without consulting your doctor first.

Bioplak 125 mg is administered orally.

The recommended dose is:

Adults and children over 16 years

The dosage will be determined by your doctor according to your needs. It is recommended to take 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 of day.

If you think the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

If you take more Bioplak 125 mg than you should

The main symptoms of overdose are: headache, dizziness, ringing in the ears, 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, phone 91 562 04 20, indicating the medicine and the amount administered. Bring this leaflet, some of the remaining tablets, and the packaging to the hospital or to your doctor so they know what 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 to take the next one. Do not take a double dose to make up for forgotten doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Due to its effect on platelet aggregation, acetylsalicylic acid may increase the risk of bleeding.

Common side effects (may affect up to 1 in 10 people):

• Gastrointestinal disorders, such as stomach ulcers, duodenal ulcers, gastrointestinal bleeding, abdominal pain, stomach discomfort, nausea, vomiting.
• Respiratory disorders, such as difficulty breathing, bronchospasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinemia (with high doses).

Uncommon side effects (may affect up to 1 in 100 people):

• Reye's syndrome in children under 16 years with febrile conditions, flu, or chickenpox (see "What you need to know before you take Bioplak 125 mg").
• Hepatic disorders, especially in patients with juvenile arthritis.

In long-term treatments and with high doses, the following may appear: dizziness, ringing in the ears, deafness, sweating, headache, confusion, and kidney problems.

Treatment should be stopped immediately if the patient notices any episode of deafness, ringing in the ears, or dizziness.

In patients who have presented 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: 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 which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and further information

Composition of Bioplak 125 mg

• The active ingredient is acetylsalicylic acid. Each tablet contains 125 mg of acetylsalicylic acid.
• The other ingredients are microcrystalline cellulose, talc, pregelatinized corn starch, lemon flavor, and sodium saccharin.

Appearance of the product and pack contents

White, round, and scored tablets. The tablet can be divided into equal doses.

It is presented in PVC blisters sealed with a heat-sealable aluminum foil in packs of 30 tablets and 500 tablets (clinical packaging).

Marketing authorization holder

Laboratorios ERN S.A.

Perú, 228 – 08020 Barcelona. Spain.

Manufacturers

Laboratorios ERN, S.A.

Gorcs i Lladó, 188 – 08210 Barberá del Vallés. Barcelona. Spain.

Date of last revision of this leaflet: April 2019

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/