Package Insert: Information for the User

Bioplak 250 mg Tablets

Acid Acetylsalicylic

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, 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 effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

Acetylsalicylic acid, at the present dose in this medication, belongs to a group of medications called antiplatelet agents. Platelets are blood components, smaller than red and white blood cells, that 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 thrombi formation and reduce the risk of artery obstruction, as:

• You have previously experienced a myocardial infarction or angina pectoris.
• You have experienced a transient or permanent non-hemorrhagic ischemic stroke.
• You have undergone a surgical intervention, such as coronary angioplasty or coronary bypass surgery.

Do not take Bioplak 250 mg

• If you are allergic to acetylsalicylic acid or any of the other components of this medication (listed in section 6).
• If you have or have had a gastric, duodenal ulcer, or recurring stomach pain.
• If you have had allergic reactions of the asthmatic type (difficulty breathing, choking, bronchospasm, and in some cases, coughing or ringing in the ears) when taking anti-inflammatory agents, acetylsalicylic acid, analgesics, as well as tartrazine dye.
• If you have or have had asthma, rhinitis, or urticaria.
• If you have hemophilia or other bleeding disorders that predispose you to internal bleeding.
• If you have kidney 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 250 mg, especially if you are in any of the following situations:

• You have recently undergone surgery, including dental surgery.
• If you are to undergo surgery, including dental surgery in the next seven days.
• If you are taking anti-inflammatory agents or other types of medications, as certain medications may interact with Bioplak 250 mg and produce undesirable effects (see "Taking Bioplak 250 mg with other medications").
• If you have hypertension, reduced kidney function, heart or liver function, bleeding disorders, or are taking anticoagulants.
• If you are allergic to other anti-inflammatory agents or antirheumatics.
• If you have a deficiency of glucose-6-phosphate dehydrogenase.
• If 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 disease.

Older adults

Older adults are more prone to experiencing adverse effects.

Taking Bioplak 250 mg with other medications

Inform your doctor or pharmacist if you are taking, or have recently taken, other medications, including those purchased without a prescription, homeopathic medications, herbal remedies, and other health-related products, as it may be necessary to discontinue treatment or adjust the dosage of one or more of them.

This is especially important in the case of:

• Other analgesics or nonsteroidal anti-inflammatory drugs (medications used to treat pain and/or muscle inflammation).
• Metamizol (a substance used to reduce pain and fever), as taking them together may reduce the effect of acetylsalicylic acid on platelet aggregation (blood cells clump 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 (medications used to "thin" the blood and prevent the formation of blood clots) such as warfarin.
• Medications to reduce blood sugar levels (oral antidiabetic agents).
• High blood pressure (diuretics and ACE inhibitors).
• Barbiturates (medications used to treat seizures).
• Some antidepressants, such as selective serotonin reuptake inhibitors, as it increases the risk of bleeding.
• Corticosteroids, as it may potentiate the risk of gastrointestinal bleeding.
• Cimetidine and ranitidine (used to treat stomach acid).
• Digoxin (a medication for the heart).
• Phenytoin and valproic acid (antiepileptic medications).
• Lithium (used to treat depression).
• Methotrexate (used to treat cancer and rheumatoid arthritis).
• Medications used to treat gout (probencid).
• The antibiotic Vancomycin and sulfonamides (used to treat infections).
• Zidovudine (used to treat HIV infections).
• Medications used to prevent transplant rejection (cyclosporine and tacrolimus).
• Interferon alpha.

Taking Bioplak 250 mg with food, drinks, and alcohol

Take this medication after meals or with some food.

If you regularly consume alcohol (three or more alcoholic beverages - beer, wine, liquor per day), taking Bioplak 250 mg may cause gastrointestinal bleeding.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The consumption of this medication during the first and second trimesters of pregnancy may be hazardous to the embryo or fetus and should be monitored by your doctor.

You should not take Bioplak 250 mg during the third trimester of pregnancy.

Bioplak 250 mg is excreted in breast milk, so you should not take this medication during breastfeeding.

Driving and operating machinery

No adverse effects on the patient's ability to drive vehicles or operate machinery have been detected.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment with Bioplak 250 mg. Do not discontinue treatment without consulting your doctor first.

Bioplak 250 mg is administered orally.

The recommended dose is:

Adults and children over 16 years old

The dosage will be established by your doctor according to your needs. It is recommended to administer 1 to 3 tablets every 24 hours.

The tablets should be taken whole, with a sufficient amount of liquid, preferably with food and if possible at the same time of day.

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Ifyou take moreBioplak250 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 which tablets you have taken.

If you forgot to take Bioplak 250 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 compensate for the missed doses.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Frequent 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, bronchial spasm, rhinitis.
• Urticaria, skin rashes, angioedema.
• Hypoprothrombinemia (with high doses).

Rare adverse effects (may affect up to 1 in 100 people):

• Reye's syndrome in individuals under 16 years with febrile illnesses, flu, or chickenpox (see “What you need to know before starting to take Bioplak 250 mg”).
• Liver disorders, especially in patients with juvenile arthritis.

In long-term treatments and with high doses, the following may appear: dizziness, ear noises, hearing loss, sweating, headache, confusion, and kidney problems.

Treatment should be immediately suspended if the patient notes any episode of hearing loss, ear noises, or dizziness.

In patients who have presented an allergic reaction to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs, anaphylactic or anaphylactoid reactions may occur. This could also happen in patients who have not previously shown hypersensitivity to these medications.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bioplak 250 mg

• Theactiveingredient is acetylsalicylic acid. Each tablet contains 250 mg of acetylsalicylic acid.
• The other components are microcrystalline cellulose, talc, pregelatinized cornstarch, lemon flavor, and sodium saccharin.

Appearance of the product and content of the packaging

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

It is presented in sealed blisters of polyvinyl chloride (PVC) with a thermosoldered aluminum foil in containers of 30 tablets.

Holder of the marketing authorization

Laboratorios ERN S.A.

Perú, 228 – 08020Barcelona. Spain.

Manufacturers

Laboratorios ERN, S.A.

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

Last review date of thisleaflet: April 2019

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/