Warning

Laboratorios ERN, S.A. informs that some of the contents of this website are addressed exclusively to healthcare professionals, authorized for prescribing or dispensing of drugs. Specialized knowledge is required for proper interpretation.

_Bioplak familia

Bioplak

Acetyl salicylic acid.

Platelet antiaggregate.

Small easy to swallow tablets.


    Packet with 30 125 mg acetyl salicylic acid tablets.

    Financed by the S.N.S.

    N.C. 672976.2


    Packet with 30 250 mg acetyl salicylic acid tablets.

    Financed by the S.N.S.

    C.N. 672099.8


    Packet with 500 125 mg acetyl salicylic acid tablets.

    C.N. 605120.7

The dosage will be established by your doctor according to your necessities. The administration of 1 -3 tablets every 24 hours is recommended.

The tablets must be ingested whole, with a sufficient quantity of liquid, preferably with food and if possible at the same time of day.

MEDICATION GUIDE
BIOPLAK 125/250 MG TABLETS

Acetyl salicylic acid.
Each tablet contains 125/250mg of acetyl salicylic acid.
The other components are: microcrystalline cellulose, talc, pregelatinised corn starch, aroma of lemon and sodium saccharin.
Read the whole leaflet carefully before starting to take this medication.
-Keep this leaflet. You may need to reread it.
-If you have any doubts, consult your doctor or pharmacist.
-This medicine has been prescribed to you personally, you must not give it to other people. It may cause them harm, even when their symptoms are the same as yours.
Holder of the authorisation for the commercialisation and fabrication of the product.
Laboratorios ERN, S.A. C/ Pedro IV, 499 08020 Barcelona – España
Responsible for manuafacturing
Laboratorios ERN, S.A. C/Perú 228 - 08020  Barcelona. España
Laboratorios ERN, S.A. Gorcs Lladó, 188 - 08210 Barberá del Vallés, Barcelona. España.

1. WHAT IS BIOPLAK 125/250mg AND WHAT IS IT USED FOR?

BIOPLAK 125/250mg is tablets. It is presented in packets of 30 tablets. Acetyl salicylic acid is the dose present in this medicine, and it belongs to the antiplatelet group of medicines. Platelets are blood components, smaller than red or white blood cells which are added when the blood clots. By preventing this action, anti platelet drugs reduce the possibility of clots occurring (thrombus).

Your doctor has prescribed BIOPLAK 125/250 to prevent the formation of thrombi and reduce the risk of obstruction of the arteries, as :
-you have previously suffered a heart attack, myococardio or angina pectoris.
-you have had a transitory or permanent non haemorrhage cerebrovascular accident.
-you have gone through coronary angioplasty surgery or a by-pass operation.

2. BEFORE TAKING BIOPLAK 125/250mg

Do not take BIOPLAK 125/250mg:
-If you suffer from or have suffered from gastric ulcers, repeated duodenal or gastric discomfort.
-If you have had allergic reactions like asthmatic ones (breathing difficulty, drowning feeling, bronco spasms, and in some cases coughing or whistling when breathing) upon taking anti inflammatories, acetyl salicylic acid, painkillers, or the colouring agent, tartrazine.
-If you are allergic to any component in this medicine.
-If you suffer from or have suffered asthma, rhinitis, or hives.
-If you suffer from haemophilia or other blood coagulation problems which predispose you to internal haemorrhages.
-If you have kidney and/or liver problems (renal and/or hepatic insufficiency).
-If you are under 16, as acetyl salicylic acid has been associated with Reye’s Syndrome, an infrequent but serious illness.
-If you are in the third trimester of pregnancy.

Be especially careful with BIOPLAK 125/250mg:

Tell your doctor before taking this medicine if you find yourself in any of the following situations:
•    if you have recently had surgery, including dental surgery
•    if you have to have surgery,including dental, in the next 7 days
•    if you are taking anti inflammatories or other types of medication as certain medicines can interact with BIOPLAK 125/250mg and produce unwanted effects (see “Use of other medicines”)
•    if you suffer from hypertension, have reduced kidney, heart or liver operation, you present alterations in blood clotting or are being treated with anticlotting medication
•    if you are allergic to other anti inflammatories or anti rheumatics
•    if you have a dehydrogenase glucose-6-phosphate deficiency
•    if you suffer from rhinitis and/or hives
•    after the administration of a vaccine

Take BIOPLAK 125/250mg with food and drink:
Take this medicine after meals or with some food.

If you regularly consume alcohol (three o more alcoholic drinks – beer, wine, spirits... a day), taking BIOPLAK 125/250mg can provoke a gastric haemorrhage.

Pregnancy and breast feeding:
Consult your doctor or pharmacist before taking this medicine.

IMPORTANT FOR WOMEN
If you are pregnant or think you could be, consult your doctor before taking this medication. The consumption of Bioplak during the first and second trimester of pregnancy could be dangerous for the foetus or embryo and must be monitored by your doctor. You must not take Bioplak during the third trimester of pregnancy.
Breast feeding

Consult your doctor or pharmacist before taking any medication.

BIOPLAK 125/250mg is excreted with maternal milk, and so must not be taken when breast feeding.

Children:
Do not administer to those under 16.

The elderly:
Elderly patients are more likely to suffer its side effects.

Driving and the use of machines
No effect has been described.

Taking other medication:
Certain medicines can interact with BIOPLAK 125/250mg, and in these cases it may be necessary to change the dose or interrupt the treatment with some medicines. Inform your doctor or pharmacist if you are taking or have recently taken any medicine-including those acquired without prescription.
Bear in mind that these instructions may also be applicable with medicines you have taken before or may takein the future.

This is especially careful in the case of:
•    Analgesics
•    Medication for the circulation (oral anti coagulants).
•    Medication to reduce the amount of sugar in the blood (oral anti diabetics).
•    Diuretics.
•    Barbiturates (medication used for the treatment of convulsions).
•    Some anti depressives, like selective inhibitors of serotonin replenishment as they increase the possibility of hemorrhage.
•    Corticoids, as they can increase the risk of digestive hemorrhage.
•    Cymetidine and ranitidine (used with stomach acid).
•    Dygoxine (heart medication).
•    Phenitone and valproic acid (anti epilectics).
•    Lithium (used with depressions).
•    Methotrexate (used in the treatment of cancer and rheumatoid arthiritis).
•    Medication used in the treatment of gout.
•    The antibiotic Vancomicine and Sulphamides (used with infections).
•    Zidovudine (used in the treatment of HIV infections).
•    Cyclosporine, used in transplants.
•    Alpha interpheron.

3. HOW TO TAKE BIOPLAK 125/250 mg

Follow these instructions unless your doctor has given you different ones.

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with BIOPLAK 125/250 mg.

Do not interrupt the treatment without first consulting with your doctor.

If you consider the effect of BIOPLAK 125/250mg to be too strong or weak, tell your doctor or pharmacist.

BIOPLAK 125/250mg is administered orally.

Administration:
Adults
The dosage will be established by your doctor according to your necessities. The administration of 1 -3 tablets every 24 hours is recommended.

The tablets must be ingested whole, with a sufficient quantity of liquid, preferably with food and if possible at the same time of day.

If you take more BIOPLAK 125/250mg than you should:
The principal symptoms of overdose are: headache, dizziness, buzzing in the ears, blurred vision, drowsiness, sweating, nausea, vomiting and occasionally diarrhoea.

In the case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, go to a medical centre or call the Toxicology Information Service, telephone 915620420, indicating the product and the amount administered.

If you forgot to take BIOPLAK 125/250mg:

Do not take a double dose to compensate the forgotten ones.

4. POSSIBLE SIDE EFFECTS

As with all medicines BIOPLAL 125/250mg can have side effects. Due to its effect on the addition of platelets, acetyl salicylic acid can increase the risk of bleeding.

Frequent side effects:
•    Gastrointestinal disorders, like gastric ulcers, duodenal ulcers, gastrointestinal bleeding, abdominal pain, gastric discomfort, nausea, vomiting.
•    Breathing disorders, such as breathing difficulty, bronchial spasms, rhinitis.
•    Hives, skin rashes, angioedema.
•    Hypothrombism (with high doses)

Infrequent side effects:
•    Reye’s syndrome in those under 16, with fevers, flu or chicken pox (see ‘Before taking BIOPLAK 125/250mg’).

Hepatic disorders, especially in patients with juvenile arthiritis.

In extended treatments and with high doses  dizziness, noises in the ears, deafness, sweating, headaches, confusion and kidney problems can appear.

The treatment must be stopped immediately if the patient experiences any type of deafness, noises in the ears or dizziness.

Patients who have experienced allergic reactions to acetyl salicylic acid and other non steroid anti inflammatories antiphilactic or antiphilactoid reactions can occur. This can also occur in those patients who have not previously shown hyper sensibility to these drugs.

If you appreciate these, or any other side effect not described in this leaflet, consult your doctor or pharmacist.

5. CONSERVATION OF BIOPLAK 125/250mg

Keep BIOPLAK 125/250mg out of sight and reach of children.

Special conservation conditions are not necessary.

Expiry: Do not use BIOPLAK 125/250mg after the expiry date indicated on the container.