BIOTROPIL 1200 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
   1. Table of contents of the leaflet
2. What is Biotropil and what is it used for
3. How to take Biotropil
4. Possible side effects
5. How to store Biotropil
6. Contents of the pack and other information
   1. Warnings and precautions
   2. Special caution should be exercised in patients:
   3. Remember to inform your doctor about all diseases you have had.
   4. Side effects
   5. Biotropil and other medicines
   6. Biotropil with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Dosage
   10. How to take Biotropil
   11. Stopping Biotropil treatment
   12. What to do in case of overdose
   13. Storage
   14. Other information
   15. Pregnancy and breastfeeding
   16. Breastfeeding
   17. How to take Biotropil
   18. Dose
   19. Method of administration
   20. If necessary, the dose is increased every 3-4 days by 4.8 g per day (i.e., 4 tablets of 1200 mg), up to a maximum dose of 24 g per day. The daily dose is given in 2 or 3 divided doses.
   21. Treatment of dizziness
   22. Use in children
   23. Use in the elderly
   24. Use in patients with kidney and/or liver function disorders
   25. Patients with liver function disorders
   26. Special warnings
   27. Side effects
   28. Overdose
   29. Effect on ability to drive and use machines
   30. Interactions with other medicines and other interactions
   31. Pregnancy and breastfeeding
   32. Dosage and method of administration
   33. In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.
7. Possible side effects
8. How to store Biotropil
9. Contents of the pack and other information
   1. Marketing Authorisation Holder and Manufacturer
   2. 20 Dec. 2013

Leaflet attached to the packaging: information for the user

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
You should keep this leaflet, so that you can read it again if you need to.
If you have any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed specifically for you. Do not pass it on to others.
The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist.
See section 4.

Table of contents of the leaflet

1. What is Biotropil and what is it used for
2. How to take Biotropil
3. Possible side effects
4. How to store Biotropil
5. Contents of the pack and other information

1. What is Biotropil and what is it used for

Biotropil is a medicine belonging to the group of nootropic medicines, which act on nerve cells and support blood circulation in the brain.
Biotropil reduces blood viscosity, increases blood flow through the vessels in the brain without dilating these vessels, and also increases oxygen utilization and glucose consumption in ischemic brain tissue.
Biotropil is used:
In adults:

• to treat cortical disorders (short-term, severe muscle spasms in one or more limbs or torso);
• to treat dizziness (feeling of spinning, loss of balance, feeling of falling, and fear of falling).

In children:

• to treat dyslexic disorders (difficulty learning to read and write).

2. How to take Biotropil

Adults:
Usually 1-2 tablets 2-3 times a day.
The medicine should be taken during meals.
Do not exceed the recommended dose.
Children over 12 years:
Usually 1 tablet 2-3 times a day.
The medicine should be taken during meals.
Do not exceed the recommended dose.
Treatment should be carried out under the supervision of a doctor.
If you feel that the medicine is too weak or too strong, you should consult a doctor.
Do not use in children under 12 years without a doctor's recommendation.

3. Possible side effects

Like all medicines, Biotropil can cause side effects, although not everybody gets them.
Possible side effects:

• Common (may affect up to 1 in 10 people):insomnia, excitement, headaches, dizziness, nausea, allergic reactions (hives, skin itching).
• Uncommon (may affect up to 1 in 100 people):dry mouth, gastrointestinal disorders (e.g., diarrhea, constipation), changes in blood test results (rarely of clinical significance).
• Rare (may affect up to 1 in 1,000 people):hypersensitivity reactions (e.g., angioedema, anaphylactic shock).

If you experience serious side effects, you should stop taking the medicine and consult a doctor.

4. How to store Biotropil

Store in a room temperature (15-25°C), in a dry and dark place.
Protect from light and moisture.
Store the medicine in a place inaccessible to children.
Do not use the medicine after the expiry date stated on the packaging.

5. Contents of the pack and other information

1 tablet contains active substance:piracetam 400 mg.
Other ingredients are: lactose monohydrate, corn starch, povidone, magnesium stearate.
Packaging: 30 tablets
Marketing Authorisation Holder: BIOTON S.A.ul. Romera 2, 05-220 Zielonka
Manufacturer: BIOTON S.A.ul. Romera 2, 05-220 Zielonka
Date of last revision of the leaflet: 01.02.2010

Warnings and precautions

Before starting to use Biotropil, you should discuss it with your doctor:

• if you have severe kidney disease (end-stage renal failure);
• if you have Huntington's disease (a progressive and incurable genetic disorder of the nervous system, characterized by irritability, depression, memory disorders, and involuntary movements).

Special caution should be exercised in patients:

• with a risk of bleeding (e.g., stomach and intestinal ulcers);
• with hemostasis disorders (a mechanism that prevents blood from flowing out of blood vessels), both in normal conditions and during damage to blood vessels;
• with a history of hemorrhagic stroke;
• taking anticoagulant medicines (e.g., acenocoumarol) or medicines that inhibit platelet aggregation (e.g., acetylsalicylic acid) - see "Biotropil and other medicines";
• undergoing major surgical procedures (including dental surgery);

if you have kidney function disorders (renal failure).
Your doctor may recommend a lower dose of the medicine - see section 3 "How to take Biotropil".
if you are elderly.
If you are regularly taking Biotropil and are elderly, your doctor will order regular blood tests and adjust the dose of the medicine accordingly.
In elderly patients with liver function disorders, your doctor will adjust the dose of the medicine - see section 3 "How to take Biotropil".
if you are taking Biotropil to treat myoclonus.
Do not stop taking Biotropil, even if it does not prevent myoclonus or seizures from recurring. You should consult your doctor - see section 3 "Stopping Biotropil treatment".

Remember to inform your doctor about all diseases you have had.

Side effects

See section 3 "How to take Biotropil".

Biotropil and other medicines

You should inform your doctor about all medicines you are taking, including those available without a prescription.
Biotropil may enhance the effect of anticoagulant medicines (e.g., acenocoumarol) and medicines that inhibit platelet aggregation (e.g., acetylsalicylic acid), increasing the risk of bleeding.
Biotropil may reduce the effect of antiepileptic medicines (e.g., phenytoin, carbamazepine, sodium valproate), reducing their effectiveness.
Biotropil may interact with alcohol, enhancing its sedative effect.

Biotropil with food and drink

Biotropil should be taken during meals.

Pregnancy and breastfeeding

Biotropil should not be used during pregnancy and breastfeeding, unless your doctor considers it absolutely necessary.

Driving and using machines

Biotropil may cause drowsiness and dizziness. If you experience such symptoms, you should not drive or operate machinery.

Dosage

The dosage is determined by your doctor individually, depending on your condition and response to treatment.

1. Myoclonus treatment:Usually 600-1200 mg per day, divided into 3-4 doses.
2. Seizure treatment in the elderly:Usually 600 mg per day, divided into 2-3 doses.
3. Treatment of neurological disorders in children:The dosage is determined by your doctor individually.

The maximum daily dose is 1200 mg.

How to take Biotropil

The medicine should be taken orally, during meals, with a sufficient amount of liquid.

Stopping Biotropil treatment

Do not stop taking Biotropil on your own. You should consult your doctor if you need to stop treatment.
Sudden stopping of Biotropil treatment may cause myoclonus or seizures to recur.

What to do in case of overdose

In case of overdose, you should immediately contact your doctor or go to the nearest hospital.
Symptoms of overdose may include: drowsiness, dizziness, nausea, vomiting, vision disorders, seizures.

Storage

Store in a room temperature (15-25°C), in a dry and dark place.
Protect from children.

Other information

The medicine should be used in accordance with your doctor's recommendations.
If you have any doubts, you should consult your doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
There is a lack of sufficient data on the use of piracetam in pregnant women.
Piracetam passes through the placental barrier. Therefore, Biotropil should not be used in pregnant women, unless there are clear indications and the benefits of taking the medicine outweigh the risk to the fetus, and the clinical condition of the pregnant patient requires treatment with piracetam.

Breastfeeding

Piracetam passes into breast milk.
Therefore, Biotropil should be avoided during breastfeeding or you should stop driving and operating machinery.
The medicine may affect your ability to drive and operate machinery. This effect should be taken into account.
During treatment with Biotropil, side effects such as nervousness, drowsiness, and excessive motor activity may occur. You should be careful when driving or operating machinery.
Biotropil contains lactose (a sugar found in milk). If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking this medicine.
Biotropil contains about 1.5 to 3 mmol (or 35 to 70 mg) of sodium per 24 g of piracetam (i.e., in 30 Biotropil 800 tablets or 20 Biotropil 1200 tablets). This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

How to take Biotropil

This medicine should always be used in accordance with your doctor's recommendations. If you have any doubts, you should consult your doctor or pharmacist.

Dose

1. For children over 3 years:
2. For children aged 3-7 years: 16 g of piracetam per day, in 2-3 divided doses.
3. For children aged 7-14 years: 24 g of piracetam per day, in 2-3 divided doses.
4. For adults and adolescents over 14 years: 24 g of piracetam per day, in 2-3 divided doses.

Method of administration

Tablets should be taken before meals.
The medicine can be taken during meals or between meals.
Tablets should be taken with a small amount of water.

If necessary, the dose is increased every 3-4 days by 4.8 g per day (i.e., 4 tablets of 1200 mg), up to a maximum dose of 24 g per day. The daily dose is given in 2 or 3 divided doses.

In combination therapy with other antibiotics, the doses of other medicines should be maintained within the recommended therapeutic doses. If clinical improvement is achieved and possible, the doses of other medicines should be reduced.
In patients with myoclonus, the symptoms may sometimes change, so every 6 months the doctor may attempt to reduce the dose or discontinue the medicine. To do this, the dose of the medicine should be reduced by 1.2 g (i.e., 1 tablet of 1200 mg) every 2 days, in order to prevent a sudden recurrence of the disease or the occurrence of seizures (generalized slow seizures due to sudden discontinuation of the medicine).

Treatment of dizziness

2.4 g per day should be administered in 3 divided doses (i.e., 1 tablet of 800 mg 3 times a day) for 8 weeks.

Use in children

Treatment of childhood units in logopedic therapy.
In combination with logopedic therapy in children aged 8 to 13 years:
3.2 g of the medicine per day in 2 divided doses (i.e., 2 tablets of 800 mg 2 times a day).

Use in the elderly

In elderly patients with liver function disorders, the doctor will adjust the dose of the medicine.

Use in patients with kidney and/or liver function disorders

Patients with kidney function disorders who do not have renal failure do not require a dose change. Patients with renal failure who have a creatinine clearance of less than 30 ml/min should receive 50% of the daily dose. In patients with renal failure and concomitant liver failure, the doctor will adjust the dose of the medicine.

Patients with liver function disorders

In patients with liver function disorders who do not have liver failure, a dose change is not required. Patients with liver failure should receive 50% of the daily dose.

Special warnings

Piracetam is excreted by the kidneys, so special caution should be exercised in patients with renal failure. The doctor will adjust the dose of the medicine according to the patient's health status.

Side effects

Uncommon:

• Gastrointestinal disorders (e.g., nausea, vomiting, diarrhea, abdominal pain).
• Neurological disorders (e.g., dizziness, insomnia, excitement, nervousness).

Rare:

• Liver function disorders (increased transaminase activity).
• Allergic reactions (e.g., rash, itching).

Very rare:

• Myoclonus.
• Seizures (in patients with a predisposition).
• Vision disorders.

Overdose

So far, no cases of piracetam overdose have been reported. In case of overdose, symptomatic treatment should be used.
Piracetam is not dialyzable.

Effect on ability to drive and use machines

Piracetam does not affect the ability to drive and use machines.

Interactions with other medicines and other interactions

Piracetam may enhance the effect of anticoagulant medicines. Caution should be exercised when using piracetam with anticoagulant medicines.
Piracetam may enhance the effect of stimulant medicines. Caution should be exercised when using piracetam with stimulant medicines.
Piracetam may reduce the effect of antiepileptic medicines. Caution should be exercised when using piracetam with antiepileptic medicines.
Piracetam may affect the absorption of medicines containing acetylsalicylic acid. Caution should be exercised when using piracetam with medicines containing acetylsalicylic acid.
Piracetam may enhance the effect of alcohol.
Piracetam should not be used concomitantly with benzodiazepine derivatives.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, piracetam should only be used when the benefit to the mother outweighs the potential risk to the child.

Dosage and method of administration

The dose and frequency of administration are determined by your doctor individually.
Method of administration: oral.
Tablets should be taken during meals, with a large amount of water.
Do not exceed the recommended dose.
If you miss a dose, you should take it as soon as possible, unless it is almost time for the next dose. In this case, you should skip the missed dose and take the next dose according to your doctor's recommendations.
Do not take two doses at the same time.
Do not stop treatment without consulting your doctor.
The medicine should be stored at room temperature, in a dry and dark place, out of the reach of children.

In case of any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (affects 1 to 10 users in 100):

• nervousness
• hyperkinesia (increased muscle activity)
• weight gain

Uncommon (affects 1 to 10 users in 1,000):

• depression
• drowsiness
• asthenia (a condition characterized by fatigue, exhaustion, weakness)

Frequency not known (cannot be estimated from the available data):

• bleeding disorders (impaired blood clotting)
• anaphylactic reactions (allergic reactions)
• You should immediately inform your doctor if you experience symptoms such as: skin redness, swelling, hives, throat swelling, shortness of breath, difficulty breathing.
• hypersensitivity (allergy)
• anxiety
• confusion (disorientation)
• hallucinations
• ataxia (disorder of coordination)
• balance disorders
• headache
• paralysis
• dizziness
• abdominal pain
• diarrhea
• nausea
• vomiting
• angioedema (sudden accumulation of fluid in the skin and mucous membranes, especially in the throat, tongue, face, or joints)
• itching
• hives (rash with intense itching and blistering)

Reporting of side effects
If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products (current address, phone number, and e-mail).

5. How to store Biotropil

Do not store above 25°C.
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What it contains

• The active substance of the medicine is piracetam.
• Biotropil 800
• One film-coated tablet contains 800 mg of piracetam.
• Biotropil 1200
• One film-coated tablet contains 1200 mg of piracetam.
• Other ingredients of the medicine are:
• tablet core: macrogol 6000, lactose monohydrate, sodium croscarmellose, magnesium stearate;
• tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc.

What Biotropil looks like and what the pack contains
Biotropil 800
Film-coated tablets, white, oblong, biconvex, with a smooth surface, with a dividing line on one side.
Film-coated tablets are packaged in PVC/PVDC/Aluminum blisters, together with the patient leaflet, in a cardboard box.
Pack size: 20, 30, 60, 90, 120, or 150 film-coated tablets
Biotropil 1200
Film-coated tablets, white, oblong, biconvex, with a smooth surface, with a dividing line on one side.
Film-coated tablets are packaged in PVC/PVDC/Aluminum blisters, together with the patient leaflet, in a cardboard box.
Pack size: 20, 24, 30, 60, 90, 96, or 120 film-coated tablets.
Not all pack sizes may be available.

Marketing Authorisation Holder and Manufacturer

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
email: [email protected]
Date of last revision of the leaflet:

20 Dec. 2013

BOARD OF DIRECTORS
QUALITY AND DEVELOPMENT DIRECTOR
Pharm. Andrzej Ostrowicz
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