BIOTROPIL 800 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 use Biotropil
4. Possible side effects
5. How to store Biotropil
6. Contents of the packaging and other information
   1. Warnings and precautions
   2. Special caution should be exercised in patients:
   3. It is essential to remember to inform the doctor about all diseases that have occurred so far.
   4. See section 3 "How to use Biotropil".
   5. Pregnancy and breastfeeding
   6. Driving and operating machinery
   7. Dosage
   8. Discontinuation of Biotropil treatment
   9. Biotropil and other medications
   10. Possible side effects
   11. Storage
   12. Pregnancy and breastfeeding
   13. Breastfeeding
   14. Driving and operating machinery
7. How to use Biotropil
   1. Dose
   2. Method of administration
   3. In case of taking a higher dose than recommended
   4. Missing a dose of the medicine
   5. Discontinuation of the medicine
   6. In case of need, the dose is increased every 3-4 days by 4.8 g per day (i.e. by 4 tablets of 1200 mg), up to a maximum daily dose of 24 g. The daily dose is given in 2 or 3 divided doses.In combined treatment with other antibiotics, the doses of other medications should be maintained within the recommended therapeutic ranges. If clinical improvement is achieved and it is possible - the doses of other medications should be reduced.In patients with myoclonus, the dose of the medicine may be reduced every 6 months. To do this, the dose of the medicine should be reduced by 1.2 g (i.e. by 1 tablet of 1200 mg) every 2 days, in order to prevent sudden recurrence of the disease or the occurrence of generalized seizures (slow generalized seizures due to sudden withdrawal of the medicine).The duration of treatment depends on the clinical picture.Treatment should be continued for at least 1-2 weeks after the symptoms have subsided.In patients with epilepsy, sudden withdrawal of the medicine should be avoided.In patients with kidney and/or liver function disorders, the doctor will adjust the dose of the medicine accordingly.Patients with kidney function disorders who do not have renal failure do not need to adjust the dose. Patients with renal failure, whose creatinine clearance is less than 30 ml/min, should receive 50% of the daily dose. Patients with liver function disorders, the doctor will adjust the dose of the medicine accordingly.Patients with renal failure. The doctor will adjust the dose of the medicine according to the patient's health status.The dose should be individualized according to the patient's clinical condition.The initial dose is usually 2.4-4.8 g per day, given in 2-3 divided doses.In case of need, the dose is increased every 3-4 days by 4.8 g per day (i.e. by 4 tablets of 1200 mg), up to a maximum daily dose of 24 g. The daily dose is given in 2 or 3 divided doses.In combined treatment with other antibiotics, the doses of other medications should be maintained within the recommended therapeutic ranges. If clinical improvement is achieved and it is possible - the doses of other medications should be reduced.In patients with myoclonus, the dose of the medicine may be reduced every 6 months. To do this, the dose of the medicine should be reduced by 1.2 g (i.e. by 1 tablet of 1200 mg) every 2 days, in order to prevent sudden recurrence of the disease or the occurrence of generalized seizures (slow generalized seizures due to sudden withdrawal of the medicine).The duration of treatment depends on the clinical picture.Treatment should be continued for at least 1-2 weeks after the symptoms have subsided.In patients with epilepsy, sudden withdrawal of the medicine should be avoided.In case of any further doubts about the use of this medicine, you should consult a doctor or pharmacist.
8. Possible side effects
9. How to store Biotropil
10. Contents of the packaging and other information
    1. Responsible entity and manufacturer
    2. December 20, 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 necessary.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to a specific person. It should not be given to others.
The medicine may harm another person, even if the symptoms of their illness 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 use Biotropil
3. Possible side effects
4. How to store Biotropil
5. Contents of the packaging and other information

1. What is Biotropil and what is it used for

Biotropil is a medicine from 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 the brain's ischemic tissue.
Biotropil is used:

• In adults:
• to treat memory disorders of cortical origin (short-term, severe ("lightning") muscle contractions in one or more limbs or torso);
• to treat dizziness (feeling of spinning, loss of balance, sinking, and fear of falling).
• In children:
• to treat dyslexic disorders (difficulty learning to read and write).

2. How to use Biotropil

Adults:
Usually 1-2 tablets 2-3 times a day.
The medicine should be taken during meals.
The recommended dose should not be exceeded.
Children over 12 years old:
Usually 1 tablet 2-3 times a day.
The medicine should be taken during meals.
The recommended dose should not be exceeded.
Treatment should be carried out for a longer period (at least 4 weeks), and its effectiveness should be assessed by a doctor.
If the patient feels that the medicine is working too weakly or too strongly, they should consult a doctor.
The medicine should not be discontinued without consulting a doctor.

3. Possible side effects

Like any medicine, Biotropil can cause side effects, although not everybody gets them.
Possible side effects:

• Nervous system disorders: headaches, dizziness, insomnia, agitation, feeling of anxiety, hand tremors.
• Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain.
• Circulatory system disorders: decrease in blood pressure.
• Allergic reactions: skin rash, itching, hives, angioedema.

In case of severe side effects, the medicine should be discontinued immediately and a doctor consulted.

4. How to store Biotropil

Store at room temperature (15-25°C), in a dry and dark place.
Protect from children.
Do not use after the expiration date stated on the packaging.

5. Contents of the packaging and other information

1 tablet contains active substance:piracetam 400 mg.
Other ingredients are: lactose monohydrate, corn starch, povidone, magnesium stearate.
Packaging: 30 tablets
Responsible entity: BIOTON S.A., ul. Poprzeczna 29, 02-953 Warszawa
Manufacturer: BIOTON S.A., ul. Poprzeczna 29, 02-953 Warszawa

Warnings and precautions

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

• if the patient has severe kidney disease (end-stage renal failure);
• if the patient has Huntington's chorea (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. in gastric and intestinal ulcer disease);
• 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 medications (e.g. acenocoumarol) or medications that inhibit platelet aggregation (e.g. acetylsalicylic acid) - see "Biotropil and other medications";
• undergoing major surgical procedures (including dental surgery);

if the patient has kidney function disorders (renal failure).
The doctor may recommend using lower doses of the medicine - see section 3 "How to use Biotropil".
if the patient is elderly.
In the case of regular use of Biotropil in elderly patients, the doctor will order regular blood tests and adjust the dose of the medicine accordingly.
In elderly patients with liver function disorders, the doctor will adjust the dose of the medicine accordingly - see section 3 "How to use Biotropil".
if the patient is taking Biotropil to treat myoclonus.
Do not discontinue treatment in these patients to avoid recurrence of myoclonus or generalized seizures associated with sudden withdrawal of the medicine - see "Discontinuation of Biotropil treatment".

It is essential to remember to inform the doctor about all diseases that have occurred so far.

See section 3 "How to use Biotropil".

See "Biotropil and other medications".

Pregnancy and breastfeeding

Biotropil should not be used during pregnancy and breastfeeding, unless the doctor considers it absolutely necessary.
Before using the medicine, you should consult a doctor.

Driving and operating machinery

Biotropil may cause drowsiness and dizziness. If such symptoms occur, you should not drive vehicles or operate machinery.
You should avoid consuming alcohol while using the medicine.

Dosage

The dosage is determined by the doctor individually.
Usually used doses:

1. Adults: 3 times a day, 1 tablet (300 mg) 30 minutes before meals.
2. Children over 12 years old: the dosage is determined by the doctor.

Maximum daily dose: 900 mg.
Treatment should be continued for the period specified by the doctor.
In case of a missed dose, it should be taken as soon as possible, unless the time for the next dose is near. In such a case, the missed dose should be skipped and the next dose taken at the usual time.
A double dose should not be used to make up for a missed dose.

Discontinuation of Biotropil treatment

Biotropil treatment should not be discontinued without consulting a doctor, as this may cause worsening of the disease symptoms.
In patients treated with Biotropil for myoclonus, sudden withdrawal of the medicine may cause generalized seizures.
In case of need to discontinue treatment, the dose of the medicine should be gradually reduced under the doctor's supervision.

Biotropil and other medications

You should inform the doctor about all medications being taken, including those available without a prescription.
Biotropil may interact with the following medications:

• anticoagulant medications (e.g. acenocoumarol);
• medications that inhibit platelet aggregation (e.g. acetylsalicylic acid);
• sedatives and hypnotics;
• alcohol.

Using Biotropil with other medications may enhance sedative and hypnotic effects.
Alcohol should not be consumed while using Biotropil.

Possible side effects

Like any medicine, Biotropil can cause side effects, although not everybody gets them.
Common side effects:

• drowsiness;
• dizziness;
• fatigue;
• gastrointestinal disorders (e.g. nausea, vomiting, diarrhea, constipation);
• weakness.

Rare side effects:

• allergic reactions (e.g. rash, itching, angioedema);
• vision disorders;
• speech disorders;
• coordination disorders;
• tremors;
• sleep disorders;
• depression;
• weight gain.

In case of side effects, you should inform the doctor.

Storage

Store at room temperature (15-25°C), in a dry and dark place.
Protect from children.
Do not use after the expiration date stated on the packaging.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine.
There is insufficient data on the use of piracetam in pregnant women.
Piracetam crosses 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 is excreted into breast milk.
Therefore, Biotropil should be avoided during breastfeeding or breastfeeding should be discontinued.

Driving and operating machinery

The medicine may affect the ability to drive vehicles and operate machinery. This effect should be taken into account.
While using Biotropil, side effects such as nervousness, drowsiness, and excessive motor activity may occur. Caution should be exercised when driving vehicles or operating machinery.
Biotropil contains lactose (a sugar found in milk).
If you have been diagnosed with intolerance to some sugars, you should contact 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. per 30 tablets of Biotropil 800 or 20 tablets of Biotropil 1200). This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to use Biotropil

This medicine should always be used as directed by the doctor. In case of doubts, you should consult a doctor or pharmacist.

Dose

Adults and children over 12 years old:

• Usually 24 g of piracetam per day.
• The dose should be divided into 3 doses (e.g. 8 g 3 times a day).

In patients with kidney function disorders, the dosage should be adjusted according to the degree of renal failure.

Method of administration

Tablets should be taken during meals or between meals.
Biotropil tablets should not be taken with milk.

In case of taking a higher dose than recommended

In case of taking a higher dose than recommended, you should immediately contact a doctor or pharmacist.
Symptoms of overdose may include: nervousness, insomnia, tremors, headaches, nausea, vomiting, diarrhea.

Missing a dose of the medicine

A double dose should not be used to make up for a missed dose. The next dose should be taken as directed.

Discontinuation of the medicine

The medicine should not be discontinued without consulting a doctor, as this may cause worsening of the disease symptoms.

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

In combined treatment with other antibiotics, the doses of other medications should be maintained within the recommended therapeutic ranges. If clinical improvement is achieved and it is possible - the doses of other medications should be reduced.
In patients with myoclonus, the dose of the medicine may be reduced every 6 months. To do this, the dose of the medicine should be reduced by 1.2 g (i.e. by 1 tablet of 1200 mg) every 2 days, in order to prevent sudden recurrence of the disease or the occurrence of generalized seizures (slow generalized seizures due to sudden withdrawal of the medicine).
The duration of treatment depends on the clinical picture.
Treatment should be continued for at least 1-2 weeks after the symptoms have subsided.
In patients with epilepsy, sudden withdrawal of the medicine should be avoided.
In patients with kidney and/or liver function disorders, the doctor will adjust the dose of the medicine accordingly.
Patients with kidney function disorders who do not have renal failure do not need to adjust the dose. Patients with renal failure, whose creatinine clearance is less than 30 ml/min, should receive 50% of the daily dose. Patients with liver function disorders, the doctor will adjust the dose of the medicine accordingly.
Patients with renal failure. The doctor will adjust the dose of the medicine according to the patient's health status.
The dose should be individualized according to the patient's clinical condition.
The initial dose is usually 2.4-4.8 g per day, given in 2-3 divided doses.
In case of need, the dose is increased every 3-4 days by 4.8 g per day (i.e. by 4 tablets of 1200 mg), up to a maximum daily dose of 24 g. The daily dose is given in 2 or 3 divided doses.
In combined treatment with other antibiotics, the doses of other medications should be maintained within the recommended therapeutic ranges. If clinical improvement is achieved and it is possible - the doses of other medications should be reduced.
In patients with myoclonus, the dose of the medicine may be reduced every 6 months. To do this, the dose of the medicine should be reduced by 1.2 g (i.e. by 1 tablet of 1200 mg) every 2 days, in order to prevent sudden recurrence of the disease or the occurrence of generalized seizures (slow generalized seizures due to sudden withdrawal of the medicine).
The duration of treatment depends on the clinical picture.
Treatment should be continued for at least 1-2 weeks after the symptoms have subsided.
In patients with epilepsy, sudden withdrawal of the medicine should be avoided.

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

4. Possible side effects

Like any medicine, this medicine can cause side effects, although not everybody gets them.
Common (occurring in 1 to 10 out of 100 patients):

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

Uncommon (occurring in 1 to 10 out of 1,000 patients):

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

Frequency not known (cannot be estimated from 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, angioedema, throat swelling, shortness of breath, difficulty breathing.
• hypersensitivity (allergy)
• anxiety
• confusion (disorientation)
• hallucinations
• ataxia (coordination disorder)
• balance disorders
• headache
• insomnia
• 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)
• hair loss
• itching
• hives (rash with intense itching and blistering)

Reporting side effects
If you experience any side effects, including any side effects not listed in this 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, Medical Devices, and Biocidal Products (current address, phone number, and email on the website:

5. How to store Biotropil

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the box and blister pack.
The expiration date means the last day of the specified month.
Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging 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: macrogol 6000, lactose monohydrate, sodium carboxymethylcellulose, magnesium stearate;
• tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 4000, talc.

What Biotropil looks like and what the packaging 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, placed together with the patient leaflet in a cardboard box.
Packaging 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, placed together with the patient leaflet in a cardboard box.
Packaging size: 20, 24, 30, 60, 90, 96 or 120 film-coated tablets.
Not all packaging sizes may be available.

Responsible entity 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 update of the leaflet:

December 20, 2013

BOARD OF DIRECTORS
QUALITY AND DEVELOPMENT DIRECTOR
Pharm. Andrzej Ostrowicz
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