Memotropil

Package Leaflet: Information for the Patient

Memotropil, 800 mg, Film-Coated Tablets

Memotropil, 1200 mg, Film-Coated Tablets

Piracetam

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Memotropil and what is it used for
• 2. Important information before taking Memotropil
• 3. How to take Memotropil
• 4. Possible side effects
• 5. How to store Memotropil
• 6. Contents of the pack and other information

1. What is Memotropil and what is it used for

Memotropil contains the active substance piracetam, which belongs to the group of psychostimulant drugs.
Piracetam works by affecting energy changes in the cells of the central nervous system (CNS), increasing oxygen and glucose utilization.
Memotropil is indicated for the treatment of:

• dyslexic disorders in children, in combination with speech therapy;
• cortical myoclonus (short, sudden muscle contractions in one or more limbs or trunk);
• vertigo (feeling of spinning, loss of balance, feeling of falling, and fear of falling).

2. Important information before taking Memotropil

When not to take Memotropil:

Warnings and precautions

Particular caution should be exercised when taking Memotropil:

• in patients with renal impairment (the doctor may recommend a lower dose of the medicine);
• in patients with severe bleeding, patients at risk of bleeding (such as those with gastrointestinal ulcers), patients with hemostasis disorders (blood clotting), patients after cerebrovascular bleeding, patients undergoing major surgical procedures (including dental procedures), and patients taking anticoagulant or antiplatelet medications (including low-dose acetylsalicylic acid);
• in elderly patients.

Memotropil and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, especially:

• thyroid hormones;
• anticoagulant medications such as acenocoumarol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Pregnancy
Piracetam crosses the placental barrier.
Therefore, Memotropil should not be taken by 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.
Due to the risk of side effects in breastfed infants, breastfeeding should be discontinued during treatment with Memotropil.

Driving and using machines

Memotropil may cause drowsiness and tremors. If these occur, do not drive or operate any machines.

Memotropil 800 mg, film-coated tablets contain sunset yellow FCF (E 110) and quinoline yellow (E 104), and Memotropil 1200 mg, film-coated tablets contain sunset yellow FCF (E 110)

The medicine may cause allergic reactions.

Sodium

Memotropil 800 mg, film-coated tablets

The medicine contains 1.68 mg of sodium (the main component of common salt) per film-coated tablet.
This corresponds to 0.084% of the maximum recommended daily intake of sodium in the diet for adults.
In the maximum single dose of 12 g of piracetam (15 film-coated tablets), there is 25.2 mg of sodium. This corresponds to 1.26% of the maximum recommended daily intake of sodium in the diet for adults.

Memotropil 1200 mg, film-coated tablets

The medicine contains 2.35 mg of sodium (the main component of common salt) per film-coated tablet.
This corresponds to 0.118% of the maximum recommended daily intake of sodium in the diet for adults.
In the maximum single dose of 12 g of piracetam (10 film-coated tablets), there is 23.5 mg of sodium. This corresponds to 1.175% of the maximum recommended daily intake of sodium in the diet for adults.

Memotropil 800 mg, film-coated tablets and Memotropil 1200 mg, film-coated tablets contain lecithin (of soy origin)

The medicine contains soybean lecithin. Do not take if you are hypersensitive to peanuts or soy.

3. How to take Memotropil

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Usual dose:

Treatment of dyslexic disorders in combination with speech therapy
In combination with speech therapy, children from 8 years of age and adolescents are given 3.2 g of piracetam per day in 2 divided doses.
Treatment of cortical myoclonus
Initially, 7.2 g of piracetam per day (in 3 divided doses) is administered.
If necessary, the dose is increased every 3-4 days by 4.8 g of piracetam per day, 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 anti-myoclonic medications, the doses of other medications should be maintained at the recommended therapeutic doses. If clinical improvement is achieved and possible, the doses of other medications should be reduced.
Piracetam treatment should be continued as long as the underlying brain disease persists.
In patients with an acute episode, the doctor may try to reduce the dose or discontinue the medicine every 6 months. However, to prevent sudden relapse of the disease or seizures due to withdrawal, the doctor may reduce the piracetam dose by 1.2 g every 2-4 days.
Treatment of vertigo
The recommended dose is from 2.4 g to 4.8 g of piracetam per day in 2 or 3 divided doses.

Use in elderly patients

In elderly patients treated long-term with piracetam, the doctor will individually adjust the dose of the medicine.

Use in patients with renal impairment

The daily dose will be determined by the doctor individually, depending on the renal function.

Use in patients with hepatic impairment

There is no need to modify the dose in patients with hepatic impairment only.

Overdose of Memotropil

In case of overdose, contact your doctor or go to the nearest hospital immediately.
Piracetam has low toxicity. During administration of very high doses of the medicine, side effects may be intensified. In patients with renal failure, accumulation of the medicine may occur.

Missed dose of Memotropil

If you miss a dose, take it as soon as possible. If it is already time for the next dose, do not take the missed dose. Do not take a double dose to make up for the missed dose.

Discontinuation of Memotropil

Do not stop taking the medicine without consulting your doctor. After discontinuation of the treatment in patients with myoclonus, relapse of the disease or seizures may occur.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common side effects (in less than 1 in 10 patients)

• increased motor activity (hyperkinesia)
• weight gain
• nervousness.

Uncommon side effects (in less than 1 in 100 patients)

• drowsiness
• depression
• weakness (asthenia).

Rare side effects (frequency cannot be estimated from the available data)

• vertigo
• bleeding disorders
• nausea, vomiting, diarrhea, abdominal pain, epigastric pain
• anaphylactoid reactions (allergic), hypersensitivity. You should immediatelyinform your doctor if you experience symptoms such as: skin redness, swelling, hives, shortness of breath, throat swelling, breathing difficulties.
• coordination disorders (ataxia), balance disorders, exacerbation of epilepsy, headache, insomnia
• excitement, anxiety, confusion (disorientation), hallucinations
• angioedema, skin inflammation, itching, hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products)
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Memotropil

Do not store above 25°C. Store in the original package to protect from light and moisture.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Memotropil contains

• The active substance is piracetam. Each film-coated tablet contains 800 mg or 1200 mg of piracetam.
• The other ingredients are: tablet core: potato starch, microcrystalline cellulose, sodium carboxymethyl cellulose (type C), colloidal anhydrous silica, magnesium stearate; tablet coating: Memotropil 800 mg: (Opadry II Yellow 85G38109) with the composition: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 4000, soybean lecithin, lake with sunset yellow FCF (E 110), lake with quinoline yellow (E 104). Memotropil 1200 mg: (Opadry II Orange 85G33228) with the composition: polyvinyl alcohol, talc, titanium dioxide (E 171), macrogol 4000, soybean lecithin, lake with sunset yellow FCF (E 110), indigo carmine lake (E 132).

What Memotropil looks like and contents of the pack

The tablets are bean-shaped, biconvex, with a dividing line and a slightly rough surface. The tablet can be divided into equal doses.
The 800 mg tablets are yellow, and the 1200 mg tablets are orange.
The pack contains:
20 or 60 film-coated tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of last revision of the leaflet: