CICLOFALINA 800 MG FILM-COATED TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ciclofalina 800 mg film-coated tablets

Piracetam

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

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

Leaflet contents:

1. What Ciclofalina is and what it is used for
2. What you need to know before taking Ciclofalina
3. How to take Ciclofalina
4. Possible adverse effects
5. How to store Ciclofalina
6. Contents of the pack and other information

1. What Ciclofalina is and what it is used for

The active substance in Ciclofalina is piracetam. Piracetam is a nootropic agent without sedative or psychostimulant effects, indicated for the treatment of attention and memory disorders, and difficulties in daily activities and adaptation to the environment, which accompany states of mental deterioration due to age-related degenerative brain disease.

It is also indicated for the treatment of cortical myoclonus.

2. What you need to know before taking Ciclofalina

Do not take Ciclofalina

• If you are allergic to piracetam or to any of the other ingredients of this medicine (listed in section 6).
• If you have cerebral hemorrhage.
• If you have end-stage renal failure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

• If you have kidney problems, a lower dose will be administered depending on the severity of the kidney impairment; your doctor will indicate the appropriate dose.
• Abrupt discontinuation of treatment should be avoided in myoclonic patients, as it may trigger a myoclonic or generalized seizure.

Taking Ciclofalina with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

There has been only one reported case in which concomitant use of piracetam and thyroid hormone extracts (T3 and T4) resulted in confusion, irritability, and sleep disturbances.

To date, no further interactions with other medicines have been detected.

Taking Ciclofalina with food, drink, and alcohol

The tablets should be taken with liquid. This medicine may be taken with or without food.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Although no adverse effects have been reported in animal studies, this medicine should be avoided during pregnancy. If you take piracetam accidentally, no harm to the fetus is expected.

Breastfeeding

The use of this medicine should be avoided during breastfeeding, or breastfeeding should be discontinued during treatment.

Driving and using machines

Given the possible adverse effects observed with piracetam, your ability to drive and operate machinery may be impaired, and this should be taken into account.

Elderly patients

In elderly patients, it is recommended to visit your doctor regularly so that they can determine the correct dose.

Ciclofalina contains sunset yellow FCF (E-110)

This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may provoke asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Ciclofalina

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

The recommended dose is:

For symptomatic treatment of mental deterioration states:

Begin treatment with 6 tablets per day (4.8 g of piracetam) during the first weeks, and continue treatment with 3 tablets per day (2.4 g of piracetam).

The daily dose should be divided into 2 or 3 doses.

For treatment of cortical myoclonus:

Begin treatment with 9 tablets per day (7.2 g of piracetam) and increase the dosage by 4.8 g of piracetam (6 tablets) per day every 3–4 days, until a satisfactory response is achieved or until the maximum dose of 30 tablets per day (24 g of piracetam) is reached.

The daily dose should be divided into 2 or 3 doses, while maintaining other antimyoclonic treatments at their usual dosage. Subsequently, depending on the clinical response obtained, the dose of the other antimyoclonic drugs should be reduced, if possible.

Once treatment with this medicine has been initiated, it should be maintained as long as the underlying brain disorder persists. However, every 6 months, an attempt should be made to reduce or discontinue the treatment.

Note: Patients with kidney problems should take a lower dose (see "Warnings and precautions").

The duration of treatment depends on the type, duration, and course of the symptoms.

If you think that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

If you take more Ciclofalina than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ciclofalina

Do not take a double dose to make up for missed doses. Continue taking your normal dose at the next scheduled time.

If you stop taking Ciclofalina

To avoid the sudden recurrence of the condition, any attempt to withdraw treatment should be done by reducing the dose by 1.2 g of piracetam (1.5 tablets) every 2 days.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The frequencies of adverse effects are listed below according to the following definitions:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Frequency not known (cannot be estimated from available data)

The adverse effects reported with this medicine in controlled studies are the following:

Common: weight gain, nervousness, tremor

Uncommon: somnolence, depression, fatigue

The incidence of these side effects is less than 2%, and they generally occurred with doses exceeding 2.4 g of piracetam (3 tablets) per day in elderly patients.

In most cases, reducing the dose has been sufficient for these effects to disappear.

Other adverse effects with frequency not known:

Occasionally reported adverse effects include dizziness, gastrointestinal disorders (nausea, vomiting, diarrhoea, stomach pain), hypersensitivity reactions, lack of coordination, loss of balance, worsening of epilepsy, headache, insomnia, agitation, anxiety, confusion, hallucinations and skin disorders.

Very rarely, local pain, thrombophlebitis, fever or decreased blood pressure have been reported.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ciclofalina

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Ciclofalina

• The active substance is piracetam. Each tablet contains 800 mg of piracetam.
• The other components (excipients) are: povidone (E-1201), magnesium stearate (E-470b), and Opadry yellow [polyvinyl alcohol, macrogol 4000, quinoline yellow (E-104), talc, titanium dioxide (E-171), sunset yellow FCF (E-110)].

Appearance of the medicinal product and contents of the pack

Yellow tablets, packed in PVC/aluminum blisters and available in packs of 20 and 60 tablets.

Other presentations:

Ciclofalina 800 mg powder for oral solution. Packs containing 30 and 60 sachets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this leaflet: February 2004

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/