Ciclofalina 800 mg powder for oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: Information for the user
Ciclofalina 800 mg powder for oral solution
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 other people, even if they have the same symptoms as you, because 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:
- What Ciclofalina is and what it is used for
- What you need to know before taking Ciclofalina
- How to take Ciclofalina
- Possible side effects
- How to store Ciclofalina
- 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 components of this medicine (listed in section 6).
- If you have cerebral hemorrhage.
- If you have end-stage renal failure.
Warnings and precautions
Talk to 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 problems; 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.
Only one case has been reported in which piracetam and thyroid hormone extracts (T3 and T4) taken simultaneously resulted in confusion, irritability, and sleep disturbances.
To date, no further interactions with other medicines have been identified.
Taking Ciclofalina with food, drink, and alcohol
The tablets should be taken with liquid. This medicine can 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, fetal harm is not expected.
Breastfeeding
The use of this medicine should be avoided during breastfeeding, or breastfeeding should be discontinued during treatment.
Driving and use of machines
Given the possible adverse effects observed with piracetam, your ability to drive or operate machinery may be impaired; this should be taken into account.
Elderly patients
In elderly patients, regular medical check-ups are recommended so that the doctor can determine the appropriate dose.
Ciclofalina contains sucrose and tartrazine (E-102)
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
It also contains tartrazine (E-102) as an excipient, which may cause allergic reactions. It may cause asthma, especially 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 by administering 6 sachets per day (4.8 g of piracetam) during the first weeks, and continue treatment with 3 sachets per day (2.4 g of piracetam).
The daily dose should be divided into 2 or 3 doses.
For the treatment of cortical myoclonus:
Begin treatment with 9 sachets per day (7.2 g of piracetam) and gradually increase the dosage by 4.8 g of piracetam (6 sachets) every 3–4 days, until a satisfactory response is achieved or until the maximum of 30 sachets 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 dosages. Subsequently, depending on the clinical response obtained, the dose of the other antimyoclonic drugs may be reduced if possible.
Once treatment with this medicine has been initiated, it should be maintained for as long as the underlying brain pathology 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 symptoms.
If you think that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.
Instructions for correct administration of the preparation
Empty the powder from the sachet into a glass of water and stir to dissolve.
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 forgotten doses. Continue taking your normal dose at the next scheduled time.
If you stop taking Ciclofalina
To avoid a sudden recurrence of the condition, any attempt to discontinue treatment should be done by reducing the dose by 1.2 g of piracetam 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 are as follows:
Common: weight gain, nervousness, tremor.
Uncommon: somnolence, depression, fatigue.
The incidence of side effects in controlled studies is less than 2%, and they have generally occurred with doses exceeding 2.4 g of piracetam (3 sachets) per day in elderly patients. In most cases, reducing the dose has been sufficient for these effects to disappear.
Other adverse effects with unknown frequency:
Occasionally reported are 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 through the Spanish Pharmacovigilance System of
5. Storage of Ciclofalina
Keep out of the sight and reach of children.
Special storage conditions are not 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 the 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. Contents of the pack and other information
Composition of Ciclofalina
- The active substance is piracetam. Each sachet contains 800 mg of piracetam.
- The other components (excipients) are: sucrose, sodium saccharin, lemon flavor, tartrazine (E-102), and ammonium glycyrrhizinate.
Appearance of the medicine and contents of the pack
White powder contained in single-dose sachets made of coated paper/aluminum/polyethylene, available in packs of 30 and 60 sachets.
Other presentations:
Ciclofalina 800 mg film-coated tablets. Packs containing 20 and 60 tablets.
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 review of this leaflet: February 2004
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/