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Package Leaflet: Information for the User
Ciclofalina 800 mg Powder for Oral Solution
Piracetam
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Contents of the pack:
The active substance of Ciclofalina is piracetam. Piracetam is a nootropic substance, without sedative or psycho-stimulant effects, indicated for the treatment of attention and memory disorders, difficulties in daily activity and adaptation to the environment, which accompany states of mental deterioration due to a degenerative brain disease related to age.
It is also indicated for the treatment of cortical myoclonus.
Do not take Ciclofalina
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
Taking Ciclofalina with other medicines
Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.
Only one case has been described in which piracetam and thyroid hormone extracts (T3 and T4) taken at the same time have led to confusion, irritability, and sleep disorders.
To date, no further interactions with other medicines have been detected.
Taking Ciclofalina with food, drink, and alcohol
The tablets should be taken with the help of a liquid. This medicine can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Although no adverse effects have been described in animal studies, this medicine should be avoided during pregnancy. If you take piracetam accidentally, it is not expected to affect the fetus.
Breastfeeding
The use of this medicine should be avoided during breastfeeding or breastfeeding should be discontinued during treatment.
Driving and using machines
Considering the possible side effects observed with piracetam, it is possible that they may affect the ability to drive and use machinery, which should be taken into account.
Elderly patients
In elderly patients, it is recommended to visit the doctor regularly so that they can indicate the correct dose.
Ciclofalina contains sucrose and tartrazine (E-102)
This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.
It also contains tartrazine (E-102) as an excipient, which may cause allergic reactions. It can cause asthma, especially in patients allergic to acetylsalicylic acid.
Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
The recommended dose is:
For the symptomatic treatment of mental deterioration states:
Start treatment by administering 6 sachets per day (4.8 g of piracetam) for the first few weeks, and continue treatment with 3 sachets per day (2.4 g of piracetam).
The daily dose will be administered in 2 or 3 doses.
For the treatment of cortical myoclonus:
Start treatment with 9 sachets per day (7.2 g of piracetam) and gradually increase the dose by 4.8 g of piracetam (6 sachets) per day, every 3-4 days, until a satisfactory response is obtained or up to a maximum of 30 sachets per day (24 g of piracetam).
The daily dose will be administered in 2 or 3 doses, maintaining the other antimioclonic treatments with their posology. Then, depending on the clinical response obtained, the dose of the other antimioclonic medicines will be reduced, if possible.
Once treatment with this medicine has been started, it should be maintained for as long as the original cerebral pathology persists. However, every 6 months, an attempt should be made to decrease or discontinue 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.
Instructions for the correct administration of the preparation
The powder from the sachets is poured into a glass of water and shaken to obtain its dissolution.
If you take more Ciclofalina than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 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 when it is due.
If you stop taking Ciclofalina
To avoid the sudden reappearance of the condition, the attempt to withdraw treatment should be made by reducing the dose by 1.2 g of piracetam every 2 days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequencies of side 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 the available data)
The side effects described with this medicine are the following:
Common: weight gain, nervousness, tremor.
Uncommon: somnolence, depression, fatigue.
The incidence of side effects in controlled studies is less than 2% and, in general, have been presented with doses higher than 2.4 g of piracetam (3 sachets) per day in elderly patients. In most cases, a reduction in dose has been sufficient for them to disappear.
Other side effects of unknown frequency:
Vertigo, intestinal disorders (nausea, vomiting, diarrhea, stomach pain), hypersensitivity reactions, lack of coordination, loss of balance, worsening of epilepsy, headache, insomnia, agitation, anxiety, confusion, hallucinations, and skin disorders have also been occasionally described.
Very rarely, local pain, thrombophlebitis, fever, or decreased blood pressure have been reported.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist, even if it is possible that they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System.
Keep out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date which is stated on the packaging after "CAD". The expiry date is the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on how to dispose of the packaging and any unused medicine, ask your pharmacist. This will help protect the environment.
Composition of Ciclofalina
Appearance and packaging of the product
White powder packaged in monodose sachets of paper, aluminum, and polyethylene, and presented in packs of 30 and 60 sachets.
Other presentations:
Ciclofalina 800 mg film-coated tablets. Packs containing 20 and 60 tablets.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of last revision of this leaflet: February 2004
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
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