CICLOFALINA 800 mg FILM-COATED TABLETS
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How to use CICLOFALINA 800 mg FILM-COATED TABLETS
Introduction
Leaflet: Information for the user
Ciclofalina 800 mg film-coated tablets
Piracetam
Read the entire leaflet carefully before starting to take this medication, 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 medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet:
- What is Ciclofalina and what is it used for
- What you need to know before taking Ciclofalina
- How to take Ciclofalina
- Possible side effects
- Storage of Ciclofalina
- Package contents and additional information
1. What is Ciclofalina and what is it used for
The active ingredient of Ciclofalina is piracetam. Piracetam is a nootropic substance, without sedative or psychostimulant effects, indicated for the treatment of attention and memory disorders, difficulties in daily activities and adaptation to the environment, which accompany mental deterioration due to age-related cerebral degenerative 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 any of the other components of this medication (listed in section 6).
- If you have a cerebral hemorrhage.
- If you have terminal renal insufficiency.
Warnings and precautions
Consult your doctor or pharmacist before starting to take this medication.
- If you have kidney problems, a smaller dose will be administered according to the severity of the kidney problems; your doctor will indicate the dose to take.
- Abrupt withdrawal of treatment should be avoided in myoclonic patients, as it may cause a myoclonic or generalized crisis.
Taking Ciclofalina with other medications
Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.
Only one case has been reported in which piracetam and thyroid hormone extracts (T3 and T4) taken together have caused confusion, irritability, and sleep disorders.
To date, no other interactions with other medications have been detected.
Taking Ciclofalina with food, drink, and alcohol
The tablets should be taken with the help of a liquid. This medication can be taken with or without food.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.
Pregnancy
Although no adverse effects have been reported in animal studies, this medication should be avoided during pregnancy. If you take piracetam accidentally, it is not expected to affect the fetus.
Breastfeeding
The use of this medication 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 to indicate the correct dose.
Ciclofalina contains orange yellow S (E-110)
This medication may cause allergic reactions because it contains orange yellow S (E-110). It can cause asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Ciclofalina
Follow the administration instructions of this medication exactly as 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:
Start treatment by administering 6 tablets per day (4.8 g of piracetam) for the first few weeks, and continue treatment with 3 tablets 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 tablets per day (7.2 g of piracetam) and gradually increase the dose by 4.8 g of piracetam (6 tablets) per day, every 3-4 days, until a satisfactory response is obtained or up to a maximum of 30 tablets 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 medications will be reduced, if possible.
Once treatment with this medication has 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 the effect of this medication 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, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 interrupt treatment with 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 (1.5 tablets) every 2 days.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone will experience them.
The frequencies of side effects have been 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 side effects described with this medication, in controlled studies, are as follows:
Common: weight gain, nervousness, tremor
Uncommon: somnolence, depression, fatigue.
The incidence of these side effects is less than 2% and, in general, have been reported with doses higher than 2.4 g of piracetam (3 tablets) per day in elderly patients.
In most cases, a dose reduction 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 reported.
Very rarely, local pain, thrombophlebitis, fever, or decreased blood pressure have been reported.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.
5. Storage of Ciclofalina
Keep out of sight and reach of children.
No special storage conditions are required.
Do not use this medication after the expiration date shown on the packaging after "CAD". The expiration date is the last day of the month indicated.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Ciclofalina
- The active ingredient 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), orange yellow S (E-110)].
Appearance of the product and package contents
Yellow tablets packaged in PVC/Aluminum blisters and presented in packages of 20 and 60 tablets.
Other presentations:
Ciclofalina 800 mg powder for oral solution. Packages containing 30 and 60 sachets.
Not all package sizes may be marketed.
Marketing authorization holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona Spain
INDUSTRIAS FARMACEUTICAS ALMIRALL PRODESFARMA, S.L.
Ctra. Nacional II, Km. 593 Sant Andreu de la Barca 08740 (Barcelona) Spain
Date of the last revision of this leaflet: February 2004
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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