Package Insert: Information for the User

Ciclofalina 800 mg powder for oral solution

Piracetam

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 not listed in this package insert. See section 4.

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 states of mental deterioration due to a degenerative brain disease related to age.

It is also indicated for the treatment of cortical myoclonias.

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; the dose to be taken will be indicated by your doctor.
• It is recommended to avoid abrupt withdrawal of treatment in myoclonic patients, as it may cause a myoclonic or generalized crisis.

Taking Ciclofalina with other medications

Inform your doctor or pharmacist that you are using, have used recently, or may have to use any other medication.

Only one case has been described in which piracetam and thyroid hormone extracts (T3 and T4) taken together have led to confusion, irritability, and sleep disorders.

No other interactions with other medications have been detected to date.

Taking Ciclofalina with food, drink, and alcohol

The tablets should be taken with the help of some 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Although no adverse effects have been described in animal studies, it is recommended to avoid taking this medication during pregnancy. If you take piracetam accidentally, it is not expected to affect the fetus.

Breastfeeding

It is recommended to avoid using this medication during the breastfeeding period or to suppress breastfeeding during treatment.

Driving and operating machinery

Considering the possible adverse effects observed with piracetam, it is possible that they may affect your ability to drive and operate machinery, which should be taken into account.

Older patients

In older patients, it is recommended to visit your doctor regularly to be told the correct dose.

Ciclofalina contains sacarose and tartrazine (E-102)

This medication contains sacarose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

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.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

For symptomatic treatment of mental deterioration states:

Start 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 will be administered in 2 or 3 doses.

For treatment of cortical myoclonias:

Start treatment with 9 sachets per day (7.2 g of piracetam) and increase the dosage 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 other anti-myoclonic treatments with their dosage. Then, based on the clinical response obtained, the dose of other anti-myoclonic medications will be reduced, if possible.

Once treatment with this medication has been initiated, it should be maintained as long as the original cerebral pathology persists. However, every 6 months, an attempt should be made to reduce or discontinue treatment.

Nota: Patients with kidney problems should take a lower dose (see "Advertencias y precauciones").

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

If you believe the effect of this medication is too strong or too weak, consult your doctor or pharmacist.

Instructions for correct administration of the preparation

The powder from the sachets is poured into a glass with 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Ciclofalina

Do not take a double dose to compensate for the missed 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 1.2 g of piracetam every 2 days.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

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

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

Frequent (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)

Unknown frequency (cannot be estimated from available data)

The adverse effects described with this medication are as follows:

Frequent: weight gain, nervousness, tremor.

Uncommon: drowsiness, depression, fatigue.

The incidence of side effects in controlled studies is less than 2% and, generally, have been presented with doses greater than 2.4 g of piracetam (3 packets) per day in elderly patients. In most cases, a reduction in dose has been sufficient for these to disappear.

Other adverse effects of unknown frequency:

Occasional vertigo, gastrointestinal disturbances (nausea, vomiting, diarrhea, stomach pain), hypersensitivity reactions, lack of coordination, loss of balance, worsening of epilepsy, headache, insomnia, agitation, anxiety, confusion, hallucinations, and skin alterations have also been described.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System of

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Ciclofalina

• The active principle is piracetam. Each sachet contains 800 mg of piracetam.
• The other components (excipients) are: saccharose, sodium saccharin, lemon essence, tartrazine (E-102) and ammonium glycyrrhizinate.

Appearance of the product and contents of the packaging

White powder that is packaged in single-dose sachets of paper/aluminum/polyethylene and presented in containers of 30 and 60 sachets.

Other presentations:

Ciclofalina 800 mg film-coated tablets. Containers containing 20 and 60 tablets.

Some package sizes may not be marketed.

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2004

Detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

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