Prospect: Information for the User

Ciclofalina 800 mg Film-Coated Tablets

Piracetam

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 not listed in this prospect. 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 decline 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 (including those 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.
• Withdrawal from treatment should be avoided 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 need 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.

To date, no more interactions with other medications have been detected.

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

Use of this medication should be avoided during the breastfeeding period or the breastfeeding should be discontinued during treatment.

Driving and operating machinery

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

Older patients

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

Ciclofalina contains Yellow Orange S (E-110)

This medication may cause allergic reactions because it contains Yellow Orange S (E-110). 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 tablets a day (4.8 g of piracetam) during the first weeks, and continue treatment with 3 tablets a 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 tablets a day (7.2 g of piracetam) and increase the dosage 4.8 g of piracetam (6 tablets) a day every 3-4 days, until a satisfactory response is obtained or up to a maximum of 30 tablets a day (24 g of piracetam).

The daily dose will be administered in 2 or 3 doses, maintaining other anticonvulsant treatments with their dosage. Then, based on the clinical response obtained, the dose of other anticonvulsant 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.

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 believe 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 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 (1.5 tablets) every 2 days.

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

Like all medications, this medication may produce adverse effects, although not all people 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, in controlled studies, are as follows:

Frequent:weight gain, Nervousness, tremor

Uncommon:drowsiness, depression, fatigue.

The incidence of these side effects is less than 2% and, generally, have been presented with doses greater than 2.4 g of piracetam (3 tablets) 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:

Occasionally, 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 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 System of Pharmacovigilance of Medicines for human use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Ciclofalina

• The active principle 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), yellow-orange S (E-110)].

Appearance of the product and contents of the packaging

Yellow tablets that are packaged in PVC/Aluminum blisters and are presented in containers of 20 and 60 tablets.

Other presentations:

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

Some package sizes may not be commercially available.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

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

Last review date of this leaflet: February 2004

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