Leaflet: information for the user

Cinitaprida Cinfa 1 mg tablets EFG

Read this leaflet carefully before you start taking this medicine, because 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 must not give it to others even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

Cinitaprida Cinfa belongs to a group of medicines called prokinetics, which act by stimulating gastrointestinal motility.

Cinitaprida Cinfa is indicated for the treatment of gastroesophageal reflux for enhancing the effect of proton pump inhibitors (medicines that reduce gastric acid production) and mild-moderate functional disorders of the gastrointestinal motility.

Do not take Cinitaprida Cinfa

• If you are allergic to cinitaprida or any of the other ingredients of this medication (listed in section 6).
• If you have gastrointestinal bleeding, obstruction, or perforation.
• If you have a history of tardive dyskinesia induced by neuroleptics (rapid and repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Cinitaprida Cinfa if you are an elderly patient and taking the medication for a prolonged period, as it may cause tardive dyskinesia (rapid and repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Other medications and Cinitaprida Cinfa

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Cinitaprida may increase the neurological effects of some medications, especially those used to treat nervous system disorders, insomnia, and moderate or intense pain.

Cinitaprida may decrease the effect of digoxin, a medication used to treat heart failure.

On the other hand, some medications may decrease the action of cinitaprida. This is the case for some medications used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cinitaprida Cinfa with food, drinks, and alcohol

Cinitaprida should not be taken with alcohol as it potentiates its sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:

There are no data on the use of cinitaprida in pregnant women. Animal studies do not suggest direct or indirect harmful effects on reproductive toxicity. As a precaution, it is recommended to avoid the use of cinitaprida during pregnancy. The doctor will decide whether or not to take cinitaprida.

Breastfeeding:

The passage of the medication to breast milk is unknown. As a precaution, it is recommended to avoid the use of this medication during breastfeeding.

Driving and operating machinery

Do not drive or operate hazardous machinery during treatment with Cinitaprida Cinfa.

Cinitaprida Cinfa contains lactose

This medication contains lactose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Cinitaprida Cinfa contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

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

Remember to take your medication.

Use in children and adolescents

Cinitaprida Cinfa is not recommended for use in children and adolescents, as there is no experience of use in these age groups.

Use in adults (over 20 years)

The recommended dose for adults (over 20 years) is 1 tablet, 3 times a day, 15 minutes before each meal.

Increasing the recommended doses is not more effective or convenient.

Your doctor will indicate the duration of your treatment with Cinitaprida Cinfa. Do not stop treatment prematurely. The tablets should be taken orally with a glass of water.

If you estimate that the action of Cinitaprida Cinfa is too strong or too weak, inform your doctor or pharmacist.

?If you take more Cinitaprida Cinfa 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.

The symptoms of overdose may be: drowsiness, disorientation, and extrapyramidal reactions (involuntary facial, neck, and tongue muscle movements) that usually disappear when treatment is suspended.

?If you forgot to take Cinitaprida Cinfa

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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 may experience them.

Adverse effects may be:

Rare (may affect up to 1 in 100 people)

Some patients may notice mild sedation or drowsiness.

Unknown frequency (cannot be estimated from available data)

• May cause extrapyramidal reactions (involuntary facial, neck, and tongue muscle movements).
• May appear skin reactions such as rash, itching, angioedema (swelling of lips and tongue that may affect the larynx), gynecomastia (excessive development of breast glands) and galactorrhea (milk secretion).

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below30°C.

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

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Cinitaprida Cinfa

The active ingredient is cinitaprida (as tartrate acid). Each tablet contains 1 mg of cinitaprida.

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, carboxymethylcellulose sodium (type A) (from potato), colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

Cinitaprida Cinfa 1 mg are yellow-colored, round, biconvex tablets with a breaking bar on one face. They are presented in Aluminio/PVC-PVDC 60 blister packs. Each package contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa, S.A Laboratories

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

NORMON, S.A. Laboratories

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet:January 2021

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

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/76576/P_76576.html

QR code to:https://cima.aemps.es/cima/dochtml/p/76576/P_76576.html