Cinitapride CINFA 1 mg tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Cinitapride Cinfa 1 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

1. What Cinitapride Cinfa is and what it is used for
2. What you need to know before taking Cinitapride Cinfa
3. How to take Cinitapride Cinfa
4. Possible adverse effects
5. How to store Cinitapride Cinfa

Package contents and other information

1. What Cinitaprida Cinfa is and what it is used for

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

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

2. What you need to know before taking Cinitapride Cinfa

Do not take Cinitapride Cinfa

• If you are allergic to cinitapride or to any of the other ingredients of this medicine (listed in section 6).
• If you have gastrointestinal bleeding, obstruction, or perforation.
• If you have a history of tardive dyskinesia induced by neuroleptics (rapid, 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 taking Cinitapride Cinfa if you are an elderly patient and plan to take the medicine for a prolonged period, as this may cause tardive dyskinesia (rapid, repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Other medicines and Cinitapride Cinfa

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

Cinitapride may enhance the neurological effects of certain medicines, especially those used to treat nervous system disorders, insomnia, and moderate to severe pain.

Cinitapride may reduce the effect of digoxin, a medicine used to treat heart failure.

On the other hand, some medicines may reduce the action of cinitapride. This is the case with certain medicines used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cinitapride Cinfa with food, drinks, and alcohol

Cinitapride should not be taken with alcohol, as alcohol may enhance its sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy:

There are no data regarding the use of cinitapride in pregnant women. Animal studies do not suggest direct or indirect harmful effects in terms of reproductive toxicity. As a precautionary measure, it is preferable to avoid using cinitapride during pregnancy. Your doctor will decide whether or not you should take cinitapride.

Breastfeeding:

It is unknown whether the medicine passes into breast milk. As a precautionary measure, it is preferable to avoid using this medicine during breastfeeding.

Driving and using machines

Do not drive or operate dangerous machinery while being treated with Cinitapride Cinfa.

Cinitapride Cinfa contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

Cinitapride Cinfa contains sodium

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

3. How to take Cinitapride Cinfa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in children and adolescents

Administration of Cinitapride Cinfa is not recommended in children and adolescents due to lack of experience with use in these age groups.

Use in adults (over 20 years of age)

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

It is neither more effective nor advisable to increase the recommended doses.

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

If you feel that the effect of Cinitapride Cinfa is too strong or too weak, inform your doctor or pharmacist.

? If you have taken more Cinitapride Cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose may include: drowsiness, disorientation, and extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue), which normally resolve upon discontinuation of treatment.

? If you forget to take Cinitapride Cinfa

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for the next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Adverse effects may include:

Uncommon (may affect up to 1 in 100 people)

Some patients may experience mild sedation or drowsiness.

Frequency not known (cannot be estimated from available data)

• Extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue) may occur.
• Skin reactions may appear, such as rash, itching, angioedema (swelling of lips and tongue that may affect the larynx), gynecomastia (excessive development of mammary glands), and galactorrhea (milk secretion).

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinitapride Cinfa

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Cinitapride Cinfa

The active substance is cinitapride (as acid tartrate). Each tablet contains 1 mg of cinitapride.

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

Appearance of the product and contents of the container

Cinitapride Cinfa 1 mg are yellow, round, biconvex tablets with a score line on one side. They are presented in aluminum/PVC-PVDC blisters of 60. Each package contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Date of latest review of this leaflet: January 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package 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