Cinitapride Normon 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cinitaprida Normon 1 mg tablets EFG

Cinitaprida

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

• Keep this leaflet; 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 other people, 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 such effects are not listed in this leaflet. See section 4.

Leaflet contents

1. What Cinitaprida Normon is and what it is used for
2. What you need to know before taking Cinitaprida Normon
3. How to take Cinitaprida Normon
4. Possible adverse effects
5. How to store Cinitaprida Normon
6. Contents of the pack and other information

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

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

Cinitapride 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 gastrointestinal motility disorders.

2. What you need to know before starting Cinitapride Normon

• Do not take Cinitapride Normon

• 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 neuroleptic-induced tardive dyskinesia (involuntary, repetitive, rapid movements of the head, neck, trunk, or limbs that may appear months after discontinuing treatment).

• Warnings and precautions

Consult your doctor or pharmacist before starting cinitapride if you are an elderly patient and will be taking the medicine for a prolonged period, as this may cause tardive dyskinesia (involuntary, repetitive, rapid movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

• Taking Cinitapride Normon with other medicines

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.

Conversely, some medicines may reduce the action of cinitapride. This applies particularly to certain medicines used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

• Taking Cinitapride Normon with alcohol

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

• Pregnancy, breastfeeding, and fertility

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 available on the use of cinitapride in pregnant women. Animal studies do not indicate any direct or indirect harmful effects related to reproductive toxicity. As a precautionary measure, it is advisable to avoid using cinitapride during pregnancy.

Your doctor will decide whether or not you should take cinitapride.

Breastfeeding:

It is unknown whether the medicine is excreted in breast milk. As a precautionary measure, it is advisable to avoid using this medicine during breastfeeding.

• Driving and using machines

Do not drive or operate dangerous machinery during treatment with cinitapride.

• Cinitapride Normon contains lactose and sodium

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

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

3. How to take Cinitaprida Normon

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

Remember to take your medicine.

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. Do not stop the treatment prematurely.

The tablets should be taken orally with a glass of water.

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

Use in children and adolescents

Administration of cinitapride is not recommended in children and adolescents due to lack of experience in these age groups.

The tablet's score line should not be used to split the tablet.

If you take more Cinitaprida Normon than you should

If you have taken more cinitapride than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount taken.

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

If you forget to take Cinitaprida Normon

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 your next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

If you stop treatment with Cinitaprida Normon

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

4. Possible adverse effects

Like all medicines, Cinitaprida Normon may produce adverse effects, although not everyone experiences them.

The 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinitapride Normon

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 drains or household waste. Unused medicines and their containers should be taken to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cinitaprida Normon

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

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

Appearance of the product and contents of the pack

Cinitaprida Normon 1 mg is presented as tablets. The tablets are yellow, round, biconvex, and scored on one side. Each pack contains 50 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: June 2018

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