Cinitapride Kern Pharma 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cinitaprida Kern Pharma 1 mg tablets EFG

Read all of this 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; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, including any adverse reactions not listed in this leaflet.

Contents of this leaflet:

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

1. What Cinitaprida Kern Pharma is and what it is used for

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

Cinitaprida Kern Pharma 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 starting to take Cinitapride Kern Pharma

Do not take Cinitapride Kern Pharma

• If you are allergic (hypersensitive) to cinitapride or to any of the other components of Cinitapride Kern Pharma.
• If you have gastrointestinal bleeding, obstruction, or perforation.
• If you have a history of neuroleptic-induced tardive dyskinesia (repetitive, involuntary 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 Cinitapride Kern Pharma if you are an elderly patient and are expected to take the medicine for a prolonged period, as this may cause tardive dyskinesia (repetitive, involuntary movements of the head, neck, trunk, or limbs that may appear months after treatment has been stopped).

Taking Cinitapride Kern Pharma with other medicines

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

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

Cinitapride Kern Pharma may reduce the effect of digoxin, a medicine used to treat certain heart function disorders (heart failure).

On the other hand, some medicines may reduce the action of Cinitapride Kern Pharma. This applies particularly to certain medicines used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cinitapride Kern Pharma with food, drinks, and alcohol

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

Pregnancy, breastfeeding and fertility

Pregnancy:

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Cinitapride Kern Pharma must not be administered during the first trimester of pregnancy.

Breastfeeding:

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Do not drive or operate dangerous machinery during treatment with Cinitapride Kern Pharma.

Cinitapride Kern Pharma contains lactose

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

3. How to take Cinitapride Kern Pharma

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

Use in adults (over 20 years of age)

The usual 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 Kern Pharma. 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 Kern Pharma is too strong or too weak, inform your doctor or pharmacist.

If you take more Cinitapride Kern Pharma than you should

If you have taken more Cinitapride Kern Pharma than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service at: 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 Cinitapride Kern Pharma

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

If you stop treatment with Cinitapride Kern Pharma

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

4. Possible adverse effects

Like all medicines, Cinitapride Kern Pharma can cause adverse effects, although not everyone will experience them. Adverse effects may include:

• Rarely, extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue).
• Some patients may experience mild sedation or drowsiness.
• Very rarely, skin reactions such as rash, itching, and very occasionally angioedema (swelling of the lips and tongue which may affect the larynx), and gynecomastia (excessive development of mammary glands).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinitapride Kern Pharma

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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cinitaprida Kern Pharma

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

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate.

Appearance of the product and contents of the pack

Cinitaprida Kern Pharma 1 mg is presented as tablets. The tablets are yellow, round, biconvex, and have a break line on one side. Each pack contains 50 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This patient information leaflet was approved in December 2013

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