Cinitapride Stada 1 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cinitaprida Stada 1 mg tablets EFG

Read the entire 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, 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 they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

This medicine 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 Cinitaprida Stada

Do not take Cinitaprida Stada

• if you are allergic to the active substance or to any of the other components 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 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 taking cinitapride:

• If you are an elderly patient and are taking the medicine for a prolonged period, as this may cause tardive dyskinesia (rapid and repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Taking Cinitaprida Stada 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.

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 Cinitaprida Stada with food, drinks, and alcohol

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

Pregnancy and breastfeeding

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.

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 this medicine.

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 this medicine.

Cinitaprida Stada contains lactose

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

Cinitaprida Stada 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 Cinitaprida Stada

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

Remember to take your medicine.

Use in children and adolescents

Administration of cinitapride 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 daily, 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 this medicine. Do not stop 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.

If you take more Cinitaprida Stada 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: 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 Stada

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 until the next scheduled dose at the usual 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 produce adverse effects, although not everyone will experience 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 such as rash, itching, angioedema (swelling of lips and tongue which may affect the larynx), gynecomastia (excessive development of mammary glands), and galactorrhea (milk secretion) may appear.

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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinitapride Stada

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

No special storage conditions are required.

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 collection point at your pharmacy. If you are in doubt, 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 Stada

• The active substance is cinitapride (as acid tartrate). Each tablet contains 1 mg of cinitapride.
• The other components are monohydrate lactose, microcrystalline cellulose, sodium carboxymethylstarch type A (from potato), anhydrous colloidal silica, and magnesium stearate.

Appearance of the medicinal product and contents of the pack

Cinitaprida Stada 1 mg tablets are presented as round, biconvex, light yellow tablets. Each box contains 50 tablets in PVC/PVDC/aluminum blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

SAG Manufacturing, S.L.U.

Crta. N-I, Km 36, San Agustin de Guadalix

28750 Madrid,

Spain

or

Galenicum Health, S.L.U

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona,

Spain

Date of the most recent revision of this leaflet: July 2020

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