CINITAPRIDA STADA 1 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Cinitaprida Stada 1 mg Tablets EFG

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

• Keep this package leaflet, you may need to read it again. - If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Cinitaprida 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 mild to moderate functional disorders of gastrointestinal motility.

2. What you need to know before you take Cinitaprida Stada

Do not take Cinitaprida Stada

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have bleeding, obstruction, or perforation of the gastrointestinal tract
• 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 cinitaprida:

• If you are an elderly patient and take the medicine 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).

Taking Cinitaprida Stada with other medicines

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

Cinitaprida may increase the neurological effects of some medicines, especially those used to treat diseases of the nervous system, insomnia, and moderate to severe pain relief.

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

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

Taking Cinitaprida Stada with food, drinks, and alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

There are no data on the use of cinitaprida in pregnant women. Animal studies do not suggest direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of cinitaprida during pregnancy.

Your doctor will decide whether you should take this medicine or not.

Breast-feeding

It is unknown whether the medicine passes into breast milk. As a precautionary measure, it is preferable to avoid the use of this medicine during breast-feeding.

Driving and using machines

Do not drive or operate hazardous machinery during treatment with this medicine.

Cinitaprida Stada contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Cinitaprida Stada contains sodium

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

3. How to take Cinitaprida Stada

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in children and adolescents

Administration of cinitaprida is not recommended 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.

It is not more effective or convenient to increase the recommended doses.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment before.

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

If you think the action of cinitaprida is too strong or too weak, tell your doctor or pharmacist.

If you take more Cinitaprida Stada than you should

If you have taken more cinitaprida than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken.

The symptoms of overdose may be: drowsiness, disorientation, and extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue) that normally disappear when treatment is discontinued.

If you forget to take Cinitaprida Stada

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects may be:

Uncommon (may affect up to 1 in 100 people)

Some patients may notice mild sedation or drowsiness.

Frequency not known (cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinitaprida 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 which is stated on the packaging after Exp. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you are in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cinitaprida Stada

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

Appearance and packaging of the product

Cinitaprida Stada 1 mg tablets are presented in the form of round, biconvex tablets, light yellow in color. 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 last revision of this package leaflet: July 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es.