Patient Information Leaflet: Cinitaprida Stada 1 mg Tablets EFG

Read 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, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

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

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

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

3. How to take Cinitaprida Stada

4. Possible side effects

5. Storage of Cinitaprida Stada

6. Contents of the pack and additional information

Cinitaprida belongs to a group of medications called prokinetics, which act by stimulating gastrointestinal motility.

This medication is indicated for the treatment of gastroesophageal reflux for enhancing the effect of proton pump inhibitors (medications that reduce gastric acid production) and mild-moderate functional disorders of gastrointestinal motility.

Do not take Cinitaprida Stada

- if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6)

- if you have gastrointestinal hemorrhage, 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 starting to take cinitaprida:

- If you are an elderly patient and take the medication for a prolonged period, as it could 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 medications

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

Cinitaprida may increase the neurological effects of some medications, especially those used to treat nervous system disorders, insomnia, and moderate or intense pain.

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

On the other hand, some medications may decrease the action of cinitaprida. This is the case for some medications 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 potentiates its sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

The doctor will decide whether or not you should take this medication.

Breastfeeding

The passage of the medication to breast milk is unknown. As a precaution, it is recommended to avoid the use of this medication during breastfeeding.

Driving and operating machinery

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

Cinitaprida Stada contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Cinitaprida Stada contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

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.

Increasing the recommended doses is not more effective or convenient.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment before.

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

If you estimate that the action of cinitaprida 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 cinitaprida than you should, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken.

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

If you forgot to take Cinitaprida Stada

Do not take a double dose to compensate for the missed doses. Take the missed dose when you remember and then continue with your regular schedule. However, if there are only a few hours left before the next dose, do not take the missed dose and wait for the next dose at the scheduled time.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects may include:

Rare (may affect up to 1 in 100 people)

Some patients may notice mild sedation or drowsiness.

Unknown frequency (cannot be estimated from available data)

- Extrapyramidal reactions (involuntary facial, neck, and tongue muscle movements) may occur.

- Skin reactions such as rash, itching, angioedema (swelling of lips and tongue that may affect the larynx), gynecomastia (excessive breast gland development) and galactorrhea (milk secretion) may appear.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after "Cad." The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the pharmacy's "Punto Sigre". If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Cinitaprida Stada

- The active ingredient is cinitaprida (as tartrate acid). Each tablet contains 1 mg of cinitaprida.

- The other components are lactose monohydrate, microcrystalline cellulose, carboxymethylstarch sodium type A (from potato), anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

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

Last review date of this leaflet: July 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.