Package Insert: Information for the Patient

Cinitaprida Teva 1 mg Tablets EFG

Read this package insert carefully before starting to take this medication, as it contains important information for you.

- Keep this package insert, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed to you alone, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

3. How to take Cinitaprida Teva

4. Possible adverse effects

5. Storage of Cinitaprida Teva

6. Contents of the package 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 Teva

- 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 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 starting to take cinitaprida:

- If you are an elderly patient and take the medication 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).

Other medications and Cinitaprida Teva

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

Cinitaprida may increase the neurologic 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 Teva 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 in terms of reproductive toxicity. As a precaution, it is recommended to avoid the use of cinitaprida during pregnancy.

The doctor will decide whether or not to 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 Teva contains lactose

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

Cinitaprida Teva 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. If in 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.

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 Teva 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.

Symptoms of overdose may include: 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 Teva

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 may experience them.

Adverse effects may be:

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.

This medication does not require special storage conditions.

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 Take-Back Point. 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 Teva

- 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 Teva 1 mg tablets are presented in the form of round, biconvex, 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

TEVA B.V.

Swensweg 5, Haarlem, 2031 GA

Netherlands

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.

C/ San Gabriel, 50

Esplugues de Llobregat

08950 Barcelona,

Spain

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Teva Pharma, S.L.U

C/ Anabel Segura, 11, Edifício Albatros B, 1ª planta,

Alcobendas, 28108, Madrid (Spain)

Date of the last review of this leaflet: April 2021

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

You can access detailed and updated information about this medication by scanning with your smartphone the QR code included in the cartonage. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/85895/P_85895.html

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