Leaflet: information for the user

Cinitaprida Normon 1 mg tablets EFG

Cinitaprida

Read this 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 is Cinitaprida Normon and what it is used for

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

3. How to take Cinitaprida Normon

4. Possible side effects

5. Storage of Cinitaprida Normon

6. Contents of the pack and additional information

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

Cinitaprida 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 Normon

• If you are allergic to cinitaprida or any of the other ingredients 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 cinitaprida if you are an elderly patient and taking 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).

• Taking Cinitaprida Normon 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. In the case of some medications used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

• Taking Cinitaprida Normon with alcohol

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

• Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become 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.

Your doctor will decide whether you should take or not take cinitaprida.

Breastfeeding:

The excretion of the medication in 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 cinitaprida.

• Cinitaprida Normon contains lactose and sodium

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

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 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 cinitaprida. 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 weak, inform your doctor or pharmacist.

Use in children and adolescents

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

The groove should not be used to break the tablet.

If you take more Cinitaprida Normon 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 Normon

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 interrupt treatment with Cinitaprida Normon

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

Like all medications, Cinitaprida Normon 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 tissue 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: https://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.

Store below 30°C.

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 packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Cinitaprida Normon

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

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

Appearance of the product and contents of the packaging

Cinitaprida Normon 1 mg is presented in the form of tablets. They are yellow-colored, round, biconvex, and scored on one side. Each package contains 50 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:June 2018

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