CINATAPRIDE CINFA 1 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cinitaprida Cinfa 1 mg Tablets EFG

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Cinitaprida Cinfa is and what it is used for
2. What you need to know before taking Cinitaprida Cinfa
3. How to take Cinitaprida Cinfa
4. Possible side effects
5. Storage of Cinitaprida Cinfa

Contents of the packaging and additional information

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

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

Cinitaprida Cinfa is indicated for the treatment of gastroesophageal reflux to enhance the effect of proton pump inhibitors (medications that reduce gastric acid production) and mild to moderate functional disorders of gastrointestinal motility.

2. What you need to know before taking Cinitaprida Cinfa

Do not take Cinitaprida Cinfa

• If you are allergic to cinitaprida or 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 taking Cinitaprida Cinfa 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 Cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, 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 to severe pain relief.

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 with some medications used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cinitaprida Cinfa with Food, Drinks, and Alcohol

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 precautionary measure, it is recommended to avoid the use of cinitaprida during pregnancy. Your doctor will decide whether it is convenient for you to take cinitaprida.

Breastfeeding:

It is unknown whether the medication passes into breast milk. As a precautionary measure, it is recommended to avoid the use of this medication during breastfeeding.

Driving and Using Machines

Do not drive or operate hazardous machinery during treatment with Cinitaprida Cinfa.

Cinitaprida Cinfa Contains Lactose

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

Cinitaprida Cinfa Contains Sodium

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

3. How to Take Cinitaprida Cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

Remember to take your medication.

Use in Children and Adolescents

The administration of Cinitaprida Cinfa is not recommended in children and adolescents, as there is no experience with its use in these age groups.

Use in Adults (Over 20 Years Old)

The recommended dose for adults (over 20 years old) 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 Cinfa. Do not discontinue treatment before then. The tablets should be taken orally with a glass of water.

If you think the action of Cinitaprida Cinfa is too strong or too weak, inform your doctor or pharmacist.

If You Take More Cinitaprida Cinfa Than You Should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

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 Cinfa

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 scheduled dose.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone experiences 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 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 can affect the larynx), gynecomastia (excessive development of breast tissue), and galactorrhea (milk secretion) may appear.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Cinitaprida Cinfa

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

Store below 30°C.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE Collection Point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Cinitaprida Cinfa

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

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

Appearance of the Product and Packaging Contents

Cinitaprida Cinfa 1 mg are yellow, round, biconvex tablets with a break line on one face. They are presented in aluminum/PVC-PVDC blisters of 60. Each package contains 50 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Package Leaflet:January 2021

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

You can access detailed and updated information on this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/76576/P_76576.html

QR code to: https://cima.aemps.es/cima/dochtml/p/76576/P_76576.html