CINITAPRIDA KERN PHARMA 1mg TABLETS

Introduction

Package Leaflet: Information for the User

Cinitaprida Kern Pharma 1 mg tablets EFG

Read the 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 questions, 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 not listed in this package leaflet.

Contents of the package leaflet:

1. What Cinitaprida Kern Pharma is and what it is used for
2. What you need to know before taking Cinitaprida Kern Pharma
3. How to take Cinitaprida Kern Pharma
4. Possible side effects
5. Storage of Cinitaprida Kern Pharma
6. Package contents and additional information

1. What Cinitaprida Kern Pharma is and what it is used for

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

Cinitaprida Kern Pharma 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 Kern Pharma

Do not take Cinitaprida Kern Pharma

• If you are allergic (hypersensitive) to cinitaprida or any of the other components of Cinitaprida Kern Pharma.
• 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 Kern Pharma 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).

Taking Cinitaprida Kern Pharma with other medications

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

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

Cinitaprida Kern Pharma may decrease the effect of digoxin, a medication used to treat certain heart conditions (heart failure).

On the other hand, some medications may decrease the action of Cinitaprida Kern Pharma. In the case of some medications used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cinitaprida Kern Pharma with food, beverages, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy:

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. Cinitaprida Kern Pharma should not be administered during the first trimester of pregnancy.

Breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

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

Cinitaprida Kern Pharma 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.

3. How to take Cinitaprida Kern Pharma

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

Remember to take your medication.

Use in children and adolescents

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

Use in adults (over 20 years old)

The usual 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 Kern Pharma. Do not stop treatment before.

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

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

If you take more Cinitaprida Kern Pharma than you should

If you have taken more Cinitaprida Kern Pharma than you should, consult your doctor or pharmacist immediately or call the Toxicology 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 muscle movements of the face, neck, and tongue) that normally disappear when treatment is discontinued.

If you forget to take Cinitaprida Kern Pharma

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

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

If you interrupt treatment with Cinitaprida Kern Pharma

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

4. Possible side effects

Like all medications, Cinitaprida Kern Pharma can cause side effects, although not everyone will experience them. The side effects may be:

• Rarely, extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue).
• Some patients may notice mild sedation or drowsiness.
• Very rarely, skin reactions such as rash, itching, and very occasionally angioedema (swelling of the lips and tongue that can affect the larynx) and gynecomastia (excessive development of breast tissue) may occur.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cinitaprida Kern Pharma

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 any unused medication in the SIGRE collection point at the pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Cinitaprida Kern Pharma

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

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium glycolate starch, colloidal silica, and magnesium stearate.

Appearance of the product and package contents

Cinitaprida Kern Pharma 1 mg is presented in tablet form. The tablets are yellow, round, biconvex, and have a break line on one side. Each package contains 50 tablets.

Marketing authorization holder

Kern Pharma, S.L.

Pol. Ind. Colón II, C/Venus 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

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

This package leaflet was approved in December 2013

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/.