CIDINE 1 mg/5 ml ORAL SOLUTION

Introduction

Patient Information Leaflet

Cidine 1 mg/5 ml Oral Solution

Cinitapride

Read the entire leaflet carefully before starting to take this medication, as 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 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 leaflet.

Contents of the Leaflet:

1. What Cidine 1 mg/5 ml Oral Solution is and what it is used for
2. What you need to know before taking Cidine 1 mg/5 ml Oral Solution
3. How to take Cidine 1 mg/5 ml Oral Solution
4. Possible side effects
5. Storage of Cidine 1 mg/5 ml Oral Solution
6. Package contents and additional information

1. What Cidine 1 mg/5 ml Oral Solution is and what it is used for

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

Cidine 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 Cidine 1 mg/5 ml Oral Solution

Do not take Cidine 1 mg/5 ml Oral Solution

• if you are allergic to cinitapride 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 Cidine 1 mg/5 ml Oral Solution

• 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 Cidine 1 mg/5 ml Oral Solution with other medications

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

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

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

On the other hand, some medications may decrease the action of Cidine. This is the case with some medications used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

Taking Cidine 1 mg/5 ml Oral Solution with food, beverages, and alcohol

Cidine 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 cinitapride 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 cinitapride during pregnancy.

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

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 Cidine.

Cidine 1 mg/5 ml Oral Solution contains sorbitol

This medication contains 2.975 mg of sorbitol in each 5 ml of oral solution. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Cidine 1 mg/5 ml Oral Solution contains 250 mg of propylene glycol and 5 mg of benzoic acid.

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

3. How to take Cidine 1 mg/5 ml Oral Solution

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

Administration of Cidine 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 one 5 ml measure, three times a day, 15 minutes before each meal.

A graduated measuring cup is included in the package to measure the amount of medication to be taken. Drink the medication directly from the cup and wash it after each use.

Increasing the recommended doses is not more effective or convenient.

Your doctor will indicate the duration of your treatment with Cidine. Do not stop treatment before.

If you think the effect of Cidine is too strong or too weak, inform your doctor or pharmacist.

If you take more Cidine 1 mg/5 ml Oral Solution than you should

If you have taken more Cidine 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.

Symptoms of overdose may include: drowsiness, disorientation, and extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue) that usually disappear when treatment is discontinued.

If you forget to take Cidine 1 mg/5 ml Oral Solution

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you remember and then follow 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Cidine can cause side effects, although not everyone will experience them.

Side effects may include:

Uncommon (may affect up to 1 in 100 people)

• Some patients may experience mild sedation or drowsiness.

Frequency unknown (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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this 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 Cidine 1 mg/5 ml Oral Solution

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 stated on the package 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 pharmacy's SIGRE collection point. If you have any doubts, 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 Cidine 1 mg/5 ml Oral Solution

• The active ingredient is cinitapride (as tartaric acid salt). 5 ml of solution contain 1 mg of cinitapride.
• The other ingredients are sorbitol (E-420), propylene glycol, benzoic acid (E-210), tangerine flavor, disodium edetate, and purified water.

Appearance of the product and package contents

Cidine 1 mg/5 ml Oral Solution is a clear, yellow liquid with a tangerine flavor. It is presented in bottles containing 250 ml of solution, and a graduated measuring cup is included.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of the last revision of this leaflet: March 2019

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/