CIDINE 1 mg TABLETS

Introduction

Patient Information Leaflet

Cidine 1 mg Tablets

Cinitaprida

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 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 leaflet.

Contents of the Leaflet:

1. What Cidine 1 mg Tablets are and what they are used for
2. What you need to know before taking Cidine 1 mg Tablets
3. How to take Cidine 1 mg Tablets
4. Possible side effects
   1. Storage of Cidine 1 mg Tablets
   2. Package contents and additional information

1. What Cidine 1 mg Tablets are and what they are 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 for mild to moderate functional disorders of gastrointestinal motility.

2. What you need to know before taking Cidine 1 mg Tablets

Do not take Cidine 1 mg Tablets

• 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 starting to take Cidine 1 mg Tablets

• 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 Tablets with other medications

Inform your doctor or pharmacist that 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 diseases of the nervous system, 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 Tablets with food, drinks, 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 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 Cidine.

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 Tablets contain 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.

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 Tablets

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

Remember to take your medication.

Use in children and adolescents

The 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 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 Cidine. Do not discontinue treatment before.

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

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

If you take more Cidine 1 mg Tablets 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.

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 Cidine 1 mg Tablets

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 doubts 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 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, pharmacist, or nurse, even if it is a possible side effect 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 Tablets

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 shown 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 Point at the pharmacy. If in doubt, 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 Tablets

• The active ingredient is cinitaprida (as tartaric acid salt). Each tablet contains 1 mg of cinitaprida.
• The other ingredients are sodium carboxymethyl starch (potato), microcrystalline cellulose, anhydrous lactose, colloidal silicon dioxide, magnesium stearate (E-470b).

Appearance of the product and package contents

Cidine 1 mg Tablets are presented in the form of round, bisected, light yellow tablets with a notch on the upper surface. Each box contains 50 tablets.

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/