Prospect: information for the patient

Cidine 1 mg Tablets

Cinitaprida

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others

people who have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect.

in this prospect.

Content of the prospect:

1.What Cidine 1 mg Tablets are and for what they are used

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

3.How to take Cidine 1 mg Tablets

4.Possible adverse effects

1. Storage of Cidine 1 mg Tablets
2. Contents of the package and additional information

Cidine belongs to a group of medicines called prokinetics, which act by stimulating gastrointestinal motility.

Cidine is indicated for the treatment of gastroesophageal reflux for enhancing the effect of proton pump inhibitors (medicines that reduce gastric acid production) and mild-moderate functional disorders of the gastrointestinal motility.

Do not take Cidine 1 mg Tablets

• if you are allergic to cinitapride or any of the other ingredients of this medicine (listed in section 6).
• if you have gastrointestinal haemorrhage, obstruction or perforation.
• if you have a history of tardive dyskinesia (rapid and repetitive movements of the head, neck, trunk or limbs that may appear months after stopping treatment) induced by neuroleptics.

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 medicine 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 stopping treatment).

Taking Cidine 1 mg Tablets with other medicines

Inform your doctor or pharmacist that you are taking, have taken recently or may have to take any other medicine.

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

Cidine may reduce the effect of digoxin, a medicine used to treat heart failure.

On the other hand, some medicines may reduce the action of Cidine. This is the case for some medicines 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are no data on the use of cinitapride in pregnant women. Animal studies do not suggest direct or indirect harmful effects on reproductive toxicity. As a precaution, it is recommended to avoid the use of cinitapride during pregnancy.

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

Breastfeeding

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

Driving and operating machinery

Do not drive or operate hazardous machinery during treatment with Cidine.

Cidine 1 mg Tablets contain lactose

This medicine contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with him before taking this medicine.

This medicine 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. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in children and adolescents

Administration of Cidine in children and adolescents is not recommended, as there is no experience of use in these age groups.

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.

Increasing the recommended doses is not more effective or convenient.

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 estimate that 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 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 Cidine 1 mg Tablets

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

Like all medications, Cidine 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 movements) may occur.
• Skin reactions such as rash, itching, angioedema (swelling of lips and tongue that may affect the larynx), gynecomastia (excessive development of breast tissue) and galactorrhea (milk secretion) may appear.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: 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.

No special storage conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the pharmacy's designated collection point. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Cidine 1 mg Tablets

• The active ingredient is cinitaprida (as tartrate acid). Each tablet contains 1 mg of cinitaprida.
• The other components are carboxymethylcellulose sodium (from potato), powdered cellulose, anhydrous lactose, colloidal silica, magnesium stearate (E-470b).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, 151

08022 - Barcelona (Spain)

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-6108740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: March 2019

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