Cidine 1 mg/5 ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Cidine 1 mg/5 ml Oral solution

Cinitapride

Read the entire patient information leaflet carefully before you start taking this medicine, 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 medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Package leaflet contents:

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. Contents of the pack and other information

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

Cidine belongs to a group of medicines 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 (medicines 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/5 ml Oral Solution

Do not take Cidine 1 mg/5 ml Oral Solution

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Cidine 1 mg/5 ml Oral Solution

• if you are elderly and take the medicine for a prolonged period, as this may cause tardive dyskinesia (rapid, repetitive movements of the head, neck, trunk, or limbs that may appear months after treatment has been stopped).

Taking Cidine 1 mg/5 ml Oral Solution with other medicines

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

Cidine may enhance the neurological effects of certain medicines, especially those used to treat nervous system disorders, insomnia, and moderate to severe pain.

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

Conversely, certain medicines may reduce the action of Cidine. This includes some medicines 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, drinks, and alcohol

Do not take Cidine with alcohol, as alcohol enhances its sedative effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

There are no data available 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 preferable to avoid using cinitapride during pregnancy.

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

Breastfeeding

It is unknown whether the medicine passes into breast milk. As a precautionary measure, it is preferable to avoid using this medicine during breastfeeding.

Driving and using machines

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

Cidine 1 mg/5 ml Oral Solution contains sorbitol

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

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

This medicine contains less than 23 mg of sodium (1 mmol) per dose; essentially “sodium-free”.

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

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in children and adolescents

Administration of Cidine is not recommended in children and adolescents due to lack of experience with use in these age groups.

Use in adults (over 20 years of age)

The recommended dose for adults (over 20 years of age) is one 5 ml dose, three times daily, 15 minutes before each meal.

A graduated dosing cup is included in the package to measure the amount of medicine to be taken. Drink the medicine directly from the cup and rinse it after each use.

It is neither more effective nor advisable to increase the recommended doses.

Your doctor will determine the duration of your treatment with Cidine. Do not stop the treatment prematurely.

If you feel that 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount taken.

Symptoms of overdose may include: drowsiness, disorientation, and extrapyramidal reactions (involuntary muscle movements of the face, neck, and tongue), which normally disappear upon discontinuation of treatment.

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

Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, then continue with your regular schedule. However, if it is almost time for the next dose, do not take the missed dose and wait to take the next dose at the scheduled time.

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

4. Possible adverse effects

Like all medicines, Cidine may produce adverse effects, although not everyone experiences them.

The adverse effects may include:

Uncommon (may affect up to 1 in 100 people)

• Some patients may experience 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 lips and tongue which may affect the larynx), gynecomastia (excessive development of mammary glands), and galactorrhea (milk secretion) may appear.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cidine 1mg/5 ml Oral Solution

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container after Exp. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cidine 1 mg/5 ml Oral Solution

• The active substance is cinitapride (as acid tartrate). 5 ml of solution contain 1 mg of cinitapride.
• The other components are sorbitol (E-420), propylene glycol, benzoic acid (E-210), mandarin essence, disodium edetate, and purified water.

Appearance of the product and contents of the container

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

Marketing Authorization Holder and Manufacturing Responsible

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 most recent review of this leaflet: March 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/