Prospect: information for the patient

Cidine 1 mg/5 ml Oral Solution

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 to you, and you must not give it to other people even if they 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.

Content of the prospect:

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

2.What you need to know before starting to take Cidine 1 mg/5 ml Oral Solution

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

4.Possible adverse effects

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

6.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 for mild-moderate functional gastrointestinal motility disorders.

Do not take Cidine 1 mg/5 ml Oral Solution

• if you are allergic to cinitapride or any of the other ingredients in 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 stopping treatment).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take 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 stopping treatment).

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

Inform your doctor or pharmacist that you are taking, have taken recently, 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 or intense 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 for 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, drinks, and alcohol

Cidine should not be taken with alcohol as it potentiates 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 medication.

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

The passage of the medication to breast milk is unknown. As a precaution, it is recommended to avoid the use of this medication during breastfeeding.

Driving and operating machinery

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 indicated that you (or your child) suffer from an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child) 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; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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 of use in these age groups.

Use in adults (over 20 years)

The recommended dose for adults (over 20 years) is one 5 ml measure, taken three times a day, 15 minutes before each meal.

A measuring cup is included in the package to measure the amount of medication to be taken. Drink the medication directly from the measuring 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 prematurely.

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/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 Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken.

Symptoms of overdose may include: 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/5 ml Oral Solution

Do not take a double dose to compensate for the missed doses. Take the missed dose as soon as 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 may experience them.

Adverse effects may be:

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 muscle movements) may occur.
• Skin reactions such as rash, itching, angioedema (swelling of lips and tongue that may affect the larynx), gynecomastia (excessive breast gland development), 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 SIGRE collection point at the pharmacy. 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/5 ml Oral Solution

• The active ingredient is cinitaprida (as tartrate acid). 5 ml of solution contain 1 mg of cinitaprida.
• 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 packaging

Cidine 1 mg/5 ml Oral Solution is a transparent, yellow liquid with a mandarin scent. It is presented in bottles containing 250 ml of solution and includes a graduated dosing cup.

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, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Last review date of this leaflet: March 2019

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