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CINITAPRIDE NORMON 1mg TABLETS

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About the medicine

How to use CINITAPRIDE NORMON 1mg TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Cinitaprida Normon 1 mg Tablets EFG

Cinitaprida

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this package leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Cinitaprida Normon and what is it used for
  2. What you need to know before taking Cinitaprida Normon
  3. How to take Cinitaprida Normon
  4. Possible side effects
  5. Storage of Cinitaprida Normon
  6. Contents of the pack and further information

1. What is Cinitaprida Normon and what is it used for

Cinitaprida belongs to a group of medicines called prokinetics, which work by stimulating gastrointestinal motility.

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

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2. What you need to know before taking Cinitaprida Normon

  • Do not take Cinitaprida Normon
  • If you are allergic to cinitaprida or 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 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 cinitaprida 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 treatment has been discontinued).

  • Taking Cinitaprida Normon with other medicines

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

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

Cinitaprida may decrease the effect of digoxin, a medicine used to treat heart failure.

On the other hand, some medicines may decrease the action of cinitaprida. In the case of some medicines used to treat Parkinson's disease, abdominal pain, or respiratory diseases such as chronic bronchitis.

  • Taking Cinitaprida Normon with alcohol

Cinitaprida should not be taken with alcohol, as it enhances its sedative effects.

  • Pregnancy, breastfeeding, and fertility

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

Pregnancy:

There are no data on the use of cinitaprida in pregnant women. Animal studies do not suggest direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of cinitaprida during pregnancy.

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

Breastfeeding:

It is unknown whether the medicine is excreted in breast milk. As a precautionary measure, it is preferable to avoid the use of this medicine during breastfeeding.

  • Driving and using machines

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

  • Cinitaprida Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Cinitaprida Normon

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

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, nor convenient to increase the recommended doses.

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

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

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

Use in children and adolescents

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

The score line should not be used to divide the tablet.

If you take more Cinitaprida Normon than you should

If you have taken more cinitaprida than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount taken.

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 Cinitaprida Normon

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 dose at the scheduled time.

If you stop treatment with Cinitaprida Normon

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

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, Cinitaprida Normon can cause side effects, although not everybody gets them.

Side effects may be:

Uncommon (may affect up to 1 in 100 people)

Some patients may notice mild sedation or drowsiness.

Frequency not known (cannot be estimated from the 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 may affect the larynx), gynecomastia (excessive development of breast tissue), and galactorrhea (milk secretion) may appear.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cinitaprida Normon

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

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Cinitaprida Normon

The active substance is cinitaprida (as hydrogen tartrate). Each tablet contains 1 mg of cinitaprida.

The other ingredients (excipients) are: lactose, microcrystalline cellulose, sodium carboxymethyl starch (type A) (potato), colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

Cinitaprida Normon 1 mg is presented in the form of tablets. They are yellow, round, biconvex tablets with a score line on one side. Each pack contains 50 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of last revision of this package leaflet:June 2018

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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Frequently Asked Questions

Is a prescription required for CINITAPRIDE NORMON 1mg TABLETS?
CINITAPRIDE NORMON 1mg TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
How much does CINITAPRIDE NORMON 1mg TABLETS cost in pharmacies?
The average pharmacy price for CINITAPRIDE NORMON 1mg TABLETS is around 6.73 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures CINITAPRIDE NORMON 1mg TABLETS?
CINITAPRIDE NORMON 1mg TABLETS is manufactured by Laboratorios Normon S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CINITAPRIDE NORMON 1mg TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CINITAPRIDE NORMON 1mg TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CINITAPRIDE NORMON 1mg TABLETS?
Other medicines with the same active substance () include BLASTON 1 mg TABLETS, CIDINE 1 mg TABLETS, CIDINE 1 mg/5 ml ORAL SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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