Cinitapride Teva 1 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Cinitaprida Teva 1 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet Contents
- What Cinitaprida Teva is and what it is used for
- What you need to know before taking Cinitaprida Teva
- How to take Cinitaprida Teva
- Possible adverse effects
- How to store Cinitaprida Teva
- Contents of the pack and other information
1. What Cinitapride Teva is and what it is used for
Cinitapride belongs to a group of medicines called prokinetics, which work by stimulating gastrointestinal motility.
This medicine 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 starting to take Cinitaprida Teva
Do not take Cinitaprida Teva
- if you are allergic to the active substance or to any of the other components 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 (involuntary, repetitive, rapid movements of the head, neck, trunk, or limbs that may appear months after discontinuation of treatment).
Warnings and precautions
Consult your doctor or pharmacist before starting cinitapride:
- If you are an elderly patient and are taking the medicine for a prolonged period, as this may lead to tardive dyskinesia (involuntary, repetitive, rapid movements of the head, neck, trunk, or limbs that may appear months after discontinuation of treatment).
Other medicines and Cinitaprida Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Cinitapride may enhance the neurological effects of certain medicines, especially those used to treat nervous system disorders, insomnia, and moderate to severe pain.
Cinitapride may reduce the effect of digoxin, a medicine used in the treatment of heart failure.
Conversely, certain medicines may reduce the action of cinitapride. This includes some medicines used to treat Parkinson’s disease, abdominal pain, or respiratory diseases such as chronic bronchitis.
Taking Cinitaprida Teva with food, drinks, and alcohol
Cinitapride must not be taken 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 regarding 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 this medicine.
Breastfeeding
It is unknown whether the medicine is excreted in breast milk. As a precautionary measure, it is preferable to avoid using this medicine during breastfeeding.
Driving and use of machines
Do not drive or operate dangerous machinery during treatment with this medicine.
Cinitaprida Teva contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him or her before taking this medicine.
Cinitaprida Teva contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.
3. How to take Cinitaprida Teva
Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
Remember to take your medicine
Use in children and adolescents
The administration of cinitapride is not recommended in children and adolescents due to lack of experience in these age groups.
Use in adults (over 20 years of age)
The recommended dose for adults (over 20 years of age) is 1 tablet, 3 times a day, 15 minutes before each meal.
It is neither more effective nor advisable to increase the recommended doses.
Your doctor will determine how long you should take this medicine. Do not stop treatment prematurely.
The tablets should be taken orally with a glass of water.
If you feel that the effect of cinitapride is too strong or too weak, inform your doctor or pharmacist.
If you take more Cinitaprida Teva than you should
If you have taken more cinitapride than you should, consult 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 resolve upon discontinuation of treatment.
If you forget to take Cinitaprida Teva
Do not take a double dose to make up for missed doses. Take the missed dose as soon as you remember, and then continue with your regular schedule. However, if it is almost time for your 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, this medicine can cause adverse effects, although not everyone experiences them.
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 that 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 or pharmacist, 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 Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Cinitapride Teva
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Punto Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cinitapride Teva
- The active substance is cinitapride (as acid tartrate). Each tablet contains 1 mg of cinitapride.
- The other components are monohydrate lactose, microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica, and magnesium stearate.
Appearance of the medicine and contents of the pack
Cinitapride Teva 1 mg tablets are presented as round, biconvex, yellow tablets. Each box contains 50 tablets in PVC/PVDC/aluminum blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TEVA B.V.
Swensweg 5, Haarlem, 2031 GA
The Netherlands
Manufacturer
SAG Manufacturing, S.L.U.
Crta. N-I, Km 36, San Agustin de Guadalix
28750 Madrid,
Spain
or
Galenicum Health, S.L.U.
C/ San Gabriel, 50
Esplugues de Llobregat
08950 Barcelona,
Spain
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Teva Pharma, S.L.U
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, 28108, Madrid (Spain)
Date of the most recent revision of this leaflet: April 2021
Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.
You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85895/P_85895.html
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