Pausedal 25 mg, tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Pausedal 25 mg tablets
Levosulpiride
Read the entire 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 must not be given to other people, even if they have the same symptoms as you, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
Leaflet Contents:
- What Pausedal is and what it is used for
- What you need to know before taking Pausedal
- How to take Pausedal
- Possible side effects
- How to store Pausedal
- Contents of the pack and other information
1. What Pausedal is and what it is used for
Pausedal belongs to a group of medicines called gastrointestinal motility stimulants.
It is used to treat digestive disorders in which stimulation of stomach and intestinal movements (gastrointestinal motility) is required, when they have not responded to hygienic-dietary measures.
2. What you need to know before taking Pausedal
Do not take Pausedal
- If you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6).
- If you have epilepsy or a history of seizures (convulsions) or manic-depressive psychosis.
- If you are at risk of, or currently suffer from, bleeding, obstruction, or perforation of the stomach or intestine.
- If you have phaeochromocytoma (a type of tumor of the glands located above the kidneys).
- If you have been diagnosed with breast cancer (malignant mastopathy).
- If you are pregnant or breastfeeding.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Pausedal
If increased gastrointestinal motility could be harmful for you.
Interaction of Pausedal with other medicines
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
Certain medicines may interact with Pausedal; in such cases it may be necessary to adjust the dose or discontinue treatment with one of them.
It is especially important that you inform your doctor if you are taking any of the following medicines:
- Anticholinergics (medicines used to treat certain respiratory, gastrointestinal, nervous system, heart, or eye disorders)
- Painkillers (narcotics, analgesics)
- Antidopaminergics (medicines used to treat certain mental disorders such as psychosis or depression, or to prevent vomiting)
Pausedal with food and drink
Do not drink alcohol while being treated with Pausedal.
You should take Pausedal at least 20 minutes before meals.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy or breastfeeding.
Driving and using machines
Pausedal may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce your reaction ability. These effects may impair your capacity to drive or operate machinery. Therefore, do not drive, operate machinery, or perform other activities requiring special attention until your doctor has assessed your response to this medicine.
Pausedal contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.
3. How to take Pausedal
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Use in adults
The recommended dose is 1 tablet of Pausedal every 8 hours (3 times a day), equivalent to 3 Pausedal tablets per day (75 mg of levosulpiride).
Use in elderly patients
In elderly patients, the daily dose of Pausedal will be determined by the physician according to individual needs.
Use in children
This medicine must not be used in children.
Method of administration
This medicine is for oral use.
Take the tablets at least 20 minutes before meals.
The tablets must be swallowed whole with sufficient water and must not be broken or chewed.
If you take more Pausedal than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at Tel. 91 562 04 20, indicating the medicine and the amount ingested.
Symptoms of overdose are mainly drowsiness and tremors.
If you forget to take Pausedal
Do not take a double dose to make up for missed doses. It is recommended to consult your doctor or pharmacist.
If you stop taking Pausedal
Your doctor will advise you on the duration of your treatment with Pausedal. Do not discontinue treatment prematurely, as otherwise the intended effect may not be achieved.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, Pausedal may cause adverse effects, although not everyone experiences them.
Approximately between 1 and 10% of patients have reported adverse effects, the most common being somnolence, sedation, breast tension, menstrual disturbances, galactorrhea (milk secretion from the breast), gynecomastia (enlargement of breast tissue in men).
Also reported as very common (≥ 1/10): hoarseness, abdominal cramps, weight gain, hypersalivation (increased saliva secretion), insomnia, constipation, dizziness and/or fatigue; and as uncommon (≥ 1/1,000 to < 1/100): increased blood levels of prolactin (a hormone that stimulates milk production).
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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Pausedal
Keep out of the sight and reach of children.
No special storage conditions are required.
Do not use Pausedal after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Pausedal
- The active substance is levosulpiride. Each tablet contains 25 mg of levosulpiride.
- The other components are sodium carboxymethylstarch from potato, lactose, microcrystalline cellulose (E-460i), magnesium stearate (E-572).
Appearance of the product and contents of the pack
Pausedal is available as white tablets marked with "25" on one side, packed in aluminum/PVC blisters. Each pack contains 30 or 60 tablets.
Marketing Authorization Holder and Manufacturer
Laboratorios Alter, S.A.
Mateo Inurria, 30
28036 Madrid
Spain
The last revision of this leaflet was in October 2011
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/