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PAUSEDAL 25 mg TABLETS

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This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.
About the medicine

How to use PAUSEDAL 25 mg 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

Pausedal 25 mg Tablets

Levosulpiride

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

  • Keep this 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 signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

  1. What is Pausedal and what is it used for
  2. What you need to know before you take Pausedal
  3. How to take Pausedal
  4. Possible side effects
  5. Storing Pausedal
  6. Contents of the pack and other information

1. What is Pausedal and what is it used for

Pausedal belongs to a group of medicines called gastrointestinal motility stimulants.

It is used to treat digestive disorders where stimulation of stomach and intestinal movements (gastrointestinal motility) is needed when they have not responded to hygienic-dietary measures.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take Pausedal

Do not take Pausedal

  • If you are allergic to levosulpiride or any of the other ingredients of this medicine (listed in section 6).
  • If you are epileptic or have a history of convulsive states (seizures) or manic-depressive psychosis.
  • If you are at risk of or have bleeding, obstruction, or perforation of the stomach or intestine.
  • If you have a pheochromocytoma (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 an increase in gastrointestinal motility may be harmful to you.

Interaction of Pausedal with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

Certain medicines may interact with Pausedal; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is especially important that you inform your doctor if you are using any of the following medicines:

  • Anticholinergics (medicines used to treat some respiratory, gastrointestinal, nervous system, heart, or eye diseases)
  • Pain relief medicines (narcotics, analgesics)
  • Antidopaminergics (medicines used to treat some mental illnesses such as psychoses or depression or to prevent vomiting)

Pausedal with food and drinks

Do not drink alcohol if you are being treated with Pausedal.

You should take Pausedal at least 20 minutes before meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may 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 changes in vision, and reduce your reaction ability. These effects can make it difficult for you to drive vehicles or operate machines. Therefore, do not drive, operate machines, or engage in other activities that require special attention until your doctor assesses your response to this medicine.

Pausedal contains lactose

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

3. How to take Pausedal

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

Use in adults

The recommended dose is 1 Pausedal tablet every 8 hours (3 times a day), which is 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 established by the doctor according to their needs.

Use in children

This medicine should not be used in children.

Method of administration

This medicine is for oral administration.

Take the tablets at least 20 minutes before meals.

The tablets should be swallowed whole with a sufficient amount of water and should 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 Tel. 91 562 04 20, indicating the medicine and the amount ingested.

The symptoms of overdose are mainly drowsiness and the appearance of tremors.

If you forget to take Pausedal

Do not take a double dose to make up for forgotten doses. It is recommended to consult your doctor or pharmacist.

If you stop taking Pausedal

Your doctor will indicate the duration of your treatment with Pausedal. Do not stop treatment before then, as the expected effect will not be achieved.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Approximately 1 to 10% of patients have reported side effects, the most frequent being drowsiness, sedation, breast tension, menstrual changes, galactorrhea (milk secretion through the breast), and gynecomastia (enlargement of breast tissue in men).

Ronchopathy, abdominal cramps, weight gain, hypersalivation (increased saliva secretion), insomnia, constipation, dizziness, and/or fatigue have also been reported as very frequent (≥ 1/10); and as uncommon (≥ 1/1,000 to <1>

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them 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. Storing Pausedal

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use Pausedal after the expiration date stated on the packaging. The expiration 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 medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pausedal

  • The active ingredient is levosulpiride. Each tablet contains 25 mg of levosulpiride.
  • The other ingredients are sodium starch glycolate, lactose, microcrystalline cellulose (E-460i), magnesium stearate (E-572).

Appearance and packaging of the product

Pausedal is presented in the form of white tablets with the marking "25" on one of their faces, packaged 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

This leaflet was last revised in October 2011

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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Discuss questions about PAUSEDAL 25 mg TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Frequently Asked Questions

Is a prescription required for PAUSEDAL 25 mg TABLETS?
PAUSEDAL 25 mg TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in PAUSEDAL 25 mg TABLETS?
The active ingredient in PAUSEDAL 25 mg TABLETS is levosulpiride. This information helps identify medicines with the same composition but different brand names.
How much does PAUSEDAL 25 mg TABLETS cost in pharmacies?
The average pharmacy price for PAUSEDAL 25 mg TABLETS is around 4.93 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures PAUSEDAL 25 mg TABLETS?
PAUSEDAL 25 mg TABLETS is manufactured by Laboratorios Alter S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of PAUSEDAL 25 mg 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 PAUSEDAL 25 mg 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 PAUSEDAL 25 mg TABLETS?
Other medicines with the same active substance (levosulpiride) include LEVOGASTROL 25 mg TABLETS, LEVOSULPIRIDE STADA 25 mg TABLETS, Levosulpirida aristo 25 mg comprimidos efg. 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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