Package Insert: Information for the User

Pausedal 25 mg Tablets

Levosulpiride

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms of illness 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 package insert.

1. What Pausedal is and for what it is used

2. What you need to know before starting to take Pausedal

3. How to take Pausedal

4. Possible adverse effects

5. Storage of Pausedal

6. Contents of the package and additional information

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

It is used for the treatment of digestive alterations in which the movements of the stomach and the intestine (gastrointestinal motility) need to be stimulated when they have not responded to hygienic and dietary measures.

Do not take Pausedal

• If you are allergic to levosulpiride or any of the other components of this medication (listed in section 6).
• If you are epileptic or have a history of convulsive states (convulsions) or manic-depressive psychosis.
• If you have a risk of suffering or suffering from gastric or intestinal hemorrhage, obstruction, or perforation.
• If you have phaeochromocytoma (a type of tumor of 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.

Pausedal interaction with other medications

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medication.

Certain medications 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 to inform your doctor if you are using any of the following medications:

• Anticholinergics (medications used to treat some respiratory, gastrointestinal, nervous system, heart, or eye diseases)
• Pain medications (narcotics, analgesics)
• Antidopaminergic medications (medications used to treat some mental disorders such as psychosis or depression or to prevent vomiting)

Pausedal with food and drinks

Do not take alcohol while taking 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication should not be used during pregnancy or breastfeeding.

Driving and operating machines

Pausedal may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may reduce your reaction time. These effects may impair your ability 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 medication.

Pausedal contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult with 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 medication should not be used in children.

Administration form

This medication 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, call or the Toxicological Information Service Tel. 91 562 04 20, indicating the medication and the amount ingested.

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

If you forgot to take Pausedal

Do not take a double dose to compensate for the missed doses. It is recommended to consult your doctor or pharmacist.

If you interrupt the treatment with Pausedal

Your doctor will indicate the duration of your treatment with Pausedal. Do not suspend the treatment beforehand, as this will not achieve the desired effect.

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

Like all medications, Pausedal may produce adverse effects, although not all people will experience them.

Approximately between 1 and 10% of patients have reported adverse effects, with the most common being drowsiness, sedation, breast tenderness, menstrual irregularities, galactorrhea (milk secretion through the nipple), and gynecomastia (enlargement of breast tissue in men).

Other adverse effects reported as very common (≥ 1/10): snoring, abdominal cramps, weight gain, hypersalivation (increased saliva secretion), insomnia, constipation, dizziness, and/or fatigue; and as uncommon (≥ 1/1,000 to <1

Reporting Adverse Effects

If you experienceanytype ofadverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep out of sight and reach of children.

No special storage conditions are required.

Do not use Pausedal after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications 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 Pausedal

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

Appearance of the product and contents of the packaging

Pausedal is presented in the form of white tablets with the marking "25" on one of its faces, packaged in aluminum/PVC blisters. Each package contains 30 or 60 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review of this leaflet was October 2011

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