GAPULSID 1 mg TABLETS

Introduction

Leaflet:information for the patient

Gapulsid 1 mg EFG tablets

cinitapride

Read the entire leaflet carefully before starting to takethis medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Gapulsid is and what it is used for
2. What you need to know before taking Gapulsid
3. How to take Gapulsid
4. Possible side effects

5 Conservation of Gapulsid

1. Package contents and additional information

1. What Gapulsid is and what it is used for

Gapulsid contains cinitapride, which belongs to a group of medications called prokinetics, which act by stimulating gastrointestinal motility.

This medication is indicated in adults for the treatment of gastroesophageal reflux to enhance the effect of proton pump inhibitors (medications that reduce gastric acid production) and mild-moderate functional disorders of gastrointestinal motility.

2. What you need to know before taking Gapulsid

Do not take Gapulsid

• If you are allergic to the active ingredient or any of the other components of this medication (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 repeated 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 starting to take cinitapride:

• If you are an elderly patient and take the medication for a prolonged period, as it may cause tardive dyskinesia (rapid and repeated movements of the head, neck, trunk, or limbs that may appear months after treatment has been discontinued).

Other medications andGapulsid

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Cinitapride may increase the neurological effects of some medications, especially those used to treat nervous system disorders, insomnia, and moderate to severe pain.

Cinitapride may decrease the effect of digoxin, a medication used to treat heart failure.

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

TakingGapulsidwith food,drinks, and alcohol

Cinitapride 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 medication.

Pregnancy:

There are no data on 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 recommended to avoid using cinitapride during pregnancy.

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

Breastfeeding:

It is unknown whether the medication is excreted in breast milk. As a precautionary measure, it is recommended to avoid using this medication during breastfeeding.

Fertility

There are no data on fertility available with the use of cinitapride in humans.

Driving and using machines

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

Gapulsidcontains lactose

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

Gapulsidcontains sodium

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

3. How to take Gapulsid

Follow the administration instructions of this medication indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in childrenand adolescents

The administration of cinitapride is not recommended in children and adolescents due to the 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 not more effective or convenient to increase the recommended doses.

Your doctor will indicate the duration of your treatment with cinitapride. Do not discontinue treatment before.

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

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

If you take moreGapulsidthan you should

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

The 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 takeGapulsid

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 scheduled dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences 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 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 can affect the larynx), gynecomastia (excessive development of breast tissue), and galactorrhea (milk secretion) may appear.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Gapulsid

Keep this medication out of sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date shown on the box after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in your pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition ofGapulsid

• The active ingredient is cinitapride (as hydrogen tartrate). Each tablet contains 1 mg of cinitapride.
• The other components (excipients) are: lactose, microcrystalline cellulose (E460), sodium carboxymethyl starch Type A, colloidal anhydrous silica, and magnesium stearate (E470b). See section 2: Gapulsid contains lactose.

Appearance of the product and package contents

Gapulsid 1 mg tablets are yellow, round, and biconvex. Each box contains 50 or 100 tablets in PVC/PVDC/aluminum blisters.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Novatin Limited

230, Second Floor

Eucharistic Congress Road,

MST9039 Mosta,

Malta

Manufacturer

SAG Manufacturing, S.L.U.

Crta. N-I, Km 36,

San Agustín de Guadalix 28750

Spain

or

Galenicum Health S.L.U.

Sant Gabriel, 50

Esplugues de Llobregat

08950 Barcelona,

Spain

This medication is authorized in the member states of the European Economic Areaand in the United Kingdom (Northern Ireland)with the following names:

Czech Republic: Gapulsid

Croatia: Gapulsid 1 mg tablets

Spain: Gapulsid 1 mg EFG tablets

Date of the last revision of this leaflet:

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