NORAFLAT FORTE 120 mg CHEWABLE TABLETS

Introduction

Leaflet: information for the patient

Noraflat Forte 120 mg chewable tabletssimethicone

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

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 10 days.

Contents of the leaflet

1. What is Noraflat Forte and what is it used for
2. What you need to know before taking Noraflat Forte
3. How to take Noraflat Forte
4. Possible side effects
5. Storage of Noraflat Forte
6. Package contents and additional information

1. What is Noraflat Forte and what is it used for

Noraflat Forte contains the active ingredient simethicone, which belongs to a group of medications that act by destroying gas bubbles, facilitating their elimination and relieving the discomfort they cause.

Noraflat Forte is indicated for the symptomatic relief of gas in adults and adolescents from 12 years of age.

You should consult a doctor if it worsens or does not improve after 10 days or if you have constipation that does not improve.

2. What you need to know before taking Noraflat Forte

Do not take Noraflat Forte:

If you are allergic to simethicone or any of the other components of this medication (listed in section 6).

If you have a known or suspected intestinal perforation or obstruction.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Noraflat Forte.

If symptoms worsen or persist after 10 days of treatment, or if you have constipation that does not improve, you should stop treatment and consult a doctor.

Children

There are other formulations available for children.

Simethicone is not recommended for the treatment of infant colic due to limited available information.

Taking Noraflat Forte with other medications

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

The absorption of levothyroxine (a medication used to treat thyroid diseases and disorders) may be affected if simethicone is administered at the same time, so the intake of levothyroxine preparations and simethicone preparations should be separated by at least 4 hours.

Pregnancy and breastfeeding

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.

Driving and using machines

Noraflat Forte has no influence on the ability to drive or use machines.

Noraflat Forte contains sorbitol (E-420), glucose, and sodium

This medication contains 890 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

Sorbitol can cause gastrointestinal upset and a mild laxative effect.

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

It may harm teeth.

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

3. How to take Noraflat Forte

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults and adolescents over 12 years of age:

The recommended dose is 1 chewable tablet (120 mg of simethicone) three times a day, after each of the main meals.

Do not take more than 4 tablets per day (corresponding to 480 mg of simethicone).

Method of administration

This medication is administered orally.

Chew the tablets well before swallowing (do not swallow them whole).

If symptoms worsen or persist after 10 days of treatment, or if you have constipation that does not improve, you should stop treatment and consult a doctor.

If you take more Noraflat Forte than you should

No cases of overdose are known.

Even if a much higher dose than indicated is ingested, it is very unlikely that side effects will occur, due to the lack of digestive absorption of the medication.

In case of overdose or accidental ingestion, go to a medical center, consult your doctor or pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Noraflat Forte

Do not take a double dose to make up for forgotten doses.

If symptoms persist, you can take another dose, following the instructions indicated in this section 3. How to take Noraflat Forte.

If you have any other questions 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 will experience them.

During the period of use of simethicone, the following side effects of unknown frequency (cannot be estimated from the available data) have been observed:

• Transient moderate constipation and nausea.
• Eructation may occur, which is the normal mechanism of gas elimination with this treatment.
• Allergic reactions (hypersensitivity) such as rash, itching, swelling of the face or tongue, or difficulty breathing.

Reporting side effects

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

5. Storage of Noraflat Forte

Keep this medication out of the sight and reach of children.

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. Use Noraflat Forte within 12 months of opening the bottle.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Noraflat Forte

• The active ingredient is simethicone. Each tablet contains 120 mg of simethicone.
• The other ingredients (excipients) are: Sorbitol (E-420), sodium saccharin (E-954), aluminum and magnesium metasilicate, magnesium stearate, and strawberry flavor (contains glucose).

Appearance of the product and package contents

Noraflat Forte tablets are white, round, biconvex, and strawberry-flavored.

They are available in plastic containers containing 40 tablets.

Other presentations

Noraflat 40 mg chewable tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last revision of this leaflet:January 2024

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