NORAFLAT 40 mg CHEWABLE TABLETS

Introduction

Patient Information Leaflet

Noraflat 40 mg Chewable Tabletssimethicone

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

Follow the administration instructions for the medicine 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 not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 10 days.

Contents of the Leaflet:

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

1. What Noraflat is and what it is used for

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

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

You should consult a doctor if your symptoms worsen or do not improve after 10 days or if you have constipation that does not improve.

2. What you need to know before taking Noraflat

Do not take Noraflat:

If you are allergic to simethicone or any of the other components of this medicine (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.

If your symptoms worsen, or if they persist after 10 days of treatment, or if you have constipation that does not improve, you should stop treatment and consult your 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 with other medicines

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

The absorption of levothyroxine (a medicine used to treat thyroid diseases and dysfunctions) 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 medicine.

Driving and using machines

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

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

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

It may harm your teeth.

This medicine contains 240 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 with your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

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

3. How to take Noraflat

Follow the administration instructions for the medicine 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 2 chewable tablets (80 mg of simethicone) three times a day, after each of the main meals.

Do not take more than 12 tablets per day (corresponding to 480 mg of simethicone).

Method of administration

This medicine is administered orally.

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

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

If you take more Noraflat 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 medicine.

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 medicine and the amount ingested.

If you forget to take Noraflat

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.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

• 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Noraflat

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

Do not use this medicine after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated. Use Noraflat within 10 months of opening the bottle.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Noraflat

• The active ingredient is simethicone. Each tablet contains 40 mg of simethicone.
• The other ingredients (excipients) are: sucrose, sorbitol (E-420), sodium saccharin (E-954), magnesium aluminometasilicate, and strawberry flavor (contains glucose).

Appearance of the product and package contents

Noraflat tablets are white, round, biconvex, and have a strawberry flavor.

They are available in plastic containers containing 30 or 100 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/