Noraflat Forte 120 mg chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Noraflat Forte 120 mg chewable tablets simeticone

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided 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 any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 10 days.

Contents of the leaflet

1. What Noraflat Forte is and what it is used for
2. What you need to know before taking Noraflat Forte
3. How to take Noraflat Forte
4. Possible adverse effects
5. How to store Noraflat Forte
6. Contents of the pack and other information

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

Noraflat Forte contains the active substance simethicone, which belongs to a group of medicines that work by breaking down gas bubbles, facilitating their elimination and relieving discomfort caused by gas.

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

You should consult a doctor if your condition 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 to any of the other ingredients of this medicine (listed in section 6).

If you have known or suspected intestinal perforation or obstruction.

Warnings and precautions

Consult your doctor or pharmacist before taking Noraflat Forte.

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

Children

Other formulations are available for children.

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

Taking Noraflat Forte with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

The absorption of levothyroxine (a medicine used to treat diseases and dysfunctions of the thyroid gland) may be affected if simethicone is administered at the same time. Therefore, preparations containing levothyroxine and those containing simethicone should be taken at least 4 hours apart.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Noraflat Forte has no influence on the ability to drive or operate machinery.

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

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

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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

May harm teeth.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially “sodium-free”.

3. How to take Noraflat Forte

Follow exactly the dosage instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults and adolescents over 12 years of age:

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

Do not take more than 4 tablets per day (equivalent to 480 mg simeticone).

Method of administration

This medicine is administered orally.

You must chew the tablets well before swallowing (they should not be swallowed whole).

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

If you take more Noraflat Forte than you should

No cases of overdose are known.

Even if a much larger than recommended amount is ingested, adverse effects are highly unlikely due to the lack of gastrointestinal 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 at telephone number: 91 562 04 20, stating the medicine and the quantity ingested.

If you forget to take Noraflat Forte

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

If symptoms persist, you may take another dose, following the instructions given in section 3. How to take Noraflat Forte.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

The following adverse effects have been observed during the period of simethicone use, with frequency not known (cannot be estimated from the available data):

• Moderate, transient constipation and nausea.
• Belching may occur, which constitutes the normal mechanism for gas elimination with this treatment.
• Allergic reactions (hypersensitivity) such as rash, itching of the skin, swelling of the face or tongue, or difficulty breathing.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Noraflat Forte

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

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated. Use Noraflat Forte within 12 months after first opening the bottle.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please consult your pharmacist on how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the container and additional information

Composition of Noraflat Forte

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

Appearance of the product and contents of the pack

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

They are supplied 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 most recent review of this package leaflet: January 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/