Package Insert: Information for the Patient

Noraflat Forte 120 mg Chewable Tablets
Simeticone

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, pharmacist, or nurse.

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

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

2. What you need to know before starting to take Noraflat Forte

3. How to take Noraflat Forte

4. Possible adverse effects

5. Storage of Noraflat Forte

6. Contents of the package and additional information

Noraflat Forte contains the active ingredient simethicone, which belongs to a group of medications that works by breaking down gas bubbles, facilitating their elimination and alleviating the discomfort they cause.

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

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

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 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 if they persist after 10 days of treatment, or if you have constipation that does not improve, discontinue treatment and consult your doctor.

Children

There are other commercial formulations available for children.

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

Taking Noraflat Forte with other medications

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

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

Pregnancy and breastfeeding

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

Driving and operating machines

The influence of Noraflat Forte on the ability to drive or operate machines is negligible.

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 indicated that you (or your child) suffer from an intolerance to certain sugars, or if you 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 may cause gastrointestinal discomfort and a mild laxative effect.

This medication contains glucose. If your doctor has indicated that you suffer from an intolerance to certain sugars, consult with them 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”.

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

Adults andadolescents over 12 years:

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

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

Administration Form

This medication is administered orally.

You must chew the tablets well before swallowing them (do not swallow them whole).

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

If you take more Noraflat Forte than you should

No cases of overdosing have been reported.

Even in the event of ingesting a much higher dose than indicated, it is very unlikely that adverse 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Noraflat Forte

Do not take a double dose to compensate for the missed 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.

Like all medications,this medicationmay cause adverse effects, although not everyone will experience them.

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

• Moderate transient constipation and nausea.
• Eructations may occur, which constitute the normal mechanism of elimination of gases with this treatment.
• Allergic reactions (hypersensitivity) such as rash, itching on the skin,swellingin the face or tongue, or difficulty breathing.

Reporting Adverse Effects

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

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated. Use Noraflat Forte within 12 months after the first opening of the bottle.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Noraflat Forte

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

Appearance of the product and contents of the packaging

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

They are presented inplastic containerscontaining 40 tablets.

Other presentations

Noraflat 40 mg chewable tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:January 2024

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