Patient Information Leaflet

Noraflat 40 mg Chewable Tablets
Simeticone

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 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 you get worse or do not improve after 10 days.

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

Noraflat is indicated for symptomatic relief of gas in adults andadolescents from12 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:

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.

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 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 machinery

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

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

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

It may harm your teeth.

This medication contains 240 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have 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 with your doctor before taking this medication.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

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. In case of doubt, ask your doctor or pharmacist.

Adults andadolescents over 12 years:

The recommended dose is 2 chewable tablets (80 mg of simethicone) three times a day, after each of the main meals.

Do not administer more than 12 tablets per 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 than you should

No cases of overdosing have been reported.

Even in the event of ingesting a much larger amount 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

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.

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:

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 of Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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 Noraflaten within 10 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

• The active ingredient is simeticone. Each tablet contains 40 mg of simeticone.
• The other components (excipients) are: Saccharose, sorbitol (E-420), sodium saccharin (E-954), magnesium aluminometasilicate and strawberry aroma (contains glucose).

Appearance of the product and contents of the packaging

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

They are presented in plastic containers containing 30 or 100 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/