Noraflat 40 mg chewable tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Noraflat 40 mg chewable tablets simethicone
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use of this medicine provided in this leaflet or those given 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 effects, consult your doctor or pharmacist, even if they are effects 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.
Leaflet contents:
- What Noraflat is and what it is used for
- What you need to know before taking Noraflat
- How to take Noraflat
- Possible side effects
- How to store Noraflat
- Contents of the pack and other information
1. What Noraflat is and what it is used for
Noraflat contains the active substance simethicone, which belongs to a group of medicines that works by breaking down gas bubbles, facilitating their elimination and relieving the discomfort they cause.
Noraflat 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
Do not take Noraflat:
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.
If symptoms worsen, or persist beyond 10 days of treatment, or if you have constipation that does not improve, you should stop treatment and consult your doctor.
Children
Other formulations are available for children.
Simethicone is not recommended for the treatment of infant colic due to limited available information.
Taking Noraflat 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, levothyroxine-containing preparations and simethicone-containing preparations should be taken at least 4 hours apart.
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 operate machinery.
Noraflat contains sucrose, glucose, sorbitol (E-420), and sodium
This medicine contains sucrose and glucose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.
It may harm your teeth.
This medicine contains 240 mg of sorbitol per tablet. Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition 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 less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.
3. How to take Noraflat
Follow exactly the instructions for use provided in this leaflet or those 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 simeticone) three times a day, after each of the main meals.
Do not administer more than 12 tablets per day (equivalent to 480 mg of simeticone).
Method of administration
This medicine is administered orally.
You must chew the tablets thoroughly before swallowing them (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 than you should
There are no known cases of overdose.
Even if a much larger than recommended amount is ingested, adverse effects are very 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, 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 may take another dose, following the instructions given in this section 3. How to take Noraflat.
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 everyone experiences them.
The following adverse effects have been observed during the period of use of simethicone, 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, 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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated. Use Noraflat within 10 months after first opening the bottle.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Noraflat
- The active substance is simeticone. Each tablet contains 40 mg of simeticone.
- The other components (excipients) are: Sucrose, sorbitol (E-420), sodium saccharin (E-954), magnesium aluminometasilicate, and strawberry flavour (contains glucose).
Appearance of the product and contents of the pack
Noraflat tablets are white, round, biconvex tablets with a strawberry flavour.
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 most recent review of this 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 Medical Devices (AEMPS) http://www.aemps.gob.es/