NORMOFLUDIL 200 mg ORAL SOLUTION GRANULES

Introduction

Patient Information Leaflet

Normofludil 200 mg granules for oral solution

Acetylcysteine

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 or pharmacist.

• 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 condition worsens or does not improve after 5 days of treatment.

Contents of the Leaflet

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

1. What Normofludil is and what it is used for

Acetylcysteine belongs to a group of medicines called mucolytics.

It works by reducing the viscosity of mucus, making it more fluid and easier to expel.

This medicine is indicated to reduce the viscosity of mucus and phlegm, making it easier to expel, in cases of colds and flu, for adults and adolescents from 12 years of age.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

2. What you need to know before taking Normofludil

Do not take Normofludil

• If you are allergic to acetylcysteine or any of the other components of this medicine (listed in section 6).
• If you have a stomach or duodenal ulcer.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normofludil

• If you have asthma or a severe respiratory disease.
• The possible sulfur-like odor (like rotten eggs) of the medicine is characteristic of the active ingredient, but it does not indicate that the medicine is in poor condition.
• If you experience stomach discomfort when taking the medicine. In this case, you should stop treatment and consult your doctor.
• During the first few days of treatment, you may notice an increase in mucus and phlegm, which will decrease as treatment progresses.

Children and adolescents.

This medicine should not be taken by children under 12 years of age. There are other presentations more suitable for this population.

Other medicines and Normofludil

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

Do not take this medicine if you are being treated with antitussive medicines (for cough) or those that reduce bronchial secretions (such as antihistamines and anticholinergics), as this may cause an accumulation of fluidified mucus.

When taking any medicine that contains minerals such as iron or calcium, or any medicine with antibiotics such as amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the intake of Normofludil by at least 2 hours.

Taking Normofludil with food and drinks

The intake of food and drinks does not affect the efficacy of the medicine.

The medicine can be taken with or without food.

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.

This medicine should not be taken during pregnancy or breastfeeding.

Driving and using machines

Normofludil may cause drowsiness. If it causes drowsiness, do not drive or use hazardous machinery.

Normofludil contains sorbitol (E-420), aspartame (E-951), and orange yellow S (E-110).

This medicine contains 10 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

This medicine contains 723.5 mg of sorbitol in each sachet. 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 your doctor before taking this medicine.

Sorbitol may cause gastrointestinal upset and a mild laxative effect.

This medicine may cause allergic reactions because it contains orange yellow S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Normofludil

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.

The recommended dose is:

The usual doses of Normofludilare:

Adults: 1 sachet, 3 times a day. Do not exceed the dose of 3 sachets per day.

How to take:

Normofludil is taken orally.

Dissolve the contents of the sachet in a glass of water.

It is recommended to drink plenty of liquid throughout the day.

You should consult a doctor if your condition worsens or does not improve after 5 days of treatment.

Use in children and adolescents

Patients between 12 and 18 years: administer 1 sachet, 3 times a day. Do not exceed the dose of 3 sachets per day.

Children under 12 years of age should not take this medicine.

There are other presentations more suitable for this population.

If you take more Normofludil than you should

If you take more Normofludil than you should, you may notice: nausea, vomiting, heartburn, and stomach pain, diarrhea, or any other side effect described in section 4. Possible side effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount ingested.

4. Possible side effects

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

The following side effects may occur:

Rarely, they may affect 1 in 1,000 patients: drowsiness, nausea, vomiting, headache, stomach pain and heartburn, diarrhea, skin rash, and ringing in the ears.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Normofludil

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. 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 Normofludil

The active ingredient is acetylcysteine. Each single-dose sachet contains 200 mg of acetylcysteine.

The other ingredients are: aspartame (E-951), sorbitol (E-420), orange flavor, colloidal silica, and orange yellow S (E-110) colorant.

Appearance of the product and package contents:

Normofludil is presented in single-dose sachets containing granules for oral solution. Each package contains 30 sachets.

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:February 2016

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