Normofludil 200 mg granules for oral solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Normofludil 200 mg granules for oral solution
Acetylcysteine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Always follow exactly the instructions for administration of the medicine contained in this leaflet or those provided 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 any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
- You must consult a doctor if you worsen or do not improve after 5 days of treatment.
Contents of the leaflet
- What Normofludil is and what it is used for
- What you need to know before taking Normofludil
- How to take Normofludil
- Possible side effects
- How to store Normofludil
- Contents of the pack and other information
1. What Normofludil is and what it is used for
Acetylcysteine belongs to a group of medicines known as mucolytics.
It works by reducing the viscosity of mucus, liquefying it and facilitating its elimination.
This medicine is indicated to reduce the viscosity of mucus and phlegm, facilitating their expulsion, in 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 starting Normofludil
Do not take Normofludil
- If you are allergic to acetylcysteine and its derivatives, or to 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 suffer from a serious respiratory disease.
- The possible sulfur-like odor (resembling rotten eggs) of the medicine is characteristic of the active ingredient and does not indicate that the medicine is spoiled.
- If you experience stomach discomfort when taking the medicine. In this case, you should stop treatment and consult your doctor.
- During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease over the course of treatment.
Children and adolescents
This medicine must not be taken by children under 12 years of age. There are other formulations more suitable for this population.
Other medicines and Normofludil
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
You must 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 accumulation of liquefied mucus.
When taking medicines containing minerals such as iron or calcium, or medicines containing antibiotics such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines, you should separate the administration of these medicines from Normofludil by at least 2 hours.
Taking Normofludil with food and drink
Taking food or drinks does not affect the effectiveness of the medicine.
The medicine may be taken with or without food.
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.
This medicine must not be taken during pregnancy or breastfeeding.
Driving and using machines
Normofludil may cause drowsiness. If you experience drowsiness, do not drive or operate dangerous machinery.
Normofludil contains sorbitol (E-420), aspartame (E-951), and sunset yellow FCF (E-110).
This medicine contains 10 mg of aspartame per sachet.
Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
This medicine contains 723.5 mg of sorbitol per sachet.
Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or with hereditary fructose intolerance (HFI), a rare genetic disorder in which fructose cannot be broken down, you (or your child) should consult your doctor before taking this medicine.
Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.
This medicine may cause allergic reactions because it contains sunset yellow FCF (E-110). It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
3. How to take Normofludil
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose is:
Usual doses of Normofludil are:
Adults: 1 sachet, three times a day. Do not exceed a 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 fluids 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 of age: administer 1 sachet, three times a day. Do not exceed a dose of 3 sachets per day.
Children under 12 years of age must not take this medicine.
There are other more suitable presentations available for this population.
If you take more Normofludil than you should
If you take more Normofludil than you should, you may experience: nausea, vomiting, burning sensation and stomach pain, diarrhoea, or any other adverse 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 at telephone number 91.562.04.20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone will experience them.
The following adverse effects may occur:
Rare – may affect up to 1 in 1,000 patients: drowsiness, nausea, vomiting, headache, stomach pain and burning, diarrhoea, skin rash, and tinnitus.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicines: https://www.notificaram.es. By reporting adverse 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging once they are no longer needed. This will help protect the environment.
6. Contents of the pack and other information
Composition of Normofludil
The active substance is acetylcysteine. Each single-dose sachet contains 200 mg of acetylcysteine.
The other components are: aspartame (E-951), sorbitol (E-420), orange flavour, colloidal silica, and orange-yellow S dye (E-110).
Appearance of the product and contents of the pack:
Normofludil is presented in single-dose sachets containing granules for oral solution. Each pack contains 30 sachets.
Marketing Authorisation 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: February 2016
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es