Package Insert: Information for the Patient

Normofludil 200 mg Powder for Oral Solution

Acetilcisteína

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 or pharmacist.

• 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 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 5 days of treatment.

1. What is Normofludil and how is it used

2. What you need to know before starting to take Normofludil

3. How to take Normofludil

4. Possible adverse effects

5. Storage of Normofludil

6. Contents of the package and additional information

Acetilcisteína belongs to a group of medications called mucolítics.

It acts by reducing the viscosity of mucus, liquefying it and facilitating its elimination.

This medication is indicated to reduce the viscosity of mucus and phlegm, facilitating its expulsion, in colds and flu, for adults and adolescents 12 years and older.

Consult a doctor if it worsens or does not improve after 5 days of treatment.

Do not take Normofludil

• If you are allergic to acetylcysteine and its derivatives, or to any of the other components of this medication (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 are asthmatic or have a severe respiratory disease.
• The possible sulfurous smell (like rotten eggs) of the medication is due to the active ingredient, but it does not indicate that the medication is spoiled.
• If you experience stomach discomfort while taking the medication. In that case, you should discontinue treatment and consult your doctor.
• During the first days of treatment, you may observe an increase in mucus and phlegm, which will decrease over time.

Children and adolescents

This medication cannot be taken by children under 12 years old. There are other presentations more suitable for this population.

Other medications and Normofludil

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

You should not take this medication if you are being treated with cough suppressants or with medications that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause a buildup of fluidified mucus.

When taking medications that contain minerals such as iron or calcium, or medications with antibiotics (such as amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin, and some tetracyclines), you should separate your 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 medication.

The medication can be taken with or without food.

Pregnancy and breastfeeding

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

This medication should not be taken during pregnancy or breastfeeding.

Driving and operating machinery

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

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

This medication contains 10 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

This medication contains723.5 mg ofsorbitol

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 if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder 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 may cause allergic reactions because it contains yellow orange S (E-110). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

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.

The recommended dose is:

The usual doses ofNormofludilare:

Adults:1 packet, 3 times a day. Do not exceed a dose of 3 packets per day.

How to take:

Normofludil is taken orally.

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

It is recommended to drink an abundant amount of liquid during the day.

You should consult a doctor if you worsen or do not improve after 5 days of treatment.

Use in children and adolescents

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

Children under 12 years old cannot take this medication.

There are other presentations more suitable for this population.

If you take more Normofludil than you should

If you take moreNormofludilthan you should, you may experience: nausea, vomiting, heartburn and stomach pain, diarrhea or any other adverse effect described in section 4. Possible adverse effects.

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

Like all medications, this medication may have adverse effects, although not all people will experience them.

The following adverse effects may occur:

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

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Ask your pharmacisthow to disposeofthepackaging and of themedicines that you no longerneed. This will help protect the environment.

Composition ofNormofludil

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

The other components are: aspartame (E-951), sorbitol (E-420), orange essence, colloidal silica, and yellow-orange food coloring S (E-110).

Appearance of the product and content of the packaging:

Normofludil is presented in single-dose packets containing oral granulate. Each package contains 30 packets.

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:February 2016

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