Normofludil 600Mg 20 Dispersible Tablets

Normofludil ® 600 mg dispersible tablets

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet. You may need to read it again.
• If you need advice or more information, ask your pharmacist.

• If you experience side effects, consult your doctor or pharmacist, even if they are side effects that are not listed in this leaflet. See section 4.
• You must see a doctor if you do not feel better or if you feel worse after 5 days.

Package leaflet content:

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

Acetylcysteine, the active ingredient in this medicine, belongs to a group of medicines called mucolytics, which act by reducing the viscosity of mucus, making it thinner and facilitating its elimination.

This medicine is indicated to facilitate the elimination of excess mucus and phlegm, in colds and flu, for adults.

You must see a doctor if you do not feel better or if you feel worse after 5 days.

Do not take Normofludil

• If you are allergic to acetylcysteine ​​or any of the other ingredients of this medicine (listed in section 6).
• Do not administer to children under 2 years of age.

Warnings and cautions

Talk to your doctor or pharmacist before taking Normofludil.

• If you are asthmatic or have a severe respiratory disease, you should consult your doctor before taking this medicine.
• The possible sulfur odor (rotten eggs) of the medicine is typical of the active ingredient, but does not indicate that the medicine is in poor condition.
• If you notice stomach discomfort when taking the medicine, you should stop the treatment and consult your doctor or pharmacist. Caution is advised in patients with a peptic ulcer or a history of peptic ulcer.
• During the first days of treatment you may observe an increase in mucus and phlegm, which will decrease throughout the treatment.

Children and adolescents

Children and adolescents should not take this medicine. There are other more suitable presentations for this population.

Other medicines and Normofludil

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Joint therapy with nitroglycerin can cause headache and the occurrence of hypotension, which can be severe, should be monitored.

Co-administration with the antiepileptic carbamazepine may cause a decrease in the effectiveness of carbamazepine.

Do not administer together with antitussive (cough) medications or with those that decrease bronchial secretions (such as antihistamines and anticholinergics), as an accumulation of fluidized mucus may occur.

When you are taking any medicine that contains minerals such as iron or calcium, or some type of antibiotic medicine (amphotericin B, ampicillin sodium, cephalosporins, lactobionate, erythromycin and some tetracyclines) you must separate your taking from taking Normofludil at least 2 hours. Normofludil dissolution with other medications is not recommended.

Taking Normofludil with food and drink

Taking food and drink does not affect the effectiveness of this medicine.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you might be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

It should be avoided during lactation.

Driving and using machines

There is no evidence of effects on the ability to drive and use machines.

Normofludil contains aspartame

This medicine contains 35 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that can be harmful in case of phenylketonuria (NCF), a rare genetic disease in which phenylalanine accumulates because the body is not able to eliminate it correctly.

Follow exactly the instructions for administration of the medicine contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The recommended dose is:

In adults: One tablet, once a day. Do not exceed the dose of one tablet a day.

Normofludil is taken by mouth.

Dissolve 1 dispersible tablet in a glass of water. Stir with a spoon before administration. The solution obtained is taken directly from the glass.

It is recommended to drink plenty of fluids during the day.

You must talk to a doctor if you do not feel better or if you feel worse after 5 days of treatment.

Use in children and adolescents

Children and adolescents cannot take this medicine. There are other more suitable presentations for this population.

If you take more Normofludil than you should

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

In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call the Toxicology Information Service, telephone 91 562 04 20 indicating the medicine and the amount ingested.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If you forget to take Normofludil 

Do not take a double dose to make up for a forgotten dose. If you miss a dose, wait for the next one.

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

The following side effects may occur:

Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, ringing in the ears, tachycardia, vomiting, diarrhea, stomatitis, abdominal pain, nausea, hives, rash, angioedema, itching, increased body temperature , hypotension.

Rare (may affect up to 1 in 1,000 people): drowsiness, bronchospasm, shortness of breath, digestive discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, bleeding, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with at least one other drug simultaneously.

Not known (cannot be estimated from the available data): swelling of the face.

In the event of any alteration to the skin or mucous membranes, the administration of acetylcysteine ​​should be stopped immediately and medical attention should be sought.

Communication of adverse effects

If you experience any kind of side effect, consult your doctor or pharmacist, even if it is about possible side effects that are not listed in this leaflet. You can also communicate them directly through the Spanish Pharmacovigilance System for Medicines for Human Use: https://www.notificaRam.es. By reporting side effects you can help provide more information on the safety of this medicine.

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

Store below 25ºC.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Deposit the containers and medicines you do not need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of medicines that you no longer need. This way you will help to protect the environment.

What Normofludil contains 

• The active substance is acetylcysteine. Each tablet contains 600 mg of acetylcysteine.
• The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropyl cellulose, crospovidone, aspartame (E-951), calcium carbonate, lemon essence, orange essence and magnesium stearate.

Normofludil 600Mg Leaflet 20 Dispersible Tablets