Cinfamucol Acetylcysteine Forte 600 mg 20 Effervescent Tablets

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

This medication is indicated to reduce the viscosity of mucus and phlegm, facilitating their expulsion in colds and flu in adults.

You should see a doctor if it worsens or if it does not improve after 5 days.

Do not take cinfamucol acetylcysteine ​​forte

• 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 precautions

Talk to your doctor or pharmacist before taking Cinfamucol Acetylcysteine ​​Forte.

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

Taking cinfamucol acetylcysteine ​​forte with other medicines

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

Concomitant therapy with nitroglycerin may cause headache and hypotension, which can be severe, should be monitored for.

Co-administration with the antiepileptic carbamazepine may result in decreased efficacy of carbamazepine.

Do not take together with antitussive medications (for cough) or with those that reduce bronchial secretions (such as antihistamines and anticholinergics), as it may cause an accumulation of fluidized mucus.

When you are taking any medication that contains minerals such as iron or calcium, or any medication with antibiotics (amphotericin B, sodium ampicillin, cephalosporins, lactobionate, erythromycin and some tetracyclines) you should separate your intake from the intake of acetylcysteine ​​at least 2 hours . The dissolution of cinfamucol acetylcysteine ​​forte with other medications is not recommended.

Cinfamucol acetylcysteine ​​forte with food and drink

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

Pregnancy and lactation

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before using this medicine.

Its intake should be avoided during lactation.

Driving and using machines

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

Cinfamucol acetylcysteine ​​forte contains sodium.

This medicine contains 194.04 mg sodium (main component of cooking/table salt) in each tablet. This equates to 9.7% of the recommended maximum daily sodium intake for an adult.

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:

Adults

1 tablet, 1 time a day. Do not exceed the dose of 1 tablet (600 mg) per day.

How to drink

Cinfamucol acetylcysteine ​​forte is taken orally.

The effervescent tablets should be dissolved in a glass of water, do not drink until the effervescence has completely stopped. It is recommended to drink plenty of fluids throughout the day.

You should see a doctor if you get worse or if you do not get better 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 Cinfamucol Acetylcysteine ​​Forte than you should

If you take more cinfamucol acetylcysteine ​​forte 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, immediately consult your doctor or pharmacist or call the Toxicological Information Service, telephone: 91 562 04 20, indicating the medication and the amount ingested.

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

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

The following side effects may occur:

Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, stomatitis, abdominal pain, nausea, urticaria, rash, angioedema, pruritus, 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 people): allergic reactions, anaphylactic shock, haemorrhage, serious skin reactions such as Stevens-Johnson syndrome and Lyell syndrome, sometimes identified with at least one other drug taken simultaneously.

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

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

Communication of adverse effects

If you get any side effects, talk to your doctor or pharmacist, including possible side effects not listed in this leaflet. You can also notify 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.

Keep the tube perfectly closed to protect it from moisture.

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

Medications should not be thrown down the drain or in the trash. Deposit the containers and medicines that you do not need at the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you don't need. This way you will help to protect the environment.

Composition of Cinfamucol Acetylcysteine ​​Forte

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.
• The other ingredients are: anhydrous citric acid (E-330), maltodextrin (from corn starch), sodium hydrogen carbonate, sodium saccharin (E-954), orange flavoring (flavouring preparations, flavoring substances, natural flavoring substances, maltodextrin corn, gum arabic (E-414), ascorbic acid (E-300) and butylated hydroxyanisole (BHA) (E-320)). and leucine.

Appearance of the product and contents of the container

Cinfamucol acetylcysteine ​​forte is presented as an effervescent tablet, white, cylindrical, flat and in packs of 10 or 20 tablets.

They are presented in polypropylene tubes closed with a polyethylene cap filled with silica gel as a drying agent. Each package contains a tube with 10 effervescent tablets.

Marketing authorization holder and manufacturer

Marketing Authorization Holder

Cinfa Laboratories, S.A.

Olaz-Chipi Highway, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Cinfamucol Acetylcysteine ​​Forte 600 Mg 20 Effervescent Tablets