Acetylcysteine Tarbis 200 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Acetylcysteine Tarbis 200 mg oral solution granules EFG

Read the entire leaflet carefully before you start taking/using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

1. What Acetylcysteine Tarbis is and what it is used for.
2. What you need to know before taking Acetylcysteine Tarbis.
3. How to take Acetylcysteine Tarbis.
4. Possible side effects.
5. Storage of Acetylcysteine Tarbis.
6. Contents of the package and other information.

1. What Acetilcisteína Tarbis is and what it is used for

Acetylcysteine, the active substance of this medicine, belongs to a group of medicines called mucolytics and is used to liquefy excessive and/or thick bronchial secretions.

This medicine is indicated to help eliminate excess mucus and phlegm in respiratory conditions associated with excessive or thick mucous secretions, such as acute and chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), emphysema, pulmonary complications of cystic fibrosis, and other related conditions.

2. What you need to know before starting to take Acetylcysteine Tarbis

Do not take Acetylcysteine Tarbis

• If you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
• In children under 2 years of age.

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetylcysteine.

If you have asthma or suffer from a serious respiratory disease, you should consult your doctor before taking this medicine.

The possible sulfurous odor (like rotten eggs) of the medicine is characteristic of the active substance and does not indicate that the medicine is in poor condition.

If you experience stomach discomfort while taking the medicine, you should stop treatment and consult your doctor or pharmacist. Caution is recommended in patients with peptic ulcer or a history of peptic ulcer.

During the first days of treatment, you may notice an increase in mucus and phlegm, which will gradually decrease as treatment continues.

Use with caution during long-term treatment in patients with histamine intolerance.

Children and adolescents

This medicine is contraindicated in children under 2 years of age.

Other medicines and Acetylcysteine Tarbis

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

Concomitant therapy with nitroglycerin may cause headache, and the occurrence of hypotension—which may be severe—should be monitored.

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

Do not take together 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), separate their administration from that of acetylcysteine by at least 2 hours.

It is not recommended to dissolve acetylcysteine with other medicines.

Taking Acetylcysteine Tarbis with food and drinks

Taking this medicine with food or drinks does not affect its efficacy.

Pregnancy, breastfeeding, and fertility

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.

Its use should be avoided during breastfeeding.

Driving and use of machines

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

Warning about excipients

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Acetylcysteine Tarbis

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults, adolescents and children over 7 years of age:

200 mg of acetylcysteine (1 sachet of acetylcysteine 200 mg, 3 times daily), every 8 hours. Do not exceed a dose of 3 sachets (600 mg of acetylcysteine) per day.

Pulmonary complications of cystic fibrosis

The recommended dose is:

Adults, adolescents and children over 7 years of age:

200 to 400 mg of acetylcysteine every 8 hours (1 to 2 sachets of acetylcysteine 200 mg, 3 times daily).

Acetylcysteine is taken orally.

The contents of the sachets should be dissolved in a glass of water and mixed with a teaspoon. It is recommended to drink plenty of fluids throughout the day.

This medicine is contraindicated in children under 2 years of age.

If you take more Acetylcysteine Tarbis than you should

If you take more acetylcysteine than you should, you may experience: nausea, vomiting, stomach burning and pain, diarrhoea, or any other adverse effect described in section 4. Possible adverse effects.

In case of overdose or accidental ingestion, consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915 620 420, indicating the medication and the amount taken.

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

If you forget to take Acetylcysteine Tarbis

Do not take a double dose to make up for the forgotten dose.

If you interrupt treatment with Acetylcysteine Tarbis

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 people): hypersensitivity, headache, tinnitus, tachycardia, vomiting, diarrhoea, stomatitis, abdominal pain, nausea, urticaria, skin rash, angioedema, pruritus, increased body temperature, hypotension.

Rare (may affect up to 1 in 1,000 people): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 people): allergic reactions, anaphylactic shock, haemorrhage, severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome, sometimes identified in association with the concomitant use of another medicinal product.

Frequency not known (cannot be estimated from available data): facial swelling.

If any changes occur in the skin or mucous membranes, acetylcysteine administration must be immediately discontinued and medical advice sought.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Tarbis

Keep this medicine out of 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. Unused containers and medicines should be handed over to the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylcysteine Tarbis

The active substance is acetylcysteine. Each sachet contains 200 mg of acetylcysteine.

The other components (excipients) are: mannitol, anhydrous colloidal silica, sodium saccharin, orange flavour, and β-carotene colouring.

Appearance of the medicine and contents of the pack

Acetylcysteine Tarbis 200 mg is presented in paper and aluminium sachets with an inner polyethylene coating. Each pack contains 30 sachets of white, slightly orange-coloured granules with a characteristic odour.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Tarbis Farma, S. L.

Gran Vía Carlos III 94

08028 Barcelona

Spain

Manufacturer

Farmasierra Manufacturing S. L.

Irún Road km 26,200.

28706 – San Sebastián de los Reyes. Madrid. Spain

Date of the most recent revision of this leaflet: July 2007

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

( http://www.aemps.gob.es).