Acetylcysteine Sandoz Care 600 mg effervescent tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Acetylcysteine Sandoz Care 600 mg effervescent tablets

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

Always follow exactly the instructions for administration of this medicine as described in this leaflet or as directed 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 doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of this leaflet:

1. What Acetylcysteine Sandoz Care is and what it is used for
2. What you need to know before taking Acetylcysteine Sandoz Care
3. How to take Acetylcysteine Sandoz Care
4. Possible adverse effects
5. How to store Acetylcysteine Sandoz Care
6. Contents of the pack and other information

1. What Acetilcisteína Sandoz Care is and what it is used for

Acetylcysteine belongs to a group of medicines called mucolytics.

It works by reducing the viscosity of mucus, making it less thick and helping its elimination.

This medicine is indicated to help eliminate excess mucus and phlegm in catarrhal and influenza-like conditions in adults.

You should consult your doctor if you worsen or do not improve after 5 days.

2. What you need to know before starting to take Acetylcysteine Sandoz Care

Do not take Acetylcysteine Sandoz Care:

• if you are allergic to acetylcysteine or to 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

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 sulphurous odour (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 when taking the medicine, stop treatment and consult your doctor. Caution is recommended in patients with peptic ulcer or history of peptic ulcer.

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

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

Taking Acetylcysteine Sandoz Care with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

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

Concomitant administration with the antiepileptic carbamazepine may lead to a reduction in carbamazepine efficacy.

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, the administration should be separated from acetylcysteine by at least 2 hours.

Dissolving acetylcysteine together with other medicines is not recommended.

Taking Acetylcysteine Sandoz Care with food and drink

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might 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 using machines

There is no evidence of effects on the ability to drive or operate machinery.

Acetylcysteine Sandoz Care contains lactose, sorbitol and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 139 mg of sodium (main component of table/cooking salt) per tablet. This corresponds to 6.0% of the maximum daily recommended sodium intake for an adult.

This medicine contains 40 mg of sorbitol per tablet.

3. How to take Acetylcysteine Sandoz Care

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

Adults: 1 tablet, once daily. Do not exceed the dose of 1 tablet per day.

How to take Acetylcysteine Sandoz Care:

Acetylcysteine is taken by mouth.

Dissolve in a glass of water; do not drink until effervescence has completely stopped. 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

This medicine must not be given to children and adolescents. Other formulations more suitable for this population are available.

If you take more Acetylcysteine Sandoz Care 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 side effects.

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

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 can cause adverse effects, although not everyone will experience them.

The following adverse effects may occur:

Uncommon (may affect up to 1 in 100 patients): 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 patients): somnolence, bronchospasm, breathing difficulty, gastrointestinal discomfort.

Very rare (may affect up to 1 in 10,000 patients): allergic reactions, anaphylactic shock, haemorrhage, serious 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, administration of acetylcysteine must be stopped immediately and medical advice should be sought.

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 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 Sandoz Care

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

Triple-layer paper/aluminum/polyethylene pouch:

Do not store above 30°C.

Polypropylene tube:

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging, after CAD/EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Acetylcysteine Sandoz Care 600 mg

• The active substance is acetylcysteine. Each effervescent tablet contains 600 mg of acetylcysteine.

• The other components (excipients) are: anhydrous lactose, sodium hydrogen carbonate, sodium saccharin dihydrate, sodium citrate, anhydrous sodium carbonate, sodium cyclamate, mannitol (E-421), ascorbic acid, blackberry flavour (containing sorbitol and mannitol (E-421)), and anhydrous citric acid.

Appearance of the medicine and contents of the container

White, smooth, round effervescent tablets.

The product is available in containers (bottles) containing 20 effervescent tablets. Alternatively, the effervescent tablets are packaged in 10 or 20 sealed triple-layer foil sachets made of paper/aluminum/polyethylene.

Some pack sizes may not be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee, 1
39179 Barleben
Germany

or

Hermes Pharma GmbH
Hans-Urmiller-Ring 52
82515 Wolfratshausen
Germany

Date of the most recent revision of this leaflet: September 2020.

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