ACETYLCYSTEINE AUROVITAS 200 mg ORAL SOLUTION GRANULES IN SACHETS

Introduction

Package Leaflet:information for the user

Acetylcysteine Aurovitas 200 mg granules for oral solution in sachets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Acetylcysteine Aurovitas and what is it used for
2. What you need to know before you take Acetylcysteine Aurovitas
3. How to take Acetylcysteine Aurovitas
4. Possible side effects

5 Storage of Acetylcysteine Aurovitas

1. Contents of the pack and further information

1. What is Acetylcysteine Aurovitas and what is it used for

Acetylcysteine Aurovitas contains the active substance acetylcysteine, which acts by dissolving the thick, viscous mucus of the respiratory tract.

This medicine is indicated in adults and adolescents over 12 years of age as an adjunct for the treatment of acute respiratory conditions associated with excessive mucus in the lungs and respiratory tract, when the mucus is too thick and viscous to cough up easily.

2. What you need to know before you take Acetylcysteine Aurovitas

Do not take Acetylcysteine Aurovitas

if you are/allergic

• allergicto acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
• Children under 2 years of age should not use this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking acetylcysteine.

• Changes in skin and mucous membranes.

If new changes occur in the skin and mucous membranes, you should consult a doctor immediately and stop using acetylcysteine.

• Bronchial asthma.
• Past or present stomach or intestinal ulcers.
• Hypersensitivity to histamine.

Long-term treatment should be avoided in these patients, as this medicine influences histamine metabolism and may cause intolerance symptoms (e.g. headache, nasal discharge, itching).

• Inability to expectorate mucus
• Acetylcysteine may increase the intensity of vomiting.

Children

Acetylcysteine is not recommended in children under 12 years of age (due to the high content of active ingredient).

Other medicines and Acetylcysteine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies particularly to:

• Cough suppressants

The combined use of acetylcysteine with cough suppressants may cause a dangerous accumulation of secretion due to the reduction of the cough reflex. A particularly careful diagnosis is required for this combination therapy. It is essential that you ask your doctor before using this combination.

• Antibiotics

Experimental studies show evidence of a weakening effect of antibiotics (tetracyclines, aminoglycosides, penicillins) due to acetylcysteine. For safety reasons, antibiotics should be taken separately and with an interval of at least 2 hours.

• Activated charcoal
• Glyceryl trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels.

Your doctor will monitor if you have low blood pressure, which could be severe and could be detected by headache.

• Carbamazepine

The combination of acetylcysteine and carbamazepine (a medicine for epilepsy) may reduce the therapeutic effect of carbamazepine.

• It is not recommended to use acetylcysteine, in solution, with other medicines.
• Acetylcysteine may interfere with heavy metal salts, such as gold and iron salts, and with calcium salts. Therefore, it is best to separate the intake of acetylcysteine and these salts or administer them by another route.

Laboratory tests

Tell your doctor that you are taking acetylcysteine if you need a test for:

it may affect the determination of:

• salicylates:medicines for treating pain, inflammation, or rheumatism.
• ketone bodies in urine.

Pregnancy,breast-feeding and fertility

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

Pregnancy

Since there is not enough experience with the use of this medicine in pregnant women, it is recommended that, as a precautionary measure, acetylcysteine should not be used during pregnancy. You should use acetylcysteine during pregnancy only if your doctor considers it absolutely necessary.

Breast-feeding

There is no information available on the excretion of acetylcysteine in breast milk. Therefore, you should use this medicine during breast-feeding only if your doctor considers it absolutely necessary.

Fertility

There are limited data on the influence of acetylcysteine on fertility in humans. Animal studies do not show effects on human fertility at the recommended doses.

Driving and using machines

The influence on the ability to drive and use machines is not known.

Acetylcysteine Aurovitascontains sucrose

This medicine contains 0.66 g of sucrose per dose (0.66 g sucrose/1 sachet).

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

Acetylcysteine Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; this is, essentially “sodium-free”.

3. How to take Acetylcysteine Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose, unless your doctor prescribes otherwise, is:

Adults and adolescents over 12 years of age:

Take 200 mg (1 sachet) of acetylcysteine every 8 hours, 3 times a day. Do not take more than 600 mg/day.

Use in children:

Do not use in children under 12 years of age.

There are other formulations that are more suitable for this population.

Method of administration

This medicine can be taken with or without food.

Dissolve the granulated contents of one sachet in half a glass of water or other liquid and mix until it becomes a homogeneous solution. Use a glass or plastic cup (never use a rubber or metal cup). Partially used sachets can be stored until the next intake (it is recommended to use the other half within 24 hours). However, solutions should be used immediately.

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are not sure.

When opening the sachet, there may be a slight smell of sulfur (rotten eggs). This is a normal characteristic of this medicine and does not mean it is not safe to use.

Duration of treatment

If your symptoms worsen or do not improve after 5 days, you should consult your doctor.

If you take moreAcetylcysteine Aurovitasthan you should

In case of overdose, stomach and intestinal irritation may occur, such as abdominal pain, nausea, vomiting, diarrhea.

To date, no serious side effects or symptoms of intoxication have been observed, even in the case of massive overdose. However, if an overdose with acetylcysteine is suspected, please inform your doctor.

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

If you forget to take Acetylcysteine Aurovitas

Do not take a double dose to make up for forgotten doses. Simply take your next dose at the usual time.

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

4. Possible side effects

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

Stop taking this medicine and contact your doctor if you get signs of an allergic reaction or a severe skin reaction.

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions.

Rare(may affect up to 1 in 10,000 people)

• Severe allergic reactionssuch as skin rash, itching, fluid accumulation (edema), breathing difficulties, and loss of consciousness.

Other possible side effects may occur with the following frequencies:

Uncommon(may affect up to 1 in 100 people)

• Headache.
• Fever.
• Inflammation of the inner lining of the mouth.
• Abdominal pain.
• Nausea, vomiting.
• Diarrhea.
• Ringing or buzzing in the ears.
• Fast heart rate.
• Low blood pressure.
• Itching, hives, skin rash.
• Severe, mostly painful, inflammation of the deep layers of the skin, mainly on the face.

Rare(may affect up to 1 in 1,000 people)

• Breathing difficulties.
• Bronchospasm.
• Indigestion.

Very rare(may affect up to 1 in 10,000 people)

• Bleeding.
• Dizziness.

Frequency not known(frequency cannot be estimated from the available data)

• Inflammation of the tissue in the face caused by excess fluid.
• Reduction of platelet accumulation in the blood.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Acetylcysteine Aurovitas

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

Do not use this medicine after the expiry date which is stated on the sachet and carton after “EXP”. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Acetylcysteine Aurovitas

• The active substance is acetylcysteine.

Each sachet contains 200 mg of acetylcysteine.

• The other ingredients (excipients) are: sucrose, sodium saccharin, orange flavor (corn syrup, natural and artificial flavorings, gum arabic).

Appearance and packaging of the product

Granules for oral solution in sachets.

White to off-white granular powder packaged in sachets.

Sizes of packaging:

14, 18, 20, 24, 30, and 60 sachets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

O

Arrow Generiques

26 Avenue Tony Garnier,

Lyon 69007

France

This medicine is authorised in the Member States of the European Economic Area under the following names:

Belgium: Acetylcysteine AB 200 mg granules for oral solution in sachet/granulés pour solution buvable en sachet/ Granulat zur Herstellung einer Lösung zum Einnehmen im Beutel

Spain: Acetilcisteína Aurovitas 200 mg granulado para solución oral en sobres EFG

France: ACETYLCYSTEINE ARROW 200 mg, granulés pour solution buvable en sachet

Italy: Nakys

Portugal: Acetilcisteína Generis

Date of last revision of this leaflet: June 2024

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