ACETYLCYSTEINE AUROVITAS 600 MG ORAL SOLUTION GRANULES IN SACHETS

Introduction

Package Leaflet:information for the user

Acetylcysteine Aurovitas 600 mg granules for oral solution in sachets EFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

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

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 taking Acetylcysteine Aurovitas
3. How to take Acetylcysteine Aurovitas
4. Possible side effects

5 Storage of Acetylcysteine Aurovitas

1. Package contents and additional information

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

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

This medication is indicated in adults 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 taking Acetylcysteine Aurovitas

Do not take Acetylcysteine Aurovitas

if you are/allergic

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take acetylcysteine.

• Changes in skin and mucous membranes.

If new changes occur in the skin and mucous membranes, you should consult a doctor immediately and discontinue the use of acetylcysteine.

• Bronchial asthma.
• Past or current history of stomach or intestinal ulcers.
• Hypersensitivity to histamine.

Long-term treatment should be avoided in these patients, as this medication 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 for children and adolescents (due to the high content of active ingredient). There are other medications with a lower amount of active ingredient for them.

Other medications and Acetylcysteine Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. 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 combined treatment. 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 medication 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 medication for epilepsy) may reduce the therapeutic effect of carbamazepine.

• The use of acetylcysteine is not recommended in solution with other medications.
• 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:

may affect the determination of:

• salicylates: medicationsfor pain, inflammation, or rheumatism.
• ketone bodies in urine.

Pregnancy,breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

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

Breastfeeding

There is no information available on the excretion of acetylcysteine in breast milk. Therefore, you should use this medication during breastfeeding 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 medication contains 1.98 g of sucrose per dose (1.98 g sucrose/1 sachet).

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

Acetylcysteine Aurovitas contains sodium

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

3. How to take Acetylcysteine Aurovitas

Follow the administration instructions of this medication exactly as indicated 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:

Take 600 mg of acetylcysteine (1 sachet) once a day. Do not take more than 1 sachet per day.

Use in children and adolescents:

Do not use in children and adolescents. There are other formulations that are more suitable for this population.

Method of administration

This medication 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 with rubber or metal). 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 medication exactly as described in this package leaflet or as your doctor or pharmacist has indicated. Consult your doctor or pharmacist if you are unsure.

When opening the sachet, there may be a slight odor of sulfur (rotten eggs). This is a normal characteristic of this medication 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 cases 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 medication and the amount ingested.

If you forget to take Acetylcysteine Aurovitas

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Stop taking this medication and contact your doctor if you experience signs of allergy 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), respiratory 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.
• Accelerated heartbeats.
• Low blood pressure.
• Itching, hives, skin rash.
• Severe, usually painful, inflammation of the deep layers of the skin, mainly on the face.

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

• Difficulty breathing.
• Bronchospasm.
• Indigestion.

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

• Bleeding.
• Dizziness.

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Acetylcysteine Aurovitas

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

Do not use this medication after the expiration date shown on the sachet and box after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Acetylcysteine Aurovitas

• The active ingredient is acetylcysteine.

Each sachet contains 600 mg of acetylcysteine.

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

Appearance of the product and package contents

Granules for oral solution in sachets.

White to off-white granular powder packaged in sachets.

Package sizes:

10, 14, 20, 30, and 60 sachets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 medication is authorized in the Member States of the European Economic Area under the following names:

Belgium: Acetylcysteine AB 600 mg granules for oral solution in sachets/granulés pour solution buvable en sachet/Granulat zur Herstellung einer Lösung zum Einnehmen im Beutel

Spain: Acetylcysteine Aurovitas 600 mg granules for oral solution in sachets EFG

Italy: Nakys

Portugal: Acetylcysteine Generis

Date of the last revision of thispackage leaflet: June 2024

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