Acetylcysteine Aurobindo Italia
Italy
Table of Contents
Package leaflet: Information for the user
Acetylcysteine Aurobindo Italia 600 mg oral solution granules in sachet
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Acetylcysteine Aurobindo Italia is and what it is used for
- What you need to know before taking Acetylcysteine Aurobindo Italia
- How to take Acetylcysteine Aurobindo Italia
- Possible side effects
- How to store Acetylcysteine Aurobindo Italia
- Contents of the pack and other information
1. What Acetilcisteina Aurobindo Italia is and what it is used for
Acetilcisteina Aurobindo Italia contains the active substance acetylcysteine, which liquefies thick mucus in the airways.
Acetilcisteina Aurobindo Italia 600 mg granules for oral solution is indicated in adults as an adjunct in the treatment of acute respiratory conditions associated with excessive mucus in the lungs and airways, when the mucus is too thick and viscous to be cleared easily by coughing.
2. What you need to know before taking Acetylcysteine Aurobindo Italia
Do not take Acetylcysteine Aurobindo Italia:
- If you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in section 6).
- Children under 2 years of age must not use this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Acetylcysteine Aurobindo Italia if you have:
- Skin and mucous membrane disorders. If new skin or mucous membrane disorders occur, you must consult a doctor immediately and stop using acetylcysteine.
- Bronchial asthma.
- A history of stomach or intestinal ulcers, or if you currently suffer from them.
- Histamine hypersensitivity. In these patients, long-term therapy should be avoided, as Acetylcysteine Aurobindo Italia affects histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
- Inability to expel mucus.
- Acetylcysteine may increase the intensity of vomiting.
Children and adolescents
Acetylcysteine Aurobindo Italia must not be used in children under 2 years of age (see section
"Do not take Acetylcysteine Aurobindo Italia").
Acetylcysteine Aurobindo Italia is not recommended in children and adolescents (due to the
high content of active ingredient). Other medicines with a lower amount of active ingredient are
available for them.
Other medicines and Acetylcysteine Aurobindo Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicine.
This particularly applies to:
- Cough suppressants. The combined use of Acetylcysteine Aurobindo Italia with cough suppressants may cause dangerous accumulation of secretions due to reduced cough reflex. For this combination therapy, particularly careful diagnosis is required. You should consult your doctor before using this combination.
- Antibiotics. Experimental studies show evidence that acetylcysteine may weaken the effect of antibiotics (tetracyclines, aminoglycosides, penicillins). For safety reasons, antibiotics should be taken separately, at an interval of at least 2 hours. This does not apply to medicines containing the active substances cefixime or loracarbef. These may be taken simultaneously with acetylcysteine.
- Activated charcoal
- Glycerol trinitrate: a medicine also known as nitroglycerin, used to dilate blood vessels. Your doctor will monitor you for possible lowering of blood pressure, which could be severe and may be indicated by the onset of headache.
- Carbamazepine: the combination of acetylcysteine and carbamazepine (a medicine for epilepsy) may reduce the effects of carbamazepine.
- Acetylcysteine Aurobindo Italia may interfere with heavy metal salts, such as gold and iron salts, and with calcium salts. Therefore, it is advisable to separate the administration of acetylcysteine and these salts in time, or to choose a different route of administration.
Laboratory tests
Inform your doctor that you are taking Acetylcysteine Aurobindo Italia if you are due to undergo any
of the following tests; it may affect the measurement of:
- Salicylates: medicines used to treat pain, inflammation, or rheumatic conditions;
- Ketone bodies in urine.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
The administration of acetylcysteine during pregnancy and breastfeeding should only occur after
a careful assessment of the risk-benefit balance.
Pregnancy
There are insufficient data on the use of acetylcysteine in pregnant women. Acetylcysteine has not
been shown to have harmful effects on the fetus; however, as a precautionary measure, the use of
Acetylcysteine Aurobindo Italia during pregnancy is not recommended. Acetylcysteine Aurobindo
Italia should be used during pregnancy only if your doctor considers it absolutely necessary.
Breastfeeding
There is no information available on the excretion of acetylcysteine into breast milk. A potential risk
to the newborn/infant cannot be excluded. Therefore, Acetylcysteine Aurobindo Italia should be
used during breastfeeding only if your doctor considers it absolutely necessary.
Fertility
There is limited data on the influence of acetylcysteine use on human fertility. Animal studies have
not shown harmful effects on fertility at recommended doses.
Driving and using machines
Acetylcysteine Aurobindo Italia is not known to affect the ability to drive or use machines.
Acetylcysteine Aurobindo Italia contains sucrose
Acetylcysteine Aurobindo Italia 600 mg granules for oral solution contains 1.98 g of sucrose per
dose (1.98 g/1 sachet).
If you have been diagnosed with an intolerance to certain sugars, please contact your doctor before
taking this medicine.
Acetylcysteine Aurobindo Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is essentially ‘sodium-free’.
3. How to take Acetylcysteine Aurobindo Italia
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Unless otherwise prescribed by your doctor, the recommended dose is:
Adults: Take 1 sachet of 600 mg of Acetylcysteine Aurobindo Italia once daily. Do not take
more than one sachet per day.
Use in children and adolescents:
Do not use in children and adolescents. Other formulations better suited for this
population are available.
Method of administration
Acetylcysteine Aurobindo Italia 600 mg granules for oral solution can be taken during or
independent of meals.
Dissolve the granules from one sachet in half a glass of water or another liquid, and stir until the
solution becomes homogeneous. Use a glass or plastic glass (never use rubber or metal containers). The reconstituted solution should be administered immediately after preparation. Partially used sachets may be stored until the next dose (it is recommended to use the remaining half within 24 hours).
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Upon opening the package, you may notice a slight sulfur-like odor (rotten eggs). This is a
normal characteristic of this medicine and does not indicate that it is unsafe to use.
Duration of use
The duration of treatment will be determined by your doctor based on your symptoms.
If you take more Acetylcysteine Aurobindo Italia than you should
In case of overdose, gastrointestinal irritations may occur, such as abdominal pain, nausea, vomiting, and diarrhea.
To date, no serious adverse effects or symptoms of poisoning have been observed, even in cases of large overdose. However, if you suspect an overdose with Acetylcysteine Aurobindo Italia,
inform your doctor.
If you forget to take Acetylcysteine Aurobindo Italia
Do not take a double dose to make up for the forgotten dose. Take the next dose at your usual time.
If you stop taking Acetylcysteine Aurobindo Italia
Do not stop taking Acetylcysteine Aurobindo Italia prescribed by your doctor without consulting him/her, as this could reduce the effectiveness of the treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Acetylcysteine Aurobindo Italia may cause side effects, although not everybody experiences them.
Stop taking Acetylcysteine Aurobindo Italia and contact your doctor if you experience signs of an allergic reaction or a severe skin reaction.
Uncommon (may affect up to 1 in 100 people)
- Allergic reactions
Very rare (may affect up to 1 in 10,000 people)
- Severe allergic reactions, such as rash, itching, fluid accumulation (edema), difficulty breathing, 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 heartbeat
- Decreased blood pressure
- Itching, blistering, rash
- Severe swelling, mostly painful, of the deeper layers of the skin, mainly of the face.
Rare (may affect up to 1 in 1,000 people)
- Shortness of breath
- Bronchospasm
- Indigestion
Very rare (may affect up to 1 in 10,000 people)
- Bleeding
- Dizziness
Not known (frequency cannot be estimated from the available data)
- Swelling of facial tissues due to excess fluid
- Reduced platelet aggregation
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Acetylcysteine Aurobindo Italia
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the sachet and the carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Acetilcisteina Aurobindo Italia contains
- The active substance is acetylcysteine. Each sachet contains 600 mg of acetylcysteine.
- The other components are: Sucrose, sodium saccharin, orange flavour (corn syrup, natural and artificial flavouring substances, gum arabic).
Description of the appearance of Acetilcisteina Aurobindo Italia and contents of the pack
Granulate for oral solution.
White to almost white granular powder in sachets.
Acetilcisteina Aurobindo Italia 600 mg granulate for oral solution is available in packs containing 20 and 30 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy
Manufacturer
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus, 19, Venda Nova,
2700-487 Amadora
Portugal
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Italy: Acetilcisteina Aurobindo Italia
Portugal: Acetilcisteína Generis Phar