ACC contains the active substance acetylcysteine and liquefies viscous mucus in the airways.

ACC 200 mg powder for oral solution is used to loosen mucus and to ease coughing up in cases of respiratory diseases with viscous mucus in children from 6 years, adolescents and adults.

Do not take ACC 200mg

if you are/have

allergic to acetylcysteine or any of the ingredients of this medicine (listed in section 6)

children under 6 years of age

Warnings and precautions

Talk to your doctor or pharmacist before taking ACC if you have

skin and mucosal changes

The occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell’s syndrome has very rarely been reported in connection with the use of acetylcysteine. If skin and mucosal changes newly occur, medical advice should be sought without delay and use of acetylcysteine be terminated.

bronchial asthma

a history of stomach or bowel ulcers or currently have them a hypersensitivity to histamine

Longer-term therapy should be avoided in these patients, since ACC influences the histamine metabolism and may lead to symptoms of intolerance (e.g. headache, running nose, itching).

an inability to cough up mucous

The dissolution of acetylcysteine formulations together with other medicinal products is not recommended.

Children

 ACC 200mg is not recommended in children under 6 years (on ACC account of the high content of active substance). Other medicines with lower amount of active substance are available for them.                                                                                                     

Other medicines and ACC 200mg

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

     Cough-relieving agents

Combined use of ACC with cough-relieving agents may cause a dangerous congestion of secretion due to the reduced cough reflex. Especially careful diagnosis is required for this combination treatment. It is imperative 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 at an interval of at least 2 hours. This does not apply to medicines with the active substances cefixime or loracarbef. These may be taken with acetylcysteine at the same time.

Activated charcoal

Glycerol trinitrate: a medicine known also as nitroglycerin, used to widen the blood vessels Your doctor will monitor you for reduced blood pressure, which could be serious and may be indicated by headache.

Laboratory tests

Tell your doctor that you are taking ACC if you require a test for the following; it can affect the determination of:

     salicylates: medicines to treat pain, inflammation or rheumatism      ketone bodies in the urine

Pregnancy and breast-feeding

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.

Since adequate experience concerning the use of acetylcysteine during pregnancy and lactation is not available, you should use ACC during pregnancy and lactation only if your attending physician considers this absolutely necessary.

Driving and using machines

ACC is not known to influence the ability to drive or operate machines.

ACC 200mg       contains      sucrose,     lactose      and      glucose    This medicinal product  contains 2.7 g sucrose in each sachet. This should be taken into ACC ount in patients with diabetes mellitus.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose, if not otherwise prescribed by the doctor, is:

Method of administration

Dissolve ACC 200mg in a glass of water and take it after meals.

Duration of use

If your symptoms worsen or do not improve after 4-5 days, you should consult a doctor.

Note

The possible presence of sulfurous smell is not indicative of product alterations but is a characteristic of the active ingredient contained in this preparation.

If you take more ACC 200mg than you should

In the event of an overdose, irritations in the stomach and bowel tract may occur, such as abdominal pain, nausea, vomiting, diarrhoea.

No severe side effects or symptoms of intoxication have been observed so far, not even in the case of massive overdose. However, if an overdose with ACC is suspected, please inform your doctor.

If you forget to take ACC 200mg

Do not use a double dose to make up for a forgotten dose. Just use your next dose at the usual time.

If you stop taking ACC 200mg

Do not stop taking ACC prescribed by your doctor without medical advice as this could reduce the success of therapy.

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

Like all medicines, ACC can cause side effects, although not everybody gets them. The following side effects may occur:

Uncommon side effect, may affect up to 1 in 100 people Hpersensitivity reaction indicated by

-          Headache

-          Fever

-          Inflammation of the inner lining of the mouth

-          Ringing or buzzing in the ears

-          ACC elerated heart beat

-          Reduced blood pressure

-          Itching, formation of hives, skin rash

-          Generalised rash

-          Mostly painful severe swelling of deep skin layers, mainly in the face Abdominal pain

Nausea, vomiting Diarrhoea

Rare, may affect up to 1 in 1,000 people Breathlessness

Bronchospasm - predominantly in patients with hyperreactive bronchial system in the presence of bronchial asthma

Indigestion: the main symptom is usually pain or discomfort in the upper tummy(abdomen).

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

·         Bleeding

·         Sudden skin rash, breathing difficulties and fainting (within minutes to hours) due to hypersensitivity (severe allergic reaction including anaphylactic shock). May be life- threatening.

·         Steven-Johnsons Syndrome or Lyell Syndrome: severe skin reactions (mucosal lesions only or both mucosal and skin lesions including bubble formation) in temporal association with the use of acetylcysteine. If skin or mucous membrane abnormalities develop, medical advice should therefore immediately be sought and the use of acetylcysteine discontinued.

Not known: frequency cannot be estimated from the available data Tissue swelling in the face caused by excess fluid

Reduced clumping of blood platelets

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 the carton after ``EXP``.

The expiry date refers to the last day of that month.

ACC  200 mg powder for oral solution: Do not store above 30°C

The reconstituted solution should be used immediately after dissolving.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.