ACC DIRECT 600mg x 10 sachets COUGHT (PACK OF 5 )

. Contents of the package and additional information

1. What is ACC Direct and what is it used for?
ACC Direct contains the active substance acetylcysteine and liquefies the thick secretion in the respiratory tract.
ACC Direct is used to liquefy secretions and relieve coughs in diseases of the respiratory system with the presence of thick secretions.
The product can only be used by adults.

2. What should you know before taking ACC Direct?

Do not take ACC Direct
• if you are allergic to acetylcysteine or to any of the other ingredients of this medicine (listed in point 6);

Children under 2 years of age should not use this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking ACC Direct if:
• changes in the skin. The occurrence of severe skin reactions, such as Stevens-Johnson syndrome and Lyell syndrome, has been reported very rarely in association with the use of acetylcysteine. If new changes occur on the skin and mucous membranes, medical help should be sought immediately and the use of acetylcysteine should be stopped immediately;
• bronchial asthma;
• ulcers of the stomach or intestines (gastro-intestinal ulcers) in the past or at present;
• hypersensitivity to histamine. Longer duration treatment should be avoided in such patients, as ACC Direct affects histamine metabolism and may cause intolerance symptoms (e.g. headache, runny nose, itching);
• intolerance to fructose, as this product contains sorbitol;
• phenylketonuria, as this product contains a source of phenylalanine.
• inability to expectorate. The use of ACC Direct, especially at the beginning of treatment, can lead to liquefaction and increased formation of bronchial secretions. If you have difficulty in expectorating secretions, your doctor should take appropriate measures.

ACC Direct should not be used in case of liver or kidney failure to avoid additional intake of nitrogen-containing substances.

Children and adolescents
Drugs with mucolytic action may limit the patency of the airways in children under 2 years of age due to the physiological characteristics of the airways in this age group and limited ability to expectorate secretions. Therefore, drugs with mucolytic action should not be used in children under 2 years of age.

ACC Direct is not suitable for children and adolescents. Other suitable dosage forms are available.

Other medicines and ACC Direct
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This applies in particular to:

cough relievers (antitussives). The use of ACC Direct in combination with cough relievers can lead to a dangerous accumulation of secretions due to a reduced cough reflex. A careful diagnosis is necessary before the administration of such combined treatment. Be sure to consult your doctor before starting treatment with this combination.
antibiotics. To avoid the influence of antibiotics on the effect of acetylcysteine, they should be taken separately, with an interval of at least 2 hours. This does not apply to medicines whose active substance is cefixime or loracarbef. No interaction was observed with both active substances, which is why they can be taken simultaneously with acetylcysteine.
activated carbon. Activated charcoal can reduce the effect of acetylcysteine.
glyceryl trinitrate. Increased vasodilatation and a decreased effect on platelets have been reported with the concomitant use of glyceryl trinitrate and acetylcysteine.
Your doctor will check your blood pressure for a possible drop, which could be serious and a sign of it would be a headache.

Laboratory researches
Tell your doctor that you are taking ACC Direct if you are due to have any of the following tests, as it may affect the results of:
• salicylates: medicines to relieve pain, inflammation or rheumatism;
• ketone bodies in urine.

Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

• Pregnancy
There is insufficient data on the use of acetylcysteine in pregnant women, therefore you should use ACC Direct during pregnancy only if your doctor considers it absolutely necessary.

• Breastfeeding
There is no information on whether acetylcysteine passes into breast milk. Therefore, you should use ACC Direct during breastfeeding only if your doctor considers it absolutely necessary.

Driving and using machines
There is no evidence that acetylcysteine affects the ability to drive and use machines, or it has a negligible effect.

ACC Direct contains sorbitol and aspartame
If you have been told by your doctor that you have an intolerance to some types of sugars, consult your doctor before taking this medicinal product, as it contains sorbitol.
The medicinal product contains a source of phenylalanine (aspartame). It can be harmful to people with phenylketonuria.

3. How to take ACC Direct?
Always take this medicine exactly as described in the leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is 1 sachet daily, unless your doctor has prescribed another dose.

Application method
The powder for oral administration from one sachet of ACC Direct should be poured directly onto the tongue. It stimulates the secretion of saliva and this makes it easier to swallow.
Please note that the powder should not be chewed before swallowing.