ACC

ACC acute 200 effervescent tablets

Important notes (mandatory information)

ACC akut 200 mg Cough Relief Effervescent Tablets. Active ingredient: Acetylcysteine. Areas of application: for dissolving mucus and making it easier to cough up in respiratory diseases with viscous mucus.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

ACC akut 200 mg Cough Relief Effervescent Tablets
Active ingredient: Acetylcysteine

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 4 – 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS ACC AKUT 200 MG COUGH RELIEF AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING ACC AKUT 200 MG COUGH RELIEF?
3. HOW SHOULD ACC AKUT 200 MG COUGH RELIEF BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ACC AKUT 200 MG COUGH RELIEF BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS ACC AKUT 200 MG COUGH RELIEF AND WHAT IS IT USED FOR?

ACC akut 200 mg Cough Relief is a medicine for liquefying viscous mucus in the respiratory tract. ACC akut 200 mg Cough Relief is used for dissolving mucus and making it easier to cough up in respiratory diseases with viscous mucus.

2. WHAT SHOULD YOU BE AWARE OF BEFORE TAKING ACC AKUT 200 MG COUGH RELIEF?

ACC akut 200 mg Cough Relief must not be taken if you are allergic to acetylcysteine or any of the other ingredients of this medicine listed in section 6. ACC akut 200 mg Cough Relief must not be used in children under 2 years of age due to the high active ingredient content.

Warnings and precautions

Please talk to your doctor or pharmacist before taking ACC akut 200 mg Cough Relief. Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in temporal connection with the use of acetylcysteine. If new skin and mucous membrane changes occur, you should therefore seek medical advice immediately and stop using acetylcysteine. Caution is advised if you suffer from bronchial asthma. Caution is advised if you have had or currently have a stomach or intestinal ulcer, especially if you are taking other medicines that can irritate the gastric mucosa. Caution is advised in patients with histamine intolerance. Long-term therapy should be avoided in these patients, as ACC akut 200 mg Cough Relief influences histamine metabolism and can lead to intolerance symptoms (e.g. headache, runny nose, itching). The use of ACC akut 200 mg Cough Relief can, especially at the beginning of treatment, lead to a liquefaction and thus an increase in the volume of bronchial secretions. If you are unable to cough this up sufficiently, your doctor will take appropriate measures for you.

Children and adolescents

Due to their respiratory system and limited ability to cough up mucus, mucolytics can lead to a blockage of the respiratory tract in children under 2 years of age. Therefore, mucolytics must not be used in children under 2 years of age.

Taking ACC akut 200 mg Cough Relief with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Interaction studies have only been conducted in adults.

Antitussives (cough suppressants)

When ACC akut 200 mg Cough Relief and cough suppressants are used in combination, a dangerous accumulation of secretions can occur due to the restricted cough reflex, so the indication for this combination treatment should be made with particular care. Therefore, always consult your doctor before using this combination.

Activated charcoal

The use of activated charcoal can reduce the effect of acetylcysteine.

Antibiotics

Experimental studies indicate that the effect of antibiotics (tetracyclines, aminoglycosides, penicillins) is weakened by acetylcysteine. For safety reasons, antibiotics should therefore be taken separately and at a time interval of at least 2 hours. This does not apply to medicines containing the active ingredients cefixime and loracarbef. These can be taken at the same time as acetylcysteine.

Nitroglycerin

The simultaneous administration of ACC akut 200 mg Cough Relief can possibly lead to an increase in the vasodilatory effect of glycerol trinitrate (nitroglycerin). A potentially occurring blood-thinning effect could contribute to this. If your doctor considers a combined treatment with nitroglycerin and ACC akut 200 mg Cough Relief to be necessary, he/she will monitor you for a possible drop in blood pressure (hypotension), which can be severe and may be indicated by a possible headache.

Carbamazepine

When used together with carbamazepine, the effect of carbamazepine can be reduced due to the lowered plasma level.

Changes in the determination of laboratory parameters

Acetylcysteine can influence the determination of salicylates. In urine tests, acetylcysteine can influence the results of the determination of ketone bodies. Dissolving ACC akut 200 mg Cough Relief at the same time as other medicines is not recommended.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect 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 insufficient experience with the use of acetylcysteine in pregnant women, you should only use ACC akut 200 mg Cough Relief during pregnancy if your doctor considers it absolutely necessary.

Breast-feeding

There is no information on the excretion of acetylcysteine in breast milk. Therefore, you should only use ACC akut 200 mg Cough Relief during breast-feeding if your doctor considers it absolutely necessary.

Driving and using machines

ACC akut 200 mg Cough Relief has no or negligible influence on the ability to drive or use machines.

ACC akut 200 mg Cough Relief contains lactose, sorbitol and sodium

Please only take ACC akut 200 mg Cough Relief after consulting your doctor if you know that you suffer from an intolerance to certain sugars. This medicine contains a maximum of 20.0 mg sorbitol per effervescent tablet. This medicine contains 98.9 mg sodium (main component of cooking salt/table salt) per effervescent tablet. This corresponds to 4.9 % of the maximum daily intake of sodium recommended for an adult with food.

3. HOW SHOULD ACC AKUT 200 MG COUGH RELIEF BE TAKEN?

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

The recommended dose is

The following information applies unless your doctor has prescribed ACC akut 200 mg Cough Relief differently. Please adhere to the instructions for use, otherwise ACC akut 200 mg Cough Relief will not work properly.

Age	Total daily dose
Children aged 2 – 5 years	2 – 3 times a day, 1/2 effervescent tablet each (corresponding to 200 – 300 mg acetylcysteine per day)
Children and adolescents aged 6 – 14 years	2 times a day, 1 effervescent tablet each (corresponding to 400 mg acetylcysteine per day)
Adolescents aged 14 years and older and adults	2 – 3 times a day, 1 effervescent tablet each (corresponding to 400 – 600 mg acetylcysteine per day)

Type and total duration of use

If the clinical picture worsens or if there is no improvement after 4 - 5 days, you should consult a doctor. Take ACC akut 200 mg Cough Relief after meals. Please dissolve the effervescent tablet in a glass of drinking water and drink the contents of the glass completely. The effervescent tablet can be divided into equal doses.

Note

A slight smell of hydrogen sulphide that occurs during storage of the product is due to the normal ageing process of the product. As long as the expiry date has not been exceeded, it is harmless and irrelevant to the effectiveness and tolerability of the product.

If you have taken more ACC akut 200 mg Cough Relief than you should

In case of overdose, irritation of the gastrointestinal tract (e.g. abdominal pain, nausea, vomiting, diarrhoea) may occur. Serious side effects or symptoms of poisoning have not been observed even after massive overdose of acetylcysteine. If you suspect an overdose of ACC akut 200 mg Cough Relief, please inform your doctor.

If you forget to take ACC akut 200 mg Cough Relief

If you forget to take ACC akut 200 mg Cough Relief once, or if you have taken too little, please continue taking ACC akut 200 mg Cough Relief the next time as described in the dosage instructions. Do not take double the amount if you have forgotten to take the previous dose.

If you stop taking ACC akut 200 mg Cough Relief

Please do not stop treatment with ACC akut 200 mg Cough Relief without consulting your doctor. Your illness could worsen as a result.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 people treated
Common:	1 to 10 in 100 people treated
Uncommon:	1 to 10 in 1,000 people treated
Rare:	1 to 10 in 10,000 people treated
Very rare:	less than 1 in 10,000 people treated
Not known:	frequency cannot be estimated from the available data.

The following side effects can occur

Uncommon:

• Hypersensitivity reactions
• Headache
• Tinnitus
• Palpitations
• Vomiting, diarrhoea, oral mucosal inflammation, abdominal pain, nausea
• allergic reactions: hives, itching, rash, skin and mucous membrane swelling
• Fever
• Drop in blood pressure

Rare:

• Shortness of breath, bronchospasms – mainly in patients with hyperreactive bronchial system in bronchial asthma
• Indigestion
• Heartburn

Very rare:

• Hypersensitivity reactions up to shock
• Bleeding

Not known:

• Fluid retention in the face

Very rarely, severe skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in temporal connection with the use of acetylcysteine. In most of these reported cases, at least one other medicine was taken at the same time, which could possibly increase the described effects on the mucous membrane. If new, serious skin and mucous membrane changes occur, you should therefore seek medical advice immediately and stop using ACC akut 200 mg Cough Relief. You must not take ACC akut 200 mg Cough Relief any more. Various studies have confirmed a decrease in platelet aggregation (clumping of certain blood components) during the use of acetylcysteine. The clinical significance of this is unclear so far.

Countermeasures

If the first signs of a hypersensitivity reaction occur (see above), ACC akut 200 mg Cough Relief must not be taken again. In this case, please contact a doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD ACC AKUT 200 MG COUGH RELIEF BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the sealed edge bag after "use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. In this way, you help to protect the environment. Further information can be found at www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What ACC akut 200 mg Cough Relief contains

The active ingredient is acetylcysteine. Each effervescent tablet contains 200 mg acetylcysteine. The other ingredients are: ascorbic acid, citric acid, lactose, mannitol (Ph.Eur.), sodium carbonate, sodium citrate (Ph.Eur.), sodium hydrogen carbonate, saccharin sodium, blackberry flavour (contains sorbitol).

What ACC akut 200 mg Cough Relief looks like and contents of the pack

ACC akut 200 mg Cough Relief are white, round, smooth effervescent tablets with a one-sided break notch and a blackberry smell. ACC akut 200 mg Cough Relief is available in packs of 20 effervescent tablets.

Pharmaceutical entrepreneur

Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Telefax: (08024) 908-1290
E-mail: service@hexal.com

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This package leaflet was last revised in September 2020.

Source: Information from the package leaflet
Status: 09/2021
Active ingredient: Acetylcysteine. Areas of application: for dissolving mucus and making it easier to cough up in respiratory diseases with viscous mucus.