ACC

ACC direct 600 mg powder for oral use in a sachet

Important notes (mandatory information)

ACC direkt 600 mg powder for oral use in sachets. 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 direkt 600 mg powder for oral use in sachets for adults and adolescents aged 14 and over
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 directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• If you have any further questions, ask your doctor or pharmacist.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to 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 is in this package leaflet

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

1. WHAT IS ACC DIREKT AND WHAT IS IT USED FOR?

ACC direkt contains the active ingredient acetylcysteine and is used to liquefy viscous mucus in the respiratory tract. ACC direkt is used to dissolve mucus and make it easier to cough up in respiratory diseases with viscous mucus. This medicine may only be used by adults and adolescents aged 14 and over.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING ACC DIREKT?

ACC direkt must not be taken if you are allergic to acetylcysteine or any of the other ingredients of this medicine listed in section 6.

Children and adolescents under 14 years of age

ACC direkt is not suitable for use in children under 14 years of age. Other suitable dosage forms are available.

Warnings and precautions

Please talk to your doctor or pharmacist before taking ACC direkt if you:

• notice skin changes. Very rarely, the occurrence of serious skin reactions such as Stevens–Johnson syndrome and Lyell syndrome has 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.
• suffer from bronchial asthma.
• have had or have a stomach or intestinal ulcer (gastrointestinal ulcers) in the past, especially if you are taking other medicines that can irritate the gastric mucosa.
• suffer from histamine intolerance. Long-term therapy should be avoided in these patients, as ACC direkt influences histamine metabolism and can lead to intolerance symptoms (e.g. headache, runny nose, itching).
• suffer from fructose intolerance, as this medicine contains sorbitol.
• suffer from phenylketonuria, as this medicine contains a source of phenylalanine.
• have difficulty coughing up secretions. The use of ACC direkt, especially at the beginning of treatment, can lead to liquefaction and thus to an increase in the volume of bronchial secretions. If you are unable to cough this up sufficiently, your doctor should take appropriate measures for you.

The simultaneous dissolution of acetylcysteine-containing preparations with other medicines is not recommended.

Taking ACC direkt 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. This applies in particular to:

• cough suppressants (antitussives): When ACC direkt 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.
• antibiotics: To avoid an influence on the effectiveness of acetylcysteine, antibiotics should 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 have no interactions and can be taken at the same time as acetylcysteine.
• activated charcoal: The use of activated charcoal can reduce the effect of acetylcysteine.
• glyceryl trinitrate: An increase in the vasodilatory effect of glyceryl trinitrate (nitroglycerin) has been reported when given together with acetylcysteine. Your doctor will monitor you for a possible drop in blood pressure. This can be severe and may be indicated by a possible headache.
• carbamazepine: When used together with carbamazepine, the effect of carbamazepine may be reduced due to lowered plasma levels.

Determination of laboratory parameters
If a laboratory test is to be carried out, please inform your doctor that you are taking ACC direkt, as it can influence the determination of:

• salicylates (active ingredients for the treatment of pain, inflammation or rheumatism)
• ketone bodies in urine tests

Pregnancy and breast-feeding

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. Since there is insufficient experience with the use of acetylcysteine during pregnancy and breast-feeding, you should only use ACC direkt during pregnancy and breast-feeding if your doctor considers it absolutely necessary.

Driving and using machines

Acetylcysteine has no or negligible influence on the ability to drive and use machines.

ACC direkt contains sorbitol, aspartame and sodium

This medicine contains 0.5 mg aspartame per sachet. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare inherited disorder in which phenylalanine builds up because the body cannot break it down properly. This medicine contains up to 527 mg sorbitol per sachet. Sorbitol is a source of fructose. Talk to your doctor before you (or your child) take (or is given) this medicine if your doctor has told you that you (or your child) have an intolerance to some sugars, or if you have been diagnosed with hereditary fructose intolerance (HFI) - a rare inherited disorder in which a person cannot break down fructose. This medicine contains less than 1 mmol (23 mg) sodium per sachet, i.e. it is almost "sodium-free".

3. HOW SHOULD ACC DIREKT BE TAKEN?

Always take this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is 1 sachet once a day, unless otherwise prescribed by your doctor.

Method of administration

Place the powder from one sachet of ACC direkt on your tongue. The powder stimulates the flow of saliva, so it can be swallowed easily. Please note that the powder must not be chewed before swallowing. It can be taken without water. The simultaneous dissolution of acetylcysteine-containing preparations with other medicines is not recommended.

Note

A slight smell of hydrogen sulphide that occurs during storage of the preparation is due to the normal ageing process of the product and is characteristic of the active ingredient contained in this preparation.

Elderly and weakened patients

Patients with a restricted cough reflex (elderly and weakened patients) should take the powder in the morning if possible.

Contact your doctor if you do not feel better or if you feel worse after 4 - 5 days.

If you have taken more ACC direkt than you should

Overdosage can cause irritation in the gastrointestinal tract (e.g. abdominal pain, nausea, vomiting, diarrhoea). Serious side effects or symptoms of poisoning have not been observed to date, even after massive overdosage of acetylcysteine. However, if you suspect an overdose of ACC direkt, please notify your doctor.

If you forget to take ACC direkt

Do not take double the amount to make up for a forgotten dose. Take the next dose at the usual time.

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. Stop taking ACC direkt and contact your doctor immediately if you experience signs of an allergic reaction or a serious skin reaction.

Uncommon (may affect up to 1 in 100 people):

• hypersensitivity reactions
• allergic reactions (itching, formation of a nettle rash [urticaria], severe swelling under the skin [angioedema], rash)
• rapid heartbeat (tachycardia)
• drop in blood pressure (hypotension)
• headache
• ringing in the ears (tinnitus)
• inflammation of the oral mucosa (stomatitis)
• abdominal pain, nausea, vomiting and diarrhoea
• fever

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

• shortness of breath, bronchospasms – mainly in patients with a hyperreactive bronchial system in the presence of bronchial asthma
• indigestion (dyspepsia)

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

• severe allergic reactions up to shock
• severe skin reactions such as Stevens–Johnson syndrome and Lyell syndrome*
• occurrence of bleeding (haemorrhage), sometimes associated with hypersensitivity reactions

Not known (frequency cannot be estimated from the available data):

• fluid retention in the face (facial oedema)
• reduced platelet aggregation

Very rarely, the occurrence of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis has 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 intensify the described effects on the mucous membrane. If you experience serious skin and mucous membrane changes, you should therefore seek medical advice immediately and stop using acetylcysteine. If the first signs of a hypersensitivity reaction occur (see above), ACC direkt must not be taken again. In this case, please contact a doctor.

Reporting of side effects

If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department 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 about the safety of this medicine.

5. HOW SHOULD ACC DIREKT 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 sachet and carton after "use by" or "exp". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you have finished using 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 direkt contains

The active ingredient is acetylcysteine. Each sachet contains 600 mg acetylcysteine. The other ingredients are tripalmitin; polysorbate 65; sorbitol (Ph.Eur.); xylitol; citric acid; sodium dihydrogen citrate; magnesium citrate; carmellose sodium (Ph.Eur.); aspartame; blackberry flavour (contains vanillin, maltodextrin, D-glucono-1,5-lactone, sorbitol, highly dispersed silicon dioxide, mannitol, magnesium carbonate); magnesium stearate (Ph.Eur.) [vegetable].

What ACC direkt looks like and contents of the pack

ACC direkt is a white to slightly yellowish powder that may contain easily disintegrating agglomerates and has a blackberry-like and possibly slightly sulphurous odour. ACC direkt is packed in sealed aluminium-paper-foil sachets and inserted into a folding box. Each sachet contains 1.6 g of powder.

Pack sizes

8, 10, 14, 20, 30, 60 and 90 sachets. Not all pack sizes may be marketed.

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 January 2021.

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.