Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Acetylcysteine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
for
Acepiro 600 mg Effervescent Tablets contains the active substance acetylcysteine. Acetylcysteine belongs to a group of medicines called mucolytics which work by thinning the mucus (phlegm) so that it can be coughed up more easily. Acepiro 600 mg Effervescent Tablets is used to loosen mucus and to ease coughing up in cases of respiratory diseases with viscous mucus. It should be used in adults only.
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e Acepiro 600 mg Effervescent Tablets
Do not take Acepiro 600 mg Effervescent Tablets
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Acepiro 600 mg Effervescent Tablet
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ulcers inside your mouth, throat or nose, stop using this medicine and talk to your doctor straightaway. Speak with your doctor if you have problems coughing up phlegm, as you may need help to drain the phlegm from your airways. The use of Acepiro 600 mg Effervescent Tablets may, particularly at the start of treatment, lead to a loosening and therefore increased volume of bronchial secretion. If you are not sufficiently capable of coughing this up, your doctor will take appropriate measures. Caution is required if you have a past or present history of a stomach or duodenal ulcer, especially when used concomitantly with other medicinal products known to irritate the mucous membrane of the gastrointestinal tract. Caution is required in patients with histamine intolerance. Prolonged treatment should be avoided in these patients because Acepiro 600 mg Effervescent Tablets influences histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching). If you are on a restricted salt diet (see 'Acepiro 600 mg Effervescent Tablets contains sodium') If you have liver or kidney problems Effervescent tablets can be a choking hazard if swallowed whole, especially in the elderly. Ensure that tablet is fully dissolved before you take it
Consult your doctor if any of the abovementioned warnings apply to you, or have applied to you in the past. Children and adolescents Do not give this medicine to children and adolescents (see above "Do not take Acepiro 600 mg Effervescent Tablets"). Other medicines and Acepiro 600 mg Effervescent Tablets Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. You must tell your doctor or pharmacist if you are taking any of the following medicines: •
Antibiotics. This medicine can prevent antibiotics (medicines which control or prevent infections) from working properly. If you are taking antibiotics, make sure you take this medicine two hours before or after taking your antibiotics.
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Cough medicines, which should not be used at the same time as Acepiro 600 mg Effervescent Tablets, as you must be able to cough up the loosened phlegm.
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Medicines to treat angina attacks, (tightness in your chest, neck and arm), Acepiro 600 mg Effervescent Tablets may increase the blood pressure-lowering effect of nitroglycerin (a medicine used to treat angina). Your doctor will need to monitor your blood pressure if you use nitroglycerin and Acepiro 600 mg Effervescent Tablets at the same time.
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Activated charcoal, used to treat poisoning
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Changes in the determination of laboratory parameters Acetylcysteine may affect the assay of salicylates. Acetylcysteine may affect the results of the determination of ketone bodies in urine tests
This medicine can make medicines and supplements containing metals like iron, zinc, copper and manganese less effective. If you are taking a supplement that contains metals, make sure you take it at a different time of the day to Acepiro 600 mg Effervescent Tablets.
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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. There is little information about the use of acetylcysteine during pregnancy or breastfeeding and your doctor will only recommend this medicine if the benefits of taking it outweigh the risks. Driving and using machines Acepiro 600 mg Effervescent Tablets has no influence on the ability to drive and use machines. Acepiro 600 mg Effervescent Tablets contains sodium This medicine contains 138.79 mg sodium (main component of cooking/table salt) in each effervescent tablet. This is equivalent to 6.94% of the recommended maximum daily dietary intake of sodium for an adult. Acepiro 600 mg Effervescent Tablets contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Acepiro 600 mg Effervescent Tablets contains sorbitol This medicine also contains 0.52 mg sorbitol (E420) in each effervescent tablet.
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Acepiro 600 mg Effervescent Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults The recommended dose is 1 effervescent tablet each day. Method of administration Dissolve the tablet in half a glass of water. Make sure the tablet dissolves completely and then drink immediately. Acepiro 600 mg Effervescent Tablets should be taken after food. Duration of treatment will be determined by your doctor based on your symptoms. If you take more Acepiro 600 mg Effervescent Tablets than you should Taking too much medicine may cause you to feel or be sick, or give you diarrhoea. If you have taken too many tablets, contact your doctor or pharmacist straightaway. If you forget to take Acepiro 600 mg Effervescent Tablets Do not take a double dose to make up for a forgotten dose. Take your tablet as soon as you remember, unless it is almost time for your next dose. If it is almost time for your next dose, then just take the next dose as usual. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse. 4.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Acepiro 600 mg Effervescent Tablets and get medical advice straight away if you experience any of these very rare side effects (may affect up to 1 in 10,000 people):
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severe bleeding (haemorrhaging) blistering, peeling, bleeding, scaling, or fluid filled patches on any part of your skin. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may have a serious skin problem.
Other side effects include: Uncommon: may affect up to 1 in 100 people
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Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: United Kingdom (Northern Ireland) Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store By reporting side effects, you can help provide more information on the safety of this medicine.
5.
Acepiro 600 mg Effervescent Tablets •
Keep this medicine out of the sight and reach of children.
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Do not use this medicine after the expiry date which is stated on the strip and the carton after "EXP". The expiry date refers to the last day of that month.
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Store in the original package in order to protect from moisture.
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This medicine does not require any special temperature storage conditions.
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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.
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What Acepiro 600 mg Effervescent Tablets contains
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Manufacturer HERMES PHARMA GmbH, Georg-Kalb-Straße. 5, 82049 Pullach i. Isartal, Germany
This leaflet was last revised in May 2025.
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Acepiro 600 mg effervescent tablets comes as tablet containing 600mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Acepiro 600 mg effervescent tablets is acetylcysteine.
Medicines with the same active substance, strength and form include: NACSYS 600mg Effervescent Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Acepiro 600 mg effervescent tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Acepiro is indicated in adults as a mucolytic agent for the treatment of respiratory tract diseases in which a reduction in bronchial secretion viscosity is required to facilitate expectoration.
Posology
Adults:
600 mg acetylcysteine once daily.
Paediatric population:
Children aged 2 years and older, and adolescents
The safety and efficacy of Acepiro in children aged 2 years and older, and adolescents, have not been established.
Children under 2 years of age
Acepiro is contraindicated in children 0 to 2 years (see sections 4.3 and 4.4).
Duration of therapy
Duration of therapy should be determined by the clinician, depending on the nature and severity of the condition
Method of administration
For oral use
Before oral use the tablet should be dissolved in half a glass of water.
Acepiro should be taken after food.
Hepatic and renal impairment
Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may results in an increase in adverse drug reactions due to drug accumulation.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Children less than 2 years of age (see section 4.4).
Due to the high active substance content Acepiro must not be used in children and adolescents. Other strengths are available.
Acepiro should be used with caution in patients with asthma or a history of bronchospasm. Should bronchospasm occur, use should be discontinued immediately.
Very rarely, serious skin reactions such as Stevens-Johnson syndrome and Lyell syndrome have been reported in temporal association with the use of acetylcysteine. Patients should be advised to seek immediate medical advice if new skin or mucosal lesions occur and use should be discontinued as a precaution.
Acepiro should be administered with caution in patients with a reduced cough reflex (e.g. elderly or frail patients). Particularly at the beginning of treatment, the volume of bronchial secretions may be increased due to liquefaction. In patients unable to cough up bronchial secretions effectively, postural drainage and broncho-aspiration should be performed.
The effervescent tablets should be dissolved fully before intake (see section 4.2). Not fully dissolved tablets present a risk of choking and aspiration, particularly to elderly patients.
This product should be used with caution by patients with bronchial asthma and patients with a history of peptic ulcer disease.
Caution is required in patients with histamine intolerance. Prolonged treatment should be avoided in these patients because Acepiro influences histamine metabolism and may lead to symptoms of intolerance (e.g. headache, runny nose, itching).
Paediatric population
Mucolytic medicinal products may obstruct the airways of children below 2 years of age, due to infant physiology. The ability to cough up mucus may be limited. Mucolytic medicinal products must not be used in children under 2 years of age.
The safety and efficacy is not established children aged 2 years and older and adolescents.
Hepatic and renal impairment
Hepatic and renal impairment can reduce clearance and increase acetylcysteine plasma levels which may results in an increase in adverse drug reactions due to drug accumulation.
Excipients
This medicinal product contains 138.79 mg sodium per effervescent tablet, equivalent to 6.94% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine also contains 0.52 mg sorbitol (E420) in each effervescent tablet. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
The content of sorbitol in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly.
Interaction studies have only been performed in adults.
Antibiotics: in vitro tests indicate that certain antibiotics (tetracycline, aminoglycosides, penicillin) are inactivated when directly mixed with acetylcysteine. Where concomitant use of oral antibiotics is required, separate administration by an interval of at least two hours. This does not apply to cefixime and loracarbef.
Nitroglycerin: acetylcysteine may potentiate the vasodilatory effect of nitroglycerine. Monitor patient for hypotension in cases where concomitant treatment is necessary.
The use of activated charcoal may attenuate the effect of acetylcysteine.
Antitussives: do not administer concomitantly with antitussives, as cough suppression may result in dangerous secretory congestion.
Laboratory tests: may affect colorimetric assay of salicylates. Acetylcysteine may affect the results of the determination of ketone bodies in urinalyses.
Acetylcysteine has a possible chelating effect and may reduce the bioavailability of certain heavy metal salts. As a precaution, acetylcysteine and heavy metal salts should be taken separately at different times of the day.
Pregnancy
There are no or limited amount of data from the use of acetylcysteine in pregnant women. Animal studies do not indicate harmful effects on pregnancy, embryo/foetal development, parturition or postnatal development (see section 5.3).
Breast-feeding
No information is available on excretion of acetylcysteine in human milk.
Administration of acetylcysteine during pregnancy and lactation should take place only after a strict risk /benefit assessment
Fertility
Animal studies do not indicate harmful effects of acetylcysteine on fertility (see section 5.3)..
Acepiro has no influence on the ability to drive and use machines.
The following table shows undesirable effects after oral use of acetylcysteine according to system organ class (SOC).
System organ class
Undesirable effect
Uncommon
(≥1/1,000 to <1/100)
Rare
(≥1/10,000 to <1/1,000)
Very rare
(<1/10,000)
Not known
(cannot be estimated from the available data)
Immune system disorders
Hypersensitivity reactions
Anaphylactic reactions, anaphylactic shock
Nervous system disorders
Headache
Ear and labyrinth disorders
Tinnitus
Cardiac disorders
Tachycardia1
Vascular disorders
Haemorrhage1
Respiratory, thoracic and mediastinal disorders
Dyspnoea2, bronchospasm1,2
Gastrointestinal disorders
Stomatitis, abdominal pain, nausea, vomiting, diarrhoea
Dyspepsia
Skin and subcutaneous tissue disorders
Pruritus1, urticaria1, exanthema1, rash1, angioedema1
Stevens-Johnson syndrome, Lyell syndrome
General disorders and administration site conditions
Pyrexia
Facial oedema
Investigations
Lowered blood pressure1
1Associated with hypersensitivity reactions
2 Mainly in patients with a hyper-reactive bronchial system associated with asthma
There have been very rare reports of the occurrence of severe skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome with a temporal connection to acetylcysteine administration.
In the majority of these reported cases, at least one other pharmaceutical substance that may possibly have potentiated the mucocutaneous effects described was being taken. Therefore, medical advice should be sought promptly and administration of acetylcysteine stopped if new skin and mucous membrane changes occur. Administration of acetylcysteine must be stopped immediately
A decrease in platelet aggregation in the presence of acetylcysteine has been confirmed in various studies. The clinical significance of this has not yet been established.
In patients with peptic ulcer or a history thereof, acetylcysteine may have an undesirable effect on the gastric mucosa.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
There have been no reports of toxic overdose with oral pharmaceutical forms of acetylcysteine. No serious adverse reactions were observed in clinical study volunteers receiving oral doses of 11.6 g acetylcysteine per day for three months.
Overdose may lead to gastrointestinal effects such as nausea, vomiting and diarrhoea.
In the case of an overdose of acetylcysteine, management should be supportive.
Experience with maximum daily doses of up to 30 g acetylcysteine has been obtained from intravenous acetylcysteine treatment of paracetamol intoxication in humans.
Ask anything about Acepiro 600 mg effervescent tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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