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
This medicine is called Acetylcysteine 200 mg Powder for Oral Solution (referred to as Acetylcysteine 200 mg Powder throughout this leaflet). Each sachet 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. Acetylcysteine 200 mg Powder is used to treat: 2.
breathing difficulties caused by too much mucus in the lungs and airways or the mucus being too thick and sticky to cough up easily.
e Acetylcysteine 200 mg Powder
Do not take Acetylcysteine 200 mg Powder:
Acetylcysteine 200 mg Powder On opening the sachet, Acetylcysteine 200 mg Powder may smell of sulphur (rotten eggs). This is a normal characteristic of this medicine and does not mean that it is not safe to use. Upon addition of water the solution will have a citrus odour. Children and adolescents Do not use in children under the age of 12 years. Other medicines and Acetylcysteine 200 mg Powder Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines which you have bought without a prescription. You must tell your doctor or pharmacist if you are taking any of the following medicines: –
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medicines to treat coughs (e.g. cough syrup) activated charcoal, used to treat poisoning drugs used to treat bacterial infections, antibiotics (e.g. cefalexin, cefuroxime, cefadroxil, cefaclor, ceftriaxone). This medicine can prevent some antibiotics from working properly if they are taken at the same time as it. If you have been told this applies to you, you should take this medicine either two hours before or two hours after taking your antibiotics. If you are not sure if this applies to you, talk to your doctor or pharmacist. medicines to treat angina attacks, (tightness in your chest, neck and arm) (e.g. glyceryl trinitrate) carbamazepine, used to treat some forms of epilepsy, a painful condition of the face called trigeminal neuralgia and help control serious mood disorders. Carbamazepine when taken with acetylcysteine may reduce carbamazepine levels.
Acetylcysteine 200 mg Powder with food, drink and alcohol There are no special requirements to consider when taking this medicine with food, drink or alcohol. 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. Driving and using machines Acetylcysteine 200 mg Powder should not affect your ability to drive or operate machinery. If you experience side effects which may affect these abilities, do not drive or operate machinery until the effects have completely disappeared. Acetylcysteine 200 mg Powder contains sorbitol, aspartame and sunset yellow
Acetylcysteine 200 mg Powder
Always take this medicine exactly as your doctor, nurse or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Adults and adolescents over the age of 12 years The recommended dose is 1 sachet 3 times a day, or as prescribed by your doctor.
Directions for use Empty the sachet contents into a small amount of water in a glass and stir until it dissolves (mixes) completely, just before drinking. It is important to drink all of the mixture. Abundant fluid intake supports the mucolytic effect of acetylcysteine. If you take more Acetylcysteine 200 mg Powder than you should If you accidentally take more Acetylcysteine 200 mg Powder than you have been prescribed, contact your doctor or get medical advice immediately. If possible, take the sachets, the box and this leaflet with you to show the doctor. The following are all symptoms of an overdose: Feeling or being sick and diarrhoea. If you forget to take Acetylcysteine 200 mg Powder If you forget to take a dose, take it as soon as possible. Take the next dose at the correct time, in accordance with the instructions given by your doctor. However, if it is almost time to take the next dose, do not take the dose you have missed; only take the next dose as normal. Do not take a double dose to make up for a forgotten dose. If you have further questions on the use of this medicine, ask your doctor or pharmacist. 4.
Like all medicines, Acetylcysteine 200 mg Powder can cause side effects, although not everybody gets them. Stop taking Acetylcysteine 200 mg Powder and get medical advice straight away if you experience any of these very rare side effects (affecting less than 1 in 10,000 people): –
severe, life-threatening allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue 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.
Tell your doctor or pharmacist if any of the following side effects become serious or last longer than a few days: Uncommon side effects (affecting less than 1 in 100 people)
Not known (this means the frequency cannot be estimated from the information available)
Acetylcysteine 200 mg Powder
Keep this medicine out of the sight and reach of children. Store in the original package to protect from moisture. Once the contents of the sachet have been dissolved in water use this medicinal product immediately. Do not store the solution. Do not use this medicine after the expiry date which is stated on the sachet and carton after EXP. The expiry date refers to the last day of that month. 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. 6.
What Acetylcysteine 200 mg Powder contains –
The active substance is acetylcysteine. Each sachet contains 200 mg acetylcysteine.
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The other ingredients (excipients) are aspartame, sorbitol, lemon flavour (contains maltodextrin, a form of glucose) and sunset yellow.
What Acetylcysteine 200 mg Powder looks like and contents of the pack Acetylcysteine 200 mg Powder is a white to slightly pink coloured powder. Acetylcysteine 200 mg Powder is available in boxes of 10, 18, 20 or 30 sachets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Colonis Pharma Limited 25 Bedford Square Bloomsbury London WC1B 3HH United Kingdom Manufacturer Lamp San Prospero S.p.A. Via della Pace 25/A 41030, San Prospero (MO)
Italy
This leaflet was last revised in February 2025.
Acetylcysteine 200mg Powder for Oral Solution comes as oral solution containing 200mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Acetylcysteine 200mg Powder for Oral Solution is acetylcysteine.
Medicines with the same active substance, strength and form include: Acetylcysteine 200mg Powder for oral solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Acetylcysteine 200mg Powder for Oral Solution, 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.
Mucolytic adjuvant in the therapy of respiratory disorders associated with thick, viscous, mucus hypersecretion.
Posology
Adults and adolescents over the age of 12 years
200 mg (1 sachet) 3 times a day. Maximum recommended daily dose 600 mg/day.
The duration of therapy is dependent on the nature and severity of the illness, and should be decided by the doctor treating the patient for adults and adolescents.
Abundant fluid intake supports the mucolytic effect of acetylcysteine.
Method of administration
Dissolve the contents of one sachet completely in a glass containing a little water just before use, stirring as needed with a teaspoon.
Hypersensitivity to the active substance, other chemically similar substance (for example carbocisteine, erdosteine or mecysteine) or to any of the excipients listed in section 6.1.
Patients with phenylketonuria, as the product contains aspartame.
Patients with bronchial asthma should be closely monitored during therapy; if bronchospasm occurs, treatment with Acetylcysteine 200 mg Powder for Oral Solution should be discontinued immediately.
Administration of acetylcysteine, especially at the beginning of treatment, may liquefy bronchial secretions and, at the same time, increase their volume. If the patient is unable to expectorate efficiently, to avoid retention of secretions postural drainage and tracheal suction should be used.
Caution is recommended in patients with a history of peptic ulcers, especially in the case of concomitant administration with other medicines that have a known irritation effect on the gastric mucosa.
Acetylcysteine can moderately affect histamine metabolism, therefore caution should be taken when administering the drug for a prolonged period of treatment in patients with histamine intolerance, as symptoms of intolerance may appear (headache, vasomotor rhinitis, pruritus).
There are no studies on the efficacy and safety of acetylcysteine 200 mg three times daily in adolescent population. However, mild to severe adverse reactions have been reported with the use of IV acetylcysteine in adults and adolescents.
This medicine contains 723.34 mg sorbitol in each sachet. Patients with rare hereditary problems of fructose intolerance should not take this medicine.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.
This medicine contains 26 mg of aspartame in each sachet. Aspartame is hydrolysed in the gastrointestinal tract when orally ingested. One of the major hydrolysis products is phenylalanine. This may be harmful to people with phenylketonuria a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly. Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
This medicine contains a colouring agent called sunset yellow (E110), which may cause allergic reactions.
Acetylcysteine can cause interference with the colorimetric assay method for the determination of salicylates.
Acetylcysteine can interfere with tests for ketones in urine.
Upon opening the sachet the powder may smell of sulphur (rotten egg smell). This is a normal characteristic of the active substance. Upon addition of water the solution will have a citrus odour.
Paediatric population
Due to the physiological characteristics of the airways in children younger than 2 years, the ability to expectorate may be limited. Therefore, mucolytic substances should not be given to children under 2 years.
Drug Interactions
Antitussive drugs and acetylcysteine should not be administered concomitantly because reducing the cough reflex may lead to a build-up of bronchial secretions.
Activated charcoal may reduce the effect of acetylcysteine.
It is advisable not to mix Acetylcysteine 200 mg Powder for Oral Solution with other medicinal products.
In vitro tests have shown that when cephalosporin antibiotics and acetylcysteine are mixed, there is a degree of antibiotic inactivation. It is precautionary to advise the administration of oral antibiotics at least two hours before or after acetylcysteine.
Concurrent use of nitroglycerin and acetylcysteine causes significant hypotension and leads to temporal artery dilation with possible onset of headache.
If concurrent use of nitroglycerin and acetylcysteine is required, patients should be monitored and warned for hypotension that can be severe and accompanied by a headache.
Concomitant use of acetylcysteine and carbamazepine may result in sub-therapeutic carbamazepine levels.
Pregnancy
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Acetylcysteine 200 mg Powder for Oral Solution during pregnancy.
Breastfeeding
There is insufficient information on the excretion of acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.
No studies on the effects on the ability to drive or use machines have been performed. Acetylcysteine 200 mg Powder for Oral Solution has no known effect on the ability to drive and use machines.
Adverse reactions are listed below, by system organ class and frequency.
System Organ Class
Frequency / Adverse Reactions
Uncommon
(≥1/1,000, < 1/100)
Rare
(≥1/10,000, < 1/1,000)
Very rare
(< 1/10,000)
Not known
Immune system disorders
Hypersensitivity
Anaphylactic shock, anaphylactic/ anaphylactoid reaction
Nervous system disorders
Headache
Ear and labyrinth disorders
Tinnitus
Cardiac disorders
Tachycardia
Vascular disorders
Hypotension
Haemorrhage
Respiratory, thoracic and mediastinal disorders
Bronchospasm, dyspnoea
Gastrointestinal disorders
Vomiting, diarrhoea, stomatitis, abdominal pain, nausea
Dyspepsia
Skin and subcutaneous tissue disorders
Urticaria, rash, angioedema, pruritus
General disorders and administration site conditions
Fever
Oedema of the face
The occurrence of serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in temporal association with the use of acetylcysteine. In most of these cases reported at least one other drug was administered at the same time, which may have possibly enhanced the described mucocutaneous effects.
In case of the recurrence of skin and mucosal lesions, medical advice should be sought at once and the use of acetylcysteine terminated immediately.
A decreased blood platelet aggregation in the presence of acetylcysteine has been confirmed by various studies. The clinical relevance has not yet been clarified to date.
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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
An acute overdose of acetylcysteine can cause gastrointestinal symptoms such as nausea, vomiting and diarrhoea.
Treatment of Overdose
Treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition.
Ask anything about Acetylcysteine 200mg Powder for Oral Solution. 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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