Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
The name of your medicine is Acetylcysteine 200 mg Powder for Oral Solution (referred to as Acetylcysteine 200 mg Powder in this leaflet). Each sachet contains the active substance acetylcysteine. Acetylcysteine belongs to the group of medicines called mucolytics which work by thinning the mucus (phlegm) so that it can be coughed up more easily. This medication is used to treat breathing difficulties caused by too much mucus in the lungs and airways or the mucus being too thick and sticky to cough up easily, for adults and adolescents from 12 years of age. You should consult a doctor if it gets worse or does not improve after 5 days.
medicine • if, before you start taking this medicine, you have a reduced ability or inability to cough,
then it may be necessary to remove the mucus by suction after this medicine has loosened it
• if you are due to have any blood or urine tests, as acetylcysteine can interfere with some
laboratory tests. 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 it is not safe to use. Children and adolescents Children between 2 and 12 years of age should not take this medicine. There are other presentations more suitable for this population. 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 medicines obtained without a prescription. You must tell your doctor or pharmacist if you are taking any of the following medicines:
carbamazepine. 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, breast-feeding and fertility 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. As a precautionary measure, it is preferable to avoid its use during pregnancy. It should be avoided during breastfeeding. 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 sucrose and lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor or pharmacist before taking this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per sachet, that is to say essentially 'sodiumfree'.
• medicines to treat coughs (e.g. cough syrup) or with those that decrease bronchial secretions
(such as antihistamines and anticholinergics), as they may cause an accumulation of liquified mucus. • activated charcoal, used to treat poisoning. • medicines used to treat bacterial infections, antibiotics (e.g. cefalexin, cefuroxime, cefadroxil,
cefaclor, ceftriaxone), amphotericin B, ampicillin sodium, cephalosporins, erythromycin lactobionate and some tetracyclines. This medicine can prevent some antibiotics from working properly if they are taken at the same time as it. If you have been told that 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). • if you are taking any medicine that contains minerals such as iron or calcium. • co-administration with the antiepileptic carbamazepine may result in decreased efficacy of
Adults and adolescents over the age of 12 years The recommended dose is 1 sachet taken three times a day, or as prescribed by your doctor. Directions for use Empty the contents of one sachet into a glass containing 150 ml of water and stir using a teaspoon until it dissolves completely (within 5 minutes). It is important to drink all of the mixture immediately. Do not store the solution. Drink plenty of liquids. Staying hydrated supports the mucolytic (mucus thinning) effect of acetylcysteine. You should consult a doctor if your condition gets worse or does not improve after 5 days of treatment. Use in children Children under 12 years of age cannot take this medicine. There are other presentations more suitable for this population. If you take more Acetylcysteine 200 mg Powder than you should If you accidently take more Acetylcysteine 200 mg Powder then 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 signs of overdose:
• nausea (feeling sick), vomiting (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 the missed dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine 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
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)
• Headache • A ringing sound in the ears (tinnitus) • A fast heart rate • Feeling or being sick • Diarrhoea • Inflammation of the skin in your mouth and on your lips
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
position Rare side effects (affecting less than 1 in 1,000 people)
• Drowsiness • Tightness of your airways • Shortness of breath • Indigestion Not known (frequency cannot be estimated from the information available)
• Pain in your abdomen (tummy) • An itchy, raised rash • Swelling of the deeper layers of skin, caused by a build-up of fluid • Itchy skin • Fever • Low blood pressure, this could cause dizziness when standing up quickly from a lying/seated
• Swelling of the face 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 the Yellow Card Scheme at: 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.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK Manufacturer Waymade PLC, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, UK This leaflet was last revised in February 2025 PL 06464/3113 Acetylcysteine 200 mg Powder for Oral Solution
To request a copy of this leaflet in Braille, large print or audio format, contact the licence holder at the above address or telephone: 01268 535200 (select option Medical Information) / e-mail: [email protected]
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.
Children under 12 years old:
Children under 12 years of age cannot take this medicine.
There are other presentations more suitable for this population.
Method of administration
Empty the contents of one sachet into a glass containing 150 ml of water and stir using a teaspoon until it dissolves completely (within 5 minutes). It is important to drink all of the mixture.
This medicine can be taken with or without food. Concomitant intake of the medicine with food does not affect its effectiveness.
If the patient does not improve or worsens after 5 days of treatment, the clinical situation should be evaluated.
Acetylcysteine 200 mg Powder for Oral Solution must not be used when:
• 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, is present.
• Do not administer to children under 2 years of age.
Mucolytic agents may induce respiratory obstruction in children under 2 years of age. Due to the physiological characteristics of the airways in this age group, expectoration capacity may be limited. Therefore, mucolytic agents should not be used in children under 2 years of age (see 4.3 Contraindications).
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.
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 sucrose and lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per, that is to say, essentially 'sodium-free'.
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.
Caution is recommended in the use of the product in patients with peptic ulcer or a history of peptic ulcer, especially in concomitant administration with other drugs with known effect of irritation of gastric mucosa. If the appearance of gastric discomfort is observed, the clinical situation should be reevaluated.
Acetylcysteine can affect histamine metabolism in a moderate way, therefore it should be administered with caution in long-term treatment in patients with histamine intolerance, since symptoms of intolerance (headache, vasomotor, rhinitis, pruritus) may occur.
If after 5 days there is no improvement or other symptoms appear, the clinical situation should be re-evaluated.
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.
Due to its possible chelating effect, it should be taken into account that acetylcysteine can reduce the bioavailability of the salts of some metals such as gold, calcium and iron. In this case it is recommended to space the doses at least 2 hours apart.
In vitro tests have shown that when antibiotics such as cephalosporin, amphotericin B, ampicillin sodium, erythromycin lactobionate or some tetracyclines and acetylcysteine are mixed, they may be physically incompatible or 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. This does not apply to loracarbef.
Concurrent administration of nitroglycerin and acetylcysteine causes significant hypotension and leads to temporal artery dilation with possible onset of headache.
If concurrent administration 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 subtherapeutic levels of carbamazepine.
Pediatric population
Interaction studies have only been performed in adults.
Pregnancy
Clinical data on the use of acetylcysteine in pregnant women are limited. 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.
Before using the drug during pregnancy, an assessment of the risks versus the potential benefits should be made. It is recommended that acetylcysteine be administered under medical supervision during pregnancy.
Breastfeeding
There is insufficient information on the excretion of acetylcysteine in human milk. A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue or abstain from Acetylcysteine 200 mg Powder for Oral Solution therapy, taking into account the benefit of breast-feeding for the infant and the benefit of therapy for the mother.
It is recommended to be administered under medical supervision during breastfeeding.
Fertility
The potential effect of acetylcysteine in fertility is unknown. Animal studies do not indicate deleterious effects on fertility in humans at recommended doses (see section 5.3).
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
Sleepiness
Ear and labyrinth disorders
Tinnitus
Cardiac disorders
Tachycardia
Vascular disorders
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
Additional explorations
Hypotension
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 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
There is no specific antidote for acetylcysteine, so treatment of overdose is to be symptomatic and supportive treatment as indicated by the patient's clinical condition. The airways should be kept clear of secretions by lying the patient down and performing bronchial suction. If deemed necessary, gastric lavage should be performed (if no more than 30 minutes have passed since ingestion).
Healthy volunteers received 11.2 g acetylcysteine daily for three months, with no serious adverse effects.
Oral doses of up to 500 mg acetylcysteine/kg body weight were tolerated without any symptoms of intoxication.
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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