Acetylcysteine 600 mg soluble tablets – patient leaflet, side effects, dosage

1. What Acetylcysteine is and what it is used for

Acetylcysteine 600 mg soluble tablets (referred to as Acetylcysteine throughout this leaflet) contain a medicine called acetylcysteine. This belongs to a group of medicines called mucolytics. It works by making the mucus (phlegm) less sticky which makes the mucus easier to cough up.

Acetylcysteine is used for problems with the breathing passages (respiratory tract).

2. What you need to know before you take Acetylcysteine

Do NOT take Acetylcysteine if you:

• Are allergic to acetylcysteine or any of the other ingredients of this medicine (listed in section 6)
• Are under 14 years of age.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Acetylcysteine: • If you have asthma

• If you have a history of stomach ulcers
• If you are allergic to histamine. If you are not able to tolerate food and drinks that contain large amount of histamine such as wine, tomatoes or processed food, then this medicine is not suitable for you because acetylcysteine affects how histamine is broken down in the body. The most common symptoms of histamine intolerance are migraine headaches, flushing, hives and rhinitis (stuffy, runny nose) and itching.
• If you are on a restricted salt diet (see Acetylcysteine contains sodium) • If you have hereditary problems with some sugars (see Acetylcysteine contains sorbitol)
• If you have liver or kidney problems.

Serious skin rashes (Stevens-Johnson syndrome and Lyell’s syndrome) have rarely been reported with the use of acetylcysteine. The rash can often involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are frequently followed by flu-like symptoms of fever, headache and body ache.

The rash may progress to widespread blistering and peeling of the skin. If you develop a rash or these skin symptoms you should stop taking these tablets and contact your doctor immediately.

These soluble tablets can be a choking hazard if swallowed whole, especially in the elderly. Ensure that the tablet is fully dissolved before you take it.

Other medicines and Acetylcysteine

Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. In particular:

• Cough-relieving medicines (antitussives) used in combination with acetylcysteine can cause a dangerous build-up of secretions • Activated charcoal can reduce the effects of acetylcysteine
• Antibiotics (e.g. aminoglycosides, penicillins, tetracycline) may not work as well when taken at the same time as acetylcysteine. If you need to take antibiotics and acetylcysteine you should leave at least two hours between taking these medicines. This does not apply to antibiotics such as cefixime and loracarbef, these medicines can be taken at the same time as acetylcysteine • Glyceryl trinitrate used to treat chest pain (angina). Simultaneous administration of acetylcysteine and glyceryl trinitrate may increase the normal effect of glyceryl trinitrate which is used to help widen the blood vessels in patients with chest pain. If your doctor considers combined treatment with these medicines to be necessary, you will be monitored for possible lowering of blood pressure (hypotension), which can be serious and may be indicated by headaches.

Effects of Acetylcysteine on laboratory tests

This medicine may affect a test for salicylate (such as aspirin) in the blood. It may also affect the results when testing for ketones in urine. Ketones are produced by the breakdown of fat in the body, for example in people with high levels of sugar in the blood.

Acetylcysteine with food, drink and alcohol

Acetylcysteine should be taken after food.

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.

Acetylcysteine should not be taken during pregnancy or breast-feeding. If you are unsure you should talk to your doctor before taking this medicine.

Driving and using machines

Acetylcysteine should not affect your ability to drive or use machinery.

Acetylcysteine contains sodium

This medicine contains 356.8 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 17.8% of the recommended maximum daily dietary intake of sodium for an adult.

Acetylcysteine contains sorbitol

Sorbitol is a source of fructose. 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 genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.

3. How to take Acetylcysteine

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

For oral administration only. Acetylcysteine 600 mg soluble tablets should be dissolved completely in a glass of water before use and taken after food.

Adults and children aged 14 years and over:

The usual dose is 1 tablet, once daily.

Dissolve the soluble tablet in a glass of water and take after food.

Your doctor should let you know how long to take your medicine for.

Children under the age of 14 years

Acetylcysteine 600 mg soluble tablets are not suitable for children under the age of 14.

If you take more Acetylcysteine than you should

If you take more Acetylcysteine than you should, talk to your doctor or contact your nearest hospital casualty department immediately. Take your tablet pack with you. You may have diarrhoea, heartburn, stomach ache or feel sick.

If you forget to take Acetylcysteine

If you have forgotten to take a dose, leave out that dose completely. Take your next dose at the normal time. Do not take a double dose to make up for a forgotten dose. If you have trouble remembering to take your tablets, tell your doctor or pharmacist.

If you stop taking Acetylcysteine

You should talk to your doctor or pharmacist before stopping taking these tablets. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Stop taking Acetylcysteine and see a doctor or contact your nearest hospital casualty department immediately:

• If you have swelling of the lips, throat or tongue, difficulty in swallowing or breathing. This could be a sign of an allergic reaction
• Any changes to the skin or mucus membranes (such as your nose, mouth, lips and genitals) including skin rashes, blistering or peeling of the skin. These may be accompanied by flu-like symptoms. These could be signs of serious skin reactions such as Stevens-Johnson Syndrome or Lyell’s Syndrome.

Other side effects reported with this medicine are shown below:

Uncommon (may affect up to 1 in 100 people)

• Headache
• Ringing in the ears (tinnitus)
• Increased heart rate
• Feeling sick or being sick
• Diarrhoea
• Stomach pains
• Swelling in the mouth and swelling of the lips
• Skin rashes and itching
• Fever
• Low blood pressure.

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

• Indigestion

• Shortness of breath.

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

  • Bleeding in the upper respiratory tract.

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

• Swelling of the face.

Laboratory tests

Your doctor may want to perform some laboratory tests while you are taking these tablets.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Acetylcysteine

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special temperature storage conditions. Keep the tablet tube tightly closed to protect from light and moisture.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

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. Contents of the pack and other information

What Acetylcysteine contains

• The active substance is acetylcysteine.
• The other ingredients are ascorbic acid, citric acid, sodium hydrogen carbonate, sodium carbonate, sorbitol (E420), macrogol 6000, sodium citrate, sodium saccharin (E954) and lemon flavouring.

What Acetylcysteine looks like and contents of the pack

Acetylcysteine soluble tablets are round, flat-faced tablets with bevelled edges.

The tablets are supplied in white polypropylene tubes with tamper-evident polyethylene caps and a desiccant (to keep the tablets dry). Each tube contains 15 tablets and are packed in a cardboard carton containing 30 tablets (2 tubes per pack).

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Ridge Pharma Limited

Merlin House, Brunel Road

Theale, Reading, Berkshire

RG7 4AB, United Kingdom

Manufacturer

PharmaEstica Manufacturing OÜ

Vanapere Tee 3, Pringi Kula

Viimsi Vald, Harju Maakond

74011, Estonia

This leaflet was last revised in October 2025.

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