Tussmuco Effervescent Tablets

TUSSMUCO 600 contains the active substance called acetylcysteine which belongs to a group of medicines called mucolytics. Mucolytics work by thinning the mucus and phlegm to help clear congestion.

Do not take TUSSMUCO 600:

• If you are hypersensitive (allergic) to acetylcysteine or any of the other ingredients of TUSSMUCO 600 (listed in section 6).
• If you are pregnant or planning to become pregnant.
• If you have a history of stomach ulcers.

Warnings and precautions

Take special care with TUSSMUCO 600:

• If you develop a hypersensitivity reaction which may include but is not limited to severe blisters and bleeding of the lips, eyes, mouth, nose and genitals or fever, chills, aching muscles and generally feeling unwell (these are associated with skin conditions such as Stevens-Johnson syndrome or Lyell’s syndrome) (see Possible side effects).
• If you have asthma.

Children and adolescents

TUSSMUCO 600, should not be used in children less than 14 years of age (see section 3).

Other medicines and TUSSMUCO 600

Always tell your healthcare provider if you are taking any other medicine (this includes complementary or traditional medicines). Tell your doctor if you are taking any of the following:

• Any cough suppressant medicines.
• Any antibiotics especially antibiotics called ‘tetracyclines’. TUSSMUCO 600 and these antibiotics should be taken 2 hours apart.
• Nitroglycerine or glyceryl trinitrate, which is used in heart failure, high blood pressure and to reduce pain associated with chest pains due to reduced blood flow also known as angina. Your doctor will need to monitor you, especially if you develop headaches.
• Blood pressure lowering medication especially a medicine classified as a ‘angiotensin converting enzyme inhibitor (ACE inhibitor).
• Activated charcoal.

As TUSSMUCO 600 liquifies thick phlegm, the amount of phlegm will increase. If you are unable to cough up this phlegm, consult your doctor to ensure effective steps are taken to remove this phlegm especially during the start of treatment with TUSSMUCO 600. This is of particular concern if you are an elderly or frail patient.

If you suffer from histamine intolerance as TUSSMUCO 600 affects how your body breaks down histamine. General symptoms of histamine intolerance are usually headaches, runny nose and itching.

If you have kidney or liver problems.

Do not share medicines prescribed for you with any other person. Always take TUSSMUCO 600 exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Adults and adolescents from 14 years of age: The usual dose of TUSSMUCO 600 is half (1/2) of an effervescent tablet taken twice daily or one (1) effervescent tablet taken once daily (equivalent to 600 mg acetylcysteine per day) fully dissolved in a glass of water taken after meals. A clear solution is produced when TUSSMUCO 600 effervescent tablet is dissolved in a glass of water. If a TUSSMUCO 600 effervescent tablet is not fully dissolved, it may cause choking and aspiration, particularly to elderly patients. TUSSMUCO 600 effervescent tablets should not be taken for more than 14 days without medical advice.

Children: Due to the high content of active substance (acetylcysteine 600 mg per tablet), TUSSMUCO 600 should not be used in children less than 14 years of age.

If you take more TUSSMUCO 600 than you should contact the nearest hospital or poison control centre. Overdoses may include stomach related irritations such as nausea, vomiting and diarrhoea. Infants are at risk of producing an excessive amount of phlegm or mucous.

If you forget to take TUSSMUCO 600 do not take a double dose to make up for forgotten individual doses. TUSSMUCO 600 is indicated for once daily dosing (see section 3).

TUSSMUCO 600 can have side effects. Not all side effects reported for TUSSMUCO 600 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TUSSMUCO 600 please consult your healthcare provider for advice. If any of the following happens, stop taking TUSSMUCO 600 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

In the event of overdosage, consult your doctor or pharmacist. If neither is available, these are all very serious side effects. If you have them, you may have had a serious reaction to TUSSMUCO 600. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Abnormal bleeding (haemorrhage) when you injure yourself.
• Yellowing of the skin and eyes, dark urine, and tiredness, which may be symptoms of liver problems (jaundice).
• Increased heartbeat (tachycardia).
• Shortness of breath (dyspnoea).
• Congestion of the lungs (bronchospasm).
• Sudden irregular movement of the body as a result of involuntary muscle contractions (convulsions).
• Temporary loss of consciousness (syncope).
• Increased blood pressure (hypertension).
• Painful, swollen joints as a result of a buildup of acid in the bloodstream (acidosis).

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• painful red areas, blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN).

Less frequent side effects:

• Headache;
• blurred vision;
• ringing in the ears (tinnitus);
• lowered blood pressure;
• sudden reddening of the skin on the face, neck and upper chest due to increased blood flow (flushing);
• fever;
• painful, stiff joints (arthralgia);
• mouth wounds, swelling or sores in the mouth (stomatitis);
• nausea, diarrhoea, vomiting, stomach pains.

Side effects with an unknown frequency:

• Indigestion (dyspepsia).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website.

• Store all medicines out of reach of children.
• Store below 25 °C in a cool dry place.
• Do not use after the expiry date stated as ‘Exp’ on the label.
• Do not store in a bathroom.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).