Tussmuco 200 mg Effervescent Tablets

TUSSMUCO contains the active substance N - acetylcysteine. It belongs to a group of medicines called mucolytics which works by thinning the mucus (phlegm) so that it can be coughed up more easily. TUSSMUCO 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.

Do not take TUSSMUCO:

• if you are hypersensitive (allergic) to N - acetylcysteine or any of the other ingredients of TUSSMUCO (listed in section 6).
• if you are pregnant.
• if you suffer from ulcers (sores) in your digestive tract.

Do not give TUSSMUCO to children under 2 years of age.

Warnings and precautions

Take special care with TUSSMUCO:

• if you have asthma.
• if you have been told that you have a sore that has developed on the lining of the oesophagus, stomach or small intestine known as a peptic ulcer.
• if you are unable to discharge matter from your throat or lungs as TUSSMUCO will liquefy phlegm and increase the volume. You need to be able to expectorate.
• do not use TUSSMUCO for more than 14 days without consulting with your doctor.

There have been reports of hypersensitivity reactions with high fever, skin redness, joint pains and/or eye infections (Stevens - Johnson syndrome) and acute hypersensitivity reactions accompanied by fever and blisters on the skin or peeling of the skin (Lyell syndrome). If you develop a rash or these symptoms, you must consult a doctor immediately and stop using TUSSMUCO.

if you are intolerant to histamine, TUSSMUCO may not be suitable for you because it affects how histamine is broken down in your body. The most common symptoms of histamine intolerance are headaches, runny nose and itching.

Other medicines and TUSSMUCO

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:

• Antibiotics. Allow an interval of at least two hours between the antibiotics and TUSSMUCO effervescent tablets.
• Medicines used to suppress cough referred to as antitussives.
• Activated charcoal.
• Medicines such as nitroglycerin used to treat angina symptoms, such as chest pain.
• TUSSMUCO may affect certain tests such as urine tests.
• Do not mix TUSSMUCO with other medicines.

Pregnancy, breastfeeding and fertility

You should not take TUSSMUCO if you are pregnant or breastfeeding your baby. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine.

Do not share medicines prescribed for you with any other person. Always take TUSSMUCO 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.

The effervescent tablet must be dissolved in a glass of water before drinking it. The usual dose of TUSSMUCO for adults and adolescents from 14 years of age is:

• 1 effervescent tablet 2 to 3 times daily.

For children from 6 to 14 years of age:

• 1 effervescent tablet twice daily.

For children from 2 to 5 years of age:

• ½ (half) an effervescent tablet 2 to 3 times daily.

Do not use the medicine for more than 14 consecutive days without consulting a doctor.

TUSSMUCO can have side effects. Not all side effects reported for TUSSMUCO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking TUSSMUCO, please consult your healthcare provider for advice.

If any of the following happens, stop taking TUSSMUCO 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 (anaphylactic shock, hypersensitivity, angioedema, dyspnoea, oedema of the face),
• rash or itching (urticaria),
• 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). These are all very serious side effects. If you have them, you may have had a serious reaction to TUSSMUCO. 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:

• congestion of the lungs (bronchospasm),
• changes in the way your heart beats, for example, if you notice it beating faster (tachycardia).
• abnormal bleeding when you injure yourself (haemorrhage),

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Less frequent side effects:
• ringing in the ears (tinnitus),
• mouth wounds, swelling or sores in the mouth (stomatitis),
• pain that occurs between the chest and pelvic regions (abdominal pain),
• if you have liquid, or watery bowel movements when you go to the toilet (diarrhoea), vomiting, heartburn, indigestion, nausea,
• headache,
• fever,
• abnormally low blood pressure (hypotension),
• itchy skin which can result in redness, bumps, spots or blisters, dry, cracked, leathery or scaly skin (pruritus),
• a widely - spread rash accompanied by a fever (exanthema).

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: https://www.sahpra.org.za/health-products-vigilance/ Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of TUSSMUCO.

Store all medicines out of reach of children. Store at or below 25 °C. Keep in original packaging until required for use. Do not store in a bathroom. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).