Gencetyl 200 mg/600 mg Effervescent Tablets

• GENCETYL contains the active ingredient acetylcysteine. It dissolves thick mucus (phlegm) in the respiratory tract and relieves tight chest conditions.

Do not take GENCETYL:

• If you are hypersensitive (allergic) to acetylcysteine or to any of the other components of GENCETYL tablets (see “WHAT GENCETYL CONTAINS”).
• If you are pregnant.
• Do not give GENCETYL effervescent tablets to children under two years of age.

Warnings and precautions with GENCETYL

Talk to your doctor before taking GENCETYL

• If you have asthma.
• If you have a history of stomach ulcers.

Take special care with GENCETYL tablets:

• If you have notice any changes to your skin such as those seen in Stevens-Johnson syndrome and Lyell's syndrome, which is characterised by severe blisters and bleeding in the lips, eyes, mouth, nose and genitals or fever, chills, aching muscles and generally feeling unwell. Stop treatment and seek medical advice immediately.
• If you experience difficulty breathing, stop treatment and seek medical advice.
• If you experience nausea and vomiting. Seek medical advice.
• If you have histamine intolerance. If you are not able to tolerate food and drinks that contain large amounts of histamines, GENCETYL may not be suitable for you, because it affects how histamines are broken down in the body. The most common symptoms of histamine intolerance are headaches, runny nose and itching.

Do not share medicines prescribed for you with any other person. Always take GENCETYL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

Before taking GENCETYL tablets dissolve the effervescent tablet in one glass of water and drink the whole contents of the glass. You should check with your doctor or pharmacist if you are unsure.

If you have the impression that the effect of GENCETYL tablets is too strong or too weak, talk to your doctor or pharmacist.

Do not use GENCETYL tablets continuously for more than 14 days without consulting a doctor.

The usual doses are:

• Children 2 to 5 years: GENCETYL 200 mg: ½ (half) an effervescent tablet 2 to 3 times daily (equivalent to 200 to 300 mg acetylcysteine/day).
• Children 6 to 14 years: GENCETYL 200 mg: 1 effervescent tablet twice daily (equivalent to 400 mg acetylcysteine/day).
• Adults and children older than 14 years: GENCETYL 200 mg: 1 effervescent tablet 2 to 3 times daily (equivalent to 400 to 600 mg acetylcysteine/day). GENCETYL 600 mg: ½ effervescent tablet twice daily or 1 effervescent tablet once daily (equivalent to 600 mg acetylcysteine per day).

If you take more GENCETYL than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you missed a dose of GENCETYL

If you forget to take GENCETYL, take it as soon as you remember. Do not take a double or larger dose to make up or the forgotten individual doses.

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

Stop taking GENCETYL and seek medical help immediately if you have any of the following allergic reactions: If any of the following happens, stop taking GENCETYL and tell your doctor immediately or go to your casualty department at your nearest hospital:

• Allergic reaction causing swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or itching. These are all very serious side effects. If you have them, you may have had a serious allergic reaction to GENCETYL tablets. 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:

• Changes in the way your heart beats, for example, if you notice it beating faster.
• Low blood pressure.
• Difficulty breathing or fast breathing. 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:
• Rash, itching, hives or swelling of the skin.
• Headache, convulsions (fits) or fainting.
• Buzzing, hissing, whistling, ringing or other persistent noise in the ears.
• Blurred vision.
• Increase in heart rate.
• Bleeding or increase in blood pressure.
• Stomach pain.
• Sores inside your mouth.
• Diarrhoea.
• Vomiting.
• Heartburn.
• Nausea.
• Skin reactions.
• Fever.

Side effects of unknown frequency:

• Indigestion.

If any of the side effects get serious, or if you experience one of the above –mentioned serious side effects, call the nearest doctor immediately. If you experience any side effects not listed 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. This includes any possible side effects not listed in this leaflet. You can also report side effects via the “6.04 Adverse Drug reaction Reporting Form” found online under SAHPRA’s publications: https://www.sahpra.org.za/publications/Index/8. By reporting side effects, you can help provide more information on the safety of this medicine.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Store at or below 25 °C (room temperature).
• Do not remove blisters from the original carton until required for use.
• Keep HDPE containers tightly closed.
• Keep all medicines out of the reach and sight of children.
• 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).