Rocylteine 200 mg Effervescent Tablets

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

Do not take ROCYLTEINE:

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

Warnings and precautions with ROCYLTEINE

Talk to your doctor before taking ROCYLTEINE

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

Take special care with ROCYLTEINE 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, ROCYLTEINE 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.

As the thick phlegm becomes more fluid, its volume will increase, especially at the beginning of the treatment. If you are unable to efficiently cough up this fluid phlegm, you must consult a doctor so that adequate measures can be taken to remove the phlegm.

Other medicines and ROCYLTEINE

Always tell your healthcare professional if you are taking any other medicine (this includes complementary or traditional medicines). Do not take ROCYLTEINE with cough suppressants (antitussives) unless under careful diagnosis and advice from your doctor, as this may cause an accumulation of mucous in the airway. Do not take ROCYLTEINE tablets together with any antibiotics, as this may alter the effectiveness of the antibiotic Allow an interval of at least two hours between the antibiotics and ROCYLTEINE tablets. Do not take ROCYLTEINE with activated charcoal, as this may reduce the effects of ROCYLTEINE. Do not take ROCYLTEINE with nitroglycerin (used for heart failure, high blood pressure and to treat and prevent chest pain) as it may cause your blood pressure to drop. Consult your doctor prior to use if you are taking carbamazepine (for epilepsy) as ROCYLTEINE may alter the effects of carbamazepine. Tell your doctor prior to undergoing any laboratory tests while take ROCYLTEINE. Dissolving ROCYLTEINE with other medicines is not recommended.

Pregnancy, breastfeeding and fertility

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 health care provider for advice before taking this medicine. Do not take ROCYLTEINE if:

• You are pregnant,
• You are breastfeeding.

Driving and using machines

ROCYLTEINE has no known influence on the ability to drive or use machinery.

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

Before taking ROCYLTEINE 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 ROCYLTEINE tablets is too strong or too weak, talk to your doctor or pharmacist. Do not use ROCYLTEINE tablets continuously for more than 14 days without consulting a doctor.

The usual doses are:

Children 2 to 5 years:

ROCYLTEINE 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:

ROCYLTEINE 200 mg: 1 effervescent tablet twice daily (equivalent to 400 mg acetylcysteine/day).

Adults and children older than 14 years:

ROCYLTEINE 200 mg: 1 effervescent tablet 2 to 3 times daily (equivalent to 400 to 600 mg acetylcysteine/day). ROCYLTEINE 600 mg: ½ effervescent tablet twice daily or 1 effervescent tablet once daily (equivalent to 600 mg acetylcysteine per day).

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

If you take more ROCYLTEINE 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 ROCYLTEINE

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

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

Stop taking ROCYLTEINE and seek medical help immediately if you have any of the following allergic reactions: If any of the following happens, stop taking ROCYLTEINE 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 ROCYLTEINE 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).