Acc Effervescent Tablets

• ACC 600 contains the active substance 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 ACC 600 if:

• If you are hypersensitive (allergic) to acetylcysteine or any of the other ingredients of ACC 600 (listed in section 6).
• If you have a history of stomach ulcers.
• If you are pregnant or plan to become pregnant (see “Pregnancy and breastfeeding”). Please consult with your doctor.
• Do not give ACC 600 effervescent tablets to children less than 14 years of age.
• ACC On The Go is for adult use only.

Warnings and precautions

Take special care with ACC 600:

• If you have asthma.
• If you have or have a history of stomach ulcers.
• 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.
• If you have a skin condition called Stevens-Johnson syndrome or 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.
• If you are intolerant to histamines. If you are not able to tolerate food and drinks that contain large amounts of histamines, ACC 600 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.

Other medicines and ACC 600

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

• Cough relieving medicines (cough suppressant medicines).
• Antibiotics such as tetracyclines used to treat bacterial infections; these medicines should be taken 2 hours apart.
• Nitroglycerine or glyceryl trinitrate used for heart failure, high blood pressure and to treat and prevent chest pain from not enough blood flow to the heart (angina).
• Activated charcoal.

ACC 600 with food and drink

ACC 600 effervescent tablets should be taken dissolved in a glass of water after food. ACC On The Go can be taken without water.

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

Always take ACC 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.

ACC 600 (effervescent tablets):

Adults and adolescents from 14 years of age: The usual dose is ½ an effervescent tablet twice daily or 1 effervescent tablet once daily (equivalent to 600 mg acetylcysteine per day). The effervescent tablets must be taken with a glass of water after food. Do not give ACC 600 effervescent tablets to children less than 14 years of age.

ACC On The Go:

For adults only: The usual dose of one sachet (600 mg) should be placed directly on the tongue. The oral powder of one sachet should be placed directly on the tongue. The oral powder stimulates salivation so the oral powder can be swallowed easily. The oral powder should not be chewed before swallowing.

Elderly and weakened patients: Patients with a reduced cough reflex (elderly and weakened patients) should take the oral powder preferably in the morning. ACC 600 should not be taken for more than 14 days without medical advice.

If you take more ACC 600 than you should

Overdoses with ACC 600 may include irritations in the stomach and bowel tract, such as abdominal pain, nausea, vomiting, diarrhoea.

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

If you forget to take ACC 600

Do not take a double dose to make up for forgotten individual doses.

ACC 600 can have side effects. Not all side effects reported for ACC 600 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ACC 600, please consult your health care provider for advice.

If any of the following happens, stop taking ACC 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.
• Seizures (fits).
• Fainting.
• Stevens-Johnson syndrome (rare skin condition with severe blisters and bleeding in the lips, eyes, mouth, nose and genitals),
• Toxic epidermal necrolysis (severe skin reactions that starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell).

These are all very serious side effects. If you have them, you may have had a serious reaction to ACC 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:

• Difficulty breathing.
• Changes in the way your heart beats, for example, if you notice it beating faster.
• Yellowing of the skin and eyes, dark urine, and tiredness, which may be symptoms of liver problems.

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:

• Headache,
• Blurred vision,
• Ringing in the ear,
• Bleeding,
• High blood pressure,
• Nausea,
• Vomiting,
• Diarrhoea,
• Stomach pain,
• Mouth ulcers and cold sores,
• High level of acid in the body,
• Skin rash,
• Swelling,
• Itching,
• Flushing,
• Painful, swollen joints,
• Fever,
• Low blood pressure.

Frequency unknown side effects:

• Indigestion,
• Swelling of the face.

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 (whoumc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ACC 600. Suspected side effects can also be reported directly to the Holder of Certificate of Registration (HCR) via the link: https://pvi1j.solutions.iqvia.com or the e-mail address, [email protected].

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Store at or below 25 °C in a cool dry place.

• Do not use ACC 600 after the expiry date, which is stated on the carton after Exp. The expiry date refers to the last day of that month.

• Keep the tubes tightly closed in order to protect from moisture.

• Keep the sachet in the carton until required for use.

• Protect from light.