ETHAMBUTOL MEDIVISION

Read all of this leaflet carefully before you start taking ETHAMBUTOL MEDIVISION.

  • Keep this leaflet. You may need to read it again.
  • If you have further questions, please ask your doctor or your pharmacist.
  • ETHAMBUTOL MEDIVISION has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS:

S4

PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM:

ETHAMBUTOL MEDIVISION contains ethambutol 400 mg (COATED TABLETS)

Ethambutol 84

WHAT ETHAMBUTOL MEDIVISION CONTAINS:

Each tablet contains:

Ethambutol Hydrochloride 400 mg.

The other ingredients are maize starch, microcrystalline cellulose, povidone, stearic acid, sodium starch glycollate, colloidal anhydrous silica, purified talc, magnesium stearate, hypromellose, ethyl cellulose, macrogol 6000, colourants (titanium dioxide).

WHAT ETHAMBUTOL MEDIVISION IS USED FOR:

ETHAMBUTOL MEDIVISION is used to treat tuberculosis (TB) together with other medicines. It is important that you take your medicine on a daily basis and complete the treatment.

BEFORE YOU TAKE ETHAMBUTOL MEDIVISION:

Do not take ETHAMBUTOL MEDIVISION:

If you are hypersensitive / allergic to ETHAMBUTOL MEDIVISION or to any of the ingredients of ETHAMBUTOL MEDIVISION

  • If you have any kind of kidney disease.
  • If you suffer from epilepsy.
  • If you suffer from any eye disease e.g. optic neuritis (eye nerve damage).

It is important that you tell your doctor or healthcare professional if you suffer from any of the conditions mentioned above, if you are taking ETHAMBUTOL MEDIVISION or have been prescribed ETHAMBUTOL MEDIVISION.

Take special care with ETHAMBUTOL MEDIVISION

Caution should be observed with the use of ETHAMBUTOL MEDIVISION tablets in the following patients:

  • Impaired kidney function – tell your doctor if you have any kidney problems so that they may adjust your dose accordingly.
  • Patients with eye problems: should visual problems occur during treatment with ETHAMBUTOL MEDIVISION stop using the medicine and report this immediately to your doctor.
  • If you have nerve disorders inform your doctor.

Pregnancy and Breast-feeding

ETHAMBUTOL MEDIVISION should not be used if you are pregnant or intending to fall pregnant.
If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare professional for advice before taking this medicine.

Driving and using machinery

ETHAMBUTOL MEDIVISION may cause illusions and therefore caution is advised when you driving and using any machinery.

Taking other medicines with ETHAMBUTOL MEDIVISION:

Always tell your healthcare professional if you are taking any other medicine. This includes complementary or traditional medicines.

When you are taking ETHAMBUTOL MEDIVISION, it is especially important to tell your doctor or healthcare professional if you are taking any of the following:

  • Neurotoxic medicines – e.g. those medicines used for cancer such as vincristine, vinblastine, paclitaxel;
    medicines used for fits eg. phenytoin; excessive alcohol.

HOW TO TAKE ETHAMBUTOL MEDIVISION

Adults and children over 13 years:

Treatment is based on your body weight and therefore your doctor will prescribe the dose of ETHAMBUTOL MEDIVISION for you accordingly.

ETHAMBUTOL MEDIVISION is not recommended in children under 13 years of age.

If you take more ETHAMBUTOL MEDIVISION than you should:

Too much ETHAMBUTOL MEDIVISION can cause side effects to occur. If you experience any signs and symptoms that are untoward, get medical help immediately by calling your nearest doctor or healthcare professional.

If you forget to take ETHAMBUTOL MEDIVISION:

If you have missed a dose of ETHAMBUTOL MEDIVISION Tablets, take it as soon as you remember. However if it is almost time for your next dose, skip the missed dose and go back to your regular scheduling. Never double your dose.

POSSIBLE SIDE-EFFECTS

ETHAMBUTOL MEDIVISION may cause side effects.

If any of the below conditions occur, stop taking ETHAMBUTOL MEDIVISION and inform your doctor immediately or go to the casualty department at your nearest hospital

  • Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing’, ‘rash or itching’.
  • Blurred vision, eye pain, red-green colour blindness and any loss of vision.

If you experience any of the below conditions you may be having an allergic reaction to ETHAMBUTOL MEDIVISION. You may need urgent medical attention or hospitalisation:

These are all very serious side effects.

Tell your doctor immediately or go to the casualty department at your nearest hospital if any of the following side effects occur:

  • Acute gouty arthritis – chills, pain and swelling of joints, especially big toe, ankle and knee; tense hot skin over affected joints.
  • Confusion, illusions
  • Numbness, tingling, burning pain or weakness in hands or feet
  • Malaise / depression
  • Low white blood cell count
  • Any kidney or liver problems

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

Tell your doctor if you notice any of the following:

  • Abdominal pain
  • Loss of appetite
  • Nausea and vomiting
  • Headache
  • Dizziness

Not all side effects reported for ETHAMBUTOL MEDIVISION are included in this leaflet. Should your general health worsen while taking ETHAMBUTOL MEDIVISION, please consult your doctor, pharmacist or other health care professional for advice

STORAGE & DISPOSAL INORMATION FOR ETHAMBUTOL MEDIVISION:

Store this medicine away from heat and moisture at or below 25 ̊ C

Do not refrigerate or freeze this medicine.

Keep the container tightly closed.

Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy.

Store all medicines out of reach and sight of children.

PRESENTATION:

Tablets are placed in an (PET/Al/LLDPE) aluminium sachet, kept in a (HDPE) white plastic container, which is sealed at the mouth with an aluminium tagger and is closed with a white HDPE screw-on lid or they are packed in PVC / PVDC blister with either 10 tablets per blister or 28 tablets per blister. Pack sizes include 28, 30, 40, 60, 84, 100 and 500 tablets

IDENTIFICATION:

ETHAMBUTOL MEDIVISION

White circular, shallow, biconvex, film coated tablets with break line on one side and plain surface on the other side.

REGISTRATION NUMBER:

43/20.2.3/0470

NAME AND BUSINESS ADDRESS OF HOLDER OF THE CERTIFICATE OF REGISTRATION:

Medivision (Pty) Ltd

100 Northern Parkway Rd

Crownwood Office

Ormonde

DATE OF PUBLICATION OF THE PATIENT INFORMATION LEAFLET:

29 July 2016

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