Ethionamide Macleods 250 mg Tablets

Tuberculosis (TB) treatment in combination with other medicine to treat tuberculosis when other first-line TB medicines do not help.

Do not take ETHIONAMIDE MACLEODS 250 MG TABLETS:

• If you are hypersensitive (allergic) to ethionamide, or to any of the ingredients of ETHIONAMIDE MACLEODS 250 MG TABLETS listed in section 6).
• If you are hypersensitive (allergic) to isoniazid, pyrazinamide or niacin (other medicines used to treat tuberculosis), as you may also be sensitive to ETHIONAMIDE MACLEODS 250 mg TABLETS.
• If you have liver disease.
• If you are pregnant or breastfeeding your baby.

Warnings and precautions

Inform your doctor if you have the following medical conditions before taking ETHIONAMIDE MACLEODS 250 mg TABLETS:

• Depression or other mental illness.
• Liver disease.
• Chronic alcoholism.
• Hypothyroidism (under functioning thyroid which leads to weight gain, lack of energy, thinning of hair, drying of skin and slowed mentality).
• Diabetes.
• Porphyria (ETHIONAMIDE MACLEODS 250 mg TABLETS should be avoided in porphyria).

ETHIONAMIDE MACLEODS 250 mg TABLETS will not be prescribed to you if you do not have normal liver function. Your doctor will monitor your liver function by performing blood tests before and during treatment (on a monthly basis) with ETHIONAMIDE MACLEODS 250 mg TABLETS. Your doctor will discontinue ETHIONAMIDE MACLEODS 250 mg TABLETS if your liver enzyme tests are abnormally high.

Your doctor may prescribe periodic eye examinations as ETHIONAMIDE MACLEODS 250 mg TABLETS may cause blurred vision, double vision and inflammation of the nerves of the eye causing loss of vision. Your doctor may prescribe Vitamin B 6 (pyridoxine) or Vitamin B 3 (niacin) with ETHIONAMIDE MACLEODS 250 mg TABLETS to minimise adverse reactions such as dizziness, drowsiness or have neuropathy (damage to the nerves resulting in poor coordination, muscle weakness, pain in the fingers or toes, or numbness). Diabetes may be difficult to manage. Your doctor will monitor your blood glucose levels on a regular basis. ETHIONAMIDE MACLEODS 250 mg TABLETS may cause hypothyroidism or goitre (an abnormal swelling of the thyroid gland that causes a lump to form in the neck). Your doctor will monitor your thyroid function by doing regular blood tests. In order to minimise gastrointestinal side-effects, ETHIONAMIDE MACLEODS 250 mg TABLETS may be taken at bedtime or in divided doses with meals. Your doctor may also prescribe medicine for nausea and vomiting.

Other medicines and ETHIONAMIDE MACLEODS 250 MG TABLETS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines). When you are taking ETHIONAMIDE MACLEODS 250 mg TABLETS, it is especially important to tell your doctor or healthcare professional if you are taking any other medicine and especially:

• thioacetazone – a medicine used in the treatment of tuberculosis (TB)
• cicloserin – a medicine used in the treatment of tuberculosis (TB)
• isoniazid– a medicine used in the treatment of tuberculosis (TB)
• terizidone – a medicine used in the treatment of tuberculosis (TB)
• rifampicin – a medicine used in the treatment of tuberculosis (TB)

Do not share medicines prescribed for you with any other person. Always take ETHIONAMIDE MACLEODS 250 MG TABLETS exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure. In order to minimise gastrointestinal side-effects, ETHIONAMIDE MACLEODS 250 mg TABLETS may be taken at bedtime or in divided doses with meals.

Your doctor may prescribe pyridoxine (Vitamin B 6) to prevent damaging nervous tissue (brain and peripheral nerves). Tablets should not be divided. Adults: 15 – 20 mg/kg/day. Maximum of four tablets per day. Children: Over 10 years: Same as per adult dose. Under 10 years: As determined by your doctor. If you have the impression that the effect of ETHIONAMIDE MACLEODS 250 MG TABLETS is too strong or too weak, talk to your doctor or pharmacist.

If you take more ETHIONAMIDE MACLEODS 250 MG TABLETS 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. Too much ETHIONAMIDE MACLEODS 250 mg TABLETS can increase the intensity of side effects. If you forget to take ETHIONAMIDE MACLEODS 250 MG TABLETS If you have missed a dose of ETHIONAMIDE MACLEODS 250 mg 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.

ETHIONAMIDE MACLEODS 250 MG TABLETS can have side effects. Not all side effects reported for ETHIONAMIDE MACLEODS 250 MG TABLETS are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking ETHIONAMIDE MACLEODS 250 MG TABLETS, please consult your health care provider for advice.

If any of the following happens, stop taking ETHIONAMIDE MACLEODS 250 mg TABLETS and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of face, tongue or throat
• difficulties in swallowing
• hives and difficulties in breathing
• severe skin reactions that can include blistering of the skin.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to ETHIONAMIDE MACLEODS 250 mg 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:

• low blood platelet count resulting in bleeding or bruising more easily than normal with red, pinpoint-sized rash
• low blood sugar (e.g., increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting)
• hypothyroidism (under functioning thyroid which leads to weight gain, lack of energy, thinning of hair, drying of skin and slowed mentality)
• goitre (abnormal swelling of the thyroid gland that causes a lump to form in the neck)
• mental illness
• seizures
• tingling of hands or feet
• vision changes (e.g., loss of vision)
• yellowing of the skin or eyes (signs of inflammation of the liver); blood tests may reveal increase in liver enzymes.

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

Tell your doctor if you notice any of the following side-effects and they worry you or if any of these symptoms are severe or do not go away:

• feeling depressed, anxious, restless
• dizziness, drowsiness, headache
• double or blurred vision
• low blood pressure when standing up from sitting or lying down; this may make you feel faint or dizzy
• nausea, diarrhoea, vomiting, stomach pain, increased salivation, metallic taste, mouth sores, loss of appetite, weight loss
• hair loss, increased sensitivity of the skin to sunlight, acne, red and inflamed skin with itchy rash
• joint pain
• enlarged breasts, inability to maintain an erection in men, absence of monthly period in women
• weakness

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 (who- umc.org) found on SAHPRA website or to Macleods Pharmaceuticals SA (Pty) Ltd. at [email protected]. By reporting side effects, you can help provide more information on the safety of ETHIONAMIDE MACLEODS 250 MG TABLETS.

Store at or below 25 °C. Keep strip pack in carton and sachet in HDPE container until required for use. Store this medicine away from light and moisture.

Any expired or outdated medicines and unused medicines can be returned to your nearest pharmacy. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). STORE ALL MEDICINES OUT OF REACH OF CHILDREN.