Winthrop Isoniazid 100 mg Tablets

WINTHROP ISONIAZID is an antibiotic, which kills bacteria that cause tuberculosis (also known as TB). WINTHROP ISONIAZID is used to prevent tuberculosis and it is also used in combination with other antibiotic (or antituberculosis) medicines to prevent and treat tuberculosis.

Do not take WINTHROP ISONIAZID if:

• You know you are hypersensitive (allergic) to isoniazid or any of the other ingredients of WINTHROP ISONIAZID tablets, or to medicines such as ethionamide or pyrazinamide (also used to treat tuberculosis) and niacin (also known as vitamin B 3 ). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue (see section 4)
• you have ever suffered from liver damage caused by a medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking WINTHROP ISONIAZID, if:

• You are alcohol dependent or drink excessively. You may be more likely to suffer from fits, mental disturbances or liver problems if you regularly drink alcohol whilst taking WINTHROP ISONIAZID.
• you have liver problems, including hepatitis
• you have kidney problems
• have been told by your doctor that you have a slow acetylator status. Your doctor may wish to change your dose or monitor you closely.
• you have epilepsy or have ever had convulsions (fits) (WINTHROP ISONIAZID can increase the likelihood of fits)
• you have a mental illness (psychosis)
• you suffer from porphyria, you should report any symptoms of porphyria to your doctor immediately (a change in the colour of your urine; your skin may become sensitive, inflamed or begin to blister)
• you are diabetic (have high blood sugar), under-weight or malnourished, alcoholic, pregnant, elderly, have kidney problems, or suffer from human immunodeficiency virus (HIV) infection. You may be at risk to develop peripheral neuropathy (weakness, numbness and pain, usually in your hands and feet, but also in other areas of your body). Your doctor may advise that you use pyridoxine (vitamin B 6 ) to prevent or treat this.
• you have a bleeding tendency
• the person taking WINTHROP ISONIAZID is a child
• you are aged 65 years or older.

Take special care with WINTHROP ISONIAZID: Tell your doctor immediately if you develop:

• Yellowing of your skin, gums or eyes (jaundice), or tiredness, weakness, general feeling of illness (malaise), loss of appetite, nausea or vomiting. These could be symptoms of liver problems such as hepatitis (inflamed liver)
• blistering of the skin, mouth, eyes and genital area, red/purple rash, fever, headache, cough and joint pain (Stevens-Johnson syndrome), severe extensive skin damage, e.g. separation of the epidermis and superficial mucous membranes (known as toxic epidermal necrolysis)
• if you develop fever, unexplained tiredness or shortness of breath, cough, swollen lymph nodes, muscle pains, diarrhoea, a full feeling quickly while eating or a rash or itching. These may be symptoms of ‘DRESS syndrome’, a medicine hypersensitivity reaction which affects your internal organs and increases the white cells in your blood (also see section 4).

While taking WINTHROP ISONIAZID you must visit your doctor at least once a month. Tell your doctor if you experience any problems with your treatment.

Do not share WINTHROP ISONIAZID prescribed for you with any other person. Your doctor will decide what dose of WINTHROP ISONIAZID you need. WINTHROP ISONIAZID may be given alone to prevent tuberculosis (TB) or will be given with other effective antituberculosis medicines to treat your TB. Always take WINTHROP ISONIAZID and other medicines exactly as your doctor has instructed you take. You should check with your doctor or pharmacist if you are unsure.

Do not stop taking your medicine unless your doctor has instructed you to do so.

Recommended dose: 3 to 5 mg per kg body mass in single or divided doses up to a maximum of 300 mg daily.

Children: The usual daily dose for children aged three months and above is from 10 to 20 mg per kg body mass in single or divided doses daily.

If aluminium-containing antacids are taken, they must be taken at least one hour after WINTHROP ISONIAZID.

If you have the impression that the effect of WINTHROP ISONIAZID is too strong or too weak, tell your doctor or pharmacist.

If you take more WINTHROP ISONIAZID 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 forget to take WINTHROP ISONIAZID

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for the forgotten tablets.

If you stop taking WINTHROP ISONIAZID

You must take WINTHROP ISONIAZID for the whole time the doctor has told you to take the tablets. Do not stop and start taking the tablets at any time. This may cause WINTHROP ISONIAZID to be less effective and your infection will not be treated properly.

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

If any of the following happens, stop taking WINTHROP ISONIAZID and tell your doctor or pharmacist immediately or go to the nearest hospital:

Frequency unknown:

• you have signs of a serious allergic reaction which can include swelling of your lips, face, throat or tongue, hands, feet, ankles, or throat which may cause difficulty in swallowing or breathing or collapse
• severe extensive skin damage, e.g. peeling or separation of the skin and superficial mucous membranes (known as toxic epidermal necrolysis)
• skin blistering, red/purple rash, fever, headache, cough and joint pain (Stevens-Johnson syndrome)
• a medicine reaction that causes rash, fever, inflammation of internal organs, abnormalities in the blood and systemic illness (DRESS syndrome). These are all very serious side effects. If you have them, you may have had a serious reaction to WINTHROP ISONIAZID. 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:

Less frequent:

• blotchy red skin rash (erythema multiforme)
• immune system problems with symptoms that include tiredness, joint pain and skin rashes (called lupus-like syndrome)
• inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis)

Frequency unknown:

• yellowing of your skin or whites of the eyes (jaundice), fever, dark urine and pale stools, tiredness, feel weak or generally unwell, loss of appetite (anorexia), feeling sick (nausea) or vomiting. These may be early signs of liver problems (hepatitis).
• your fits get worse or you start to have fits
• vision problems such as loss of sight, blurred vision and reduced vision
• blood disorders which are determined by blood tests. These include thrombocytopenia (signs may include bruising more easily than usual).
• blood disorders (e.g. low or abnormal number of white blood cells) which are determined by blood tests. Signs may include getting infections more easily than normal, fever, sore throat, mouth ulcers or tiredness.
• blood disorders which are determined by blood tests. Signs may include chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine (haemolytic anaemia), or weight loss, night sweats and fever (eosinophilia).
• blistering, peeling, bleeding, scaling or fluid filled patches on any part of your skin. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may have a serious skin problem.
• high blood sugar levels, signs of which include increased hunger, increased thirst and going to the toilet more often
• mental health problems, signs of which may include hallucinations (seeing things that are not there), delusions, confusion, disturbed thoughts and a lack of self-awareness
• rapid and shallow breathing, confusion, fatigue, headache, sleepiness, lack of appetite, yellowing of the skin or increased heart rate (these could be symptoms of metabolic acidosis)

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequency unknown:

• inflammation in your blood vessels
• headache
• dizziness
• nerve problems which can cause memory loss, movement problems (muscle weakness) or the loss of full control of bodily movements and may affect your manner of walking (ataxia), tingling and loss of feeling (this can be prevented with the use of pyridoxine)
• unusual skin sensations such as feeling numb, tingling, pricking, burning or creeping on the skin (paraesthesia)
• vertigo (feeling off balance or as if your head is spinning)
• feeling sick (nausea) or being sick (vomiting)
• dry mouth
• constipation
• chronic or recurrent stomach pain.
• memory problems, diarrhoea, scaly skin rash this may be due to niacin deficiency (pellagra)
• loss of appetite (anorexia)
• skin conditions, including acne, lumpy red rash, red/purple skin discolouration (purpura), itching and skin scaling
• hair loss
• decreased flow of urine
• breast enlargement in men
• fever

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 or pharmacist. You can also report side effects to:

• The Pharmacovigilance Unit at Sanofi: [email protected] (email) or 011 256-3700 (tel), or
• SAHPRA 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 WINTHROP ISONIAZID.

Store at or below 25 ° C. Store in well closed containers. Protect from light. Store all medicines out of reach of children. Do not use your tablets after the expiry date shown on the container. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).