Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

WHO-PQ RECOMMENDED
PATIENT INFORMATION LEAFLET

This patient information leaflet focuses on uses of the medicine covered by WHO’s Prequalification Team Medicines. The recommendations for use are based on WHO guidelines and on information from stringent
regulatory authorities.*
The medicine may be authorised for additional or different uses by national medicines regulatory authorities.

*

https://extranet.who.int/pqweb/sites/default/files/documents/75%20SRA%20clarification_Feb2017_newtempl.pdf
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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

Information for the patient[TB302 trade name]†
Isoniazid/rifampicin
Read all of this leaflet carefully before you start taking this medicine because it contains important
information for you.
-Keep this leaflet. You may need to read it again.
If you have questions about the medicine, ask your health care provider.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if
their signs of illness seem to be the same as yours.
If you are concerned about any side effects, talk to your health care provider. This includes unwanted
effects not listed in this leaflet. See section 4.

-What is in this leaflet
1.
2.
3.
4.
5.
6.

What [TB302 trade name] is and what it is used for
What you need to know before you take [TB302 trade name]How to take [TB302 trade name]
Possible side effects
How to store [TB302 trade name]Contents of the pack and other information

1.
What [TB302 trade name] is and what it is used for[TB302 trade name] is a combination of two antimycobacterial agents, rifampicin and isoniazid.
[TB302 trade name] is used in children weighing less than 25 kg, for the prevention and treatment oftuberculosis caused by the bacterium Mycobacterium tuberculosis.
This product is intended for use in children. Safety information on use in adults is also provided.
2.
What you need to know before you take [TB302 trade name]
Do not take [TB302 trade name] if you:-are hypersensitive (allergic) to isoniazid or rifampicin, or any of the other ingredients of [TB302 tradename] (see section 6, What [TB302 trade name] contains).
have acute liver disease,
have drug-induced liver disease,
have experienced liver damage linked to isoniazid or rifampicin before,
have experienced severe side effects of isoniazid or rifampicin, such as drug fever or chills,
if you are using voriconazole (a medicine used to treat fungal infections)
if you are using a medicine against HIV infection that belongs to the class of protease inhibitors or a
medicine against Hepatitis C that belongs to the class of direct acting antivirals.

Warnings and precautions[TB302 trade name] may cause liver disease (hepatitis). You should be attentive to symtoms that might bedue to liver damage, such as unexplained loss of appetite, nausea, vomiting, dark urine, yellow
discouloration of the skin (jaundice), persistent fatigue of greater than 3 days duration and abdominal pain
and tenderness. If these occur, you should immediately report this to your health care provider.

†Trade names are not prequalified by WHO. This is the national medicines regulatory agency’s responsibility.
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dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

You may be at special risk for developing hepatitis- if you are older than 35 years,- if you drink alcoholic beverages daily (see “[TB302 trade name] with food and drink”)- if you have a chronic liver disorder- if you are a user of injection drugs (e. g. heroin)
If you belong to one of these groups your health care provider will closely check your liver function.
Furthermore, you will be carefully monitored- if you use any chronically administered medication concurrently (see “Other medicines and [TB302trade name]”),- if you suffer from tingling in the hands and feet (peripheral neuropathy),- if you are pregnant- if you are HIV infected.
If you get flu-like symptoms such as fever, headache, muscle aches etc., you should report this to your healthcare provider, since [TB302 trade name] may be the cause.
Tingling in the hands and feet (peripheral neuropathy) is the most common side effect of isoniazid, one of
the active agents in [TB302 trade name] (see “Possible side effects). You should report any such symptoms
to your health care provider. A certain vitamin, pyridoxine, should be administered routinely at doses of 10
mg per day during treatment with [TB302 trade name], since it largely reduces the risk of developing
neuropathy.
If you are hypersensitive to ethionamide or niacin (nicotinic acid), you should inform your health careprovider, because you may also be hypersensitive to [TB302 trade name].
If you have epilepsy or a history of psychiatric disease, you should report this to your health care provider,since it may affect your ability to tolerate [TB302 trade name].
If you have kidney problems, diabetes or porphyria, it is important that you inform your health care provider
about this, since [TB302 trade name] may then be unsuitable for you.
If you are taking cortisone or any cortisone-like drug, you should report this to your health care provider,since the cortisone dose may have to be increased while taking [TB302 trade name].
[TB302 trade name] may cause a reddish orange discouloration of body fluids such as urine, sputum andtears. This is due to rifampicin, and does not require medical attention. Also, contact lenses may become
discoloured due to [TB302 trade name].
[TB302 trade name] may lower the effects of oral contraceptive pills. Therefore a different or additional
method of contraception (e.g. condoms, intra-uterine device, pessary) should be used during treatment with
[TB302 trade name] .
It is important that your health care provider knows about all your signs of illness, even when you think they
are not related to tuberculosis infection.
Other medicines and [TB302 trade name]Tell your health care provider if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. These may affect the action of [TB302 trade name] , or [TB302
trade name] may affect their action. Side effects of either medicine may become worse and/or the medicines
may become less effective.

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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3November 2021

You should not take [TB302 trade name] with:- voriconazole (a medicine used to treat fungal infections).
- HIV protease inhibitors (drugs used to treat HIV infection).
- Direct-acting antivirals for the treatment of chronic Hepatitis C.
- aluminium hydroxide (medicine used to treat diseases related to the gastric acid)
The active agents in [TB302 trade name] may also interact with a great number of other medicines, including
for instance:- drugs to treat HIV infection (e.g. efavirenz, nevirapine)- drugs to treat fungal infections (e.g. ketoconazole, fluconazole)- antibiotics (e.g. clarithromycin)- drugs to treat malaria (e.g. quinine)- immunosuppressant drugs (e.g. cyclosporine, tacrolimus)- drugs to treat heart conditions (e.g. verapamil, digoxin)- drugs to treat blood lipids (e.g. simvastatin)- some drugs to treat diabetes (e.g. glibenclamide)- oral contraceptive pills- medicines to treat epileptic seizures (e.g. phenytoin, carbamazepine, valproate)- medicines used to help you sleep (benzodiazepines, e.g. diazepam, flurazepam, triazolam, midazolam)- medicines for the treatment of certain psychiatric conditions (neuroleptics, e.g. chlorpromazine,haloperidol)- medicines for prevention of blood clots (coumarin or indandione derivates, e.g. warfarin)- medicines used at surgery (narcotics, e.g. alfentanil, enflurane)- corticosteroids (e.g. prednisolone, medicines for the treatment of inflammations and other diseases,
such as asthma or rheumatoid arthritis)- medicines to treat pain (e.g. morphine, paracetamol)- codeine (medicine to treat cough)- disulfiram (medicine used for the treatment of chronic alcoholism).
Taking any of these drugs together with [TB302 trade name] may be unsuitable or require dose adjustment.
[TB302 trade name] with food and drink[TB302 trade name] should be taken on an empty stomach (at least one hour prior to or two hours after ameal).
You should not drink alcohol while taking [TB302 trade name]. This increases the risk of liver damage.
When taken with cheese or fish (histamine- or tyramine-rich food) [TB302 trade name] may cause
redness,/itching of the skin, hot feeling, rapid or pounding heartbeat, sweating, chills or clammy feeling,headache, and/or lightheadedness. If you experience these side effects, you should avoid eating cheese andfish while taking this medicine.
Pregnancy and breast-feeding
If you become pregnant, or are planning to become pregnant, you must contact your health care provider todiscuss the potential benefits and risks of the tuberculosis therapy for you and your child.
Isoniazid and rifampicin are excreted into the breast milk of lactating mothers. No negative effects have beenreported in breast-fed-infants whose mothers were receiving these drugs. However, drug concentrations inbreast milk are so low that you cannot rely upon breast-feeding for adequate tuberculosis prophylaxis ortherapy for your child.

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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

Driving and using machines[TB302 trade name] may cause visual disturbances, dizziness and other side effects on the nervous
system that can impair your ability to drive and to use machines.
Other ingredients of [TB302 trade name]
This medicine contains 3.13 mg aspartame in each tablet. Aspartame is a source of phenylalanine. It may be
harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up
because the body cannot remove it properly.
3.
How to take [TB302 trade name][TB302 trade name] should always be taken exactly as described by the health care provider.
You should check with your health care provider if you are not sure.
The dose of [TB302 trade name] depends the the patient’s weight. The medicine should be given once daily.
Try to give [TB302 trade name] at the same time each day.
Your health care provider will decide on the duration of treatment that is suitable for the patient.
Children weighing less than 25 kg
The following table shows the doses for prevention or treatment of tuberculosis according to children’s
weight:Patient’s weight
4-7 kg
8-11 kg
12-15 kg
16-24 kg> 25 kgDose
1 tablet2 tablets
3 tablets
4 tablets--**

For these patients, formulations containing more isoniazid/rifampicin should be used.

[TB302 trade name] is not recommended for children with a body weight of less than 4 kg.
Kidney disease
If the child has kidney-disease, then the health care giver may prescribe separate formulations of thecomponent drugs in [TB302 trade name].
Liver disease
If the child has liver disease, the health care provider will apply special precautionary measures (see section2).
How to take [TB302 trade name]
The tablets should be taken on an empty stomach (at least one hour prior to or two hours after a meal).
Disperse the tablets in drinking water before giving the dose. Each tablet should be dispersed in a minimumof 10 mL of water, the maximum volume of water recommended for dispersion of a dose is 50 mL

Instructions for giving {DotWHOPAR_ProductName}Look up the child’s weight in the above dosing table
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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

Then look under number of tablets of [TB302 trade name]which shows how many tablets of [TB302
trade name] will be required
1. The required amount of drinking water should be taken in a small and clean cup and the required
number of tablets should be added. At least 10 mL drinking water should be used to disperse thetablets.
2. The cup should be gently swirled until tablets disperse, and the entire mixture should begiven/taken immediately.
3. The cup should be rinsed with an additional 10 mL water, which should be drunk by the patient toensure the entire dose is taken.

If the child takes more [TB302 trade name] than they should
If the child accidentally takes too many tablets, immediately contact the health care provider or the nearest
hospital emergency department. Take the tablet container with you so that you can easily describe what you
have taken. If the child has taken too much [TB302 trade name], he or she may develop vomiting,gastrointestinal disturbances, fever, headache, dizziness, slurring of speech, hallucinations and/or visualdisturbances. The child may also get a reddish-orange discolouration of the skin, facial swelling and itching.
If you forget to give [TB302 trade name]
It is important not to miss a dose. If a dose is missed, the missed dose should be given as soon as possible,
unless the next regular dose is scheduled within 6 hours. Skip the missed dose if it is almost time for the next
regular dose.
Do not give a double dose to make up for a forgotten dose.
If the child vomits less than 1 hour after taking this medicine, give them another dose. You do not need togive another dose if they were sick more than 1 hour after taking [TB302 trade name].
If you stop giving [TB302 trade name]
Do not stop giving this medicine without checking with your health care provider. Stopping these tablets too
early may no longer protect the child from the infection or cause it to come back.
If you have any further questions on the use of this medicine, ask the health care provider.
4.
Possible side effects
Like all medicines, [TB302 trade name] can cause side effects, although not everybody gets them. Whentreating tuberculosis, it is not always possible to differentiate between unwanted effects caused by [TB302trade name], and those caused by any other medicines you may be taking at the same time. For this reason, itis important that you inform your health care provider of any change in your health.
The following side effects have been reported in patients treated with [TB302 trade name]:
The most important adverse effects of isoniazid and rifampicin are nerve injuries (see below) and severe andsometimes fatal inflammation of the liver (hepatitis).
Very common side effects(may affect more than 1 in 10 people):-sensations of tingling, pricking, or numbness of the skin, especially in the feet and hands (peripheral
neuropathy). Your health care provider will prescribe a supplementary medicine with a vitamin called
pyridoxine, in order to counteract this (see above, “Take special care with [TB302 trade name] ”).

-increased liver enzymes as measured in blood samples (see above, “Take special care with [TB302 tradename] ”). Usually, liver enzyme increases occur during the first 1-3 months of therapy and return tonormal despite continued treatment. When the values rise above a certain level, your health care provider
may decide to stop treatment with [TB302 trade name] \.

-Flushing
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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

Common side effects(may affect up to 1 in 10 people):- reddish discoloration of body fluids such as urine, sputum, tears, saliva and sweat.
- diarrhoea- stomach pain
loss of appetite,- feeling sick (nausea)- vomiting
skin reactions with rash and/or itching- disturbances of the menstrual cycle.
Uncommon side effects(may affect up to 1 in 100 people)- inflammation of the liver (hepatitis)- fits (epileptic seizures)
headache- inflammation of the brain- personality changes and memory impairment.
If you notice signs of illness suggestive for liver damage (see “Take special care with [TB302 trade name] ”),
you should inform your health care provider immediately.
Rare side effects(may affect up to 1 in 1000 people)- inflammation of the stomach lining (gastritis)
infection of the intestines (bowel infection)- inflammation of the kidney (nephritis)- skin sensitivity to light (photosensitivity reactions)- inflammation or swelling of the conjunctiva or pinkeye (conjuctivitis)
Side effects of which it is not known how often they may occur- allergic reactions with fever, muscle aches, and cough- severe skin reactions with fever, blisters and involvement of the mucous membranes or lifethreatening anaphylactic reactions- dizziness, drowsiness- confusion, disorientation, hallucination,- inflammation of the lungs (pneumonitis)- inflammation of the optic nerve (optic neuritis)- build up of acid in the body (metabolic acidosis), increased blood levels of glucose, a vitamin
deficiency syndrome called pellagra (with e.g. dementia, loose stools and skin inflammation)- metallic taste, dry mouth, flatulence, constipation.
- difficulty in passing urine- changes in the white blood cell counts (leucopenia, neutropenia, eosinophilia,agranulocytosis), possibly resulting in an increased risk of infection.
- decreased red blood cell counts (anaemia), possibly leading to fatigue, weakness and shortness ofbreath.
- decreased platelet count, which may result in an increased risk of bruising and bleeding.

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Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

November 2021

Reporting of side effects
If you get any side effects,talk to your health care provider. This includes unwanted effects not listed in thisleaflet. If available, you can also report side effects directly through the national reporting system. By
reporting side effects, you can help improve understanding about the safety of this medicine.

5.
How to store [TB302 trade name]
Keep this medicine out of the sight and reach of children.
Bottle packo Do not store above 25°C. Store in dry place. Protect from light.
o Once opened, use within 120 days
oStrip packs
Do not store above 25°C. Store in dry place. Protect from light

Do not use this medicine after the expiry date stated on the strip pack, carton or bottle, after “EXP”. The
expiry date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration or that it is different from the description
below.
Do not throw away any medicines in wastewater or household waste. Ask your health care provider how tothrow away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What [TB302 trade name] contains
The active ingredients are isoniazid 50 mg and rifampicin 75 mg- The other ingredients of [TB302 trade name] are microcrystalline cellulose, crospovidone, povidone,
bleached shellac, croscarmellose sodium, aspartame, Trusil raspberry flavour and magnesium stearate.
What [TB302 trade name] looks like and contents of the pack
[TB302 trade name] are brick-red, mottled, circular, uncoated biconvex tablets having a deep score on one
side and a plain surface on the other side.
The score-line is decorative only and not to divide the tablet into equal doses.
Bottle packThe tablets are packed in an LDPE bag put in a triple laminated sachet, kept in an HPDE bottle (round, milky
white container with screw thread cap), finally sealed with a tagger seal along with the pack insert.
Pack size: 100 tablets
Strip packThe tablets are packed in Alu/Alu strip pack of 10 tablets. Such 10 strips are packed in a carton along withthe pack insert.
Pack size: 10x10 tablets
The tablets are packed in Alu/Alu strip pack of 28 tablets. Such 3 strips are packed in a carton along with thepack insert.
Pack size: 3 x 28 tablets

Page 8 of 9Isoniazid/rifampicin 50mg/75mg
dispersible tablets(Macleods Pharmaceuticals Ltd), TB302

WHOPAR Part 3

Supplier and Manufacturers
Supplier
Macleods Pharmaceuticals Limited
304, Atlanta Arcade
Marol Church road
Andheri (East)
Mumbai – 400 059
India

November 2021

Manufacturers
Macleods Pharmaceuticals Limited
Unit II, Phase II
Plot No 25-27, Survey No 366
Premier Industrial Estate
Kachigam, Daman, 369 210
India

Tel:+91 22 66762800, +91 260 2244337
Fax: +91 -22-28216599
Email: vijay@macleodspharma.com
sjadhav@macleodspharma.com
exports@macleodspharma.com

Tel:+91 260 2241565, +91 22 28216599
Fax: + 91 260 2241565
Email: jayaramk@macleodspharma.com

Oxalis Labs
Village Theda P.O. Lodhimajra
Baddi, Dist.: Solan
Himachal Pradesh
India
For any information about this medicine, contact the local representative of the supplier.
This leaflet was last revised in November 2021.

Detailed information on this medicine is available on the World Health Organization (WHO) website:
https://extranet.who.int/pqweb/medicines

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