Rifampicin/Isoniazid Tablets USP 450mg/300mg

PACKAGE LEAFLET: INFORMATION FOR THE USER

Rifampicin/Isoniazid 450mg/300mg Coated Tablets

Important things you know need to about Rifampicin/Isoniazid 450mg/300mg Tablets

The name of your medicine is Rifampicin/Isoniazid 450mg/300mg Coated Tablets (called Rifampicin/Isoniazid 450mg/300mg Tablets in this leaflet).

It is very important that you take Rifampicin/Isoniazid 450mg/300mg Tablets exactly as your doctor has told you. There is a chance of you having a severe and dangerous allergic reaction if you do not take your tablets every day as you are told
You must keep taking it until your doctor tells you to stop.
If you are taking any other medicines, including medicines you have bought from the pharmacy or shop, you must make sure your doctor knows
Rifampicin/Isoniazid 450mg/300mg Tablets makes all of your body fluids an orange or red colour. Do not worry – this is normal and not harmful
Take Rifampicin/Isoniazid 450mg/300mg Tablets on an empty stomach. This means at least 30 minutes before food or 2 hours after food
While you are taking Rifampicin/Isoniazid 450mg/300mg Tablets, you should not eat matured cheeses, cured meat, some fish (like tuna, salmon and mackerel) or drink wine and beer (see ?Taking Rifampicin/Isoniazid 450mg/300mg Tablets with food and drink?)
If you get a temperature, are sick, begin to feel more unwell, lose your appetite or have yellowing of the skin, gums or eyes, you must talk to your doctor straight away.

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 any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

What Rifampicin/Isoniazid 450mg/300mg Tablets are and what they are used for
What you need to know before you take Rifampicin/Isoniazid 450mg/300mg Tablets
How to take Rifampicin/Isoniazid 450mg/300mg Tablets
Possible side effects
How to store Rifampicin/Isoniazid 450mg/300mg Tablets
Contents of the pack and other information
What Rifampicin/Isoniazid 450mg/300mg Tablets are and what they are used for

Rifampicin/Isoniazid 450mg/300mg Tablets contain two different medicines called Rifampicin and Isoniazid. They both belong to a group of medicines called anti-tuberculous drugs. They work by killing the bacteria that cause tuberculosis.

Rifampicin/Isoniazid 450mg/300mg Tablets are used to treat tuberculosis (also known as TB).

What you need to know before you take Rifampicin/Isoniazid 450mg/300mg Tablets

Do not take Rifampicin/Isoniazid 450mg/300mg Tablets if:

You are allergic (hypersensitive) to
- Rifampicin
- Isoniazid
- any of the other ingredients of the Rifampicin/Isoniazid 450mg/300mg

Tablets (see Section 6: Contents of the pack and other information)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

You have yellowing of the skin and eyes (jaundice)
You are taking saquinavir or ritonavir for an HIV infection (see ?Taking other medicines? section below)

Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Rifampicin/Isoniazid 450mg/300mg Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Rifampicin/Isoniazid 450mg/300mg Tablets

You have liver problems
You have any kidney problems and if you are having more than 600mg Rifampicin per day
You have diabetes. Your diabetes may become more difficult to control while taking this medicine
You have epilepsy
You have or have ever had mental health problems (such as depression or schizophrenia)
You feel numb or weak in your arms and legs (peripheral neuropathy)
You have an HIV infection
You are underweight or malnourished
You drink alcohol every day or you are an alcoholic
You inject yourself with drugs
You are a black or Hispanic woman
You have a rare blood problem called ?porphyria?
You have a problem with bleeding or a tendency to bruise easily
Your doctor has told you that your body takes a long time to get rid of some drugs (you have a slow acetylator status)
You wear contact lenses. Taking Rifampicin/Isoniazid 450mg/300mg Tablets may permanently stain soft contact lenses
The person taking this medicine is a child
You are aged 65 years or older

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Rifampicin/Isoniazid 450mg/300mg Tablets.

Blood Tests

Your doctor will need to check your blood before you take this medicine. This will help your doctor know if any changes happen to your blood after taking this medicine. If you are aged 35 years or older, you will also need to have monthly blood tests to check how your liver is working.

Take special care with Rifampicin/Isoniazid 450mg/300mg Tablets

Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported with the use of Rifampicin/Isoniazid 450mg/300mg Tablets.

SJS/TEN can appear initially as reddish target spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities.

The highest risk for occurrence of serious skin reactions is within 2 days to 2 months after treatment initiation depending on the condition.?If you develop a serious rash or another of these skin symptoms, stop taking Rifampicin/Isoniazid 450mg/300mg Tablets and contact your doctor or seek medical attention immediately.

Other medicines and Rifampicin/Isoniazid 450mg/300mg Tablets

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Rifampicin/Isoniazid 450mg/300mg Tablets can affect the way some other medicines work. Also, some medicines can affect the way Rifampicin/Isoniazid 450mg/300mg Tablets work.

In particular, do not take this medicine, and tell your doctor, if you are taking:

Saquinavir or ritonavir used for HIV infection

The following medicines can make Rifampicin/Isoniazid 450mg/300mg Tablets work less well:

Antacids used for indigestion. Take Rifampicin/Isoniazid 450mg/300mg Tablets at least 1 hour before taking antacids
Other medicines used for TB such as P-aminosalicylic acid (PAS) and cycloserine. PAS and Rifampicin/Isoniazid 450mg/300mg Tablets should be taken at least 8 hours apart

Tell your doctor if you are taking any of the following medicines:

Heart and blood medicines

Medicines for high blood pressure
Medicines for heart problems or to control your heartbeat
Medicines used to thin the blood such as warfarin
Medicines used to lower cholesterol
Water tablets (diuretics) such as eplerenone

Mental health, epilepsy and motor neurone medicines

Medicines for thought disorders known as ?antipsychotics? such as haloperidol
Medicines to calm or reduce anxiety (hypnotics, anxiolytics)
Medicines to help you sleep (barbiturates)
Medicines used for epilepsy such as phenytoin and carbamazepine
Some medicines used for depression such as amitriptyline and nortriptyline
Riluzole – used for motor neurone disease

Medicines for infections and the immune system

Some medicines used for an HIV infection such as stavudine and zalcitabine
Some medicines used for viral infections such as indinavir, efavirenz, amprenavir, nelfinavir, atazanavir, lopinavir, nevirapine, daclatasvir, simeprevir, sofosbuvir and telaprevir
Medicines used for fungal infections
Medicines used for bacterial infections (antibiotics)
Medicines used for lowering your immune systems such as ciclosporin, sirolimus and tacrolimus
Praziquantel – used for tapeworm infections
Atovaquone – used for pneumonia

Hormone and cancer medicines

Some hormone medicines (estrogen, systemic hormones, progestogens) used for contraception or some types of cancer such as ethinylestradiol, levonorgestrel or dydrogesterone
Some hormone medicines (anti-estrogens) used for breast cancer or endometriosis such as tamoxifen, toremifene and gestrinone
Some medicines used for cancer (cytotoxics) such as imatinib
Levothyroxine (thyroid hormone) used for thyroid problems
Irinotecan – used for cancer

Pain and inflammation medicines

Non-steroidal anti-inflammatory drugs (NSAIDs) such as etoricoxib, aspirin and indomethacin
Medicines used for pain such as codeine, morphine, fentanyl or pethidine
Corticosteroids used for inflammation such as hydrocortisone, betamethasone and prednisolone
Methadone – used for heroin withdrawal

Other medicines

Medicines used for diabetes
Medicines used to relax muscles before surgery (anaesthetics) such as halothane
Some medicines used for feeling sick or being sick such as ondansetron and aprepitant
Other antibiotic medicines such as cefazolin
Quinine – used for malaria
Theophylline – used for wheezing or difficulty in breathing

Taking Rifampicin/Isoniazid 450mg/300mg Tablets with food and drink

Isoniazid may interact with foods containing histamine or tyramine (e.g. matured cheeses, cured meat, some fish like tuna, salmon and mackerel, wine and beer), causing symptoms including headache, sweating, flushing, fast, uneven or forceful heartbeat (palpitations), dizziness, feel lightheaded or faint (due to low blood pressure). These foods should be avoided if you are receiving Isoniazid. Your doctor will be able to advise further.

Pregnancy, breast-feeding and fertility

Talk to your doctor before taking this medicine if you are pregnant, plan to get pregnant or think you are pregnant.

Rifampicin/Isoniazid 450mg/300mg Tablets may make the contraceptive ?pill? work less well. This means you should change to a different type of contraception. Instead, you must use a reliable barrier method of contraception such as condoms or the ?coil? while taking Rifampicin/Isoniazid 450mg/300mg Tablets. If you have any questions or are unsure about this talk to your doctor or pharmacist.

You should not breast-feed if you are taking Rifampicin/Isoniazid 450mg/300mg Tablets. This is because small amounts may pass into the mothers? milk. If you are breast-feeding or planning to breastfeed, talk to your doctor or pharmacist before taking any medicine.

Driving and using machines

You may feel dizzy or faint, have problems with vision or have other side effects that could affect your ability to drive while taking this medicine. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of Rifampicin/Isoniazid 450mg/300mg Tablets

Rifampicin/Isoniazid 450mg/300mg Tablets contain:

Sucrose:?If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking Rifampicin/Isoniazid 450mg/300mg Tablets
Sodium:?These tablets contain less than 1 mmol sodium (23mg) per daily dose and are essentially ?sodium-free?.
How to take Rifampicin/Isoniazid 450mg/300mg Tablets

Always take Rifampicin/Isoniazid 450mg/300mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Keep taking this medicine

You must take the tablets every day for the whole time the doctor has told you to take them
Do not stop and start taking the tablets. This may increase the risk of side effects and your TB will not be treated properly

How to take the tablets

Take this medicine by mouth
Swallow the tablets whole, with a drink of water
Take at least 30 minutes before a meal or 2 hours after a meal. They are best taken at least 30 minutes before breakfast
Take all your tablets together each day, as a single dose
Do not give this medicine to children
If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

Your doctor may ask you to take Vitamin B6 during treatment with Rifampicin/Isoniazid 450mg/300mg Tablets, especially if you are malnourished, elderly or a diabetic.

How much to take

The usual dose is:

Adults and the Elderly weighing less than 50kg

3 tablets each day
If you are elderly, your doctor may monitor your treatment more closely

Adults and the Elderly weighing more than 50kg

Rifampicin/Isoniazid 450mg/300mg Tablets are usually prescribed

Children

This medicine is not recommended for use in children.

If you take more Rifampicin/Isoniazid 450mg/300mg Tablets than you should

If you take more Rifampicin/Isoniazid 450mg/300mg Tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

You may feel sick (nausea), be sick (vomiting), have stomach pain, itching or a headache. You may also feel tired, sleepy, dizzy, light-headed, have blurred or strange visions (hallucinations) and faint or feel faint. Other signs of taking too much include swelling of the face, eyes or eyelids, slurring of speech, difficulty breathing, fast heartbeat, uneven heartbeats, fits and heart attack.

If you forget to take Rifampicin/Isoniazid 450mg/300mg Tablets

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.

Tests

Taking Rifampicin/Isoniazid 450mg/300mg Tablets may affect the results of some blood tests. In particular, tests for folate, vitamin B₁₂?and liver function. If you are going to have a blood test, it is important to tell your doctor that you are taking Rifampicin/Isoniazid 450mg/300mg Tablets.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking and go to a hospital straight away if you notice any of the following serious side effects:

You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, wheezing, swelling of your lips, face, throat or tongue
Serious skin rashes including Steven-Johnson syndrome, toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms.?See also section 2.
Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).?See also section 2.
A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalized exanthematous pustulosis).?See also section 2.
You bruise more easily than usual. Or you may have a painful rash of dark red spots under the skin which do not go away when you press on them (purpura). This could be because of a serious blood problem
You have severe bleeding (haemorrhage)
You have chills, tiredness, unusually pale skin colour, shortness of breath, fast heartbeat or dark coloured urine. These could be signs of a serious type of anaemia
You have blood in your urine or an increase or decrease in the amount of urine you produce. You may also get swelling, especially of the legs, ankles or feet. This may be caused by serious kidney problems
You have a sudden severe headache. This could be a sign of bleeding in the brain
Shortness of breath and wheezing
You get confused, sleepy, cold clammy skin, shallow or difficult breathing, a racing heartbeat or your skin is paler than normal. These could be signs of shock
You get more infections more easily than normal. Signs include fever, sore throat or mouth ulcers. This could be because you have a low number of white blood cells
You have bleeding from your nose, ear, gums, throat, skin or stomach. Signs may include a feeling of tenderness and swelling in your stomach, purple spots on your skin and black or tar-like stools

If you experience any of the following side effects contact your doctor as soon as possible:

Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis, frequency not known).
Yellowing of the skin or whites of the eyes, or urine getting darker and stools paler, fatigue, weakness, malaise, loss of appetite, nausea or vomiting caused by liver problems (hepatitis, may affect up to 1 in 100 people).

Talk to your doctor straight away if you notice any of the following serious side effects:

Mental problems with unusual thoughts and strange visions (hallucinations)
Severe watery diarrhoea that will not stop and you are feeling weak and have a fever. This may be something called ?Pseudomembranous colitis?
Your fits get worse or you start to have fits
Flu-like symptoms including chills, fever, headache, dizziness and bone pains

Tell your doctor as soon as possible if you have any of the following side effects:

Water retention (oedema) which may cause swollen face, stomach, arms or legs
Muscle weakness or pain or loss of muscle reflexes
Dizziness, feel lightheaded and faint especially when you stand or sit up quickly (due to low blood pressure)
Swollen fingers, toes or ankles
Balance problems with dizziness (vertigo)
Being unable to concentrate, feeling nervous, irritable or depressed
Feeling very tired and weak or difficulty sleeping (insomnia)
Unusual skin sensations such as feeling numb, tingling, pricking, burning or creeping on the skin (paraesthesia)
Short-term memory loss, anxiety, being less alert or responsive
Blurred or distorted eyesight
Wasting of muscles or other body tissues
Weight loss, night sweats and fever. These could be signs of a blood condition called eosinophilia
Feeling sick or being sick

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Skin flushing or itching
Irregular periods
Constipation, diarrhoea, stomach discomfort or dry mouth
Headache
Loss of appetite (anorexia)
Breast enlargement in men
Increased thirst, going to the toilet more often and feeling tired. Your blood sugar may be high
Acne
Inflammation of the blood vessels.

Other side effects you should discuss with your doctor if you are concerned about them

You notice a discolouration (yellow, brown, orange or red colour) in your teeth, urine, sweat, phlegm (sputum), saliva or tears. This is quite common and you need not worry. However, the colour may permanently stain soft contact lenses. The colour in tears may last for some time after you have stopped having Rifampicin/Isoniazid 450mg/300mg Tablets.

Blood tests

A blood test may show changes in the way the liver is working

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Rifampicin/Isoniazid 450mg/300mg Tablets

Keep this medicine in a safe place where children cannot see or reach it.

Do not use Rifampicin/Isoniazid 450mg/300mg Tablets after the expiry date which is stated on the carton and blister packs. The expiry date refers to the last day of that month.

Store below 25?C. Keep the blister in the outer carton, protect from moisture.

Medicines should not be disposed of via water waste or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

What Rifampicin/Isoniazid 450mg/300mg Tablets contain:

Each tablet contains 450mg of Rifampicin and 300mg of Isoniazid. These are the active ingredients
The other ingredients are Sodium Lauryl Sulphate, Calcium Stearate, Sodium Carboxymethyl Cellulose, Magnesium Stearate, Microcrystalline Cellulose, Acacia, Gelatin, Kaolin, Magnesium Carbonate Light, Talc, Titanium Dioxide, Colloidal Silicon Dioxide, Polyvinylpyrollidone K30, Sucrose, Carnauba Wax, Colophony, White Beeswax, Hard Paraffin, Erythrosine.

What Rifampicin/Isoniazid 450mg/300mg Tablets look like and contents of the pack

The tablets are cyclamen, smooth, shiny, round, curved and sugar-coated.

Pack Size:

Blister packs of 7,14, 28, 30, 56, 60, 84, 100, 120, 240, 360 and 500 film sugar coated tablets in cardboard cartons.

Blister material is PVC / PVDC and aluminium foil / PVC.

Not all pack size may be marketed.

Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222825)