Package leaflet: Information for the user

Isoniazid 100mg tablets

Isoniazid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, or pharmacist or nurse has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information oradvice.

•    If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Isoniazid tablets are and what they are used for

2.    What you need to know before you take Isoniazid tablets

3.    How to take Isoniazid tablets

4.    Possible side effects

5.    How to store Isoniazid tablets

6.    Contents of the pack and other information

1. WHAT ISONIAZID TABLETS ARE AND WHAT THEY ARE USED FOR

Isoniazid is an antibiotic (antibacterial medicine) for treating infections. It belongs to a group of antibiotics called antituberculosis drugs and is used to treat and prevent tuberculosis (TB), an infectious disease mainly affecting the lungs.

Isoniazid tablets with food and drink

Isoniazid tablets should be taken preferably on an empty stomach, i.e. at least 30 minutes before a meal or 2 hours aftera meal. Tablets must be swallowed whole and not chewed. Isoniazid may interact with foods containing histamine (e.g. tuna fish) or tyramine (e.g. cheese, red wine). These foods should be avoided if you are receiving isoniazid.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You may be given additional vitamin supplementation if you are taking this medicine whilst pregnant.

You and your baby may be given additional vitamin supplementation if you take this medicine while you are breastfeeding. Yourbaby should be checked by your doctor at regular intervals.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. However, you may experience side-effects such as dizziness and confusion during treatment with isoniazid. Therefore, do not drive a car or operate machinery until you know how isoniazid affects you.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ISONIAZID TABLETS

3. HOW TO TAKE ISONIAZID TABLETS

Do not take Isoniazid tablets:

•    if you are allergic to Isoniazid or any of the other ingredients of this medicine (listed in section 6).

•    if you have ever suffered from liver damage caused by a medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Isoniazid tablets

•    if you have or have had problems with your liver or kidneys

•    if you drink a lot of alcohol. It is also best to avoid alcohol whilst you are taking this medicine

•    if you are diabetic

•    if you are pregnant, may become pregnant or are breast feeding

•    if you have the HIV infection

•    if you have suffered mental disturbances (psychosis)

•    if you have malnutrition

•    if you have epilepsy or have ever had convulsions (fits)

•    if you are presently taking itraconazole (to treat fungal infections). It is not recommended to combine isoniazid and itraconazole

Other medicines and Isoniazid tablets

Tell your doctor or pharmacist if you are taking, have recently

taken or might take any other medicines.

Isoniazid may interact with other medicines.

Please inform your doctor or pharmacist if:

•    you are taking other medicine to treat tuberculosis (TB) (e.g. para-aminosalicylic acid)

•    you are taking disulfiram for alcohol dependence

•    you are taking any medication for epilepsy (e.g. carbamazepine, primidone, phenytoin)

•    you are taking any other drugs for tuberculosis (e.g. rifampicin, cycloserine)

•    you are taking medication for HIV infection (e.g. stavudine)

•    you are taking a vitamin B6 or B3 supplement

•    you are taking medication for asthma or chronic obstructive pulmonary disease (e.g. theophylline)

•    you are taking medication for anxiety (e.g. benzodiazepines; diazepam, triazolam, chlorzoxzone)

•    you are taking medication for high blood pressure (e.g. propranolol)

•    you are taking drugs containing levodopa (used in the treatment of Parkinson's disease)

•    you are taking cycloserine (used to treat tuberculosis and urinary tract infections)

•    you are taking ketoconazole (used to treat fungal infections)

•    you are taking zalcitabine (used in HIV infection)

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For adults, the recommended dose is dependent on bodyweight. The maximum dose is three (3) of the 100 mg tablets daily. For the treatment of tuberculous meningitis, a higher dose may be given, particularly during the first 1 to 2 weeks of treatment.

For elderly patients, lower doses may be needed if the liver and kidneys are not working so well.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are notsure.

Your doctor will want to perform tests at regular intervals to monitor your liver.

This will require you to give a blood sample.

Use in children

The dose for children is dependent on bodyweight, and can be given in single or divided doses.

If you take more Isonazid tablets than you should

If you (or someone else) take too many, or you think a child may have swallowed any tablets, contact your nearest hospital casualty department or tell your doctor immediately. Take this leaflet, and any tablets that you still have to show the doctor.

You may experience some of these side effects; Slurred speech, high blood sugar, slow breathing, hallucinations, dizziness, fits, or coma.

If you forget to take Isoniazid tablets

If you miss a dose, just carry on with the next one as normal. Do not take a double dose to make up for a forgotten dose.

If you have forgotten several doses tell your doctor when you have your next check-up or blood test. Occasionally people get headache, sleeplessness, excessive dreaming, irritability or nervousness if several doses are missed, or when the treatment is stopped.

If you stop taking Isoniazid tablets

Keep taking the medicine for as long as your doctor has told you, even if you are feeling better. If you stop the medicine too soon, your infection may not be completely cured. You should not stop treatment unless your doctor or health care provider tells you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Conditions you need to look out for:

•    skin rash, breathing difficulties and possibly collapse

•    severe skin reactions with ulcers or blisters, accompanied by a general feeling of being unwell (Stevens- Johnson syndrome)

•    severe skin reaction with blisters that may also affect the mouth and other parts of the body and may be accompanied by fever, sore throat, headache and/or diarrhoea (erythema multiforme)

•    feeling tired, lose yourappetite and feel sick and unwell

•    yellow discoloration of yourskin oreyes

Contact a doctor immediately if you get any of these symptoms. Stop taking isoniazid Tablets.

Other side effects of Isoniazid may include;

General

•    Hypersensitivity and allergic reactions such as e.g. itching, rash, nettle fever, sometimes with swelling in the skin, mucous membranes and other parts of the body, vascular inflammation, fever, joint pain.

Nervous system

•    Dizziness

•    Muscle weakness

•    Tingling or numbness in hands orfeet

•    Loss of tendon reflexes

•    Overactive reflexes

•    Convulsions

•    Eye problems, double vision

•    Headache

•    Tremors

•    Memory problems

•    Depression and paranoia

•    Feeling irritable

•    Feeling anxious

•    Unable to concentrate

Skin

•    Rash

•    Acne

•    Scaly skin sores

•    Sensitivity to sunlight

•    Inflammation of blood vessels (vasculitis), which may be visible as red or purple

•    Raised spots on the skin, but can affect other parts of the body

Blood

•    Increase in a certain type of white blood cells (leukocytes, eosinophiles)

•    Decrease in or complete lack of a certain type of white blood cells (granulocytes)

•    Reduction in the number of platelets

•    Anaemia

•    Blood clotting abnormalities Digestive system

•    Pancreatitis (the sudden onset of a severe pain in the centre ofyourabdomen)

•    Constipation

•    Dry mouth

•    Feeling sick/being sick

•    Diarrhoea

Liver

•    Increase in liverenzymes

•    Inflammation of the liver (hepatitis), which may be severe. Fatal cases have occurred

Metabolism and nutrition disorders

•    High blood sugar levels

•    Low blood sugar levels

Hormones

•    High levels of cortisol in the blood (Cushing's syndrome)

•    Hormone imbalance in women with menstrual cycle disorders

•    Increase in size of breasts (in men)

Heart

•    Irregularheartbeat

•    Changes in blood pressure, resulting in dizziness (vertigo)

Respiratory system

•    Asthma

Other

•    Connective tissue disorders such as Lupus syndrome which can affect the skin and kidneys (symptoms may include a butterfly shaped rash over the cheeks and nose, tiredness, a high temperature, feeling or being sick, joint pain and weight loss).

Although isoniazid usually improves people's mood, it can cause mental disturbances. These side effects usually disappear when you stop taking Isoniazid.

Abnormal antibodies in the blood (called ANA).

Serious side effects are more common in people over 35 or in those who metabolise isoniazid more slowly. You may be given a vitamin supplement to try and prevent some of these side effects.

If you feel unwell in anyway, tell yourdoctor as soon as you can. Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE ISONIAZID TABLETS

Keep this medicine out of the sight and reach of children. You should keep your tablets below 25°C.

Do not use this medicine after the expiry date which is stated on the carton after EXR The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. CONTENTS OF THE PACKAND OTHER INFORMATION

What Isoniazid tablets contains

•    The active substance is Isoniazid. Each tablet contains 100 mg of Isoniazid.

•    The other ingredients are: Calcium Hydrogen Phosphate, Maize Starch (dried), Purified Talc, Colloidal Anhydrous Silica, Magnesium Stearate.

What Isoniazid tablets look like and contents of the pack

Isoniazid tablets are white, circular, biconvex, uncoated tablets having plain surface on both the sides.

Isoniazid tablets are available in Blister packs of 7, 10, 14, 20, 28,30,56,60,84, 90,100or112.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Morningside Healthcare Ltd

115 Narborough Road, Leicester, LE3 0PA, UK

Manufacturer

Morningside Pharmaceuticals Ltd Pavilion Way, Loughborough, LE11 5GW, UK

This leaflet was last revised in February 2015.

Kidneys & Bladder

• Difficulty urinating