Isoniazid 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isoniazid

Available from:

Morningside Healthcare Ltd

ATC code:

J04AC01

INN (International Name):

Isoniazid

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5055132715075

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 on to others. It may harm them, even if their signs
of illness 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
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU 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 drinking
alcohol whilst you are taking this medicine,
!
if you are diabetic,
!
if you have extra-pulmonary TB (outside the lungs),
!
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Isoniazid 100 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
100 mg of the active ingredient, isoniazid.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
White, circular, biconvex, uncoated tablets having plain surface on
both the sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Isoniazid 100 mg Tablets are indicated for the treatment of all forms
of pulmonary
and extra-pulmonary tuberculosis.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Official guidance should always be consulted when selecting the dose
regimens to be
used for adults and children (according to age and body weight), the
duration of
therapy and the total content of the combination treatment regimen.
Posology:
ADULTS:
The dose of isoniazid for the treatment of tuberculosis is commonly 4
to 5 mg per
kilogram bodyweight daily given by mouth in single or divided doses up
to a
maximum of 300 mg daily. Up to 10 mg per kilogram body-weight daily
may be
given particularly during the first 1 to 2 weeks of treatment of
tuberculous meningitis.
A dose of 15 mg per kilogram has been given two or three times weekly
in
intermittent treatment regimens.
ELDERLY:
No dosage reduction is necessary in the elderly, but caution should be
exercised due
to the possible decrease in renal and hepatic function.
PAEDIATRIC POPULATION:
The usual daily dose for children aged three months and above is from
10 up to 15mg
per kilogram body-weight daily in single or divided doses.
Isoniazid should not be used in children aged 0 to 3 months because of
the lack of
specific data.
Method of administration:
Isoniazid 100 mg tablets should be taken preferably on an empty
stomach, i.e. at least
30 minutes before a meal or 2 hours after a meal. Tablets must be
swallowed whole
and not chewed.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to