Isoniazid 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Isoniazid

Available from:

RPH Pharmaceuticals AB

ATC code:

J04AC01

INN (International Name):

Isoniazid

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010900; GTIN: 5015313012423

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
• 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. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours
• In this leaflet, Isoniazid 50 mg & 100 mg Tablets
BP are called Isoniazid.
IN THIS LEAFLET:
1. What Isoniazid is for
2. Before you take Isoniazid
3. How to take Iso
niazid
4. Possible side effects
5. How to store Isoniazid
6. Further information
PET004977_UK
.
1. WHAT ISONIAZID IS FOR
Isoniazid belongs to a group of medicines called
antibacterials. Isoniazid works by killing bacteria
that cause tuberculosis (also known as TB).
Isoniazid is used to treat tuberculosis inside the lungs
(pulmonary TB) and outside the lungs (extra-
pulmonary TB)
Tuberculosis is a serious infectious disease that can
be passed on to other people. If left untreated it can
spread through your body and may be fatal. It is
important that you receive effect
ive treatment for
this condition.
2. BEFORE YOU TAKE ISONIAZID
DO NOT TAKE ISONIAZID IF:
• You are allergic to Isoniazid or any of the other
ingredients of Isoniazid (see Section 6)
• You have ever had serious liver problems after
taking any medicine.
If any of the above applies to you, talk to your
doctor or pharmacist.
CHECK WITH YOUR DOCTOR BEFORE TAKING ISONIAZID IF:
• You have epilepsy or have ever had convulsions
(fits)
• You have diabetes
• You drink a lot of alcohol regularly
• You have, or have had, problems w
ith your liver
or kidneys.
• You suffer or have suffered from psychosis (mental
disturbances with hallucinations or delusions)
• You are malnourished (severely underfed)
• You have HIV infection
• You have extra-pulmonary TB (outside the lungs)
TELL YOUR DOCTOR IF YOU ARE TAKING ANY OF THE
FOLLOWING MEDICINES:
• Stavudine (used for the treatment of HIV)
• Any medicine for the treatment of epilepsy such as
carbamazepin

Summary of Product characteristics

OBJECT 1
ISONIAZID 50MG TABLETS BP
Summary of Product Characteristics Updated 08-Dec-2022 | RPH
Pharmaceuticals AB
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Isoniazid Tablets BP 50mg
2. Qualitative and quantitative composition
Isoniazid BP 50mg
Excipient with known effect
Lactose monohydrate - 30mg/tablet
For the full list of excipients, see section 6.1
3. Pharmaceutical form
White biconvex uncoated tablets embossed 50 151 on one face and EVANS
on the obverse.
4. Clinical particulars
4.1 Therapeutic indications
Isoniazid is indicated in the treatment of all forms of pulmonary and
extra-pulmonary tuberculosis.
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 5mg per