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ISONIAZID 100MG TABLETS

Active substance(s): ISONIAZID / ISONIAZID / ISONIAZID

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Package leaflet: Information for the user

These are to:
!
Gynaecomastia (increased size of breasts in men).
Check that your liver is working properly.
!
!
Low levels of vitamin B6 and nutrition problems. This can
Make sure your medicine is working properly.
!
make you feel irritable, have difficulty sleeping, weak
Isoniazid 100mg Tablets
Check
the
dose
you
are
taking
is
right
for
you.
!
muscles, and cracks at the corner of the mouth or lose
Isoniazid
weight.
!
Eye problems such as visual disturbances and eye pain.
Read all of this leaflet carefully before you start taking
!
you are taking cycloserine (used to treat tuberculosis and
If you take more Isoniazid tablets than you should
!
If you have severe problems with your kidneys, you may
this medicine because it contains important information
urinary tract infections),
If you (or someone else) take too many tablets, or you think a
get loss of hearing and ringing in your ears.
for you.
you are taking ketoconazole or itraconazole (used to treat
!
child may have swallowed any tablets, contact your nearest
!
Tingling or numbness in the hands or feet (pins and
Keep this leaflet. You may need to read it again.
!
fungal infections).
hospital casualty department or tell your doctor immediately.
needles).
!
If you have any further questions, ask your doctor or
Take this leaflet, and any tablets that you still have to show
!
Constipation.
pharmacist.
Isoniazid tablets with food and drink
the
doctor.
!
Difficulty in starting to pass urine.
!
This medicine has been prescribed for you only. Do not
Isoniazid tablets should be taken preferably on an empty
!
Upset stomach and diarrhoea.
pass it on to others. It may harm them, even if their signs
stomach, i.e. at least 30 minutes before a meal or 2 hours
You
may
experience
some
of
these
side
effects;
slurred
!
Fever.
of illness are the same as yours.
after a meal. Tablets must be swallowed whole and not
speech, high blood sugar, slow breathing, hallucinations,
!
Feeling and being sick.
!
If you get any side effects, talk to your doctor or
chewed.
dizziness,
fits,
or
coma.
!
Loss of appetite and chills.
pharmacist. This includes any possible side effects not
Isoniazid may interact with foods containing histamine (e.g.
!
Dry mouth.
listed in this leaflet. See section 4.
tuna fish) or tyramine (e.g. cheese, red wine). These foods
If
you
forget
to
take
Isoniazid
tablets
!
Overactive reflexes.
should be avoided if you are taking Isoniazid tablets.
If you miss a dose, just carry on with the next one as normal.
!
Dizziness or feeling if the room is spinning round
What is in this leaflet
Do
not
take
a
double
dose
to
make
up
for
a
forgotten
(vertigo).
1. What Isoniazid tablets are and what they are used for
Pregnancy, breast-feeding and fertility
dose.
!
Red or itchy skin rash or peeling of the skin.
2. What you need to know before you take Isoniazid tablets
If you are pregnant or breast-feeding, think you may be
3. How to take Isoniazid tablets
pregnant or are planning to have a baby, ask your doctor or
If you have forgotten several doses tell your doctor when you
Side effects with this medicine are more common in people
4. Possible side effects
pharmacist for advice before taking this medicine.
have
your
next
check-up
or
blood
test.
Occasionally
people
aged over 35 and in people who break down isoniazid more
5. How to store Isoniazid tablets
get headache, sleeplessness, excessive dreaming, irritability
slowly. The risk of having side effects increases with high
6. Contents of the pack and other information
You may be given additional vitamin supplementation if you
or
nervousness
if
several
doses
are
missed,
or
when
the
doses of Isoniazid tablets.
are taking this medicine whilst pregnant.
treatment is stopped.
1. What Isoniazid tablets are and what they are used for
Reporting of side effects
You and your baby may be given additional vitamin
If you stop taking Isoniazid tablets
If you get any side effects, talk to your doctor or pharmacist.
Isoniazid is an antibiotic (antibacterial medicine) for treating
supplementation if you take this medicine whilst you are
Do
not
stop
taking
Isoniazid
tablets
without
first
talking
to
This includes any possible side effects not listed in this
infections. It belongs to a group of antibiotics called
breast-feeding. Your baby should be checked by your doctor
your doctor. It is important you take the full course of this
leaflet. You can also report side effects directly via the Yellow
antituberculosis drugs and is used to treat and prevent
at regular intervals.
medicine, as directed by your doctor, in order to clear the
Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
tuberculosis (TB), an infectious disease mainly affecting the
infection that causes tuberculosis.
side effects you can help provide more information on the
lungs.
Driving and using machines
If you stop taking this medicine suddenly you may get
safety of this medicine.
No studies on the effects on the ability to drive and use
withdrawal symptoms including a headache, difficulty in
2. What you need to know before you take Isoniazid
machines have been performed. However, you may
sleeping, having more dreams, feeling irritable and feeling
5. How to store Isoniazid tablets
tablets
experience side-effects such as dizziness and confusion
nervous.
during treatment with isoniazid. Therefore, do not drive a car
Keep this medicine out of the sight and reach of children.
Do not take Isoniazid tablets:
or operate machinery until you know how isoniazid affects
If you have any further questions on the use of this medicine,
!
if you are allergic to isoniazid or any of the other
you.
ask your doctor or pharmacist.
This medicinal product does not require any special storage
ingredients of this medicine (listed in section 6),
conditions.
!
if you have ever suffered from liver damage caused by a
3. How to take Isoniazid tablets
4. Possible side effects
medicine.
Do not use this medicine after the expiry date which is stated
Always take Isoniazid tablets exactly as your doctor has told
Like all medicines, this medicine can cause side effects,
on the carton after EXP. The expiry date refers to the last day
you.
although not everybody gets them.
of that month.
Warnings and precautions
Talk to your doctor or pharmacist before taking Isoniazid
Important:
If you experience any of the following side effects
Do not throw away any medicines via wastewater or
tablets:
Your doctor will choose the dose that is right for you.
contact your doctor as soon as possible:
household waste. Ask your pharmacist how to throw away
!
if you have or have had problems with your liver or
Your dose will be shown clearly on the label that your
Inflammation
of
the
pancreas,
which
causes
severe
pain
!
medicines you no longer use. These measures will help
kidneys,
pharmacist puts on your medicine. If it does not, or you
in the abdomen and back (pancreatitis, frequency not
protect the environment.
!
if you drink a lot of alcohol. It is also best to avoid drinking
are not sure, ask your doctor or pharmacist.
known).
alcohol whilst you are taking this medicine,
Remember: Isoniazid tablets should not be taken with food.
Severe extensive skin damage (separation of the
!
6. Contents of the pack and other information
!
if you are diabetic,
You should swallow Isoniazid tablets whole with a glass of
epidermis
and
superficial
mucous
membranes)
(toxic
!
if you have extra-pulmonary TB (outside the lungs),
water.
epidermal necrolysis (TEN), may affect up to 1 in 1,000
What Isoniazid tablets contain
!
if you have the HIV infection,
people).
!
The active substance is isoniazid. Each tablet contains
!
if you have suffered mental disturbances (psychosis),
Adults
A drug reaction that causes rash, fever, inflammation of
!
100mg of isoniazid.
!
if you have malnutrition,
The usual dose of Isoniazid tablets is 4 to 5 mg per kilogram
internal
organs,
hematologic
abnormalities
and
systemic
!
The other ingredients are: calcium hydrogen phosphate,
!
if you have epilepsy or have ever had convulsions (fits),
(kg) of your bodyweight per day, up to a maximum of 300 mg
illness (DRESS syndrome, may affect up to 1 in 1,000
maize starch (dried), purified talc, colloidal anhydrous
!
if you are presently taking itraconazole (to treat fungal
daily. This may be taken as a single dose or as divided doses
people).
silica and magnesium stearate.
infections). It is not recommended to combine isoniazid
throughout the day. Your doctor will tell you exactly how
Yellowing of the skin or whites of the eyes, or urine
!
and itraconazole.
much medicine to take and when to take it. Higher doses (up
getting darker and stools paler, fatigue, weakness,
What Isoniazid tablets look like and contents of the pack
to 10 mg per kg per day) may be used to treat tuberculous
malaise, loss of appetite, nausea or vomiting caused by
Isoniazid tablets are white, circular, biconvex uncoated
Other medicines and Isoniazid tablets
meningitis (tuberculosis causing inflammation of the brain's
liver
problems
(hepatitis,
may
affect
up
to
1
in
100
tablets having plain surface on both the sides.
Tell your doctor or pharmacist if you are taking, have recently
membranes).
people).
taken or might take any other medicines, including medicines
Isoniazid tablets are available in blister packs of 7, 10, 14,
obtained without a prescription or herbal medicines. Isoniazid
Elderly
Other side effects:
20, 28, 30, 56, 60, 84, 90, 100 or 112.
may interact with other medicines.
If you are elderly, your doctor may tell you to take a slightly
Convulsions
(fits).
!
Not all pack sizes may be marketed.
lower dose because your liver and kidneys are not working
Severe stomach pain.
!
Please inform your doctor or pharmacist if:
as well as they should.
Connective tissue disorders such as Lupus syndrome
!
Marketing Authorisation Holder
!
you are taking another medicine to treat tuberculosis (TB)
which can affect the skin and kidneys (symptoms may
Morningside Healthcare Ltd
(e.g. para-aminosalicylic acid, rifampicin, cycloserine),
Use in children
include a butterfly-shaped rash over the cheeks and
115 Narborough Road, Leicester, LE3 0PA, UK
!
you are taking disulfiram for alcohol dependence,
The usual dose of children above the age of three months is
nose, tiredness, a high temperature, feeling or being sick,
!
you are taking any medication for epilepsy (e.g.
10 to 15 mg per kg of body weight per day. This may be
joint pain and weight loss).
Manufacturer
carbamazepine, primidone, phenytoin),
taken by your child as a single dose or as divided doses
Mental disturbances including psychotic reactions such
!
Morningside Pharmaceuticals Ltd
!
you are taking medication for HIV infection (e.g.
throughout the day. Your doctor will tell you exactly how
as hallucinations and delusions.
5 Pavilion Way, Loughborough, LE11 5GW, UK
stavudine, zalcitabine),
much medicine your child should take and when to take it.
Blood disorders which may make you more likely to get
!
!
you are taking a vitamin B6 or B3 supplement,
infections.
This leaflet was last revised in October 2016.
!
you are taking medication for asthma or chronic
Children under three months should not take Isoniazid
High blood sugar levels, although you may not notice any
!
obstructive pulmonary disease (e.g. theophylline),
tablets.
symptoms.
you are taking medication for anxiety (e.g.
!
Inflammation of blood vessels (vasculitis) - frequency not
!
benzodiazepines: diazepam, triazolam, chlorzoxazone),
Medical check-ups
known.
you are taking medication for high blood pressure (e.g.
!
While you are taking this medicine, your doctor may ask you
!
Acidosis (upset of the acid balance in the body) which
propranolol),
to have check-ups and blood tests.
may make you feel or be sick, be drowsy or have breath
you are taking drugs containing levodopa (used in the
!
that smells of “pear drops”.
treatment of Parkinson's disease),

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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