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TEVA NIZATIDINE 150 MG CAPSULES

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NIZATIDINE 150 mg
& 300 mg CAPSULES
PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you
start using this medicine.
• Keep this leaflet. You may need to read it
again.
• If you have further questions, please 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.
• If any of the side effects get serious, or if
you notice any side effects not listed in
this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:

1.
2.
3.
4.
5.
6.

What Nizatidine is and what it is used for
Before you take Nizatidine
How to take Nizatidine
Possible side effects
How to store Nizatidine
Further information

WHAT NIZATIDINE IS AND WHAT
IT IS USED FOR
Nizatidine belongs to a group of medicines
called histamine H2 antagonists, which
reduce the amount of acid in the stomach.
Nizatidine is used:
• to treat ulcers of the stomach and small
intestine, including those caused by
non-steroidal anti-inflammatory drugs
(NSAID’s) e.g. ibuprofen, diclofenac
• to prevent ulcers from recurring
• in the treatment of mild to moderate
reflux disease (reflux disease is a
condition in which the food pipe becomes
irritated or inflamed because of acid
backing up from the stomach).

BEFORE YOU TAKE NIZATIDINE
Do NOT take Nizatidine if you:
• are allergic (hypersensitive) to nizatidine,
other H2-receptor antagonists e.g.
cimetidine or any of the other ingredients
of this medicine.
Take special care with Nizatidine:
Tell your doctor before you start to take this
medicine if you:
• have liver or kidney problems.
If you need to have a urine test inform the
doctor that you are taking Nizatidine as it can
affect the results of the test.
Taking other medicines
Talk to your doctor if you are taking any of
the following:
• very high doses of salicylates e.g.
aspirin, as nizatidine may increase

their absorption leading to higher than
expected blood levels
• ketoconazole or itraconazole (used to
treat fungal infections), as nizatidine may
reduce their effectiveness.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and Breast-feeding:
If you are pregnant, planning to become
pregnant or breast-feeding, ask your doctor
for advice before taking this medicine.
Driving and using machines:
Nizatidine may cause sleepiness and
dizziness, if affected do not drive or operate
machinery.

HOW TO TAKE NIZATIDINE
Always take Nizatidine exactly as your doctor
has told you. You should check with your
doctor or pharmacist if you are not sure.
The capsules should be swallowed
preferably with a drink of water.
The usual dose is:
Adults (including the elderly):
• For the treatment of ulcers of the
stomach or small intestine:
One 300 mg capsule taken as a single
dose every evening or one 150 mg
capsule taken in the morning and another
in the evening.
Treatment will last for 4 to 8 weeks
depending on how fast your ulcer heals.
• For the treatment of ulcers caused by
NSAID use:
One 300 mg capsule taken as a single
dose every evening or one 150 mg
capsule taken in the morning and evening.
Treatment will last for up to 8 weeks.
NSAIDS can still be used during ulcer
treatment.
• For the prevention of ulcer recurrence:
One 150 mg capsule every evening.
Treatment may last for up to one year.
• For the treatment of mild to moderate
reflux disease:
Either one 150 mg capsule twice a day or
one 300 mg capsule of nizatidine twice a
day. Treatment will last for 6 to 12 weeks.
Children and adolescents (under 16 years of
age):
Nizatidine is not recommended for use in
children and adolescents under 16 years of
age.
Patients with kidney problems:
If you have moderate or severe kidney
problems your doctor may give you a lower
dose.
If you take more nizatidine than you should
If you (or someone else) swallow a lot of the
capsules all together, or if you think a child
has swallowed any of the capsules, contact
your nearest hospital casualty department or
your doctor immediately. An overdose is
likely to cause excess production of tears,

increased saliva production, vomiting,
constriction of the pupils of the eyes and
diarrhoea. Please take this leaflet, any
remaining capsules and the container with
you to the hospital or doctor so that they
know which capsules were consumed.
If you forget to take nizatidine
If you forget to take a capsule take one as
soon as you remember, unless it is nearly
time to take the next one. Do not take a
double dose to make up for a forgotten dose.
Take the remaining doses at the correct time.
If you have any further questions on the use
of this product, ask your doctor or
pharmacist.

POSSIBLE SIDE EFFECTS
Like all medicines, nizatidine can cause side
effects, although not everybody gets them.
If the following happens, stop taking the
capsules and tell your doctor immediately or
go to the casualty department at your
nearest hospital:
• an allergic reaction (swelling of the lips,
face or neck leading to severe difficulty in
breathing; skin rash or hives).
This is a very serious but rare side effect.
You may need urgent medical attention or
hospitalisation.
If the following happens, tell your doctor
immediately:
• blistering or peeling of the skin
particularly associated with fever and
general illness
• jaundice (yellowing of the skin and whites
of the eyes).
The following side effects have been
reported at the approximate frequencies
shown
Rare (affecting fewer than one person in
1,000 but more than one person in 10,000):
• anaemia (low blood count causing
unusual tiredness or weakness), gout and
blood vessel inflammation
• marked rises in liver enzymes
• sweating
• skin reaction causing skin peeling
• joint and muscle pain
• ‘serum sickness’ characterised by fever,
rash, swelling, swollen glands
• mildly raised liver enzymes.
Very rare (affecting fewer than one person in
10,000):
• unusual bleeding or unexplained bruising
• confusion
• reduced sexual desire, impotence
(inability to achieve or maintain an
erection)
• feeling sick
• fever
• breast enlargement in males
• yellowing of the skin and eyes (cholestatic
jaundice caused by bile blocking small
passages in the liver).

The following side effects have also been
reported:
• increased testosterone levels
• liver problems and hepatitis (inflammation
of the liver)
• kidney problems
• abnormal dreams, sleepiness
• tiredness, headache, dizziness
• itching, hives
• abnormal creatinine levels in the blood
• chest pain, cough, common cold, sore
throat.
If any of the side effects get serious, or if you
notice any side effects not mentioned in this
leaflet, please tell your doctor or pharmacist.

HOW TO STORE NIZATIDINE
Keep out of the reach and sight of children.
Store in the package supplied. Do not
transfer the capsules to another container.
Do not use Nizatidine after the expiry date
that is stated on the outer packaging. The
expiry date refers to the last day of that
month.
Medicines should not be disposed of via
wastewater or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help to
protect the environment.

FURTHER INFORMATION
What Nizatidine capsules contain:
• The active ingredient is nizatidine.
• The other ingredients are pregelatinised
starch, dimeticone, povidone, magnesium
stearate. The capsule shell contains
gelatin, titanium dioxide (E171), red and
yellow iron oxide (E172). The printing ink
contains shellac, soya lecithin, antifoam
DC 1510 and black iron oxide (E172).
What Nizatidine capsules look like and
contents of the pack:
• The 150 mg capsules are white / orange
hard gelatin capsules. They are printed
‘NTD’ on the cap and ‘150’ on the body in
black ink.
• The 300 mg capsules are white / caramel
hard gelatin capsules. They are printed
‘NTD’ on the cap and ‘300’ on the body in
black ink.
• The 150 mg capsules are available in pack
sizes of 20, 28, 30, 50 or 100 capsules.
The 300 mg capsules are available in pack
sizes of 7, 10, 15, 20, 28, 30, 50 or 100
capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised: January 2012
PL 00289/0396-7
H18496

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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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