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NIZATIDINE 300 MG CAPSULES HARD

Active substance(s): NIZATIDINE

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Package leaflet:
Information for the patient

Nizatidine 150 mg
Capsules, Hard
Nizatidine 300 mg
Capsules, Hard
(nizatidine)

TBC
1211122

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.

TBC
1211122

What is in this leaflet
1. What Nizatidine is and what it is used for
2. What you need to know before you take
Nizatidine
3. How to take Nizatidine
4. Possible side effects
5. How to store Nizatidine
6. Contents of the pack andother information
1. What Nizatidine is and what it is used for
Nizatidine belongs to a group of medicines
called H2-receptor antagonists (anti-ulcer
medicines), which reduce the amount of acid in
your stomach.
This medicine is used to:
• heal and stop ulcers in the stomach, or the
part where it empties into the small intestine
(duodenum)
• heal and stop problems caused by acid in the
gullet (oesophagus) or too much acid in the
stomach. This can cause pain or discomfort
known as indigestion, acid reflux or heartburn
• prevent ulcers which may be caused by
NSAID (non-steroidal anti-inflammatory drug)
treatment i.e. ibuprofen, diclofenac - often used
to treat arthritis
• stop these ulcers from coming back.
2. What you need to know before you
take Nizatidine
Do not take Nizatidine:
• if you are allergic to nizatidine or any of the
other ingredients of this medicine (listed in
section 6)
• if you have taken a similar anti-ulcer medicine
before and you suffered an unusual or allergic
reaction. An allergic reaction may include rash,
itching, difficulty breathing or swelling of the
face, lips, throat or tongue.

Warnings and precautions
Talk to your doctor or pharmacist before
taking Nizatidine
• if you have liver or kidney problems.
Other medicines and Nizatidine
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines. This includes medicines obtained
without a prescription.
• a medicine called a salicylate (i.e. Aspirin),
normally used to relieve minor aches and pains.
Pregnancy and breast-feeding
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.
Driving and using machines
You should have no problems with driving or
using machines when taking this medicine.
Nizatidine contains Allura red E129 (150 mg only)
May cause allergic reactions.
3. How to take Nizatidine
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Adults (including older people)
For stomach or duodenal ulcers: The
recommended dose is 150 mg in the morning and
150 mg in the evening or 300 mg taken as a single
dose in the evening for 4 weeks. If your ulcer has
not fully healed after 4 weeks, your doctor will treat
you for a further 4 weeks. If you are also taking a
non-steroidal anti-inflammatory drug (NSAID), the
recommended dose is the same as above.
To treat indigestion, acid reflux, heartburn: The
recommended dose is 150 mg to 300 mg taken
twice a day for up to 12 weeks.
To prevent ulcers coming back: The recommended
dose is 150 mg taken in the evening.
Patients with kidney problems:
Your doctor may change the dose. If you have
kidney problems, your doctor may prescribe a
lower or less frequent dose.
Duration of treatment
It is important that you keep taking the medicine
until you finish the full course of treatment.
Use in children children and adolescents
Nizatidine should not be given to children
or adolescents.
If you take more Nizatidine than you should
Contact your doctor or nearest hospital
emergency department immediately. Signs of
an overdose may include watery eyes, increased
saliva, being sick, narrowing of the pupils of the
eyes and diarrhoea. Take the carton or container
and any remaining capsules with you.
LT1573AD

Date: 28 Aug 2014
Description Nizatidine 150/300mg 30
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 414539

SAP No. N/A

Superceded Affiliate Item Code 390190
TrackWise PR No. 414539
04569/ 0471/
MA No. 0472

Packing Site/Printer N/A
Supplier Code LT1573AD
Sign-offs

Vendor Job No. 228653
Proof No. 3
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 16:13
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 240mm

Body Text Size 9 pt

TBC
1211122

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.gov.uk/yellowcard
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Nizatidine
Keep this medicine out of the sight and reach of
children. Do not store above 25°C. Do not use this
medicine after the expiry date which is stated on
the carton or container after 'EXP'. 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 pack and other information
What Nizatidine contains
The active substance is nizatidine.
Each capsule contains either 150 mg or 300 mg
of nizatidine.
The other ingredients are croscarmellose sodium,
pregelatinised starch, talc and magnesium stearate.
The capsule is made of gelatin, titanium dioxide
(E171), red (300 mg only) and yellow iron oxide
(E172) and black printing ink (shellac, macrogol,
potassium hydroxide and black iron oxide (E172)).
The 150 mg capsule also contains the colourants
Allura red (E129) (see section 2 “Nizatidine contains
Allura red (E129)”) and Quinoline yellow (E104).
What Nizatidine looks like and contents of
the pack
Your medicine comes as a hard capsule containing
white to off-white powder. The 150 mg capsule has a
light yellow body and dark yellow cap, the body has
'NZ 150' and the cap has 'G', both printed in black.
The 300 mg capsule has a light brown body and
cap, the body has 'NZ 300' and the cap has 'G', both
printed in black.
Nizatidine is available in blisters and plastic
containers of 28 or 30 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Herts, EN6 1TL, United
Kingdom.
Manufacturer
Generics [UK] Limited, Potters Bar, Herts, EN6 1TL,
United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.

TBC
1211122

If you forget to take Nizatidine
Take the next dose as soon as you remember
unless it is almost time for your next dose.
Do not take a double dose to make up for a
forgotten dose.
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.
If you notice any of these while taking this
medicine, stop taking this medicine and see
your doctor straight away or go to your nearest
hospital emergency department immediately:
Rare (may affect up to 1 in 1,000 people)
• any kind of skin rash or 'hives' (small itchy spots),
boils or sore lips, swelling of the face, lips, tongue,
throat or other parts of the body, fever, sudden
wheezing and coughing, uttering or tightness of
the chest, chest pain, feeling faint and difficulty
breathing due to an allergic reaction
• yellowing of the whites of the eyes or skin, dark
urine, pale coloured bowel movements, itching
due to problems with your liver
• bruising more easily, bleeding, particularly of
the mouth and nose, or bruising under the skin.
In severe cases, blood in the urine or faeces and
headaches due to low platelets in your blood
• frequent infections such as fever, severe chills,
sore throat or mouth ulcers due to lack of white
blood cells.
These side effects are rare but serious. You may
need medical attention.
Other possible side effects
Common (may affect up to 1 in 10 people)
• sweating
• sleepiness.
Rare (may affect up to 1 in 1,000 people)
• unusual tiredness, shortness of breath when
exercising, dizziness and looking pale due to a
decrease in red blood cells (anaemia)
• flaking or peeling of the skin
• narrowing or blockage of the blood vessels,
causing a general feeling of being unwell, with
fever, tiredness and weight loss
• joint pain, aching muscles, muscle tenderness or
weakness not caused by exercise
• if you are a man, breast enlargement or an
inability to get or maintain an erection
• high uric acid levels in the blood (shown on
blood tests), which may cause severe pain and
swelling in the joints, kidney stones (gout)
• increased liver enzymes (which may be seen in
blood tests)
• fever
• nausea (feeling sick)
• confusion
• increase in some white blood cells which may be
seen in a blood test

This leaflet was last revised
414539
in: 05/2014 LT1573AD

Date: 28 Aug 2014
Description Nizatidine 150/300mg 30
Component Type Leaflet

Pharma Code TBC

Affiliate Item Code 414539

SAP No. N/A

Superceded Affiliate Item Code 390190
TrackWise PR No. 414539
04569/ 0471/
MA No. 0472

Packing Site/Printer N/A
Supplier Code LT1573AD
Sign-offs

Vendor Job No. 228653
Proof No. 3
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

No. of colours
Colours

1

Time: 16:13
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro
Dimensions 170 x 240mm

Body Text Size 9 pt

Expand view ⇕

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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