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NIZATIDINE 150MG CAPSULES

Active substance(s): NIZATIDINE

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Final version 18/11/07 Size 120X 250mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

Nizatidine 150mg & 300mg Capsules

Read all this leaflet carefully before you start taking this medicine:
- Keep this leaflet. You may need to read it again.
- If you have any 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:
1.
2.
3.
4.
5.
6.

What Nizatidine Capsules are and what they are used for
Before you take Nizatidine Capsules
How to take
Possible side effects
How to store
Further information

1. What Nizatidine Capsules are and what they are used for
Nizatidine belongs to a group of medicines called histamine H2-receptor
antagonists, which reduce acidity in your stomach. Nizatidine capsules are used
to

treat non cancerous stomach and duodenal ulcers (ulcers at the top
of the small intestine)

protect healed ulcers in the intestines

treat a type of heartburn called ‘reflux oesophagitis’ (irritation of the
oesophagus, the tube that takes food and liquids into your stomach).

2. Before you take Nizatidine Capsules
Do not take Nizatidine Capsules if you:




are allergic to Nizatidine, to any of the other ingredients (listed under
Section 6) or to other medicines of this type. (An allergic reaction may
include rash, itching, swelling or breathing difficulties)
have kidney or liver problems
are pregnant, planning to become pregnant or breast-feeding.

Taking other medicines

Tell your doctor if you are taking and have recently taken any other medicines,
including medicines obtained without a prescription. Especially aspirin in
high doses and other medicines containing salicylate, as Nizatidine may
increase the absorption of these medicines in your blood.
You can take antacids whilst taking Nizatidine.

Warning about colourant

The 150mg capsules contain colour sunset yellow (E110), which can cause
allergic-type reactions including rashes, cough and wheeziness.

3. How to take
Always take Nizatidine Capsules exactly as your doctor has told you. If you are
not sure, check with your doctor or pharmacist. Swallow the capsules with
water. You can take the capsules with or without food.
Usual doses

Duodenal or benign stomach ulcer: One 300mg capsule in the evening
or one 150mg capsule in both morning and evening. You will usually be
given enough capsules for 4 weeks, but you may need to take them for a
further 4 weeks.

Protecting a healed duodenal or stomach ulcer: One 150mg capsule
in the evening.

Reflux oesophagitis: One 150mg capsule twice a day for up to 3
months. Your doctor may increase this dose to 300mg twice daily.

If you have a stomach/duodenal ulcer and are also taking medicines
known as non-steroidal anti-inflammatory drugs (NSAIDs): 300mg
daily for up to 8 weeks.
Continued over page

Final version

Length of treatment

Keep taking the capsules for as long as your doctor has told you to, even if you
start to feel better.

If you forget to take the capsules

If you miss a dose, just take the next dose when it is due and then carry on as
before. Do not take a double dose to make up for a forgotten dose.

If you take more than you should

If you ever take too many capsules, tell your doctor or go to the nearest
hospital casualty department at once.

4. Possible side effects
Like all medicines Nizatidine capsules can cause side effects, although not
everybody gets them. Tell your doctor or pharmacist at once, if you have
any of the following side effects:

itching, skin rash, feeling sweaty, weak, tired or sleepy. Very occasionally
patients have developed liver problems or jaundice (yellowing of the skin
or whites of the eyes).

a few patients have had nausea, fever, bruising, aching muscles or joints,
impotence or swollen breast tissue in men (this is reversible on stopping
treatment). Some patients have felt confused or have had altered blood
test results. It is not known whether Nizatidine can cause these
symptoms.

very rarely serious allergic reactions, such as swollen face lips, tongue and
throat causing difficulty swallowing or breathing.
If you have any of the above or any other unpleasant side effects, tell your
doctor, nurse or pharmacist at once and ask if you should continue with
your medication.

5. How to store
Store below 30°C. Keep all medicines out of the sight and reach of children.
Do not use the capsules after the expiry date stated on the label.
Return any unused capsules to a pharmacist for safe disposal. Only keep them
if your doctor tells you to.

6. Further information
What Nizatidine Capsules contain
Nizatidine capsules are available in two strengths; 150mg and 300mg. The
active ingredient which makes the medicine work is Nizatidine. Each capsule
contains 150mg or 300mg of Nizatidine. The other ingredients are:
croscarmellose sodium, povidone, maize starch, dimeticone, talc, quinoline
yellow (E104), titanium dioxide (E171), yellow iron oxide (E172), gelatin,
shellac, black iron oxide (E172), soya lecithin (E322) and antifoam. The 150mg
capsules also contain sunset yellow (E110). The 300mg capsules also contain
erythrosine (E127).
What Nizatidine capsules look like and the contents of the pack:
Nizatidine 150mg capsules are yellow capsules marked B14.
Nizatidine 300mg capsules are orange/yellow capsules marked B15.
They are packed in blisters and supplied in packs of 28 and 30 capsules.
Marketing authorisation holder
and manufacturer
Dr Reddy’s Laboratories(UK) Ltd
6 Riverview Road, Beverley East
Yorkshire.HU17 0LD

This leaflet was last approved on
16/05/2008
Date of preparation: 25.09.2003
Nizatidine 150mg Capsules, PL08553/0187
Nizatidine 300mg Capsules. PL08553/0188
© Dr Reddy’s Laboratories (UK) Limited
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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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