Nizatidine 300mg Capsules
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. What Nizatidine Capsules are and what they are used for
2. Before you take Nizatidine Capsules
3. How to take
4. Possible side effects
5. How to store
6. 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.
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 Component code