Teva Nizatidine 150 Mg Capsules
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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. What Nizatidine is and what it is used for
2. Before you take Nizatidine
3. How to take Nizatidine
4. Possible side effects
5. How to store Nizatidine
6. Further information
Q 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).
Q 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.
fake special care with Nizatidine:
fell 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.
faking 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.
0 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.
0 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 (inflammatior 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.
0 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 howto dispose of medicines no longer required. These measures will help to protect the environment.
0 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
