Nizatidine 300 mg capsules – patient leaflet, side effects, dosage

1. WHAT NIZATIDINE IS AND WHAT IT IS USED FOR

The name of your medicine is Nizatidine 150 mg or 300 mg Capsules (throughout this leaflet, product name is referred as Nizatidine).

• Each capsule contains either 150 or 300 mg of nizatidine. Nizatidine belongs to a group of medicines called H₂ antagonists, which reduce the amount of acid in the stomach.

• Your medicine is used to treat ulcers of the stomach and small intestine

  (duodenum), including those caused by non-steroidal anti- inflammatory drugs (NSAIDS) e.g. ibuprofen, diclofenac.

• It is also used to prevent these ulcers from recurring and in the treatment of reflux disease (heartburn).

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 this medicine (listed on section 6) or have a known sensitivity to H₂-receptor antagonists e.g. cimetidine.

Warnings and precautions

Talk to your doctor or pharmacist before taking nizatidine if you have:

• kidney problems
• Liver problems.

Other medicines and Nizatidine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

• Very high doses of salicylates e.g. aspirin, as nizatidine may increase their absorption leading to higher than expected blood levels.

Pregnancy and Breast-feeding:

• Nizatidine is not recommended if you are pregnant, breast- feeding, or planning on becoming pregnant.
• 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

Nizatidine has no influence on the ability to drive and use machines.

3. HOW TO TAKE NIZATIDINE

Your doctor has decided the dose which is suited to you. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The capsules should be swallowed with a drink of water.

The recommended doses are:

ADULTS:

For the treatment of ulcers of the stomach or small intestine:

One 300 mg capsule of nizatidine taken as a single dose every evening or one 150 mg capsule taken in the morning and evening.

Treatment will last for four to eight weeks depending on how fast healing occurs.

For the treatment of ulcers caused by NSAIDs use:

One 300 mg capsule of nizatidine taken as a single dose every evening or one 150 mg capsule taken in the morning and evening.

Treatment will last for up to eight weeks. NSAIDS can still be used during ulcer treatment.

For the prevention of ulcer recurrence:

One 150 mg capsule every evening.

For the treatment of reflux disease:

Either one 150 mg capsule twice a day or one 300 mg capsule of nizatidine twice a day. Treatment may last for up to 12 weeks.

CHILDREN:

Not recommended.

PATIENTS WITH KIDNEY PROBLEMS:

If you have moderate or severe kidney problems your doctor may advise 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. Overdose may cause excess production of tears, increased saliva production, vomiting, constriction of the pupils of the eyes and diarrhoea.

50 mm

Nizatidine 150mg & 300mg Capsules Package leaflet: Information for the patient

123XXXX-V1

Space for PC

123XXXX-V1 POM Marketing Authorisation Holder and Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK

E-mail : info@medreich.co.uk

This leaflet was last revised in May 2026

To request a copy of this leaflet in Braille, large print please call, 02088311580 (UK only)

Please be ready to give the following information:

Product name Reference number

Nizatidine 150 mg Capsules PL 21880/0100

Nizatidine 300 mg Capsules PL 21880/0101

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 medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following have been reported:

Rare (may affect up to 1 in 1,000 people)

Liver problems including:

• Jaundice (yellowing of the skin and whites of the eyes)
• Hepatitis (Inflammation of the liver).

Rarely allergic reactions have occurred. Tell your doctor immediately if you experience any of the following symptoms:

• Difficulty in breathing
• Swelling of the face, tongue or throat
• Rash, itching
• Blood problems (a bruise-like rash, unusual bleeding or unexplained bruising).

Other possible side effects:

The most common (may affect up to 1 in 10 people) side effects are:

• Increased sweating
• Skin rash (nettle rash or hives).

The following rare (may affect up to 1 in 1,000 people) side effects have also been reported but may not be directly due to nizatidine:

• Blood disorders, gout and blood vessel inflammation
• Joint pain, muscle pain
• Dermatitis (causing itchy, flaking skin)
• Breast enlargement in men
• Impotence
• Fever
• Feeling sick
• Confusion.

Not known (cannot be estimated from the available data):

• Headache
• Diarrhoea.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA yellow card in the google play or apple app store. 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. Store in the package supplied. Do not transfer the capsules to another container.

Do not use this medicine after the expiry date which is stated on the carton. 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 of Nizatidine 150 mg capsule contains 150mg of Nizatidine.
• Each capsule of Nizatidine 300 mg capsule contains 300mg of Nizatidine. The other ingredients are:

• Capsule contents: Pregelatinised starch, Dimeticone, Povidone,

  Magnesium stearate.

• Capsule shell: 150mg: Gelatin, Titanium dioxide (E171), Yellow iron oxide (E172).

  300mg: Gelatin, Red iron oxide (E172), Titanium dioxide (E17), Yellow iron oxide (E172), Black iron oxide (E172).

• Printing ink: Denatured alcohol, Shellac, n-butyl alcohol, Black iron oxide (E172).

What Nizatidine looks like and contents of the pack

• 150 mg: No. 2 white / yellow hard gelatine capsule imprinted axial

  “NTD” on the cap and “150” on the body with black ink.

• 300 mg: No. 1 white / brown hard gelatine capsule imprinted axial

  “NTD” on the cap and “300” on the body with black ink.

Nizatidine tablet is available in Blister packs

• 150 mg: containing 20, 28, 30, 50, 100 capsules
• 300 mg: containing 10, 15, 20, 28, 30, 50, 100 capsules.

Not all pack sizes may be marketed.

Unit 7

MED/NIZ/PIL/03

15/18/19.05.26(MA)

Internal Approval issued on CD issued on