What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet, the original can be viewed in PDF format using the link above.

The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: PL 00166/0124.

De-Noltab

PATIENT INFORMATION LEAFLET

De-Noltab® 120 mg tablets

Tri-potassium di-citrato bismuthate

Read all of this leaflet carefully before you start taking this medicine

  • 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. 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What De-Noltab is and what it is used for
2. Before you take De-Noltab
3. How to take De-Noltab
4. Possible side effects
5. How to store De-Noltab
6. Further information

1. What De-Noltab is and what it is used for

The active ingredient in De-Noltab belongs to the group of products that treat ulcers in the stomach or small intestine.

When De-Noltab tablets enter the stomach or intestine the tablet breaks up and coats the ulcer. It forms a protective barrier which protects the ulcer from the stomach acid, giving it time to heal. This protective layer stays in place during your meal but needs renewing before the next meal.

One of the factors causing peptic ulcers is a germ called Helicobacter pylori. For the ulcer to heal permanently the germ must be destroyed. De-Noltab helps clear up or reduce infections caused by this germ. Your doctor may give you De-Noltab in combination with other treatments to help destroy Helicobacter pylori.

2. Before you take De-Noltab

Do not take De-Noltab

  • if you have severe kidney problems.
  • if you are allergic (hypersensitive) to tri-potassium di-citrato bismuthate or any of the other ingredients of De-Noltab (see list in section 6 ‘Further information’).

Take special care with De-Noltab

Tell your doctor if you

  • have kidney problems.
  • have been taking De-Noltab at high doses for a long time. This is not recommended because long term use could cause damage to the brain.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The combination of De-Noltab with:

  • other drugs that contain bismuth may cause damage to the brain
  • a class of antibiotics called tetracyclines may affect the working of the antibiotic. Your doctor or pharmacist will be able to tell you if any of your medication belongs to this class of drugs.

Taking De-Noltab with food and drink

Do not eat or drink anything, or take other medicines particularly antacids, half an hour before or after taking De-Noltab tablets. Milk, fruit, or fruit juice in particular can prevent the medicine from working properly.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Do not use De-Noltab during pregnancy or if you are breast feeding, unless clearly necessary.

Driving and using machines

It is unlikely that De-Noltab will affect your ability to drive or use machines.

Important information about some of the ingredients of De-Noltab

This medicine contains approximately 2 mmol (approximately 40 mg) potassium per tablet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet (see section 6 for the list of ingredients).

3. How to take De-Noltab

Instructions for proper use

Take a tablet with about half a glass of water.

Do not eat, drink, or use other medicines half an hour before or after taking a dose of De-Noltab.

Dosage

Always take De-Noltab exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose for adults and the elderly is one tablet to be taken four times a day on an empty stomach, half an hour before each of the three main meals and two hours after the last meal of the day

or

Two tablets twice daily, half an hour before breakfast and half an hour before the evening meal.

Duration of treatment

The maximum duration of one course of treatment is two months. Your doctor will not prescribe continuous treatment with De-Noltab, but it is possible that he/she may prescribe you one more course after completion of the first course.

If you take more De-Noltab than you should

Drink plenty of water and phone your doctor or a hospital casualty department immediately.

If you forget to take De-Noltab

Do not take a double dose to make up for a forgotten one.

If you forget to take a dose, take the forgotten one before the next meal, provided this does not result in taking a double dose. If that should be the case, omit the forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, De-Noltab can cause side effects, although not everybody gets them.

Potentially life threatening allergic reaction may occur while you are taking De-Noltab. Signs of allergy include:

  • rash
  • wheezing
  • breathlessness
  • swollen eyelids, face or lips
  • and in extreme cases collapse

If you get any of these symptoms soon after taking De-Noltab, don’t take any more. Tell a doctor immediately and take the packaging and this leaflet with you. These are serious but very rare side effects (likely to affect less than 1 in 10,000 patients)

De-Noltab may cause the following:

Very common side effects (likely to affect more than 1 in 10 patients)

  • blackening of your stools (faeces). This is nothing to worry about and will disappear once you stop treatment

Uncommon side effects (likely to affect more than 1 in 1000 and less than 1 in 100 patients)

  • nausea, vomiting, constipation or diarrhoea
  • rash and itching

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store De-Noltab

Do not store above 25 °C.

Keep out of the reach and sight of children.

Do not take De-Noltab after the expiry date which is stated on the carton and aluminium foil strip after EXP. The expiry date refers to the last day of that month.

6. Further information

What De-Noltab contains

  • The active ingredient is tri-potassium di-citrato bismuthate, equivalent to 120 mg bismuth trioxide per tablet.
  • The other ingredients are povidone (E1201), polacrillin potassium, macrogol, magnesium stearate (E572) and maize starch. The coating contains hypromellose (E468) and macrogol.

What De-Noltab looks like and contents of the pack

De-Noltab tablets are creamy white, round, sugar coated tablets with marking of ‘gbr152’ on one side and company logo on the other side. They are available in packs of 112 tablets as a treatment course for one month.

Marketing Authorisation Holder

Astellas Pharma Ltd.
2000 Hillswood Drive
Chertsey
Surrey
KT16 0RS
UK

Manufacturer

Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden
The Netherlands

This leaflet was last approved in January 2013.

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