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DE-NOLTAB

Active substance(s): TRI-POTASSIUM DI-CITRATO BISMUTHATE

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138656

De-Noltab

®

120 mg tablets

Tri-potassium di-citrato bismuthate

138656

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.

138656-LFT De-Nol Tab 120 GB.indd 1

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.

De-Nol
Tab 120
Great Britain
LFT 170 x 190 mm
LFT_220
VTB 4019
Eq. to: N/A

30.11.2012
el

Black

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.

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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 DeNoltab, 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.

138656

138656-LFT De-Nol Tab 120 GB.indd 2

10-12-12 11:42

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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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