De-Noltab
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.
De-Nol_
Tab 120_
Great Britain LFT 170 x 190 mm
LFT_220_
VTB 4019_
Eq. to: N/A_
STUDIOKEIJZER el
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. c=g>
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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 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)
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138656-LFT De-Nol Tab 120 GB.indd 2
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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