De-Noltab 120mg tablets

Country: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Tripotassium dicitratobismuthate

Disponibbli minn:

Astellas Pharma Ltd

Kodiċi ATC:

A02BX05

INN (Isem Internazzjonali):

Tripotassium dicitratobismuthate

Dożaġġ:

120mg

Għamla farmaċewtika:

Oral tablet

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 01030300; GTIN: 5013346019150

Fuljett ta 'informazzjoni

DE-NOLTAB
®
120 MG TABLETS
Tri-potassium di-citrato bismuthate
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 anyth

Karatteristiċi tal-prodott

OBJECT 1
DE-NOLTAB
Summary of Product Characteristics Updated 18-Sep-2012 | Astellas
Pharma Ltd
1. Name of the medicinal product
DE-NOLTAB
2. Qualitative and quantitative composition
Tri-potassium di-citrato bismuthate equivalent to 120mg Bi
2
O
3
3. Pharmaceutical form
Film-coated tablet
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of gastric and duodenal ulcers.
4.2 Posology and method of administration
_For Adults, and the Elderly:_
One tablet to be taken four times a day, half an hour before each of
the three main meals and two hours
after the last meal of the day, or
Two tablets to be taken twice daily, half an hour before breakfast and
half an hour before the evening
meal, or
As directed by the physician
The maximum duration for one course of treatment is two months;
De-Noltab should not be used for
maintenance therapy.
_For children:_
Not recommended.
4.3 Contraindications
In cases of severe renal insufficiency.
Harmful to people on a low potassium diet.
Hypersensitivity to the active substance(s) or to any of the
excipients.
4.4 Special warnings and precautions for use
Prolonged use of high doses of bismuth compounds is not recommended
because this has occasionally led
to reversible encephalopathy. It is, not advisable to take other
bismuth-containing drugs concomitantly.
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.
4.5 Interaction with other medicinal products and other forms of
interaction
No other medicines, food or drink, in particular antacids, milk, fruit
or fruit juices, should be consumed
within half an hour before or after a dose of De-Nol as they may
influence its effect. The efficacy of oral
tetracyclines may be inhibited.
4.6 Pregnancy and lactation
On theoretical grounds De-Noltab is contraindicated in pregnancy. No
information is available on
excretion in breast milk.
4.7 Effects on ability to drive and use machines
None rep