De-nol Consumer Medicine Information

120 mg Colloidal bismuth subcitrate

Tablet

What is in this leaflet

This leaflet answers some common questions about DE-NOL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the expected benefits.

Use DE-NOL as instructed. If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What DE-NOL is used for

This medicine is used to treat digestive disorders such as:

  • an ulcer: - a gastric ulcer occurs in the stomach; a duodenal ulcer occurs in the tube leading out of the stomach.
  • indigestion caused by infection of the stomach with bacteria (germs) called Helicobacter pylori. This medicine is used along with an antibiotic medication.
  • This medicine works by forming a protective coat over the ulcer. This helps the ulcer to heal. DE-NOL also acts against Helicobacter pylori bacteria.
  • DE-NOL is usually prescribed along with antibiotic medication to treat Helicobacter pylori bacterial infection.

Your doctor may have prescribed DE-NOL for another reason. Ask your doctor why this medicine has been prescribed for you.

This medicine is available only with a doctor's prescription.

Before you take DE-NOL

When you must not take DE-NOL.

Do not take this medicine if you have an allergy to:

  • colloidal bismuth subcitrate
  • any of the ingredients listed at the end of this leaflet (see Product Description)

Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

Do not take this medicine if you have, or have had, any severe kidney disease. If you are unsure if this applies to you, ask your doctor.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take DE-NOL

Tell your doctor if you have a known allergy to DE-NOL or any ingredients listed at the end of this leaflet.

Tell your doctor if:

  1. you have or have had any medical conditions
  2. you have an allergy to DE-NOL or any of the ingredients listed at the end of this leaflet
  3. you have any allergies to any other medicines or any other substances, such as food, preservatives or dyes
  4. you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking this medicine.

This medicine is not addictive

Taking other medicines

Do not take any other medicines half an hour before or after taking DE-NOL tablets. Other medicines could interfere with the action of DE-NOL or their uptake could be reduced if taken at the same time as DE-NOL.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with DE-NOL.

These medicines may be affected by DE-NOL or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take DE-NOL

Follow carefully all directions given to you by your doctor or pharmacist. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

How much to take

Take:

EITHER

Two tablets half an hour before breakfast and two tablets half an hour before dinner or at bedtime.

OR

One tablet half an hour before each of your three main meals and one tablet before going to bed.

How to take DE-NOL

Swallow the tablets with some water. Do not consume any food or drink for half an hour after taking DE-NOL.

When to take DE-NOL

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Take DE-NOL half an hour before food.

How long to take DE-NOL

Follow carefully all directions given to you by your doctor and the pharmacist. These directions may differ from the information contained in this leaflet.

Do not take this medicine for longer than your doctor tells you. If you use this medicine for longer than your doctor or pharmacist tells you, the chance of side effects may increase.

When necessary, 2 months is the maximum recommended course of DE-NOL. Before another course of DE-NOL treatment be given, a 2 month period free of bismuth- containing medications is essential. If you are unsure how long to use DE-NOL, ask your doctor or pharmacist for help.

If you forget to use DE-NOL

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to take your medicine, ask your doctor or pharmacist for some hints.

While you are using DE-NOL

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not use any other bismuth-containing medicines whilst using DE-NOL.

Things to be careful of

Do not take large amounts of this medicine for a long time. If you take large amounts of this medicine for a long time the chance of side effects increases.

Ask your doctor or pharmacist if you are concerned about the length of time you have been using this medicine.

Side-Effects

Like all medicines, DE-NOL can cause some side effects. Side effects not listed in this leaflet may occur in some patients.

Tell your doctor or pharmacist if you have any unpleasant effects while you are taking DE-NOL even if you do not think the effect is connected with the medicine or is not listed in this leaflet.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • black bowel motions
  • nausea
  • vomiting
  • constipation
  • diarrhoea

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • signs of an allergic reaction, which may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin.

The above list includes serious side effects, which may require medical attention.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

In case of Overdose

If you take too much

Immediately telephone your doctor or the Poisons Information Centre (0800 POISON and 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention

Take DE-NOL as advised by your doctor.

A large overdose may damage the kidneys. This may not be obvious for 10 days.

Large amounts of this medicine taken for a long time may cause brain problems. Symptoms include headache, high fever, hallucinations, confusion, paralysis of part or all of the body, behaviour disturbances, speech disturbances, irregular eye movements, stiff neck and sensitivity to light.

After using DE-NOL

Keep DE-NOL in pack until required.

Storage

Keep your tablets in a cool dry place at normal room temperature (not more than 25C).

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep DE-NOL where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not use DE-NOL after the expiry date on the package.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What DE-NOL looks like

DE-NOL tablets are creamy white, round, convex tablets imprinted with 'gbr 152'.

Ingredients

Active ingredients:

Each DE-NOL tablet contains colloidal bismuth subcitrate equivalent to 120 mg bismuth trioxide as the active ingredient.

Inactive ingredients:

  • hypromellose
  • Macrogol 6000
  • magnesium stearate
  • maize starch
  • polacrilin potassium
  • povidone
  • This medicine does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.
  • This is not all the information available on DE-NOL. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.

This leaflet was prepared in August 2004.

DE-NOL is a registered trademark of Yamanouchi Europe BV.