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DOMPERIDONE 10mg TABLETS

Please read this leaflet carefully before you start to take your medicine.

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

If you have further questions, please ask your doctor or your pharmacist.

This medicine has been prescribed for you personally and you should 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 get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET

  • 1. What Domperidone 10mg Tablets are and what they are used for
  • 2. Before you take Domperidone 10mg Tablets
  • 3. How to take Domperidone 10mg Tablets
  • 4. Possible side effects
  • 5. How to store Domperidone 10mg Tablets
  • 6. Further information

1. WHAT DOMPERIDONE 10mg TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Domperidone 10mg Tablets.

Domperidone is an anti-emetic which can stop you feeling sick.

The active ingredient is domperidone maleate.

Each tablet contains 10mg domperidone as domperidone maleate.

Domperidone is used to treat:

  • nausea and vomiting
  • complaints of the stomach, which occur with delayed emptying of the stomach. This can result in symptoms such as feeling full (during or just after eating), bloating, belching, nausea, heartburn and stomach ache.

2. BEFORE YOU TAKE DOMPERIDONE 10mg TABLETS

Important information about one of the ingredients in your medicine

These tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

DO NOT TAKE Domperidone 10mg Tablets if you:

  • have ever had an allergic reaction to domperidone or any of the other ingredients listed in section 6, Further Information
  • have or think you may have a serious intestinal problem such as internal bleeding (symptom being persistent black bowel motions), or an obstruction or perforation of the stomach or intestine (usually this involves severe stomach cramps)
  • suffer from a tumour of the pituitary gland called prolactinoma

Before you use Domperidone 10mg Tablets tell your doctor if you:

  • have a liver or kidney disorder
  • are pregnant, or likely to become pregnant
  • are breast-feeding
  • suffer from heart problems as this medicine may affect your heart rate. This risk may be greater if you are over 60 years of age or if you are on doses of more than 30mg/day.

Driving and using machinery

It is unlikely that these tablets will affect your ability to drive or operate machinery.

Taking other medicines

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicine, even those not prescribed by a doctor, including any of the following:

  • opioid analgesics, used to treat pain
  • ketoconazole, used to treat fungal infections
  • ritonavir, used to treat HIV infection
  • erythromycin, used to treat infections
  • antimuscarinics, used to treat bladder or gastro-intestinal disorders
  • amantadine, used to treat viral infections
  • bromocriptine or cabergoline, used for the treatment of pituitary tumours or Parkinson s disease

If taken with other medicines the effect of Domperidone 10mg Tablets or the effects of the other medicine may be altered.

3. HOW TO TAKE DOMPERIDONE 10mg TABLETS

These tablets have been prescribed for you by a doctor. Take them exactly as he or she has told you. Please read the label carefully.

Domperidone should be used at the lowest effective dose in adults and children.

The tablets should be swallowed whole with a sufficient quantity of liquid (e.g. one glass of water).

Adults and adolescents (weighing 35kg or more i.e. approximately 5 stone)

The usual dose for the treatment is 1 to 2 tablets taken 3 to 4 times a day before meals. Do not take more than 8 tablets (80mg) in 24 hours.

Infants and Children

Children weighing less than 35kg (5 stone) should not take these tablets. The usual dose for the treatment is 0.25 0.5mg per kg bodyweight taken 3 to 4 times a day before meals. Your pharmacist may be able to help you if you are not sure.

People with kidney problems

Your doctor may tell you to take a lower dose or take the medicine less often.

Your doctor may advise you to take your medicine in a different way, so you should always follow your doctor s advice about how and when to take your medicine and always read the label. If you feel that the effect of Domperidone 10mg Tablets is too strong or too weak, talk to your doctor or pharmacist.

If your complaint shows no improvement after 28 days while taking Domperidone 10mg Tablets, consult your doctor to see if you need to go on taking this medicine.

If you take more Domperidone 10mg Tablets than you should

If you take more tablets than you should, tell your doctor immediately or go to the nearest hospital.

You may be given active charcoal, which can prevent the absorption of domperidone, if taken soon after having taken the overdose. Symptoms of overdose are drowsiness, disorientation, irregular eye movements and strange movements of the body, especially in children.

If you forget to take your tablets

Take your tablets as soon as you remember. If it is almost time for your next dose, wait until that is due and continue as normal. Do not take a double dose to make up for the forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Domperidone 10mg Tablets can have side
effects.

If any of the following side effects occur, STOP TAKING your Domperidone 10mg Tablets and tell your doctor immediately or go to your nearest hospital as it may be an allergic reaction:

  • welling of the hands, feet, ankles, face, lips or throat
  • problems with breathing
  • skin rash, itching or hives

If you experience any of the following, STOP TAKING
Domperidone 10mg Tablets and talk to your doctor:

  • convulsions (fits)
  • uncontrolled movements, including irregular eye movements, unusual tongue movements, twisting, turning movements of the neck, or trembling and stiffness of the muscles. This reaction may be more likely to occur in children.
  • heart rhythm disorders- symptoms include fast or slow heart beat

Rare side effects

In rare cases domperidone may:

  • cause milk to leak from the breast
  • disrupt menstrual flow
  • cause breast growth in men

Very rare side effects

  • mild stomach cramps
  • diarrhoea
  • headache
  • drowsiness
  • nervousness or restlessness
  • raised liver function tests (this is detected in a blood test)

Frequency unknown

  • sudden cardiac death

Domperidone may be associated with an increased risk of heart
rhythm disorder and cardiac arrest. This risk may be more likely in those over 60 years old or taking doses higher than 30mg per day.

Domperidone should be used at the lowest effective dose in adults and children.

If you notice any side effects not mentioned in this leaflet, or if any of the side effects listed become serious or last longer than a few days please inform your doctor or pharmacist.

5. HOW TO STORE DOMPERIDONE 10mg TABLETS

Do not use your Domperidone 10mg Tablets after the expiry date printed on the package. If you have any tablets that are out of date, please return them to your pharmacist for disposal.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN. Store the tablets in the original package.

6. FURTHER INFORMATION

Domperidone 10mg Tablets are white coloured, round, biconvex tablets. The active ingredient is domperidone maleate. Each tablet also contains several inactive ingredients. These include lactose monohydrate, maize starch, microcrystalline cellulose, povidone, magnesium stearate, colloidal anhydrous silica and sodium laurilsulfate.

Domperidone 10mg Tablets are supplied in cartons of 10, 30 or 100 tablets.

The marketing authorisation holder:

Athlone Pharmaceuticals Limited, Ballymurray, Co.Roscommon, Ireland.

Distributor:

Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT.

Product Licence Number: PL30464/0093

This leaflet was last revised in April 2012.


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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