Domperidone 10mg Tablets
8
30 mm
Domperidone Tablets
400x140 mm Front
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).
What is in this leaflet
1. What Domperidone Tablets are and what they are used for
2. What you need to know before you take Domperidone Tablets
3. How to take Domperidone Tablets
4. Possible side effects
5. How to store Domperidone Tablets
6. Contents of the pack and other information
1. What Domperidone Tablets are and What they are used for
Domperidone Tablets contain active ingredient called Domperidone and belongs to a class of medicine called anti-emetics.
This medicine is used in adults and in children to treat nausea (feeling sick) and vomiting (being sick).
2. What you need to know before you take Domperidone Tablets
Do not take Domperidone Tablets if :
• you have been told you are allergic to Domperidone or any of the other ingredients in the tablets (these are listed in Section 6),
• you have a moderate or severe liver disease
• your ECG (electrocardiogram) shows a heart problem called "prolonged QT corrected interval"
• you have or had a problem where your heart cannot pump the blood round your body as well as it should (condition called heart failure).
• you have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood.
• you are taking certain medicines (see "Other medicines and Domperidone Tablets")
• you have a tumour of the pituitary gland (prolactinoma)
• you have a blockage or tear in your intestines
• you have black, tarry bowel motions (stools) or notice blood in your bowel motions. This could be a sign of bleeding in the stomach or intestines.
Warnings and precautions
Before taking this medicine contact your doctor if you:
• suffer from liver problems (liver function impairment or failure) (see "Do not take Domperidone Tablets")
• suffer from kidney problems (kidney function impairment or failure). It is advisable to ask your doctor for advice in case of prolonged treatment as you may need to take a lower dose or take this medicine less often, and your doctor may want to examine you regularly.
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. The risk also increases when Domperidone is given together with some drugs. Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/ HIV (see section "other medicines and Domperidone Tablets").
Domperidone should be used at the lowest effective dose in adults and children.
While taking domperidone, contact your doctor if you experience heart rhythm disorders such as palpitations, trouble breathing, loss of consciousness. Treatment with Domperidone should be stopped.
Other medicines and Domperidone Tablets
Do not take Domperidone Tablets if you are taking medicine to treat:
• fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole
• bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin, pentamidine (these are antibiotics)
• heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide, dofetilide, sotalol, diltiazem, verapamil)
• psychoses (e.g., haloperidol, pimozide, sertindole)
• depression (e.g., citalopram, escitalopram)
• gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
• allergy (e.g., mequitazine, mizolastine)
• malaria (in particular halofantrine)
• AIDS/HIV (protease inhibitors)
• cancer (e.g., toremifene, vandetanib, vincamine)
Tell your doctor or pharmacist if you are taking drugs to treat infection, heart problems or AIDS/HIV.
It is important to ask your doctor or pharmacist if Domperidone is safe for you when you are taking any other medicines, including medicines obtained without prescription.
Domperidone Tablets with food, drink and alcohol
It is recommended to take Domperidone Tablets before meals, as when taken after meals the absorption of the medicine is slightly delayed.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Small amounts of Domperidone have been detected in breast milk. Domperidone may cause unwanted side effects affecting the heart in a breast-fed baby. Domperidone should be used during breast feeding only if your physician considers this clearly necessary. Ask your doctor for advice before taking this medicine.
Driving and using machines
• At normal doses, this medicine does not affect your ability to drive or use machines.
• If you notice symptoms of drowsiness, disorientation and lack of co-ordination do not drive or use machines.
Domperidone Tablets contain lactose
• If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.
_3. How to take Domperidone Tablets_
• Follow these instructions closely unless your doctor has advised you otherwise.
Duration of treatment:
Symptoms usually resolve with 3-4 days of taking this medicine. Do not take Domperidone for longer than 7 days without consulting your doctor.
Taking this medicine
• Swallow the tablets whole with a drink of water.
• Take the tablets 15 to 30 minutes before a meal |
• Do not crush or chew them
140 mm
400mm
Adults and adolescents 12 years of age and older with a body weight of 35 kg or more
Tablets 10 mg -The usual dose is one tablet taken up to three times per day, if possible before meals.
Do not take more than three tablets per day.
Children and adolescents from birth to a body weight of less than 35 kg
Tablets are not suitable for children weighing less than 35 kg.
If Domperidone is for a child, ask your doctor for the children's formulation.
If you take more tablets than you should
If you have used or taken too much Domperidone, contact your doctor, pharmacist or the poison centre immediately, in particular if a child has taken too much. In the event of overdose, symptomatic treatment could be implemented. An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.
Symptoms of overdose are: sleepiness, confusion, uncontrolled movements, such as irregular eye movements, or abnormal posture.
If you forget to take the tablets
Take your medicine as soon as you remember. If it is almost time for your next dose, wait until that is due and then continue as normal. Do not take double dose to make up for the forgotten dose.
4. Possible Side Effects
Like all medicines, these tablets can cause side effects, although not everybody gets them.
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.
STOP TAKING this medicine and seek immediate medical help if you suffer from any of the following:
Very Rare (may affect up to 1 in 10,000 people)
• Allergic reaction: symptoms may include difficulty breathing; hives (also known as nettle rash or urticaria); swelling of the face, tongue, throat, lips, hands or feet; or collapse.
• Fits
• Uncontrollable movement of the face or limbs
• Uneven heart beat and/or chest pain
If you experience any of the following tell your doctor promptly:
Rare (may affect up to 1 in 1,000 people)
• Temporary stopping of periods
• Secretion of milk from the breasts
• Breast enlargement (also in men)
Very Rare (may affect up to 1 in 10,000 people)
• Feeling agitated or nervous
• Stomach cramps
Other side effects which may occur include:
Very Rare (may affect up to 1 in 10,000 people)
• Headache
• Drowsiness
• Skin rashes or itching
Not known (frequency cannot be estimated from the available data)
Disorders of the cardiovascular system: heart rhythm disorders (rapid or irregular heart beat) have been reported; if this happens, you should stop the treatment immediately. 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 30 mg per day. Domperidone should be used at the lowest effective dose in adults and children.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: "http://www.mhra.gov.uk/yellowcard". By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store this medicine
• Keep this medicine out of the sight and reach of children
• This medicinal product does not require any special storage conditions.
• Do not use the tablets after the expiry date (EXP.) shown on the carton or label. The expiry date refers to the last day of the month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Domperidone Tablet Contains
• Each tablet contains 10mg of the active substance Domperidone (as Domperidone maleate)
• The other ingredients are: lactose monohydrate, maize starch, povidone, sodium laurylsulphate, microcrystalline cellulose, colloidal anhydrous silica and magnesium stearate.
What Domperidone tablets looks like and contents of the pack
• Domperidone Tablets are white, round tablets with the markings "BL" on one side and "10" on the reverse.
• The tablets are available in pack sizes of 10, 20, 30, 50 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address:
Bristol Laboratories Ltd,
Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, United Kingdom, HP4 1EG Telephone: 0044 (0)1442 200922 Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Domperidone 10mg Tablets, PL 17907/0096
This leaflet was last revised in November 2014
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
140 mm
400 mm
SAME SIZE ARTWORK
400 x 140 mm
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