MOTILIUM 10MG TAB 30’S

Description:
Consumption of this product is responsibility of the person who uses and recommends, consult your doctor before taking any medication. Prescription required
Medication name: Motilium
Comparable patent medicine: Motilium
Active ingredient: Domperidone
Presentation: Tablets
Concentration: 10mg
Extended-release tablets: No
Lab: Janssen-Cilag, SA de CV
Box of 30 Tablets
Made in: Mexico
 
Pharmacies online, Rx online, Drugs online, Pharmacy online, Drugs online, prescription online, Drug store online, Brand Name drugs and generic drugs, all located in Pharmacy Del Niño
For the dyspeptic symptom complex that is often associated with delayed gastric emptying, gastro-oesophageal reflux and oesophagitis. It is also for nausea and vomiting of functional, organic, infectious or dietetic origin or induced by radiotherapy or drug therapy.
1. Name of the medicinal product
Motilium 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains domperidone maleate 12.72 mg equivalent to domperidone 10 mg.
Excipients with known effect:
Each film-coated tablet contains 53.88mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets - white to faintly cream coloured, circular, biconvex tablets.
4. Clinical particulars
4.1 Therapeutic indications
Motilium is indicated for the relief of the symptoms of nausea and vomiting.
4.2 Posology and method of administration
Motilium should be used at the lowest effective dose for the shortest duration necessary to control nausea and vomiting.
It is recommended to take oral Motilium before meals. If taken after meals, absorption of the drug is somewhat delayed.
Patients should try to take each dose at the scheduled time. If a scheduled dose is missed, the missed dose should be omitted and the usual dosing schedule resumed. The dose should not be doubled to make up for a missed dose.
Usually, the maximum treatment duration should not exceed one week.
See section 4.4. for further information.
Adults and adolescents (12 years of age and older and weighing 35 kg or more)
One 10mg tablet up to three times per day with a maximum dose of 30 mg per day.
Hepatic Impairment
Motilium is contraindicated in moderate or severe hepatic impairment (see section 4.3). Dose modification in mild hepatic impairment is however not needed (see section 5.2).
Renal Impairment
Since the elimination half-life of domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Motilium should be reduced to once or twice daily depending on the severity of the impairment, and the dose may need to be reduced. Such patients on prolonged therapy should be reviewed regularly (see sections 4.4 and 5.2)
Paediatric population
The efficacy of Motilium in children less than 12 years of age has not been established (see section 5.1).
The efficacy of Motilium in adolescents 12 years of age and older and weighing less than 35 kg has not been established.
4.3 Contraindications
Motilium is contraindicated in the following situations:
• Known hypersensitivity to domperidone or any of the excipients
• Prolactin-releasing pituitary tumour (prolactinoma).
• when stimulation of the gastric motility could be harmful e.g in patients with gastro-intestinal haemorrhage, mechanical obstruction or perforation.
• in patients with moderate or severe hepatic impairment (see section 5.2).
• in patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances or underlying cardiac diseases such as congestive heart failure (see section 4.4)
• co-administration with QT-prolonging drugs, at the exception of apomorphine (see sections 4.4 and 4.5)
• co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
MOTILIUM 10MG 30 TABLETS
Product Description
 
MOTILIUM is used to treat the following conditions in adults:
nausea and vomiting
discomfort caused by a slow moving stomach known as gastroparesis. Symptoms include not being able to finish a meal, a feeling of being "too full" or bloated after a meal, a loss of appetite, feeling sick and maybe vomiting, or belching without relief
DOSE :
The usual dose in adults is one tablet three times a day.
For nausea and vomiting this medicine is usually used for a maximum of 1 week.
The other conditions the initial duration of treatment is up to a maximum of 4 weeks.
How to take it
MOTILIUM is best taken 15 to 30 minutes before meals, and if necessary at bedtime.
Side effects
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some side effects. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you experience any of the following:
headache, trouble sleeping, nervousness, depression dizziness, tiredness or irritability
sleepiness or drowsiness, fits or seizures, agitation
dry mouth or thirst
regurgitation, diarrhoea, constipation, nausea, changes in appetite or heartburn
rash or itchy skin
itchy eyes and crusty eyelids with discharge
mouth ulcers or cold sores.
These are mild side effects of MOTILIUM. Tell your doctor if they continue.
uncontrollable movements of the face or arms and legs, excessive trembling, excessive muscle stiffness or muscle spasm
irregular or no menstrual period
unusual secretion of breast milk or decrease in sex drive in men or women
breast tenderness or breast enlargement in men and women.
These effects will reverse on stopping treatment.
Tell your doctor immediately if you notice any of the following as you may need urgent medical care:
fast or irregular heart beats
swelling of hands, ankles or feet
passing urine more frequent or pain when passing urine.
STOP using MOTILIUM and tell your doctor immediately if any of the following happen:
you have an allergic reaction to MOTILIUM (allergy can be recognised, for instance, by skin rash, itching, shortness of breath and/or swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing)
Other side effects not listed above may also occur in some people. Tell your doctor if you notice any other effects.
Product description
What it looks like
MOTILIUM tablets are white, film coated, round tablets. Each tablet is marked "M/10" on one side and "JANSSEN" on the reverse. They are available in blister in carton of 25 or 100 tablets. (AUST R 39510)
Ingredients
Each MOTILIUM tablet contains:
10 mg of domperidone as the active ingredient.
lactose, maize starch, microcrystalline cellulose, pregelatinised potato starch, povidone, magnesium stearate, hydrogenated cottonseed oil, sodium lauryl sulfate and hypromellose.