Motilium M Tablets (Generic Domperidone Maleate Tablets)

1. Motilium M Tablets (Generic Domperidone Maleate Tablets) © The Swiss Pharmacy

2. Motilium M Tablets (Generic Domperidone Maleate Tablets) Motilium M (Generic Domperidone Maleate Tablets) is used to treat nausea and vomiting in in adults and adolescents, 12 years of age and older and weighing 35kg or more. It is also used to treat 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. © The Swiss Pharmacy

3. Motilium M Tablets (Generic Domperidone Maleate Tablets) Motilium M tablets are manufactured by Johnson & Johnson Private Limited, India in the strength of 10 mg. © The Swiss Pharmacy

4. Motilium M Tablets (Generic Domperidone Maleate Tablets) Chemical Structure - Domperidone Maleate © The Swiss Pharmacy

5. Motilium M Tablets (Generic Domperidone Maleate Tablets) The active ingredient contained in Motilium M tablets is Domperidone Maleate. Each uncoated Motilium M tablet contains Domperidone Maleate equivalent to 10 mg Domperidone base. © The Swiss Pharmacy

6. Motilium M Tablets (Generic Domperidone Maleate Tablets) Uses of Motilium M 10 mg tablets: Motilium M (Generic Domperidone Maleate Tablets) is used for the short- term treatment in adults of symptoms associated with idiopathic or diabetic gastroparesis (once control of diabetes has been established by diet and/or insulin, an attempt should be made to discontinue Motilium). Motilium M is used for symptomatic treatment of the dyspeptic symptom complex that may be associated with delayed gastric emptying such as epigastric sense of fullness, abdominal distension or swelling, or epigastric pain or discomfort. Domperidone is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease. Motilium is also used to treat intractable nausea and vomiting from any other cause. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

7. Motilium M Tablets (Generic Domperidone Maleate Tablets) Recommended Adult Dosage Motilium M Tablets Motilium M Tablets (Generic Domperidone Maleate Tablets) 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 tablets before meals. If taken after meals, absorption of the drug is somewhat delayed. Usually, the maximum treatment duration should not exceed one week. Adults And Adolescents (12 Years of Age and Older and Weighing 35 Kg or More): One 10 mg tablet up to three times per day with maximum dose of 30 mg per day. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

8. Motilium M Tablets (Generic Domperidone Maleate Tablets) Recommended Dosage Paediatric Population: The efficacy of Domperidone in children less than 12 years of age has not been established. The efficacy of Domperidone (Motilium M tablets) in adolescents 12 years of age and older and weighing less than 35 kg has not been established. Hepatic Impairment: Motilium is contraindicated in moderate or severe hepatic impairment. Dose modification in mild hepatic impairment is however not needed. Renal Impairment: Since the elimination half-life of Domperidone is prolonged in severe renal impairment, on repeated administration, the dosing frequency of Domperidone tablets 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. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

9. Motilium M Tablets (Generic Domperidone Maleate Tablets) Contraindications ➔Motilium M is contraindicated in patients with a known hypersensitivity to Domperidone Maleate or any component of the tablet. ➔In patients who have known existing prolongation of cardiac conduction intervals, particularly QTc, patients with significant electrolyte disturbances underlying cardiac diseases such as congestive heart failure. ➔Co-administration with medicines that prolong the QTc interval. ➔Co-administration with potent CYP3A4 inhibitors. ➔Prolactin-releasing pituitary tumour (prolactinoma). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

10. Motilium M Tablets (Generic Domperidone Maleate Tablets) Contraindications ➔Whenever stimulation of gastric motility might be dangerous, e.g. in the presence of gastro-intestinal haemorrhage, mechanical obstruction or perforation. ➔In patients with moderate or severe hepatic impairment ➔Renal impairment URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

11. Motilium M Tablets (Generic Domperidone Maleate Tablets) Storage Instructions Motilium M Tablets (Generic Domperidone Maleate Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

12. Motilium M Tablets (Generic Domperidone Maleate Tablets) Warnings Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Use In Infants: Neurological side effects are rare. Since metabolic functions and the blood- brain barrier are not fully developed in the first months of life the risk of neurological side effects is higher in young children. Overdosing may cause extrapyramidal symptoms in children, but other causes should be taken into consideration. Renal Impairment: The elimination half-life of Motilium (Domperidone Maleate Tablets) is prolonged in severe renal impairment. For repeated administration, the dosing frequency of Domperidone should be reduced to once or twice daily depending on the severity of the impairment. The dose may also need to be reduced. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

13. Motilium M Tablets (Generic Domperidone Maleate Tablets) Warnings Cardiovascular Effects: Domperidone has been associated with prolongation of the QT interval on the electrocardiogram. During post- marketing surveillance, there have been very rare cases of QT prolongation and torsades de pointes in patients taking Domperidone. These reports included patients with confounding risk factors, electrolyte abnormalities and concomitant treatment which may have been contributing factors. Use With Apomorphine: Domperidone is contra-indicated with QT prolonging drugs including Apomorphine, unless the benefit of the co- administration with Apomorphine outweighs the risks, and only if the recommended precautions for co-administration mentioned in the apomorphine SmPC are strictly fulfilled. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

14. Motilium M Tablets (Generic Domperidone Maleate Tablets) Possible Side Effects Motilium M Tablets (Generic Domperidone Maleate Tablets) side effects reported during clinical trials and postmarketing experience are given below: Common: Dry mouth Uncommon: Loss of libido, Anxiety, Somnolence, Headache, Diarrhoea, Rash, Pruritus, Galactorrhoea, Breast pain, Breast tenderness and Asthenia Frequency Not known: Anaphylactic reaction (including anaphylactic shock), Agitation, Nervousness, Convulsion, Extrapyramidal disorder, Oculogyric crisis, Ventricular arrhythmias, Sudden cardiac death, QTc prolongation, Torsade de Pointes, Urticaria, Angioedema, Urinary retention, Gynaecomastia, Amenorrhoea, Liver function test abnormal, Blood prolactin increased URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

15. Motilium M Tablets (Generic Domperidone Maleate Tablets) Motilium M Tablets Overdosage Symptoms of Motilium M Tablets (Generic Domperidone Maleate Tablets) overdosage may include agitation, altered consciousness, convulsions, disorientation, somnolence and extrapyramidal reactions. There is no specific antidote to Domperidone Maleate, but in the event of overdose, standard symptomatic treatment should be given immediately. Gastric lavage as well as the administration of activated charcoal, may be useful. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Close medical supervision and supportive therapy is recommended. Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

16. Motilium M Tablets (Generic Domperidone Maleate Tablets) Motilium M Tablets During Pregnancy Domperidone Maleate (Motilium M tablets) has been classified by the US FDA as Pregnancy Category C drug, is a dopamine antagonist used for short-term treatment of nausea and vomiting. There are limited post-marketing data on the use of Domperidone in pregnant women. A study in rats has shown reproductive toxicity at a high, maternally toxic dose. The potential risk for humans is unknown. Because animal studies are not always predictive of human response and there are limited post- marketing data on the use of Domperidone Maleate ( Motilium Tablets) in pregnant women, this medicine should only be used during pregnancy only if clearly needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy

17. Motilium M Tablets (Generic Domperidone Maleate Tablets) Motilium M Tablets Motilium M Tablets (Generic Domperidone Maleate Tablets) are manufactured by Johnson & Johnson Private Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9576_Motilium-Tablets.html © The Swiss Pharmacy