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Digest - Hematopoietic

DOMREME

 

1. PRESENTATION:   1

Each Film coated Tablet contains:

Domperidone ……. 10mg

Excipients: : Microcrystalline Cellulose, Lactose, Maize Starch, Povidone, Sodium Starch Glycolate, Colloidal Silicon Dioxide, Magnesium Stearate, Talc, Hypromellose, Macrogol 400, Titanium Dioxide.

WHAT IS DOMREME AND WHAT ARE ITS USES

The active ingredient in Domreme tablets is domperidone; this is a type of medicine called a dopamine antagonist, which acts as a gastric motility agent. Domperidone helps to move food faster through the oesophagus, stomach, and intestines, so that it does not stay for too long in the same place or flow backwards.

 

2. INDICATIONS

In adults, Domreme tablets are used to treat the symptoms of nausea, vomiting, feeling of fullness during or shortly after a meal, stomach discomfort, and backflow of the stomach contents to the oesophagus.

In children, Domreme tablets are used to treat the symptoms of nausea and vomiting.

 

3. DOSAGE AND ADMINISTRATION

Follow your doctor’s instructions.

Adults and adolescents (over 12 years and weighing 35kg or more): The Domreme dose recommended for adults is 1-2 tablets 3-4 times daily with maximum daily dose of 80mg.

Duration of treatment is four weeks.

Infants and Children: 0.25-0.5mg/kg 3-4 times daily with a maximum daily dose of 2.4mg/kg (but do not exceed 80mg daily).

Tablets are unsuitable for use in children weighing less than 35kg.

It is recommended to take oral Domreme before meals.  If taken after meals, absorption of the drug is somewhat delayed.

If you take a dose larger than normal:

In case you take a dose larger than normal stop taking the medicine and contact your doctor immediately. 

Overdosage symptoms: drowsiness, disorientation and extrapyramidal reactions especially in children.  Treatment: There is no antidote for Domperidone, but in case of poisoning, gastric lavage and administration of active charcoal may be proven useful.  Anticholinergic, anti-parkinson drugs may be helpful in controlling the extrapyramidal reactions.

If you miss a dose:

If you have to take the medicine continuously and you miss taking a dose, take the missed dose as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

 

4. CONTRAIDICATIONS

Domreme is contra-indicated if you are hypersensitive to domperidone or to any of the excipients of the product. It is also contra-indicated if you have a disease or tumour of the pituitary gland (prolactinoma). Domreme is not indicated if you have severe tummy cramps, or persistent black stools or blood in the stool.

 

5. WARNINGS & PRECAUTIONS:

Domreme should be administered with caution in case of renal insufficiency and cannot be used in cases of hepatic insufficiency.

The dose should be determined accurately and followed strictly in neonates, infants, toddlers and small children.

This product contains lactose, therefore if you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

6. PREGNACY AND LACTATION:

Pregnancy:

Domreme should only be used during pregnancy, if this is justified by the anticipated therapeutic benefit.

Consult your doctor or pharmacist before taking any medicine.

Lactation:

Domreme is not indicated during breast-feeding.

Consult your doctor or pharmacist before taking any medicine.

 

7. DRIVING AND OPERATING MACHINERY:

Domreme does not affect the ability to drive or operate machinery

 

8. UNDESIRABLE EFFECTS

As with all medicines Domreme may cause undesirable effects.

Immune system: allergic reactions

Endocrine system: increased prolactin levels

Nervous system: extrapyramidal side-effects

Gastrointestinal system: gastro-intestinal disorders including intestinal cramps

Skin: urticaria

Reproductive system and breast disorder: galactorrhoea, gynaecomastia, amenorrhoea.

Increased prolactin levels leading to neuron-endocrinological side-effects (galactorrhoea, gynaecomastia).

Extrapyramidal symptoms are very rare in neonates and infants, and ‘exceptional in adults’. These side-effects reverse spontaneously and completely as soon as the treatment is stopped.

If you experience undesirable effects that are not mentioned above, please inform your doctor.

 

9. DRUG INTERACTIONS:

A number of medicines interact with Domreme and should not be used concomitantly. However, a few of them can be used concomitantly under special precautions. In this case, your doctor can change the posology or take other precautions if needed. 

If you are about to take Domreme it is important to inform your doctor or pharmacist about any other medicines you are taking and particularly any of the following:

CYP3A4 inhibitors for example ketoconazole, ritonavir and erythromycin.

 

10. SHELF LIFE:  60 months      

 

11. STORAGE:   It is stored at a temperature below 25οC, away from light and moisture and safely away from the reach of children 

 

12. SPECIFICATION: Manufactured ‘specification 

Name and Address of Manufacturer

Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU   

Name and Address of Registrationer: NHẤT ANH Pharmaceutical Ltd. Co. (122/7-9 Dang Van Ngu Str., Ward 14, Phu Nhuan Dist., HCMC

                                                                            

Please read carefully before use.

Further more information please ask your doctor or pharmacist

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