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Donormyl Doxylamine 15 mg Coated Tablets – for insomnia – Pack of 10

Recommended for treating occasional insomnia in adults.

In accordance with French law, customers are limited to 3 units of doxylamine products per month.
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Warning: This is a medicine




    

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Donormyl Doxylamine 15 mg Coated Tablets – for insomnia – Pack of 10

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  • Donormyl 15mg 10 Comprimés pelliculés, Doxylamine, Insomnie

Buy Donormyl Doxylamine 15 mg Coated Tablets – for insomnia – Pack of 10

Warning: This is a medicine. Please ensure you carefully read all literature provided with your product prior to use. In case of doubt, ask your Doctor or Pharmacist for advice before taking this medicine.

Voir le résumé des caractéristiques du produit (RCP)      pdf Version PDF
Voir la notice d'utilisation du médicament      pdf Version PDF

1. Product Name


Donormyl 15 mg, breakable coated tablet

2. Ingredients


Per tablet:
Doxylamine succinate: 15.00 mg
For a full list of excipients, see section 6.1.

3. Product Type


Breakable, coated tablet

4. Product Information


4.1. Therapeutic Indications
This medicine can be used to treat occasional insomnia in adults.

4.2. Instructions for Use and Dosage
For adult use only.

Dosage
7.5-15.0 mg (or half to 1 full tablet) per day.
– If necessary, this can be increased to 30 mg (2 full tablets) per day.
– If you are elderly, or suffer from kidney or liver dysfunction, take a lower dose.

Method of Administration
To be taken orally.
Take a single dose per day – at night, between 15 and 30 minutes before bed.
Do not use this medicine for more than 2 to 5 days.
If your insomnia lasts for more than 5 days, consult your doctor – your treatment will need to be re-evaluated.

4.3. Do NOT use if:
– you are allergic to antihistamines;
– you have a personal or family history of acute, closed-iridocorneal angle glaucoma;
– you have urethral or prostate problems that may cause urinary retention; or
– you are under 15.

4.4. Warnings and Precautions for Use
Warnings
Insomnia has many possible causes, many of which do not require a course of medical treatment.
Like all hypnotics or sedatives, doxylamine hydrogen succinate can aggravate pre-existing sleep apnoea (i.e. increase the number and length of apnoeas – pauses in breathing – during sleep).

Like all medicines, doxylamine hydrogen succinate stays in the system for a period of roughly 5 half-lives (see section 5.2).
– In those who are elderly, or suffer from kidney or liver dysfunction, the half-life can be considerably longer.

With repeated doses, the medicine or its metabolites reach equilibrium much later, and at a much higher level. Only after equilibrium is achieved can the effectiveness and safety of the medicine be assessed jointly. It may be necessary to alter the dosage (see section 4.2).

Elderly people should use H1-antihistamines with caution due to the risk of narcotisation and/or feelings of dizziness that may put them at risk of suffering dangerous falls (e.g. while getting up during the night).

Precautions for Use
In the elderly, and those with kidney or liver dysfunction, there is a risk of increased plasma concentrations and lower plasma clearance. Such users should take a lower dose.

Contains lactose. Do not use if you have an intolerance to galactose, a Lapp lactase deficiency, or glucose-galactose malabsorption (these are rare hereditary disorders).

4.5. Interactions with Other Medicines and Other Substances
Avoid interactions with:
– Alcohol: this increases the sedative effect of H1-antihistamines. Reduced alertness affects your ability to drive or to operate machinery safely. Avoid alcoholic drinks and medicines containing alcohol.

Interactions to take into consideration:
– Atropine and atropinic substances (e.g. imipraminic antidepressants, anticholinergic antiparkinsons, atropinic antispasmodics, disopyramide, phenothiazinic neuroleptics):
these aggravate atropinic undesirable effects such as urinary retention, constipation and dry mouth.
– Other central nervous system depressants: morphinic derivatives (e.g. analgesics, antitussives and substitute treatments), neuroleptics; barbiturates; benzodiazepines; anxiolytics excluding benzodiazepines; sedative antidepressants (e.g. amitriptyline, doxepin, mianserin, mirtazapine and trimipramine); sedative H1-antihistamines; centrally-acting antihypertensives; and others (baclofen, pizotifen and thalidomide): these aggravate depression of the central nervous system. Reduced alertness affects your ability to drive or to operate machinery safely.

4.6. If you are pregnant or breast-feeding:
If you are pregnant:
Clinical data currently available indicates that doxylamine can be used safely at all stages of pregnancy. If using in the late stages of pregnancy, be aware of this medicine's atropinic and sedative properties while monitoring your baby's development.

If you are breast-feeding:
Donormyl is not known to pass into breast milk. However, given the possibility that it may act alternately as a sedative and a stimulant on your baby, you advised not to use this medicine while breast-feeding.

4.7. If you drive or operate machinery:
Warning – this medicine may cause drowsiness.
Avoid using other sedatives if you drive or operate machinery (see section 4.5).
Your alertness will be reduced further by lack of sleep.

4.8. Undesirable Effects
– Anticholinergic effects: constipation, dry mouth, accommodation problems, heart palpitations.
– Drowsiness (in which case, the dose must be lowered).

4.9. Excessive Dose
The first signs of acute Doxylamine poisoning are drowsiness and signs of anticholinergic syndrome (which include restlessness, mydriasis, accommodation paralysis, dry mouth, flushed face and neck, hyperthermia and sinus tachycardia).

Delirium, hallucinations and athetotic movements, which are more commonly observed in children, are signs of convulsions (a rare complication of heavy overdose).

Even in the absence of convulsions, acute poisoning can cause rhabdomyolysis, which can be complicated by acute kidney failure. Since this muscular condition is not uncommon, broad screening (by measuring creatine phosphokinase activity) is justified.

Treatment is symptomatic. If treatment commences during an early stage, administration of activated carbon (50 g for adults; 1 g/kg for children) is desirable.

5. Pharmacological Properties


5.1. Pharmacodynamic Properties
Systemic Antihistamine
ATC Code: R06AA09

Doxylamine hydrogen succinate, a member of the ethanolamine class, is a sedative and atropinic H1-antihistamine with demonstrable effectiveness in both reducing the time that it takes to get to sleep and improving quality of sleep.

5.2. Pharmacokinetic Properties
Absorption
On average, maximum concentration of doxylamine hydrogen succinate in the blood is achieved 2 hours after ingestion.

The average plasma elimination half-life is 10 hours.

Doxylamine hydrogen succinate is metabolised partly in the liver by the processes of demethylation and N-acetylation.

The various metabolites created by the breaking down of the molecule have little quantitative significance because 60% from the ingested dose is expelled in the urine as pure doxylamine.

6. Pharmaceutical Information


6.1. Excipients
Lactose monohydrate, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, hypromellose, macrogol 6000, dye*
*Composition: hypromellose, titanium dioxide, propylene glycol, purified water

6.2. Shelf Life
30 months

6.3. Packaging
Polypropylene tube with polyethylene cap, containing 10 breakable, coated tablets

7. Marketing Authorisation Holder


BRISTOL MYERS SQUIBB
3, RUE JOSEPH MONIER
92500 RUEIL-MALMAISON
FRANCE

8. Marketing Authorisation No.


367 519-3
Polypropylene tube with polyethylene cap, containing 10 breakable, coated tablets

9. Prescription and Delivery Conditions


Non-prescription medicine

If your symptoms persist, consult your doctor.


Last updated the 29/07/2015 at 15:55
Additional Information
Brand Upsa
Symptom sleep disorder
Pour qui Réservé à l'adulte
Forme Comprimé
Femme enceinte Oui
Pour diabétique Oui
Homéopathie Non
acl code 3675193
EAN 3400936751934

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