Welldorm 143.3mg/5ml elixir

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Chloral hydrate

Доступна с:

Marlborough Pharmaceuticals Ltd

код АТС:

N05CC01

ИНН (Международная Имя):

Chloral hydrate

дозировка:

28.66mg/1ml

Фармацевтическая форма:

Oral solution

Администрация маршрут:

Oral

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 04010100; GTIN: 5060129500022

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
WELLDORM 143.3MG PER 5ML ELIXIR
CHLORAL HYDRATE
Please read both sides of this leaflet carefully before you start to
take your medicine.
It will tell you what you need to know about Welldorm Elixir.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
Remember this medicine is only for YOU. Never give it to anybody else,
even if their symptoms are the same
as yours. If you are experiencing unpleasant side effects you should
consult your doctor.
IN THIS LEAFLET:
1. What Welldorm Elixir is and what it is used for
2. Before you take Welldorm Elixir
3. How to take Welldorm Elixir
4. Possible side effects
5. How to store Welldorm Elixir
6. Further information
1. WHAT WELLDORM ELIXIR IS AND WHAT IT IS USED FOR
Welldorm Elixir contains Chloral Hydrate which is one of a group of
medicines called hypnotics (sleep inducing drugs). Welldorm
Elixir is used for the short-term treatment of severe insomnia
(sleeping problems) which is interfering with normal daily life.
Welldorm will normally be given in addition to other non drug
therapies e.g. counselling.
Welldorm is normally only used in children and adolescents under the
supervision of a medical specialist.
2. BEFORE YOU TAKE WELLDORM ELIXIR
DO NOT TAKE WELLDORM ELIXIR IF YOU OR THE PATIENT:
• have severe liver or kidney problems
• have severe heart problems
• suffer from porphyria (an inherited blood disorder)
• are a child under 2 years of age
SPEAK TO YOUR DOCTOR BEFORE TAKING WELLDORM ELIXIR IF YOU:
• are allergic to chloral hydrate or any of the other ingredients in
Welldorm Elixir
• are suffering from stomach problems (gastritis).
TAKING OTHER MEDICINES
Please tell you doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
It is important to tell your doctor if you are taking any of the
following:
• medicines to thin your blood (such as Warfarin).
• medicines for depression or nervous disorders.

Характеристики продукта

OBJECT 1
WELLDORM ELIXIR
Summary of Product Characteristics Updated 01-Jul-2014 | Marlborough
Pharmaceuticals Ltd
1. Name of the medicinal product
Welldorm Elixir
Chloral Hydrate 143mg per 5ml Oral Solution
2. Qualitative and quantitative composition
Each 5ml of Chloral Hydrate Oral Solution contains 143.3mg of Chloral
hydrate BP.
3. Pharmaceutical form
Oral Solution
4. Clinical particulars
4.1 Therapeutic indications
Chloral Hydrate Oral Solution is used for the short-term treatment of
severe insomnia which is interfering
with normal daily life and where other therapies have failed.
Chloral Hydrate Oral Solution should be used as an adjunct to
non-pharmacological therapies.
In children aged 2-11 years treatment should be as an adjunct to
behavioural therapy and sleep hygiene
management, and usually for duration of less than 2 weeks.
The use of hypnotics in children and adolescents is not generally
recommended and if used should be
under the supervision of a medical specialist.
4.2 Posology and method of administration
Route of administration: oral. Chloral Hydrate Oral Solution should be
administered as a SINGLE DAILY
DOSE, 15-30 minutes before bedtime with water or milk.
ADULTS AND CHILDREN 12 YEARS AND OVER: The usual dose is 15-30ml
(430-860 mg). Higher doses should
not exceed a maximum of 70ml of elixir (2g chloral hydrate) per dose.
ELDERLY: Dosage as for adults except for the frail elderly or those
with hepatic impairment, where a
reduction in dose may be appropriate.
CHILDREN (BETWEEN 2 AND 11 YEARS): 1-1.75 ml/kg (30-50mg/kg) of
bodyweight. The dose should not
exceed 35ml (1g) chloral hydrate.
CHILDREN (UNDER 2 YEARS): not recommended.
4.3 Contraindications
Chloral Hydrate Oral Solution should not be used in patients with a
marked hepatic or renal impairment,
or in patients with severe cardiac disease. Should not be used in
patients susceptible to acute attacks of
porphyria.
4.4 Special warnings and precautions for use
Elderly patients are more likely to experience the undesirable effects
of hypnotics su