Cloral betaine 707mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Cloral betaine

Available from:

DE Pharmaceuticals

ATC code:

n/a

INN (International Name):

Cloral betaine

Dosage:

707mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04010100

Patient Information leaflet

1
uk-pil-Welldorm tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
WELLDORM 707MG TABLETS
Cloral Betaine
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 Tablets. 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 find that you are experiencing unpleasant side effects you
should consult your doctor.
IN THIS LEAFLET:
1. What Welldorm Tablets are and what they are used for
2. Before you take Welldorm Tablets
3. How to take Welldorm Tablets
4. Possible side effects
5. How to store Welldorm Tablets
6. Further information
1. WHAT WELLDORM TABLETS ARE AND WHAT THEY ARE USED FOR
Welldorm Tablets contain cloral betaine, which is one of a group of
medicines called
hypnotics (‘sleeping tablets’). Cloral betaine rapidly breaks down
in the stomach to form chloral
hydrate. Welldorm tablets are 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 used in adolescents under the supervision of a medical
specialist.
2. BEFORE YOU TAKE WELLDORM TABLETS
DO NOT TAKE WELLDOM TABLETS 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 12 years of age.
SPEAK TO YOUR DOCTOR BEFORE TAKING WELLDORM TABLETS IF YOU:
• are allergic to chloral hydrate or any of the other ingredients in
Welldorm Tablets
• are suffering from stomach problems (gastritis).
TAKING OTHER MEDICINES
Please tell your 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
FOL

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Welldorm Tablets 707mg
Cloral Betaine 707mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Cloral Betaine 707mg Tablets contain 707mg cloral betaine, equivalent
to
414mg of chloral hydrate.
3
PHARMACEUTICAL FORM
Film coated tablets
4.1
THERAPEUTIC INDICATIONS
Cloral Betaine Tablets are used for the short-term treatment of severe
insomnia which is interfering with normal daily life and where other
therapies
have failed.
Cloral Betaine Tablets should be used as an adjunct to
non-pharmacological
therapies.
The use of hypnotics in 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. Cloral Betaine Tablets 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 one to two
tablets
(414 – 828 mg). Higher doses should not exceed a maximum of 4
tablets (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: Cloral Betaine Tablets are not suitable for use in children
under 12
years of age; for children between 2 and 11 years Chloral Hydrate
143mg per
5ml Oral Solution is recommended.
4.3
CONTRAINDICATIONS
Cloral Betaine Tablets 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 experience the undesirable effects of
hypnotics such
as ataxia and confusion which may lead to falls and injury. For use in
the frail elderly
it is recommended that a lower dose be administered. (See 4.2 Posology
and method
of administration)
Best avoided in the presence of gastritis and in patients who have
previously exhibited
an idiosyncrasy or hyperse