WELLDORM TABLETS 707MG

Active substance: CHLORAL BETAINE

View full screen / Print PDF » Download PDF ⇩

Transcript
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 following:
• medicines to thin your blood (such as Warfarin).
• medicines for depression or nervous disorders.
• medicines intended to reduce muscle spasms.
Taking Welldorm Tablets with food and drink
Alcohol can increase the sedative effect of chloral hydrate. Alcohol should therefore be avoided whilst
taking this medicine.
Welldorm Tablets should be taken with water or milk.
Pregnancy and breast feeding
Welldorm Tablets should not be taken if you are pregnant or trying to become pregnant or you are breast
feeding.
Driving and using machines
Please note, your ability to drive or operate hazardous machinery may be impaired by drowsiness as a
result of taking Welldorm Tablets.
Important information about some of the ingredients of Welldorm Tablets
Welldorm Tablets contain azorubine carmoisine (E122) which may cause an allergic reaction.
Welldorm Tablets also contain sodium methyl parahydroxybenzoate (E219) and sodium propyl
parahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
Laboratory Tests
If you are having blood tests for your thyroid, tell your doctor or nurse as chloral hydrate may interfere
with these tests.

3. How to take Welldorm Tablets

Always take Welldorm Tablets exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure. Welldorm Tablets should be taken as a single daily dose usually 15-30
minutes before bedtime.
The usual doses are:
Adults and Children aged 12 years and over and the Elderly:
1 - 2 tablets. In the frail elderly or patients with liver problems a smaller dose may be required.
Do not take more than 4 tablets per day.
Children 2 - 11 years :
An oral solution of Welldorm is available.
If you are unsure about how to take your medicine, ask your doctor or pharmacist.
Welldorm Tablets are usually prescribed for the short term treatment of sleeping problems, usually for less
than 2 weeks. However if you take Welldorm Tablets over a long period of time, you may find that the tablets
take longer to work and do not last for as long. This is called “tolerance” to the medicine. If you find you are
becoming “tolerant” to Welldorm Tablets do not increase the number you take. Speak to your doctor.
If you take more Welldorm Tablets than you should
In the event of an accidental overdose, contact your nearest hospital casualty department or tell your doctor
immediately. It is advisable to have the medicine in its original packaging available for the doctor or hospital.
Signs of an overdose include, vomiting, breathing problems, abnormal heartbeat, abnormally low body
temperature, pin point pupils, low blood pressure or coma.
If you stop taking Welldorm Tablets
Suddenly stopping Welldorm Tablets may cause delerium (severe confusion). Contact your doctor before
you stop taking the medicine, he will advise you on how to stop.

4. Possible side effects

This medicine can cause side effects in some people.
Examples of side effects which may occur are:
• Stomach irritation
• Excitement
• Wind
• Headache
• Allergic skin reactions
• Lack of co-ordination (ataxia)
• Confusion
•  etonuria (a condition in which ketone bodies are present in the urine)
K
• Gut swelling
which can only be detected by tests arranged by your doctor.
If you are elderly you may be more susceptible to confusion and co-ordination problems which may lead to
falls and injury.
If you find that you are experiencing unpleasant side effects you should consult your doctor.

5. How to store Welldorm Tablets

Store below 25ºC. Do not refrigerate. Store in the original package.
Keep out of the reach and sight of children.
The expiry date is printed on the end panel of the carton and on the tablet blisters.
Do not use your medicine after this date.
If your doctor decides to stop treatment, return any left over tablets to your pharmacist. Medicines should
not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines
no longer required. These measures will help to protect the environment.

6. Further information

What Welldorm Tablets contain
The active substance in Welldorm Tablets is Cloral Betaine. Each tablet contains 707mg of cloral betaine
(equivalent to 414mg chloral hydrate).
In addition to cloral betaine, Welldorm Tablets contain povidone, maize starch, sodium citrate, purified talc,
magnesium stearate, hypromellose (E464), hydroxypropylcellulose (E463), macrogol 400, macrogol 8000,
disodium edetate, azorubine carmoisine (E122), brlliant blue FCF aluminium lake (E133), titanium dioxide,
(E171), sodium methyl parahydroxybenzoate (E219), sodium propyl parahydroxybenzoate (E217).
What Welldorm Tablets look like and contents of the pack
They are bluish-purple film coated oval tablets. A pack size of 30 tablets is available.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire SN8 1LW. Tel: 01672 514187
Email: info@marlborough-pharma.co.uk
Manufacturer
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR.
The Product Licence number is PL 23138/0015.
Date of preparation March 2011.

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)