Cloral Betaine 707mg Tablets
GB 723-0634-APIL PACKAGE LEAFLET: INFORMATION FOR THE USER
Cloral Betaine 707mg Tablets
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 Cloral BetaineTablets. 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 Cloral Betaine Tablets are and what they are used for
2. Before you take Cloral Betaine Tablets
3. How to take Cloral Betaine Tablets
4. Possible side effects
5. How to store Cloral Betaine Tablets
6. Further information
1. What C loral Betaine Tablets are and what they are used for
Cloral Betaine 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. Cloral Betaine tablets are used for the short-term treatment of severe insomnia (sleeping problems) which is interfering with normal daily life.
Cloral Betaine will normally be given in addition to other non drug therapies e.g. counselling. Cloral Betaine is normally used in adolescents under the supervision of a medical specialist.
2. Before you take Cloral Betaine Tablets
Do not take Cloral Betaine 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 Cloral Betaine Tablets if you:
* are allergic to chloral hydrate or any of the other ingredients in Cloral Betaine 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 Cloral Betaine Tablets with food and drink
Alcohol can increase the sedative effect of chloral hydrate. Alcohol should therefore be avoided whilst taking this medicine.
Cloral Betaine Tablets should be taken with water or milk.
Pregnancy and breast feeding
Cloral Betaine 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 Cloral Betaine Tablets.
Important information about some of the ingredients of Cloral Betaine Tablets
Cloral Betaine Tablets contain azorubine carmoisine (E122) which may cause an allergic reaction.
Cloral Betaine 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 Cloral Betaine Tablets
Always take Cloral Betaine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Cloral Betaine 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 Chloral hydrate is available.
If you are unsure about how to take your medicine, ask your doctor or pharmacist.
Cloral Betaine Tablets are usually prescribed for the shortterm treatment of sleeping problems, usually for less than 2 weeks. However if you take Cloral Betaine 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 Cloral Betaine Tablets do not increase the number you take.
Speak to your doctor.
If you take more Cloral Betaine 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 Cloral Betaine Tablets
Suddenly stopping Cloral Betaine 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 • Ketonuria (a condition in which ketone bodies are present in the urine)
• 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 Cloral Betaine Tablets
Store below 25°C. Do not refrigerate. Store in the original package.
Keep out of the sight and reach 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 howto dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Cloral Betaine Tablets contain
The active substance in Cloral Betaine Tablets is Cloral Betaine. Each tablet contains 707mg of cloral betaine (equivalent to 414mg chloral hydrate).
In addition to cloral betaine, Cloral Betaine 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 Cloral Betaine 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
Marlborough Pharmaceuticals Ltd, 35A High Street, Marlborough, Wiltshire SN8 1LW.
Manufacturer
Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR.
The Product Licence number is PL 23138/0015.
For information in large print tape,CD or Braille, telephone 01672 514187
11001177
Date of preparation November 2014.