Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Cloral Betaine 707mg Tablets
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Cloral betaine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Cloral BetaineTablets contain cloral betaine, which is one of a group of medicines called hypnotics (sleep inducing drugs). Adults: Cloral betaine tablets are used for the short-term (maximum 2 weeks) treatment of severe sleeplessness (insomnia) which is interfering with normal daily life and where non-drug therapies (such as behavioural therapy and sleep hygiene) and other drugs have failed. Cloral betaine tablets should be used in addition to non-drug therapies. Adolescents aged 12 years and above: Cloral betaine tablets are used for the short-term (maximum 2 weeks) treatment of severe sleeplessness (insomnia) in children and adolescents with suspected or definite disorders that affect the development of the neurological system and brain (neurodevelopmental disorders). It is only used when the sleeplessness interferes with normal daily life and other therapies (non-drug therapies and other drugs) have failed. Cloral betaine tablets should be used in addition to behavioural therapy and sleep hygiene management. The use of cloral betaine tablets in adolescents is not generally recommended and if used should be under the supervision of a medical specialist.
What you need to know before you take it
e Cloral Betaine Tablets Do not take Cloral Betaine Tablets if you
- are allergic to cloral betaine or any of the other ingredients (listed in section 6)
- have severe liver or kidney problems
- have severe heart problems
- suffer from porphyria (an inherited blood disorder)
- have active inflammation of the stomach or gullet (gastritis or oesophagitis), a stomach or gut ulcer or perforation of the stomach or gut wall
- are pregnant or breast feeding 1 uk-pil-Cloral Betaine tablets
Do not give Cloral Betaine Tablets to children under 12 years of age. Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Cloral Betaine Tablets:
- if you are elderly or frail (weak)
- if you have mild or moderate kidney impairment
- if you have mild or moderate liver impairment,
- if you suffer from alcoholism or drug addiction problems
- if you have dependency to sleep medications
- if you have had inflammation of the stomach or gullet (gastritis or oesophagitis), an ulcer in the stomach or the gut (gastric or duodenal ulcer) or perforation of the stomach or gut wall in the past,
- if you have heart disease or heart rhythm abnormalities (including so called QT prolongation seen with ECG monitoring)
- if you have low potassium or magnesium levels
Other medicines and Cloral Betaine Tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. It is important to tell your doctor if you are taking any of the following:
- sleep medication and tranquilisers (sedatives, hypnotics).
- medicines to thin your blood (such as Warfarin).
- medicines for depression or nervous disorders.
- medicines intended to reduce muscle spasms.
- medicines that affect the heart rhythm, such as medicines for heart rhythm abnormalities, medicines against malaria, some medicines against allergies (antihistamines), medicines to treat certain mental health disorders (antipsychotics) and medicines that lower potassium or magnesium levels (diuretics). Cloral Betaine Tablets with food, drink and alcohol Alcohol can increase the sedative effect of chloral hydrate. Alcohol should therefore be avoided whilst taking this medicine. Cloral Betaine Tablets should be administered as a single daily dose, 15-30 minutes before bedtime, 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 that your ability to drive or operate hazardous machinery may be impaired by drowsiness as a result of taking Cloral Betaine Tablets. Ask your doctor whether you may drive or operate machines. Important information about some of the ingredients of Cloral Betaine Tablets Clobal Betaine Tablets contain azorubine carmoisine (E122) which may cause an allergic reaction. Clobal Betaine Tablets also contain sodium methyl parahydroxybenzoate (E219) and sodium propylparahydroxybenzoate (E217) which may cause allergic reactions (possibly delayed).
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Laboratory Tests If you are having blood tests for your thyroid, tell your doctor or nurse as cloral betaine may interfere with these tests.
How to take it
Cloral Betaine Tablets Always take Cloral Betaine Tablets exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. For Cloral Betaine Tablets to work successfully, your doctor will need to identify the most appropriate dose for treating your sleeplessness. Your doctor will help you to select the most appropriate strength and dose. Cloral Betaine Tablets should be taken as a single daily dose,15-30 minutes before bedtime, with water or milk. The usual recommended doses for Cloral Betaine Tablets are: Adults and Children aged 12 years, adolescents and the Elderly: The usual starting dose is 1 – 2 tablets. In the frail elderly or patients with liver problems a smaller dose may be required. No more than 4 tablets should be taken in any one day. Cloral Betaine Tablets are not suitable for use in children under 12 years of age. If you are unsure about how to take your medicine, ask your doctor or pharmacist. Duration of treatment and Stopping treatment Cloral Betaine Tablets are usually prescribed for the short term treatment of sleeping problems when other non-drug therapies (such as behavioural therapy and sleep hygiene) and other drugs have failed, for a maximum treatment period of 2 weeks. Repeat courses of Cloral Betaine Tablets are not recommended and can only be administered following medical specialist re-assessment, because there is a risk of abuse and dependence. If you take Cloral Betaine Tablets over a long period of time, you may find that the tablets take longer to work and the effect does 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 amount you take. Speak to your doctor. Following prolonged treatment with Cloral Betaine Tablets, the dose should be slowly reduced before discontinuation, because there is a risk of withdrawal symptoms. Suddenly stopping Cloral Betaine Tablets may cause delirium (severe confusion). Contact your doctor before you stop taking the medicine, as they will advise you how to stop. 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 forget to take Cloral Betaine Tablets If you have missed one dose, this dose should be omitted, and the next dose should be taken at the usual time. Do not take a double dose to make up for a forgotten dose.
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4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking the medicine and seek urgent medical advice if you have: • • • • •
Hypersensitivity and allergic reactions such as itchy skin, skin redness and swelling and skin rash, sudden wheezing, swelling of the face, lips, tongue, throat, or body, rash, fainting or difficulty breathing or swallowing. Difficulty in breathing (dyspnoea) or very slow and/or shallow breathing (respiratory depression) Heart problems such as slow, fast or irregular heartbeat (which might reflect serious heart problems such as QTc prolongation) Sudden or severe confusion (delirium) Kidney injury with symptoms such as reduced urine output
Tell your doctor if you notice any of the following side effects or notice any other effects not listed: • • • • • • • • •
Headache Mental side effects such as anxiety, restlessness, excitation or confusion Loss of coordination of muscle movements (ataxia) Stomach and intestinal problems such as abdominal pain, distension of the abdomen, flatulence, nausea and vomiting (as these might reflect serious problems such as stomach irritation, gastric necrosis, gastric perforation or gut swelling). Long-term use of this medication leading to tolerance (usual doses not producing the desired effect), Dependence on the medication and its abuse, Chronic intoxication with mental symptoms or any other symptoms described here Withdrawal symptoms which may be severe and include hallucinations and delirium Ketonuria (a condition in which ketone bodies are present in the urine) 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. If any of the symptoms become troublesome, or if you notice anything else not mentioned here, please go and see your doctor. He/she may want to adjust the dose or give you a different medicine. Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible
Possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting the side effects you can help provide more information on the safety of this medicine.
How to store it
Cloral Betaine Tablets Store below 25oC. Do not refrigerate. Store in the original package. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the end panel of the carton and tablet blisters. The expiry date refers to the last day of the month.
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If your doctor decides to stop treatment, return any left over tablets to your pharmacist. Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
Contents of the pack and other information
What Cloral Betaine Tablets contain The active substance is Cloral Betaine. Each tablet contains 707mg of cloral betaine (equivalent to 414mg chloral hydrate). In addition to cloral betaine, Clobal 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), brilliant blue FCF aluminium lake (E133), titanium dioxide (E171). What Cloral Betaine Tablets look like and contents of the pack
Elongated, bluish-purple coloured tablet with a smooth film coat. Very slight odour of chloral. A pack size of 30 tablets is available. Marketing Authorisation Holder Marlborough Pharmaceuticals Ltd, Sovereign House, Miles Gray Road, Basildon, Essex SS14 3FR, United Kingdom Manufacturer Recipharm Limited, Vale of Bardsley, Ashton-under-Lyne, Lancashire, OL7 9RR. The Product Licence number is PL 23138/0015. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. This leaflet was last revised in July 2021.
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Frequently asked questions about Cloral Betaine 707mg Tablets
How do I take Cloral Betaine 707mg Tablets?
Cloral Betaine 707mg Tablets comes as tablet containing 707mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Cloral Betaine 707mg Tablets?
The active substance in Cloral Betaine 707mg Tablets is cloral betaine.
Are there equivalent medicines to Cloral Betaine 707mg Tablets?
Medicines with the same active substance, strength and form include: Welldorm Tablets 707mg. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Cloral Betaine 707mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Cloral Betaine 707mg Tablets without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: cloral betaine
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Adults:
Cloral betaine tablets are indictafor the short-term treatment (maximum 2 weeks) of severe insomnia which is interfering with normal daily life and where other therapies (behavioural and pharmacologic) have failed. Cloral betaine tablets should be used As an adjunct to non-pharmacologic therapies.
Adolescents aged 12 years and above:
Cloral betaine tablets are used for the short-term treatment (maximum 2 weeks) of severe insomnia in adolescents with suspected or definite neurodevelopmental disorder, when the insomnia is interfering with normal daily life and other therapies (behavioural and pharmacologic) have failed. Treatment should be as an adjunct to behavioural therapy and sleep hygiene management. The use of cloral betaine tablets 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
Conditions for Use:
The treatment should be as short as possible and should not exceed the maximum treatment period of 2 weeks.
Repeat courses of cloral betaine tablets are not recommended and can only be administered following medical specialist re-assessment, since the risk of abuse and dependence increases with the duration of treatment (see section 4.4).
Following prolonged treatment with cloral betaine tablets the dose should be slowly tapered before discontinuation.
The use of Cloral Betaine Tablets in adolescents is not generally recommended and if used should be under the supervision of a medical specialist (see section 4.1).
Posology:
Cloral Betaine Tablets should be administered as a single daily dose, 15-30 minutes before bedtime with water or milk.
Adults
The usual dose is one to two tablets (equivalent to 414 – 828 mg chloral hydrate). Higher doses should not exceed a maximum of 4 tablets (equivalent to 2 g chloral hydrate) per dose.
Elderly population
Dosage as for adults except for the frail elderly or those with hepatic impairment, where a reduction in dose may be appropriate (see section 4.4).
Paediatric population
Adolescents aged 12 years and above:
The adult dose should be taken.
Children between 2 and 11 years:
Cloral Betaine Tablets are not suitable for use in children under 12 years of age; for children between 2 and 11 years, chloral hydrate oral solution isavailable.
Children under 2 years:
Cloral betaine should not be used because the safety and efficacy in children aged under 2 years has not been established (see sections 4.4).
Hepatic impairment:
Cloral Betaine is contraindicated in patients with severe hepatic impairment (see section 4.3). Specific guidelines for dosage adjustments in mild and moderate hepatic impairment are not available; cloral betaine is extensively metabolized by the liver and, therefore, dose adjustments may be warranted.
Renal impairment:
Cloral Betaine is contraindicated in patients with renal failure or severe renal impairment (see section 4.3). Specific guidelines for dosage adjustments in mild and moderate renal impairment are not available; dose adjustments may be warranted.
Method of administration:
Oral use.
4.3. Contraindications
- Hypersensitivity to the active substance, chloral hydrate or to any of the excipients listed in section 6.1,
- in patients with severe hepatic impairment,
- in patients with severe renal impairment,
- in patients with severe cardiac disease,
- in patients with active gastritis, oesophagitis, gastric or duodenal ulcers or perforation,
- in patients susceptible to acute attacks of porphyria.
4.4. Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2).
Tolerance, dependence, withdrawal, misuse:
Tolerance, dependence and withdrawal symptoms have been reported with cloral betaine. Abrupt discontinuation should not be undertaken in patients receiving prolonged treatment with cloral betaine. Sudden withdrawal of the drug may cause delirium and hallucinations. Slowly withdraw cloral betaine.
Individuals with a history of alcohol or drug abuse or dependence may be at greater risk for abuse and misuse of cloral betaine. Prior to prescribing cloral betaine, each patient's risk for abuse or misuse should be assessed and patients receiving cloral betaine should be monitored for the development of behaviours or conditions of abuse or misuse while on therapy.
Gastrointestinal disorders:
Cloral betaine should be used with caution in patients with history of gastritis, oesophagitis, gastric or duodenal ulceration or perforation. Cloral betaine is contraindicated in patients with active gastritis, oesophagitis, gastric or duodenal ulcers or perforation (see section 4.3).
Hepatic and renal impairment
Cloral betaine should be used with caution in patients with mild to moderate hepatic and renal impairment and is contraindicated in patients with severe hepatic and renal impairment (see sections 4.2 and 4.3).
Elderly patients
Elderly patients are more likely to 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 the lowest effective dose be administered (see section 4.2 and 4.5).
QT prolongation
Cloral betaine should be used with caution and particular care in patients with low potassium levels, bradyarrhythmia, congenital long QT syndrome and other heart disorders (especially arrhythmia) (see sections 4.5 and 4.8).
4.5. Interaction with other medicinal products and other forms of interaction
No formal assessments of pharmacokinetic interactions between chloral hydrate and other therapeutic medicinal products have been conducted.
Concomitant use of alcohol and cloral betaine may potentiate the sedative effect; concomitant use should be avoided.
In combination with CNS depressants an enhancement of the central depressive effect may occur. Concomitant use with antipsychotics, hypnotics, anxiolytics/sedatives, antidepressant agents, centrally acting muscle relaxants, narcotic analgesics, anti-epileptic drugs, anaesthetics and sedative antihistamines should be avoided.
The concomitant use of drugs that also prolong the QT interval in ECG (for example, antiarrhythmics of Class IA or III, antibiotics, agents against malaria, H1 antihistamines, antipsychotics or medicinal products known to cause hypokalaemia or hypomagnesaemia) can lead to cardiac arrhythmias (see sections 4.4 and 4.8).
Chloral hydrate followed by intravenous furosemide may result in sweating, hot flushes and variable blood pressure including hypertension due to a hypermetabolic state caused by displacement of thyroid hormone from its bound state.
Delirium may occur, especially in the elderly, particularly when used in conjunction with psychotropics or anticholinergics.
In patients taking anticoagulants, when chloral hydrate is added to or withdrawn from the drug regimen, or its dosage changed, careful monitoring of the prothrombin time is required.
Chloral hydrate may interfere with laboratory tests of thyroid function.
4.6. Fertility, pregnancy and lactation
Cloral Betaine Tablets should not be used in pregnancy and lactation.
Pregnancy
Little information is available on the possible adverse effects of chloral hydrate on human pregnancy. Chloral hydrate is known to cross the human placenta at term, but its use during relatively few pregnancies did not cause a detectable increase in abnormal outcomes. Some data suggest that prolonged administration of sedative doses of cloral betaine to neonates increases the likelihood of hyperbilirubinemia.
Breast Feeding
Low levels of chloral hydrate have been found in breast milk. Although breastfeeding infants may be sedated by chloral hydrate in breast milk, the highest concentration measured in the milk (about 15 µg/ml) was considerably lower than that which would be measured in blood at a clinically active dose (100 µg/ml).
Fertility
There is no information relating to the effects of Cloral Betaine Tablets 707mg on fertility.
4.7. Effects on ability to drive and use machines
Patients receiving Cloral Betaine Tablets should be warned that their ability to drive or use machinery may be impaired by drowsiness.
4.8. Undesirable effects
The adverse reactions presented in the below table have been reported. The frequency grouping is defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
System Organ Class
Frequency and Adverse Reaction
Immune system disorders:
Not known: hypersensitivity, allergic skin reactions
Metabolism and nutrition disorders:
Not known: ketonuria
Psychiatric disorders:
Not known: anxiety, hyperactivity, confusion, tolerance, dependence, delirium, abuse, chronic intoxication, withdrawal symptoms
Nervous system disorders:
Not known: headache, ataxia
Respiratory, thoracic and mediastinal disorders:
Not known: dyspnoea, respiratory depression
Cardiac disorders:
Not known: QTc prolongation, arrhythmias (see sections 4.4 and 4.5)
Gastrointestinal disorders:
Not known: gastric irritation, abdominal distension, flatulence, gastric necrosis, gastric perforation, nausea, vomiting, gastritis
Renal and urinary disorders:
Not known: parenchymatous renal injury
Elderly patients:
Ataxia, confusion, falls and injuries.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Symptoms:
The signs and symptoms of overdose involve the cardiovascular, respiratory and central nervous systems. These may include respiratory depression, arrhythmias, hypothermia, pin-point pupils, hypotension or coma.
Gastric irritation may result in vomiting and even gastric necrosis. If the patient survives, icterus due to hepatic damage and albuminuria from renal damage may appear.
Serious problems have arisen with doses as little as 4g and l0g can be fatal.
Management:
Overdosage should be treated with gastric lavage or inducing vomiting to empty the stomach. Supportive measures must be used.
Haemodialysis, and in some cases haemoperfusion, have been reported to be effective in promoting the clearance of trichloroethanol.
💬 Ask about this leaflet
Ask anything about Cloral Betaine 707mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.