WELLDORM TABLETS
Active substance: CHLORAL BETAINE
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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 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.
1. What Welldorm Tablets are and what they are used for
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 25C. 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. 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.
6. Further information
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 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.
1. What Welldorm Tablets are and what they are used for
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 25C. 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. 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.
6. Further information
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
