PROCHLORPERAZINE 5MG TABLETS
Active substance: PROCHLORPERAZINE MALEATE
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Package Leaflet: Information for the User
Prochlorperazine 5mg tablets
Read all of this leaflet carefully before you start taking this medicine: Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
In this leaflet
1. 2. 3. 4. 5. 6. What Prochlorperazine tablets are and what they are used for Before you take Prochlorperazine tablets How to take Prochlorperazine tablets Possible side effects How to store Further information
1. What Prochlorperazine tablets are and what they are used for
Prochlorperazine tablets belong to a group of drugs known as phenothiazines, which act on the central nervous system. In adults they are used in the treatment of vertigo (dizziness) and Meniere's syndrome (falling to one side), the short term treatment of anxiety and to treat schizophrenia and other mental (psychotic) disorders. The tablets may also be used for the prevention and treatment of nausea and vomiting in adults and children.
2. Before you take Prochlorperazine tablets
Do not take Prochlorperazine tablets if you have:
a known hypersensitivity to prochlorperazine, other phenothiazines or to any other ingredients in the tablets (see Section 6) phaeochromocytoma (tumour near the kidney) or tumours which grow if your prolactin levels are high Depression of central nervous system or coma glaucoma (raised eyeball pressure) an enlarged prostate or if you are or may be pregnant, or breast-feeding history of blood disorders or an unexplained fever you are diabetic or have high blood sugar (hyperglycaemia) you have a history of alcohol problems avoid weather extremes if you are over 65 years old avoid direct sunlight (it can lead to sun sensitive rash)
Check with your doctor before taking Prochlorperazine tablets if you have:
heart failure or prolonged QT (ECG change which increases the risk of potentially serious cardiac arrhythmias) liver or kidney problems, history of jaundice epilepsy or have ever had fits (seizures) Parkinsons disease hypothyroidism (reduced activity of the thyroid gland) depression, or if you have high risk of stroke myasthenia gravis (condition causing weak muscles)
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription (as they may alter the effects of this medicine) especially: antacids, anti-Parkinson medications (such as clonidine (for migraine and to lower blood levodopa), and lithium (may interfere with pressure) absorption of Prochlorperazine tablets) drugs affecting blood marrow, such as sedatives such as barbiturates (sedative effect carbamazepine, cytotoxics, or certain is intensified) antibiotics anticholinergic drugs, anticonvulsants, and drugs prolonging QT (ECG change which general anaesthesia might result in serious cardiac arrhythmias), such as certain antiarrhythmics, antihypertensive drugs such as alpha antidepressants, and antipsychotics blockers, such as guanethidine ritonavir (for HIV) central nervous system stimulants such as adrenaline, amphetamines disopyramide (a cardiac drug) hypoglycaemic agents (medicines for desferroxamine, used if you have too much diabetes) iron in your blood neuroleptics, pimozide, atomoxetine, antidepressants
Alcohol
This medicine will add to the effects of alcohol; therefore alcohol should be avoided during treatment.
Pregnancy and breast-feeding
Prochlorperazine should not be used in pregnancy, unless your doctor considers it absolutely necessary. As prochlorperazine is passed into breast milk, breastfeeding should be suspended during treatment. The following symptoms may occur in newborn babies, of mothers that have used Prochlorperazine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Driving and using machines
This medicine may cause some people to become drowsy or less alert than usual. If you are affected, do not drive or operate dangerous machinery.
Sugar intolerance
If a doctor has told you that you have an intolerance to some sugars, check with your doctor before taking these tablets, as they contain a type of sugar called lactose.
3. How to take Prochlorperazine tablets
You will be prescribed the lowest dose needed to control your symptoms. You should check with your doctor or pharmacist if you are unsure. Do not stop taking your medicine or change the dose unless your doctor tells you to. The tablets should be swallowed with a glass of water.
Do not crush the tablets or handle them more than you need to because you may develop a skin reaction. Dose for nausea and vomiting Adults: Prevention of nausea and vomiting 510mg two or three times a day. Treatment of nausea and vomiting: 20mg followed if necessary by 10mg two hours later. Children: Prevention and treatment of nausea and vomiting: The dose will depend on the child's bodyweight and will be calculated on the basis of 250 micrograms per kilogram bodyweight two or three times a day. Prochlorperazine is not recommended for children weighing less than 10 kilograms or children less than two years of age. Dose for vertigo and Meniere's syndrome: Adults: 5mg three times daily, increased if needed to 30mg daily. Dosage may be reduced gradually to 5-10mg daily. Dose for anxiety Adults: Initially 15-20mg daily in divided doses. This may be increased if necessary to a maximum of 40 mg daily in divided dose. Dose for schizophrenia and other psychotic (mental) disorders: Adults: The usual dose is 12.5mg twice daily for 7 days. The dose is then increased by 12.5mg at 4-7 day intervals until it has a satisfactory effect. After you have been on an effective dose for some weeks, your doctor may advise you to try to reduce the dosage.
Elderly:
Elderly patients with mental disorders should be started on a lower dose of Prochlorperazine. It should be used with caution during very hot or very cold weather to reduce the risk of an extreme rise or fall in body temperature.
If you take more than you should
If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets with you and the container or packaging, so they can be identified.
If you forget to take a tablet
If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines Prochlorperazine tablets can cause side effects. Do not be alarmed by this list of side effects. Most people take prochlorperazine without any problems, Stop taking the tablets and contact a doctor at once if you develop any of the following effects: you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. a fever or an unusually bad sore throat or bruising. These could be symptoms of a blood disorder. jaundice (yellowing of the skin and whites of the eyes) sometimes preceded by a sudden onset of fever, 1-3 weeks after start of treatment. a combination of high-temperature, pale complexion, muscle stiffness and changes in levels of alertness. These are signs of a serious condition called neuroleptic malignant syndrome. You have blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing Tell your doctor at once if you notice any of the following side effects or if you have any other unusual or worrying effects. - drowsiness, nasal stuffiness, dry mouth, - swollen breasts and impotence can occasionally insomnia (sleeplessness), agitation occur in men, but only after long term use. - lowering of blood pressure and postural - unusual breast milk production in women and hypotension (fall of blood pressure when absence of menstrual periods can also moving from lying down) particularly in the sometimes occur. elderly - a greyish discoloration of exposed skin may - visual disturbances, changes in heart rate develop, usually in women who have taken - skin rashes and with high doses increased Prochlorperazine continuously for long periods sensitivity to sunlight. Therefore in sunny (4-8 years). weather, direct exposure to sunlight should - passing large amounts of urine, excessive thirst be avoided. and having a dry mouth or skin. You may be - abnormal movement usually in young patients more likely to get infections, such as thrush. and an inability to control certain muscles of This could be due to too much sugar in your the body such as tongue, mouth, arms and legs Blood (hyperglycaemia). can occur at the start of treatment and after dose increases. These symptoms usually disappear. - muscle rigidity, tremors (uncontrolled shaking of the hands or limbs) in adults and the elderly may occur.
5. How to store
Do not store above 25C. Store in a dry place. Keep the container tightly closed. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging. If your doctor tells you to stop the treatment, return any unused tablets to your pharmacist for safe disposal.
6. Further information
The active ingredient (which makes these tablets work) is prochlorperazine maleate BP. Each tablet contains 5mg prochlorperazine maleate BP. The tablets also contain lactose, maize starch, pre-gelatinised maize starch, sodium starch glycollate, sucrose and magnesium stearate. The tablets are uncoated almost white or pale buff coloured, with flat bevelled edges and are available in containers of 28, 30, 56, 60, 84, 90, 100, 500, 1000 and in blister packs of 28 and 84 tablets.
Prochlorperazine 5mg Tablets PL8553/0091 Dr. Reddys Laboratories (UK) Limited Component code
Marketing authorisation holder and manufacturer Dr. Reddys Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK.
Leaflet revision date November 2011
Prochlorperazine 5mg tablets
Read all of this leaflet carefully before you start taking this medicine: Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
In this leaflet
1. 2. 3. 4. 5. 6. What Prochlorperazine tablets are and what they are used for Before you take Prochlorperazine tablets How to take Prochlorperazine tablets Possible side effects How to store Further information
1. What Prochlorperazine tablets are and what they are used for
Prochlorperazine tablets belong to a group of drugs known as phenothiazines, which act on the central nervous system. In adults they are used in the treatment of vertigo (dizziness) and Meniere's syndrome (falling to one side), the short term treatment of anxiety and to treat schizophrenia and other mental (psychotic) disorders. The tablets may also be used for the prevention and treatment of nausea and vomiting in adults and children.
2. Before you take Prochlorperazine tablets
Do not take Prochlorperazine tablets if you have:
a known hypersensitivity to prochlorperazine, other phenothiazines or to any other ingredients in the tablets (see Section 6) phaeochromocytoma (tumour near the kidney) or tumours which grow if your prolactin levels are high Depression of central nervous system or coma glaucoma (raised eyeball pressure) an enlarged prostate or if you are or may be pregnant, or breast-feeding history of blood disorders or an unexplained fever you are diabetic or have high blood sugar (hyperglycaemia) you have a history of alcohol problems avoid weather extremes if you are over 65 years old avoid direct sunlight (it can lead to sun sensitive rash)
Check with your doctor before taking Prochlorperazine tablets if you have:
heart failure or prolonged QT (ECG change which increases the risk of potentially serious cardiac arrhythmias) liver or kidney problems, history of jaundice epilepsy or have ever had fits (seizures) Parkinsons disease hypothyroidism (reduced activity of the thyroid gland) depression, or if you have high risk of stroke myasthenia gravis (condition causing weak muscles)
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines including medicines obtained without a prescription (as they may alter the effects of this medicine) especially: antacids, anti-Parkinson medications (such as clonidine (for migraine and to lower blood levodopa), and lithium (may interfere with pressure) absorption of Prochlorperazine tablets) drugs affecting blood marrow, such as sedatives such as barbiturates (sedative effect carbamazepine, cytotoxics, or certain is intensified) antibiotics anticholinergic drugs, anticonvulsants, and drugs prolonging QT (ECG change which general anaesthesia might result in serious cardiac arrhythmias), such as certain antiarrhythmics, antihypertensive drugs such as alpha antidepressants, and antipsychotics blockers, such as guanethidine ritonavir (for HIV) central nervous system stimulants such as adrenaline, amphetamines disopyramide (a cardiac drug) hypoglycaemic agents (medicines for desferroxamine, used if you have too much diabetes) iron in your blood neuroleptics, pimozide, atomoxetine, antidepressants
Alcohol
This medicine will add to the effects of alcohol; therefore alcohol should be avoided during treatment.
Pregnancy and breast-feeding
Prochlorperazine should not be used in pregnancy, unless your doctor considers it absolutely necessary. As prochlorperazine is passed into breast milk, breastfeeding should be suspended during treatment. The following symptoms may occur in newborn babies, of mothers that have used Prochlorperazine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.
Driving and using machines
This medicine may cause some people to become drowsy or less alert than usual. If you are affected, do not drive or operate dangerous machinery.
Sugar intolerance
If a doctor has told you that you have an intolerance to some sugars, check with your doctor before taking these tablets, as they contain a type of sugar called lactose.
3. How to take Prochlorperazine tablets
You will be prescribed the lowest dose needed to control your symptoms. You should check with your doctor or pharmacist if you are unsure. Do not stop taking your medicine or change the dose unless your doctor tells you to. The tablets should be swallowed with a glass of water.
Do not crush the tablets or handle them more than you need to because you may develop a skin reaction. Dose for nausea and vomiting Adults: Prevention of nausea and vomiting 510mg two or three times a day. Treatment of nausea and vomiting: 20mg followed if necessary by 10mg two hours later. Children: Prevention and treatment of nausea and vomiting: The dose will depend on the child's bodyweight and will be calculated on the basis of 250 micrograms per kilogram bodyweight two or three times a day. Prochlorperazine is not recommended for children weighing less than 10 kilograms or children less than two years of age. Dose for vertigo and Meniere's syndrome: Adults: 5mg three times daily, increased if needed to 30mg daily. Dosage may be reduced gradually to 5-10mg daily. Dose for anxiety Adults: Initially 15-20mg daily in divided doses. This may be increased if necessary to a maximum of 40 mg daily in divided dose. Dose for schizophrenia and other psychotic (mental) disorders: Adults: The usual dose is 12.5mg twice daily for 7 days. The dose is then increased by 12.5mg at 4-7 day intervals until it has a satisfactory effect. After you have been on an effective dose for some weeks, your doctor may advise you to try to reduce the dosage.
Elderly:
Elderly patients with mental disorders should be started on a lower dose of Prochlorperazine. It should be used with caution during very hot or very cold weather to reduce the risk of an extreme rise or fall in body temperature.
If you take more than you should
If you accidentally take more tablets or somebody else takes any tablets, contact a doctor or go to your nearest hospital casualty department at once. Take any remaining tablets with you and the container or packaging, so they can be identified.
If you forget to take a tablet
If you miss a dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.
4. Possible side effects
Like all medicines Prochlorperazine tablets can cause side effects. Do not be alarmed by this list of side effects. Most people take prochlorperazine without any problems, Stop taking the tablets and contact a doctor at once if you develop any of the following effects: you have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. a fever or an unusually bad sore throat or bruising. These could be symptoms of a blood disorder. jaundice (yellowing of the skin and whites of the eyes) sometimes preceded by a sudden onset of fever, 1-3 weeks after start of treatment. a combination of high-temperature, pale complexion, muscle stiffness and changes in levels of alertness. These are signs of a serious condition called neuroleptic malignant syndrome. You have blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing Tell your doctor at once if you notice any of the following side effects or if you have any other unusual or worrying effects. - drowsiness, nasal stuffiness, dry mouth, - swollen breasts and impotence can occasionally insomnia (sleeplessness), agitation occur in men, but only after long term use. - lowering of blood pressure and postural - unusual breast milk production in women and hypotension (fall of blood pressure when absence of menstrual periods can also moving from lying down) particularly in the sometimes occur. elderly - a greyish discoloration of exposed skin may - visual disturbances, changes in heart rate develop, usually in women who have taken - skin rashes and with high doses increased Prochlorperazine continuously for long periods sensitivity to sunlight. Therefore in sunny (4-8 years). weather, direct exposure to sunlight should - passing large amounts of urine, excessive thirst be avoided. and having a dry mouth or skin. You may be - abnormal movement usually in young patients more likely to get infections, such as thrush. and an inability to control certain muscles of This could be due to too much sugar in your the body such as tongue, mouth, arms and legs Blood (hyperglycaemia). can occur at the start of treatment and after dose increases. These symptoms usually disappear. - muscle rigidity, tremors (uncontrolled shaking of the hands or limbs) in adults and the elderly may occur.
5. How to store
Do not store above 25C. Store in a dry place. Keep the container tightly closed. Keep out of the reach and sight of children. Do not use after the expiry date printed on the packaging. If your doctor tells you to stop the treatment, return any unused tablets to your pharmacist for safe disposal.
6. Further information
The active ingredient (which makes these tablets work) is prochlorperazine maleate BP. Each tablet contains 5mg prochlorperazine maleate BP. The tablets also contain lactose, maize starch, pre-gelatinised maize starch, sodium starch glycollate, sucrose and magnesium stearate. The tablets are uncoated almost white or pale buff coloured, with flat bevelled edges and are available in containers of 28, 30, 56, 60, 84, 90, 100, 500, 1000 and in blister packs of 28 and 84 tablets.
Prochlorperazine 5mg Tablets PL8553/0091 Dr. Reddys Laboratories (UK) Limited Component code
Marketing authorisation holder and manufacturer Dr. Reddys Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK.
Leaflet revision date November 2011
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.
