PROMAZINE 25MG TABLETS
Active substance: PROMAZINE HYDROCHLORIDE
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PAGE 1: FRONT FACE (INSIDE OF REEL)
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Pharma code 70334
PACKAGE LEAFLET: INFORMATION FOR THE USER 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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Avoid exposure to direct sunlight while you are taking this medicine, as this medicine may cause you to become sensitive to sunlight, particularly if you are taking high doses.
Driving and using machines Promazine may cause drowsiness, dizziness, and cloudy or blurred vision. If you are affected by any of these, DO NOT drive or operate machinery.
3
HOW TO TAKE PROMAZINE
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. DO NOT take Promazine with: medicines to correct problems with heart rhythm IN THIS LEAFLET: e.g. quinidine, disopyramide, procainamide, amiodarone, dofetilide, sotalol, bretylium 1. What Promazine is and what it is used for antimalarials e.g. quinine and mefloquine 2. Before you take Promazine antibiotics such as sparfloxacin, moxifloxacin, 3. How to take Promazine intravenous erythromycin 4. Possible side effects certain types of (tricyclic or tetracyclic) 5. How to store Promazine antidepressants such as amitriptyline, 6. Further information maprotiline other antipsychotics e.g. risperidone, PROMAZINE IS AND WHAT IT IS 1 WHAT FOR amisulpride, sertindole, haloperidol and pimozide USED cisapride, a medicine used in the treatment of Promazine is one of a group of medicines called certain gastro-intestinal disorders phenothiazines, which are used to treat a range of certain antihistamines e.g. terfenadine. disorders including anxiety, agitation and Talk to your doctor if you are taking any of the disturbed behaviour. following: Promazine is used to treat: medicines which can affect the chemicals in your agitation and restlessness in the elderly bloodstream known as electrolytes, such as: short-term additional management of diuretics e.g. furosemide psychomotor agitation (unintentional and antibiotics e.g. amphotericin B purposeless motions brought on by mental corticosteroids e.g. hydrocortisone tension; symptoms may take the form of chemotherapy drugs e.g. cisplatin restlessness, pacing, tapping fingers or feet, sulphonylureas (used to treat diabetes) e.g. abruptly starting and stopping tasks, gliclazide or glibenclamide meaninglessly moving objects around, and more). antiepileptics e.g. phenytoin blood pressure tablets 2 BEFORE YOU TAKE PROMAZINE calcium channel blockers e.g. amlodipine sympathomimetics e.g. salbutamol DO NOT take Promazine if you: are allergic (hypersensitive) to promazine, any antimuscarinics e.g. inhalations used for bronchitis such as ipratropium bromide other phenothiazine, or any of the other anticholinergics used to treat Parkinsons or ingredients of this medicine restlessness, such as procyclidine, benzhexol, have phaeochromocytoma (adrenal gland orphenadrine tumour resulting in high blood pressure, tetrabenazine, used to treat essential tremor, flushing, diarrhoea). chorea, tics, and related disorders Promazine should not be given to patients in a ritonavir (an antiviral for HIV/AIDS) coma or suffering from central nervous system anti-anxiety or sleeping drugs e.g. diazepam, (CNS) depression, symptoms include decreased temazepam, zopiclone rate of breathing, decreased heart rate, and loss reboxetine (used to treat depression) of consciousness. lithium, (used to treat certain types of Take special care with Promazine depression) Talk to your doctor before you start to take this memantine, used to treat dementia medicine if you: sibutramine, used to help weight loss have a history of jaundice (yellowing of the cimetidine, used to treat stomach ulcer, reflux skin or whites of the eyes caused by liver or oesophagitis, ZollingerEllison syndrome, or blood problems) other conditions where gastric acid reduction blood dyscrasias (blood disorders which may is beneficial be characterised by fever or chills, sore throat, antacids, used to treat indigestion and heartburn ulcers in your mouth or throat, unusual metoclopramide, used to treat feeling or being tiredness or weakness, unusual bleeding or sick unexplained bruising) kaolin, used to treat diarrhoea have liver, kidney or heart disease antispasmodics to treat gut spasm e.g. have previously had a stroke, transient mebeverine hydrochloride ischaemic attack (TIA, stroke that lasts only a few medicines used for pain relief called opioid minutes) or heart attack, have a family history analgesics e.g. tramadol, morphine, codeine of strokes, or have other risk factors which adrenaline or noradrenaline may increase the risk of stroke, such as high alcohol. cholesterol, uncontrolled high blood pressure, If you are to undergo a surgical procedure that diabetes, you smoke or are a heavy drinker have personal or a family history of a certain type requires a general anaesthetic, make sure you tell of heart disorder known as QT-prolongation your doctor that you are taking Promazine. have a history of unexplained fainting or blackouts Important information about some of the have any disease of the lungs, lower and ingredients of Promazine upper airways, or any condition which causes Patients who are intolerant to lactose should difficulty in breathing note that Promazine contain a small amount of have Parkinsons disease (tremor, stiffness and lactose. If your doctor has told you that you have shuffling) an intolerance to some sugars, contact your have epilepsy doctor before taking this medicinal product. have hypothyroidism (underactive thyroid gland) Promazine 25 mg and 50 mg tablets contain suffer from depression E102 (tartrazine) and the 50 mg tablets also have myasthenia gravis (progressive muscular contain E110 (sunset yellow) which may cause weakness) allergic reactions. have an enlarged prostate (causing difficulty in Taking Promazine with food and drink passing water) have personal or a family history of glaucoma DO NOT drink alcohol whilst taking Promazine. (increased pressure in the eye) Pregnancy and breast-feeding are taking any other neuroleptic medicines DO NOT take Promazine if you are pregnant, are elderly, as it is more likely that you may planning to become pregnant or breast-feeding.
Always take Promazine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a drink of water. The usual dose is: Adults: For psychomotor agitation 100-200 mg four times daily. The Elderly: For agitation and restlessness 25-50 mg four times daily.
Children: Promazine is not recommended for use in children. If you take more Promazine than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, confusion, low blood pressure, low body temperature, fits and coma are possible. Rarely breathing difficulties may occur. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
The following have been reported at an unknown frequency: blood clots in the vein especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood If you forget to take Promazine vessels to the lungs causing chest pain and If you forget to take a tablet, take one as soon as difficulty in breathing. If you notice any of you remember unless it is more than 2 hours after these symptoms seek medical advice the missed dose; if so, ignore the missed dose immediately. and wait until the time of the next dose. DO NOT In elderly people with dementia, a small take a double dose to make up for a forgotten dose. increase in the number of deaths has been reported for patients taking antipsychotics Stopping treatment with Promazine compared with those not receiving DO NOT stop taking your medicine without antipsychotics. talking to your doctor first even if you feel better. Your medicine should only be withdrawn If any of the side effects get serious, or if you gradually under close supervision by your doctor. notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE PROMAZINE
Like all medicines, Promazine can cause side effects, although not everybody gets them. Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens: an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing or severe skin rash or hives. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if any of the following serious but rare effects happen: high body temperature, muscle rigidity, increased involuntary movement or tremor and altered consciousness (neuroleptic malignant syndrome) involuntary restless or repetitive limb movements, shaking, inability to sit or stand still jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems) Torsades de pointes, a life threatening irregular heart beat (symptoms may include recurrent episodes of palpitations, dizziness, fainting, feeling sick, paleness of the skin, cold sweats, shortness of breath and chest pain) cardiac arrest (symptoms include loss of consciousness, breathing stops and no heartbeat or pulse can be felt. Some people may first notice that they have a racing heartbeat or feel dizzy or light-headed just before they faint.)
Keep out of the reach and sight of children. Store the tablets below 25C. Keep the container tightly closed. Do not use Promazine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater 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 Promazine Tablets contain: The active ingredient is promazine hydrochloride 25 mg or 50 mg. The other ingredients are lactose, maize starch, magnesium stearate (E572), talc (E553), light kaolin (E559), sucrose, shellac (E904), beeswax (E901), carnauba wax (E903), tartrazine (E102), titanium dioxide (E171), sodium benzoate (E211), povidone, acetylated monoglyceride, black iron oxide (E172) and propylene glycol (E1520) The 50 mg tablets also contain sunset yellow (E110) and erythrosine (E127).
What Promazine Tablets look like and contents of the pack: Promazine 25 mg Tablets are round biconvex yellow sugar-coated tablets coded 7Z1 on one side and plain on the reverse. Promazine 50 mg Tablets are round biconvex orange sugar-coated tablets coded 7Z2 on one side and plain on the reverse. The following side effects have also been reported: The pack sizes are 50, 100, 250 and 1,000. nasal congestion Not all pack sizes may be marketed. dry mouth Marketing Authorisation Holder and Manufacturer agitation, excitement Marketing Authorisation holder and company apathy (lack of feeling or emotion) responsible for manufacture: dizziness, headache TEVA UK Limited, Eastbourne, BN22 9AG. fast heart rate abdominal pain, diarrhoea, constipation This leaflet was last revised: January 2010 difficulty in passing water (especially with an PL 00289/0798-9 enlarged prostate) PM/20/316 87643-U
(Backup)
PROMAZINE 25 mg AND 50 mg TABLETS
suffer from certain of the side effects such as drowsiness, low blood pressure, high or low body temperature or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Ask your doctor for advice before taking any medicine.
drowsiness, confusion, difficulty sleeping epileptic fits low blood pressure eye problems including blurred vision, clouding or opacity of the front part of the eye (cornea) or lens of the eye, purplish pigmentation of the cornea, the membrane that covers the white part of the eye and lines the inside of the eyelids (conjunctiva), the retina or the skin round the eyes high body temperature or low body temperature (especially in the elderly) skin rash or itchiness sensitivity to light contact sensitisation (inflammation of the skin or red, itchy skin rash, due to an immune reaction in response to a substance which has come into contact with the skin) suffering from infections more frequently, which may be due to a severe reduction in the number of white blood cells lethargy, weakness, dizzy spells and feeling faint, pale skin, which may be due to a reduction in the number of red blood cells (anaemia) weight gain in women, production of breast milk or menstrual disturbance in men, impotence (inability to achieve or maintain an erection), or breast enlargement in rare cases, sudden unexplained death has occurred.
Pharma code 70334
(Main)
PAGE 2: REAR FACE (OUTSIDE OF REEL)
Pharma code 70334
PACKAGE LEAFLET: INFORMATION FOR THE USER 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. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Avoid exposure to direct sunlight while you are taking this medicine, as this medicine may cause you to become sensitive to sunlight, particularly if you are taking high doses.
Driving and using machines Promazine may cause drowsiness, dizziness, and cloudy or blurred vision. If you are affected by any of these, DO NOT drive or operate machinery.
3
HOW TO TAKE PROMAZINE
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. DO NOT take Promazine with: medicines to correct problems with heart rhythm IN THIS LEAFLET: e.g. quinidine, disopyramide, procainamide, amiodarone, dofetilide, sotalol, bretylium 1. What Promazine is and what it is used for antimalarials e.g. quinine and mefloquine 2. Before you take Promazine antibiotics such as sparfloxacin, moxifloxacin, 3. How to take Promazine intravenous erythromycin 4. Possible side effects certain types of (tricyclic or tetracyclic) 5. How to store Promazine antidepressants such as amitriptyline, 6. Further information maprotiline other antipsychotics e.g. risperidone, PROMAZINE IS AND WHAT IT IS 1 WHAT FOR amisulpride, sertindole, haloperidol and pimozide USED cisapride, a medicine used in the treatment of Promazine is one of a group of medicines called certain gastro-intestinal disorders phenothiazines, which are used to treat a range of certain antihistamines e.g. terfenadine. disorders including anxiety, agitation and Talk to your doctor if you are taking any of the disturbed behaviour. following: Promazine is used to treat: medicines which can affect the chemicals in your agitation and restlessness in the elderly bloodstream known as electrolytes, such as: short-term additional management of diuretics e.g. furosemide psychomotor agitation (unintentional and antibiotics e.g. amphotericin B purposeless motions brought on by mental corticosteroids e.g. hydrocortisone tension; symptoms may take the form of chemotherapy drugs e.g. cisplatin restlessness, pacing, tapping fingers or feet, sulphonylureas (used to treat diabetes) e.g. abruptly starting and stopping tasks, gliclazide or glibenclamide meaninglessly moving objects around, and more). antiepileptics e.g. phenytoin blood pressure tablets 2 BEFORE YOU TAKE PROMAZINE calcium channel blockers e.g. amlodipine sympathomimetics e.g. salbutamol DO NOT take Promazine if you: are allergic (hypersensitive) to promazine, any antimuscarinics e.g. inhalations used for bronchitis such as ipratropium bromide other phenothiazine, or any of the other anticholinergics used to treat Parkinsons or ingredients of this medicine restlessness, such as procyclidine, benzhexol, have phaeochromocytoma (adrenal gland orphenadrine tumour resulting in high blood pressure, tetrabenazine, used to treat essential tremor, flushing, diarrhoea). chorea, tics, and related disorders Promazine should not be given to patients in a ritonavir (an antiviral for HIV/AIDS) coma or suffering from central nervous system anti-anxiety or sleeping drugs e.g. diazepam, (CNS) depression, symptoms include decreased temazepam, zopiclone rate of breathing, decreased heart rate, and loss reboxetine (used to treat depression) of consciousness. lithium, (used to treat certain types of Take special care with Promazine depression) Talk to your doctor before you start to take this memantine, used to treat dementia medicine if you: sibutramine, used to help weight loss have a history of jaundice (yellowing of the cimetidine, used to treat stomach ulcer, reflux skin or whites of the eyes caused by liver or oesophagitis, ZollingerEllison syndrome, or blood problems) other conditions where gastric acid reduction blood dyscrasias (blood disorders which may is beneficial be characterised by fever or chills, sore throat, antacids, used to treat indigestion and heartburn ulcers in your mouth or throat, unusual metoclopramide, used to treat feeling or being tiredness or weakness, unusual bleeding or sick unexplained bruising) kaolin, used to treat diarrhoea have liver, kidney or heart disease antispasmodics to treat gut spasm e.g. have previously had a stroke, transient mebeverine hydrochloride ischaemic attack (TIA, stroke that lasts only a few medicines used for pain relief called opioid minutes) or heart attack, have a family history analgesics e.g. tramadol, morphine, codeine of strokes, or have other risk factors which adrenaline or noradrenaline may increase the risk of stroke, such as high alcohol. cholesterol, uncontrolled high blood pressure, If you are to undergo a surgical procedure that diabetes, you smoke or are a heavy drinker have personal or a family history of a certain type requires a general anaesthetic, make sure you tell of heart disorder known as QT-prolongation your doctor that you are taking Promazine. have a history of unexplained fainting or blackouts Important information about some of the have any disease of the lungs, lower and ingredients of Promazine upper airways, or any condition which causes Patients who are intolerant to lactose should difficulty in breathing note that Promazine contain a small amount of have Parkinsons disease (tremor, stiffness and lactose. If your doctor has told you that you have shuffling) an intolerance to some sugars, contact your have epilepsy doctor before taking this medicinal product. have hypothyroidism (underactive thyroid gland) Promazine 25 mg and 50 mg tablets contain suffer from depression E102 (tartrazine) and the 50 mg tablets also have myasthenia gravis (progressive muscular contain E110 (sunset yellow) which may cause weakness) allergic reactions. have an enlarged prostate (causing difficulty in Taking Promazine with food and drink passing water) have personal or a family history of glaucoma DO NOT drink alcohol whilst taking Promazine. (increased pressure in the eye) Pregnancy and breast-feeding are taking any other neuroleptic medicines DO NOT take Promazine if you are pregnant, are elderly, as it is more likely that you may planning to become pregnant or breast-feeding.
Always take Promazine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The tablets should be swallowed preferably with a drink of water. The usual dose is: Adults: For psychomotor agitation 100-200 mg four times daily. The Elderly: For agitation and restlessness 25-50 mg four times daily.
Children: Promazine is not recommended for use in children. If you take more Promazine than you should If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause drowsiness, confusion, low blood pressure, low body temperature, fits and coma are possible. Rarely breathing difficulties may occur. Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.
The following have been reported at an unknown frequency: blood clots in the vein especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood If you forget to take Promazine vessels to the lungs causing chest pain and If you forget to take a tablet, take one as soon as difficulty in breathing. If you notice any of you remember unless it is more than 2 hours after these symptoms seek medical advice the missed dose; if so, ignore the missed dose immediately. and wait until the time of the next dose. DO NOT In elderly people with dementia, a small take a double dose to make up for a forgotten dose. increase in the number of deaths has been reported for patients taking antipsychotics Stopping treatment with Promazine compared with those not receiving DO NOT stop taking your medicine without antipsychotics. talking to your doctor first even if you feel better. Your medicine should only be withdrawn If any of the side effects get serious, or if you gradually under close supervision by your doctor. notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE PROMAZINE
Like all medicines, Promazine can cause side effects, although not everybody gets them. Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens: an allergic reaction causing swelling of the lips, face or neck leading to severe difficulty in breathing or severe skin rash or hives. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation. Tell your doctor immediately if any of the following serious but rare effects happen: high body temperature, muscle rigidity, increased involuntary movement or tremor and altered consciousness (neuroleptic malignant syndrome) involuntary restless or repetitive limb movements, shaking, inability to sit or stand still jaundice (yellowing of the skin or whites of the eyes caused by liver or blood problems) Torsades de pointes, a life threatening irregular heart beat (symptoms may include recurrent episodes of palpitations, dizziness, fainting, feeling sick, paleness of the skin, cold sweats, shortness of breath and chest pain) cardiac arrest (symptoms include loss of consciousness, breathing stops and no heartbeat or pulse can be felt. Some people may first notice that they have a racing heartbeat or feel dizzy or light-headed just before they faint.)
Keep out of the reach and sight of children. Store the tablets below 25C. Keep the container tightly closed. Do not use Promazine after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater 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 Promazine Tablets contain: The active ingredient is promazine hydrochloride 25 mg or 50 mg. The other ingredients are lactose, maize starch, magnesium stearate (E572), talc (E553), light kaolin (E559), sucrose, shellac (E904), beeswax (E901), carnauba wax (E903), tartrazine (E102), titanium dioxide (E171), sodium benzoate (E211), povidone, acetylated monoglyceride, black iron oxide (E172) and propylene glycol (E1520) The 50 mg tablets also contain sunset yellow (E110) and erythrosine (E127).
What Promazine Tablets look like and contents of the pack: Promazine 25 mg Tablets are round biconvex yellow sugar-coated tablets coded 7Z1 on one side and plain on the reverse. Promazine 50 mg Tablets are round biconvex orange sugar-coated tablets coded 7Z2 on one side and plain on the reverse. The following side effects have also been reported: The pack sizes are 50, 100, 250 and 1,000. nasal congestion Not all pack sizes may be marketed. dry mouth Marketing Authorisation Holder and Manufacturer agitation, excitement Marketing Authorisation holder and company apathy (lack of feeling or emotion) responsible for manufacture: dizziness, headache TEVA UK Limited, Eastbourne, BN22 9AG. fast heart rate abdominal pain, diarrhoea, constipation This leaflet was last revised: January 2010 difficulty in passing water (especially with an PL 00289/0798-9 enlarged prostate) PM/20/316 87643-U
(Backup)
PROMAZINE 25 mg AND 50 mg TABLETS
suffer from certain of the side effects such as drowsiness, low blood pressure, high or low body temperature or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Ask your doctor for advice before taking any medicine.
drowsiness, confusion, difficulty sleeping epileptic fits low blood pressure eye problems including blurred vision, clouding or opacity of the front part of the eye (cornea) or lens of the eye, purplish pigmentation of the cornea, the membrane that covers the white part of the eye and lines the inside of the eyelids (conjunctiva), the retina or the skin round the eyes high body temperature or low body temperature (especially in the elderly) skin rash or itchiness sensitivity to light contact sensitisation (inflammation of the skin or red, itchy skin rash, due to an immune reaction in response to a substance which has come into contact with the skin) suffering from infections more frequently, which may be due to a severe reduction in the number of white blood cells lethargy, weakness, dizzy spells and feeling faint, pale skin, which may be due to a reduction in the number of red blood cells (anaemia) weight gain in women, production of breast milk or menstrual disturbance in men, impotence (inability to achieve or maintain an erection), or breast enlargement in rare cases, sudden unexplained death has occurred.
Pharma code 70334
(Main)
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.
