Stemetil 5 Mg Tablets
Out of date information, search anotherPACKAGE LEAFLET:
INFORMATION FOR THE USER
Stemetil 5 mg Tablets
prochlorperazine maleate
SANOFI^
GIs this leaflet hard to see or read? Phone 01483 505515 for help
Read all of this leaflet carefully before you start taking this medicine
• Keep this leaflet. You may need to read it again
• If you haveanyfurtherquestions,askyour doctor or pharmacist
• This medicine has been prescribed foryou. Do not pass it on to others. It may harm them, even if their symptoms are the same asyours
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell yourdoctor or pharmacist
In this leaflet:
I.What Stemetil Tablets are and what they are used for
2. Before you take Stemetil Tablets 3. How to take Stemetil Tablets 4. Possible side effects 5. How to store Stemetil Tablets 6. Furtherinformation
1. What Stemetil Tablets are and what they are used for
]
Stemetil Tablets contain a medicine called prochlorperazine maleate. This belongs to a group of medicines called ‘phenothiazene antipsychotics’. It works by blocking the effects of a chemical in the brain.
Stemetil Tablets can be used to:
• Treat balance problemsordizziness (vertigo). This includes problems of the inner ear such as ‘Meniere’s Syndrome’ or ‘labyrinthitis’
• Stop you feeling sick (nausea) or being sick (vomiting). This can be from any cause including migraines
• Treat schizophrenia
• Treat over-active behaviourorthoughts (mania)
• Treat anxiety in the short-term, when used in addition to other medicines
2. Before you take Stemetil Tablets
XDo not take this medicine and tell your doctor if:
X You are allergic (hypersensitive) to prochlorperazine maleate orany of the other ingredients of Stemetil Tablets (listed in Section 6 below)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue
Take special care with Stemetil Tablets
Check with your doctor or pharmacist
before taking your medicine if:
* You are allergic to phenothiazine medicines such as chlorpromazine
* You have heart problems or a family history of heart problems
* You have ever had a stroke
* You have liver or kidney problems
* You have thyroid problems
* You have an enlarged prostate gland. This meansyou mayhave problemswhen passing water (urine)
* You or someone else in yourfamily has a history of blood clots, as medicines like these have been associated with formation of blood clots
* You have Parkinson’sdisease
* You have dementia
* You have epilepsy or have ever had fits (seizures)
* You have depression
* You have a tumouron youradrenal gland called ‘phaeochromocytoma’
* You have a type of muscle weakness called ‘myasthenia gravis’
* You have or have ever had glaucoma (signs include painful eyes with blurred vision)
* You have or have ever had a low number of white blood cells (agranulocytosis). This would lead you to get infections more easily than usual
* You nave low blood levels of potassium, calcium and magnesium. Yourdoctor may perform blood tests to check on these
* You are not eating properly orare very under-weight
* You have a history of alcohol problems
* You are elderly (65 years of age or older)
* The person is a child. This is because children may develop unusual face and body movements (dystonic reactions)
* You are diabetic or have high levels of sugar in your blood (hyperglycaemia). mi Yourdoctor may want to monitor
you more closely. 1 IHHB
11503013-06
If you are not sure if any of the above apply to you, talkto yourdoctor or pharmacist before taking Stemetil Tablets.
Taking other medicines
Please tell yourdoctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Stemetil Tablets can affect the way some other medicines work. Also some medicines can affect the way Stemetil Tablets works.
In particular, tell yourdoctor if you are takingany of the following:
• Medicines to help you steep (sedatives, barbiturates)
• Other medicines used to calm emotional and mental conditions
• Medicinesusedfordepression
• Medicines used for Parkinson’s disease such as levodopa
• Medicines for ffts (epilepsy) such as carbamazepine
• Medicines used to control your heartbeat such as amiodarone, disopyramide, propanolol or quinidine
• Medicines for high blood pressure such as doxazosin, terazosin, guanethidine or clonidine
• Medicinesusedfordiabetes
• Medicines used for cancer (cytotoxics)
• Medicines used for infections (antibiotics)
• Medicinesforindigestionand heartburn (antacids)
• Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence
• Amphetamines - used forAttention Deficit Hyperactivity Disorder (ADHD)
• Adrenaline - used for life threatening allergic reactions
• Desferrioxamine - used when you have too much iron in your blood
• Lithium - used for some types of mental illness
Taking Stemetil Tablets with food and drink
Do not drink alcohol while you are taking Stemetil Tablets. This is because alcohol can add to the effects of Stemetil Tablets and can cause serious breathing difficulties.
Pregnancy and breast-feeding
Do not take Stemetil Tablets if:
• You are pregnant, might become pregnant orthinkyou might be pregnant
• You are breast-feeding or planning to breast-feed
The following symptoms may occur in newborn babies, of mothers that have used Stemetil Tablets 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 yourdoctor.
Ask yourdoctor or pharmacist for advice before taking any medicine if you are pregnant orbreast-feeding.
_ Driving and using machines
You mayfeetsleepyaftertakingthis medicine. If this happens, do not drive or use any tools or machines.
Important information about some of the ingredients of Stemetil Tablets • Lactose. This medicine contains lactose, a type of sugar. If you have been told by yourdoctor that you can not tolerate some sugars, talkto yourdoctor before taking Stemetil Tablets
3. How to take Stemetil Tablets
Always take Stemetil Tablets exactly asyour doctor has told you. You should check with yourdoctoror pharmacist if you are not sure.
Taking this medicine
• Take this medicine by mouth
• Do not give to children under 1 yearof age orwho weigh less than 10 kg
• You should not let the tablets touch your skin forvery long, asyou may get skin redness, swelling and itching (contact skin sensitisation)
• If you feel the effect ofyour medicine is too weakor too strong, do not change the dose yourself, butaskyourdoctor
How much to take Adults:
Treatment of balance problems or dizziness (Vertigo):
•The usual dose is 5 mg three times each day
•This may be increased to a total daily dose of 30 mg each day •After several weeks treatment, your doctor may decide to gradually lower your daily dose to5to10mg each day
Stopping you feeling sick or being sick:
•The usual dose is5or10mg •This may be taken two or three times each day
How much to take (continued)
Adults
Treatment of feeling sick or being sick:
•To begin with you will usually take 20 mg •This may be followed by10mg two hours later
Treatment of schizophrenia and overactive behaviour or thoughts (mania):
•The starting dose is usually 12.5 mg twice each dayforseven days •Yourdoctor may increase yourdose up to a total daily dose of 75 to 100 mg each day
•After several weeks of treatment, your doctor may then lower your dose to a total daily dose of 25 to 50 mg each day
Short-term treatment of anxiety:
•The starting dose will be15to 20 mg each day in divided doses •Yourdoctor maythen increase yourdose to a total daily aose of 40 mg each day
Elderly:
•Yourdoctor may prescribe a lower dose •You should be careful during very hot or very cold weather to make sure that you do not get too hot or too cold.
Children (over 1 year of age and weighing more than 10 kg): Stopping your child feeling sick or
being sick:
•Yourdoctor will decide the dose accordingyourchild’s weight •A dose of0.25 mg for each kilogram of your child’s weight is usually given •This dose may be given two or three times a day
If you take more Stemetil Tablets than you should
If you take more Stemetil Tabletsthan you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. Taking too much Stemetil Tablets may cause symptoms such as feeling sleepy or dizzy, increased or rapid heartbeat, feeling very cold and confused, writhing movements, feeling restless, stiffness or shaking. You may lose consciousness.
If you forget to take Stemetil Tablets
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to makeup for a forgotten dose.
If you stop taking Stemetil Tablets
Keep taking Stemetil Tablets until your doctortellsyou to stop. Do not stop taking Stemetil Tablets just becauseyou feel better. If you stop, your illness may come backand you may have other effects such as feeling or being sick or difficulty sleeping. Yourdoctor will gradually stop your medicine to prevent these effects happening.
Exposure to sunlight
Stemetil Tablets can cause your skin to be more sensitive to sunlight. You should avoid exposure to direct sunlight while taking this medicine.
Tests
Yourdoctor may do regulartests while you are taking this medicine. These might include blood tests and an ECG to checkyour heart is working properly.
If you have any further questions on the use of this product, askyourdoctoror pharmacist.
4. Possible side effects
Like all medicines, Stemetil Tablets can cause side effects, although not everybody gets them.
Stop taking Stemetil Tablets and see a
doctor or go to a hospital straight away if:
• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling ofyour lips, face, throat ortongue
• You have an unusually pale complexion, sweating, high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called ‘neuroleptic malignant syndrome’
• You have frequent infections such as fever, sore throat or mouth ulcers. These could be signs of a blood problem called leucopenia
• You may get infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• You have yellowing ofyourskin or eyes (jaundice). These coula be signs of liver problems
• You haveveryfast, uneven orforceful heartbeats (palpitations) and experience breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain
• You have blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which maytravel through blood vesselstothe lungseausing chest pain and difficulty in breathing. Ifyounoticeanyofthesesymptoms mg seek medical advice immediately
• You have rigid or stiff muscles, trembling orshaking, unusual eye movements (including rolling of the eyes), difficulty moving, or loss of muscle power
Tell your doctor as soon as possible if you have any of the following side effects:
• Breathing problems
• Changes in yourskin or eye colourafter taking Stemetil Tablets for a long period of time
• Problems with youreyesight after taking Stemetil Tablets for a long period of time
• Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)
• Passing large amountsof urine, excessive thirst and having adry mouth or skin. You may be more likely to get infections, such as thrush. This could be due to too much sugar in your blood (hyperglycaemia)
Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days
• Abnormal production of breast milk in men and women
• Breastenlargementin men
• Loss of menstrual periods
• Difficulty in getting or maintainingan erection (impotence)
• Difficultysleeping(insomnia)
• Feeling restless or agitated
• Dry mouth
• Yourskin being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
• Skin redness, swelling and itching from touching the medicine
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotics compared with those not receiving antipsychotics.
Reporting of side effects
If you get any side effects, talkto yourdoctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3,
Rue D'Argens, GZR-1368 Gzira
Website: www.medicinesauthority.gov.mt
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Stemetil Tablets
Keep this medicine in a safe place where children cannot see or reach it.
Do not use Stemetil Tablets after the expiry date which is stated on the blister and carton, after EXP. The expiry date refers to the last day of that month.
Store protected from light.
Medicines should not be disposed of via wastewater or household waste. Askyour pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Stemetil Tablets contains
• Each tablet contains 5 mg of the active substance, prochlorperazine maleate.
• The other ingredients are lactose, maize starch, aerosil (E551) and magnesium stearate
What Stemetil Tablets look like and contents of the pack
Stemetil Tablets are off-white to pale cream coloured circular tablets. The tablets marked “STEMETIL” and “5” on one side
Stemetil Tablets are available in blister packs containing 28 or 84 tablets.
Marketing Authorisation Holder and Manufacturer
MarketingAuthorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey,
GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U. Avda. Leganes, 62,
Alcorcon 28923 (Madrid) Spain
This leaflet does not contain all the information about your medicine. If you have any questions orare not sure about anything, askyourdoctoror pharmacist.
This leaflet was last revised in 06/2013 ©Sanofi, 1973 - 2013
4
11503013-06