STEMETIL 5 MG TABLETS - patient leaflet, side effects, dosage

3. How to take Stemetil Tablets

Always take Stemetil Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth
• Do not give to children under 1 year of age or who weigh less than 10 kg
• You should not let the tablets touch your skin for very long, as you may get skin redness, swelling and itching (contact skin sensitisation)
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
• 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 to 5 to 10 mg each day
• The usual dose is 5 or 10 mg
• This may be taken two or three times each day
• Tobegin with you will usually take 20 mg
• This may be followed by 10 mg two hours later
• The starting dose is usually 12.5 mg twice each day for seven days
• Your doctor may increase your dose 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
• The starting dose will be 15 to 20 mg each day in divided doses
• Your doctor may then increase your dose to a total daily dose of 40 mg each day
• Your doctor 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.
• Your doctor will decide the dose according your child’s weight
• A dose of 0.25 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 Tablets than 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 make up for a forgotten dose.

If you stop taking Stemetil Tablets

Keep taking Stemetil Tablets until your doctor tells you to stop. Do not stop taking Stemetil Tablets just because you feel better.

If you stop, your illness may come back and you may have other effects such as feeling or being sick or difficulty sleeping. Your doctor 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

Your doctor may do regular tests while you are taking this medicine. These might include blood tests and an ECG to check your heart is working properly.

If you have any further questions on the use of this product, ask your doctor or 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 of your lips, face, throat or tongue
• 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 of your skin or eyes (jaundice). These could be signs of liver problems
• You have very fast, uneven or forceful 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 may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately
• You have rigid or stiff muscles, trembling or shaking, unusual eye movements (including rolling of the eyes), difficulty moving, or loss of muscle power
• Breathing problems
• Changes in your skin or eye colour after taking Stemetil Tablets for a long period of time
• Problems with your eyesight 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 amounts of urine, excessive thirst and having a dry 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)
• Abnormal production of breast milk in men and women
• Breast enlargement in men
• Loss of menstrual periods
• Difficulty in getting or maintaining an erection (impotence)
• Difficulty sleeping (insomnia)
• Feeling restless or agitated
• Dry mouth
• Your skin 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, talk to your doctor, 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:

Malta

ADR Reporting, The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GZR-1368 Gzira

Website:

e-mail:

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.
• Stemetil Tablets should be stored below 25°C and protected from strong light.
• 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.
• If the tablets become discoloured or show signs of any deterioration, you should consult your pharmacist who will advise you what to do.

• 6. Further information

What Stemetil Tablets look like and contents of the pack

Stemetil 5mg Tablets are pale cream, round tablets marked ‘STEMETIL 5’ on one side and plain on the reverse.

Stemetil 5mg Tablets are available as blister packs of 100 tablets

PL 18799/2514

This product is manufactured by: Famar Health Care Services Madrid S.A.U., Alcorcon, Spain. and is procured from within the EU and repackaged by the Product Licence holder:

B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex,HA4 0NU, UK. Leaflet revision and issue date (Ref.) 15.03.2017

Stemetil is a registered trademark of MAY & BAKER Ltd.

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