Trifluoperazine 1mg/5ml Syrup

Document: leaflet MAH BRAND_PLPI 18799-2484 change

PATIENT INFORMATION LEAFLET

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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE STELAZINE

Keep this medicine out of the sight and reach of children.

Do not use Stelazine after the expiry date which is stated on the carton and bottle label after ‘Exp'. The expiry date refers to the last day of that month.

Do not store above 25⁰C.

Store in the original container in order to protect from light.

Do not throw away medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION

What Stelazine contains

The active substance in Stelazine is trifluoperazine hydrochloride. Each 5ml syrup contains 1mg of trifluoperazine present as hydrochloride.

Stelazine also contains sodium saccharin, sodium benzoate (E211), citric acid anhydrous (E330), sodium citrate, sorbitol (E420), quinoline yellow (E104), sunset yellow (E110), peach flavour and purified water. What Stelazine looks like and contents of the pack Stelazine is a clear pale yellow, peach flavoured syrup and comes in amber glass bottles, containing 200ml syrup.

Manufactured by: Universal Products Ltd., Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, UK.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Stelazine® 1mg/5ml Syrup ¹-

PL 18799/2484

Leaflet date: 18.08.2015

Stelazine® 1mg/5ml Syrup

(trifluoperazine hydrochloride)

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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Stelazine 1mg/5ml Syrup but it will be referred as Stelazine throughout this leaflet.

In this leaflet:

1. What Stelazine is and what it is used for

2. Before you take Stelazine

3. How to take Stelazine

4. Possible side effects

5. How to store Stelazine

6. Further information

1. WHAT STELAZINE IS AND WHAT IT IS USED FOR

Stelazine contains the active ingredient trifluoperazine hydrochloride, which belongs to a class of drugs called phenothiazine tranquilisers, also referred to as a neuroleptic drug. It influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain.

• At a low dose, Stelazine is used to manage anxiety and depression. It is used in this way for short periods of time. Stelazine may also be used to treat nausea (feeling sick) and vomiting (being sick).

• At high doses, Stelazine is used to treat and prevent relapses of schizophrenia (a serious mental illness). It can also be used for short periods of time to treat bad agitation or dangerous behaviour.

2. BEFORE YOU TAKE STELAZINE

DO NOT take Stelazine if:

• You know that you are allergic to trifluoperazine hydrochloride or any of the other ingredients of Stelazine (see section 6 of this leaflet).

• You are suffering from liver problems, blood disease, inability of the heart to maintain adequate circulation causing breathlessness and swelling of the ankles.

• If you have previously had to stop taking other medicines for psychiatric problems like stelazine (known as phenothiazines) because they have affected your blood cells or caused jaundice (yellowing of the skin or eyes). Ask your doctor about this.

Take special care with Stelazine and tell your doctor if you are:

• suffering from any disease involving the heart and blood vessels (cardiovascular disease) including chest pain (angina) and irregular heart beats

• suffering from a brain disorder causing tremors, rigidity and slowing of movement (Parkinson’s disease)

• suffering from fits (epilepsy)

• suffering from an eye disease called narrow angle glaucoma which causes increased pressure inside the eye

• suffering from abnormal muscle weakness (Myasthenia gravis)

• suffering from an enlargement of prostate gland

• exposed to extremes in temperature as this medicine can affect body temperature control

• an elderly person

• if you suffer from loss of cognitive (memory, language, intelligence) ability - dementia

• if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

• if you have had a stroke or have any of the following that can increase your risk of having a stroke (e.g. heart attack, uncontrolled high blood pressure, diabetes, family history of strokes, you smoke or drink excess alcohol)

Even though some of the above may appear obvious, it is important

that your doctor is aware if any of them apply to you.

Patient Type

Low dosage For the treatment of anxiety or nausea and vomiting

High dosage For the control of schizophrenia and related conditions

Adults

The usual dose is 2mg to 6mg a day

High dose in adults is 5-25mg a day in divided doses

Elderly

(over 65 years of age)

The starting dose of syrup should be no more than half that of adult patients

Children	For children aged 3-5	High dose in children
	years, the dose is no	(aged 6-12 years) is
	more than 1mg a day.	5mg in divided
	For children aged 6-12 years the dose is no more than 4mg a day.	doses.

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.

The effects of these medicines may change, especially if you are taking:

• sleeping tablets,

• strong pain killers (e.g. codeine)

• medicines which result in lowering of blood pressure (e.g. guanethidine)

• anticholinergic medicines used to reduce saliva and lung secretions (e.g. atropine, procyclidine)

• antidepressants (e.g. other phenothiazines, lithium)

• medicines for fits (anticonvulsants)

• medicines for Parkinson’s disease (e.g. levodopa)

• blood thinning medicines (anticoagulants such as warfarin)

• medicines used to treat iron poisoning (desferrioxamine)

• antacids used to treat indigestion.

• medicines for psychiatric conditions (neuroleptics)

• heart medicines which prolong the QT interval (e.g quinidine, disopyramide, procainamide, amiodarone, sotalol)

• drugs causing electrolyte imbalances (e.g diuretics)

You should tell your doctor or dentist that you are taking Stelazine before being given an anaesthetic.

Taking Stelazine with food and drink

You should not drink alcohol whilst you are taking this medicine. Stelazine can be taken with or without food.

Pregnancy and breast-feeding

Do not take Stelazine if you are pregnant, think you may be pregnant or are planning to become pregnant, or while breast-feeding, unless your doctor decides that treatment is essential. It is particularly important not to take Stelazine during the first three months of pregnancy.

Ask your doctor or pharmacist for advice before taking any medicine. The following symptoms may occur in newborn babies, of mothers that have used Trifluoperazine 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

Stelazine may make you feel drowsy or dizzy or give you blurred vision. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.

Important information about some of the ingredients of Stelazine

This medicine also contains:

Sorbitol (E420), which is a sugar. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine. Sorbitol can also cause stomach upset and diarrhoea in some patients.

Sunset yellow (E110) which may cause allergic reactions.

Sodium benzoate which may increase the risk of jaundice in newborn babies. This medicinal product contains 55.22mmol sodium per dose. To be taken into consideration for patients on a controlled sodium diet.

3. HOW TO TAKE STELAZINE

Always take Stelazine exactly as your doctor has told you. The pharmacist's label on your pack will tell you how much and how often you should take your Syrup. Please read the label carefully. You should check with your doctor or pharmacist if you are not sure. Do not take more than your doctor has recommended.

Your doctor will decide on a suitable dose depending on your condition. The usual dose is shown in the table below. You will usually need to take your medicine twice or three times a day, depending on the dose your doctor has chosen for you.

Remember each 5ml spoonful of syrup contains 1mg of ‘Trifluoperazine'

During treatment your doctor should regularly check you for physical side effects, changes in your blood counts or liver function, and any heart problem, especially if you taking this medicine for a long time or are also taking other medicines.

If you stop taking Stelazine

Continue to take Stelazine even if you no longer feel ill. Do not stop taking this medicine without talking with your doctor first, especially if you have taken large doses for a long time. When the time comes to stop your doctor will probably decrease your dose gradually as stopping the Syrup suddenly may cause ill-effects such as nausea (feeling sick), vomiting (being sick), sweating and difficulty in sleeping. For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine. If you stop taking this medicine suddenly, your symptoms may come back.

If you take more Stelazine than you should:

If you think that you, or any other person, have taken too much Syrup, contact your doctor or hospital casualty department immediately. Take this leaflet and any remaining Syrup with you so that the medical staff know exactly what you have taken.

If you forget to take your Stelazine :

If you miss a dose, wait until your next dose. Do not take the dose you have missed. You can then carry on as before. Do not take more than one dose at a time.

4. POSSIBLE SIDE EFFECTS

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. Like all medicines, Stelazine can sometimes cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following:

• Very rarely, patients may experience a fast or irregular heart beat, constipation, difficulty or inability to pass urine or a high temperature.

• Rarely, Stelazine can affect certain types of breast cancers or lead to breast enlargement in men or to inappropriate milk production or altered menstrual cycle (e.g. periods stop).

• Rarely patients may develop Neuroleptic Malignant Syndrome. This causes a high temperature, rigid muscles, drowsiness, occasional loss of consciousness, and requires emergency admission to hospital for treatment.

• If you have chest pain (angina) and your pain is getting worse.

• Very occasionally, medicines such as Stelazine can have effects on muscle control. If this happens, symptoms can include slurred speech, odd movements of the face, particularly of the tongue, eyes, head or neck (such as twisting of the neck which causes an unnatural positioning of the head, rigid muscles, tremors or restlessness and difficulty in sitting still). Some patients (especially on high doses of this medicine) experience problems with muscle control which may continue for years. Such patients may experience constant chewing or tongue movements or other gentle movements of the neck, head or trunk. Uncontrollable movements of the arms and legs have also been reported in these patients.

• Occasionally, some patients have complained of feeling slowed down, whilst

• Rarely, jaundice (yellowing of skin and whites of eyes), eye problems, skin colouring (pigmentation) and blood problems.

• If you suffer from a sore throat, high fever, feel very tired, become pale, develop bruises and nose bleeds. These may indicate blood problems developing as a result of using this 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.

Some patients may also experience weakness, drowsiness, dizziness, restlessness, difficulty in sleeping, dry mouth, blurred vision, muscle weakness, loss of appetite, faintness on standing up, skin rashes (including increased sensitivity to the sun), weight gain, water retention causing swelling or confusion.

Your doctor should check your progress regularly if you are on Stelazine to make sure no unwanted effects are developing.

Reporting of side effects

By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE TRIFLUOPERAZINE

Keep this medicine out of the sight and reach of children.

Do not use Trifluoperazine after the expiry date which is stated on the carton and bottle label after ‘Exp'. The expiry date refers to the last day of that month.

Do not store above 25⁰C.

Store in the original container in order to protect from light.

Do not throw away medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. FURTHER INFORMATION

What Trifluoperazine contains

The active substance in Trifluoperazine is trifluoperazine hydrochloride.

Each 5ml syrup contains 1mg of trifluoperazine present as hydrochloride.

Trifluoperazine also contains sodium saccharin, sodium benzoate (E211), citric acid anhydrous (E330), sodium citrate, sorbitol (E420), quinoline yellow (E104), sunset yellow (E110), peach flavour and purified water.

What Trifluoperazine looks like and contents of the pack

Trifluoperazine is a clear pale yellow, peach flavoured syrup and comes in amber glass bottles, containing 200ml syrup.

Manufactured by: Universal Products Ltd., Fairfield, Bradshaw Lane, Greenhalgh, Kirkham, Preston, Lancashire, PR4 3JA, UK.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

Trifluoperazine® 1mg/5ml Syrup ^ ^

PL 18799/2484

Leaflet date: 18.08.2015

Trifluoperazine 1mg/5ml Syrup

(trifluoperazine hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Trifluoperazine 1mg/5ml Syrup but it will be referred as Trifluoperazine throughout this leaflet.

In this leaflet:

1. What Trifluoperazine is and what it is used for

2. Before you take Trifluoperazine

3. How to take Trifluoperazine

4. Possible side effects

5. How to store Trifluoperazine

6. Further information

1. WHAT TRIFLUOPERAZINE IS AND WHAT IT IS USED FOR

Trifluoperazine contains the active ingredient trifluoperazine hydrochloride, which belongs to a class of drugs called phenothiazine tranquilisers, also referred to as a neuroleptic drug. It influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain.

• At a low dose, Trifluoperazine is used to manage anxiety and depression. It is used in this way for short periods of time. Trifluoperazine may also be used to treat nausea (feeling sick) and vomiting (being sick).

• At high doses, Trifluoperazine is used to treat and prevent relapses of schizophrenia (a serious mental illness). It can also be used for short periods of time to treat bad agitation or dangerous behaviour.

2. BEFORE YOU TAKE TRIFLUOPERAZINE

DO NOT take Trifluoperazine if:

• You know that you are allergic to trifluoperazine hydrochloride or any of the other ingredients of Trifluoperazine (see section 6 of this leaflet).

• You are suffering from liver problems, blood disease, inability of the heart to maintain adequate circulation causing breathlessness and swelling of the ankles.

• If you have previously had to stop taking other medicines for psychiatric problems like Trifluoperazine (known as phenothiazines) because they have affected your blood cells or caused jaundice (yellowing of the skin or eyes). Ask your doctor about this.

Take special care with Trifluoperazine and tell your doctor if you

are:

• suffering from any disease involving the heart and blood vessels (cardiovascular disease) including chest pain (angina) and irregular heart beats

• suffering from a brain disorder causing tremors, rigidity and slowing of movement (Parkinson’s disease)

• suffering from fits (epilepsy)

• suffering from an eye disease called narrow angle glaucoma which causes increased pressure inside the eye

• suffering from abnormal muscle weakness (Myasthenia gravis)

• suffering from an enlargement of prostate gland

• exposed to extremes in temperature as this medicine can affect body temperature control

• an elderly person

• if you suffer from loss of cognitive (memory, language, intelligence) ability - dementia

• if you or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots

Even though some of the above may appear obvious, it is important

that your doctor is aware if any of them apply to you.

Patient Type

Low dosage For the treatment of anxiety or nausea and vomiting

High dosage For the control of schizophrenia and related conditions

Adults

The usual dose is 2mg to 6mg a day

High dose in adults is 5-25mg a day in divided doses

Elderly

(over 65 years of age)

The starting dose of syrup should be no more than half that of adult patients

Children	For children aged 3-5	High dose in children
	years, the dose is no	(aged 6-12 years) is
	more than 1mg a day.	5mg in divided
	For children aged 6-12 years the dose is no more than 4mg a day.	doses.

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.

The effects of these medicines may change, especially if you are taking:

• sleeping tablets,

• strong pain killers (e.g. codeine)

• medicines which result in lowering of blood pressure (e.g. guanethidine)

• anticholinergic medicines used to reduce saliva and lung secretions (e.g. atropine, procyclidine)

• antidepressants (e.g. other phenothiazines, lithium)

• medicines for fits (anticonvulsants)

• medicines for Parkinson’s disease (e.g. levodopa)

• blood thinning medicines (anticoagulants such as warfarin)

• medicines used to treat iron poisoning (desferrioxamine)

• antacids used to treat indigestion.

• medicines for psychiatric conditions (neuroleptics)

• heart medicines which prolong the QT interval (e.g quinidine, disopyramide, procainamide, amiodarone, sotalol)

• drugs causing electrolyte imbalances (e.g diuretics)

You should tell your doctor or dentist that you are taking Trifluoperazine before being given an anaesthetic.

Taking Trifluoperazine with food and drink

You should not drink alcohol whilst you are taking this medicine. Trifluoperazine can be taken with or without food.

Pregnancy and breast-feeding

Do not take Trifluoperazine if you are pregnant, think you may be pregnant or are planning to become pregnant, or while breast-feeding, unless your doctor decides that treatment is essential. It is particularly important not to take Trifluoperazine during the first three months of pregnancy.

Driving and using machines

Trifluoperazine may make you feel drowsy or dizzy or give you blurred vision. You should not drive or use machines when you first start to take this medicine until you are certain that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use machines.

Important information about some of the ingredients of Trifluoperazine

This medicine also contains:

Sunset yellow (E110) which may cause allergic reactions.

3. HOW TO TAKE TRIFLUOPERAZINE

Always take Trifluoperazine exactly as your doctor has told you. The pharmacist's label on your pack will tell you how much and how often you should take your Syrup. Please read the label carefully. You should check with your doctor or pharmacist if you are not sure. Do not take more than your doctor has recommended.

Remember each 5ml spoonful of syrup contains 1mg of ‘Trifluoperazine'

If you stop taking Trifluoperazine

Continue to take Trifluoperazine even if you no longer feel ill. Do not stop taking this medicine without talking with your doctor first, especially if you have taken large doses for a long time. When the time comes to stop your doctor will probably decrease your dose gradually as stopping the Syrup suddenly may cause ill-effects such as nausea (feeling sick), vomiting (being sick), sweating and difficulty in sleeping.

For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine. If you stop taking this medicine suddenly, your symptoms may come back.

If you take more Trifluoperazine than you should:

If you forget to take your Trifluoperazine :

If you miss a dose, wait until your next dose. Do not take the dose you have missed. You can then carry on as before. Do not take more than one dose at a time.

4. POSSIBLE SIDE EFFECTS

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. Like all medicines, Trifluoperazine can sometimes cause side effects, although not everybody gets them.

Tell your doctor immediately if you notice any of the following:

• Very rarely, patients may experience a fast or irregular heart beat, constipation, difficulty or inability to pass urine or a high temperature.

• Rarely, Trifluoperazine can affect certain types of breast cancers or lead to breast enlargement in men or to inappropriate milk production or altered menstrual cycle (e.g. periods stop).

• If you have chest pain (angina) and your pain is getting worse.

• Very occasionally, medicines such as Trifluoperazine can have effects on muscle control. If this happens, symptoms can include slurred speech, odd movements of the face, particularly of the tongue, eyes, head or neck (such as twisting of the neck which causes an unnatural positioning of the head, rigid muscles, tremors or restlessness and difficulty in sitting still). Some patients (especially on high doses of this medicine) experience problems with muscle control which may continue for years. Such patients may experience constant chewing or tongue movements or other gentle movements of the neck, head or trunk. Uncontrollable movements of the arms and legs have also been reported in these patients.

• Occasionally, some patients have complained of feeling slowed down, whilst

• Rarely, jaundice (yellowing of skin and whites of eyes), eye problems, skin colouring (pigmentation) and blood problems.

• If you suffer from a sore throat, high fever, feel very tired, become pale, develop bruises and nose bleeds. These may indicate blood problems developing as a result of using this 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.

Your doctor should check your progress regularly if you are on Trifluoperazine to make sure no unwanted effects are developing.