Stelazine 1MG and 5MG Tablets and Stelazine 1mg/5ml Syrup (Trifluoperazine hydrochloride)

Stelazine 1MG and 5MG Tablets and Stelazine 1mg/5ml Syrup (Trifluoperazine hydrochloride)

What Stelazine Tablets are and what they are used for

Stelazine Tablets contain the active ingredient trifluoperazine hydrochloride, which belongs to a class of drugs called phenothiazine tranquilisers. 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 Tablets are used to manage anxiety and depression. It is used in this way for short periods of time.

Stelazine tablets may also be used to treat nausea (feeling sick) and vomiting (being sick).

At high doses, Stelazine Tablets are used to treat and prevent relapses of schizophrenia (a serious mental illness) and related conditions.

Before you take Stelazine Tablets

DO NOT take Stelazine Tablets if:

• You know that you are allergic to trifluoperazine hydrochloride or any of the other ingredients of Stelazine Tablets.
• You are suffering from liver problems, blood disorders, inability of the heart to maintain adequate circulation causing breathlessness and swelling of the ankles.
• 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 and eyes). Ask your doctor about this.
• You are having a special X-ray examination of the brain or spinal cord involving a chemical called metrizamide (your doctor will be able to help you).

Take special care with Stelazine Tablets 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, abnormal muscle weakness (Myasthenia gravis) or enlargement of prostate gland.
• exposed to extremes in temperature as this medicine can affect body temperature control.
• an elderly person.

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.

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.
• anaesthetics used prior to surgery.
• 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.

Taking Stelazine Tablets with food and drink

You should not drink alcohol whilst you are taking this medicine.

Pregnancy and breast feeding

Do not take Stelazine Tablets 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” Tablets during the first three months of pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Stelazine” Tablets 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 Tablets

This medicine also contains sucrose. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine.

How to take Stelazine Tablets

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

Swallow the tablets with a glass of water. The tablets can be taken with or without food.

Your doctor will decide on a suitable dose depending on your condition.

Adults:

The normal adult dose for anxiety or vomiting is 2-6mg daily, and for schizophrenia is 10-15mg daily. The dose may be split over two or three times a day.

Children:

For children aged 6-12 years the dose for anxiety or nausea and vomiting is no more than 4mg a day and for children aged under 12 years the starting dose for schizophrenia is no more than 5mg a day.

The pharmacist’s label on your pack will tell you how much and how often you should take your tablets. Please read the label carefully. Do not take more than your doctor has recommended. 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 are also taking other medicines.

Important information about some of the ingredients of Stelazine⁸ 1 mg/5ml Syrup

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

How to take Stelazine 1mg/5ml Syrup

Always take Stelazine 1 mg/5ml Syrup 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 “Stelazine’^;

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 2 mg 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	The starting dose of syrup should be no more than half that of adult patients
Children	For children aged 3-5 years, the dose is no more than 1mg a day. For children aged 6-12 years the dose is no more than 4mg a day.	High dose in children (aged 6-12 years) is 5mg in divided doses.

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 Tablets 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 tablets 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 Tablets than you should:

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

If you forget to take your Stelazine Tablets:

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.

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” Tablets can sometimes cause side effects, although not everybody gets them.

Stop taking Stelazine Tablets immediately and call your doctor if you experience signs of allergic reaction.

Signs of an allergic reaction include a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Tell your doctor straight away if you notice any of the following

Serious side effects:

• 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.
• Rarely, Stelazine” Tablets 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 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.
• Very occasionally, medicines such as Stelazine Tablets 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.
• Very rarely, patients may also experience a fast or irregular heartbeat, constipation, difficulty or inability to pass urine or a high temperature.
• Occasionally, some patients have complained of feeling slowed down, whilst others of being agitated.
• If you have angina and your pain is getting worse.
• There have been very rare reports of jaundice (yellowing of skin and whites of eyes), eye problems, skin colouring (pigmentation) and blood problems.
• 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, weight gain, water retention causing swelling or confusion.

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.

How to store Stelazine Tablets

Keep out of the reach and sight of children.

Do not use Stelazine Tablets after the expiry date which is stated on the box. If your tablets are out of date, take them to your pharmacist who will get rid of them safely.

Do not store above 25°C. Store in the original package.

Further information

The active substance in Stelazine” Tablets is trifluoperazine hydrochloride. Stelazine” Tablets are available in two strengths, containing either 1 mg or 5 mg trifluoperazine hydrochloride. Stelazine” Tablets also contains sucrose, calcium sulphate dihydrate, maize starch, gelatin, talc, stearic acid, carnauba wax (E903) and opadry OY-4492 blue.