Document: leaflet MAH GENERIC_PL 17780-0458 change

• leaflet MAH BRAND_PLPI 18799-2523
• leaflet MAH BRAND_PLPI 30900-2115
• leaflet MAH GENERIC_PL 17780-0458

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PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Pericyazine 2.5mg Tablets

Read all of this leaflet carefully before you

start taking this medicine because it

contains information important for you.

•    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 signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What pericyazine is and what it is used for

2.    What you need to know before you take pericyazine

3.    How to take pericyazine

4.    Possible side effects

5.    How to store pericyazine

6.    Contents of the pack and other information

1. What pericyazine is and what it is used for

The name of your medicine is Pericyazine 2.5mg Tablets (referred to as pericyazine throughout this leaflet).This belongs to a group of medicines called ‘phenothiazines’. It works by blocking the effect of a chemical in the brain. It can be used for:

•    Schizophrenia

•    The short term treatment of anxiety, agitation and violent or dangerously impulsive behaviour when used with other medicines

2. What you need to know before you take pericyazine

XDo not take this medicine and tell your doctor if:

X You are allergic (hypersensitive) to

pericyazine or any of the other ingredients in this medicine (listed in Section 6)

X Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue X You are pregnant, might become pregnant or think you may be pregnant (see Section below: ‘Pregnancy and breast-feeding’)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking pericyazine.

HI

Warnings and Precautions Talk to your doctor or pharmacist before you take this medicine if:

▲    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 Parkinson’s disease

▲    You have dementia

▲    You have epilepsy or have had fits (seizures)

▲    You have depression

▲    You have ever had alcohol problems

▲    You have an enlarged prostate gland

▲    You have had glaucoma (painful eyes with blurred vision)

▲    You have a tumour on the adrenal gland called ‘phaeochromocytoma’

▲    You have a form of muscle weakness called ‘myasthenia gravis’

▲    You have a low number of white blood cells (agranulocytosis). This means you may get infections more easily than usual. Your doctor may do blood tests to check this

▲    You have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these

▲    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

▲    You are not eating properly

▲    You are allergic to other phenothiazine medicines such as prochlorperazine

▲    You are elderly, this is because elderly people are more likely to get certain side effects particularly during very hot or very cold weather. In these conditions, you could be at risk of hyperthermia or hypothermia

▲    You are elderly and also have dementia, tell your doctor if this is the case

▲    You are diabetic or have high levels of sugar in your blood (hyperglycaemia). Your doctor may want to monitor you more closely.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before you take pericyazine.

Turn

Over

Other medicines and pericyazine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because pericyazine can affect the way some other medicines work. Also some medicines can affect the way pericyazine works. In particular, check with your doctor if you are taking any of the following:

•    Medicines to control your heartbeat such as amiodarone, disopyramide or quinidine

•    Medicines for high blood pressure such as doxazosin, terazosin, guanethidine, clonidine or propranolol

•    Medicines for indigestion and heartburn (antacids)

•    Medicines for diabetes

•    Medicines for Parkinson’s disease such as levodopa or selegiline

•    Medicines for fits (epilepsy) such as carbamazepine or phenobarbital

•    Medicines to help you sleep or lower your anxiety

•    Other medicines used to calm emotional and mental problems

•    Medicines for depression

•    Some medicines used for infections (antibiotics) such as moxifloxacin

•    Some medicines used for cancer (cytotoxics)

•    Amphetamines - used for Attention Deficit Hyperactivity Disorder (ADHD)

•    Anticholinergic medicines - includes some medicines used for irritable bowel syndrome, asthma or incontinence

•    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

Pericyazine with alcohol

Do not drink alcohol while being treated with pericyazine. This is because alcohol can add to the effects of pericyazine and cause serious breathing problems.

Pregnancy and breast-feeding

Do not take this medicine if:

•    You are pregnant, might become pregnant or think you may be pregnant

Do not breast-feed if you are being given pericyazine. This is because small amounts may pass into mothers’ milk. If you are breast-feeding or planning to breast-feed talk to your doctor or pharmacist before taking any medicine.

The following symptoms may occur in newborn babies of mothers that have used pericyazine 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.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy after taking this medicine. If this happens, do not drive or use any tools or machines.

Pericyazine tablets contain lactose and methylhydroxybenzoate

•    Lactose. This medicine contains lactose, a type of sugar. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking pericyazine tablets

•    Methylhydroxybenzoate. This medicine contains methylhydroxybenzoate, a type of preservative. This may cause allergic reactions which may not happen straight away. Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

3. How to take pericyazine

Always take pericyazine 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

•    Swallow the tablets whole with a drink of water

•    Do not touch the tablets for any longer than is necessary 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

Recommended dose Adults

Schizophrenia

•    The starting dose is 75mg daily in divided doses

•    The dose may be increased by 25mg per day at weekly intervals depending on your illness

•    The highest dose is usually not more than 300mg per day

Anxiety, agitation and violent or dangerously impulsive behaviour

•    The starting dose is 15mg to 30mg daily, divided into two doses. The larger dose should be taken in the evening

Elderly

Schizophrenia

•    The starting dose is 15mg to 30mg daily, in divided doses

•    The dose may then be increased depending on your illness

Anxiety, agitation and violent or dangerously impulsive behaviour

•    The starting dose is 5mg to 10mg daily, divided into two doses. The larger dose should be taken in the evening

Use in children

Pericyazine is not recommended for children. Exposure to sunlight

Pericyazine can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine.

Tests

Before and during treatment your doctor may want to carry out some tests. These might include blood tests and an ECG to check your heart is working properly.

If you take more pericyazine than you should

If you take more pericyazine 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. The following effects may happen: feeling drowsy, loss of consciousness, increased or rapid heartbeat, changes in heart beat, uneven heart beats and feeling very cold. You may also experience dizziness, light-headedness, fainting (due to low blood pressure) and movements that you cannot control (for example of the eyes, neck, arms and legs).

If you forget to take pericyazine

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 tablet.

If you stop taking pericyazine

Keep taking pericyazine until your doctor tells you to stop. Do not stop taking pericyazine just because you feel better. If you stop taking pericyazine suddenly, your illness may come back and you may have other effects such as feeling or being sick and difficulty sleeping. In some cases you may also get symptoms such as feeling restless or movements that you cannot control (for example of the eyes, neck, arms and legs).

Your doctor will gradually stop your medicine to prevent these effects happening.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking pericyazine and see a doctor or

go to a hospital straight away if:

•    You have swelling, pain or redness in your legs as this could be a sign of a blood clot (deep vein thrombosis).

•    You have chest pain or difficulty in breathing as this could be a sign of a blood clot which has travelled through blood vessels to the lungs (pulmonary embolism)

•    You have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swelling

•    You have yellowing of the skin or eyes (jaundice). These could be signs of liver damage

•    You have frequent infections such as fever, severe chills, 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 movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs

•    You have a high temperature, sweating, stiff muscles, fast heartbeat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called ‘neuroleptic malignant syndrome’