PACKAGE LEAFLET:

INFORMATION FOR THE USER

Pericyazine 10mg/5ml Syrup

Read all of this leaflet carefully before you take

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

In this leaflet:

1.    What pericyazine is and what it is used for

2.    Before you take pericyazine

3.    How to take pericyazine

4.    Possible side effects

5.    How to store pericyazine

6.    Further Information

1. What pericyazine is and what it is used for

The name of your medicine is Pericyazine 10mg/5ml Syrup (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:

Adults

•    Schizophrenia

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

Children

•    Schizophrenia

•    Other behavioural problems

2. Before you take pericyazine

Do 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)

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

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.

Take special care with pericyazine Check with your doctor or pharmacist before you take this medicine if:

▲    You have liver or kidney problems

▲    You have thyroid problems

▲    You have heart problems or a family history of heart problems

▲    You have ever had a stroke

▲    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

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Packaging code : 302284 Old packaging code : 301227

Update : 26/03/2015 - V1

_Produ_ct : PERICYAZINE SYR 100ML

Packaging type : Leaflet

Country : GB Languages : EN

Graphic designer :CR Plant : Colomiers

Format : 157x210-DCPL3P8V Plant barcode : 284 Colors :

Pantone Reflex Blue

Fonts : Ocean Sans Pro SAN ZapfDingbats

Min font size used : 9.5 pt Logo version :

▲    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.

Taking other medicines

Please tell your doctor 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 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

Taking pericyazine with food and drink

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

Talk to your doctor or pharmacist before taking 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 breastfeed 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 difficultly 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.

Important information about some of the

ingredients of pericyazine

•    Sucrose. This medicine contains sucrose. If you have been told by your doctor that you cannot tolerate some sugars, talk to your doctor before taking pericyazine

•    Sodium. This syrup contains 28mg sodium per 5ml dose. To be taken into consideration by people on a controlled sodium diet.

•    Small amounts of sulphites. These may cause severe allergic reactions (hypersensitivity) and difficulty in breathing (bronchospasm). This is more likely to happen if you have a history of asthma or allergies. The chances of this happening are rare.

Tell a doctor or nurse straight away if you get a rash, swallowing or breathing problems and 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

•    Take care when taking the syrup and avoid skin contact as you may get skin redness, swelling and itching (contact skin sensitisation)

•    Take the medicine as directed by your doctor and pharmacist.

•    If you are not sure how much to take, check with them first.

•    If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

Turn

Over

Packaging code : 302284 Old packaging code : 301227

Update : 26/03/2015 - V1

_Produ_ct : PERICYAZINE SYR 100ML

Packaging type : Leaflet

Country : GB Languages : EN

Graphic designer :CR Plant : Colomiers

Format : 157x210-DCPL3P8V Plant barcode : 284 Colors :

Pantone Reflex Blue

Fonts : Ocean Sans Pro SAN ZapfDingbats

Min font size used : 9.5 pt Logo version :

How much to take Adults:

Schizophrenia and other behavioural problems

•    The starting dose is 37.5ml (75mg) daily in divided doses

•    The dose may be increased by 12.5ml (25mg) per day at weekly intervals depending on your illness

•    The highest dose is usually not more than 150ml (300mg) per day

Anxiety, agitation and violent or dangerously impulsive behaviour

•    The starting dose is 7.5ml to 15ml (15-30mg) daily in two divided doses. The larger dose should be taken in the evening

Elderly:

Schizophrenia and other behavioural problems

•    The starting dose is 7.5ml to 15ml (15-30mg) daily in divided doses

Anxiety, agitation and violent or dangerously impulsive behaviour

•    The starting dose is 2.5ml to 5ml (5-10mg) daily in two divided doses. The larger dose should be taken in the evening

Children (over 1 year of age):

Schizophrenia and other behavioural problems

•    Your doctor will decide on the dose according to the child’s weight

•    The initial dose for a child weighing 10kg is 0.25ml (0.5mg)

•    The dose should be increased by 0.5ml (1mg) for each additional 5kg of bodyweight up to a total dose of 5ml (10mg) daily

•    The highest dose that should be prescribed to keep the illness under control is twice that of the first dose given.

•    Pericyazine is not recommended for infants under 1 year of age

Anxiety, agitation and violent or dangerously impulsive behaviour

•    Pericyazine is not recommended for use in children with these conditions

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, lightheadedness, 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.

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 lower your dose until you 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, pericyazine 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 ₃

(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’

•    You have a very fast, uneven or forceful heartbeat (palpitations). You may also have breathing problems such as wheezing, shortness of breath, tightness in the chest and chest pain

•    You have a long lasting, painful erection of the penis

Tell a pharmacist or doctor as soon as possible if you have any of the following side effects:

•    You are breathing more slowly or less deeply than normal

•    Feeling restless and not being able to keep still (akathisia)

•    Feeling dizzy, lightheaded or faint when you stand or sit up quickly (due to low blood pressure)

•    Rigid or stiff muscles, trembling or shaking, difficulty moving

•    Passing large amounts of urine, excessive thirst and having a dry mouth or skin. You may also be more likely to get infections, such as thrush. This could be due to too much sugar in your blood (hyperglycaemia)

Talk to your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:

•    Abnormal production of breast milk in men and women

•    Breast enlargement in men

•    Loss of menstrual periods

•    Difficulty in getting or keeping an erection (impotence)

•    Difficulty sleeping (insomnia)

•    Feeling agitated

•    Dry mouth

•    Being more sensitive to the sun than usual

•    Stuffy nose

•    Skin rashes

•    Skin redness, swelling and itching (contact skin sensitisation)

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.goy.uk/vellowcard.

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

As with other phenothiazine medicines, there have been very rare reports of sudden death with pericyazine. These are possibly caused by heart 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.

5. How to store pericyazine

Keep this medicine in a safe place where children cannot see or reach it

Do not use pericyazine after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Discard any medicine remaining 1 month after opening the bottle. Pericyazine must be protected from 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.

6. Further Information

What Pericyazine 10mg/5ml Syrup contains

•    Each 1ml of syrup contains 2mg of the active substance, pericyazine

•    The other ingredients are sucrose, caramel, spearmint oil, peppermint oil, fruit cup 868, Polysorbate 20, citric acid anhydrous, sodium citrate, sodium sulphite anhydrous (E221), sodium metabisulphite (E223), ascorbic acid, sodium benzoate (E211) and purified water

What pericyazine syrup looks like and contents of the pack

•    Pericyazine syrup is a clear orange brown syrupy liquid. Supplied in 100ml and 1 litre amber glass bottles. Not all pack sizes may be sold.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Zentiva, One Onslow Street, Guildford, Surrey,

GU1 4YS, UK

The Manufacturer is:

Unither Liquid Manufacturing, 1-3 Allee de la Neste,

Z.I. d’en Signal, 31770 Colomiers, France

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about, anything, ask your doctor or pharmacist.

This leaflet was last revised in March 2015. ‘Zentiva' is a registered trademark © 2015 Zentiva.