What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL17780/0459.


Pericyazine 10mg Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pericyazine 10mg Tablets

Read all of this leaflet carefully before you are given this medicine because it contains important information 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 only. Do not pass it on to others. It may harm them, even if their symptoms 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.

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 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. Before you take pericyazine

Do not take this medicine and tell your doctor if:

  • 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
  • You are pregnant, might become pregnant or think you may be pregnant (see Section below: ‘Pregnancy and breast-feeding’)
  • You have urine retention due to a prostate disorder
  • You are taking a dopaminergic antiparkinsonism drug
  • You have increased pressure in the eye (glaucoma)
  • You have a history of a low white blood cell count
  • It is intended for a child younger than 1 year.

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 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.

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 including amitriptyline and amitriptylinoxide
  • Some medicines used for infections (antibiotics) such as moxifloxacin
  • Some medicines used for cancer (cytotoxics)
  • Medicines which can alter electrolytes (salt levels) in your blood
  • 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

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 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 tablets

  • Lactose. This medicine contains lactose, a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
  • 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. This medicine contains 0.003 mg benzoate salt in each tablet.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

How much to take

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 to10mg daily, divided into two doses. The larger dose should be taken in the evening

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, 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 (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 get a bloated feeling and cramping pain in the abdomen (stomach) be sick (vomit) have indigestion, heartburn, upset stomach, constipation, loss of appetite, dry mouth. This could be caused by an obstruction or blockage of the intestine.
  • 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, light-headed 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)
  • Problems with eyesight
  • You have difficulty in passing water (urine)
  • Changes in eye colour.

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)
  • Reduced sexual desire in women
  • Feeling drowsy or sleepy
  • 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)
  • Putting on weight
  • Body temperature changes
  • Feeling anxious
  • Mood changes

Blood tests

  • The results of some blood tests may show higher levels of liver enzymes than normal.

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

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How to store pericyazine

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

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

Pericyazine tablets 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 Tablets contain

  • Each tablet contains 10mg of the active substance,pericyazine
  • The other ingredients are lactose, microcrystalline cellulose (E460), sodium starch glycollate, magnesium stearate, colloidal silicon dioxide (E551) and methylhydroxybenzoate (E218)

What pericyazine looks like and contents of the pack

Pericyazine 10mg Tablets are very pale lime-yellow with S172 on one face and a breakline on the other. Supplied in blisters of 84 and plastic bottles of 500 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Zentiva Pharma UK Limited
12 New Fetter Lane
London
EC4A 1JP
UK

The Manufacturer is:

Famar Health Care Services Madrid, S.A.U.
Avda. Leganés, 62
Alcorcón 28923 (Madrid)
Spain

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 2021.

‘Zentiva’ is a registered trademark © 2021 Zentiva.

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