Pericyazine 10 mg Tablets – patient leaflet, side effects, dosage

1. What pericyazine is and what it is used for

The name of your medicine is Pericyazine 10 mg 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

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.

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
• have ever had a stroke
• have liver or kidney problems
• have thyroid problems
• have Parkinson’s disease
• have dementia
• have epilepsy or have had fits (seizures)
• have depression

• have ever had alcohol problems

• have an enlarged prostate gland
• have had glaucoma (painful eyes with blurred vision)
• have a tumour on the adrenal gland called ‘phaeochromocytoma’
• have a form of muscle weakness called ‘myasthenia gravis’
• 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
• have low blood levels of potassium, calcium and magnesium. Your doctor may do blood tests to check on these
• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots
• are not eating properly
• are allergic to other phenothiazine medicines such as prochlorperazine
• 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
• are elderly and also have dementia, tell your doctor if this is the case
• 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.

Other medicines and pericyazine

Please 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 including amitriptyline and amitriptylinoxide
• 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 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

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. Sodium. 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

The recommended dose is

Adults

Schizophrenia

• The starting dose is 75 mg daily in divided doses
• The dose may be increased by 25 mg per day at weekly intervals depending on your illness
• The highest dose is usually not more than 300 mg per day

Anxiety, agitation and violent or dangerously impulsive behaviour

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

Elderly

Schizophrenia

• The starting dose is 15 mg to 30 mg 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 5 mg to10 mg 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

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

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).
• 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)
• have an allergic reaction. The signs may include: rash, itching, fever, difficulty in breathing or wheezing, chills, swelling
• have yellowing of the skin or eyes (jaundice). These could be signs of liver damage
• have frequent infections such as fever, severe chills, sore throat or mouth ulcers. These could be signs of a blood problem called ‘leucopenia’
• get infections more easily than usual. This could be because of a blood disorder (agranulocytosis)
• have movements that you cannot control, mainly of the tongue, mouth, jaw, arms and legs
• 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’
• 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.
• 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
• 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 or pharmacist. 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.

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

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

6. Contents of the pack and other information

What pericyazine contains

• Each tablet contains 10 mg 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 10 mg tablets are circular, 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

Marketing Authorisation Holder:

Zentiva Pharma UK Limited,

12 New Fetter Lane, London, EC4A 1JP, UK. Manufacturer:

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 July 2022

1065031953 / 11503202-09