Pericyazine 2.5mg Tablets
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
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H
Neulactil® 2.5mg Tablets
(pericyazine)
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.
The name of your medicine is Neulactil 2.5mg Tablets but will be referred to as Neulactil throughout this leaflet.
What is in this leaflet:
1. What Neulactil is and what it is used for
2. What you need to know before you take Neulactil
3. How to take Neulactil
4. Possible side effects
5. How to store Neulactil
6. Contents of the pack and other information
Neulactil 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 Neulactil
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)
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 Neulactil.
LJ 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 Neulactil.
Other medicines and Neulactil
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 Neulactil can affect the way some other medicines work. Also some medicines can affect the way Neulactil works.
In particular, check with your doctor if you are taking any of the following:
Medicines to control your heart beat 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
Neulactil with alcohol
Do not drink alcohol while being treated with Neulactil. This is because alcohol can add to the effects of Neulactil 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 Neulactil. 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 Neulactil 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 breastfeeding.
Driving and using machines
You may feel sleepy after taking this medicine. If this happens, do not drive or use any tools or machines.
Neulactil 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 Neulactil
• 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 Neulactil
Always take Neulactil 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
Neulactil is not recommended for children. Exposure to sunlight
Neulactil 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 Neulactil than you should
If you take more Neulactil 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 heart beat, 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 Neulactil
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 Neulactil
Keep taking Neulactil until your doctor tells you to stop. Do not stop taking Neulactil just because you feel better. If you stop taking Neulactil 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 Neulactil 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 heart beat, 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 heart beat (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).
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)
As with other phenothiazine medicines, there have been very rare reports of sudden death with Neulactil. 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 any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Neulactil
• Keep out of the sight and reach of children.
• Do not take the tablets after the expiry date which is stated on the carton and blisters label after 'Exp'. The expiry date refers to the last day of that month.
• Store in original package in order to protect from light.
• If the tablets become discoloured or show any other signs of deterioration, seek the advice of your pharmacist.
• 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 Neulactil contain
Each tablet contains 2.5mg of the active substance pericyazine
The other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica and methylparahydroxybenzoate (E218).
What Neulactil looks like and contents of the pack
Neulactil 2.5mg Tablets are a very pale lime-yellow colour, with 'NEULACTIL' embossed on one face and a breakline on the other.
Neulactil 2.5mg Tablets are available in pack of 100 tablets
Manufactured by: Famar Health Care Services Madrid S.A.U., Avda. Leganes, 62, Alcorcon 28923 (Madrid), Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Neulactil® 2.5mg Tablets; PL 18799/2523
Leaflet date: 19.09.2016
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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Pericyazine 2.5mg Tablets but will be referred to as Pericyazine throughout this leaflet.
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
Pericyazine 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:
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.
L^J 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.
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 heart beat 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 breastfeeding.
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 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
• 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 heart beat, 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.
• You have a very fast, uneven or forceful heart beat (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).
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)
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 any side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Pericyazine
• Keep out of the sight and reach of children.
• Do not take the tablets after the expiry date which is stated on the carton and blisters label after 'Exp'. The expiry date refers to the last day of that month.
• Store in original package in order to protect from light.
• If the tablets become discoloured or show any other signs of deterioration, seek the advice of your pharmacist.
• 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.
4. Possible side effects
6. Further information
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 heart beat, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious but rare side effect called 'neuroleptic malignant syndrome'
What Pericyazine contain
Each tablet contains 2.5mg of the active substance pericyazine
The other ingredients are anhydrous lactose, microcrystalline cellulose, sodium starch glycollate, magnesium stearate, colloidal anhydrous silica and methylparahydroxybenzoate (E218).
What Pericyazine looks like and contents of the pack
Pericyazine 2.5mg Tablets are a very pale lime-yellow colour, with 'NEULACTIL' embossed on one face and a breakline on the other.
Pericyazine 2.5mg Tablets are available in pack of 100 tablets
Manufactured by: Famar Health Care Services Madrid S.A.U., Avda. Leganes, 62, Alcorcon 28923 (Madrid), Spain.
Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare,
Unit 4, Bradfield Road, Ruislip, Middlesex,
HA4 0NU, UK.
Pericyazine 2.5mg Tablets; PL 18799/2523
Leaflet date: 19.09.2016