PERICYAZINE 10MG TABLETS

Active substance: PERICYAZINE

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Transcript
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’)

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.

DATE:
06/11/13
DATE OF PROOF:
CODE:

UK PIL DATED DECEMBER 2012
REPORTING OF SIDE EFFECTS

DT

DATE:

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

06464/3012F

04-1957

Pericyazine 10mg tabs
PRODUCT:

ARTWORKER:

Waymade
CUSTOMER:

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 06/11/13

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 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 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.
Important information about some of the ingredients of Pericyazine tablets

Lactose anhydrous. This medicine contains lactose, a type of sugar. If you have been told by your doctor that you can
not 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

WARNING!

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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

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

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Read all of this leaflet carefully before you are given 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.

WARNING!

27mm

PERICYAZINE 10mg TABLETS
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

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

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).

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

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 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 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 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

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 06/11/13

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.

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)

DT

06/11/13
DATE OF PROOF:

DATE:

04-1957

ARTWORKER:

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side
effects not listed in this leaflet.

UK PIL DATED DECEMBER 2012
REPORTING OF SIDE EFFECTS

06464/3012F

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

CODE:

Pericyazine 10mg tabs
PRODUCT:

CUSTOMER:

Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

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).

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.
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 use Pericyazine after the expiry date (Exp) which is stated on the carton and the label. This expiry date refers to
the last day of that month.
Store in original package to protect from light.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.
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 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 10mg Tablets are a very pale lime-yellow colour, with ‘NEULACTIL 10’ embossed on one face and a breakline on the
other.
Pericyazine 10mg Tablets are available in pack of 100 tablets
POM

PL No: 06464/3012

This product is manufactured by FAMAR HEALTH CARE SERVICES MADRID S.A.U., Avda. Leganés, 62, Alcorcón 28923
(Madrid), Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 22.10.2013

WARNING!

Children
Pericyazine is not recommended for children

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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

WARNING!

27mm

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

How much to take

2. Before you take Neulactil
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’)

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.

DATE:
06/11/13
DATE OF PROOF:
CODE:

UK PIL DATED DECEMBER 2012
REPORTING OF SIDE EFFECTS

DT

DATE:

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 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 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

06464/3012F

04-1957

Neulactil 10mg tabs
PRODUCT:

ARTWORKER:

Waymade
CUSTOMER:

PRE-PRESS NO.:

Q.A.
APPROVED:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 06/11/13

Take special care with Neulactil
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 Neulactil.

Taking Neulactil with food and drink
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 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 Neulactil tablets

Lactose anhydrous. This medicine contains lactose, a type of sugar. If you have been told by your doctor that you can
not tolerate some sugars, talk to your doctor before taking Neulactil 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 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

WARNING!

1. What Neulactil is and what it is used for
The name of your medicine is Neulactil 10mg Tablets (referred to as Neulactil 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

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

In this leaflet:
1. What Neulactil is and what it is used for
2. Before you take Neulactil
3. How to take Neulactil
4. Possible side effects
5. How to store Neulactil
6. Further Information

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Read all of this leaflet carefully before you are given 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.

WARNING!

27mm

NEULACTIL® 10mg TABLETS
(pericyazine)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000F

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

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 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).

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Leaflet Flat Size = 180 x 429

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 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 have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Neulactil 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 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

DATE:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.2 - waymade - 06/11/13

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.

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)

DT

06/11/13

ARTWORKER:

DATE OF PROOF:

DATE:

04-1957
PRE-PRESS NO.:

Q.A.
APPROVED:

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 side effects gets serious or lasts longer than a few days, or if you notice any side
effects not listed in this leaflet.

UK PIL DATED DECEMBER 2012
REPORTING OF SIDE EFFECTS

06464/3012F
CODE:

Neulactil 10mg tabs
PRODUCT:

CUSTOMER:

Waymade

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 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 use Neulactil after the expiry date (Exp) which is stated on the carton and the label. This expiry date refers to the
last day of that month.
Store in original package to protect from light.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your
pharmacist who will tell you what to do.
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 10mg Tablets contain

Each tablet contains 10mg 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 10mg Tablets are a very pale lime-yellow colour, with ‘NEULACTIL 10’ embossed on one face and a breakline on the
other.
Neulactil 10mg Tablets are available in pack of 100 tablets
POM

PL No: 06464/3012

This product is manufactured by FAMAR HEALTH CARE SERVICES MADRID S.A.U., Avda. Leganés, 62, Alcorcón 28923
(Madrid), Spain and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 22.10.2013
Neulactil is a registered trademark

WARNING!

Children
Neulactil is not recommended for children

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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

WARNING!

27mm

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

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

How much to take

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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