PIPORTIL DEPOT 50 MG/ML SOLUTION FOR INJECTION

Active substance: PIPOTIAZINE PALMITATE

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• Paranoid psychoses - this illness may make you feel very anxious or
afraid for your own well-being. You may also think that other people
are ‘out to get you’ when they are not

PACKAGE LEAFLET: INFORMATION FOR THE USER

Piportil® Depot 50 mg/ml
Solution for Injection

2. Before you are given Piportil

Pipotiazine palmitate
Is this leaflet hard to see or read?
Phone 01483 505515 for help
Read all of this leaflet carefully before you start using this
medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or
pharmacist.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor, nurse or pharmacist.
In this leaflet:
1. What Piportil is and what it is used for
2. Before you are given Piportil
3. How Piportil is given
4. Possible side effects
5. How to store Piportil
6. Further information

1. What Piportil is and what it is used for

i

Piportil contains a medicine called pipotiazine palmitate. This belongs
to a group of medicines called 'phenothiazines'. It works by blocking
the effects of a chemical in the brain.
Piportil can be used for:
• Schizophrenia - this illness can make you feel, see or hear things
which do not exist, have strange and frightening thoughts, change
how you act and make you feel alone. Sometimes people with these
symptoms may also feel tense, anxious or depressed

Do not have this medicine and tell your doctor if:
X You are allergic (hypersensitive) to pipotiazine, other phenothiazine
medicines or the other ingredient of Piportil (listed in Section 6
below) Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
X You have a blocked artery in the brain
X You have a tumour on the adrenal gland called a
‘phaeochromocytoma’
X You have liver or kidney problems
X You have severe heart problems
Do not have this medicine if any of the above apply to you. If you are
not sure, talk to your doctor or nurse before being given Piportil.
You should not be given Piportil if you are in a coma.
Take special care with Piportil
Check with your doctor or nurse before you have this
medicine if:
▲ You have or have ever had severe breathing problems
▲ You have or have ever had an enlarged prostate gland
▲ You have or have ever had problems with your thyroid gland
▲ You have brain damage
▲ You have Parkinson’s disease
▲ You have epilepsy or have had fits (seizures)
▲ Your doctor has told you that you might have a stroke
▲ You or members of your family have ever had glaucoma (painful
eyes with blurred vision)
▲ You have a form of muscle weakness called ‘myasthenia gravis’
▲ 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 have low blood levels of potassium, magnesium or calcium. Your
doctor may do a blood test to check on these

▲ You have previously taken other phenothiazine medicines such as
chlorpromazine and have ever had side effects when you suddenly
stopped taking them
▲ You have suddenly stopped drinking alcohol and are having signs
of withdrawal. This may happen if you suddenly stop after drinking
large amounts for a long time, or stop after a period of very heavy
drinking
▲ You are not eating properly
▲ You are elderly, particularly during very hot or very cold weather
▲ 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 applies to you, talk to your doctor
or nurse before being given Piportil.
Taking other medicines
Please tell your doctor or nurse 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 Piportil can
affect the way some other medicines work.
Also some medicines can affect the way Piportil works.
In particular, do not have this medicine and tell your doctor if you
are taking:
• Clozapine - used for mental illness, such as schizophrenia and
psychoses
The following medicines can increase the chance of you getting
side effects, when taken with Piportil:
• Medicines to control your heartbeat (such as amiodarone,
disopyramide or quinidine)
• Some medicines for high blood pressure or prostate problems (such
as doxazosin or terazosin)
• Some medicines for severe pain (such as morphine, codeine or
pethidine)
• Medicines to help you sleep (sedatives)
• Medicines for depression
• Other medicines used to calm emotional and mental problems (such
as olanzapine or prochlorperazine)
• Desferrioxamine - used when you have too much iron in your blood







Sibutramine - used for weight loss
Tetrabenazine - used for muscle tremors or tics
Adrenaline - used for life threatening allergic reactions
Lithium - used for some types of mental illness
Anti-cholinergic medicines - includes some medicines for irritable
bowel syndrome, asthma or incontinence
• Anaesthetics
• Water tablets (diuretics)
The following medicines can affect the way Piportil works or
Piportil can affect the way some of these medicines work:
• Medicines for Parkinson’s disease (such as levodopa, apomorphine,
pergolide, lisuride, bromocriptine or cabergoline)
• Medicines for indigestion and heartburn (antacids)
• Medicines for diabetes
• Amfetamines - used for Attention Deficit Hyperactivity Disorder
(ADHD)
• Guanethidine - used for high blood pressure
• Clonidine - used for migraines or high blood pressure
• Cimetidine - used for stomach ulcers
• Ritonavir - used for HIV infections
• Kaolin - used for diarrhoea
Having Piportil with food and drink
Do not drink alcohol while you are having Piportil. This is because
alcohol can increase the effects of Piportil and cause serious breathing
problems.
Pregnancy and breast-feeding
Talk to your doctor before having this medicine if you are pregnant,
might become pregnant, or think you may be pregnant. The following
symptoms may occur in newborn babies, of mothers that have used
Piportil 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.
You should not breast-feed if you are having Piportil. 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 having this medicine.

Ask your doctor or nurse for advice before taking any medicine if you
are pregnant or breast-feeding.
Driving and using machines
You may feel sleepy after having this medicine. If this happens, do not
drive or use any tools or machines.
Important information about some of the ingredients of Piportil
Piportil contains sesame oil. This may cause se vere allergic
(hypersensitivity) reactions. The chances of this happening are rare.
Tell a doctor or nurse straight away if you get a rash, swallowing or
breathing problems and swelling of your lips, face, throat or tongue.

3. How Piportil is given
Piportil is normally given by a doctor or nurse. This is because it needs
to be given as a deep injection into a muscle.
How much Piportil is given
If you are not sure why you are being given Piportil or have any
questions about how much Piportil is being given to you, speak to
your doctor or nurse. The usual dose is:
Adults Piportil is given every 4 weeks.
• Your first dose will be 25 mg
• This may be increased up to a maximum dose of 200 mg
• The usual dose is 50 to 100 mg given every 4 weeks
Elderly Your doctor will start you on a lower dose of 5 to 10 mg
Children Piportil should not be given to children.
Exposure to sunlight
Piportil can make your skin more sensitive to sunlight. Keep out of
direct sunlight while having 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 have more Piportil than you should
It is unlikely that your doctor or nurse will give you too much medicine.
Your doctor and nurse will monitor your progress, and check the
medicine you are given. Ask them if you are not sure why you are
getting a dose of medicine.

Having too much Piportil may make you feel drowsy and you may
become unconscious. You may also feel very cold, have a fast or
irregular heartbeat or severe muscle spasms. If you start getting any
of these symptoms tell your doctor or nurse straight away. If you are
away from the hospital, return straight away and speak to your doctor
or nurse or go to the casualty department.
If you miss a dose of Piportil
Your doctor or nurse will have instructions on when to give you this
medicine. It is unlikely that you will not be given the medicine as it has
been prescribed. However, if you do think you have missed a dose, tell
your doctor or nurse.
If you stop having Piportil
Keep having Piportil until your doctor tells you to stop. If you stop
having Piportil, your illness may come back and you may have other
effects after stopping such as feeling or being sick, sweating and
difficulty sleeping. You may also get tics (such as muscle spasms in
your face, rolling eyes, jerking muscles) or feel restless.

4. Possible side effects
Like all medicines, Piportil can cause side effects, although not
everybody gets them.
Tell a nurse or doctor straight away if you have:
• An allergic reaction. The signs may include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue
• Yellowing of the skin or eyes (jaundice)
• A sudden high temperature or an infection due to low numbers
of white blood cells. These could be signs of a problem called
‘leucopenia’
• 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 side effect called ‘neuroleptic malignant syndrome’
• An uneven or fast heartbeat
• Breathing problems such as feeling wheezy, short of breath and
tightness in the chest
• Movements that you cannot control of the tongue, mouth, jaw, arms
and legs

• Blood clots in the veins especially in the legs (symptoms include
swelling, pain and redness in the leg), which may travel through
blood vessels to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms seek medical advice
immediately
Tell a nurse or doctor as soon as possible if you have any of the
following side effects:
• Breathing problems
• Changes in skin or eye colour after having Piportil for a long time
• Feeling dizzy, light-headed or faint when you stand or sit up quickly
(due to low blood pressure)
• Feeling restless and unable to sit still
• 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 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 nurse if any of the following side effects gets
serious or lasts longer than a few days:
• Feeling drowsy, especially at the start of treatment
• 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
• Weight gain
• Being more sensitive to the sun than usual
• Stuffy nose
• Skin rashes
Talk to your doctor or nurse 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.
As with other phenothiazine medicines, there have been very rare
reports of sudden death with Piportil. These are possibly caused by
heart problems.

In elderly people with dementia, a small increase in the number of
deaths has been reported for patients taking antipsychotics compared
with those not receiving antipsychotics.

5. How to store Piportil
This medicine will be kept by your doctor or pharmacist in a safe place
where children cannot see or reach it. Store in the original package in
order to protect from light.
Do not use Piportil after the expiry date, which is stated on the ampoule
and the carton. The expiry date refers to the last day of the month.
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 Piportil contains
• Each 1 ml of the injection contains 50 mg of the active substance,
pipotiazine palmitate
• The other ingredient is sesame oil which contains an antioxidant
called butylhydroxyanisole (E320)
What Piportil looks like and contents of the pack
Piportil® Depot Injection 50 mg/ml is a yellow liquid supplied in 10 x
1 ml and 10 x 2 ml clear glass ampoules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email:uk-medicalinformation@sanofi.com
Manufacturer
SANOFI-AVENTIS S.P.A, Loc. Valcanello, 03012 Anagni (FR), ITALY
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 06/2012.
© Sanofi, 1980 - 2012
89025245

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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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