Piportil Depot 50 Mg/Ml Solution For Injection
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Piportil® Depot 50 mg/ml Solution for Injection
Pipotiazine palmitate
SANOFI O
Is this leaflet hard to see or read? Phone 0845 372 7101 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
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 howyou act and make you feel alone. Sometimes people with these symptoms may also feel tense, anxious or depressed
• 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
2. Before you are given Piportil
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:
A You have or have ever had severe breathing problems A You have or have ever had an enlarged prostate gland A You have or have ever had problems with your thyroid gland A You have brain damage A You have Parkinson’s disease A You have epilepsy or have had fits (seizures)
A Your doctor has told you that you might have a stroke A You or members of your family have ever had glaucoma (painful eyes with blurred vision)
A You have a form of muscle weakness called ‘myasthenia gravis’
A 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 A 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
A 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
A You are not eating properly
A You are elderly, particularly during very hot or very cold weather
A 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, orthinkyou 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.
1HI 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 severe 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 unlikelythatyourdoctoror 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 unlikelythatyou 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
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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.
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. m h ra. go v. u k/y e 11 o wca rd
By reporting side effects you can help provide more information on the safety of this medicine.
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: 0845 372 7101
emaiku k-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, askyour doctor or pharmacist.
This leaflet was last revised in 11/2013.
©Sanofi, 1980-2013