Piportil Depot 50mg/1ml solution for injection ampoules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Pipotiazine palmitate

Tilgængelig fra:

Sanofi

ATC-kode:

N05AC04

INN (International Name):

Pipotiazine palmitate

Dosering:

50mg/1ml

Lægemiddelform:

Solution for injection

Indgivelsesvej:

Intramuscular

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04020200; GTIN: 5035074112286

Indlægsseddel

_i_
IS THIS LEAFLET HARD TO SEE OR READ?
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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
how you 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 S

Produktets egenskaber

OBJECT 1
PIPORTIL DEPOT INJECTION
Summary of Product Characteristics Updated 18-Feb-2014 | SANOFI
1. Name of the medicinal product
Piportil Depot 50 mg/ml Solution for Injection
2. Qualitative and quantitative composition
Each 1ml ampoule contains 50mg of the active substance pipotiazine
palmitate.
Also contains 875mg/ml of sesame oil.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for Injection
A clear, yellow liquid.
4. Clinical particulars
4.1 Therapeutic indications
For the maintenance treatment of schizophrenia and paranoid psychoses
and prevention of relapse,
especially where compliance with oral medication is a problem
4.2 Posology and method of administration
Patients should be stabilised on Piportil Depot under psychiatric
supervision. Administration should be by
deep intramuscular injection into the gluteal region. A wide variation
of response can be expected. The
following dosage recommendations are suitable for either indication.
_Adults_:
Initially 25mg should be given to assess the response of the patient
to the drug. Further
doses should be administered at appropriate intervals, increasing by
increments of 25 or 50
mg until a satisfactory response is obtained. In clinical practice,
Piportil Depot has been
shown to have a long duration of action, allowing intervals of 4 weeks
between injections
for maintenance therapy. Dosage should be adjusted under close
supervision to suit each
individual patient in order to obtain the best therapeutic response
compatible with
tolerance.
The duration of action depends on the dose administered, allowing
dosage intervals to be
varied to suit individual circumstances.
Most patients respond favourably to a dose of 50-100 mg every 4 weeks,
the maximum
recommended dose is 200 mg every four weeks.
_Elderly _:
Neuroleptics should be used cautiously in the elderly: A reduced
starting dose is
recommended, i.e. 5-10 mg might be considered.
_Children_:
Not recommended for use in children.
4.3 Contraindications
Piportil Depot should not be admin