STEMETIL 5MG/5ML SYRUP

Active substance: PROCHLORPERAZINE MESILATE

View full screen / Print PDF » Download PDF ⇩

Transcript
LIQUID MANUFACTURIN

G

Packaging code: 301671
Old packaging code: 301248

Format : 157x210-DCRL
Plant barcode : 671

Update : 10/07/2013 - V1

Colors :
Pantone Reflex Blue

Product : STEMETIL SYR
e
Packaging typ : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages: EN

Min font size used : 9 pt

Graphic designer: K.Lemaire
Plant : Colomiers

Logo version :

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Stemetil 5 mg / 5 ml Syrup

Take special care with Stemetil Syrup

Check with your doctor or pharmacist before
taking your medicine if:
▲You are allergic to phenothiazine medicines such
as chlorpromazine
Is this leaflet hard to see or read? ▲You have heart problems or a family history of
Phone 01483 505515 for help heart problems
▲You have ever had a stroke
Read all of this leaflet carefully before you start ▲You have liver or kidney problems
▲You have thyroid problems
taking this medicine
▲You have an enlarged prostate gland. This means
• Keep this leaflet. You may need to read it again
you may have problems when passing water
• If you have any further questions, ask your doctor
(urine)
or pharmacist
• This medicine has been prescribed for you. Do not
▲You have Parkinson’s disease
pass it on to others. It may harm them, even if
▲You have dementia
their symptoms are the same as yours
▲You have epilepsy or have ever had fits (seizures)
• If any of the side effects gets serious, or if you
▲You have depression
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist
▲You have a tumour on your adrenal gland called
‘phaeochromocytoma’
In this leaflet:
▲You have a type of muscle weakness called
1. What Stemetil Syrup is and what it is used for
‘myasthenia gravis’
2. Before you take Stemetil Syrup
▲You have or have ever had glaucoma (signs
3. How to take Stemetil Syrup
include painful eyes with blurred vision)
4. Possible side effects
▲You have or have ever had a low number of white
5. How to store Stemetil Syrup
blood cells (agranulocytosis). This would lead you
6. Further information
to get infections more easily than usual
▲You have low blood levels of potassium, calcium
1. What Stemetil Syrup is and what it is
and magnesium. Your doctor may perform blood
used for
tests to check on these
▲You or someone else in your family has a history
Stemetil Syrup contains a medicine called
of blood clots, as medicines like these have been
prochlorperazine mesilate. This belongs to a group
associated with formation of blood clots
of medicines called ‘phenothiazine antipsychotics’.
It works by blocking the effects of a chemical in the ▲You are not eating properly or are very underweight
brain.
▲You have a history of alcohol problems
▲You are elderly (65 years of age or older)
Stemetil Syrup can be used to:
▲The person is a child. This is because children
• Treat balance problems or dizziness (vertigo).
may develop unusual face and body movements
This includes problems of the inner ear such as
(dystonic reactions)
‘Meniere’s Syndrome’ or ‘labyrinthitis’
▲You are diabetic or have high levels of sugar in
• Stop you feeling sick (nausea) or being sick
your blood (hyperglycaemia). Your doctor may
(vomiting). This can be from any cause including
want to monitor you more closely
migraines
• Treat schizophrenia
If you are not sure if any of the above apply to you,
• Treat over-active behaviour or thoughts (mania)
talk to your doctor or pharmacist before taking
• Treat anxiety in the short-term, when used in
Stemetil Syrup.
addition to other medicines
prochlorperazine mesilate

2. Before you take Stemetil Syrup

✕ You are allergic (hypersensitive) to
prochlorperazine mesilate or any of the other
ingredients of Stemetil Syrup (listed in Section
6). Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of
your lips, face, throat or tongue

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 Stemetil Syrup can affect the way some
other medicines work. Also some medicines can
affect the way Stemetil Syrup works.

301671 - 671

Do not take this medicine and tell your
doctor if:

1

LIQUID MANUFACTURIN

G

Packaging code: 301671
Old packaging code: 301248

Format : 157x210-DCRL
Plant barcode : 671

Update : 10/07/2013 - V1

Colors :
Pantone Reflex Blue

Product : STEMETIL SYR
e
Packaging typ : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages: EN

Min font size used : 9 pt

Graphic designer: K.Lemaire
Plant : Colomiers

Logo version :

In particular, tell your doctor if you are taking any
of the following:
• Medicines to help you sleep (sedatives,
barbiturates)
• Other medicines used to calm emotional and
mental conditions
• Medicines used for depression
• Medicines used for Parkinson’s disease such as
levodopa
• Medicines for fits (epilepsy) such as carbamazepine

Important information about some of the
ingredients of Stemetil Syrup
• Sucrose: This medicine contains sucrose, which
is a type of sugar. If you have been told by your
doctor that you cannot tolerate some sugars, talk
to your doctor before taking the syrup
• Sodium: This medicine contains 27 mg of sodium per
5 ml dose. This should be taken into consideration
by people on a controlled sodium diet
• Sulphites: This medicine contains small amounts
of sulphites. These may cause severe allergic
• Medicines used to control your heartbeat such
(hypersensitivity) reactions and difficulty in
as amiodarone, disopyramide, propanolol or
breathing (bronchospasm). This is more likely
quinidine
to happen if you have a history of asthma or
• Medicines for high blood pressure such as
allergies. The chances of this happening are
doxazosin, terazosin, guanethidine or clonidine
rare. Stop taking the medicine if you get a rash,
• Medicines used for diabetes
swallowing or breathing problems or swelling of
• Medicines used for cancer (cytotoxics)
your lips, face, throat or tongue
• Medicines used for infections (antibiotics)
• Ethanol: This medicine contains small amounts
• Medicines for indigestion and heartburn (antacids) of ethanol (alcohol), less than 100 mg per 5 ml
• Anticholinergic medicines - includes some
medicines used for irritable bowel syndrome,
asthma or incontinence
• Amphetamines - used for Attention Deficit
Hyperactivity Disorder (ADHD)
• 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

3. How to take Stemetil Syrup
Always take Stemetil Syrup 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
• Do not give to children under 1 year of age or who
weigh less than 10 kg
• Do not let the syrup touch your skin, as you may
Taking Stemetil Syrup with food and drink
get skin redness, swelling and itching (contact skin
Do not drink alcohol while you are taking Stemetil
sensitisation)
Syrup. This is because alcohol can add to the effects • If you feel the effect of your medicine is too weak
of Stemetil Syrup and can cause serious breathing
or too strong, do not change the dose yourself, but
difficulties.
ask your doctor
Pregnancy and breast-feeding
Do not take Stemetil Syrup if:
• You are pregnant, might become pregnant or
think you might be pregnant
• You are breast-feeding or planning to breast-feed

How much to take
Adults:
Treatment of balance problems or dizziness
(vertigo):
• The usual dose is 5 ml three times each day
• This may be increased to a total daily dose of
The following symptoms may occur in newborn
30 ml each day
babies, of mothers that have used Stemetil Syrup
• After several weeks treatment, your doctor may
in the last trimester (last three months of their
decide to gradually lower your daily dose to 5
pregnancy): shaking, muscle stiffness and/or
to 10 ml each day
weakness, sleepiness, agitation, breathing problems,
Stopping you feeling sick or being sick:
and difficulty in feeding. If your baby develops any
• The usual dose is 5 or 10 ml
of these symptoms you may need to contact your
• This may be taken two or three times each day
doctor.
Treatment of feeling sick or being sick:
• To begin with you will usually take 20 ml
Ask your doctor or pharmacist for advice before
• This may be followed by 10 ml two hours later
taking any medicine if you are pregnant or breastTreatment of schizophrenia and over-active
feeding.
behaviour or thoughts (mania):
• The starting dose is usually 12.5 ml twice each
day for seven days
• Your doctor may increase your dose up to a
Driving and using machines
total daily dose of 75 to 100 ml each day
• After several weeks of treatment, your doctor
You may feel sleepy after taking this medicine.
may then lower your dose to a total daily dose
If this happens, do not drive or use any tools or
of 25 to 50 ml each day
2
machines.

LIQUID MANUFACTURIN

G

Packaging code: 301671
Old packaging code: 301248

Format : 157x210-DCRL
Plant barcode : 671

Update : 10/07/2013 - V1

Colors :
Pantone Reflex Blue

Product : STEMETIL SYR
e
Packaging typ : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages: EN

Min font size used : 9 pt

Graphic designer: K.Lemaire
Plant : Colomiers

Logo version :

Short-term treatment of anxiety:
• The starting dose will be 15 to 20 ml each day
in divided doses
• Your doctor may then increase your dose to a
total daily dose of 40 ml each day
Elderly:
• Your doctor may prescribe a lower dose
• You should be careful during very hot or very
cold weather to make sure that you do not get
too hot or too cold
Children (over 1 year of age and weighing
more than 10 kg):
Stopping your child feeling sick or being
sick:
• Your doctor will decide the dose according to
your child’s weight
• A dose of 0.25 mg for each kilogram of your
child’s weight is usually given
• This dose may be given two or three times a
day

4. Possible side effects
Like all medicines, Stemetil Syrup can cause side
effects, although not everybody gets them.

Stop taking Stemetil Syrup and see a doctor or
go to a hospital 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
• You have an unusually pale complexion, sweating,
high temperature, fast heartbeat, stiff muscles,
fast breathing and feel confused, drowsy or
agitated. These could be signs of a serious side
effect called ‘neuroleptic malignant syndrome’
• You have frequent infections such as fever, 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)
If you take more Stemetil Syrup than you should • You have yellowing of your skin or eyes (jaundice).
If you take more Stemetil Syrup than you should,
These could be signs of liver problems
tell a doctor or go to a hospital casualty department • You have a very fast, uneven or forceful heartbeats
straight away. Take the medicine pack with you.
(palpitations) and experience breathing problems
This is so the doctor knows what you have taken.
such as wheezing, shortness of breath, tightness in
Taking too much Stemetil Syrup may cause
the chest and chest pain
symptoms such as feeling sleepy or dizzy, increased • You have blood clots in the veins especially in the
or rapid heartbeat, feeling very cold and confused,
legs (symptoms include swelling, pain and redness
writhing movements, feeling restless, stiffness or
in the leg), which may travel through blood vessels
shaking. You may lose consciousness.
to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms
If you forget to take Stemetil Syrup
seek medical advice immediately
If you forget a dose, take it as soon as you
• You have rigid or stiff muscles, trembling or
remember it. However, if it is nearly time for the
shaking, unusual eye movements (including
next dose, skip the missed dose. Do not take a
rolling of the eyes), difficulty moving, or loss of
double dose to make up for a forgotten dose.
muscle power
If you stop taking Stemetil Syrup
Keep taking Stemetil Syrup until your doctor tells
you to stop. Do not stop taking Stemetil Syrup just
because you feel better. If you stop, your illness may
come back and you may have other effects such
as feeling or being sick or difficulty sleeping. Your
doctor will gradually stop your medicine to prevent
these effects happening.
Exposure to sunlight
Stemetil Syrup can cause your skin to be more
sensitive to sunlight. You should avoid exposure to
direct sunlight while taking this medicine.
Tests
Your doctor may do regular tests while you are
taking this medicine. These might include blood
tests and an ECG to check your heart is working
properly.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Tell your doctor as soon as possible if you have
any of the following side effects:
• Breathing problems
• Changes in your skin or eye colour after taking
Stemetil Syrup for a long period of time
• Problems with your eyesight after taking Stemetil
Syrup for a long period of time
• Feeling dizzy, light-headed or faint when you
stand or sit up quickly (due to low blood pressure)
• Very fast, uneven or forceful heartbeats
(palpitations)
• 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)
Tell your doctor or pharmacist if any of the
following side effects get 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
3

LIQUID MANUFACTURIN

G

Packaging code: 301671
Old packaging code: 301248

Format : 157x210-DCRL
Plant barcode : 671

Update : 10/07/2013 - V1

Colors :
Pantone Reflex Blue

Product : STEMETIL SYR
e
Packaging typ : Leaflet

Fonts : Ocean Sans Pro SAN

Country : GB
Languages: EN

Min font size used : 9 pt

Graphic designer: K.Lemaire
Plant : Colomiers

Logo version :

• Difficulty in getting or maintaining an erection
(impotence)
• Difficulty sleeping (insomnia)
• Feeling restless or agitated
• Dry mouth
• Your skin being more sensitive to the sun than
usual
• Stuffy nose
• Skin rashes
• Skin redness, swelling and itching from touching
the medicine
As with other phenothiazine medicines, there
have been very rare reports of sudden death with
Stemetil Syrup. 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.

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
Unither Liquid Manufacturing, 1-3 Allee de la Neste,
Z.I. d’en Sigal,
31770 Colomiers, France
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 06/2013
© Sanofi, 1973 - 2013

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 Stemetil Syrup
Keep this medicine in a safe place where children
cannot see or reach it.
Do not use Stemetil Syrup after the expiry date
which is stated on the bottle label and carton, after
EXP. The expiry date refers to the last day of that
month.
Store protected from light.
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 Stemetil Syrup contains

What Stemetil Syrup looks like and contents of
the pack
Stemetil is a dark straw coloured syrup.
Stemetil Syrup is available in amber glass bottles
containing 100 or 125 ml.

301671 - 671

• Each 5 ml of Stemetil Syrup contains 5 mg of the
active substance, prochlorperazine mesilate
• The other ingredients are sucrose, polysorbate 80
(E433), banana flavour, caramel (E150), anhydrous
citric acid (E330), sodium citrate (E331), sodium
benzoate (E211), sodium sulphite anhydrous
(E221), sodium metabisulphite powder (E223) ,
ascorbic acid L(+) (E300) and purified water

4

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.

Hide
(web2)