SURMONTIL 10 MG TABLETS

Active substance: TRIMIPRAMINE MALEATE

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET:
INFORMATION FOR THE USER

2. Before you take Surmontil Tablets

Surmontil 10mg and 25mg
Tablets

Do not take this medicine and tell
your doctor if:
✕ You are allergic (hypersensitive) to
Trimipramine
trimipramine or any of the other
ingredients of Surmontil Tablets (listed
in Section 6 Further information).
Is this leaflet hard to see or read?
Signs of an allergic reaction include: a
Phone 01483 505515 for help
rash, swallowing or breathing
Read all of this leaflet carefully before
problems, swelling of your lips, face,
you start taking this medicine
throat or tongue
• Keep this leaflet. You may need to read ✕ You have had a heart attack
it again.
✕ You have any other heart problems
• If you have any further questions, ask
including slow or uneven heart beat
your doctor or pharmacist.
✕ You have severe liver problems
• This medicine has been prescribed for
✕ You have mania (signs include very
you. Do not pass it on to others. It may
high mood, energy and unusual
harm them, even if their symptoms are
behaviour)
the same as yours.
✕ You are breast-feeding
• If any of the side effects gets serious, or Do not take this medicine if this applies to
if you notice any side effects not listed in you. If you are not sure, talk to your
this leaflet, please tell your doctor or
doctor or pharmacist before taking
pharmacist.
Surmontil Tablets.
In this leaflet:
Take special care with Surmontil
1. What Surmontil Tablets are and what
Tablets
they are used for
Thoughts of suicide and worsening of
2. Before you take Surmontil Tablets
your depression or anxiety disorder
3. How to take Surmontil Tablets
If you are depressed and/or have anxiety
4. Possible side effects
disorders you can sometimes have
5. How to store Surmontil Tablets
thoughts of harming or killing yourself.
6. Further information
These may be increased when first starting
antidepressants, since these medicines all
1. What Surmontil Tablets are
take time to work, usually about two
and what they are used for
weeks but sometimes longer.
You may be more likely to think like this:
The name of your medicine is Surmontil
▲ If you have previously had thoughts
10mg or 25mg Tablets (called Surmontil
about killing or harming yourself.
Tablets in this leaflet). Surmontil Tablets
▲ If you are a young adult. Information
contain a medicine called trimipramine.
from clinical trials has shown an
This belongs to a group of medicines
increased risk of suicidal behaviour in
called antidepressants.
adults aged less than 25 years with
Surmontil Tablets can be used to treat
psychiatric conditions who were treated
depression. They are especially useful for
with an antidepressant.
treating depression in people who also
have problems sleeping, stress (anxiety) or
feel irritable and restless (agitation).
00000

1

If you have thoughts of harming or
killing yourself at any time, contact
your doctor or go to a hospital
straight away.
You may find it helpful to tell a
relative or close friend that you are
depressed or have an anxiety disorder,
and ask them to read this leaflet. You
might ask them to tell you if they think
your depression or anxiety is getting
worse, or if they are worried about
changes in your behaviour.
Check with your doctor or pharmacist
before taking this medicine if:
▲ You are elderly
▲ You have an enlarged prostate gland
▲ You have glaucoma (painful eyes
with blurred vision)
▲ You have or have ever had fits or
seizures
▲ You have thyroid problems
If you are not sure if any of the above
apply to you, talk to your doctor or
pharmacist before taking Surmontil
Tablets.
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 Surmontil Tablets can
affect the way some other medicines
work. Also some medicines can affect
the way Surmontil Tablets work.
Tell your doctor if you are taking any
of the following medicines:
• MAOI (MonoAmine Oxidase Inhibitors)
medicine such as tranylcypromine,
phenelzine and isocarboxazid (for
depression) or selegiline (for
Parkinson’s disease), or have taken
them in the last 2 weeks

• Sedatives (such as tranquilizers or
sleeping pills)
• Medicines used to treat high blood
pressure
• Adrenaline, noradrenaline, ephedrine
or isoprenaline – used in an
emergency
• Phenylephrine or
phenylpropanolamine – found in cold
and flu preparations
Anaesthetics
If you are going to have an anaesthetic
(for an operation), tell your doctor or
dentist that you are taking Surmontil
Tablets.
Taking Surmontil Tablets with food
and drink
You should avoid drinking alcohol while
taking Surmontil Tablets.
Pregnancy and breast-feeding
Talk to your doctor before taking this
medicine if you are pregnant, might
become pregnant, or think you may be
pregnant.
Do not breast-feed if you are taking
Surmontil Tablets.
Driving and using machines
Surmontil Tablets may make you feel
sleepy or less alert. If this happens do
not drive or use any tools or machines.
Important information about some of
the ingredients of Surmontil Tablets
Surmontil Tablets contain lactose. If you
have been told that you cannot digest or
tolerate some sugars, talk to your doctor
before taking trimipramine.
3. How to take Surmontil Tablets
Always take Surmontil Tablets exactly as
your doctor has told you. You should
check with your doctor or pharmacist if
you are not sure.
00000

2

How much to take
Adults:
Depression
•Adults usually start by taking 50mg
to 75mg each day
•Your doctor may then increase the
dose to 150mg or 300mg each day
depending on your condition
•Once you start to feel better, the
usual daily dose then stays the same
at 75mg to 150mg each day
Elderly:
•Elderly usually start by taking 10mg
to 25mg three times each day
•Your doctor will then increase this
slowly
•Once you start to feel better, the
usual daily dose then stays the same
at 35mg to 75mg each day
Children:
Children should not take Surmontil
Tablets.
If you take more Surmontil Tablets
than you should
If you take more Surmontil Tablets 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: fits
(seizures), collapse and falling into a
coma.

If you forget to take Surmontil
Tablets
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 dose
If you stop taking Surmontil Tablets
Keep taking Surmontil Tablets until your
doctor tells you to stop. Do not stop taking
Surmontil Tablets just because you feel
better. This is because your illness may
come back. When your doctor tells you to
stop taking these Tablets he/she will help
you stop taking them gradually. Stopping
your medicine too quickly could cause
sleep problems, feeling irritable and
sweating more than usual.
4. Possible side effects
Like all medicines, Surmontil Tablets can
cause side effects, although not
everybody gets them.
Stop taking Surmontil Tablets and see
a doctor or go to a hospital straight
away if:
• You get swelling of the hands, feet,
ankles, face, lips or throat which may
cause difficulty swallowing or breathing,
itching of the skin and nettle rash.
This may mean you are having an
allergic reaction to Surmontil Tablets.
Talk to your doctor straight away if
you notice the following side-effects:
• Painful erection of the penis,
unrelated to sexual activity, that will not
go away (priapism)
• Yellowing of the eyes or skin. This could
be a liver problem (such as jaundice)
• Overactive behaviour or thoughts
(mania or hypomania)
• Numbness or weakness in the arms and
legs (peripheral neuropathy)
• Feeling that someone is
‘out to get you’
00000

3

• Getting infections more easily than
usual. This could be because of a blood 6. Further information
disorder (agranulocytosis)
What Surmontil Tablets contain
• Convulsions/fits
• Each Surmontil 10mg Tablet contains
• Unusual skin sensations such as
14mg of trimipramine maleate,
equivalent to 10mg of trimipramine
numbness, tingling, pricking, burning or
• Each Surmontil 25mg Tablet contains
creeping on the skin (paraesthesia)
34.9mg of trimipramine maleate,
equivalent to 25mg of trimipramine
Below is a list of other side effects that
• Other ingredients include calcium
have been reported:
hydrogen phosphate, starch potato,
• Feeling drowsy or sleepy
magnesium stearate, talc, Opadry
• Constipation
OY-L-28900 (which contains lactose
• Dry mouth
monohydrate, hypromellose, titanium
• Tremor (shaking)
dioxide and macrogol)
• Blurred vision
What Surmontil Tablets look like and
• Rapid heartbeat
contents of the pack
• Sweating more than usual
Surmontil 25mg Tablets are white to pale
• Feeling dizzy or light-headed on standing or yellow, circular and biconvex. On one face
sitting up quickly (postural hypotension)
they have ‘SURMONTIL’ impressed just
• Sexual problems
inside the perimeter around a centrally
• Delay when starting to pass water (urine) impressed ‘25’. The reverse face is plain.
Tablets are available in packs of 28, 50,
• Skin rash
56, 84 and 500. Not all pack sizes may be
marketed.
An increased risk of bone fractures has
been observed in patients taking this type Surmontil 10mg Tablets are white to pale
yellow, circular and biconvex. On one face
of medicine.
they have ‘SURMONTIL’ impressed just
If any of the side effects get serious or inside the perimeter around a centrally
lasts longer than a few days, please tell impressed ‘10’, scoreline on reverse face.
your doctor or pharmacist. Also do this Tablets are available in packs of 28, 50, 56
if you notice any side effects not listed and 84. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
in the leaflet.
Manufacturer
5. How to store Surmontil Tablets
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford,
Keep this medicine in a safe place where Surrey, GU1 4YS, UK
children cannot see or reach it.
Manufacturer
Do not use Surmontil Tablets after the
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62, Alcorcón 28923
expiry date which is stated on the blister
(Madrid) Spain
and carton after EXP. The expiry date
refers to the last day of that month.
This leaflet does not contain all the
information about your medicine. If you
Keep the blister pack in the carton to
have any questions or are not sure about
protect from light.
anything, ask your doctor or pharmacist.
Medicines should not be disposed of via
wastewater or household waste. Ask your This leaflet was last revised in 06/2012
pharmacist how to dispose of medicines
© Zentiva, 1973 - 2012
no longer required. These measures will
help to protect the environment.
00000

4

CODE

Taking this medicine
• Take this medicine by mouth
• Swallow the Tablets whole with a drink
of water
• If you have been told to take Surmontil
Tablets only once each day then you
should take it before going to bed
• It may take 7 to 10 days before you
feel the full benefit of the medicine
• If you feel the effect of your medicine is
too weak or too strong, do not change
the dose yourself, but ask your doctor

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)