Skip to Content

SURMONTIL 25MG TABLETS

Active substance(s): TRIMIPRAMINE / TRIMIPRAMINE MALEATE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET:
INFORMATION FOR THE USER

Trimipramine 25mg Tablets/
Surmontil 25mg Tablets
(trimipramine maleate)

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.

This product is available in the above names and
another strength 10mg, but will be referred to as
Trimipramine Tablets throughout this leaflet.

If you have diabetes or are at risk of getting diabetes,
your doctor may do blood tests to monitor your blood
sugar levels.

Read all of this leaflet carefully before you start
taking this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

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 Trimipramine
Tablets.

In this leaflet:
1. What Trimipramine Tablets are and what they are
used for
2. Before you take Trimipramine Tablets
3. How to take Trimipramine Tablets
4. Possible side effects
5. How to store Trimipramine Tablets
6. Further information

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 Trimipramine Tablets
can affect the way some other medicines work. Also
some medicines can affect the way Trimipramine
Tablets work.

1. What Trimipramine Tablets are and
what they are used for

Tell your doctor if you are taking any of the
following medicines:
• MAOI (MonoAmine Oxidase Inhibitors) medicine
such as tranylcypromine, phenelzine and
isocarboxazid (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
• Phenylelphrine or phenylpropanolamine – found
in cold and flu preparations
• Medicines used for chest pain (angina) or
high blood pressure such as diltiazem,
verapamil, clonidine, digitalis
• Medicines used for depression (SSRIs such as
citalopram, paroxetine, fluoxetine) tryciclics and
triptan derivatives, lithium, St John’s Wort
• Pain killers such as tramadol
• Macrolide antibiotics, antifungals or floroquinolones.

Your tablets contain a medicine called trimipramine. This
belongs to a group of medicines called antidepressants.
Trimipramine Tablets can be used to treat depression.
They are especially useful for treating depression in
people who also have problems sleeping, stress (anxiety)
or feel irritable and restless (agitation).
2. Before you take Trimipramine Tablets

1.

Do not take this medicine and tell your
doctor if:
x You are allergic (hypersensitive) to trimipramine or
any of the other ingredients of Trimipramine Tablets
(listed in Section 6 Further information). Signs of an
allergic reaction include: a rash, swelling or
breathing problems, swelling of your lips, face,
throat or tongue
x You have had a heart attack
x You have had any other heart problems including slow
or uneven heart beat
x You have severe liver problems
x You have mania (signs include very high mood, energy
and unusual behaviour)
x You are breast-feeding
Do not take this medicine if this applies to you. If you
are not sure, talk to your doctor or pharmacist before
taking Trimipramine Tablets.
Take special care with Trimipramine
Tablets
Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety disorders you
can sometimes have thoughts of harming or killing
yourself. These may be increased when first starting
antidepressants, since these medicines all take time to
work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
▲ If you have previously had thoughts about killing
or harming yourself.
▲ If you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than 25 years
with psychiatric conditions who were treated with an
antidepressant.
If you have thoughts of harming or killing yourself at any
time, contact your doctor or go to a hospital straight
away.

Anaesthetics
If you are going to have an anaesthetic (for an
operation), tell your doctor or dentist that you are taking
Trimipramine Tablets.
Taking Trimipramine Tablets and drink
You should avoid drinking alcohol while taking
Trimipramine 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 Trimipramine
Tablets.

Driving and using machines
Trimipramine 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 trimipramine
Trimipramine 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 Trimipramine Tablets
Always 2.
take Trimipramine Tablets 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
• Swallow the tablets whole with a drink of water
• If you have been told to take Trimipramine 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
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
stays the same at 35mg to 75mg each day
Children:
Children should not take Trimipramine Tablets.
If you take more Trimipramine Tablets than you
should
If you take more Trimipramine 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 Trimipramine 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 Trimipramine Tablets
Keep taking Trimipramine Tablets until your doctor tells
you to stop. Do not stop taking Trimipramine 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 3.
medicines, Trimipramine Tablets can cause side
effects, although not everybody gets them.
Stop taking Trimipramine 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
Trimipramine 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 behavior or thoughts (mania or
hypomania)
• Numbness or weakness in the arms and legs
(peripheral neuropathy)
• Feeling that someone is ‘out to get you’
• Getting infections more easily than usual. This
could be because of a blood disorder
(agranulocytosis)
• Convulsions/fits
• Unusual skin sensations such as numbness,
tingling, pricking, burning or creeping on the skin
(paraesthesia)
• Increased thirst and passing water (urine) more
often than normal. You may also feel tired and
hungry. This could be due to high blood sugar
levels or a condition called diabetes
• An uneven or fast heartbeat.

Below is a list of other side effects that have been
reported:
• Feeling drowsy or sleepy
• Constipation
• Dry mouth
• Tremor (shaking)
• Blurred vision
• Rapid heartbeat
• Sweating more than usual
• Feeling dizzy or light-headed on standing or sitting up
quickly (postural hypotension)
• Sexual problems
• Delay when starting to pass water (urine)
• Skin rash
An increased risk of bone fractures has been observed in
patients taking this kind of medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 or search for MHRA Yellow
Card in the Google Play or Apple App Store. By
reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Trimipramine Tablets
Keep out
4.of sight and reach of children.
Do not use Trimipramine Tablets after the expiry date
which is stated on the bottle and carton after EXP. The
expiry date refers to the last day of that month.
Do not store above 25°C. Keep container tightly closed
to protect from light. If the tablets become discoloured
or show any other signs of deterioration, you should
seek the advice of your pharmacist who will tell you
what to do.
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

5.
What Trimipramine
Tablets contain
• Each tablet contains 25mg trimipramine (as maleate).
• Other ingredients include starch potato, calcium
hydrogen phosphate, talc, magnesium stearate,
lactose monohydrate, hypromellose, titanium
dioxide (E171) and macrogol 400.
What Trimipramine Tablets look like and contents
of the pack
Trimipramine 25mg Tablets are white, circular,
biconvex, film-coated tablets. On one face they have
‘SURMONTIL’ impressed just inside the perimeter
around a centrally impressed ’25’. The reverse face
is plain.
They are supplied in bottles of 50 tablets.
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.,
28923 Alcorcon, Madrid, Spain. Procured from
within the EU by the Product Licence Holder:
Millsdale Pharmaceuticals, John Street, Warrington,
Cheshire, WA2 7UB, UK.
POM
PL No. 08811/ 0059
This leaflet was prepared 13th November 2017

Blind or partially sighted?
Is this leaflet hard to see or
read? Call 01925-652176
(Millsdale pharmaceuticals),
to obtain the leaflet in a
format suitable for you.

+ Expand Transcript

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