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CLOMIPRAMINE 10 MG CAPSULES HARD

Active substance(s): CLOMIPRAMINE HYDROCHLORIDE

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TBC

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What is in this leaflet
1. What Clomipramine is and what it is used for.
2. What you need to know before you
take Clomipramine.
3. How to take Clomipramine.
4. Possible side effects.
5. How to store Clomipramine.
6. Contents of the pack and other information.
1. What Clomipramine is and what it is used for
Clomipramine is available as capsules in three
different strengths.
Clomipramine belongs to a group of medicines
called tricyclic antidepressants. Clomipramine is
believed to work by increasing the levels of two
naturally occurring chemicals within the brain,
noradrenaline and 5-hydroxytryptamine (also
called serotonin).
Clomipramine is used to treat depression
(especially if you also need to be sedated),
obsessions and phobias (irrational fears). It is
also used along with other medications to treat
cataplexy. Cataplexy is a disorder which causes
muscle weakness and symptoms such as sagging
jaw, drooping head and weakness at the knees.
Attacks of cataplexy are triggered by strong
emotions. Cataplexy often affects people who have
narcolepsy (a sleep disorder).
This medicine is for adults only.
2. What you need to know before you
take Clomipramine
Do NOT take Clomipramine if you:
- are allergic to clomipramine or any of the other
ingredients of this medicine (listed in section 6)
- have ever had a rash or other allergic reaction to
any other antidepressants
- have had a heart attack within the last 3 months
- have problems with your heart beat
- have any serious liver disease
- have a mental health condition called mania
- have glaucoma (increased eye pressure)
- have difficulty in passing urine
- are taking, or within the last 3 weeks have taken
medicines for depression called monoamine
oxidase inhibitors (MAOI)
- are taking medicines called selective, reversible
monoamine oxidase-A (MAO-A) inhibitors such
as moclobemide
If you are unsure if any of the above applies to you,
please talk to your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Clomipramine if you:
- have ever had suicidal thoughts
- suffer from epilepsy (fits)
- have had a head injury or have suffered
brain damage
- are going to have electric shock therapy (ECT)
- have other problems with your heart
- have been told you have a low level of potassium
in your blood (hypokalaemia). The doctor will need
to treat this before you start taking clomipramine
- have kidney disease
- suffer from schizophrenia or other mental
health conditions
- have a blood disorder
- have an overactive thyroid gland
- have had severe constipation for a long time
- have a tumour (cancer) of the adrenal gland (such
as phaeochromocytoma or neuroblastoma)
- liver disease
- have low blood pressure
- wear contact lenses
- are elderly
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 young adults (less than 25 years old)
with mental health 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. 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.
Information for families, and caregivers
You should monitor whether your depressed patient
shows signs of behavioural changes such as unusual
anxiety, restlessness, sleeping problems, irritability,
aggressiveness, over-excitedness or other unusual
changes in behaviour, worsening of depression or
thinking about suicide. You should report any such
symptoms to the patient’s doctor, especially if they
are severe, start suddenly, or were not part of the
patient’s presenting symptoms before. You should
evaluate the emergence of such symptoms on a
day-day basis, especially during anti-depressant
treatment and when the dose is increased
or decreased, since changes may be abrupt.
Symptoms such as these may be associated
with an increased risk for suicidal thinking and
behaviour and indicate a need for very close
monitoring and possibly changes in medication.
Tell your doctor, dentist or hospital staff you are
taking Clomipramine if you are to have surgery
(including dental procedures), as the dose of
Clomipramine may need to be reduced or stopped
before you have an anaesthetic.
While you are taking Clomipramine, especially if
you take this medicine for a long time your doctor
may want to monitor you by doing blood tests and
other tests to check your heart and liver function.
You should also have regular dental check-ups, as
Clomipramine may cause dryness of the mouth
which can increase the chance of tooth decay.

Description Clomipramine Hydrochloride 25/50/10mg 5
Component Type Leaflet
Affiliate Item Code 894225
Superceded Affiliate Item Code 436707
TrackWise PR No. 894225
MA No. 04569/0229-0231
Packing Site/Printer NA
Supplier Code LT1378AH

Pharma Code TBC
SAP No. NA
Vendor Job No. 281138
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

TBC

TBC

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Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
- 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 only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

Clomipramine interacts with a large number of other
medicines. Make sure your doctor or pharmacist
knows if you are taking any of the following:
- medicines for depression, particularly MAOIs (see
section “Do not take” above) e.g. tranylcypromine,
phenelzine, moclobemide; SSRIs e.g. fluoxetine (or
have taken within the last 3 weeks), fluvoxamine,
paroxetine, sertraline; SNaRIs e.g. venlafaxine;
tricyclic and tetracyclic antidepressants e.g.
amitriptyline, dothiepin, maprotiline
- diuretics, also known as ‘water tablets’, e.g.
bendroflumethiazide, furosemide
- anaesthetics, used for the temporary loss of
bodily sensation
- antihistamines e.g. terfenadine
- medicines for other mental health conditions
such as schizophrenia or manic depression
e.g. thioridazine, lithium, clozapine, pimozide,
benzodiazepines e.g. alprazolam
- medicines for high blood pressure e.g.
guanethidine, betanidine, reserpine, clonidine or
alpha methyldopa or norepinephrine
- norepinephrine (noradrenaline), used to treat low
blood pressure
- medicines to treat heart disorders, particularly
those used to treat an abnormal heart rhythm,
e.g. disopyramide, procainamide, epinephrine
(adrenaline), isoprenaline, amiodarone, quinidine,
diltiazem and verapamil
- beta-blockers e.g. atenolol, sotalol
- anticoagulants (blood thinning tablets) e.g. warfarin
- aspirin and similar pain killing non-steroidal antiinflammatory drugs (NSAIDs)
- medicines for Parkinson's Disease, e.g. levodopa,
biperiden, entacapone or selegiline
- nicotine e.g. if you smoke or are using nicotine
replacement therapy
- anticonvulsants, used to stop seizures or fits e.g.
barbiturates such as phenobarbital, phenytoin,
carbamazepine or valproate
- decongestants used for colds and flu such as
ephedrine, phenylephrine
or phenylpropanolamine
- cimetidine, used to treat stomach ulcers
or heartburn
- methylphenidate used to treat for ADHD
- rifampicin, used to treat some infections
including tuberculosis (TB)
- quinine, for cramp or malaria treatment
- strong painkillers such as tramadol, nefopam,
morphine or morphine related substances e.g.
codeine, dihydrocodeine
- drugs of abuse including Ecstasy
- atropine or similar medicines (including eye drops)
- medicines containing oestrogens e.g. contraceptive
pill or hormone replacement therapy
- medicines called protease inhibitors, used to
treat Human Immunodeficiency Virus (HIV) e.g.
ritonavir, indinavir
- terbinafine, used orally to treat skin, hair or nail
infections due to fungus
- colestipol, cholestyramine, used to treat high
cholesterol levels
- St. John’s wort (Hypericum perforatum),
a herbal product used to treat depression
and other conditions
- disulfiram, used to help you stop drinking alcohol
- altretamine, used to treat cancer
- baclofen, used in the treatment of multiple
sclerosis and spinal damage
- pentamidine, an antibiotic used to treat pneumonia
- levacetylmethadol, used to treat addiction to
opioid drugs such as heroin.

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clomipramine hydrochloride

TBC

Clomipramine 10 mg Capsules, Hard
Clomipramine 25 mg Capsules, Hard
Clomipramine 50 mg Capsules, Hard

Other medicines and Clomipramine
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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Package leaflet: Information for the patient

Clomipramine with food, drink and alcohol
Take care when eating grapefruit, or drinking
grapefruit juice or cranberry juice as this may
increase your chance of experiencing side effects.
Be careful when drinking alcohol - it may affect you
more than usual.
Pregnancy and breast-feeding
Clomipramine should not be taken if you are
pregnant unless your doctor has told you to do so.
Clomipramine may harm your unborn child.
Clomipramine may reach your baby through
the breast milk. Therefore, you should not take
Clomipramine if you are breast-feeding.
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
Driving and using machines
If you feel dizzy, tired, have blurred vision, have
difficulty concentrating, or have other effects such
as confusion, disorientation or your depression
gets worse when you start to take Clomipramine
do not drive or work with machinery until these
effects have worn off.
Alcohol and other medicines may make these
side effects worse (see ‘Other medicines
and Clomipramine’)
The medicine can affect your ability to drive as it
may make you sleepy or dizzy.
• Do not drive while taking this medicine until you
know how it affects you.
• It is an offence to drive if this medicine affects
your ability to drive.
• However, you would not be committing an
offence if:
0 The medicine has been prescribed to treat a
medical or dental problem and
0 You have taken it according to the instructions
given by the prescriber or in the information
provided with the medicine and
0 It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not
sure whether it is safe for you to drive while taking
this medicine.
Clomipramine capsules contains lactose
If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor
before taking this medicinal product.
Clomipramine 10 mg capsules contain Sunset
yellow (E110)
This may cause allergic reactions.
3. How to take Clomipramine
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
If you have low blood potassium (hypokalaemia)
your doctor will treat this before you can
start treatment.
The recommended dose is:
• For depression a starting dose of 10 mg which
can be increased to find a dose that works for
you. This is normally 30 - 150 mg daily or up to a
maximum of 250 mg daily for severe conditions.
• For obsessions and phobias a starting dose of
25 mg which can be increased to 100 - 150 mg daily.
• For cataplexy a starting dose of 10 mg which can
be increased to a maximum of 75 mg daily.
Elderly patients often need a lower dose because
they are more likely to experience side effects. The
maximum dose for elderly patients is 75 mg daily.

Date: 17 May 2016
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Your doctor will tell you about this.
Do not stop taking Clomipramine suddenly
because this may cause withdrawal side effects. If
the decision is made by your doctor to discontinue
treatment, the dose you receive will be cut down
gradually to prevent the development of withdrawal
symptoms. You may get these side effects if you
stop taking Clomipramine suddenly: feeling or
being sick, stomach ache, diarrhoea, headache,
difficulty sleeping, nervousness or anxiety.
Use in children and adolescents (0 to 17 years):
Clomipramine is not recommended in children
and adolescents.
Method of administration
Swallow your Clomipramine capsules whole with a
drink of water.
The medicine may be taken as one dose at night,
or split into several smaller doses and taken
throughout the day. Your doctor will tell you what
to do.
Duration of treatment
Treatment is often long-term. Once an effective
dose is reached, you should continue to take this
medicine until your doctor tells you to stop.
If you take more Clomipramine than you should
Your heart and nervous system will be affected.
Contact your doctor or nearest hospital emergency
department immediately. Take the container and
any remaining capsules with you.
You may have the following signs of illness:
drowsiness, stupor (when you are unable to
move but still conscious) coma (unconscious),
ataxia (uncoordinated muscle movement),
restlessness, agitation, enhanced reflexes, muscle
stiffness, irregular muscle contractions, twisting
and writhing movements of the hands and feet,
convulsions (fits). You may also have signs of
so-called “Serotonin Syndrome” (very high blood
pressure, very high fever, muscle twitching,
confusion and coma). Other signs include: rapid
or irregular heartbeat, sudden chest pain (angina)
and in very rare cases heart attack, fever, being
sick, abnormally dilated pupil, sweating, low
blood pressure or a severe drop in blood pressure,
shortness of breath, blue skin, and a decrease or
absence of urine production.
If you forget to take Clomipramine
If you miss a dose, take the next dose at the usual
time. Then go on as before. DO NOT take a double
dose to make up for a forgotten dose.
If you stop taking Clomipramine
Speak to your doctor first before stopping
this medicine. Your doctor will tell you how to
gradually reduce your medication. This will help
avoid unwanted side effects such as feeling sick,
being sick, stomach pain, diarrhoea, sleeplessness,
headache, feeling nervous or anxious.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Some side effects can be serious
Stop taking Clomipramine and tell your doctor
immediately or go to your nearest hospital
emergency department if you notice the following:
Common (may affect up to 1 in 10 people)
• changes in your mood or behaviour such as
feeling unusually happy, excited (delirious),
irritable, confused, seeing or hearing things that
aren’t there (hallucinations) or changes in your
perception of reality (depersonalisation).
• difficulty or inability to pass urine
Uncommon (may affect up to 1 in 100 people)
• convulsions (fits)
Very rare (may affect up to 1 in 10,000 people)
• rash, changes in blood pressure, swelling of the
hands, face, tongue, neck or throat and increased
fluid in tissues, an increased heart rate, difficulty
breathing and collapse. These may all be the
signs of a severe allergic reaction
• a high temperature and sweating with rigid
muscles and confusion or agitation, or if you
experience jerky muscle movements which
you can’t control. These may be the symptoms
of a serious condition known as neuroleptic
malignant syndrome
• low numbers of white blood cells, leading to
frequent infections, such as fever, chills, sore
throat or mouth ulcers
• changes to your eyesight that may be due to high
pressure in the eye (known as glaucoma)
• very high fever or heatstroke
• disease of the liver (known as hepatitis), this
may result in jaundice. You may feel sick, be sick,
generally feel unwell, lose your appetite, have a
fever, yellowing of the skin or whites of the eyes,
light coloured stools and dark-coloured urine
• problems with how your heart beats. You may
have shortness of breath, irregular heart beat and
fainting (especially if you have low potassium
levels in your blood)
• a lower than normal level of sodium in the blood,
which may make you feel weak and confused
with aching of muscles. This may be due to
inappropriate ADH secretion, a hormone that
causes the body to retain water and dilute the
blood, reducing the amount of sodium.
Not known (frequency cannot be estimated from
the available data)
• thoughts of suicide or self-harm (see section 2 for
more information)
• breakdown of muscle, causing muscle pain,
weakness or tenderness accompanied by dark
urine (rhabdomyolysis)
• serotonin syndrome (caused by an increase in
naturally occurring messenger, serotonin, in the
brain; symptoms include agitation, confusion,
diarrhoea, high temperature, increased blood
pressure, excessive sweating and rapid heartbeat)
Other side effects that you may experience
Very common (may affect more than 1 in 10 people)
• increase in appetite, weight gain
• headaches, dizziness, feeling sick (nausea),
constipation, dry mouth, increased sweating
• shaking (particularly the hands), problems with
your eye sight including blurred vision, feeling
tired or sleepy
• problems with either your sex drive or getting or
maintaining an erection
• muscle twitching, restlessness
• changes in the amount of sugar in the blood
• changes to the amount of urine you produce or
frequency of urination.

• hot flushes
• enlarged pupils
• problems with your speech
• yawning
• feeling confused or aggressive
• feeling disorientated or agitated
• sleep disturbances
• nightmares
• worsening of existing depression
• impaired memory or concentration
• increased sensitivity of the skin to sunlight
• rash, hives or itching
• breast enlargement, spontaneous flow of milk
from the breast
• women may not be able to orgasm
• minor changes to your electrocardiogram (ECG)
may show up if your heart is tested
• numbness or tingling in the arms and legs
• movement disorder
• changes in liver function tests
• changes to sense of taste
• ringing in the ears (tinnitus).
Uncommon (may affect up to 1 in 100 people)
• clumsiness and lack of coordination, affecting
balance and walking, limb or eye movements
• increased blood pressure
• irregular heartbeats.
Rare (may affect up to 1 in 1,000 people)
• vaginal bleeding.
Very rare (may affect up to 1 in 10,000 people)
• fluid retention or generalised swelling
• hair loss
• swelling of the lungs which can cause flu-like
effects such as coughing, chest tightness, chills
wheezing and difficulty breathing.
• unexplained or easily bruising under the skin or
increased bleeding if you are cut or injured (due
to low platelet levels in your blood)
• blue or purplish spots on the skin (ecchymosis)
• bleeding in the skin causing purple patches
• abnormal reading of the electrical activity of the
brain (as seen in an electroencephalogram)
Not known (frequency cannot be estimated from
the available data)
• feeling of inner restlessness and a compelling
need to be in constant motion
• repetitive, involuntary movements
• inability to ejaculate or a delay in ejaculation
• increase in prolactin (a hormone) level in
the blood.
An increased risk of bone fractures has been
observed in patients taking this type of medicine.
If you are elderly you may be more likely to suffer
from agitation and postural hypotension. Mental
disorders such as confusion, disorientation and
hallucinations (seeing or hearing things that are
not there) are also more likely, especially at night,
and especially if you have Parkinson’s disease.
These side effects should disappear a few days
after you stop taking Clomipramine.
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, website:
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 Clomipramine
Store Clomipramine capsules below 25°C in a
dry place.
Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date,
which is stated on the pack or bottle. The expiry
date refers to the last day of that month.
If your doctor tells you to stop taking
Clomipramine please take any unused medicine
back to your pharmacist to be destroyed. Do not
throw away any medicines via wastewater or
household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Clomipramine contains
The active substance is clomipramine
hydrochloride. Each 10 mg capsule contains 10 mg
clomipramine hydrochloride. Each 25 mg capsule
contains 25 mg clomipramine hydrochloride.
Each 50 mg capsule contains 50 mg clomipramine
hydrochloride.
The other ingredients are lactose monohydrate
(see section 2 ‘Clomipramine contains lactose’),
maize starch dried, purified talc, silica, colloidal
anhydrous and magnesium stearate. The shell of
each strength of capsule also contains gelatin, iron
oxide red (E172) and titanium dioxide (E171). The
10 mg capsule shell also contains Sunset yellow
(E110) (see section 2 ‘Clomipramine contains
Sunset yellow’) and Quinoline yellow (E104).
The 25 mg capsule shell also contains iron oxide
yellow (E172) and erythrosine (E127). The 50 mg
capsule shell also contains Indigo carmine (E132).
The printing ink for the 10 mg capsule contains
shellac, iron oxide black (E172), propylene glycol
and ammonium hydroxide. The printing ink for
the 25 mg and 50 mg capsule contains shellac,
titanium dioxide (E171), propylene glycol,
ammonium hydroxide and simeticone.
What Clomipramine looks like and contents of
the pack:
Clomipramine 10 mg capsules are red and yellow
hard gelatin capsules marked ‘G CI10’.
Clomipramine 25 mg capsules are red and orange
hard gelatin capsules marked ‘G CI25’.
Clomipramine 50 mg capsules are red and blue
hard gelatin capsules marked ‘G CI50’.
The capsules are available in blisters or plastic
containers of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 56,
60, 84, 90, 100, 112, 120, 168 and 180 capsules. Not
all pack sizes may be marketed.
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom.
Manufacturer:
Generics [UK] Limited, Potters Bar, Hertfordshire,
EN6 1TL, United Kingdom.
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
This leaflet was last revised in:
April 2016

Common (may affect up to 1 in 10 people)
• reduced appetite
• stomach problems
• being sick
• diarrhoea
• fast heart rate, which you may feel as a racing
or thumping in the chest (palpitations), lightheadedness when standing up (due to low
blood pressure)
• increased anxiety

Description Clomipramine Hydrochloride 25/50/10mg 5
Component Type Leaflet
Affiliate Item Code 894225
Superceded Affiliate Item Code 436707
TrackWise PR No. 894225
MA No. 04569/0229-0231
Packing Site/Printer NA
Supplier Code LT1378AH

Pharma Code TBC
SAP No. NA
Vendor Job No. 281138
Trackwise Proof No. 1
Glams Proof No. 1
Client Market UK
Keyline/Drawing No. NA
Barcode Info NA

LT1378AH 894225

Date: 17 May 2016
No. of colours
Colours

1

Time: 13:02
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with
Main Font Myriad Pro

Body Text Size 9 pt

Dimensions 170 x 580mm

Min Text Size used 9 pt

Sign-offs

v1/May 2015

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.

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