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CLOMIPRAMINE 50 MG CAPSULES
Active substance(s): CLOMIPRAMINE HYDROCHLORIDE / CLOMIPRAMINE HYDROCHLORIDE / CLOMIPRAMINE HYDROCHLORIDE
231-30-85095-ZA LEA CLOMIPRAMINE A/S CAP TUK
08 February 2016
PAGE 1: FRONT FACE (INSIDE OF REEL)
PACKAGE LEAFLET: INFORMATION
FOR THE USER
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 you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
IN THIS LEAFLET:
1. What Clomipramine is and what it is used for
2. Before you take Clomipramine
3. How to take Clomipramine
4. Possible side effects
5. How to store Clomipramine
6. Further information
WHAT CLOMIPRAMINE IS AND WHAT IT IS USED FOR
Clomipramine belongs to a group of drugs called tricyclic antidepressants.
Clomipramine is used:
• to treat depression
• to treat phobias and obsessive states
• to treat cataplexy (collapse) associated with narcolepsy (a sleep disorder).
BEFORE YOU TAKE CLOMIPRAMINE
Pharma code 546
Do NOT take Clomipramine if you:
• are allergic (hypersensitive) to clomipramine hydrochloride, tricyclic
antidepressants or any of the other ingredients of this medicine
• have severe liver problems
• have recently had a heart attack or you suffer from any other heart
• have difficulty in passing urine
• have narrow angle glaucoma (loss of vision due to abnormally high
pressure in the eye)
• suffer from mania (a mood disorder characterised by high levels of
excitement and activity)
• are taking, or have taken within the last three weeks a medicine for
depression called a monoamine oxidase inhibitor (MAOI)
• you are aged under 18.
Take special care with Clomipramine
Tell your doctor before you start to take this medicine if you:
• suffer from epileptic fits
• have brain damage
• had a brain injury
• have irregular heartbeat or other problems with your heart
• have you been diagnosed as having a low level of potassium in your
• have a blood disorder
• have low blood pressure
• are undergoing withdrawal from alcohol or other drugs
• have problems with your thyroid
• have a history of glaucoma (increased pressure in the eye), have
narrow angle glaucoma or problems passing urine
• have a tumour of the adrenal gland (phaeochromocytoma or
• are having electroconvulsive therapy (ECT)
• suffer from panic disorders or anxiety
• suffer from chronic constipation
• wear contact lenses
• suffer from schizophrenia or other mental disorder
• are pregnant or breast-feeding
• are elderly, as you are more likely to experience side effects such as
hallucinations, psychiatric disorders, agitation, confusion, low blood
pressure on standing causing dizziness, light-headedness or fainting.
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 (less than 25 years old)
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.
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.
Tell your doctor or dentist 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.
Be careful when drinking alcohol – it may affect you more than usual.
If you think your symptoms are getting worse, go and see your doctor.
You may get withdrawal symptoms if Clomipramine is stopped abruptly.
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 to 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.
Taking other medicines
Do NOT take Clomipramine in combination with, or if you have taken
in the last 21 days medicines for depression particularly MAOIs e.g.
tranylcypromine, moclobemide phenelzine.
Talk to your doctor if you are taking any of the following:
• medicines for other mental illnesses such as schizophrenia or manic
depression e.g. thioridazine, lithium
• medicines for depression - SSRIs e.g. fluoxetine, fluvoxamine;
tricyclic and tetracyclic antidepressants e.g. amitriptyline, dothiepin,
maprotiline, barbiturates, benzodiazepines
• pimozide (used to treat mental illness)
• anaesthetics (used for the temporary loss of bodily sensation)
• barbiturates e.g. phenobarbital
• antihistamines e.g. cetirizine
• sedatives (drugs used to relieve anxiety) e.g. diazepam
• medicines to treat nasal congestion e.g. phenylephrine,
• sympathomimetic drugs e.g. adrenaline, ephedrine, isoprenaline,
noradrenaline, (also found in medicines you can buy without a
prescription to relieve a blocked nose)
• anticholinergic drugs (drugs which block some nerve endings and
stops glands secreting, speeding up the heart and making some
muscles relax) e.g. biperiden, phenothiazine, atropine
• levodopa (used to treat Parkinsonism)
• high blood pressure or irregular heart beat drugs e.g. disopyramide,
procainamide, amiodarone and sotalol, guanethidine, betanidine,
reserpine, clonidine, alpha-methyldopa or quinidine
• betablockers (used to treat heart disease) e.g. atenolol
• diuretics (water tablets) e.g. bendroflumethiazide, furosemide
• disulfiram (used to treat alcoholism)
• cimetidine (to reduce acid indigestion)
• methylphenidate (to treat Attention Deficit Disorder (ADD))
• blood thinning drugs e.g. coumarin or warfarin
• oestrogen (included in birth control pills and hormone replacement
therapy (HRT)) anticonvulsants (used to treat fits) e.g. carbamazepine,
• strong painkillers such as morphine or morphine related substances
e.g. codeine, dihydrocodeine
• drugs of abuse including Ecstasy
• medicines, called protease inhibitors, used to treat Human
Immunodeficiency Virus e.g. ritonavir, indinavir
• medicine called terbinafine used orally to treat skin, hair or nail
infections due to fungus
• quinine (used for the treatment of high fever)
• pentamidine (used to treat viral infection)
• terfenadine used to treat symptoms of allergies such as rash, runny
nose, watery eyes, hives etc.
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
Taking Clomipramine with food and drink
Do not take alcohol while taking Clomipramine as it may affect you
more than usual.
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant or breast-feeding,
ask your doctor for advice before taking this medicine.
If you take Clomipramine during pregnancy your baby may have low or
high blood pressure, shaking or spasms, shortness of breath, lethargy,
stomach pain and irritability when born.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Clomipramine Capsules may cause drowsiness and blurred vision, if
affected do not drive or operate machinery.
Important information about some of the ingredients of Clomipramine
Patients who are intolerant to lactose should note that Clomipramine
capsules contain a small amount of 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.
HOW TO TAKE CLOMIPRAMINE
Always take Clomipramine exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
If you see another doctor or go into hospital, let them or the staff know
what medicines you are taking.
The capsules should be swallowed preferably with a glass of water.
The usual dose is:
• Adults: initially, 10 mg a day. Your doctor may increase this to
30-150 mg daily, with a maximum of 250 mg daily, taken as divided
doses or as a single dose at bed time.
• Elderly: initially 10 mg a day. Your doctor may increase this to
30-75 mg a day.
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Top of page cut-off to middle of registration mark: 44 mm.
CLOMIPRAMINE 10 mg, 25 mg
AND 50 mg CAPSULES
TEVA UK Ref:
231-30-85095-ZA LEA CLOMIPRAMINE A/S CAP TUK
08 February 2016
PAGE 2: REAR FACE (OUTSIDE OF REEL)
• ECG changes in patients of normal cardiac status
• abnormal liver function test.
Tell your doctor if you have any of the following:
Uncommon (affecting fewer than one person in 100 but more than one
person in 1,000):
• high blood pressure
• irregular heart beat
• mood changes including aggression
• movement disorders
Very Rare (affecting less than 1 person in 10,000):
• glaucoma (loss of vision due to abnormally high pressure in the eye)
• heart problems
• psychotic symptoms (increased appetite, restlessness, drowsiness,
• high body temperature
• inflammation of the liver (including jaundice characterised by
yellowing of the skin and whites of the eyes)
• inflammation of lungs
• low blood pressure
• low blood sodium levels (syndrome of inappropriate antidiuretic
• swelling (oedema)
• hair loss
• blood disorders (characterised by abnormal bruising of the skin or
possibly fever or sore throat)
• coloured spots and patches on the skin
• abnormal EEG (test that measures and records the electrical activity
of your brain).
Other side effects (frequency is not known)
• abnormal muscle breakdown
• unpleasant feeling of inner restlessness
• suicidal thoughts and behaviour (see Section 2 for more information).
Children and Adolescents
Clomipramine should not be used in the treatment of depressive states,
phobias or cataplexy associated with narcolepsy for children and
adolescents under the age of 18 years as long-term safety effects
concerning growth, maturation and cognitive and behavioural
development of Clomipramine in this age group have not yet been
Also patients under 18 may have an increased risk of side effects such
as suicidal thoughts, harming themselves and hostility (predominately
Like all medicines, Clomipramine can cause side effects, although not
aggression, oppositional behaviours and anger) when they take drugs
everybody gets them.
like Clomipramine. Despite this, your doctor may prescribe Clomipramine
If the following happens, stop taking the capsules and tell your doctor for patients under 18 because he/she decides that this is in their best
immediately or go to the casualty department at your nearest hospital: interests. If your doctor has prescribed Clomipramine for you (or your
• an allergic reaction (swelling of the lips, face or neck leading to
child) and you want to discuss this, please go back to your doctor.
severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect. You may need urgent medical You should inform your doctor if any of the symptoms listed above
develop or worsen when patients under 18 are taking Clomipramine.
attention or hospitalisation.
An increased risk of bone fractures has been observed in patients
If you have any mood changes e.g. increased anxiety, aggression or
taking this type of medicines.
agitation, you should tell your doctor immediately, as this medicine
Most of the side effects are mild and may wear off after a few days
may not be suitable for you, he may ask you to stop taking it.
treatment. If they are severe or last for more than a few days, tell your
The following side effects have been reported at the approximate
doctor. Also, if your medicine upsets you in any other way, tell your
Very common (affecting more than one person in 10):
Reporting of side effects
• dry mouth
If you get any side effects, talk to your doctor or pharmacist. This
• visual disturbance e.g. blurred vision
includes any possible side effects not listed in this leaflet. You can also
• problems passing urine
report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on the
• increased appetite and weight gain
safety of this medicine.
• tiredness and dizziness
5 HOW TO STORE CLOMIPRAMINE
• involuntary muscle movements, twitching of the muscles
Keep out of the reach and sight of children.
• uncontrolled shaking
Do not store above 25°C. Store in the original package. Do not transfer
• feeling sick
them to another container. Do not use Clomipramine after the expiry
• sexual problems, difficulty in getting or maintaining an erection.
date that is stated on the outer packaging. The expiry date refers to the
last day of that month. Medicines should not be disposed of via
Common (affecting fewer than one person in 10 but more than one
wastewater or household waste. Ask your pharmacist how to dispose
person in 100):
of medicines no longer required. These measures will help to protect
• hot flushes
• pupil dilatation
• changes and disturbances in heart rhythm
6 FURTHER INFORMATION
• fall in blood pressure on standing up which causes dizziness,
light-headedness or fainting
What Clomipramine capsules contain:
• anxiety, agitation
The active ingredient is clomipramine hydrochloride. The other
ingredients are lactose monohydrate, maize starch, povidone (E1201),
sodium starch glycolate (E576), sodium laurilsulfate, magnesium
• confusion with disorientation and hallucinations
stearate (E572), gelatin, yellow iron oxide (E172), red iron oxide (E172),
• dream and sleep disturbances
black iron oxide (E172), titanium dioxide (E171). The 25 mg and 50 mg
• worsening of depressive symptoms
capsules also contain indigotine (E132). The 25 mg capsule also
• impaired memory and concentration, a sense of being disinterested, contains erythrosine (E127). The printing ink contains shellac, black
iron oxide (E172) and propylene glycol (E1520).
elevated mood and hyperactivity, excitement, depersonalisation
• muscle slackness, weakness or spasm, ‘pins and needles’, tingling
What Clomipramine capsules look like and contents of the pack:
and numbness sensation, reduced ability of muscle to stretch
Clomipramine Capsules 10 mg are hard capsules, brown and yellow,
• speech disorder
printed ‘1806’. Clomipramine Capsules 25 mg are hard capsules, brown
• being sick
and orange, printed ‘1807’. Clomipramine Capsules 50 mg are hard
• loss of appetite
capsules, brown and blue, printed ‘1808’.
The product is available in pack sizes of 28, 30, 56, 60, 100, 250, 500 or
• abdominal disorders
1000 capsules. Not all pack sizes may be marketed.
• breast enlargement and milk production in women even if they are
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company responsible for
• an unpleasant taste
manufacture: TEVA UK Limited, Eastbourne, BN22 9AG.
• ringing in the ears
• allergic reactions which may lead to skin rash, sensitivity to light and This leaflet was last revised: January 2016
210 x 323
Phobias and obsessive states
• Adults: initially 25 mg a day which may be gradually increased if
• Elderly: initially 10 mg a day which may be gradually increased if
This medicine may take up to 4 weeks to work. You may feel more
anxious at the start of treatment but this will normally decrease after
Cataplexy associated with narcolepsy
• Adults (including the elderly): Initially, 10 mg a day which may be
gradually increased if necessary, to between 10-75 mg a day.
Children and adolescents (0-17 years of age):
Clomipramine is not recommended for use in children and adolescents.
If you take more Clomipramine than you should
If you (or someone else) take too many capsules all together, or if you
think a child has swallowed any of the capsules, contact your nearest
hospital casualty department or your doctor immediately. An overdose
is likely to cause drowsiness, stupor, coma, difficulty in controlling
movements, agitation, enhanced reflexes, restlessness, fits, muscular
rigidity, involuntary jerky movements, shock, low blood pressure, a
fast or abnormal heart rate, vomiting, fever, dilated pupils, breathing
problems, sweating, blue colour to the skin, passing little or no urine.
Please take this leaflet, any remaining capsules and the container with
you to the hospital or doctor so that they know which capsules were
If you forget to take Clomipramine
If you forget to take a capsule, take one as soon as you remember, unless
it is nearly time to take the next one. Do not take a double dose to make
up for a forgotten dose. Take the remaining doses at the correct time.
If you stop taking Clomipramine
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.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
Page 2 of 3
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.