ANAFRANIL 10MG CAPSULES

Active substance: CLOMIPRAMINE HYDROCHLORIDE

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ANAFRANIL®
10, 25 and 50 mg
Capsules

In this leaflet:

●●

1.  hat Anafranil is and what it’s used for
W
2.  hings to consider before you start to
T
take Anafranil

(clomipramine hydrochloride)

Patient Information Leaflet
These medicines will be referred to as
Anafranil in this leaflet.

What you need to know about Anafranil
Your doctor has decided that you need this
medicine to help treat your condition.
Please read this leaflet carefully before you
start to take your medicine. It contains
important information. Keep the leaflet in
a safe place because you may want to read
it again.
If you have any other questions, or if there is
something you don’t understand, please ask
your doctor or pharmacist.
This medicine has been prescribed for you.
Never give it to someone else. It may not
be the right medicine for them even if their
symptoms seem to be 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.

●●

If the answer to any of these questions is YES,
tell your doctor or pharmacist because Anafranil
might not be the right medicine for you.
Are you taking other medicines?

Anafranil interacts with a large number of
other medicines. Make sure your doctor or
4.  ossible side effects
P
pharmacist knows if you are taking any of
5.  ow to store Anafranil
H
the following:
●● Medicines for depression particularly
6. Further information
●●
MAOIs e.g. tranylcypromine, phenelzine;
●●
SSRIs e.g. fluoxetine, paroxetine,
1.  hat Anafranil is and what it’s used for You should also ask yourself these questions
W
sertraline, fluvoxamine; tricyclic and
tetracyclic ­ ntidepressants e.g.
a
before taking Anafranil:
Anafranil is available either as capsules in
amitriptyline, dothiepin, maprotiline,
­
●● Do you find yourself thinking about suicide?
three different strengths or as sustained
barbiturates, ­benzodiazepines
release tablets. Clomipramine hydrochloride, ●● Do you have epilepsy (fits)?
the active ingredient in Anafranil, is one
●● Medicines for other mental illnesses such
●● Have you had a head injury and suffered
of a group of medicines called tricyclic
as schizophrenia or manic depression
brain damage?
a
­ ntidepressants. It is thought to work
e.g. thioridazine, lithium
●● Are you going to have ECT
either by increasing the amount of chemical
●● Medicines for high blood pressure
(electroconvulsive therapy)?

­ messengers” in the brain or by making their
●● Medicines to treat heart disorders,
●● Do you have irregular heartbeat or other
effects last longer.
particularly those used to treat an
problems with your heart?
Anafranil is used to treat depression,
abnormal heart rhythm
●● Have you been diagnosed as having a
o
­ bsessions and phobias (irrational fears).
●● Betablockers e.g atenolol
low level of potassium in your blood
It is also used to treat muscular weakness
●● Diuretics e.g. bendroflumethiazide,
(hypokalemia)?
(cataplexy) associated with repeat attacks of
●● Do you have kidney disease?
furosemide
extreme sleepiness (narcolepsy) in adults.
●● Anticoagulants (blood thinning tablets
●● Do you have schizophrenia or other
like warfarin)
mental disorders?
2.  hings to consider before you start to ●● Are you pregnant?
T
●● Medicines for Parkinson’s Disease
take Anafranil
●● Do you have a blood disorder?
●● Nicotine, e.g. if you smoke or are using
●● Do you have an overactive thyroid gland?
nicotine replacement therapy
Some people MUST NOT take Anafranil.
●● Anticonvulsants (used to stop seizures
●● Have you had severe constipation for a
Talk to your doctor if:
or fits. e.g. barbiturates, phenytoin,
●● you think you may be allergic to
long time?
carbamazepine or valproate)
●● Do you have a tumour (cancer) of the
c
­ lomipramine or to any of the other
i­ gredients of Anafranil tablets or capsules.
n
adrenal gland (such as ­ haeochromocytoma ●● Cold and flu drugs such as antihistamines
p
(These are listed in Section 6.)
and decongestants
or neuroblastoma)?
●● you have ever had a rash or other allergic
●● Do you have low blood pressure?
●● Cimetidine, used to treat ulcer/heartburn
reaction to any other antidepressants
●● Do you wear contact lenses?
●● Methylphenidate (Ritalin ® ) prescribed for
●● you have had a heart attack within the last
●● Are you elderly?
children with ADHD
3 months
●● Rifampicin, used to treat some infections
●● Do you have an inherited intolerance
●● you have any heart disease
including tuberculosis (TB)
to some sugars such as lactose?
●● you have any serious liver disease
●● Quinine (for cramp or malaria treatment)
The capsules contain lactose.
3.  ow to take Anafranil
H

ANAFRANIL®
75 mg sustained
release Tablets

●●

you have any other mental illness apart
from depression, obsessions or phobias
you have glaucoma (increased eye
pressure)
you have difficulty in passing urine
you are taking, or within the last 3 weeks
have taken, any other medicines for
depression, particularly monoamine
oxidase inhibitors (MAOIs) or fluoxetine
you are breast-feeding
you are aged under 18.

●●

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Strong painkillers such as morphine or
morphine related substances e.g. codeine,
dihydrocodeine
●● Drugs of abuse including Ecstasy
●● Atropine or similar medicines (including
eye drops)
●● Oestrogens (e.g. contraceptive pill or
hormone replacement therapy)
●● 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
●● Colestipol, cholestyramine, used to treat
high cholesterol levels
●● St. John’s wort (Hypericum perforatum), a
herbal product used to treat depression
and other conditions
Always tell your doctor or pharmacist about
all the medicines you are taking. This means
medicines you have bought yourself as well as
medicines on prescription from your doctor.
●●

Pregnancy and 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.
Anafranil should not be used during
pregnancy unless specifically prescribed by
your doctor. Your doctor will discuss with you
the potential risk of taking Anafranil during
pregnancy.

Will there be any problems with driving or
using machinery?
If you feel dizzy, tired, have blurred vision,
have difficulty concentrating, or have other
effects such as confusion or disorientation
when you start to take Anafranil, do not
drive or work with machinery until these
effects have worn off.
Taking Anafranil with food and drink
Take care when eating grapefruit, or drinking
grapefruit juice and cranberry juice as this
may increase your chance of experiencing
side effects.
Other special warnings
●●

●●

●●

●●

●●

●●

Be careful when drinking alcohol - it may
affect you more than usual.
Tell your doctor or dentist if you are
planning to have an operation of any
kind, as Anafranil may interact with local
or general anaesthetics.
Your doctor may want to do blood tests
and check your heart while you are taking
Anafranil.
Your doctor may want to do blood tests
to check your liver function and kidney
function.
You should go to the dentist regularly if you
take Anafranil for a long time, because it
can cause a dry mouth which may increase
the chance of tooth decay.
If you think your symptoms are getting
worse, go and see your doctor.

The active ingredient of Anafranil passes into
the breast milk. Mothers are advised not to
breast-feed their babies while taking Anafranil.

Thoughts of suicide and worsening of your
depression or anxiety disorder

The following symptoms may occur in
newborn babies, of mothers that have used
Anafranil during pregnancy: breathlessness,
tiredness, lack of energy, colic, irritability,
dizziness, headache, trembling. If your baby
develops any of these symptoms you may
need to contact your doctor.

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.

27.08.13 11:26

Typopharma GmbH
www.typopharma.com

interne Freigabe:
LFT_Famar_440x180
N/A

Production Site:
CTM:

Famar Greece
M. Dzierzon

Printing Colours:

Black

Technical Colours:

Cutting
Dimensions

# 107809
Live Text:
WO:

 Yes /
881989_DM

Comp. Description:

Leaflet_ANAFRANIL INC.
SR_HGC_10MG; 25MG; 50MG_
(6X14); 6X14); (4X14)_GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

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180 x 440 mm
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Min. Font Size Text:
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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.
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.

be on the pharmacist’s label. Check the
label carefully. If you are not sure, ask your
doctor or pharmacist.
●● 
Swallow your Anafranil tablets or capsules
whole with a drink of water.
●● 
Keep taking your medicine until your doctor
tells you to stop. Do not stop because you
do not feel any better. This medicine may
take up to 4 weeks to work.
The usual dosages for adults are as follows:
●● For depression:
10mg-150mg daily. Severe cases may
need even higher doses.
●● For obsessions and phobias:
10mg-150mg daily.
●● For cataplexy:
10mg-75mg daily.

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.

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.
Elderly patients often need a lower dose
because they are more likely to experience side
effects. Your doctor will tell you about this.
Do not stop taking Anafranil 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 Anafranil suddenly: feeling or being
sick, stomach ache, diarrhoea, headache,
difficulty sleeping, nervousness or anxiety.

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.

3.  ow to take Anafranil
H
The doctor will tell you how much Anafranil
to take and when to take it. Always follow
his/her instructions carefully. The dose will

What if you forget to take a dose?
If you miss a dose, take the next dose at
the usual time. Then go on as before.
DO NOT take a double dose.
What if you take too many?
If you, or anyone else, accidentally takes too
much Anafranil, tell your doctor or your

881989 GB.indd 2

nearest hospital casualty department
immediately. Take your medicine pack
with you so that people can see what
you have taken.

4.  ossible side effects
P
Anafranil is suitable for most people, but,
like all medicines, it can sometimes cause
side effects. The side effects are usually
mild and disappear as treatment continues.
Some side effects can be serious
Stop taking Anafranil and tell your doctor
immediately if you notice the following very
rare symptoms:
●● Rash, changes in blood pressure, swelling
and increased fluid in tissues, an increased
heart rate, difficulty with 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.
The side effects listed below have also been
reported:
More than 1 in 10 people have experienced:
Increase in appetite and weight gain.
Headaches, dizziness, nausea, constipation,
dry mouth, increased sweating, shaking
hands, tremor, difficulty in passing urine,
problems with their eyes, feeling tired or
sleepy, sexual disturbances.
Up to 1 in 10 people have experienced:
Loss of appetite, stomach upset, vomiting,
diarrhoea, lightheadedness when standing
up (due to low blood pressure), increased
anxiety, agitation, hot flushes, enlarged
pupils, speech disturbance, yawning, feeling
confused, disorientated or over-excited, sleep
disturbances, nightmares, hallucinations or,

thought disturbances, worsening of existing
depression, impaired memory and
concentration, restlessness, disturbances
in heart rhythm, increased sensitivity of
the skin to sunlight, rash and itching, breast
changes, numbness or tingling in the arms
and legs, muscle weakness, movement
disorder, changes in liver function tests,
taste disturbances, tinnitus.

Children and Adolescents
Anafranil 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 Anafranil in this age group
have not yet been demonstrated.
Also patients under 18 may have an
Up to 1 in 100 people have experienced:
increased risk of side-effects such as suicidal
Mood changes including aggression, fits,
thoughts, harming themselves and hostility
movement disorders, increased blood pressure.
(predominately aggression, oppositional
Up to 1 in 10,000 people have experienced: behaviours and anger) when they take drugs
Glaucoma, fever, hepatitis causing jaundice
like Anafranil. Despite this, your doctor may
(yellowing of the skin or whites of the eyes)
prescribe Anafranil for patients under
and light-coloured urine, oedema (generalised 18 because he/she decides that this is in their
swelling), hair loss, blood disorders (which
best interests. If your doctor has prescribed
might result in persistent sore throat, fever
Anafranil for you (or your child) and you want
or frequent infections, unexplained bruising
to discuss this, please go back to your doctor.
or bruising more easily).
You should inform your doctor if any of the
symptoms listed above develop or worsen
Also reported (frequency unknown):
Feeling of inner restlessness and a compelling when patients under 18 are taking Anafranil.
need to be in constant motion, repetitive,
5.  ow to store Anafranil
H
involuntary, purposeless movements,
Store Anafranil 75 mg sustained release
breakdown of muscle, increase in prolactin
Tablets in a dry place. Store Anafranil
(a hormone) level in the blood, and serotonin
Capsules below 30°C in a dry place.
syndrome (syndrome caused due to increase
Keep out of the reach and sight of children.
in naturally occurring messenger, serotonin,
Do not use the medicine after the expiry
in brain; manifested by symptoms like
date which is stated on the carton.
agitation, confusion, diarrhoea, high
If your doctor tells you to stop taking
temperature, increased blood pressure,
Anafranil, please take any unused medicine
excessive sweating and rapid heartbeat).
back to your pharmacist to be destroyed.
Some people have experienced:
Do not throw it away with your normal
Thoughts of suicide or self-harm (see Section
household water or waste. This will help
2 for more information).
to protect the environment.
An increased risk of bone fractures has
been observed in patients taking this type
6. Further information
of medicine.
Anafranil Capsules are available in three
Most of the side effects are mild and may
wear off after a few days treatment. If they
are severe or last for more than a few days,
tell your doctor. Also, if your medicine
upsets you in any other way, tell your doctor.

strengths containing 10, 25 or 50 mg of the
active ingredient clomipramine hydrochloride.
The gelatin capsules also contain the inactive
ingredients lactose, magnesium stearate,
titanium dioxide, black iron oxide, red iron

oxide, yellow iron oxide, brown printing ink
and purified water.
The 10 and 25 mg capsules come in blister
packs containing 84 or 100 capsules.
The 50mg capsules come in blister packs
containing 56 or 100 capsules.
Not all of these pack sizes are marketed.
Anafranil 75 mg sustained release Tablets are
dull, greyish-red film coated tablets imprinted
‘Geigy’ on one face and ‘GD’ on the other,
and contain 75 mg of the active ingredient
clomipramine hydrochloride. The tablets are
formulated to release the active ingredient
slowly. The tablet core contains the inactive
ingredients colloidal silicon dioxide, calcium
hydrogen phosphate, Eudrogit E 30D and
calcium stearate. The coating constituents are
hydroxypropylmethylcellulose, red iron oxide
(E172), polyethoxylated castor oil, purified talc,
titanium dioxide (E171) and purified water.
The tablets come in blister packs containing
28 tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Novartis Pharmaceuticals UK Ltd trading as
Geigy Pharmaceuticals, Frimley Business Park,
Frimley, Camberley, Surrey GU16 7SR, England.
Manufacturer
Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham, West Sussex,
RH12 5AB, England, United Kingdom and
Frimley Business Park, Frimley, Camberley,
Surrey, GU16 7SR, England, United Kingdom.
This leaflet was revised in August 2013
If you would like any more information, or
would like the leaflet in a different format,
please contact Medical Information at
Novartis Pharmaceuticals UK Ltd,
telephone number 01276 698370.
Anafranil is a registered
trade mark
Copyright
Novartis Pharmaceuticals UK Limited

881989 GB

27.08.13 11:26

Typopharma GmbH
www.typopharma.com

interne Freigabe:
LFT_Famar_440x180
N/A

Production Site:
CTM:

Famar Greece
M. Dzierzon

Printing Colours:

Black

Technical Colours:

Cutting
Dimensions

# 107809
Live Text:
WO:

 Yes /
881989_DM

Comp. Description:

Leaflet_ANAFRANIL INC.
SR_HGC_10MG; 25MG; 50MG_
(6X14); 6X14); (4X14)_GB

Comp. No. New:
Comp. No. Old:
Format/Dimension:
Tech. Drawing No.:

881989 GB
N/A
180 x 440 mm
N/A

Min. Font Size Text:
Proof No.: 1

9 pt
27.08.2013

! PLEASE



No

V. Mastroberti

TURN

OVERPRINTING

ON !

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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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