ANAFRANIL 10MG CAPSULES

Active substance: CLOMIPRAMINE HYDROCHLORIDE

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ANAFRANIL®
10, 25 and 50 mg
Capsules
ANAFRANIL®
75 mg sustained
release Tablets
(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.

In this leaflet:

• you have any heart disease

• Do you have low blood pressure?

1. What Anafranil is, and what it’s used for

• you have any serious liver disease

• Do you wear contact lenses?

2. Things to consider before you start to
take Anafranil

• you have any other mental illness apart
from depression, obsessions or phobias

• Are you elderly?

3. How to take Anafranil

• you have glaucoma (increased eye pressure)

4. Possible side effects
5. How to store Anafranil
6. Further information

1. What Anafranil is and what it’s used for
Anafranil is available either as capsules in
three different strengths or as sustained
release tablets. Clomipramine hydrochloride,
the active ingredient in Anafranil, is one of a
group of medicines called tricyclic
antidepressants. It is thought to work either
by increasing the amount of chemical
“messengers” in the brain or by making their
effects last longer.
Anafranil is used to treat depression,
obsessions and phobias (irrational fears). It is
also used to treat muscular weakness
(cataplexy) associated with repeat attacks of
extreme sleepiness (narcolepsy) in adults.

2. Things to consider before you start to
take Anafranil
Some people MUST NOT take Anafranil. Talk
to your doctor if:
• you think you may be allergic to
clomipramine or to any of the other
ingredients of Anafranil tablets or capsules.
(These are listed in Section 6).
• you have ever had a rash or other allergic
reaction to any other antidepressants
• you have had a heart attack within the last
3 months

• 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.
You should also ask yourself these questions
before taking Anafranil:
• Do you find yourself thinking about suicide?
• Do you have epilepsy (fits)?
• Have you had a head injury and suffered
brain damage?
• Are you going to have ECT
(electroconvulsive therapy)?
• Do you have irregular heartbeat or other
problems with your heart?
• Have you been diagnosed as having a
low level of potassium in your blood
(hypokalemia)?
• Do you have kidney disease?
• Do you have schizophrenia or other
mental disorders?
• Are you pregnant?
• Do you have a blood disorder?
• Do you have an overactive thyroid gland?
• Have you had severe constipation for a
long time?
• Do you have a tumour (cancer) of the
adrenal gland (such as
phaeochromocytoma or neuroblastoma)?

• Do you have an inherited intolerance to
some sugars such as lactose? The capsules
contain lactose.
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?

• Anticonvulsants (used to stop seizures
or fits, e.g. barbiturates, phenytoin,
carbamazepine or valproate)
• Cold and flu drugs such as antihistamines
and decongestants
• Cimetidine, used to treat ulcer / heartburn
®

• Methylphenidate (Ritalin ) prescribed for
children with ADHD
• Rifampicin, used to treat some infections
including tuberculosis (TB)

Anafranil interacts with a large number of
other medicines. Make sure your doctor or
pharmacist knows if you are taking any of
the following:

• Quinine (for cramp or malaria treatment)

• Medicines for depression particularly
MAOIs e.g. tranylcypromine, phenelzine;
SSRIs e.g. fluoxetine, paroxetine, sertraline,
fluvoxamine; tricyclic and tetracyclic
antidepressants e.g. amitriptyline, dothiepin,
maprotiline, barbiturates, benzodiazepines

• Drugs of abuse including Ecstasy

• Medicines for other mental illnesses such
as schizophrenia or manic depression
e.g. thioridazine, lithium
• Medicines for high blood pressure
• Medicines to treat heart disorders,
particularly those used to treat an
abnormal heart rhythm
• Betablockers e.g atenolol
• Diuretics e.g. bendroflumethiazide,
furosemide
• Anticoagulants (blood thinning tablets
like warfarin)
• Medicines for Parkinson’s Disease
• Nicotine, e.g. if you smoke or are using
nicotine replacement therapy

• Strong painkillers such as morphine or
morphine related substances e.g. codeine,
dihydrocodeine
• Atropine or similar medicines (including
eye drops)

Will there be any problems with driving or
using machinery?

since these medicines all take time to work,
usually about two weeks but sometimes longer.

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.

You may be more likely to think like this:

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.

• Oestrogens (e.g. contraceptive pill or
hormone replacement therapy)

• 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.

• Medicines, called protease inhibitors, used
to treat Human Immunodeficiency Virus
e.g. ritonavir, indinavir

• Your doctor may want to do blood
tests and check your heart while you are
taking Anafranil.

• Medicine called terbinafine used orally to
treat skin, hair or nail infections due to fungus

• Your doctor may want to do blood tests to
check your liver function and kidney function.

• Colestipol, cholestyramine, used to treat
high cholesterol levels

• 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.

• 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.

• If you think your symptoms are getting
worse, go and see your doctor.
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,

and behaviour and indicate a need for
very close monitoring and possibly changes
in medication.

• If you have previously had thoughts about
killing or harming yourself.

3. How to take Anafranil

• 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.

The doctor will tell you how much Anafranil to
take and when to take it. Always follow
his/her instructions carefully. The dose will be
on the pharmacist’s label. Check the label
carefully. If you are not sure, ask your doctor
or pharmacist.

If you have thoughts of harming or killing
yourself at any time, contact your doctor or
go to a hospital straight away.

• Swallow your Anafranil tablets or capsules
whole with a drink of water.

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

• 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:
10 mg–150 mg daily. Severe cases may
need even higher doses.
• For obsessions and phobias:
10 mg–150 mg daily.
• For cataplexy:
10 mg–75 mg daily.
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
GB

196722

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

4. Possible side effects
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 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.
Up to 1 in 100 people have experienced:
Mood changes including aggression, fits,
movement disorders, increased blood pressure.
Up to 1 in 10,000 people have experienced:
Glaucoma, fever, hepatitis causing jaundice
(yellowing of the skin or whites of the eyes)
and light coloured urine, oedema (generalised
swelling), hair loss, blood disorders (which
might result in persistent sore throat, fever or
frequent infections, unexplained bruising or
bruising more easily).

Also reported (frequency unknown):
Feeling of inner restlessness and a compelling
need to be in constant motion, repetitive,
involuntary, purposeless movements,
breakdown of muscle, increase in prolactin
(a hormone) level in the blood, and serotonin
syndrome (syndrome caused due to increase
in naturally occurring messenger, serotonin, in
brain; manifested by symptoms like agitation,
confusion, diarrhoea, high temperature,
increased blood pressure, excessive sweating
and rapid heartbeat).
Some people have experienced:
Thoughts of suicide or self-harm (see
Section 2 for more information).
An increased risk of bone fractures has
been observed in patients taking this type
of medicine.
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.

prescribe Anafranil for patients under 18
because he/she decides that this is in their
best interests. If your doctor has prescribed
Anafranil for you (or your child) and you
want to discuss this, please go back to
your doctor.
You should inform your doctor if any of the
symptoms listed above develop or worsen
when patients under 18 are taking Anafranil.

5. How to store Anafranil
Store Anafranil 75 mg sustained release
Tablets in a dry place. Store Anafranil
Capsules below 30ºC in a dry place.
Keep out of the reach and sight of children.
Do not use the medicine after the expiry date
which is stated on the carton.
If your doctor tells you to stop taking Anafranil,
please take any unused medicine back to your
pharmacist to be destroyed. Do not throw it
away with your normal household water or
waste. This will help to protect the environment.

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
increased risk of side-effects such as suicidal
thoughts, harming themselves and hostility
(predominately aggression, oppositional
behaviours and anger) when they take drugs
like Anafranil. Despite this, your doctor may

6. Further information
Anafranil Capsules are available in three
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 50 mg 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, Eudragit 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.
For both capsules and tablets the Product
licence holder is Novartis Pharmaceuticals UK
Ltd trading as Geigy Pharmaceuticals, Frimley
Business Park, Frimley, Camberley, Surrey
GU16 7SR, England.
The capsules and tablets are released onto the
market by Novartis Pharmaceuticals UK Ltd,
Wimblehurst Road, Horsham,
West Sussex RH12 5AB, England.
This leaflet was revised in May 2012
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

Geigy

GB

196722

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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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