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ANAFRANIL SR TABLETS 75MG

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ANAFRANIL®
SR Tablets
75 mg
(clomipramine hydrochloride)
Patient Information Leaflet
Your medicine is called Anafranil SR
Tablets 75 mg, but will be referred to as
Anafranil in this leaflet.

In this leaflet:
1. What Anafranil is, and what it’s used
for
2. Things to consider before you start
to take Anafranil
3. How to take Anafranil
4. Possible side effects
5. How to store Anafranil
6. Further information

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. (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 any heart disease
• you have any serious liver disease
• 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.

What you need to know about Anafranil 1. What Anafranil is and what it’s used
for
Your doctor has decided that you need
Anafranil is available either as capsules in
this medicine to help treat your condition.
three different strengths or as sustained
Please read this leaflet carefully before release tablets. Clomipramine
hydrochloride, the active ingredient in
you start to take your medicine. It
Anafranil, is one of a group of medicines
contains important information. Keep
called tricyclic antidepressants. It is
the leaflet in a safe place because you
thought to work either by increasing the
may want to read it again.
amount of chemical “messengers” in the
If you have any other questions, or if there
brain or by making their effects last
is something you don’t understand, please
longer.
ask your doctor or pharmacist.
Anafranil is used to treat depression,
This medicine has been prescribed for
obsessions and phobias (irrational fears).
you. Never give it to someone else. It may
It is also used to treat muscular weakness
not be the right medicine for them even if
(cataplexy) associated with repeat attacks
their symptoms seem to be the same as
of extreme sleepiness (narcolepsy) in
yours.
adults.
You should also ask yourself these
If any of the side effects gets serious, or if
questions before taking Anafranil:
you notice any side effects not listed in
this leaflet, please tell your doctor or
• Do you find yourself thinking about
pharmacist.
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 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 low blood pressure?
• Do you wear contact lenses?
• Are you elderly?
• 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?
Anafranil 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 e.g. tranylcypromine, phenelzine;
SSRIs e.g. fluoxetine, fluvoxamine;
tricyclic and tetracyclic antidepressants
e.g. amitriptyline, dothiepin, maprotiline,
barbiturates, benzodiazepines
• 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
• Drugs which affect the liver (your doctor
will know which these are). They include
nicotine and barbiturates.
• Cold and flu drugs such as
antihistamines and decongestants
• Carbamazepine or phenytoin (for
epilepsy)
• Cimetidine (for stomach problems)
• Methylphenidate (Ritalin®) prescribed
for children with ADHD
• Quinine (for cramp or malaria treatment)

• 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.
• Medicines used to reduce fat in blood.
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.

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 and liver function
while you are taking Anafranil.
• 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.
• Polyethoxylated castor oil may cause
stomach upset or diarrhoea.

Thoughts of suicide and worsening of
your depression or anxiety disorder
Will there be any problems with driving If you are depressed and/or have anxiety
disorders you can sometimes have
or using machinery?
thoughts of harming or killing yourself.
If you feel dizzy, tired or have blurred
These may be increased when first
vision when you start to take Anafranil, do
starting antidepressants, since these
not drive or work with machinery until this
medicines all take time to work, usually
effect has worn off.
about two weeks but sometimes longer.
Taking Anafranil with food and drink
You may be more likely to think like this:
You can take Anafranil with or without
food. Take care when eating grapefruit, or • If you have previously had thoughts
about killing or harming yourself.
drinking grapefruit juice and cranberry
juice as this may increase your chance of • If you are a young adult. Information
experiencing side effects.
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.
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, overexcitedness 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.

3. How to take Anafranil
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.
• Swallow your Anafranil tablets 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.

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.

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.

Up to 1 in 10 people have experienced: Also reported (frequency unknown):
Loss of appetite, stomach upset, vomiting, Feeling of inner restlessness and a
diarrhoea, lightheadedness when standing compelling need to be in constant motion,
up (due to low blood pressure), increased repetitive, involuntary, purposeless
movements, breakdown of muscle,
anxiety, agitation, hot flushes, enlarged
increase in prolactin (a hormone) level in
pupils, speech disturbance, yawning,
the blood, and serotonin syndrome
feeling confused, disorientated or over(syndrome caused due to increase
excited, sleep disturbances, nightmares,
in naturally occurring messenger,
hallucinations or thought disturbances,
serotonin, in brain; manifested by
worsening of existing depression,
symptoms like agitation, confusion,
impaired memory and concentration,
diarrhoea, high temperature, increased
restlessness, disturbances in heart
rhythm, increased sensitivity of the skin to blood pressure, excessive sweating
sunlight, rash and itching, breast changes, and rapid heartbeat).

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 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.

6. Further information
Each modified release tablet contains
75 mg of the active ingredient,
clomipramine hydrochloride in a dark pink,
capsule-shaped tablet coded ST and
breakline on both sides.
Anafranil SR Tablets 75 mg also contains
Some side effects can be serious
the following inactive ingredients: colloidal
Stop taking Anafranil and tell your
silica, dibasic calcium phosphate, calcium
doctor immediately if you notice the
stearate, methylhydroxypropyl-cellulose,
following very rare symptoms:
red iron oxide (E172), talc, titanium
• Rash, changes in blood pressure,
dioxide (E171), polyethoxylated Castor oil
What if you forget to take a dose?
swelling and increased fluid in tissues,
and ethylacrylate methylmethacrylate
If you miss a dose, take the next dose at
an increased heart rate, difficulty with
You should inform your doctor if any of the copolymer.
the usual time. Then go on as before. DO
breathing and collapse. These may all
numbness or tingling in the arms and legs, Some people have experienced:
symptoms listed above develop or worsen Anafranil SR Tablets 75 mg are available
NOT take a double dose.
be signs of a severe allergic reaction.
muscle weakness, movement disorder,
when patients under 18 are taking
Thoughts of suicide or self-harm (see
as calendar blister pack of 28 tablets.
The usual dosages for adults are as
What if you take too many?
• A high temperature and sweating with
changes in liver function tests, taste
Anafranil.
Section 2 for more information).
The tablets are manufactured by
follows:
rigid muscles and confusion or agitation, disturbances, tinnitus.
If you, or anyone else, accidentally takes
An increased risk of bone fractures has
Sigma-Tau Industrie Farmaceutiche
or if you experience jerky muscle
5. How to store Anafranil
• For depression:
too much Anafranil, tell your doctor or
Up to 1 in 100 people have
been observed in patients taking this type
Riunite S.p.A., Pomezia (Rome) Italy.
movements which you can’t control.
10 mg–150 mg daily. Severe cases may your nearest hospital casualty department
Anafranil SR Tablets 75 mg should be
experienced:
of medicine.
These may be the symptoms of a
need even higher doses.
immediately. Take your medicine pack
protected from moisture and stored below PL 30984/0077
Mood changes including aggression, fits, Most of the side effects are mild and
serious condition known as neuroleptic
with you so that people can see what you
30ºC.
• For obsessions and phobias:
movement disorders, increased blood
Procured from within the EC. Product
may wear off after a few days
malignant syndrome.
have taken.
10 mg–150 mg daily.
pressure.
Licence Holder and repackaged by:
treatment. If they are severe or last for Keep out of the sight and reach of
The side effects listed below have also
• For cataplexy:
S.C.A.C. Ltd., Unit 2a, Bandeath Industrial
Up to 1 in 10,000 people have
more than a few days, tell your doctor. children.
been reported:
10 mg–75 mg daily.
Estate, Throsk, Stirling, FK7 7NP, UK.
Do not use the medicine after the expiry
experienced:
Also, if your medicine upsets you in
More than 1 in 10 people have
The medicine may be taken as one dose
date which is stated on the carton.
any other way, tell your doctor.
This leaflet was approved in 30.10.2012
Glaucoma, fever, hepatitis causing
experienced:
at night, or split into several smaller doses
If your doctor tells you to stop taking
jaundice (yellowing of the skin or whites of Children and Adolescents
Anafranil is a registered trade mark of
Increase in appetite and weight gain.
and taken throughout the day. Your doctor
Anafranil, please take any unused
the eyes) and light coloured urine,
Anafranil should not be used in the
Novartis AG.
will tell you what to do.
Headaches, dizziness, nausea,
oedema (generalized swelling), hair loss, treatment of depressive states, phobias or medicine back to your pharmacist to be
constipation, dry mouth, increased
Elderly patients often need a lower dose
blood disorders (which might result in
cataplexy associated with narcolepsy for destroyed. Do not throw it away with your
sweating, shaking hands, tremor, difficulty persistent sore throat, fever or frequent
because they are more likely to
children and adolescents under the age of normal household water or waste. This
in passing urine, problems with their eyes, infections, unexplained bruising or
experience side effects. Your doctor will
will help to protect the environment.
18 years as long-term safety effects
feeling tired or sleepy, sexual
tell you about this.
bruising more easily).
concerning growth, maturation and
If your tablets become discoloured or
disturbances.
cognitive and behavioural development of show any other signs of any deterioration,
Anafranil in this age group have not yet
you should seek the advice of your
been demonstrated.
pharmacist who will tell you what to do.

+ 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.

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