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ANAFRANIL 75 MG SUSTAINED RELEASE TABLETS

Active substance(s): CLOMIPRAMINE HYDROCHLORIDE

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Anafranil® 75mg
sustained release
Tablets
(clomipramine hydrochloride)
Patient Information Leaflet
This medicine 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:
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

1. What Anafranil is and what it’s used for
Anafranil is available 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
(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.
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 a 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 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, paroxetine, sertraline,
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
 Nicotine, e.g. if you smoke or are using nicotine
replacement therapy
 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)
 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
 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.
The active ingredient of Anafranil passes into the breast
milk. Mothers are advised not to breast-feed their babies
while taking Anafranil.
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.
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.
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 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, 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.

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.
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 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 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.
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), delayed or no ejaculation of semen if you are
a male.
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.
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 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.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at:
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 Anafranil
Protect from moisture.
Keep out of the sight and reach 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.

6. Further information
Anafranil 75 mg sustained release Tablets are dull,
greyish-red film coated, capsule shaped, slightly convex
with bevelled edges imprinted ‘S-T’ on both sides, 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 hydroxypropyl
methylcellulose, red iron oxide (E172), hydrogenated
castor oil, talc, titanium dioxide (E171).
The tablets come in blister packs containing 28 tablets.
Manufactured by: Sigma-Tau Espana, S.A.,
28806 Alcala de Henares (Madrid).
Procured from within the EU & repackaged by PL
holder:
Kosei Pharma UK Ltd., 956 Buckingham Avenue, Slough
Trading Estate, SL1 4NL, UK.

Anafranil® 75 mg sustained release Tablets,
PL 39352/0095


Anafrani is a registered trademark of the Novartis
Pharmaceuticals UK Limited
POM
Leaflet date: 07.12.2015

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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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