ANAFRANIL SR 75MG TABLETS

Active substance: CLOMIPRAMINE HYDROCHLORIDE

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CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Anafranil SR 75mg Tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0465E

DATE OF PROOF:

23/06/14

DATE:

PROOF HISTORY:
v.1 - waymade - 23/06/14

DATE:

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

Pg 1

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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
The tablets should be protected from moisture.
KEEP ALL MEDICINES 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.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your
pharmacist.

6. Further information
Anafranil SR 75mg Tablets / Anafranil SR Tablets are a dark pink, capsule-shaped modified release tablet
marked ‘S’ breakline ’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 tablets also contain the following inactive ingredients:
Colloidal anhydrous silica, dibasic calcium phosphate, calcium stearate, ethylacrylate methylmethacrylate
copolymer, hypromellose, red iron oxide (E172), talc, titanium dioxide (E171) and polyoxyl 40 stearate
The tablets come in blister packs of 28 or 56 tablets.
POM

PL No: 6464/0465

This product is manufactured by:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A., Via Pontina km 30,400 - 00040 Pomezia (Roma) Italy
Sigma-Tau España, S.A., Poligono Azque c/Bolivia, 15, 28806 Alcalá de Henares, Madrid, Spain
Novartis Farma S.p.A, Officina di Torre Annunziata, Naples, Italy
and procured from within the EU and repackaged by the Product Licence holder:
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 23.06.2014
ANAFRANIL is a registered trademark of NOVARTIS AG

ANAFRANIL® SR 75mg TABLETS/
ANAFRANIL® SR TABLETS
(clomipramine hydrochloride)
Patient Information Leaflet
This medicine will be referred to as Anafranil in this leaflet. This product is also available as 10mg, 25mg and
50mg Capsules.
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 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 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 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
Pg 2

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PRE-PRESS NO.:

02-1808

PRODUCT:

Anafranil SR 75mg Tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

6464/0465E

DATE OF PROOF:

23/06/14

DATE:

DATE:

CUSTOMER: Waymade

PROOF HISTORY:
v.1 - waymade - 23/06/14

Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED AUGUST 2013
REPORTING OF SIDE EFFECTS

Pg 2





















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.

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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 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.

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.

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.

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.

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.

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.

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

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.

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.

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, light-headedness 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.

Pg 3

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

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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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