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ANAFRANIL 75MG SUSTAINED RELEASE TABLETS
Active substance(s): CLOMIPRAMINE HYDROCHLORIDE / CLOMIPRAMINE HYDROCHLORIDE / CLOMIPRAMINE HYDROCHLORIDE
ANAFRANIL® 75 mg sustained release Tablets
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
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:
What Anafranil is and what it’s used for
Things to consider before you start to take Anafranil
How to take Anafranil
Possible side effects
How to store Anafranil
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
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
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
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.
Medicines for high blood pressure
Medicines to treat heart disorders, particularly those used to treat an abnormal heart
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
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,
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.
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
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
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
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
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 antidepressant treatment and when the dose is increased or decreased, since changes may be
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: 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.
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
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
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
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
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,
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
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
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 or pharmacist. 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.
How to store Anafranil
Store in the original container, in order to protect from moisture.
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.
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.
Novartis Pharmaceuticals UK Ltd, Wimblehurst Road, Horsham, West Sussex, RH12 5AB, England,
United Kingdom and Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, England,
This leaflet was revised in February 2015
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
Anafranil is a registered trade mark
Copyright Novartis Pharmaceuticals UK Limited
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.