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Anafranil Sr 75mg Tablets

Document: leaflet MAH BRAND_PLPI 16369-1349 change

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


PATIENT INFORMATION LEAFLET ANAFRANIL® SR 75mg tablets

(clomipramine hydrochloride)

The name of your medicine is Anafranil SR 75mg tablets it will be referred to as Anafranil throughout the remainder of this leaflet.

This product is available in multiple strengths and all strengths will be referred to throughout 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

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.

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

•    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.

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.