Anafranil Sr 75mg Tablets
ANAFRANIL® SR 75mg Tablets
(clomipramine hydrochloride)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Anafranil SR 75mg Tablets but will be referred to as Anafranil SR throughout this leaflet.
What you need to know about Anafranil SR
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 SR is and what it's used for
2. Things to consider before you start to take Anafranil SR
3. How to take Anafranil SR
4. Possible side effects
5. How to store Anafranil SR
6. Further information
1. What Anafranil SR is and what it's used for
Anafranil SR is available either as capsules in three different strengths or as sustained release tablets. Clomipramine hydrochloride, the active ingredient in Anafranil SR, 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 SR 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 SR
Some people MUST NOT take Anafranil SR. Talk to your doctor if:
■ you think you may be allergic to clomipramine or to any of the other ingredients of Anafranil SR. (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 SR:
■ 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 SR might not be the right medicine for you.
Are you taking other medicines?
Anafranil SR 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 SR should not be used during pregnancy unless specifically prescribed by your doctor. Your doctor will discuss with you the potential risk of taking Anafranil SR during pregnancy.
The active ingredient of Anafranil SR passes into the breast milk. Mothers are advised not to breast-feed their babies while taking Anafranil SR.
The following symptoms may occur in newborn babies, of mothers that have used Anafranil SR 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 SR, do not drive or work with machinery until these effects have worn off.
Taking Anafranil SR 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 SR may interact with local or general anaesthetics.
■ Your doctor may want to do blood tests and check your heart while you are taking Anafranil SR.
■ 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 SR 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 SR
The doctor will tell you how much Anafranil SR 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 SR 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.
POM
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 SR 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 SR 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 SR, 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 SR 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 SR 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 SR 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 SR 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 SR. Despite this, your doctor may prescribe Anafranil SR for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Anafranil SR 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 SR.
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 SR
■ Protect from moisture.
■ Keep out of the sight and reach of children.
■ Do not use after the expiry date printed on the carton or blister strip.
■ If your doctor tells you to stop taking Anafranil SR, please take any unused medicine back to your pharmacist to be destroyed.
■ If the tablets become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
■ Medicines should not be disposed of via household wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Further information
What Anafranil SR contains
Anafranil SR contains clomipramine hydrochloride. Each tablet contains 75mg clomipramine hydrochloride in a special 'slow release' form.
Anafranil SR also contains the following inactive ingredients: Ethylacrylate methylmethacrylate copolymer, calcium hydrogen phosphate, colloidal silicon dioxide, calcium stearate, hydroxypropylmethylcellulose, red iron oxide, polyethoxylated castor oils, talc and titanium dioxide.
What Anafranil SR looks like and contents of the pack
The tablets are dull greyish red slow release, film-coated tablets, both sides are scored and marked with 'S T'.
Anafranil SR comes in blister packs of 28 tablets.
Manufacturer
Your tablets are manufactured by:
Sigma-Tau Industrie Farmaceutiche Riunite S.p.A,
Via Pontina km 30,400 - 00040 Pomezia (Rome), Italy.
Or
Sigma-Tau Espana, S.A., 28806 Alcala de Henares, Madrid, Spain.
Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster,
DN3 1QR.
Product Licence holder: Landmark Pharma Ltd., 7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No: 21828/0225
Leaflet revision date: 12.02.16
ANAFRANIL® is a registered trademark of Novartis AG.
If you would like the leaflet in a different format, please contact 01302 365000 and ask for the Regulatory Department.
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