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Anafranil® hydrochloride

Consumer Information

What is in this leaflet thought to be caused by a Some of the symptoms of an allergic chemical imbalance in parts of reaction may include shortness of This leaflet answers some common the brain. This imbalance affects breath, wheezing or difficulty questions about Anafranil. your whole body and can cause breathing; swelling of the face, lips, emotional and physical symptoms tongue or other parts of the body; It does not contain all the available such as feeling low in spirit, loss rash, itching or hives on the skin. information. It does not take the of interest in activities, being place of talking to your doctor or Do not start taking Anafranil if unable to enjoy life, poor appetite pharmacist. you are already taking another or overeating, disturbed sleep, medicine called a monoamine- The information in this leaflet was loss of sex drive, lack of energy oxidase inhibitor (MAOI) or you last updated on the date listed on the and feelings of guilt. have been taking it within the past final page. More recent information 2. obsessive-compulsive disorders 2 weeks. on the medicine may be available. (OCD) and phobias in adults Taking Anafranil together with a You should ensure that you speak 3. muscle weakness in people with a MAOI may cause a serious reaction to your pharmacist or doctor to sleep disorder called narcolepsy. with a sudden increase in body obtain the most up to date temperature, extremely high blood information on the medicine. You The symptoms of these disorders vary from person to person. Your pressure and (fits). Your can also download the most up to doctor will know when it is safe to date leaflet from doctor can provide you with more information. start Anafranil after the MAOI has www.novartis.com.au. been stopped. Those updates may contain important Anafranil belongs to a group of Do not take Anafranil if you are information about the medicine and called tricyclic recovering from a recent heart its use of which you should be aware. . attack. All medicines have risks and Ask your doctor if you have any It may make your condition worse. benefits. Your doctor has weighed questions about why this medicine the risks of you taking this medicine has been prescribed for you. Do not take this medicine after the against the benefits it can provide. Your doctor may have prescribed it expiry date printed on the pack or if the packaging is torn or shows If you have any concerns about this for another purpose. signs of tampering. medicine, ask your doctor or This medicine is only available with pharmacist. a doctor's prescription. In that case, return it to your pharmacist. Keep this leaflet with the medicine. You may need to read it again. Before you start to take it Before you take Tell your doctor if you have any of Anafranil the following health problems/ medical conditions: What Anafranil is used for When you must not take it • an irregular heart beat or other problems with your heart Do not take Anafranil if you have Anafranil is used to treat: an allergy to: • an inherited heart problem called congenital long QT syndrome 1. that is longer lasting • clomipramine (the active and/or more severe than the "low ingredient) or any of the other • increased pressure in the eye from moods" that everyone has from ingredients of Anafranil listed at any cause (e.g. glaucoma) time to time due to the stress of the end of this leaflet everyday life. Depression is • any other tricyclic

ANAFRANIL® 1 • difficulty in passing urine (water), Your doctor will want to know if you • disulfiram, a medicine for due to prostate trouble or any are prone to allergies. alcoholism other cause • rifampicin, an antibiotic Taking other medicines • seizures (fits) • terbinafine, a medicine used to • severe liver or kidney disease Tell your doctor or pharmacist if treat skin, hair or nail infections you are taking any other • a low level of potassium in your due to fungus medicines, including any that you blood (called hypokalaemia) • medicines used to reduce fat in buy without a prescription from a blood • a mental disorder other than the , supermarket or health one being treated (e.g. food shop. • grapefruit/grapefruit juice or , mania) cranberry juice. Some medicines and Anafranil may • problems with blood pressure interfere with each other. These You may need to take different (either too high or too low) include: amounts of your medicines or you may need to take different medicines. • a blood disorder • MAOI medicines. You must not Your doctor and pharmacist have • a thyroid problem take Anafranil together with a more information. • chronic constipation MAOI (see "When you must not take it") If you have not told your doctor • Parkinson's disease about any of these things, tell him/ • medicines for high blood pressure her before you start taking this • a tumour of the adrenal gland or heart problems medicine. Your doctor may not want you to • medicines to help you sleep or take this medicine or may want to calm you down take special precautions if you have any of the above conditions. • other medicines for depression called SSRIs or SNaRIs (e.g. How to take Anafranil Tell your doctor if you are fluoxetine, paroxetine, , pregnant or intend to become fluvoxamine) Follow all directions given to you pregnant. • medicines for other mental by your doctor and pharmacist This medicine may affect your baby disorders carefully. if you take it while you are pregnant, They may differ from the • medicines for seizures (fits) especially during the last 7 weeks of information contained in this leaflet. pregnancy. Your baby may have • medicines to prevent blood clots If you do not understand the some side effects from the medicine (e.g. ) instructions on the label, ask your during the first month after birth. • diuretic medicines, also called doctor or pharmacist for help. Tell your doctor if you are breast- fluid or water tablets feeding or plan to breast-feed. • some medicines for colds or How much to take Breast-feeding is not recommended allergies, including For depression, obsessive- while you are taking Anafranil. The and some nose drops compulsive disorders and phobias, active ingredient passes into the • anticholinergic medicines, which treatment is usually started with a breast milk and could affect your are used to relieve stomach low dose of 2 or 3 tablets (50 to 75 baby. cramps, spasms and travel mg) each day. The dose can be raised Tell your doctor if you smoke. sickness slowly up to 4 to 6 tablets each day. can affect the amount of • medicines for thyroid problems Some people will need higher doses than others because each person's Anafranil that is in your body. • , a medicine for body chemistry is different. Once Sudden changes in your usual stomach ulcers smoking habits can also change the you are feeling better, your doctor • medicines for Parkinson's disease effects of Anafranil. may be able to slowly reduce the • oestrogens (e.g. birth control dose, usually down to 2 to 4 tablets Tell your doctor if you are lactose pills, hormone replacement each day. intolerant. therapy) For muscle weakness accompanying This medicine contains lactose. • nicotine in medicines used to help narcolepsy, the dose is usually from Tell your doctor if you are allergic you quit smoking, such as 1 to 3 tablets (25 to 75 mg) each day. to any other medicines, foods, dyes nicotine patches or chewing gum If you are older than 65 years, your or preservatives. • (Ritalin®) doctor will probably start with a low dose (e.g. 1 tablet each day) to help

ANAFRANIL® 2 avoid side effects. The dose is to taking the tablets as you would This helps to prevent unwanted side gradually increased over about ten normally. effects. days to 2 to 3 tablets each day and Do not take a double dose to make Contact your doctor immediately if kept at that dose for the rest of your up for the one that you missed. you or someone you know develop treatment. This may increase the chance of you any of the following symptoms at getting an unwanted side effect. any time during treatment with When to take it Anafranil: If you have trouble remembering Take the tablets in 2 or 3 doses when to take your medicine, ask • thoughts about suicide or dying spread over the day unless your your pharmacist for some hints. • attempts to commit suicide doctor advises you otherwise. • new or worse depression If you have narcolepsy and you If you take too much • new or worse anxiety have trouble sleeping at night, take (overdose) the last dose before evening to • feeling very agitated or restless Immediately telephone your doctor avoid making your insomnia • panic attacks worse. or Poisons Information Centre (telephone 13 11 26) or go to • difficulty sleeping (insomnia) How to take it Accident and Emergency at your • new or worse irritability nearest hospital, if you think that • acting aggressive, being angry, or Swallow the tablets with a full glass you or anyone else may have taken violent of water. If your stomach is upset too much Anafranil. Do this even if after taking the tablets, take them there are no signs of discomfort or • acting on dangerous impulses with a meal or after a snack. poisoning. • an extreme increase in activity Keep the telephone numbers for and talking How long to take it these places handy. • other unusual changes in Take this medicine until your If you take too much Anafranil, you behaviour or mood doctor tells you to stop treatment. may feel sleepy, restless or agitated. Symptoms such as these may be The length of treatment will depend You may have stiffness or unusual associated with an increased risk of on your condition and on how well muscle movements, fever, sweating, suicidal thinking and behaviour and the medicine works. vomiting, difficulty breathing, a drop must be taken seriously. in blood pressure, fast or irregular For depression, the length of Before having any surgery or heartbeat, fits or other symptoms. treatment will depend on how emergency treatment, even a quickly your symptoms improve. Children are much more sensitive minor procedure, tell the doctor or This type of medicine takes time to than adults to tricyclic dentist in charge that you are work, so don't be discouraged if you antidepressants. An accidental taking Anafranil or have been don't feel better right away. Some of overdose is especially dangerous. taking it within the last two weeks your symptoms may improve in 1 or or so. 2 weeks but it can take up to 4 to 6 weeks to feel any real improvement. If possible, this medicine should be Even when you feel well, you will stopped before surgery to avoid While you are taking unnecessary side effects. usually have to take Anafranil for Anafranil several months or even longer to If this medicine causes your mouth make sure the benefits will last. to feel dry and this problem Things you must do Do not stop taking Anafranil doesn©t go away, tell your doctor or suddenly as you could suffer possible If you become pregnant while dentist. Be sure to have regular withdrawal symptoms. taking Anafranil, tell your doctor dental checkups. immediately. Continuing dryness of the mouth If you forget to take it Your doctor can discuss with you the may increase the chance of gum risks of taking it while you are disease or cavities. You can relieve If it is almost time for your next pregnant. dry mouth by frequent sips of water, dose (e.g. within 2 or 3 hours), skip sucking sugarless lollies or chewing the dose you missed and take the Be sure to keep all of your doctor©s sugarless gum. next one when you are meant to. appointments so that your progress can be checked. If you wear contact lenses and find Otherwise, take the dose as soon as that your eyes are dry, sticky or you remember, and then go back Your doctor may want to take some blood tests and check your heart and irritated, tell your doctor. blood pressure from time to time.

ANAFRANIL® 3 These side effects could damage your getting up from a sitting or lying Do not be alarmed by these lists of eyes. position. possible side effects. You may not If you are about to be started on You can usually prevent these experience any of them. Ask your any new medicine, remind your symptoms by getting up slowly and doctor or pharmacist to answer doctor and pharmacist that you flexing leg muscles and toes to get any questions you may have. are taking Anafranil. the blood flowing. When getting out Tell your doctor if you notice any Tell any other doctor, dentist or of bed, dangle your legs over the side of these side effects and they worry pharmacist who treats you that for a minute or two before standing you: you are taking Anafranil. up. • drowsiness, dizziness, blurred Be careful to stay out of direct vision or difficulty focussing your Things you must not do sunlight as much as possible until eyes, especially when treatment is you find out if your skin is more started or the dose is increased. Do not stop taking Anafranil or sensitive than usual. Wear change the dose without first • lightheadedness, especially when protective clothing and use a checking with your doctor. Do not you get up too quickly from a sunscreen. Do not use a sunlamp. let yourself run out of medicine sitting or lying position. over the weekend or on holidays. This medicine makes some people • dry mouth more sensitive to sunlight. If you stop taking this medicine • difficulty urinating (passing suddenly, your condition may worsen After you have stopped taking water) or you may have unwanted side Anafranil, you should still be • dry or sticky eyes if you wear effects such as headache, nausea careful for 1 or 2 weeks since some contact lenses (feeling sick), vomiting, diarrhoea of the effects of the medicine will and nervousness. If possible, your still be in your body. • constipation doctor will gradually reduce the • sweating or hot flushes amount you take each day before • increased appetite and weight stopping the medicine completely. gain Side effects Do not give this medicine to anyone • decreased appetite else, even if their condition seems similar to yours. Tell your doctor or pharmacist as • tired feeling and mental dullness soon as possible if you do not feel • feeling of unrest or anxiety Do not use it to treat any other well while you are taking complaints unless your doctor tells Anafranil. • a compelling need to be in you to. constant motion All medicines can have side effects. • repetitive, involuntary, Things to be careful of Sometimes they are serious, most of the time they are not. You may need purposeless movements Be careful driving, operating medical treatment if you get some of • disturbed sleep or nightmares machinery or doing jobs that the side effects. • shakiness or trembling require you to be alert while you If you are over 65 years old, you are taking Anafranil until you • nausea (feeling sick), vomiting, should be especially careful while know how it affects you. diarrhoea taking this medicine. Report any • poor appetite or weight loss This medicine may cause tiredness, side effects promptly to your dizziness, drowsiness or blurred doctor. • sores in the mouth or on the vision in some people. As people grow older, they are more tongue Be careful when drinking alcohol likely to get side effects from • headache or taking pain relievers, sleeping medicines. • reduced sexual desire or difficulty tablets or antihistamines Anafranil can cause confusion or in reaching orgasm (medicines for colds or allergies disorientation, especially in older such as hay fever) while you are • swelling of the breasts or people or those with Parkinson's taking Anafranil. discharge of milk disease. Your family or carer should • swelling of the testicles This medicine can increase the be aware of this. Special care may be drowsiness caused by alcohol and by needed. • increased sensitivity to the sun medicines that affect your nervous Patients aged 50 years or older and • ringing in the ears system. taking a medicine of this group are • hair loss If this medicine makes you feel more likely to experience bone • change in sense of taste lightheaded, be careful when fractures.

ANAFRANIL® 4 • delayed or no ejaculation of Some people may have other side • talc semen if you are a male effects not yet known or mentioned • hypromellose in this leaflet. Tell your doctor immediately or go • PVP-VA copolymer to Accident and Emergency at • cellulose-microcrystalline your nearest hospital if you notice any of the following: • polyethylene glycol (macrogol) • signs of allergy such as rash, After using Anafranil • povidone itching or hives on the skin; • sucrose swelling of the face, lips, tongue Storage • titanium dioxide or other part of the body; • Keep your medicine in the shortness of breath, wheezing or original container until it is time • iron oxide yellow CI 77492 troubled breathing to take a dose. This medicine does not contain • constant "flu-like" symptoms • Store it in a cool dry place at gluten, tartrazine or any other azo (chills, fever, sore throat, aching room temperature. dyes. joints, swollen glands, tiredness • Do not store Anafranil or any or lack of energy) Sponsor other medicine in the bathroom or • unusual bleeding or bruising near a sink. Anafranil is supplied in Australia by: • pain in the stomach or abdomen • Do not leave it in the car or on NOVARTIS Pharmaceuticals that is severe or doesn't go away windowsills. Australia Pty Limited • fast or irregular heart beat Keep the tablets where children ABN 18 004 244 160 (pounding, racing, skipping beats) cannot reach them. 54 Waterloo Road • muscle numbness, tingling or A locked cupboard at least one-and- North Ryde NSW 2113 spasms a-half metres above the ground is a Telephone: 1 800 671 203 • weakness or loss of balance good place to store medicines.

• severe dizziness or drowsiness Disposal Web site: www.novartis.com.au • fainting spells or seizures (fits) If your doctor tells you to stop ®= Registered Trademark • difficulty in speaking or slurred taking this medicine or the expiry speech date has passed, ask your This leaflet was prepared in • unusually high energy, irritability pharmacist what to do with any or outbursts of anger medicine you have left over. April 2015 • confusion or hallucinations (seeing, hearing or feeling things Australian Registration Number. that are not there) Anafranil 25 mg AUST R 10987 • frequent passing of large amounts Product description

of urine Internal use: (anf121219c) based on • yellow colour to the skin or eyes What it looks like PI (anf121219i) • eye pain Anafranil 25 mg tablets are round, pale yellow, sugar-coated tablets; • symptoms like agitation, supplied in packs of 50 tablets. confusion, diarrhoea, high temperature, increased blood Ingredients pressure, excessive sweating and rapid heartbeat (syndrome caused Anafranil tablets contain 25 mg of due to increase in naturally clomipramine hydrochloride as the occurring messenger, serotonin) active ingredient. They also contain: • a sudden increase in body • silica-colloidal anhydrous temperature, extremely high • glycerol blood pressure and severe • lactose convulsions • magnesium stearate Tell your doctor if you notice anything else that is making you • starch-maize feel unwell. • stearic acid

ANAFRANIL® 5