PROZAC 20MG PER 5ML ORAL LIQUID

PACKAGE LEAFLET: INFORMATION FOR THE USER

PROZAC 20mg per 5ml oral liquid
fluoxetine
EIGHT IMPORTANT THINGS YOU NEED TO KNOW ABOUT PROZAC Prozac treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment. Prozac is not for use In children and adolescents under 18. See section 2, Use in children and adolescents aged 8 to 18 years. Prozac wont work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you havent started feeling better. See section 3, How to take Prozac oral liquid. Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See section 2. Dont stop taking Prozac without talking to your doctor. If you stop taking Prozac suddenly or miss a dose, you may get withdrawal effects. See section 3 for further information. If you feel restless and feel like you cant sit or stand still, tell your doctor. Increasing the dose of Prozac may make these feelings worse. See section 4, Possible side-effects. Taking some other medicines with Prozac can cause problems. You may need to talk to your doctor. See section 2, Taking other medicines. If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy and breastfeeding. Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - you have any further questions, ask your If doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - any of the side effects gets serious, or if you If notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Prozac oral liquid is and what it is used for 2. Before you take Prozac oral liquid 3. How to take Prozac oral liquid 4. Possible side effects 5. How to store Prozac oral liquid 6. Further information 1. WHAT PROZAC ORAL LIQUID IS AND WHAT IT IS USED FOR Prozac contains fluoxetine which is one of a group of medicines called selective serotonin re-uptake inhibitor (SSRI) antidepressants. This medicine is used to treat the following conditions: Adults: Major depressive episodes Obsessive-compulsive disorder ulimia nervosa: Prozac is used alongside B psychotherapy for the reduction of binge-eating and purging Children and adolescents aged 8 years and above: oderate to severe major depressive disorder, M if the depression does not respond to psychological therapy after 4-6 sessions. Prozac should be offered to a child or young person with

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moderate to severe major depressive disorder only in combination with psychological therapy. 2. BEFORE YOU TAKE PROZAC ORAL LIQUID Do not take Prozac if you are: llergic (hypersensitive) to fluoxetine or any of a the other ingredients of Prozac (see Section 6). If you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the oral liquid straight away and contact your doctor immediately. aking other medicines known as nont selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of such MAOIs include medicines used to treat depression such as nialamide, iproniazide, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood).Treatment with Prozac should only be started at least 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue)). Do not take any MAOIs for at least 5 weeks after you stop taking Prozac. If Prozac has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor. Take special care with Prozac Tell your doctor if any of the following applies to you: pilepsy or fits. If you have a fit (seizures) or e experience an increase in seizure frequency, contact your doctor immediately; Prozac might need to be discontinued; ania now or in the past; if you have a manic m episode, contact your doctor immediately because Prozac might need to be discontinued; iabetes (your doctor may need to adjust your d dose of insulin or other antidiabetic treatment); iver problems (your doctor may need to adjust l your dosage); heart problems; ow resting heart-rate and/or if you know that l you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets); glaucoma (increased pressure in the eye); ngoing treatment with diuretics (water tablets), o especially if you are elderly; ongoing ECT (electro-convulsive therapy); istory of bleeding disorders or appearance of h bruises or unusual bleeding; ngoing treatment with medicines that thin the o blood (see Taking other medicines); ngoing treatment with tamoxifen (used to treat o breast cancer) (see Taking other medicines); tarting to feel restless and cannot sit or stand s still (akathisia). Increasing your dose of Prozac may make this worse; ppearance of fever, muscle stiffness or tremor, a changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so-called serotonin syndrome or neuroleptic malignant syndrome Although . this syndrome occurs rarely it may result in potentially life threatening conditions; contact your doctor immediately, since Prozac might need to be discontinued.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

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DESCRIPTIF TECHNIQUE DE LARTICLE (Remplace 7058451) NOTICE DOUBLE (L10) PROZAC 20 mg / 70 ml / Angleterre - Irlande V1_09 MAR 2013

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RECTO / VERSO EN ROULEAU / P. 1

CODE ARTICLE MU 2550

DIMENSIONS 250 x 157,5 mm

LAIZE 157,5 mm

Responsable: Mr FRANC Pascal PATHEON France 40, boulevard de Champaret CS 11006 38307 Bourgoin-Jallieu Cedex tl.: 0474938700 fax.: 0474938781

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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: - f you have previously had thoughts about killing I or harming yourself. - f you are a young adult. Information from I 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. you have thoughts of harming or killing yourself If 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. Use in children and adolescents aged 8 to 18 years: Patients under 18 have an increased risk of sideeffects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Prozac should only be used in children and adolescents aged 8 to 18 years for the treatment of moderate to severe major depressive episodes (in combination with psychological therapy) and it should not be used to treat other conditions. Additionally, only limited information concerning the long-term safety of Prozac on growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this, and if you are a patient under 18, your doctor may prescribe Prozac for moderate to severe major depressive episodes, in combination with psychological therapy, because he/she decides that this is in your best interests. If your doctor has prescribed Prozac for a patient under 18 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 Prozac. Prozac should not be used in the treatment of children under the age of 8 years. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines (up to 5 weeks ago) including medicines obtained without prescription. Prozac may affect the way some other medicines work (interaction), especially the following: ertain monoamine oxidase inhibitors (MAOIs), C some used to treat depression. Non-selective MAOIs and MAOIs type A must not be used with Prozac as serious or even fatal reactions (serotonin syndrome) can occur (see section Do not take Prozac). Treatment with Prozac should only be started at least 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue)). Some MAOIs type B (selegeline) can be used with Prozac provided that your doctor monitors you closely. lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are taken with Prozac. Your doctor will carry out more frequent check-ups. phenytoin (for epilepsy); because Prozac may influence the blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with Prozac. tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure).

edicines that may affect the hearts rhythm, m e.g. Class IA and III antiarrhythmics, antipsychotics (e.g. fentiazine derviatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine, certain antihistamines (astemizole, mizolastine). flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because Prozac may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Prozac. tamoxifen (used to treat breast cancer), because Prozac may change the blood levels of this drug and a reduction of the effect of tamoxifen cannot be excluded, your doctor may need to consider different antidepressant treatments. warfarin, NSAID or other medicines which can thin the blood (including clozapine, used to treat certain mental disorders, and aspirin); Prozac may alter the effect of these medicines on the blood. If Prozac treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests. ou should not start to take the herbal remedy Y StJohns wort while you are being treated with Prozac since this may result in an increase in side effects. If you are already taking StJohns wort when you start on Prozac, stop taking StJohns wort and tell your doctor at your next visit. Taking Prozac with food and drink ou can take Prozac with or without food, Y whatever you prefer. ou should avoid alcohol while you are taking Y this medicine. Pregnancy, breast-feeding and fertility Ask your doctor or pharmacist for advice before taking any medicine. Pregnancy Talk to your doctor as soon as possible if youre pregnant, if you might be pregnant, or if youre planning to become pregnant. In babies whose mothers took fluoxetine during the first few months of pregnancy, there have been some reports suggesting an increased risk of birth defects affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about 2 in 100 babies in mothers who took fluoxetine. You and your doctor may decide that it is better for you to gradually stop taking Prozac while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking Prozac. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like fluoxetine may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Caution should be exercised when used during pregnancy, especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistent crying, and difficulty in sucking or in sleeping. Breast-feeding Fluoxetine is excreted in breast milk and can cause side effects in babies. You should only breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower dose of fluoxetine.

RECTO / VERSO EN ROULEAU / P. 2

CODE ARTICLE MU 2550

DIMENSIONS 250 x 157,5 mm

LAIZE 157,5 mm

DESCRIPTIF TECHNIQUE DE LARTICLE (Remplace 7058451) NOTICE DOUBLE (L10) PROZAC 20 mg / 70 ml / Angleterre - Irlande V1_09 MAR 2013

Responsable: Mr FRANC Pascal PATHEON France 40, boulevard de Champaret CS 11006 38307 Bourgoin-Jallieu Cedex tl.: 0474938700 fax.: 0474938781

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Fertility Fluoxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet. Driving and using machines Prozac may affect your judgment or co-ordination. Do not drive or use machinery without advice from your doctor or pharmacist. Important information about some of the ingredients of Prozac Prozac oral liquid contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. The flavouring for this medicinal product contains small amounts of ethanol (alcohol), less than 100mg per dose (see Section 6). 3. HOW TO TAKE PROZAC ORAL LIQUID Always take Prozac exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The instructions will also be on the label on the pack. Do not take more medicine than your doctor tells you. Measure the right amount of medicine using the measuring cup, syringe or a measuring spoon, then drink it. Adults: The usual dose is: epression: The recommended dose is 5ml D oral liquid (20mg) daily. Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment. If required, the dosage can be gradually increased up to a maximum of 15ml oral liquid (60mg) daily. The dose should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when you first start taking your medicine for depression. This is usual because an improvement in depressive symptoms may not occur until after the first few weeks. Patients with depression should be treated for at least 6 months. ulimia nervosa: The recommended dose is B 15ml oral liquid (60mg) daily. bsessive-compulsive disorder: The O recommended dose is 5ml oral liquid (20mg) daily. Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment. If required, the dosage can be gradually increased up to a maximum of 15ml oral liquid (60mg) daily. If no improvement is noted within 10 weeks, your doctor will reconsider your treatment. Children and adolescents aged 8 to 18 years with depression: Treatment should be started and be supervised by a specialist. The starting dose is 10mg/day (given as 2.5ml of Prozac oral liquid). After 1 to 2 weeks, your doctor may increase the dose to 20mg/day. The dose should be increased carefully to ensure that you receive the lowest effective dose. Lower weight children may need lower doses. If there is a satisfactory response to treatment, your doctor will review the need for continuing treatment beyond 6 months. If you have not improved within 9 weeks, your doctor will reassess your treatment. Elderly: Your doctor will increase the dose with more caution and the daily dose should generally not exceed 10ml oral liquid (40mg). The maximum dose is 15ml oral liquid (60mg) daily. Liver impairment: If you have a liver problem or are using other medication that might affect Prozac, your doctor may decide to prescribe a lower dose or tell you to use Prozac every other day.

If you take more Prozac than you should f you take too much, go to your nearest hospital I emergency department (or casualty) or tell your doctor straight away. Take the bottle of Prozac with you if you can. Symptoms of overdose include: nausea, vomiting, seizures, heart problems (like irregular heart beat and cardiac arrest), lung problems and change in mental condition ranging from agitation to coma. If you forget to take Prozac f you miss a dose, do not worry. Take your next I dose the next day at the usual time. Do not take a double dose to make up for a forgotten dose. aking your medicine at the same time each day T may help you to remember to take it regularly. If you stop taking Prozac o not stop taking Prozac without asking your D doctor first, even when you start to feel better. It is important that you keep taking your medicine. Make sure you do not run out of medicine. You may notice the following effects (withdrawal effects) when you stop taking Prozac: dizziness; tingling feelings like pins and needles; sleep disturbances (vivid dreams, nightmares, inability to sleep); feeling restless or agitated; unusual tiredness or weakness; feeling anxious; nausea/ vomiting (feeling sick or being sick); tremor (shakiness); headaches. Most people find that any symptoms on stopping Prozac are mild and disappear within a few weeks. If you experience symptoms when you stop treatment, contact your doctor. When stopping Prozac, your doctor will help you to reduce your dose slowly over one or two weeks - this should help reduce the chance of withdrawal effects. If you have any further questions on the use of Prozac, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Prozac can cause side effects, although not everybody gets them. f you have thoughts of harming or killing I yourself at any time, contact your doctor or go to a hospital straight away (see Section 2). f you get a rash or allergic reaction such I as itching, swollen lips/tongue or wheezing/ shortness of breath, stop taking the medicine straight away and tell your doctor immediately. f you feel restless and cannot sit or stand still, I you may have akathisia; increasing your dose of Prozac may make you feel worse. If you feel like this, contact your doctor. ell your doctor immediately if your skin starts T to turn red or you develop a varied skin reaction or your skin starts to blister or peel. This is very rare. Some patients have had: combination of symptoms (known as serotonin a syndrome) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely); eelings of weakness, drowsiness or confusion f mostly in elderly people and in (elderly) people taking diuretics (water tablets); prolonged and painful erection; irritability and extreme agitation. eart problems, such as fast or irregular h heart rate, fainting, collapsing or dizziness upon standing which may indicate abnormal functioning of the heart rate. If you have any of the above side effects, you should tell your doctor immediately. The following side effects have also been reported in patients taking Prozac: Very common (seen in more than 1 in every 10 patients) -insomnia -headache - diarrhoea, feeling sick (nausea)

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DESCRIPTIF TECHNIQUE DE LARTICLE (Remplace 7058451) NOTICE DOUBLE (L10) PROZAC 20 mg / 70 ml / Angleterre - Irlande V1_09 MAR 2013

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Responsable: Mr FRANC Pascal PATHEON France 40, boulevard de Champaret CS 11006 38307 Bourgoin-Jallieu Cedex tl.: 0474938700 fax.: 0474938781

CODE LEATUS :

RECTO / VERSO EN ROULEAU / P. 3

CODE ARTICLE MU 2550

DIMENSIONS 250 x 157,5 mm

LAIZE 157,5 mm

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-fatigue Common (seen in 1 to 10 in every 100 patients) - not feeling hungry, weight loss - nervousness, anxiety - restlessness, poor concentration - feeling tense - decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity) - sleep problems, unusual dreams, tiredness or sleepiness -dizziness - change in taste - uncontrollable shaking movements - blurred vision - rapid and irregular heartbeat sensations -flushing -yawning - indigestion, vomiting - dry mouth - rash, urticaria, itching - excessive sweating - joint pain - passing urine more frequently - unexplained vaginal bleeding - feeling shaky or chills Uncommon (seen in 1 to 10 in every 1,000 patients) - feeling detached from yourself - strange thinking - abnormally high mood - orgasm problems - teeth grinding - muscle twitching, involuntary movements or problems with balance or co-ordination - enlarged (dilated) pupils - low blood pressure - shortness of breath - difficulty swallowing - hair loss - increased tendency to bruising - cold sweat - difficulty passing urine - feeling hot or cold Rare (seen in 1 to 10 in every 10,000 patients) - low levels of salt in the blood - untypical wild behaviour -hallucinations -agitation - panic attacks -fits - vasculitis (inflammation of a blood vessel) - rapid swelling of the tissues around the neck, face, mouth and/or throat - pain in the tube that takes food or water to your stomach - sensitivity to sunlight - producing breast milk Very rare (seen in less than 1 to 10,000 patients) - reduction in blood platelets, which increases risk of bleeding or bruising Other (frequency cannot be estimated) - thoughts of suicide or harming yourself - memory impairment - lung problems - hepatitis, abnormal liver function test results - muscle pain - problems urinating -confusion -stuttering - nose bleeds - ringing in the ears - unexplained bruising or bleeding Bone fractures an increased risk of bone fractures has been observed in patients taking this type of medicines. If you have any of the symptoms listed and they bother you, or last for some time, tell your doctor or a pharmacist.

Most of these side effects are likely to disappear with continued treatment. In children and adolescents (8-18 years) In addition to the possible side effects listed above, Prozac may slow growth or possibly delay sexual maturity. Nose bleeds were also commonly reported in children. Prozac oral liquid contains sugar which may be harmful to the teeth. 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. 5. HOW TO STORE PROZAC ORAL LIQUID Keep out of the reach and sight of children. Do not take Prozac after the expiry date (EXP) which is stated on the pack. The expiry date refers to the last day of that month. Do not store your medicine above 30C. Store in the original bottle to protect from light. If you have any other questions please talk to your doctor or pharmacist. Medicines should not be disposed of via 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 Prozac oral liquid contains The active substance is fluoxetine hydrochloride. There is 20 milligrams (mg) of fluoxetine as the hydrochloride in each 5 millilitre (ml) spoonful. Other ingredients are: benzoic acid, sucrose, glycerin, mint flavour (containing 0.23% alcohol) and purified Water. What Prozac oral liquid looks like and contents of the pack Prozac 20mg oral liquid is available in brown glass bottles containing 60ml or 70ml with dosing syringe or 140ml oral liquid. The packs may also include a measuring cup or syringe. Not all bottle sizes may be marketed. Marketing Authorisation Holder and Manufacturer The marketing authorisation holder is Eli Lilly and Company Limited, Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, U.K. The manufacturer is Patheon France, 40, boulevard de Champaret, 38300 Bourgoin-Jallieu, France. The leaflet was last approved in March 2013. Detailed information on this medicine is available on the Medicine and Healthcare products Regulatory Agency (MHRA) web site: http://www.mhra.gov.uk/ This medicinal product is authorised in the Member States of the EEA under the following names: France: Prozac Greece: Ladose Hungary: Prozac Ireland: Prozac Italy: Prozac Portugal: Prozac Spain: Prozac Sweden: Fontex United Kingdom: Prozac

sens lecture code laetus

RECTO / VERSO EN ROULEAU / P. 4
CODE LEATUS :

CODE ARTICLE MU 2550

DIMENSIONS 250 x 157,5 mm

LAIZE 157,5 mm
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DESCRIPTIF TECHNIQUE DE LARTICLE (Remplace 7058451) NOTICE DOUBLE (L10) PROZAC 20 mg / 70 ml / Angleterre - Irlande V1_09 MAR 2013
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Responsable: Mr FRANC Pascal PATHEON France 40, boulevard de Champaret CS 11006 38307 Bourgoin-Jallieu Cedex tl.: 0474938700 fax.: 0474938781

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