PROZAC

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PROZAC®

Fluoxetine hydrochloride

PACKAGE LEAFLET: Consumer Medicine Information Read this entire leaflet carefully before you start taking this medicine:

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Keep this leaflet. You may need to read it again.
If you have any further questions, ask your 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.

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.
If you are a carer or are helping someone else to take their capsules, please read this leaflet before you give the first dose.

In this leaflet:
1. What Prozac® is and what it is used for 2. Before you take Prozac®
3. How to take Prozac®
4. Possible side effects
5. How to store Prozac®
6. Further information

1. WHAT PROZAC 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
  • Bulimia nervosa: Prozac is used alongside psychotherapy for the reduction of binge-eating and purging
    Children and adolescents aged 8 years and above:
    • Moderate to severe major depressive disorder, if the depression does not respond to psychological
    therapy after 4-6 sessions. Prozac should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy.
    2. BEFORE YOU TAKE PROZAC
    MUST NOT take PROZAC if you:
  • Allergic (hypersensitive) to Fluoxetine or any of 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 capsules straight away and contact your doctor immediately.
  • Taking other medicines used to treat depression, known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include nialamide, iproniazide, selegeline, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone.

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Treatment with Prozac should only be started 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).

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:

  • have epilepsy or fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately; Prozac might need to be discontinued.
  • mania now or in the past; if you have a manic episode, contact your doctor immediately because Prozac might need to be discontinued.
  • diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic treatment);
  • liver problems (your doctor may need to adjust your dosage)
  • heart problems
  • are taking diuretics (water tablets), especially if you are elderly;
  • are having ECT (electro-convulsive therapy) treatment;
  • have a history of bleeding disorders or you develop bruises or unusual bleeding;
  • are taking medicines that thin the blood (see ‘Taking other medicines’).
  • start to experience fever, muscle stiffness or tremor, 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, Prozac might need to be discontinued.
  • Starting to feel restless and cannot sit or stand still (akathisia).Increasing your dose of Prozac may make this worse
  • Ongoing treatment with tamoxifen (used to treat breast cancer).
  • have 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.
    Use in children and adolescents aged 8 to 18 years:
    Patients under 18 have an increased risk of side-effects 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.

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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, your doctor may prescribe Prozac for patients under 18 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:

  • Certain MAO-inhibitors (used to treat depression). Non-selective MAO-inhibitors and MAO- inhibitors type A (moclobemide) must not be used with Prozac as serious or even fatal reactions (serotonin syndrome) can occur (see section “Do not take Prozac”). Some MAO-inhibitors 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.
  • Clozapine (used to treat certain mental disorders), tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure).
  • 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.
  • Warfarin or other medicines used to thin the blood; 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.
  • Tamoxifen as Prozac may affect blood levels of tamoxifen.
  • You should not start to take the herbal remedy St John’s Wort while you are being treated with
    Prozac since this may result in an increase in side effects. If you are already taking St John’s Wort when you start on Prozac, stop taking St John’s Wort and tell your doctor at your next visit.
    Taking Prozac with food and drink
  • You can take Prozac with or without food, whatever you prefer.
  • You should avoid alcohol while you are taking this medicine.
    Pregnancy and breast-feeding
    Ask your doctor or pharmacist for advice before taking any medicine.
    Pregnancy
    Talk to your doctor as soon as possible if you're pregnant, if you might be pregnant, or if you're planning to become pregnant.
    In babies whose mothers took Prozac 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 Prozac. You and your doctor may decide that it is better for you to gradually stop taking Prozac while you

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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 Prozac 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.

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.

3. HOW TO TAKE PROZAC

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 capsules than your doctor tells you.

Swallow the capsules with a drink of water. Do not chew the capsules.

Adults:

The usual dose is:

  • Depression: The recommended dose is 1 capsule (20 mg) 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 3 capsules (60 mg) 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.
  • Bulimia nervosa: The recommended dose is 3 capsules (60 mg) daily.
  • OCD: The recommended dose is 1 capsule (20 mg) 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 3 capsules (60 mg) 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. Your doctor will review the need for continuing treatment beyond 6 months, and treatment will be reassessed if no improvement is seen.
    Elderly:
    Your doctor will increase the dose with more caution and the daily dose should generally not exceed 2 capsules (40 mg). The maximum dose is 3 capsules (60 mg) daily.

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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

  • If you take too many capsules, go to your nearest hospital emergency department (or casualty) or tell your doctor straight away.
  • Take the pack 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
  • If you miss a dose, do not worry. Take your next dose the next day at the usual time. Do not take a double dose to make up for a forgotten dose.
  • Taking your medicine at the same time each day may help you to remember to take it regularly.
    If you stop taking Prozac
  • Do NOT stop taking Prozac without asking your 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 capsules.
    You may notice the following 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.

  • If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a
    hospital straight away.
  • If you get a rash or allergic reaction such as itching, swollen lips/tongue or wheezing/shortness of breath, stop taking the capsules straight away and tell your doctor immediately.
  • If you feel restless and cannot sit or stand still, you may have akathisia; increasing your dose of Prozac may make you feel worse. If you feel like this, contact your doctor.
  • Tell your doctor immediately if your skin starts 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:

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  • a combination of symptoms (known as “serotonin syndrome”) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely);
  • feelings of weakness, drowsiness or confusion mostly in elderly people and in (elderly) people taking diuretics (water tablets);
  • prolonged and painful erection;
  • irritability and extreme agitation.
    If you have any of the above side effects, you should tell your doctor immediately.
    If you have any of the following symptoms and they bother you, or last for some time, tell your doctor or a pharmacist.
    • Whole body - chills, sensitivity to sunlight, weight loss.
    • Digestive system - diarrhoea and stomach upsets, vomiting, indigestion, difficulty swallowing or a change in taste, or a dry mouth. Abnormal liver function has been reported rarely, with very rare cases of hepatitis.
    • Nervous system - headache, sleep problems or unusual dreams, dizziness, poor appetite, tiredness, abnormally high mood, uncontrollable movements, fits, extreme restlessness, hallucinations, untypical wild behaviour, confusion, agitation, anxiety, nervousness, not being able to concentrate or think properly, panic attacks; or thoughts of suicide or harming yourself.
    • Urogenital system and reproductive disorders - difficulty passing urine or passing urine too frequently, poor sexual performance, prolonged erections, and producing breast milk.
    • Respiratory System - sore throat, shortness of breath. Lung problems (including inflammatory processes of varying histopathology and/or fibrosis) have been reported rarely.
    • Bone fractures - an increased risk of bone fractures has been observed in patients taking this type of medicines.
    • Other - hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, or joint or muscle pain, low levels of sodium in the blood.
      Most of these side effects are likely to disappear with continued treatment.
      In children and adolescents (8-18 years) – Prozac may slow growth or possibly delay sexual maturity.
      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

Keep out of the reach and sight of children.
Do not take Prozac after the expiry date which is stated on the pack. Do not store your capsules above 30°C.

If you have any other questions please talk to your doctor or pharmacist.

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If your doctor decides to stop treatment, return any left-over capsules to a pharmacist. Only keep them if your doctor tells you to.
Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Prozac contains
The active substance is fluoxetine hydrochloride. Each capsule contains fluoxetine hydrochloride equivalent to 20 milligram (mg) of fluoxetine.

Other ingredients inside the capsule are: maize starch flowable and dimeticone.
The capsule shell is made of gelatin, patent blue V (E131), yellow iron oxide (E172), titanium dioxide (E171), and black edible printing ink, which contains shellac and black iron oxide (E172).

What Prozac looks like and contents of the pack

Prozac is a hard capsule. Each capsule of Prozac contains 20mg fluoxetine hydrochloride.
The capsules are yellow and green, and marked ‘Lilly 3105’. The capsules are available in PVC/aluminium blister packs.

Manufacturer

SPIMACO, Al-Qassim Pharmaceutical Plant, Saudi Pharmaceutical Industries & Medical Appliances Corporation, Saudi Arabia.

Under License from: Eli Lilly and Company

For any information about this medicine, please contact:

Eli Lilly & Company

PO Box 92120
Al Deghather Center, 2nd Floor, Khorais Road, AlOlaya, Riyadh 11653 Kingdom of Saudi Arabia Tel: +966 12175500 Fax: +966 12179900

This leaflet was last approved in 14th October 2010

To report any side effect(s):

-National Pharmacovigilance Center (NPC) o Fax:+966-1-205-7662
o E-mail:npc.drug@sfda.gov.sa
o Website:www.drug.gov.sa/npc

This is a medicament

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-Medicament is a product which affects your health and its consumption contrary to instructions is dangerous for you.
-Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who dispensed the medicament.

-The doctor and the pharmacist are the experts in medicines, their benefits and risks. -Do not by yourself interrupt the period of treatment prescribed for you.
-Do not repeat the same prescription without consulting your doctor.
-Keep all medicaments out of reach of children.

Council of Arab Health Ministers Union of Arab Pharmacists

Country of Manufacture UK

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