FLUOXETINE CAPSULES 20 mg

Please read this leaflet carefully before you take these capsules. It briefly outlines the most important things you need to know. If you want to know more about this medicine, or you are not sure about anything, ask your doctor or your pharmacist. The name of your medicine is Fluoxetine Capsules 20 mg.

WHAT IS FLUOXETINE ?

Each hard capsule contains 22.36 mg of of the active ingredient Fluoxetine Hydrochloride Ph. Eur. which is equivalent to 20 mg of Fluoxetine. The other ingredients are colloidal anhydrous silica, pregelatinised starch and simethicone emulsion. The capsule shell contains gelatin and the colours indigo carmine (E132) and titanium dioxide (E171). The printing ink contains shellac, iron oxide (E172) and Propylene Glycol (E1520).

The product is available in pack sizes of 12, 14, 20, 28, 30, 50, 60, 70, 90, 98, 100 or 500 capsules. See outer packaging or the pharmacy label for contents i.e. the number of capsules.

Fluoxetine is an antidepressant.

Fluoxetine Capsules are manufactured by Teva Pharmaceuticals, Kfar Saba, Israel on behalf of the Marketing Authorisation holder Teva Pharma BV, 3542 DR Utrecht, The Netherlands. They are distributed in the UK by Approved Prescription Services Limited, Leeds, LS27 0JG England.

WHAT IS FLUOXETINE USED FOR ?

Fluoxetine capsules are used to treat the following conditions:

In adults:

  • major depressive episodes
  • obsessive-compulsive disorder (OCD)
  • bulimia nervosa: fluoxetine is used alongside psycho-therapy for the reduction of binge-eating and purging.

In 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. Fluoxetine should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy. Ask your doctor or pharmacist if you need additional information.

BEFORE YOU TAKE FLUOXETINE

Do not take Fluoxetine and tell your doctor or pharmacist if the following apply:

  • if you are allergic (hypersensitive) to fluoxetine or any of the other ingredients in the medicine, listed above. An allergy may include rash, itching, swollen face or lips or shortness of breath.
  • if you are taking medicines known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (also called MAOIs, which are also used to treat depression), since serious or even fatal reactions can occur.

Treatment with fluoxetine 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 MAOIs called reversible MAOI-A (for instance moclobemide).

Do not take any MAOIs for at least five weeks after you stop taking Fluoxetine. If Fluoxetine has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor. Examples 0of MAOIs include nialamide, iproniazide, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone.

Take special care with Fluoxetine and tell your doctor or pharmacist 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
  • have epilepsy or have had a fit in the past; if you have a fit (seizure) or experience an increase in seizure frequency, contact your doctor immediately, the use of fluoxetine might need to be discontinued
  • have suffered from mania in the past; if you have a manic episode, contact your doctor immediately, the use of fluoxetine may need to be discontinued
  • have diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic treatment)
  • have liver problems (your doctor may need to adjust your dosage)
  • have heart problems
  • are taking diuretics (water tablets), especially when you are elderly
  • are having ECT electro-convulsive therapy) treatment
  • have a history of bleeding disorders or you develop bruises or unusual bleeding
  • are using medicinal products that affect the coagulation of 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, the use of fluoxetine might need to be discontinued
  • have suicidal thoughts or want to harm yourself. Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until improvements of your illness occur. Since it can take 3 to 4 weeks before your illness improves following treatment with fluoxetine, your doctor will monitor you closely at the start of the treatment. Other psychiatric conditions for which Fluoxetine is prescribed can also be associated with an increased risk of suicide-related events. The same precautions should therefore be observed when treating patients with other psychiatric disorders.

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. Fluoxetine 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 in other indications. Additionally, only limited information concerning the long-term safety of fluoxetine on growth, puberty, mental, emotional and behavioural development in this age group is available. Despite this, your doctor may prescribe Fluoxetine for patients under 18 for moderate to severe major depressive episodes in combination with psychological therapy because he/she decides that this is in their best interests. If your doctor has prescribed Fluoxetine 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 Fluoxetine. Fluoxetine 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 five weeks ago), including medicines obtained without prescription. This medicine may affect the way some other medicines work (interaction). An interaction could occur with:

  • MAO inhibitors (used to treat depression). Non-selective MAO inhibitors and MAO inhibitors type A (moclobemide) should not be used with Fluoxetine as serious or even fatal reactions (serotonin syndrome) can occur (see section 'Do not take Fluoxetine'). MAO inhibitors type B (selegiline) can be used with Fluoxetine provided that your doctor monitors you closely
  • lithium, tryptophan; there is an increased risk of serotonin syndrome when these drugs are co-administered with Fluoxetine. When fluoxetine is used in combination with lithium your doctor will carry out more frequent check-ups
  • phenytoin (for epilepsy); because Fluoxetine may influence blood levels of this drug, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with Fluoxetine
  • clozapine (used to treat certain mental disorders), tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension
  • flecainide or encainide (for heart problems), carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because Fluoxetine may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with Fluoxetine
  • warfarin or other medicines used to thin the blood; Fluoxetine may alter the effect of these medicines on the blood. If Fluoxetine treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain tests.
  • you should not start to take the herbal remedy St John's wort while you are being treated with Fluoxetine since this may result in an increase of undesirable effects. If you are already taking St John's wort when you start on Fluoxetine, stop taking the St John's wort and tell your doctor at your next visit.

Taking Fluoxetine with food and drink

You should avoid alcohol whilst taking fluoxetine.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Pregnancy

Information collected to date does not indicate an increased risk when used during pregnancy. However, 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 newborn children: irritability, tremor, muscle weakness, persistent crying, 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

Fluoxetine may affect your judgement or co-ordination. Do not drive or use machinery until you are sure you are not affected.

TAKING FLUOXETINE

Always take Fluoxetine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual doses are:

  • Depression: the recommended dose is 20 mg daily. Your doctor will review and adjust your dosage if necessary within 3 to 4 weeks of the start of treatment. When appropriate the dosage can be gradually increased up to a maximum of 60 mg. 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 a period of at least 6 months.
  • Bulimia nervosa: the recommended dose if 60 mg daily.
  • Obsessive-compulsive disorder (OCD): the recommended dose is 20 mg daily. Your doctor will review and adjust your dosage if necessary after 2 weeks of treatment. When appropriate the dosage can be gradually increased up to a maximum of 60 mg. If no improvement is noted within 10 weeks, treatment with Fluoxetine should be reconsidered.
  • Children and adolescents aged 8 to 18 years with depression: treatment should be started and be supervised by a specialist. The starting dose is 10 mg/day (given as 2.5 ml of fluoxetine oral liquid). After one to two weeks, your doctor may increase the dose to 20 mg/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 should review the need for continuing treatment beyond 6 months. If you have not improved, your treatment should be reassessed.

If you are elderly, your doctor will increase the dose with more caution and the daily dose should generally not exceed 40 mg. The maximum dose is 60 mg per day.

If you have a liver problem or are using other medication that might have an influence on fluoxetine, your doctor may decide to prescribe a lower dose or instruct you to Fluoxetine every other day.

Method of administration

  • Swallow the capsules with a drink of water. Do not chew the capsules
  • You can take Fluoxetine with or without food, whatever you prefer
  • Always follow your doctor's instructions as to how many capsules to take and how often to take them
  • Do not take more capsules than your doctor tells you.

If you take more Fluoxetine 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 Fluoxetine 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 Fluoxetine

  • 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 Fluoxetine

Do not stop taking Fluoxetine until your doctor tells you to. It is important that you keep taking your medicine.

  • Do not stop taking your medicine without asking your doctor first, even when you start to feel better
  • Make sure you do not run out of capsules.

You may notice the following effects when you stop taking Fluoxetine: dizziness, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, unusual tiredness or weakness, felling anxious, nausea/vomiting (feeling or being sick), tremor (shakiness), headaches. Most people find that any symptoms on stopping Fluoxetine are mild and go away on their own within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.

When stopping Fluoxetine, 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 Fluoxetine, ask your doctor or pharmacist.

AFTER TAKING FLUOXETINE

Like all medicines, Fluoxetine can cause side effects, although not everybody gets them.

  • 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 feel like you cannot sit or stand still, you may have something called akathisia. Increasing your dose of Fluoxetine 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:

  • 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 on 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, thoughts of suicide or harming yourself.

Urogenital system and reproductive disorders – difficulty passing urine or passing urine too frequently, poor sexual performance, prolonged erections, 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.

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 go away with continued treatment.

Additionally in children and adolescents (8-18 years) Fluoxetine 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.

STORING FLUOXETINE

Do not use this medicine after the expiry date shown on the outside packaging.

Store in the original container. Do not store above 30°C. Do not transfer the capsules to another container. Keep them in a secure place where children cannot get at them. This medicine is for you ONLY, do not give it to anyone else. Unless your doctor tells you to, do not keep these capsules for longer than you need. Return all unused medicines to your pharmacist for safe disposal.

FURTHER INFORMATION

This leaflet only gives a brief outline of some of the more important points about Fluoxetine. If you want to know more about these capsules or their effects, please ask your doctor or pharmacist.

Revised: March 2008

 

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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