patient information leaflet fluoxetine capsules

Patient Information Leaflet

Fluoxetine capsule 20mg

FLUOXETINE CAPSULES 20mg

Please read this leaflet carefully before you start to take your medicine. It gives you important information about your medicine. If you want to know more, or you are not sure about anything, ask your pharmacist or doctor. Keep the leaflet until you have finished the medicine.

What's in your medicine

This leaflet refers to the Fluoxetine Capsules 20mg strength only. Each hard capsule contains 20mg of the active ingredient fluoxetine hydrochloride.

The capsule also contains: pregelatinised maize starch, anhydrous colloidal silica, magnesium stearate and talc.

The capsule shell contains: E104, E127, E132, E171 and gelatin.

The printing ink contains: shellac glaze and iron oxide black (E172).

Fluoxetine Capsules are available in pack sizes of 14, 20, 28, 30, 50, 60, 90, 100, 250, 500*

*Only the marketed pack size/s will be state on the final version.

About your medicine

Fluoxetine capsules is one of a group of medicines called antidepressants that will relieve the symptoms of depression. It may also be used to treat the eating disorder bulimia nervosa and the condition obsessive-compulsive disorder.

Before taking your medicine

Make sure it is safe for you to take Fluoxetine Capsules. If you are worried or unsure about anything speak to your pharmacist or doctor before you start taking this medicine.

Do not take Fluoxetine Capsules if you:

have ever had an allergic reaction to Fluoxetine capsules or any of the ingredients in the capsule. (An allergic reaction may include a rash, itching, swelling, feeling faint or shortness of breath).
are taking monoamine oxidase inhibitors (MAOIs). MAOIs include phenelzine, tranylcypromine and isocarboxazide. MAOIs and Fluoxetine Capsules do not mix. So if you are taking any MAOIs or stopped taking them within the last 2 weeks, you must not take Fluoxetine Capsules. DO NOT take any MAOIs for at least 5 weeks after stopping Fluoxetine Capsules.

Take special care with Fluoxetine Capsules if you have:

developed a rash, feel faint, experience any swelling or have difficulty breathing after taking Fluoxetine Capsules. If any of these reactions occur, you could be allergic to the product and must stop taking it and seek medical advice immediately.
epilepsy or if you have had a fit in the past. Fluoxetine may increase the likelihood of an epileptic fit. If after taking Fluoxetine Capsules, you develop a fit for the first time or get more fits than usual, seek medical advice from your doctor.
a history of mental illness known as mania or hypomania.
heart, kidney or liver problems.
lost more weight after taking this medicine than you feel comfortable with. Fluoxetine can cause weight loss, though normally this is not excessive.
diabetes. Fluoxetine Capsules may alter your blood sugar levels. Your doctor may need to alter the dose of your insulin or other diabetes control medicine.
thoughts of ending your own life. Depression itself can lead to such thoughts. As with other antidepressants, fluoxetine may take a number of weeks to make you feel better. If you feel suicidal, do not rely on the medicine alone, but seek help or medical advice.
a history of bleeding disorders or develop unexpected bruising, reddening under the skin or bleeding from any other part of the body.
Electroconvulsive Therapy (ECT).
been taking the herbal remedy St John's wort (Hypericum perforatum). This should not be taken at the same time as Fluoxetine Capsules. Stop taking the St John's wort and mention it to your doctor at your next visit.
developed any of the following after taking Fluoxetine Capsules (see After Taking Your Medicine): feeling hot, stiff, confused, irritable, agitated, behaving strangely, or have twitchy muscles. Stop taking Fluoxetine and contact your doctor for advice.

Check with your doctor or pharmacist if you are taking any of the following:

lithium or phenothiazines (e.g. chlorpromazine) for mental illness,
flecainide or encainide for the heart,
carbamazepine or phenytoin for epilepsy or other conditions,
any other medicines for depression,
selegeline for Parkinson's disease,
tramadol for pain relief,
triptans (e.g. sumatriptan) for migraine or cluster headaches,
medicines to thin the blood (e.g. warfarin),
non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen),
aspirin,
tryptophan.

You are advised NOT to drink alcohol with this medicine. Discuss this with your doctor if you have any questions.

Driving and using machines:

Antidepressants can affect your judgement or co-ordination. Do not drive or use machinery unless you are sure that you are not affected.

Pregnancy and Breast-feeding:

Fluoxetine Capsules may usually be taken during pregnancy. Breast-feeding is not recommended whilst taking fluoxetine. Speak to your doctor if you are uncertain or have any questions.

If you see another doctor or go into hospital, let them know what medicines you are taking.

Taking your medicine

Follow your doctor's instructions. Check the pharmacy label to see how many capsules to take and how often to take them. If you are not sure how to take them ask your pharmacist or doctor.

Usual doses

Adults aged 18 years and over:

Depression: One 20mg capsule per day. Maximum daily dose should not exceed 60mg (3 capsules) per day.
Bulimia: 60mg (3 capsules) per day.
Obsessive-compulsive disorder: One 20mg capsule per day. Maximum daily dose should not exceed 60mg (3 capsules) per day.

If you suffer from kidney or liver problems or are elderly, your doctor may prescribe a different dose.

Children:

Not recommended for use in children aged under 18 years.

Swallow the capsule whole with a drink of water. Fluoxetine capsules may be taken as a single or separate doses, during or between meals.

Fluoxetine may not make you feel any better for the first 2 weeks or more. It should be taken for as long as your doctor tells you to. When dosing is stopped, active fluoxetine remains in the body for weeks. Your doctor may reduce your dose gradually at the end of treatment, though this is often not necessary.

If you forget to take Fluoxetine Capsules:

If you forget to take a dose, take one as soon as you remember. Then go on as before. DO NOT take two doses at the same time. If you are worried ask your pharmacist or doctor for advice.

If you take more Fluoxetine Capsules than you should:

Do not take more capsules than your doctor tells you to. If you ever take too many go to the nearest hospital casualty unit or tell your doctor immediately. Take the container and any remaining capsules with you to show to the doctor.

AFTER TAKING YOUR MEDICINE

This medicine sometimes causes unwanted effects in some people. These effects may include:

Whole body: oversensitivity reactions may include itching, rash, which may be itchy, difficulty breathing, breathlessness, feeling faint or fainting, swelling of face, lips, throat, tongue or other part of the body, inflammation of blood vessels, "serum sickness", chills, serotonin syndrome (feeling hot, stiff, confused, irritable, agitated, behaving strangely, or have twitchy muscles) and sensitivity of skin to light. Very rarely severe skin reactions may occur involving reddening, blistering and peeling of the skin (Lyell syndrome).
Effects on the digestive system: feeling or being sick, diarrhoea, indigestion, dry mouth, difficulty swallowing and taste disturbances. Rarely changes in liver function (detected by blood tests) can occur, and very rarely hepatitis (inflammation of the liver possibly causing yellowing of the skin and whites of the eyes).
Effects on the nervous system: headache, nervousness, dizziness, anxiety, difficulty sleeping, abnormal dreams, loss of appetite, fatigue, drowsiness, unusually excited behaviour, fits, temporary abnormal movements (e.g. twitching, tremor), hallucinations (sensing something that is not real), hyperactivity, confusion, agitation, poor concentration and thought processes, panic attacks.
Effects on the bladder and urinary system: difficulty urinating, frequent urinating.
Effects on the sexual organs: altered sexual performance, changes in sexual desire, persistent erection of penis, production of breast milk.
Other effects: hair loss, yawning, blurred vision, dilation of pupils, sweating, widening of blood vessels, joint pain, muscle pain, feeling faint on changing posture (e.g. standing up) due to lowered blood pressure, bruising. Rare cases of bleeding from the vagina, gut, skin or soft tissues have been reported.
Sodium levels: Low blood sodium levels (detected by blood test) occur in rare cases and appear to return to normal on stopping treatment with fluoxetine.
Effects on the lungs:sore throat, difficulty breathing, lung damage which can be severe. If you experience any difficulty breathing or breathlessness tell your doctor.

In rare cases, abrupt withdrawal of the medicine can cause dizziness, feeling sick, pins and needles, headache and anxiety. In most cases, these symptoms are mild and short-lived.

If you develop a rash, breathing problems or fits you should speak to your doctor immediately.

If you are concerned about any of these effects or get any other unusual effects, tell your doctor immediately.

STORING YOUR MEDICINE

Do not use the capsules after the expiry (use by) date shown on the product packaging. Do not store the capsules above 25ºC and store in the original container. KEEP THEM IN A SECURE PLACE WHERE CHILDREN CANNOT GET AT OR SEE THEM. REMEMBER, this medicine is for YOU only. NEVER give it to anyone else. It may harm them, even if their symptoms are the same as yours. Unless your doctor tells you to, do not keep medicines that you no longer need - give them back to your pharmacist for safe disposal.

Medicine: fluoxetine capsules