Blog Nashville: Fluoxetine Capsules 20mg

Fluoxetine 20mg capsules

(fluoxetine hydrochloride)

Read all of this leaflet carefully before you start taking this medicine.

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.

Index

1 What Fluoxetine capsules are and what they are used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Fluoxetine capsules are and what they are used for

Fluoxetine capsules belongs to 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 you take

Do not take Fluoxetine capsules and tell your doctor if you:

are allergic (hypersensitive) to fluoxetine or any of the other ingredients (see section 6).

are taking, or have taken within the last two weeks any monoamine oxidase inhibitors (MAOIs). MAOIs include phenelzine, tranylcypromine and isocarboxazide.

Check with your doctor or pharmacist before taking Fluoxetine capsules if you:

suffer from 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.

have a history of mental illness known as mania or hypomania.

suffer from heart, kidney or liver problems.

suffer from 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.

have a history of bleeding disorders or develop unexpected bruising, reddening under the skin or bleeding from any other part of the body.

are having Electroconvulsive Therapy (ECT).

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 young adults (less than 25 years old) 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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially

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.

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.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding is not recommended whilst taking fluoxetine.

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.

How to take

Always take Fluoxetine capsules exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

You are advised NOT to drink alcohol with this medicine.

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

Doses:

Adults:

Depression: One capsule a day. Maximum daily dose should not exceed 60mg (3 capsules) a day.

Bulimia: 60mg (3 capsules) a day.

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

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

Children and adolescents:

Not recommended for use in children aged under 18 years.

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.

If you take more than you should

If you (or someone else) swallow a lot of capsules at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose feeling sick, being sick, seizures, heart problems, lung problems, and signs of altered Central Nervous System status ranging from excitation to coma.

If you forget to take the capsules

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

If you stop taking the capsules

If you stop taking the capsules abruptly you may rarely develop dizziness, feeling sick, pins and needles, headache and anxiety. In most cases, these symptoms are mild and short-lived. Talk to your doctor before you stop taking the capsules and follow their advice. Your doctor may reduce your dose gradually at the end of treatment, though this is often not necessary.

Possible side effects

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

Stop taking Fluoxetine capsules and contact your doctor at once if you experience an allergic reaction to the capsules: rash, feeling faint, any swelling or have difficulty breathing.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

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.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to store

Keep out of the reach and sight of children.

Do not store above 25ºC

Do not use Fluoxetine capsules after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

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.

Further information

What Fluoxetine capsules contain

The active substance (the ingredient that makes the tablet work) is 20mg fluoxetine hydrochloride.

The other ingredients are 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).

What Fluoxetine capsules look like and contents of the pack

Fluoxetine capsules are hard gelatine capsules, light green cap and yellow body.

Pack sizes are 30 capsules.

Marketing Authorisation Holder and Manufacturer

Actavis

Barnstaple

EX32 8NS

Date of revision: June 2008