FLUOXETINE 20mg CAPSULES
Please read this leaflet carefully before you start to take your medicine.
This leaflet provides a summary of the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.
The name of this medicine is Fluoxetine 20mg Capsules.
What Is In This Medicine?
Each capsule contains 20mg Fluoxetine (as the hydrochloride).
Each capsule also contains dimeticone, pregelatinised starch, titanium dioxide (E171), erythrosine (E127), patent blue V and gelatin. The ink used to print on the capsules contains shellac, black iron oxide and propylene glycol.
Fluoxetine capsules are blue and white and marked 'S 136'. They are supplied in boxes of 30.
Fluoxetine belongs to a group of medicines called antidepressants.
The Product Licence/Authorisation holder is:
The Manufacturer is:
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What Is This Medicine For?
Fluoxetine is used to treat the symptoms of depression.
Before Taking This Medicine
You should not take fluoxetine if you:
- have severe kidney problems
- are breast feeding
- are allergic to fluoxetine or any of the ingredients
- are taking, or have recently been taking, any medicines known as monoamine oxidase inhibitors
- have uncontrolled epilepsy, fits or convulsions.
Special care is needed (check with your doctor) if you:
- have liver or kidney problems
- have heart disease
- are recovering from a heart attack
- have epilepsy, fits or convulsions
- are pregnant
- have had previous bleeding problems
- have diabetes.
If taken with some other medicines the effects of fluoxetine or the effects of the other medicines may be changed. Please check with your doctor if you are taking any of the following:
monoamine oxidase inhibitors (MAOIs) such as phenelzine, isocarboxazid, tranylcypromine and moclobemide - used to treat depression. You should NOT take fluoxetine if you are taking these medicines or have done so in the last 14 days. You should not start taking any MAOIs for at least 5 weeks after finishing fluoxetine treatment.
- lithium, to treat mental illness
- other antidepressants e.g. amitriptyline, tryptophan
- medicine for epilepsy e.g. phenytoin, carbamazepine
- anticoagulants used to thin the blood e.g. warfarin
- antipsychotics e.g. clozapine
- antiplatelets e.g. aspirin, ticlopidine
The herbal remedy St John’s Wort (Hypericum perforatum) should not be taken at the same time as this medicine. If you already take a St John’s Wort preparation, stop taking it and mention it to your doctor at your next visit.
Antidepressants can affect your judgement or co-ordination. Do not drive or use machinery unless you are sure that you are not affected.
Taking This Medicine
The dose of fluoxetine depends on the condition being treated and the usual doses for adults over 18 years, including the elderly, are given below:
The usual dose is one 20mg Fluoxetine capsule a day. In some cases your doctor may increase the dose up to a maximum of 80mg (four capsules) divided throughout the day.
Elderly patients may be more sensitive to the effects of fluoxetine so your doctor may prescribe a smaller dose than that stated above, up to a maximum of 60mg (three capsules) a day.
Patients who suffer from kidney and liver disease are likely to be given less frequent doses of Fluoxetine, such as one 20mg capsule every second day.
If you are not sure how many capsules to take, ask your doctor or pharmacist.
Fluoxetine is not recommended for children.
Swallow the capsules whole with a drink of water.
If you forget to take a dose at the right time, take it as soon as you remember, then go on as before but do not take two doses at the same time.
It may take several weeks before this medicine starts to work. Do not stop taking fluoxetine without consulting your doctor first.
An overdose of this medicine may be dangerous. If you have taken an overdose, tell your doctor or go to the nearest hospital casualty department immediately.
Whilst Taking This Medicine
Fluoxetine may cause problems in some people.
There may be a general feeling of weakness or fever throughout your whole body. There is also a possibility of headache, nervousness, sleeplessness, drowsiness, dizziness, visual disturbance, anxiety, confusion, big mood swings, suicidal thoughts, tremor, sweating, movement problems and seizures. If you have a seizure, stop taking Fluoxetine Capsules and contact your doctor immediately.
A few people have developed rashes, hives or other allergic reactions including more serious skin diseases with fever and joint pain.
Other problems are nausea (feeling sick), vomiting (being sick), diarrhoea, constipation, dry mouth, indigestion, anorexia and loss of appetite. Weight loss and reduced sexual performance may also occur. Some of these side effects are temporary and will reduce or disappear after a few weeks while you continue to take Fluoxetine. If you do experience these or any other unusual effects you should tell your doctor as soon as possible.
There have also been reports of liver problems, bleeding, raised blood pressure, increased and decreased heart rate.
If you stop taking Fluoxetine suddenly, you may get withdrawal symptoms such as headache, dizziness, nausea, anxiety and pins and needles. These symptoms are not serious and will disappear.
There have also been reports of milk production from the breasts.
Rarely there may be a decrease in sodium levels in the blood (hyponatraemia). This may cause confusion and sometimes seizures and is more likely to occur in the elderly or in people who are taking diuretics (water tablets).
Do not use this medicine after the expiry date, which you will find on the pack.
Do not store the capsules above 30°C. Keep container in the outer carton.
Keep your capsules out of the reach of children.
This leaflet was last revised in February 2007.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.
‘Winthrop’ is a registered trademark. © 2007 Winthrop Pharmaceuticals
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