Genofinex 20 mg Capsules

Fluoxetine belongs to a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants. GENOFINEX is used to treat the following conditions:

• Depression: a mental health disorder characterised by persistently depressed mood or loss of interest in activities, causing significant impairment in daily life. GENOFINEX is indicated for the treatment of major depressive episodes i.e. single episode and recurrent depression with associated anxiety.
• Bulimia nervosa: a serious eating disorder marked by bingeing, followed by methods to avoid weight gain.
• Obsessive-compulsive disorder: a mental disorder most commonly characterised by intrusive, repetitive thoughts resulting in compulsive behaviours and mental acts that the person feels driven to perform.

Do not take GENOFINEX:

• If you are hypersensitive (allergic) to fluoxetine or any of the ingredients of GENOFINEX.
• If you are less than 18 years of age, as safety and efficacy in children have not been established.
• If you have a severe kidney disease.
• If you are taking or have recently taken (within the last two weeks) another medicine known as a monoamine oxidase inhibitor (MAOI).
• If you are taking or have recently taken anti-psychotic medicine known as Thioridazine.

Take special care with GENOFINEX:

• If you experience worsening of your depression, or if you think of harming or killing yourself. You should contact your doctor or go to the hospital doctor immediately.
• If you experience muscle stiffness or tremor, appearance of fever, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so-called “serotonin syndrome”. Although this syndrome occurs rarely it may result in potentially life threatening conditions; contact your doctor immediately.
• If you experience swollen face or tongue, or shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction).
• If you experience epilepsy or fits. If you have a fit (seizures) or experience an increase in seizure frequency, contact your doctor immediately.
• If you suffer from kidney problems you should not take GENOFINEX (see Do not take).
• If you are diabetic.
• If you have eye problems or suffer from, or have a history of, glaucoma.
• If you have moderate or severe heart failure.
• If you are taking diuretic medications (medication which increases the excretion of water and salt from the body). As this may result in hyponatraemia (a condition that occurs when the level of sodium in the blood is too low), when taken together with GENOFINEX.
• If you experience abnormal bleeding.
• If you feel restless and feel like you cannot sit or stand still, tell your doctor. Do not increase the dose of GENOFINEX it may make these feelings worse.

Taking other medicines with GENOFINEX:

Always tell your healthcare professional if you are taking any other medicine. (This includes all complementary or traditional medicines).

Do not share medicines prescribed for you with any other person. Always take GENOFINEX exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with GENOFINEX will last. If you have the impression that the effect of GENOFINEX is too strong or too weak, talk to your doctor or pharmacist.

GENOFINEX should be swallowed whole or dispersed in approximately 100 ml water. For the treatment of major depressive episodes, a dose of 20mg/day is recommended, preferably in the morning. For the treatment of bulimia nervosa, a dose of 60 mg/day is recommended. For the treatment of obsessive-compulsive disorder, a dose of 20 to 60 mg/day is the recommended dose. The recommended dose may be increased or decreased. Doses above 80 mg/day are not recommended for any indication.

GENOFINEX should be used with caution in all elderly patients, particularly if they have systemic illness or are receiving multiple medications for concomitant diseases. Dosages over 20 mg per day are not recommended. Fluoxetine Capsules should not be used in the treatment of children or adolescents under the age of 18 years.

Taking GENOFINEX with food and drink: GENOFINEX may be taken with or without food. Avoid alcohol while you are taking this medicine.

If you take more GENOFINEX than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. These are the possible signs and symptoms of overdose: nausea, vomiting, seizures, cardiovascular dysfunction ranging from asymptomatic dysrhythmias to cardiac arrest, pulmonary dysfunction and signs of altered CNS status ranging from excitation to coma.

If you forget to take GENOFINEX: If you forgot to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you stop taking GENOFINEX: Do not stop taking GENOFINEX without asking your doctor first, even when you start to feel better. It is important that you keep taking your medicine. If needed, your doctor will gradually decrease your dose.

GENOFINEX can have side effects. Not all side effects reported for GENOFINEX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking GENOFINEX, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking GENOFINEX and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swollen face or tongue, or shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic reaction).
• Rapid or irregular heartbeat, flushing or fainting. These are all very serious side effects. If you have them, you may have had a serious reaction to GENOFINEX. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Seizures, fits or convulsions.
• If you experience muscle stiffness or tremor, appearance of fever, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so-called “serotonin syndrome”.
• Feelings of weakness, drowsiness or confusion mostly in elderly people and in (elderly) people taking diuretics (water capsules).
• Chest pains.
• Frequent or unusual bruising or bleeding, such as nose bleeds (this could indicate that GENOFINEX has had an effect on your blood, and this may need to be tested).

These are all serious side effects. You may need urgent medical attention.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Store at or below 25 °C.

• Keep in original packaging until required for use.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).