Oxactin 20mg Capsules
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Oxactin 20mg Capsules
Fluoxetine (as hydrochloride)
Eight important things you need to know about Oxactin
Please read all of the leaflet. It includes a lot of additional important information about this medicine.
• Oxactin treats depression and anxiety disorders. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.
• Oxactin is not for use in children under 8. See Use in
Children and adolescents aged 8to18 years, under Section 2, inside this leaflet
• Oxactin won't work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should ask to see you again a couple of weeks after you first start treatment. Tell your doctor if you have started feeling better. See section 3, How to take Oxactin capsules, inside this leaflet.
• Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away. See Thoughts ofharming yourself under Section 2, inside this leaflet.
• Don't stop taking Oxactin without talking to your doctor. If you stop taking Oxactin suddenly or miss a dose, you may get withdrawal effects. See Ifyou stop using Oxactin under Section 3, inside this leaflet.
• If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose of Oxactin may make these feelings worse. See section 4, Possible side effects, inside this leaflet.
• Taking some other medicines with Oxactin can cause problems. You may need to talk to your doctor. See Taking ofhermedicines and Oxactin under Section 2, inside this leaflet.
• If you are pregnant or planning to become pregnant,
talk to your doctor. See Pregnancyandbreastfeeding under Section 2, inside this leaflet.
Read this leaflet.
It includes a lot of additional important information about this medicine.
Keep this leaflet. You may need to read it again.
If you have any more questions, ask your doctor or pharmacist (chemist). You may also find it helpful to contact a self-help group, or patient organisation, to find out more about your condition. Your doctor will be able to give you details.
In this leaflet:
1. What Oxactin Capsules are and what they are used for
2. Before you take Oxactin Capsules
3. How to take Oxactin Capsules
4. Possible side effects
5. How to store Oxactin Capsules
6. Further Information
1. WHAT OXACTIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Oxactin Capsules contain fluoxetine which is one of a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants.
Oxactin Capsules are used in the treatment of:
Adults:
• Severe depression
• Anxiety disorders with compulsive thoughts or actions, which means that you may have uncontrollable thoughts or carry out repetitive actions. This condition is known as obsessive compulsive disorder.
• Binge-eating (bulimia nervosa), alongside psycho-therapy, in order to avoid binge-eating and vomiting
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. Oxactin should be offered to a child or young person with moderate to severe major depressive disorder only in combination with psychological therapy.
2. BEFORE YOU TAKE OXACTIN CAPSULES Do not take Oxactin Capsules:
• If you are allergic (hypersensitive) to fluoxetine or to any of the other ingredients of Oxactin Capsules (listed in Section 6) Ifyou 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.
• If you are taking other medicines used to treat depression, known as non-selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include nialamide, iproniazole, selegiline, moclobemide, phenelzine, tranylcypromine, isocarboxazid and toloxatone.
Treatment with Oxactin should only be started 2 weeks after discontinuation of certain reversible MAOIs (for instance moclobemide).
Do not take any MAOIs for at least 5 weeks after you stop taking Oxactin. If Oxactin has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.
• If you have uncontrolled seizures/fits which may result from epilepsy or another seizure disorder
Take special care with Oxactin Capsules
Tell your doctor if any of the following applies to you:
- if you have epilepsy or fits (seizures) or experience an increase in seizure frequency, contact your doctor immediately; Oxactin might need to be discontinued.
- mania now or in the past; if you have a manic episode, contact your doctor immediately because Oxactin might need to be discontinued.
- diabetes (your doctor may need to adjust your dose of insulin or other antidiabetic treatment).
- liver problems (your doctor may need to adjust your dosage).
- heart problems.
- if you are taking diuretics (water tablets), especially if you are elderly;
- if you are having ECT (electro-convulsive therapy) treatment;
- if you have a history of bleeding disorders or you develop bruises or unusual bleeding;
- if you are taking medicines that thin the blood (see taking other medicines)
- if you 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, Oxactin might need to be discontinued.
- if you have 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 this:
• if you have previously had thoughts of killing or harming yourself
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
If you have thoughts about harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it useful 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 that your depression or anxiety disorder is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents aged 8 to 18 years Patients younger than 18 have an increased risk of suicide attempts, suicidal thoughts and hostility (mainly aggression, oppositional behaviour and rage) if they are treated with medicines from this therapeutic class (known as selective serotonin reuptake inhibitors). Oxactin 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 to treat other conditions. 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 Oxactin Capsules to patients younger than 18 years for moderate to severe major depressive episodes in combination with psychological therapy because it is in the patients interest. If your doctor has prescribed Oxactin Capsules to a patient who is younger than 18 years, and you want to discuss this, you are requested to contact your doctor. If one of the symptoms listed above develops or worsens in patients younger than 18 years while they are taking Oxactin Capsules, you are requested to inform your doctor of this.
Oxactin 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 5 weeks ago). This includes medicines obtained without a prescription.
The effects of this medicine may change especially if you are taking:
• Certain Monoamine oxidase inhibitors (MAOI's), a certain type of antidepressant (drug for depression). Non selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) must not be used at the same time as Oxactin. MAO inhibitors type B (e.g. selegiline) can be taken at the same time as Oxactin. Your doctor will keep a close eye on you.
• Phenytoin (for epilepsy). When taken with Oxactin, the amount of phenytoin in the blood can change, which may cause side effects. If necessary, the doctor will adjust the dosage and check you regularly.
• Lithium (for manic depressive disorders) and tryptophan (for depression), which can cause an increased chance of serotonin syndrome. In this, several of the following symptoms occur: raised body temperature, stiffness, muscle twitching, rapid changes in liver function, changes in mental state, such as confusion, irritability and extreme agitation. If you are also taking lithium your doctor will monitor you closely.
• Medicines that can increase the possibility of serotonin syndrome, such as tramadol (a pain-killer), and tryptans (medicines for migraine). Tryptans also increase the chance of side effects.
• Certain drugs that are broken down by the same enzyme as fluoxetine such as flecainide or encainide (for disturbance of heart rhythm), carbamazepine (for epilepsy) and some drugs for depression (the tricyclic antidepressants). The doctor will begin with a low dosage of these drugs, or lower the dosage of fluoxetine. This also applies if you have taken Oxactin in the last 5 weeks.
• Blood-thinning medicines (e.g. acenocoumarol, phenprocoumon and warfarin). The possibility of haemorrhages can increase.
• Medicines that contain St. John's wort (Hypericum perforatum), because there may be an increase in side effects. If you are already taking St John's wort when you start on Oxactin, stop taking St John's wort and tell your doctor at your next visit.
• If you are taking drugs, that affect the blood platelets (e.g. clozapine, phenothiazines, most tricyclic antidepressants [drugs for depression] such as amitriptyline and imipramine, aspirin, and other pain-killers such as ibuprofen) or other medicines that increase the risk of bleeding.
If you are having electro-convulsive therapy (electroshock treatment), which can be used for the treatment of seizures (fits), any seizure that you have may go on for longer than normal. The doctor will monitor you more closely.
Taking Oxactin Capsules with food and drink
• You can take Oxactin with or without food, whatever you prefer
• Oxactin does not increase the effect of alcohol. However, the use of alcohol is not recommended during treatment with Oxactin.
Pregnancy, breast-feeding and fertility
Pregnancy
Talk to your doctor as soon as possible if you're pregnant, if you might be pregnant, or if you are planning to become pregnant. In babies whose mothers took fluoxetine during the first few months of pregnancy, there have been some reports suggesting an increased risk of birth defects affecting the heart. In the general population, about 1 in 100 babies are born with a heart defect. This increased to about 2 in 100 babies in mothers who took fluoxetine. You and your doctor may decide that it is better for you to gradually stop taking fluoxetine while you are pregnant. However, depending on your circumstances, your doctor may suggest that it is better for you to keep taking fluoxetine.Make sure your midwife and/or doctor know you are on Oxactin Capsules. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Oxactin Capsules may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
Breast-feeding
Fluoxetine passes into the breast-milk and can cause adverse effects in babies. If you are breast-feeding your baby, you must consider stopping breast-feeding. Ifyou continue to breast-feed your doctor will prescribe the lowest possible effective dose of fluoxetine. Ask your doctor or pharmacist for advice before taking any medicine.
Fertility
Fluoxetine has been shown to reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
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Driving and using machines
Oxactin 20mg Capsules can cause side effects which may affect concentration and/or co-ordination.Do not drive or operate machines until you are sure that Oxactin has no effect on your ability to drive or use machines.
Important information about some of the ingredients of Oxactin Capsules
This medicine contains lactose. If your doctor has told you that you do not tolerate certain sugars, contact your doctor before you take this medicine.
3. HOWTO TAKE OXACTIN CAPSULES
Always take Oxactin Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The information below is only a guideline: Your doctor will tell you what the correct dose for you is. Do not take more capsules than your doctor tells you.
Swallow the capsules with a drink of water. Do not chew the capsules.
Adults and elderly
Depression:
The recommended dose is 1 capsule (20 mg) per day. After 3 to 4 weeks the doctor may increase the dosage if the effect is not adequate. If required the dosage can be gradually increased up to a maximum of 3 capsules (60mg) daily. 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 medicines for depression. This is usual because an improvement in depressive symptoms may not occur after the first few weeks. Patients with depression should be treated for at least 6 months.
Obsessive compulsive disorder
The recommended dose is 1 capsule (20 mg) per day. After 2 weeks the doctor may review and adjust your dosage. If required, the dosage can be gradually increased up to a maximum of 3 capsules (60mg) daily.
If the treatment has not had any effect after 10 weeks, the doctor will reconsider your treatment.
Binge-eating (bulimia nervosa)
The recommended dosage is 60 mg (3 capsules per day). Children and adolescents aged 8 to 18 years with depression:
Treatment should be started and be supervised by a specialist. The starting dose is 10mg/day. After 1 to 2 weeks, your doctor may increase the dose to 20mg/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 will review the need for continuing treatment beyond 6 months, and treatment will be reassessed if no improvement is seen.
Elderly
For elderly patients the recommended maximum dosage is 40 mg, and in exceptional cases 60 mg per day.
If you notice that Oxactin Capsules are too strong or not strong enough, ask your doctor or pharmacist for advice Liver impairment:
If you have a liver problem or are using other medication that might affect Oxactin, your doctor may decide to prescribe a lower dose or tell you to use Oxactin every other day.
How long should/must you take Oxactin Capsules?
Oxactin, and most other medicines for depression, do not work immediately. You will only notice an effect after about 3 to 4 weeks. Your doctor will tell you how long you must take Oxactin Capsules for.
If you take more Oxactin Capsules than you should
If you have taken too many capsules, you should tell your doctor or go to your local hospital immediately. Take the pack of Oxactin with you if you can.
The following symptoms may occur: nausea, vomiting, fits, disturbances of the heart and blood vessels (ranging from an irregular heart beat to cardiac arrest), disturbances in the action of the lungs and changes in the central nervous system, varying from agitation to coma.
If you forget to take Oxactin Capsules?
If you have forgotten a dose, the effectiveness will usually be maintained. Take the next capsule at the usual time. Do not take a double dose to make up for a forgotten capsule. If you are not sure, ask your doctor or pharmacist.
If you stop using Oxactin Capsules Do not stop taking Oxactin without asking your doctor first, even when you start to feel better. It is important that you keep taking your medicine.
Make sure you do not run out of capsules.
Withdrawal symptoms often occur, especially if you stop suddenly. These symptoms also depend on how much and how long you have used Oxactin. The following symptoms can occur: dizziness; sensory disturbances such as pins and needles for no reason; insomnia, vivid dreams or other sleep disturbances; weakness, irritability or anxiety; nausea and/or vomiting; tremors and headache. These symptoms mostly occur in the first few days after discontinuation of the treatment, and are mild to moderate.
When stopping Oxactin, 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 about the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Oxactin Capsules can cause side effects, although not everybody gets them.
• If you develop a rash/itching or allergic reaction such as swollen lips/tongue/eyelids or difficulty breathing, stop taking the capsules immediately and contact your doctor straight away.
• If you experience restlessness and cannot sit or stand still, you may have something called 'akathisia'; increasing your dose of Oxactin may make these feelings worse. If you feel like this, contact your doctor.
• If your skin starts to peel or blister or you develop a varied skin reaction or redness, you should contact your doctor immediately, although this is very rare.
The following side effects have also been reported:
• a combination of symptoms (known as 'serotonin syndrome") including unexplained fever with quickened breathing and heart rate, sweating, shiver, tremor, confusion, jerking muscles, muscle stiffness, extreme agitation or sleepiness (rarely)
• drowsiness or confusion mostly in elderly people and people taking water tablets (diuretics), feeling of weakness.
• extreme agitation and irritability
• painful and prolonged erection
If you experience any of the side effects listed, you should tell your doctor immediately Body in general
• Tremors
• Overly sensitive to (sun)light
• Very rarely, serotonin syndrome. Symptoms of this syndrome include restlessness, confusion, sweating, delusions (hallucinations), sudden muscle twitching, sudden jerky movements, and cold shivers.
• Very rarely, severe sudden allergic reaction accompanied by fever and blisters on the skin/peeling of the skin.
Digestion
• Gastrointestinal disorders such as diarrhoea, nausea, vomiting, disturbed digestion, swallowing difficulties, changes in taste
• Dry mouth
• Abnormal results of liver function tests
• Inflammation of the liver with yellow discolouration of the skin and eyes
Central nervous system
• Headache
• Sleep disturbances, e.g. insomnia, vivid dreams
• Dizziness
• Lack of appetite
• Fatigue
• Excessive cheerfulness
• Strange movements that do not last for a long time, e.g. tremor, shaking, co-ordination problems, muscle twitching
• Fits
• Rarely, restlessness/not being able to sit still
The following side effects can also be the result of the condition itself:
• Seeing things that are not there (hallucinations)
• Confusion
• Agitation
• Anxiety and nervousness
• Reduced ability to concentrate and think, including alienation from oneself or from one's own feelings
• Panic attacks
• There have been reports of people who have thoughts about, or display behaviour with self-harm or suicidal tendencies during use of Oxactin or just after treatment with Oxactin (see section 2: Take special care with Oxactin Capsules).
Urinary tract
• Incomplete emptying of the bladder
• Having to urinate frequently Reproductive organs
• Delayed or absent ejaculation; inability to have an orgasm
• Prolonged erection
• Secretion of breast-milk Respiration
• Inflammation of the throat
• Shortness of breath
• Rare: reactions in the lungs, including inflammation and formation of connective tissue
Bone Fractures
An increased risk of bone fractures has been observed in patients taking this type of medicines
Other side effects
• Hair loss
• Yawning
• Problems with vision (blurred vision and dilation of the pupils)
• Excessive sweating
• Increase in size of blood vessels, causing redness and warmth of the extremeties, flushing of the face
• Joint pain, muscle pain
• Fall in blood pressure on standing up quickly, sometimes accompanied by dizziness
• Bruising
• Rare: bleeding, e.g. from the vagina, the gastrointestinal tract, or skin/mucous membranes
• Rare: too little sodium in the blood (characterised by confusion or drowsiness); mainly in elderly patients or patients taking water pills.
In children and adolescents (8-18 years) - Oxactin 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.
5. HOW TO STORE OXACTIN CAPSULES
Keep out of the reach and sight of children.
Do not take Oxactin Capsules after the expiry date which is printed on the carton and on the blister strip after EXP The expiry date refers to the last day of the month.
Do not store above 30°C.
If you have any other questions please talk to your doctor or pharmacist.
If your doctor decides to stop treatment, return any left-over capsules to a pharmacist. Only keep them if your doctor tells you to.
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.
6. FURTHER INFORMATION What Oxactin Capsules contain
- The active substance is fluoxetine (as hydrochloride) Each hard capsule contains 20mg fluoxetine (as hydrochloride). The other ingredients are:
Lactose monohydrate, microcrystalline cellulose (E460(i)), magnesium stearate (E572) and crospovidone.
Each capsule shell contains gelatine, yellow and black iron oxide (E172), indigo carmine (E132) and titanium dioxide (E171).
The printing ink contains shellac, black iron oxide (E172) propylene glycol (E1520) and ammonium hydroxide (E527). What Oxactin Capsules look like and contents of the pack
Oxactin 20mg Capsules are olive-coloured/green capsules marked FLE 20.
The capsules are packed in blister packs. A carton contains 10, 14, 20, 28, 30, 50, 60,100, 200, 250, 500 or 1000 hard capsules.
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer The Marketing Authorisation Holder is:
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Hertfordshire, SG4 OTW, United Kingdom.
The Manufacturer is:
Niche Generics Limited, 151 Baldoyle Industrial Estate, Baldoyle, Dublin 13, Ireland.
Niche Generics Limited, 1 The Cam Centre, Wilbury Way, Hitchin, Hertfordshire SG4 OTW, United Kingdom.
Distributed by:
Discovery Pharmaceuticals,
The Old Vicarage, Market Place,
Castle Donington, Derbyshire DE74 2JB, UK.
This Medicinal Product Is Authorised In The Member States Of The EEA Under The Following Names:
Ireland: Biozac 20mg Hard Capsules Germany: Fluxet® 20mg Hartkapseln Netherlands: Fluoxetine Capsules 20mg United Kingdom: Oxactin 20mg Capsules
This leaflet was last approved in: August 2012
Discovery*