FLUOXETINE CAPSULES 20MG
Active substance: FLUOXETINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Fluoxetine Capsules 20 mg
SZ00000LT000
In this leaflet: 1. What Fluoxetine Capsules 20 mg are and what they are used for 2. Before you take Fluoxetine Capsules 20 mg 3. How to take Fluoxetine Capsules 20 mg 4. Possible side effects 5. How to store Fluoxetine Tablets 20 mg 6. Further Information
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. 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.
Your doctor may have prescribed this medicine for a different purpose and/or different dosage from that given in the package leaflet. You must always follow the doctors prescription and the instructions given on the label of the pack.
Fluoxetine Capsules 20 mg are used for: Major depressive episodes Obsessive-compulsive disorder Bulimia nervosa (compulsive eating)
The active ingredient in these capsules, fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Fluoxetine Capsules 20 mg are an antidepressant that influences the central nervous system.
1
What Fluoxetine Capsules 20 mg are and what they are used for
Do not take Fluoxetine Capsules 20 mg If you have had any allergic reaction to fluoxetine or to any of the other ingredients in the product. If you are taking a medicine to treat depression, known as non-selective monoamine oxidase inhibitors (MAOIs), since serious or even fatal reactions can occur. Treatment with Fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI (for example isocarbaxazid, phenelzine and selegeline).
2
Before you take Fluoxetine Capsules 20 mg
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.
Take special care with Fluoxetine Capsules 20 mg If you have diabetes Fluoxetine Capsules 20 mg can raise or lower your blood sugar. The dose of your insulin or the antidiabetes medicine that you take by mouth may need to be adjusted. If you have started having fits (seizures) or have epilepsy which is under control. If you have reduced liver, kidney or heart function or have recently had a heart attack you must tell your doctor, because it may be necessary to prescribe a lower dose for you. If you have or have had mania. If you start to lose weight. If you get an allergic reaction such as itching, rash or swelling of the face, treatment with Fluoxetine Capsules 20 mg must be stopped. If you have a tendency to bleed. If you are taking a herbal preparation containing St. Johns Wort (taking a hypericum perforatum). If you are receiving electric shock treatment.
Do not take any MAOIs for at least 5 weeks after you stop taking fluoxetine. If fluoxetine has been prescribed for a long period and/or at high dose, a longer interval needs to be considered by your doctor.
However, treatment with Fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for example moclobemide).
Pregnancy Talk to your doctor as soon as possible if youre pregnant, if you might be pregnant, or if youre planning to become pregnant.
Pregnancy and breast-feeding Always ask you doctor or pharmacist for advice before taking Fluoxetine Capsules 20 mg.
Alcohol: The combination of Fluoxetine Capsules 20 mg and alcohol is not recommended.
Taking Fluoxetine Capsules 20 mg with food and drink Food: The capsules may be taken with or between meals.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is especially important that you ask your doctor for advice if you are taking medicine to thin the blood (warfarin) other medicine for depression (e.g. tricyclic antidepressants), or medicines containing tryptophan or lithium medicine for epilepsy (e.g. phenytoin or carbamazepine) pain-relieving medicines containing tramadol a natural remedy containing St. Johns Wort (Hypericum perforatum) medicines containing flecainide or encainide (for irregular heart rhythm).
Taking other medicines Certain other medicines can affect or be affected by Fluoxetine Capsules 20 mg. Some of these medicines are: Certain MAO-inhibitors (used to treat depression). Non-selective MAO-inhibitors (e.g. phenelzine) and MAO-inhibitors type A (e.g. moclobemide) must not be used with Fluoxetine Capsules 20 mg as serious or even fatal reactions (serotonin syndrome) can occur. Some MAO-inhibitors type B (selegeline) can be used with Fluoxetine Capsules 20 mg provided that your doctor monitors you closely.
Fluoxetine should normally not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe fluoxetine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed fluoxetine for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking fluoxetine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of fluoxetine in this age group have not yet been demonstrated.
Use in children and adolescents under 18 years of age:
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.
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 adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Continued on the next page >>
Driving and using machines Fluoxetine can impair judgement, thinking capacity and motor skills. This should be taken into account in situations where increased alertness is necessary, e.g. when driving or operating hazardous machinery.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding Fluoxetine is excreted in breast milk and can cause side effects. You should only breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower dose of fluoxetine.
Additional caution should be exercised especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistant crying and difficulty in suckling or in sleeping.
Make sure your midwife and/or doctor know you are taking fluoxetine. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like fluoxetine 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.
In babies whose mothers took fluoxetine during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those 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.
Urogenital system Difficulty passing urine or passing urine too frequently.
Nervous system Headache, sleep problems or unusual dreams, dizziness, loss of appetite, tiredness, abnormally high mood, uncontrolled movement, fits, extreme restlessness, hallucinations, untypical wild behaviour, confusion, agitation, anxiety, nervousness, not being able to concentrate or think properly, panic attacks, thoughts of suicide or harming yourself.
Digestive system Diarrhoea, nausea, vomiting, indigestion, difficulty swallowing or a change in taste, dry mouth. Abnormal liver function tests have been reported rarely, with very rare cases of hepatitis.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Other Hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, joint or muscle pain, low levels of sodium in the blood.
Respiratory system Sore throat, shortness of breath. Lung problems (including inflammatory processes of varying histopathology and/or fibrosis) have been reported rarely.
Other Hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, joint or muscle pain, low levels of sodium in the blood.
Reproductive disorder Poor sexual performance, prolonged erections, producing breastmilk.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Fluoxetine Capsules 20 mg Do not discontinue the treatment without consulting your doctor. When you stop taking Fluoxetine Capsules 20 mg, withdrawal reactions, e.g. headache, nausea, anxiety and dizziness, can occur. These disorders are mild and temporary. When stopping treatment with Fluoxetine Capsules 20 mg, your doctor will help you to reduce the dose slowly over one or two weeks in order to reduce the risk of withdrawal reactions.
If you forget to take Fluoxetine Capsules 20 mg Do not take a double dose to make up for a forgotten dose.
If you take more Fluoxetine Capsules 20 mg than you should When you have taken too much Fluoxetine than you should contact your doctor or a hospital. Symptoms of overdose: Nausea, vomiting, seizures, anxiety, restlessness and excessive cheerfulness.
Bulimia: 3 capsules daily (60 mg)
Obsessive thoughts and obsessive actions (OCD): Between 1 and 3 capsules daily (20 60 mg)
The usual dose is: Depression: 1 capsule daily (20 mg)
Take Fluoxetine Capsules 20 mg with water.
Always take Fluoxetine Capsules 20 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3
How to take Fluoxetine Capsules 20 mg
Children: keep out of the reach and sight of children Use by date: do not use fluoxetine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month Disposal: 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.
5 6
How to store Fluoxetine Capsules 20 mg
Further information
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist. Body as a whole Rash or allergic reaction, chills, sensitivity to sunlight, weight loss.
Like all medicines, Fluoxetine Capsules 20 mg can cause side effects, although not everybody gets them.
4
or or
Manufacturers Actavis HF, Reykjavikurvegi 78, IS-222, Hafnarf Jordur, Iceland
Marketing Authorisation Holder Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Fluoxetine Capsules 20 mg come in Aluminium/PVC blister strip packs of 28 and 30 capsules.
What Fluoxetine Capsules 20 mg look like and the contents of the pack Fluoxetine Capsules 20 mg are light green opaque capsules marked with F20 and contain an almost white powder.
The other ingredients are pregelatinised maize starch, anhydrous colloidal silica, magnesium stearate, talc, quinoline yellow (E104), indigo carmine (E132), titanium dioxide (E171) and gelatin.
What Fluoxetine Capsules 20 mg contain The active substance is fluoxetine hydrochloride equivalent to 20 mg fluoxetine.
Delta Limited, Borgartun 6, Reykjavik, IS-105, Iceland
Possible side effects
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. This leaflet was last approved in 08/2010 (to be amended after approval).
or
Karib Kemi-Pharm Limited, Karib House, 63-65 Imperial Way, Croydon, Surrey, CR0 4RR, United Kingdom
SZ00000LT000
Fluoxetine Capsules 20 mg
SZ00000LT000
In this leaflet: 1. What Fluoxetine Capsules 20 mg are and what they are used for 2. Before you take Fluoxetine Capsules 20 mg 3. How to take Fluoxetine Capsules 20 mg 4. Possible side effects 5. How to store Fluoxetine Tablets 20 mg 6. Further Information
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. 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.
Your doctor may have prescribed this medicine for a different purpose and/or different dosage from that given in the package leaflet. You must always follow the doctors prescription and the instructions given on the label of the pack.
Fluoxetine Capsules 20 mg are used for: Major depressive episodes Obsessive-compulsive disorder Bulimia nervosa (compulsive eating)
The active ingredient in these capsules, fluoxetine belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Fluoxetine Capsules 20 mg are an antidepressant that influences the central nervous system.
1
What Fluoxetine Capsules 20 mg are and what they are used for
Do not take Fluoxetine Capsules 20 mg If you have had any allergic reaction to fluoxetine or to any of the other ingredients in the product. If you are taking a medicine to treat depression, known as non-selective monoamine oxidase inhibitors (MAOIs), since serious or even fatal reactions can occur. Treatment with Fluoxetine should only be started 2 weeks after discontinuation of an irreversible MAOI (for example isocarbaxazid, phenelzine and selegeline).
2
Before you take Fluoxetine Capsules 20 mg
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.
Take special care with Fluoxetine Capsules 20 mg If you have diabetes Fluoxetine Capsules 20 mg can raise or lower your blood sugar. The dose of your insulin or the antidiabetes medicine that you take by mouth may need to be adjusted. If you have started having fits (seizures) or have epilepsy which is under control. If you have reduced liver, kidney or heart function or have recently had a heart attack you must tell your doctor, because it may be necessary to prescribe a lower dose for you. If you have or have had mania. If you start to lose weight. If you get an allergic reaction such as itching, rash or swelling of the face, treatment with Fluoxetine Capsules 20 mg must be stopped. If you have a tendency to bleed. If you are taking a herbal preparation containing St. Johns Wort (taking a hypericum perforatum). If you are receiving electric shock treatment.
Do not take any MAOIs for at least 5 weeks after you stop taking fluoxetine. If fluoxetine has been prescribed for a long period and/or at high dose, a longer interval needs to be considered by your doctor.
However, treatment with Fluoxetine can be started the following day after discontinuation of certain reversible MAOIs (for example moclobemide).
Pregnancy Talk to your doctor as soon as possible if youre pregnant, if you might be pregnant, or if youre planning to become pregnant.
Pregnancy and breast-feeding Always ask you doctor or pharmacist for advice before taking Fluoxetine Capsules 20 mg.
Alcohol: The combination of Fluoxetine Capsules 20 mg and alcohol is not recommended.
Taking Fluoxetine Capsules 20 mg with food and drink Food: The capsules may be taken with or between meals.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
It is especially important that you ask your doctor for advice if you are taking medicine to thin the blood (warfarin) other medicine for depression (e.g. tricyclic antidepressants), or medicines containing tryptophan or lithium medicine for epilepsy (e.g. phenytoin or carbamazepine) pain-relieving medicines containing tramadol a natural remedy containing St. Johns Wort (Hypericum perforatum) medicines containing flecainide or encainide (for irregular heart rhythm).
Taking other medicines Certain other medicines can affect or be affected by Fluoxetine Capsules 20 mg. Some of these medicines are: Certain MAO-inhibitors (used to treat depression). Non-selective MAO-inhibitors (e.g. phenelzine) and MAO-inhibitors type A (e.g. moclobemide) must not be used with Fluoxetine Capsules 20 mg as serious or even fatal reactions (serotonin syndrome) can occur. Some MAO-inhibitors type B (selegeline) can be used with Fluoxetine Capsules 20 mg provided that your doctor monitors you closely.
Fluoxetine should normally not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side effects, such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe fluoxetine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed fluoxetine for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking fluoxetine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of fluoxetine in this age group have not yet been demonstrated.
Use in children and adolescents under 18 years of age:
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.
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 adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Continued on the next page >>
Driving and using machines Fluoxetine can impair judgement, thinking capacity and motor skills. This should be taken into account in situations where increased alertness is necessary, e.g. when driving or operating hazardous machinery.
Ask your doctor or pharmacist for advice before taking any medicine.
Breast-feeding Fluoxetine is excreted in breast milk and can cause side effects. You should only breast-feed if it is clearly necessary. If breast-feeding is continued, your doctor may prescribe a lower dose of fluoxetine.
Additional caution should be exercised especially during late pregnancy or just before giving birth since the following effects have been reported in new born children: irritability, tremor, muscle weakness, persistant crying and difficulty in suckling or in sleeping.
Make sure your midwife and/or doctor know you are taking fluoxetine. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like fluoxetine 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.
In babies whose mothers took fluoxetine during the first few months of pregnancy, there have been some reports showing an increased risk of birth defects, in particular those 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.
Urogenital system Difficulty passing urine or passing urine too frequently.
Nervous system Headache, sleep problems or unusual dreams, dizziness, loss of appetite, tiredness, abnormally high mood, uncontrolled movement, fits, extreme restlessness, hallucinations, untypical wild behaviour, confusion, agitation, anxiety, nervousness, not being able to concentrate or think properly, panic attacks, thoughts of suicide or harming yourself.
Digestive system Diarrhoea, nausea, vomiting, indigestion, difficulty swallowing or a change in taste, dry mouth. Abnormal liver function tests have been reported rarely, with very rare cases of hepatitis.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Other Hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, joint or muscle pain, low levels of sodium in the blood.
Respiratory system Sore throat, shortness of breath. Lung problems (including inflammatory processes of varying histopathology and/or fibrosis) have been reported rarely.
Other Hair loss, yawning, blurred vision, unexplained bruising or bleeding, sweating, hot flushes, feeling dizzy when you stand up, joint or muscle pain, low levels of sodium in the blood.
Reproductive disorder Poor sexual performance, prolonged erections, producing breastmilk.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Fluoxetine Capsules 20 mg Do not discontinue the treatment without consulting your doctor. When you stop taking Fluoxetine Capsules 20 mg, withdrawal reactions, e.g. headache, nausea, anxiety and dizziness, can occur. These disorders are mild and temporary. When stopping treatment with Fluoxetine Capsules 20 mg, your doctor will help you to reduce the dose slowly over one or two weeks in order to reduce the risk of withdrawal reactions.
If you forget to take Fluoxetine Capsules 20 mg Do not take a double dose to make up for a forgotten dose.
If you take more Fluoxetine Capsules 20 mg than you should When you have taken too much Fluoxetine than you should contact your doctor or a hospital. Symptoms of overdose: Nausea, vomiting, seizures, anxiety, restlessness and excessive cheerfulness.
Bulimia: 3 capsules daily (60 mg)
Obsessive thoughts and obsessive actions (OCD): Between 1 and 3 capsules daily (20 60 mg)
The usual dose is: Depression: 1 capsule daily (20 mg)
Take Fluoxetine Capsules 20 mg with water.
Always take Fluoxetine Capsules 20 mg exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3
How to take Fluoxetine Capsules 20 mg
Children: keep out of the reach and sight of children Use by date: do not use fluoxetine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month Disposal: 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.
5 6
How to store Fluoxetine Capsules 20 mg
Further information
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell you doctor or pharmacist. Body as a whole Rash or allergic reaction, chills, sensitivity to sunlight, weight loss.
Like all medicines, Fluoxetine Capsules 20 mg can cause side effects, although not everybody gets them.
4
or or
Manufacturers Actavis HF, Reykjavikurvegi 78, IS-222, Hafnarf Jordur, Iceland
Marketing Authorisation Holder Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Fluoxetine Capsules 20 mg come in Aluminium/PVC blister strip packs of 28 and 30 capsules.
What Fluoxetine Capsules 20 mg look like and the contents of the pack Fluoxetine Capsules 20 mg are light green opaque capsules marked with F20 and contain an almost white powder.
The other ingredients are pregelatinised maize starch, anhydrous colloidal silica, magnesium stearate, talc, quinoline yellow (E104), indigo carmine (E132), titanium dioxide (E171) and gelatin.
What Fluoxetine Capsules 20 mg contain The active substance is fluoxetine hydrochloride equivalent to 20 mg fluoxetine.
Delta Limited, Borgartun 6, Reykjavik, IS-105, Iceland
Possible side effects
Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. This leaflet was last approved in 08/2010 (to be amended after approval).
or
Karib Kemi-Pharm Limited, Karib House, 63-65 Imperial Way, Croydon, Surrey, CR0 4RR, United Kingdom
SZ00000LT000
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
