Edronax 4 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Edronax® 4 mg Tablets
(reboxetine as methanesulphonate)
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.
The name of you medicine is Edronax 4 mg Tablets but it will be referred as Edronax thoughout the leaflet.
In this leaflet:
1. What Edronax is and what it is used for
2. Before you take Edronax
3. How to take Edronax
4. Possible side effects
5. How to store Edronax
6. Further information
1. WHAT EDRONAX IS AND WHAT IT IS USED FOR
The active substance in Edronax is reboxetine which is part of a group of medicines called antidepressants. Edronax is used in acute treatment of depressive illness / major depression as well as for maintaining the improvement of your symptoms when you have initially responded to treatment with reboxetine.
2. BEFORE YOU TAKE EDRONAX Do not take Edronax
• if you are allergic (hypersensitive) to reboxetine or any of the other ingredients of Edronax. For a full list of excipients, see section 6.
Take special care with Edronax Tell vour doctor if you:
• suffer from convulsions or epilepsy. Treatment with Edronax should be stopped if seizures occur.
• have any signs of urinary problems, enlarged prostate or a history of heart problems.
• are taking medicines to lower your blood pressure.
• have liver or kidney problems. Your doctor may need to adjust your dosage.
• are taking any other medicine for depression such as MAO inhibitors, tricyclics, nefazodone, SSRIs (such as fluvoxamine) or lithium.
• are taking other MAO inhibitors such as linezolid (an antibiotic) or methylene blue (see section “Taking other medicines”).
• ever had episodes of mania (overactive behaviour or thoughts).
• have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
Thoughts of suicide and worsening of vour depression:
If you are depressed 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 adults aged less than 25 years 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, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents:
Edronax should not usually be used in children and adolescents less than 18 years old. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines.
Nevertheless, it is possible that your doctor decides to prescribe Edronax to a patient under 18 if it is in the patient's interest. If your doctor has prescribed Edronax to a patient less than 18 years old and you want to discuss this, please contact him/her.
Furthermore, if any of the symptoms listed above appear or worsen when a patient under 18 is taking Edronax, you should inform your doctor.
Also, the long-term safety of Edronax in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.
Taking other medicines
Given that Edronax may interact with other medicines, tell your doctor if you are taking the following medicines:
• Certain antifungals, e.g. ketoconazole
• Certain antibiotics, e.g. erythromycin, rifampicin.
• Medicines called ergot derivatives used to treat migraine or Parkinson’s disease
• Certain antidepressants called MAO inhibitors, tricyclics, nefazodone, SSRIs (such as fluvoxamine) or lithium
• Other MAO inhibitors such as linezolid (an antibiotic) and methylene blue (used to treat high levels of methaemoglobin in the blood)
• Any potassium-losing diuretics (medicines for eliminating water), e.g. thiazides
• Medicines used to treat epilepsy e.g. phenobarbital, carbamazepine and phenytoin
• Herbal medicines containing St. John’s Wort (Hypericum perforatum)
Your doctor will tell you whether you can take Edronax with 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, herbal medicines, as well as vitamins and minerals.
Taking Edronax with food and drink Edronax can be taken with or without food.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are no adequate experiences from the use of Edronax in pregnant women.
Do not take Edronax if you are pregnant, unless your doctor considers it absolutely necessary, following a careful clinical risk/benefit consideration. Tell your doctor immediately if you are pregnant or are planning to become pregnant.
Breast-feeding
Edronax passes into the breast milk in small amounts. There is a risk of a potential effect on the baby. Therefore, you should discuss the matter with your doctor and he/she will decide whether you should stop breast-feeding or stop the therapy with Edronax.
Driving and using machines
Caution is recommended when driving or using machines.
You should not drive or operate machinery until you know you are not affected (i.e. feel drowsy) by Edronax, and that it is safe to do so.
3. HOW TO TAKE EDRONAX
• For adults the usual dose is 8 mg a day (one 4mg tablet twice a day). Based on how you respond to the medicine, after 3 to 4 weeks your doctor may tell you to take up to 10mg per day if necessary. The maximum daily dose should not exceed 12mg.
• In patients with poor kidney or liver function, the starting dose is 4 mg per day.
This may be increased depending on the individual response.
• The use of Edronax 4 mg tablets cannot be recommended for elderly patients.
• Edronax should not be used in children and adolescents under 18 years.
The tablets should be taken in two divided doses, one dose in the morning and one in the evening. You should swallow your tablet whole with a glass of water. Do not chew the tablet.
To help you remember to take Edronax, you may find it easier to take your tablets at the same time every day.
Always take Edronax exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Like other drugs Edronax will not relieve your symptoms immediately. You should start to feel better within a few weeks.
It is important that you continue to take your tablets, even though you feel better, until your doctor advises you to stop. Please be patient, if you stop taking your tablets too early, your symptoms might come back.
If you take more Edronax than you should
You should never take more tablets than your doctor recommends. If you take too many tablets, contact your doctor or local hospital immediately. If you take more Edronax than you should, you may experience symptoms of overdose including low blood pressure, anxiety and hypertension.
If you forget to take Edronax
If you forget to take Edronax, take your next dose at the normal time. Do not take a double dose to make up for a forgotten tablet.
If you intend to stop Edronax
You should not stop your medicine without talking to your doctor, as your symptoms may come back. There have been a few reports of withdrawal symptoms including headache, dizziness, nervousness and nausea, (feeling sick), when patients stopped treatment with Edronax.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Edronax can cause side effects, although not everybody gets them. With Edronax most side effects are mild and usually go away after the first few weeks of treatment.
If any of the side effects below gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common side effects (more than one in 10 patients)
• Difficulties to sleep (insomnia)
• Dizziness,
• Dry mouth
• Constipation
• Nausea (feeling sick)
• Sweating
Common side effects (less than one in 10 patients)
• Headache
• Lack or loss of appetite
• Agitation, anxiety
• Paraesthesia (pins and needles), inability to sit or stand still, altered taste sensation
• Lack of visual focus
• Increased heart rate, palpitation (heart pounding)
• Widened blood vessels, fall in blood pressure when standing up, increased blood pressure
• Vomiting
• Rash
• Sensation of incomplete emptying or slowed emptying of the bladder, urinary infection, painful urination, inability to completely empty the bladder
• Erectile dysfunction (impotence), ejaculatory pain, or ejaculatory delay
• Chills
Uncommon side effects (between 1 and 10 out of 1000 patients)
• Dilated pupils
• Spinning sensation
Rare side effects (between 1 and 10 out of 10000 patients)
• Glaucoma (a condition resulting in increased pressure in the eye)
After marketing Edronax, the following side effects have been reported:
• Hyponatremia (very low levels of sodium in the blood)
• Aggressive behaviour, hallucination
• Suicidal ideation, suicidal behaviour
Cases of suicidal ideation and suicidal behaviours have been reported during reboxetine therapy or early after treatment discontinuation (see section 2 “Take special care with Edronax”)
• Cold extremities, Raynaud’s phenomenon (poor blood circulation to the extremities usually in the toes and fingers but could also affect nose and ears, the skin turns pale and becomes cold and numb)
• Allergic skin inflammation
• Testicular pain
• Irritability
• Increased pressure in the eye Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.qov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE EDRONAX
• Do not store Edronax above 25°C.
• Keep out of the sight and reach of children.
• Do not use Edronax after the expiry date which is stated on the carton or the bottle. The expiry date refers to the last day of that month.
• If the medicine gets discoloured or shows any other signs to deterioration seek the advice of your pharmacist.
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 Edronax contains:
The active substance is reboxetine.
• Each tablet contains 4mg of reboxetine (as methanesulphonate)
The other ingredients are:
• Cellulose microcrystalline, calcium hydrogen phosphate dihydrate, crospovidone, colloidal hydrated silica and magnesium stearate.
What Edronax looks like and contents of the pack:
Edronax are white, round, convex tablets with a breakline. A ‘P’ is marked on the left side of the breakline and a ‘U’ is marked on the right side. The side opposite the breakline is marked “7671”. Edronax tablets are available in blister packs 60 tablets.
Manufactured by: Pfizer Italia S.r.l. - 63100 Localita Marino Del Tronto - Ascoli Piceno Italy.
Procured from within the EU & repackaged by PL holder: Kosei Pharma UK Ltd,
956 Buckingham Avenue, Slough, SL1 4NL, UK
POM
PL: 39352/0096; Edronax® 4 mg Tablets,
This medicinal product is authorised under the name Edronax in Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Luxembourg, Portugal, Sweden and United Kingdom. It is also authorised in Spain under the name Norebox.
Leaflet date: 30.04.2015
Edronax® is a registered trademark of Pfizer Ltd.
Reboxetine 4 mg Tablets
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.
The name of your medicine is Reboxetine 4 mg tablets but it will be referred as Reboxetine throughout the leaflet.
In this leaflet:
1. What Reboxetine is and what it is used for
2. Before you take Reboxetine
3. How to take Reboxetine
4. Possible side effects
5. How to store Reboxetine
6. Further information
1. WHAT REBOXETINE IS AND WHAT IT IS USED FOR
The active substance in Reboxetine is reboxetine which is part of a group of medicines called antidepressants. Reboxetine is used in acute treatment of depressive illness / major depression as well as for maintaining the improvement of your symptoms when you have initially responded to treatment with reboxetine.
2. BEFORE YOU TAKE REBOXETINE Do not take Reboxetine
• if you are allergic (hypersensitive) to reboxetine or any of the other ingredients of Reboxetine. For a full list of excipients, see section 6.
Take special care with Reboxetine
Tell your doctor if you:
• Suffer from convulsions or epilepsy. Treatment with Reboxetine should be stopped if seizures occur.
• Have any signs of urinary problems, enlarged prostate or a history of heart problems.
• Are taking medicines to lower your blood pressure.
• Have liver or kidney problems. Your doctor may need to adjust your dosage.
• Are taking any other medicine for depression such as MAO inhibitors, tricyclics, nefazodone,
SSRIs (such as fluvoxamine) or lithium.
• are taking other MAO inhibitors such as linezolid (an antibiotic) or methylene blue (see section “Taking other medicines”).
• ever had episodes of mania (overactive behaviour or thoughts).
• have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
Thoughts of suicide and worsening of your depression:
If you are depressed 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 adults aged less than 25 years 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, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents:
Reboxetine should not usually be used in children and adolescents less than 18 years old. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines.
Nevertheless, it is possible that your doctor decides to prescribe Reboxetine to a patient under 18 if it is in the patient's interest. If your doctor has prescribed Reboxetine to a patient less than 18 years old and you want to discuss this, please contact him/her.
Furthermore, if any of the symptoms listed above appear or worsen when a patient under 18 is taking Reboxetine, you should inform your doctor.
Also, the long-term safety of Reboxetine in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.
Taking other medicines
Given that Reboxetine may interact with other medicines, tell your doctor if you are taking the following medicines:
• Certain antifungals, e.g. ketoconazole
• Certain antibiotics, e.g. erythromycin, rifampicin.
• Medicines called ergot derivatives used to treat migraine or Parkinson’s disease
• Certain antidepressants called MAO inhibitors, tricyclics, nefazodone, SSRIs (such as fluvoxamine) or lithium
• Other MAO inhibitors such as linezolid (an antibiotic) and methylene blue (used to treat high levels of methaemoglobin in the blood)
• Any potassium-losing diuretics (medicines for eliminating water), e.g. thiazides
• Medicines used to treat epilepsy e.g. phenobarbital, carbamazepine and phenytoin
• Herbal medicines containing St. John’s Wort (Hypericum perforatum)
Your doctor will tell you whether you can take Reboxetine with 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, herbal medicines, as well as vitamins and minerals.
Taking Reboxetine with food and drink Reboxetine can be taken with or without food.
Pregnancy and Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
There are no adequate experiences from the use of Reboxetine in pregnant women.
Do not take Reboxetine if you are pregnant, unless your doctor considers it absolutely necessary, following a careful clinical risk/benefit consideration. Tell your doctor immediately if you are pregnant or are planning to become pregnant.
Breast-feeding
Reboxetine passes into the breast milk in small amounts. There is a risk of a potential effect on the baby. Therefore, you should discuss the matter with your doctor and he/she will decide whether you should stop breast-feeding or stop the therapy with Reboxetine.
Driving and using machines
Caution is recommended when driving or using machines.
You should not drive or operate machinery until you know you are not affected (i.e. feel drowsy) by Reboxetine, and that it is safe to do so.
3. HOW TO TAKE REBOXETINE
• For adults the usual dose is 8 mg a day (one 4mg tablet twice a day). Based on how you respond to the medicine, after 3 to 4 weeks your doctor may tell you to take up to 10mg per day if necessary. The maximum daily dose should not exceed 12mg.
• In patients with poor kidney or liver function, the starting dose is 4 mg per day.
• This may be increased depending on the individual response.
• The use of Reboxetine 4 mg tablets cannot be recommended for elderly patients.
• Reboxetine should not be used in children and adolescents under 18 years.
The tablets should be taken in two divided doses, one dose in the morning and one in the evening.
You should swallow your tablet whole with a glass of water. Do not chew the tablet.
To help you remember to take Reboxetine, you may find it easier to take your tablets at the same time every day.
Always take Reboxetine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Like other drugs Reboxetine will not relieve your symptoms immediately. You should start to feel better within a few weeks.
It is important that you continue to take your tablets, even though you feel better, until your doctor advises you to stop. Please be patient, if you stop taking your tablets too early, your symptoms might come back.
If you take more Reboxetine than you should
You should never take more tablets than your doctor recommends. If you take too many tablets, contact your doctor or local hospital immediately. If you take more Reboxetine than you should, you may experience symptoms of overdose including low blood pressure, anxiety and hypertension.
If you forget to take Reboxetine
If you forget to take Reboxetine, take your next dose at the normal time. Do not take a double dose to make up for a forgotten tablet.
If you intend to stop Reboxetine
You should not stop your medicine without talking to your doctor, as your symptoms may come back. There have been a few reports of withdrawal symptoms including headache, dizziness, nervousness and nausea, (feeling sick), when patients stopped treatment with Reboxetine.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Reboxetine can cause side effects, although not everybody gets them. With Reboxetine most side effects are mild and usually go away after the first few weeks of treatment.
If any of the side effects below gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common side effects (more than one in 10 patients)
• Difficulties to sleep (insomnia)
• Dizziness
• Dry mouth
• Constipation
• Nausea (feeling sick)
• Sweating
Common side effects (less than one in 10 patients)
• Headache
• Lack or loss of appetite
• Agitation, anxiety
• Paraesthesia (pins and needles), inability to sit or stand still, altered taste sensation
• Lack of visual focus
• Increased heart rate, palpitation (heart pounding)
• Widened blood vessels, fall in blood pressure when standing up, increased blood pressure
• Vomiting
• Rash
• Sensation of incomplete emptying or slowed emptying of the bladder, urinary infection, painful urination, inability to completely empty the bladder
• Erectile dysfunction (impotence), ejaculatory pain, or ejaculatory delay
• Chills
Uncommon side effects (between 1 and 10 out of 1000 patients)
• Dilated pupils
• Spinning sensation
Rare side effects (between 1 and 10 out of 10000 patients)
• Glaucoma (a condition resulting in increased pressure in the eye)
After marketing Edronax, the following side effects have been reported:
• Hyponatremia (very low levels of sodium in the blood)
• Aggressive behaviour, hallucination
• Suicidal ideation, suicidal behaviour
Cases of suicidal ideation and suicidal behaviours have been reported during reboxetine therapy or early after treatment discontinuation (see section 2 “Take special care with Edronax”)
• Cold extremities, Raynaud’s phenomenon (poor blood circulation to the extremities usually in the toes and fingers but could also affect nose and ears, the skin turns pale and becomes cold and numb)
• Allergic skin inflammation
• Testicular pain
• Irritability
• Increased pressure in the eye Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.aov.uk/vellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE REBOXETINE
• Do not store Reboxetine above 25°C.
• Keep out of the sight and reach of children.
• Do not use Reboxetine after the expiry date which is stated on the carton or the bottle. The expiry date refers to the last day of that month.
• If the medicine gets discoloured or shows any other signs to deterioration seek the advice of your pharmacist.
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 Reboxetine contains:
The active substance is reboxetine.
• Each tablet contains 4mg of reboxetine (as methanesulphonate)
The other ingredients are:
• cellulose microcrystalline, calcium hydrogen phosphate dihydrate, crospovidone, colloidal hydrated silica and magnesium stearate.
What Reboxetine looks like and contents of the pack:
Reboxetine are white, round, convex tablets with a breakline. A ‘P’ is marked on the left side of the breakline and a ‘U’ is marked on the right side. The side opposite the breakline is marked “7671”.
Reboxetine tablets are available in blisters packs of 60 tablets.
Manufactured by: Pfizer Italia S.r.l. - 63100 Localita Marino Del Tronto - Ascoli Piceno Italy.
Procured from within the EU & repackaged by PL holder:
POM
Kosei Pharma UK Ltd, 956 Buckingham Avenue, Slough, SL1 4NL, UK
PL: 39352/0096; Reboxetine 4 mg Tablets,
Leaflet date: 30.04.2015