Edronax 4mg Tablets
Out of date information, search anotherAssessed against UK PIL dated November 2008
EDRONAX® 4MG TABLETS / REBOXETINE 4MG TABLETS
(reboxetine methanesulphonate)
By Ibrahim Karir at 11:12 am, Mar 06, 2009
Your doctor will tell you w.e.
Tablets 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.
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using one of the above two names, but will be referred to as Edronax 4mg Tablets throughout this leaflet.
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 your 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.
In this leaflet:
1. What Edronax 4mg Tablets are and what they are used for
2. Before you take Edronax 4mg Tablets
3. How to take Edronax 4mg Tablets
4. Possible side effects
5. How to store Edronax 4mg Tablets
6. Further information
1. What Edronax 4mg Tablets are and what they are used for
The active substance in Edronax 4mg Tablets is reboxetine which is part of a group of medicines called antidepressants. Edronax 4mg Tablets are 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 4mg Tablets
Do not take Edronax 4mg Tablets
■ if you are allergic (hypersensitive) to reboxetine or any of the other ingredients of Edronax 4mg Tablets. For a full list of excipients, see section 6.
Take special care with Edronax 4mg Tablets
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, increased pressure in the eyes (glaucoma) 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 medicines for depression such as MAO inhibitors, tricyclics, nefazodone, SSRIs (such as fluvoxamine) or lithium.
■ ever had episodes of mania (overactive behaviour or thoughts).
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:
Edronax 4mg Tablets should normally not be used for children and adolescents under 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 4mg Tablets to a patient under 18 if it is in the patient's interest. If your doctor has prescribed Edronax 4mg Tablets 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 4mg Tablets, you should inform your doctor.
Also, the long-term safety of Edronax 4mg Tablets 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 4mg Tablets 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
■ 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
■ Any potassium-losing diuretics (medicines for eliminating water), e.g. thiazides
Taking Edronax 4mg Tablets with food and drink
Edronax 4mg Tablets can be taken with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Pregnancy
There are no adequate experiences from the use of Edronax 4mg Tablets in pregnant women. Do not take Edronax 4mg Tablets 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 planning to become pregnant.
Breast-feeding
Edronax 4mg Tablets 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 4mg Tablets.
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 4mg Tablets, and that it is safe to do so.
3. How to take Edronax 4mg Tablets
■ For adults the usual dose is 8mg 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 4mg per day. This may be increased depending on the individual response.
■ The use of Edronax 4mg Tablets cannot be recommended for elderly patients.
■ Edronax 4mg Tablets 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 4mg Tablets, you may find it easier to take your tablets at the same time every day.
Always take Edronax 4mg Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Like other drugs Edronax 4mg Tablets 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 4mg Tablets 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 4mg Tablets than you should, you may experience symptoms of overdose including low blood pressure, anxiety and hypertension.
If you forget to take Edronax 4mg Tablets
If you forget to take Edronax 4mg Tablets, 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 4mg Tablets
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 4mg Tablets.
4. Possible side effects
Like all medicines, Edronax 4mg Tablets can cause side effects, although not everybody gets them. With Edronax 4mg Tablets 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)
■ Difficult to sleep (insomnia)
■ Dry mouth
■ Constipation
■ Sweating
Common side effects (less than one in 10 patients)
■ Headache
■ Spinning sensation
■ Increased heart rate, palpitation (heart pounding), widened
blood vessels, fall in blood pressure when standing up
■ Lack of visual focus
■ Lack or loss of appetite, nausea (feeling sick)
■ Sensation of incomplete emptying or slowed emptying of the bladder, urinary infection
■ Erection disorders, ejaculatory or testicular pain, or
ejaculatory delay
■ Chills
Additionally agitation, anxiety, irritability, aggressive behaviour, hallucination, cold extremities, nausea, vomiting, paraesthesia (pins and needles), increased blood pressure allergic skin inflammation or rash have been spontaneously reported.
5. How to store Edronax 4mg Tablets
■ Do not take your Edronax 4mg Tablets after the expiry date given on the carton or blister label.
■ Do not store Edronax 4mg Tablets above 25°C.
■ Keep out of the reach and sight of children.
If your medicine becomes discoloured or shows any other sign of deterioration, you should ask your pharmacist who will advise you what to do.
If you have any left over/unused medicine, please return this to your pharmacist for safe 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.
6. Further information
What Edronax 4mg Tablets contain:
The active substance is reboxetine.
■ Each tablet contains 4 mg of reboxetine as methanesulphonate.
Each tablet also contains:
■ Microcrystalline cellulose, calcium hydrogen phosphate dihydrate, crospovidone, colloidal hydrated silica and magnesium stearate.
What Edronax 4mg Tablets look like and contents of the pack:
Each tablet is round, convex with a breakline on one side. A 'P' marked on the left side of the breakline. A 'U' will be marked on the right side of the breakline. The side opposite the breakline is marked '7671'.
Edronax 4mg Tablets are available in packs of 60 tablets in blister strips.
iPOMl PL No: 08929/0100
Manufacturer:
This product is manufactured by: Pfizer Italia S.r.l, Borgo San Michele (LT), Italy and is procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
The Product Licence holder is: BR Lewis Pharmaceuticals Ltd,
Kirk Sandall, Doncaster, DN3 1QR.
Leaflet revision and issue date (Ref): 05.03.09
Edronax® is a registered trademark of Pharmacia Italia S.p.A.
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