Davedax 4mg Tablets
Out of date information, search another1. What Edronax is and what it is used for
2. Before you take Edronax
PACKAGE LEAFLET: INFORMATION FOR THE USER Edronax® 4mg Tablets / Davedax® 4mg Tablets (reboxetine methanesulphonate)
This medicine is available in the above names but will be
referred to as Edronax 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 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 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
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.
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 your doctor if you:
• suffer from convulsions or epilepsy. T reatment 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:
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.
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