DO NOT take YENTREVE if you:
- are allergic (hypersensitive) to duloxetine or any of the other ingredients of YENTREVE (see ?Further Information?)
- have liver disease
- have severe kidney disease
- are taking or have taken within the last 14 days, another medicine known as a monoamine oxidase inhibitor (MAOI) (see ?Taking other medicines?)
- are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections. Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking YENTREVE.
Take special care with YENTREVE
The following are reasons why YENTREVE may not be suitable for you. Talk to your doctor before you take the medicine if you:
- are taking medicines to treat depression (see ?Taking other medicines?)
- are taking St. John?s Wort, a herbal treatment ( Hypericum perforatum)
- have kidney disease
- have had seizures (fits)
- have had mania
- suffer from bipolar disorder
- have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
- have a history of bleeding disorders (tendency to develop bruises)
- are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly)
- are currently being treated with another medicine which may cause liver damage.
- are taking other medicines containing duloxetine (see ?Taking other medicines?)
YENTREVE may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
Thoughts of suicide and worsening of depression or anxiety disorder
Although YENTREVE is not indicated for the treatment of depression, its active ingredient (duloxetine) is used as an antidepressant medicine. 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 like this if you:
- have previously had thoughts about killing or harming yourself
- 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 youhave 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 havean 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.
Use in children and adolescents under 18 years of age
YENTREVE should not be used for children and adolescents under 18 years. Also, you should know that 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. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of YENTREVE in this age group have not yet been demonstrated.
Taking 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.
The main ingredient of YENTREVE, duloxetine, is used in other medicines for other conditions:
- diabetic neuropathic pain, depression, anxiety and urinary incontinence Using more than one of these medicines at the same time should be avoided. Check with your doctor if you are already taking other medicines containing duloxetine.
Your doctor should decide whether you can take YENTREVE with other medicines. Do not start or stop taking any medicines, including those bought without a prescription and herbal remedies, before checking with your doctor.
You should also tell your doctor if you are taking any of the following:
Monoamine oxidase inhibitors (MAOIs): You should not take YENTREVE if you are taking or have recently taken (within the last 14 days) an antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Taking a MAOI together with many prescription medicines, including YENTREVE, can cause serious or even life-threatening side effects. You must wait at least 14 days after you have stopped taking an MAOI before you can take YENTREVE. Also, you need to wait at least 5 days after you stop taking YENTREVE before you take a MAOI.
Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics,phenobarbital and sedative antihistamines.
Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), tricyclics (such as clomipramine, amitriptyline), pethidine, St John?s Wort and venlafaxine. These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with YENTREVE, you should see your doctor.
Oral anticoagulants: Medicines which thin the blood. These medicines might increase the risk of bleeding.
Taking YENTREVE with food and drink
YENTREVE may be taken with or without food. You should take extra care if you drink alcohol while taking YENTREVE.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
- Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking YENTREVE. You should use YENTREVE only after discussing the potential benefits and any potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on YENTREVE. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (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.
If you take YENTREVE near the end of your pregnancy, your baby might have some symptoms when it is born. These usually begin at birth or within a few days of your baby being born. These symptoms may include floppy muscles, trembling, jitteriness, not feeding properly, trouble with breathing and fits. If your baby has any of these symptoms when it is born, or you are concerned about your baby?s health, contact your doctor or midwife who will be able to advise you.
- Tell your doctor if you are breast-feeding. The use of YENTREVE while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.
Driving and using machines
YENTREVE may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how YENTREVE affects you.
Important information about some of the ingredients of YENTREVE
YENTREVE contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.