DO NOT take Duloxetine if you:

• are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6)
• 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 ‘Other medicines and Duloxetine’)
• are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacin which are used to treat some infections
• are taking other medicines containing duloxetine (see ‘Other medicines and Duloxetine’)

Talk to your doctor if you have high blood pressure or heart disease.

Your doctor will tell you if you should be taking Duloxetine.

Warnings and Precautions

The following are reasons why Duloxetine may not be suitable for you. Talk to your doctor before you take Duloxetine if you:

• are taking other medicines to treat depression (see ‘Other medicines and Duloxetine’)
• 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), especially if you are pregnant (see ‘Pregnancy and breast-feeding’)
• 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 ‘Other medicines and Duloxetine’)

Duloxetine may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.

Medicines like Duloxetine (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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.

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 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.

Children and adolescents under 18 years of age

Duloxetine should normally 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. Despite this, your doctor may prescribe Duloxetine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Duloxetine 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 Duloxetine. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of duloxetine in this age group have not yet been demonstrated.

Other medicines and Duloxetine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The main ingredient of this medicine, 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 Duloxetine 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 Duloxetine if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking a MAOI together with many prescription medicines, including Duloxetine, 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 Duloxetine. Also, you need to wait at least 5 days after you stop taking Duloxetine before you take a MAOI.

Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbital and antihistamines.

Medicines that increase the level of serotonin: Triptans, tramadol, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), pethidine, St John’s Wort, MAOIs (such as moclobemide and linezolid) and buprenorphine. These medicines increase the risk of side effects; if you get any unusual symptoms taking any of these medicines together with Duloxetine, you should see your doctor.

Oral anticoagulants or antiplatelet agents: Medicines which thin the blood or prevent the blood from clotting. These medicines might increase the risk of bleeding.

Duloxetine with food, drink and alcohol

Duloxetine may be taken with or without food. Care should be taken if you drink alcohol while you are being treated with Duloxetine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

• Tell your doctor if you become pregnant, or you are trying to become pregnant, while you are taking Duloxetine. You should use duloxetine 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 Duloxetine. 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 Duloxetine 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.
• If you take Duloxetine near the end of your pregnancy there is an increased risk of excessive vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking duloxetine so they can advise you.
• Available data from the use of Duloxetine during the first three months of pregnancy do not show an increased risk of overall birth defects in general in the child. If Duloxetine is taken during the second half of pregnancy, there may be an increased risk that the infant will be born early (6 additional premature infants for every 100 women who take Duloxetine in the second half of pregnancy), mostly between weeks 35 and 36 of pregnancy.
• Tell your doctor if you are breast-feeding. The use of Duloxetine while breast-feeding is not recommended. You should ask your doctor or pharmacist for advice.

Driving and using machines

Duloxetine may make you feel sleepy or dizzy. Do not drive or use any tools or machines until you know how Duloxetine affects you.

Duloxetine contains sucrose

Duloxetine 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.

Information on sodium content

This medicine contains less than 1mmol sodium (23mg) per capsule, that is to say essentially ‘sodium-free’.