• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Duloxetine Neuraxpharm capsules are and what they are used for
2. What you need to know before you take Duloxetine Neuraxpharm capsules
3. How to take Duloxetine Neuraxpharm capsules
4. Possible side effects
5. How to store Duloxetine Neuraxpharm capsules
6. Contents of the pack and other information

• 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 Neuraxpharm capsules’)
• 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 Neuraxpharm capsules’)

Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking Duloxetine Neuraxpharm.

You should also contact your doctor:

If you experience signs and symptoms of restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting, as you might be suffering a serotonin syndrome.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, fast heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

The following are reasons why Duloxetine Neuraxpharm capsules may not be suitable for you.

Talk to your doctor before you take Duloxetine Neuraxpharm capsules if you:

• are taking other medicines to treat depression (see ‘Other medicines and Duloxetine Neuraxpharm capsules’)
• 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 Neuraxpharm capsules’)

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

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.

Duloxetine Neuraxpharm capsules 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 Neuraxpharm capsules for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Duloxetine Neuraxpharm capsules 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 this medicine. 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.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

The main ingredient of Duloxetine Neuraxpharm capsules, duloxetine, is used in other medicines for other conditions:

• depression, anxiety, urinary incontinence and diabetic neuropathic pain

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 Neuraxpharm capsules 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 Neuraxpharm capsules 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 Neuraxpharm, 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 Neuraxpharm. Also, you need to wait at least 5 days after you stop taking Duloxetine Neuraxpharm capsules 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 and MAOIs (such as moclobemide and linezolid). These medicines increase the risk of side effects; if you get any unusual symptom taking any of these medicines together with Duloxetine Neuraxpharm, 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.

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

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 this medicine. You should use Duloxetine Neuraxpharm 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 this medicine. 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 this medicine 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 this medicine 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 this medicine while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.

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

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Call your doctor or pharmacist immediately if you take more than the amount of medicine prescribed by your doctor. Symptoms of overdose include sleepiness, coma, serotonin syndrome (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of Duloxetine Neuraxpharm that has been prescribed for you in one day.

DO NOT stop taking your capsules without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need this medicine, he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.

Some patients who stop taking duloxetine suddenly have had symptoms such as:

• dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo.

These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.

If you get any side effects, talk to your doctor or pharmacist. 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.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is duloxetine. Each capsule contains 90 or 120 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule contents: hypromellose, sugar spheres , talc, sucrose, hypromellose phthalate, triethyl citrate.

Capsule shell for Duloxetine Neuraxpharm 90 mg hard gastro-resistant capsules: gelatin, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine.

Capsule shell for Duloxetine Neuraxpharm 120 mg hard gastro-resistant capsules: gelatin, titanium dioxide (E171), indigo carmine.

Duloxetine Neuraxpharm capsules are hard gastro-resistant capsules.

They are available in 2 strengths: 90 mg and 120 mg.

The 90 mg capsules are green and white.

The 120 mg capsules are blue.

Both capsule strengths are available in packs of 28 capsules.

The capsules in this pack are enclosed in PVDC laminate/aluminium blister strips.

Marketing Authorisation Holder:

Manufacturer