Xeristar 30 mg hard gastro-resistant capsules

Xeristar increases the levels of serotonin and noradrenaline in the nervous system.

Xeristar is used to treat:

• depression
• generalised anxiety disorder (chronic feeling of anxiety or nervousness)
• diabetic neuropathic pain (often described as burning, stabbing, stinging, shooting or aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure may cause pain)

Your doctor may continue to give you Xeristar when you are feeling better to prevent your depression or anxiety from returning.

DO NOT take Xeristar if you:

• are allergic (hypersensitive) to duloxetine or any of the other ingredients of Xeristar (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
• are taking other medicines containing duloxetine (see ?Taking other medicines?)Talk to your doctor if you have high blood pressure or heart disease. Your doctor will tell you if you should be taking Xeristar.

Take special care with Xeristar

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

• are taking other 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?)

Xeristar 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 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 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
Xeristar 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 Xeristar for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Xeristar 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 Xeristar. Also, the long-term safety effects concerning growth, maturation, and cognitive and behavioural development of Xeristar 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 Xeristar, duloxetine, is used in other medicines for other conditions:

• diabetic neuropathic pain, depression, anxiety and urinary incontinenceUsing 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 Xeristar 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 Xeristar if you are taking, or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Taking a MAOI together with many prescription medicines, including Xeristar, 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 Xeristar. Also, you need to wait at least 5 days after you stop taking Xeristar 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), 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 Xeristar, you should see your doctor.

Oral anticoagulants: Medicines which thin the blood. These medicines might increase the risk of bleeding.

Taking Xeristarwith food and drink
Xeristar may be taken with or without food. Care should be taken if you drink alcohol while you are being treated with Xeristar.

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 Xeristar. You should use Xeristar 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 Xeristar. 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 Xeristar 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 Xeristar while breastfeeding is not recommended. You should ask your doctor or pharmacist for advice.

Driving and using machines

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

Important information about some of the ingredients of Xeristar

Xeristar 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.

Always take Xeristar exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Xeristar starts to work in most people with depression or anxiety within two weeks of starting treatment.

Xeristar starts to work in most people with diabetic neuropathic pain within 1 week of starting treatment.

For depression and diabetic neuropathic pain:

The usual dose of Xeristar is one capsule (60 mg duloxetine) once a day, but your doctor will prescribe the dose that is right for you.

For generalised anxiety disorder:

The usual starting dose of Xeristar is 30 mg once a day after which most patients will receive 60 mg once a day, but your doctor will prescribe the dose that is right for you. The dose may be adjusted up to 120 mg a day based on your response to Xeristar.

Xeristar is for oral use. You should swallow your capsule whole with a drink of water.

To help you remember to take Xeristar, you may find it easier to take it at the same times every day.

Talk with your doctor about how long you should keep taking Xeristar. Do not stop taking Xeristar without talking to your doctor.

If you take more Xeristar than you should

Call your doctor or pharmacist immediately if you take more than the amount of Xeristar 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 forget to take Xeristar

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 Xeristar that has been prescribed for you in one day.

If you stop taking Xeristar

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 Xeristar he or she will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether.

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

• dizziness, fatigue, tingling feelings like pins and needles, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, 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 have further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Xeristar can cause side effects, although not everybody gets them. These effects are normally mild to moderate and often disappear after a few weeks.

Very common side effects (affects more than 1 user in 10)

• feeling sick (nausea), headache, dry mouth feeling sleepy and dizziness.

Common side effects (affects 1 to 10 users in 100)

• fatigue, anxiety, feeling agitated or having abnormal dreams
• tremor or numbness, including numbness or tingling of the skin
• diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain
• tinnitus (perception of sound in the ear when there is no external sound)
• blurred eyesight
• feeling the heart pumping in the chest, flushing, increased sweating
• problems getting an erection, less sex drive and abnormal orgasm ? (itchy) rash
• muscle pain, muscle tightness, muscle spasm
• increased yawning
• lack of appetite, weight loss

Uncommon side effects (affects 1 to 10 users in 1,000)

• throat inflammation
• feeling disorientated, tiredness, trouble sleeping, feeling sleepy, lack of motivation
• tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking
• restless legs syndrome
• poor sleep quality
• burping, indigestion, gastroenteritis
• vertigo, ear pain
• inflammation of the liver that may cause abdominal pain
• large pupils (the dark centre of the eye), visual disturbance
• fast or irregular heart beat
• sexual problems, including changes in ejaculation
• abnormal periods, including heavy or prolonged periods
• increased tendency to bruise, blisters or sensitivity to sunlight
• increase in blood pressure, feeling cold in your fingers and/or toes, feeling dizzy (particularly when standing up too quickly), night sweats, cold sweats, shivering or fainting
• an increased level of sugar in the blood
• need to pass more urine than normal, need to pass urine during the night, difficulty or inability to pass urine or having an urine flow decreased
• passing bright red blood in your stools, vomiting blood, or black tarry stools (faeces)
• grinding of teeth, feeling hot/cold, thirst, throat tightness, nose bleeds
• weight gain
• suicidal thoughts
• chest pain
• a sensation of restlessness or an inability to sit or stand still

Rare side effects (affects 1 to 10 users in 10,000)

• decreased thyroid gland activity
• allergic reactions
• dehydration
• mania (over activity, racing thoughts and decrease need for sleep), experiencing aggression and anger
• bad breath
• increased pressure in the eye (glaucoma)
• menopausal symptoms
• contraction of the jaw muscle
• increased level of cholesterol in the blood
• low levels of sodium in the blood (mostly in elderly people). The symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick. More serious symptoms are fainting, fits or falls
• syndrome of inadequate secretion of anti-diuretic hormone (SIADH)
• serious allergic reaction which causes difficulty in breathing or dizziness or hives
• fits
• abnormal production of breast milk in men and women
• hallucinations
• having abnormal urine odour
• suicidal behaviour ? ?Serotonin syndrome? (a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
• yellow colouration of the skin (jaundice), hepatic failure, Stevens-Johnson syndrome, sudden swelling of skin or mucosa (angioedema)

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.

Keep out of the reach and sight of children.

Do not use Xeristar after the expiry date which is stated on the carton.

Store in the original package to protect from moisture. Do not store above 30°C.

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.

What Xeristar contains

The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).

The other ingredients are:
Capsule content: hypromellose, hypromellose acetate succinate, sucrose, sugar spheres, talc, titanium dioxide (E171), triethyl citrate (See end of section 2 for further information on sucrose). Capsule shell: gelatin, sodium lauryl sulphate, titanium dioxide (E171), indigo carmine (E132), yellow iron oxide (E172) (60 mg only) and edible green ink (30 mg) or edible white ink (60 mg). Edible green ink: synthetic black iron oxide (E172), synthetic yellow iron oxide (E172), propylene glycol, shellac.
Edible white ink: titanium dioxide (E171), propylene glycol, shellac, povidone.

What Xeristar looks like and contents of the pack

Xeristar is a hard gastro-resistant capsule. Each capsule of Xeristar contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.

Xeristar is available in 2 strengths: 30 mg and 60 mg.

The 30 mg capsules are blue and white and are printed with ?30 mg? and the code ?9543?. The 60 mg capsules are blue and green and are printed with ?60 mg? and the code ?9542?.

Xeristar 30 mg is available in packs of 7 and 28 capsules.
Xeristar 60 mg is available in packs of 28, 56, 84, 98, 100 and 500 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland BV, Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Manufacturer: Lilly S.A., Avda. De la Industria, 30, 28108 Alcobendas, Madrid, Spain.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Eli Lilly Benelux S.A.N.V. TélTel 32-02 548 84 84 LuxembourgLuxemburg Eli Lilly Benelux S.A.N.V. TélTel 32-02 548 84 84

.. - . 359 2 491 41 40 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100

eská republika ELI LILLY R, s.r.o. Tel 420 234 664 111 Malta Charles de Giorgio Ltd. Tel 356 25600 500

Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800

Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Norge Eli Lilly Norge A.S. Tlf 47 22 88 18 00

Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6 817 280 Österreich Eli Lilly Ges.m.b.H. Tel 43-0 1 711 780

- .... 30 210 629 4600 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00

España Lilly S.A. Tel 34-91 663 50 00 Portugal Lilly Portugal Produtos Farmacêuticos, Lda Tel 351-21-4126600

France Lilly France S.A.S Tél 33-0 1 55 49 34 34 România Eli Lilly România S.R.L. Tel 40 21 4023000

Ireland Eli Lilly and Company Ireland Limited Tel 353-0 1 661 4377 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10

Ísland Slovenská republika

Icepharma hf. Sími 354 540 8000 Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111

Italia Eli Lilly Italia S.p.A. Tel 39- 055 42571 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250

Phadisco Ltd 357 22 715000 Sverige Eli Lilly Sweden AB Tel 46-0 8 7378800

Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315000

Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. +370 (5) 2649600

This leaflet was last approved in