Duloxetine Mylan - patient leaflet, side effects, dosage

- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Duloxetine Mylan is and what it is used for

• 2. What you need to know before you take Duloxetine Mylan

• 3. How to take Duloxetine Mylan

• 4. Possible side effects

• 5. How to store Duloxetine Mylan

• 6. Contents of the pack and other information

1. What Duloxetine Mylan is and what it is used for

Duloxetine Mylan contains the active substance duloxetine. Duloxetine Mylan increases the levels of serotonin and noradrenaline in the nervous system.

Duloxetine Mylan is used in adults 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)

Duloxetine Mylan starts to work in most people with depression or anxiety within two weeks of starting treatment, but it may take 2–4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time. Your doctor may continue to give you Duloxetine Mylan when you are feeling better to prevent your depression or anxiety from returning.

In people with diabetic neuropathic pain it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months.

2. What you need to know before you take Duloxetine Mylan

Do not take Duloxetine Mylan 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 Mylan’)

• – 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 Mylan’)

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

Warnings and precautions

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

• – are taking other medicines to treat depression or medicines known as opioids that are used to relieve

pain or to treat opioid (narcotic) addiction.

The use of these medicines together with Duloxetine Mylan can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Duloxetine Mylan”).

• – 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 Mylan’)

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

Other medicines and Duloxetine Mylan

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 Mylan, 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 Mylan 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 Mylan 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 Mylan, 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 Mylan. Also, you need to wait at least 5 days after you stop taking Duloxetine Mylan 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, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), St John’s Wort, MAOIs (such as moclobemide and linezolid), opioids (such as buprenorphine, tramadol and pethidine). These medicines may interact with Duloxetine Mylan and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms, as these might indicate a potentially life-threatening condition known as serotonin syndrome.

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 Mylan with food, drink and alcohol

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

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 Mylan. You should use Duloxetine Mylan 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 Mylan. 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 Mylan 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 Mylan 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 Mylan 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 Mylan while breast-feeding is not

recommended. You should ask your doctor or pharmacist for advice.

Driving and using machines

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

Duloxetine Mylan contains sucrose and sodium

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

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

3. How to take Duloxetine Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

For depression and diabetic neuropathic pain:

The usual dose of Duloxetine Mylan is 60 mg once a day, but your doctor will prescribe the dose that is right for you.

For generalised anxiety disorder:

The usual starting dose of Duloxetine Mylan 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 Duloxetine Mylan.

To help you remember to take Duloxetine Mylan, 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 Duloxetine Mylan. Do not stop taking Duloxetine Mylan, or change your dose, without talking to your doctor. Treating your disorder properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and difficult to treat.

If you take more Duloxetine Mylan than you should

Call your doctor or pharmacist immediately if you take more than the amount of Duloxetine Mylan 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 Duloxetine Mylan

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 Mylan that has been prescribed for you in one day.

If you stop taking Duloxetine Mylan

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 Duloxetine Mylan 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 Mylan 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 have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine 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 (may affect more than 1 in 10 people)

• headache, feeling sleepy
• feeling sick (nausea), dry mouth

Common side effects (may affect up to 1 in 10 people)

• lack of appetite
• trouble sleeping, feeling agitated, less sex drive, anxiety, difficulty or failure to experience orgasm,

unusual dreams

• dizziness, feeling sluggish, tremor, numbness, including numbness, pricking or tingling of the skin
• blurred eyesight
• tinnitus (hearing sound in the ear when there is no external sound)
• feeling the heart pumping in the chest,
• increased blood pressure, flushing
• increased yawning
• constipation, diarrhoea, stomach pain, being sick (vomiting), heartburn or indigestion, breaking

wind

• increased sweating, (itchy) rash
• muscle pain, muscle spasm
• painful urination, frequent urination
• problems getting an erection, changes in ejaculation
• falls (mostly in elderly people), fatigue
• weight loss

Children and adolescents under 18 years of age with depression treated with this medicine had some weight loss when they first start taking this medicine. Weight increased to match other children and adolescents of their age and sex after 6 months of treatment.

Uncommon side effects (may affect up to 1 in 100 people)

• throat inflammation that causes a hoarse voice
• suicidal thoughts, difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of

motivation

• sudden involuntary jerks or twitches of the muscles, sensation of restlessness or an inability to sit or

stand still, feeling nervous, difficulty concentrating, changes in sense of taste, difficulty controlling movement e.g. lack of coordination or involuntary movements of the muscles, restless legs syndrome, poor sleep quality

• large pupils (the dark centre of the eye), problems with eyesight
• feeling of dizziness or “spinning” (vertigo), ear pain
• fast and/or irregular heart beat
• fainting, dizziness, lightheadedness or fainting on standing up, cold fingers and/or toes
• throat tightness, nose bleeds
• vomiting blood, or black tarry stools (faeces), gastroenteritis, burping, difficulty swallowing
• inflammation of the liver that may cause abdominal pain and yellowing of the skin or whites of the

eyes

• night sweats, hives, cold sweats, sensitivity to sunlight, increased tendency to bruise
• muscle tightness, muscle twitching
• difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the

night, needing to pass more urine than normal, having a decreased urine flow

• abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged

periods, unusually light or missed periods, sexual dysfunction, pain in the testicles or scrotum

• chest pain, feeling cold, thirst, shivering, feeling hot, abnormal gait
• weight gain
• Duloxetine Mylan may cause effects that you may not be aware of, such as increases in liver

enzymes or blood levels of potassium, creatine phosphokinase, sugar, or cholesterol

Rare side effects (may affect up to 1 in 1,000 people)

• serious allergic reaction which causes difficulty in breathing or dizziness with swollen tongue or

lips, allergic reactions

• decreased thyroid gland activity which can cause tiredness or weight gain
• dehydration, 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 inappropriate secretion of anti-diuretic hormone (SIADH)

• suicidal behaviour, mania (over activity, racing thoughts and decreased need for sleep),

hallucinations, aggression and anger

• “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

• increased pressure in the eye (glaucoma)
• inflammation of the mouth, passing bright red blood in your stools, bad breath, inflammation of the

large intestine (leading to diarrhoea)

• liver failure, yellowing of the skin or whites of the eyes (jaundice)
• Stevens-Johnson syndrome (serious illness with blistering of the skin, mouth, eyes and genitals),

serious allergic reaction which causes swelling of the face or throat (angioedema)

• contraction of the jaw muscle
• abnormal urine odour
• menopausal symptoms, abnormal production of breast milk in men or women
• coughing, wheezing and shortness of breath which may be accompanied by a high temperature
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage)

Very rare side effects (may affect up to 1 in 10,000 people)

• inflammation of the blood vessels in the skin (cutaneous vasculitis)

5. How to store Duloxetine Mylan

Keep this medicine out of the sight and reach of children.

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

Store in the original package in order to protect from moisture.

Bottle packs only:

Use within 6 months of opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Duloxetine Mylan contains

The active substance is duloxetine.

Each capsule contains 30 mg or 60 mg of duloxetine (as hydrochloride).

The other ingredients are:

Capsule content: Sugar spheres (sucrose, maize starch), hypromellose, Macrogol, Crospovidone, talc, sucrose, hypromellose phthalate, diethyl phthalate.

Capsule shell: Brilliant blue (E133), yellow iron oxide (E172) (60 mg only), titanium dioxide (E171), gelatin and edible gold ink (30 mg only) or edible white ink (60 mg only).

Edible gold ink: shellac, propylene glycol, strong ammonia solution, yellow iron oxide (E172).

Edible white ink: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171).

What Duloxetine Mylan looks like and contents of the pack

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

Duloxetine Mylan is available in 2 strengths: 30 mg and 60 mg.

The 30 mg capsules have an opaque blue cap and opaque white body, imprinted in gold ink with ‘MYLAN’ over ‘DL 30’ on both the cap and the body.

The 60 mg capsules have an opaque blue cap and opaque yellow body, imprinted in white ink with ‘MYLAN’ over ‘DL 60’ on both the cap and the body.

Duloxetine Mylan 30 mg is available in blister packs of 7, 14, 28, 49, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 7 x1, 28 × 1, 30 × 1 capsules and in bottles containing 30, 100, 250, 500 capsules and a desiccant. Do not eat the desiccant.

Duloxetine Mylan 60 mg is available in blister packs of 14, 28, 49, 84, 98 and in a multipack of 98 comprising 2 cartons, each containing 49 capsules, in perforated blister packs containing 28 × 1, 30 × 1, and 100 × 1capsules and bottles containing 30, 100, 250 and 500 capsules and a desiccant. Do not eat the desiccant.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Pharmaceuticals Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland Manufacturers

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin, Unit 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland

Mylan Hungary Kft., Mylan utca 1, Komárom 2900, Hungary

Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg v. d. Hoehe, Hessen, 61352, Germany

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

Belgie/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Etnrapua Maw.iaH EOO4 Ten: +359 2 44 55 400	Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400	Magyarorszag Mylan EPD Kft Tel: + 36 1 465 2100
Danmark Viatris ApS Tlf: +45 28 11 69 32	Malta V.J. Salomone Pharma Ltd. Tel: + 356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800	Nederland Mylan BV Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: +372 6363 052	Norge Mylan Healthcare Norge AS Tel: +47 66 75 33 00
EXXáSa Generics Pharma Hellas EnE Tql: +30 210 993 6410	Österreich Arcana Arzneimittel GmbH Tel.: +43 1 416 2418
España Mylan Pharmaceuticals, S.L Tel: + 34 900 102 712	Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00
France Mylan S.A.S Tel : +33 4 37 25 75 00	Portugal Mylan, Lda. Tel: + 351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: + 4 0372 579 000

Ireland Mylan Ireland Limited Tel: +353 1 8711600	Slovenija Mylan Healthcare d.o.o. Tel: +386 1 23 63 180
Ísland Icepharma hf Símí: +354 540 8000	Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100
Italia Mylan Italia S.r.l. Tel: +39 02 612 46921	Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555
Kúnpog Varnavas Hadjipanayis Ltd Tql: +357 2220 7700	Sverige Mylan AB Tel: + 46 855 522 750
Latvija Mylan Healthcare SIA Tel: + 371 676 055 80	United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711600

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

69

Cases of convulsion and cases of tinnitus have also been reported after treatment discontinuation.

Cases of orthostatic hypotension and syncope have been reported especially at the initiation of treatment.

See section 4.4.

Cases of aggression and anger have been reported particularly early in treatment or after treatment discontinuation.

Cases of suicidal ideation and suicidal behaviours have been reported during duloxetine therapy or early after treatment discontinuation (see section 4.4).

Estimated frequency of post-marketing surveillance reported adverse reactions; not observed in placebo-controlled clinical trials.

Falls were more common in the elderly ( > 65 years old).

Description of selected adverse reactions

Discontinuation of duloxetine (particularly when abrupt) commonly leads to withdrawal symptoms.

Dizziness, sensory disturbances (including paraesthesia or electric shock like sensations, particularly in the head), sleep disturbances (including insomnia and intense dreams), fatigue, somnolence, agitation or

Not statistically significantly different from placebo.

Estimated frequency based on placebo-controlled clinical trials.

Estimated frequency based on all clinical trial data.