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AstraZeneca

Duloxetine Mylan
duloxetine

Package leaflet: Information for the user


Duloxetine Mylan 30 mg hard gastro-resistant capsules Duloxetine Mylan 60 mg hard gastro-resistant capsules duloxetine


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


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.



(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.



Reporting of side effects

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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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.


  1. 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.


  2. 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 x 1, 30 x 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 x 1, 30 x 1, and 100 x 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


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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:


België/Belgique/Belgien

Mylan bvba/sprl

Tél/Tel: + 32 (0)2 658 61 00

Lietuva

Mylan Healthcare UAB Tel: +370 5 205 1288


България

Майлан ЕООД

Тел: +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

Magyarország

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

Viatris 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

Viatris AS

Tlf: +47 66 75 33 00


Ελλάδα

Generics Pharma Hellas ΕΠΕ Τηλ: +30 210 993 6410

Österreich

Arcana Arzneimittel GmbH Tel.: +43 1 416 2418


España

Viatris Pharmaceuticals, S.L.U. Tel: + 34 900 102 712

Polska

Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00


France

Viatris Santé

Tél: +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

România

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

Sími: +354 540 8000

Slovenská republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 100


Italia

Mylan Italia S.r.l.

Tel: +39 02 612 46921

Suomi/Finland

Viatris Oy

Puh/Tel: +358 20 720 9555


Κύπρος

Varnavas Hadjipanayis Ltd Τηλ: +357 2220 7700

Sverige

Viatris AB

Tel: + 46 (0)8 630 19 00


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


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