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AstraZeneca

Ariclaim
duloxetine

Package leaflet: information for the user


ARICLAIM 30 mg hard gastro-resistant capsules ARICLAIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)


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 ARICLAIM 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 ARICLAIM if you are taking, or have recently taken (within the last 14 days) an 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 ARICLAIM, 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 ARICLAIM. Also, you need to wait at least 5 days after you stop taking ARICLAIM 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 ARICLAIM, 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.


Medicinal product no longer authorised

ARICLAIM with food, drink and alcohol

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


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.


Reporting of side effects


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 ARICLAIM


    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 to protect from moisture. Do not store above 30°C.

    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 to protect the environment.


  2. Contents of the pack and other information What ARICLAIM 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 sulfate, 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 ARICLAIM looks like and contents of the pack

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


ARICLAIM 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’.


ARICLAIM 30 mg is available in packs of 7, 28 and 98 capsules. ARICLAIM 60 mg is available in packs of 28 and 98 capsules.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.

Medicinal product no longer authorised

Manufacturer: Lilly S.A., Avda. De la Industria, 30, 28108 Alcobendas, Madrid, Spain.


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


België/Belgique/Belgien

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Eli Lilly Benelux S.A./N.V. Tél/Tel: + 32-(0)2 548 84 84

Lietuva

Eli Lilly Holdings Limited atstovybė Tel. +370 (5) 2649600


Luxembourg/Luxemburg

Eli Lilly Benelux S.A./N.V.

Tél/Tel: + 32-(0)2 548 84 84

България

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ТП "Ели Лили Недерланд" Б.В. - България тел. + 359 2 491 41 40


Magyarország

Lilly Hungária Kft.

Tel: + 36 1 328 5100

Česká republika

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ELI LILLY ČR, s.r.o. Tel: + 420 234 664 111


Danmark

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Eli Lilly Danmark A/S Tlf: +45 45 26 60 00

Malta

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Charles de Giorgio Ltd. Tel: + 356 25600 500


Deutschland

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Lilly Deutschland GmbH Tel. + 49-(0) 6172 273 2222

Nederland

Eli Lilly Nederland B.V. Tel: + 31-(0) 30 60 25 800


Norge

Eli Lilly Norge A.S.

Tlf: + 47 22 88 18 00

Eesti

Eli Lilly Holdings Limited Eesti filiaal Tel: +372 6 817 280

Ελλάδα

ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Τηλ: +30 210 629 4600

Österreich

Eli Lilly Ges.m.b.H. Tel: + 43-(0) 1 711 780


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España

Dista S.A..

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France

Lilly France SAS

Tél: +33-(0) 1 55 49 34 34

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Polska

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Eli Lilly Polska Sp. z o.o. Tel: +48 (0) 22 440 33 00


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Portugal

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Lilly Portugal Produtos Farmacêuticos, Lda Tel: + 351-21-4126600


Hrvatska

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Eli Lilly Hrvatska d.o.o. Tel: +385 1 2350 999

România

Eli Lilly România S.R.L. Tel: + 40 21 4023000


Ireland

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Eli Lilly and Company (Ireland) Limited Tel: + 353-(0) 1 661 4377

Slovenija

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Eli Lilly farmacevtska družba, d.o.o. Tel: +386 (0)1 580 00 10


Ísland

Icepharma hf.

Sími + 354 540 8000

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Slovenská republika Eli Lilly Slovakia, s.r.o. Tel: + 421 220 663 111


Italia

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Medicinal product no longer authorised

Eli Lilly Italia S.p.A. Tel: + 39- 055 42571

Suomi/Finland

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Oy Eli Lilly Finland Ab Puh/Tel: + 358-(0) 9 85 45 250


Κύπρος

Phadisco Ltd

Τηλ: +357 22 715000

Sverige

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Eli Lilly Sweden AB Tel: + 46-(0) 8 7378800


Latvija

Eli Lilly Holdings Limited pārstāvniecība Latvijā Tel: +371 67364000

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United Kingdom

Eli Lilly and Company Limited Tel: + 44-(0) 1256 315000


This leaflet was last revised in


a.europa.eu.