Dulsevia
On the Bulgarian pack: Дулсевиа 90 mg стомашно-устойчиви твърди капсули
90 mg hard gastro-resistant capsules · gastro-resistant capsule, hard
- Prescription only
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Duloxetine
- Made by
- KRKA, d.d., Novo mesto
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
Mediclarum has not yet read the official leaflet for this product. The exact uses and dose are in the leaflet inside the pack. Open the official leaflet
How it works
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (duloxetine hydrochloride). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.
Elimination of duloxetine is mainly through hepatic metabolism involving two P450 isozymes, CYP1A2 and CYP2D6.
Most (about 70%) of the duloxetine dose appears in the urine as metabolites of duloxetine; about 20% is excreted in the feces.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-20
Safety of the active substance
This product’s leaflet is published as a scanned document. This section quotes the US prescribing label for the same active substance (duloxetine hydrochloride). It describes the substance, not this Bulgarian product — its uses and doses can differ.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.
- The use of MAOIs intended to treat psychiatric disorders with Duloxetine delayed-release capsules or within 5 days of stopping treatment with Duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome.
- The use of Duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration (2.8) and Warnings and Precautions (5.4) ].
- Starting Duloxetine delayed-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration (2.9) and Warnings and Precautions (5.4) ].
- Concomitant use of an MAOI antidepressant with Duloxetine delayed-release capsules is contraindicated Use of Duloxetine delayed-release capsules within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid- or intravenous methylene blue-treated patients, initiation of Duloxetine delayed-release capsules is contraindicated ( 4 )
Most Common Adverse Reactions in Adult Trials The most commonly observed adverse reactions in Duloxetine delayed-release capsules-treated patients (as defined above) were: Diabetic Peripheral Neuropathic Pain: nausea, somnolence, decreased appetite, constipation, hyperhidrosis, and dry mouth.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
United States1 matching products
European UnionNo exact match for this strength and form
Spain7 matching products
- DULOTEX 90 mg · cápsula dura gastrorresistente
- DULOXETINA CINFAMED 90 mg · cápsula dura gastrorresistente
- DULOXETINA LICONSA 90 mg · cápsula dura gastrorresistente
- DULOXETINA NORMON 90 mg · cápsula dura gastrorresistente
- LUDOTIM 90 mg · cápsula dura gastrorresistente
- OXITRIL 90 mg · cápsula dura gastrorresistente
- XERISTAR 90 mg · cápsula dura gastrorresistente
CanadaNo exact match for this strength and form
Netherlands2 matching products
SwitzerlandNo exact match for this strength and form
Details
| Made by | KRKA, d.d., Novo mesto · Slovenia |
|---|---|
| Active substance | Duloxetine |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 90 mg hard gastro-resistant capsules |
| Form | gastro-resistant capsule, hard |
| Pack sizes | 7 · 10 · 14 · 28 · 30 · 56 · 60 · 90 · 100 |
| Classification | N06AX21 · Pain, sleep, mood, epilepsy and the brain |
| Name in the register | Дулсевиа 90 mg стомашно-устойчиви твърди капсули |
| Reg. no. | 20170265 |
Source: Bulgarian Drug Agency register · 2026-08-01 · not reviewed by a clinician
Източник: Изпълнителна агенция по лекарствата (ИАЛ). The publisher’s terms do not grant reproduction, so text is shortened and linked. Publisher’s terms.
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- gastro-resistant capsule, hard3 products
- 30 mg hard gastro-resistant capsules
- 60 mg hard gastro-resistant capsules
- 90 mg hard gastro-resistant capsules
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.