APO-PREGABALIN CAPSULES
As listed in the register: APO-PREGABALIN CAPSULES
50 mg · capsule
- Prescription only
- Pain, sleep, mood, epilepsy and the brain
- Active substance
- Pregabalin
- Made by
- Apotex Inc
- 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 retrieved and stored the official label for this product, so none of its text is shown here. 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 (pregabalin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Pregabalin binds with high affinity to the alpha 2 -delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues.
Although the mechanism of action of pregabalin has not been fully elucidated, results with genetically modified mice and with compounds structurally related to pregabalin (such as gabapentin) suggest that binding to the alpha 2 -delta subunit may be involved in pregabalin’s anti-nociceptive and antiseizure effects in animals.
Therefore, an increase in the metabolism of coadministered CYP1A2 substrates (e.g. theophylline, caffeine) or CYP 3A4 substrates (e.g., midazolam, testosterone) is not anticipated.
The rate of pregabalin absorption is decreased when given with food, resulting in a decrease in C max of approximately 25% to 30% and an increase in T max to approximately 3 hours.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-04-07
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 (pregabalin). It describes the substance, not this Bulgarian product — its uses and doses can differ.
- Pregabalin is contraindicated in patients with known hypersensitivity to pregabalin or any of its components.
- Angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see Warnings and Precautions (5.2) ].
- Known hypersensitivity to pregabalin or any of its components.
Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial-onset seizures are increased weight and increased appetite.
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 States46 matching products
Bulgaria4 matching products
European UnionNo exact match for this strength and form
Spain22 matching products
Netherlands12 matching products
- Linefor 50 mg 50 mg · capsule, hard
- Lyrica 50 mg 50 mg · capsule, hard
- Pregabalin Viatris Pharma 50 mg harde capsules 50 mg · capsule, hard
- Pregabaline Amarox 50 mg 50 mg · capsule, hard
- Pregabaline Brillpharma 50 mg harde capsules 50 mg · capsule, hard
- Pregabaline Krka 50 mg harde capsules 50 mg · capsule, hard
- Pregabaline Oresund Pharma 50 mg harde capsules 50 mg · capsule, hard
- Pregabaline Reddy 50 mg harde capsules 50 mg · capsule, hard
SwitzerlandNo exact match for this strength and form
Details
| Made by | Apotex Inc |
|---|---|
| Active substance | Pregabalin |
| Used in | Pain, sleep, mood, epilepsy and the brain |
| Strength | 50 mg |
| Form | capsule |
| Classification | N02BF02 · Pain, sleep, mood, epilepsy and the brain |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Approved |
| Marketed | No — authorised but not currently marketed, according to the register |
| DIN | 02518945 |
| DPD drug code | 100824 |
Source: Drug Product Database · 2026-09-30 · not reviewed by a clinician
Contains information licensed under the Open Government Licence – Canada. Reuse terms: Open Government Licence – Canada.
Other strengths and forms
6 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.