APO-NAPROXEN SR TABLETS
As listed in the register: APO-NAPROXEN SR TABLETS 750MG
750 mg · tablet (extended-release)
- Prescription only
- Muscles, joints and bones
- Active substance
- Naproxen
- Used in
- Muscles, joints and bones
- 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 (naproxen). It describes the substance, not this Bulgarian product — its uses and doses can differ.
Naproxen has analgesic, anti-inflammatory, and antipyretic properties.
Naproxen sodium has been developed as a more rapidly absorbed formulation of naproxen for use as an analgesic.
Naproxen is extensively metabolized in the liver to 6-0-desmethyl naproxen, and both parent and metabolites do not induce metabolizing enzymes.
Approximately 95% of the naproxen from any dose is excreted in the urine, primarily as naproxen (<1%), 6-0-desmethyl naproxen (<1%) or their conjugates (66% to 92%).
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-19
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 (naproxen). It describes the substance, not this Bulgarian product — its uses and doses can differ.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events.
- Naproxen tablets and naproxen sodium tablets are contraindicated in the following patients:.
- Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see Warnings and Precautions ( 5.7, 5.9 ) ].
- History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
- Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [ see Warnings and Precautions ( 5.7, 5.8 ) ].
Most common adverse reactions to naproxen were dyspepsia, abdominal pain, nausea, headache, rash, ecchymosis, and edema.
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 States3 matching products
BulgariaNo exact match for this strength and form
SpainNo exact match for this strength and form
NetherlandsNo exact match for this strength and form
SwitzerlandNo exact match for this strength and form
Details
| Made by | Apotex Inc |
|---|---|
| Active substance | Naproxen |
| Used in | Muscles, joints and bones |
| Strength | 750 mg |
| Form | tablet (extended-release) |
| Classification | M01AE02 · Muscles, joints and bones |
| Route | oral |
| Dispensing (as stated by the register) | PRESCRIPTION |
| Status | Dormant |
| Marketed | No — authorised but not currently marketed, according to the register |
| Name in the register | APO-NAPROXEN SR TABLETS 750MG |
| DIN | 02177072 |
| DPD drug code | 44216 |
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.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.