View drug registration information details.
Items | Registration information |
ID | 166 |
No | 166 |
Brand Name | HYLES 100 |
Ingredients | SPIRONOLACTONE 100MG |
Dosage Form | TABLET |
Primary Packaging | ALU-PVC BLISTER |
Storage | STORE BELOW 30C, PROTECT FROM LIGHT |
Shelf Life | 2 YEARS |
Pack Size | 10TABS/BLIST., 10BLISTS/BOX |
Dispensing Category | Prescription only |
ATC Classification | XX |
Pharmaceutical Class | DIURETICS |
Indications | TREATMENT OF HYPERTENSION AND THE MANAGEMENT OF EDEMA ASSOCIATED WITH EXCESSIVE ALDOSTERONE EXCRETION. |
Contraindications | ANURIA, ACUTE RENAL INSUFFICIENCY, SIGNIFICANT IMPAIRMENT OF RENAL EXCRETORY FUNCTION, HYPERKALEMIA, OR SENSITIVITY TO SPIRONOLACTONE. |
Side Effects | HEADACHE, DROWSINESS, GI DISTURBANCE, ATAXIA, MENTAL CONFUSION , HIRSUTISM, MENSTRUAL IRREGULARITIES, IMPOTENCE, SKIN RASH, GYNECOMASTIA |
Unit Price | 7.35THB/TA |
EDL |
Yes |
Description | YELLOW, ROUND, BICONVEX TABLETS WITH SCORED ON ONE SIDE AND THE LETTER “BERLIN” ON THE OTHER SIDE |
Note | |
License Owner | BERLIN PHARMA LAO CO.,LTD |
Manufacturer | BERLIN PHARMACEUTICAL INDUSTRY CO., LTD. |
Country | THAILAND |
Import Registration No | 1A 203/45 |
Import Registration Date | 2002-06-18 |
Activity | CERTIFICATE RELEASED |
Applied Date | 2023-05-12 |
FDD Registration No | 08 I 2648/05 |
FDD Registration Date | 2023-07-17 |
Expiry Date | 2026-07-16 |
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