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ItemsRegistration information
ID166
No166
Brand NameHYLES 100
IngredientsSPIRONOLACTONE 100MG
Dosage FormTABLET
Primary PackagingALU-PVC BLISTER
StorageSTORE BELOW 30C, PROTECT FROM LIGHT
Shelf Life2 YEARS
Pack Size10TABS/BLIST., 10BLISTS/BOX
Dispensing CategoryPrescription only
ATC ClassificationXX
Pharmaceutical ClassDIURETICS
IndicationsTREATMENT OF HYPERTENSION AND THE MANAGEMENT OF EDEMA ASSOCIATED WITH EXCESSIVE ALDOSTERONE EXCRETION.
ContraindicationsANURIA, ACUTE RENAL INSUFFICIENCY, SIGNIFICANT IMPAIRMENT OF RENAL EXCRETORY FUNCTION, HYPERKALEMIA, OR SENSITIVITY TO SPIRONOLACTONE.
Side EffectsHEADACHE, DROWSINESS, GI DISTURBANCE, ATAXIA, MENTAL CONFUSION , HIRSUTISM, MENSTRUAL IRREGULARITIES, IMPOTENCE, SKIN RASH, GYNECOMASTIA
Unit Price7.35THB/TA
EDL Yes
DescriptionYELLOW, ROUND, BICONVEX TABLETS WITH SCORED ON ONE SIDE AND THE LETTER “BERLIN” ON THE OTHER SIDE
Note
License OwnerBERLIN PHARMA LAO CO.,LTD
ManufacturerBERLIN PHARMACEUTICAL INDUSTRY CO., LTD.
CountryTHAILAND
Import Registration No1A 203/45
Import Registration Date2002-06-18
ActivityCERTIFICATE RELEASED
Applied Date2023-05-12
FDD Registration No08 I 2648/05
FDD Registration Date2023-07-17
Expiry Date2026-07-16

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