ePI IG for APAC markets, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/scc88/aseanepi/ and changes regularly. See the Directory of published versions
ASEAN eMedicinal Product Information IG›Appendix 1 Templates›Philippines TemplateHL7 FHIR R5
🇵🇭Philippines Template — Section headings map to the 21-point Philippines Patient Information Leaflet (PIL) format as defined in Appendix 1 of the ASEAN ePI IG. This example uses a fictional product for illustrative purposes.
Amoxicillin 500 mg Capsules
Patient Information Leaflet (PIL) — Philippines Template
● ActiveVersion 1.0ENPhilippines TemplateePI Type 3🇵🇭 PhilippinesPrescription Only (Rx)
Bundle Metadata
urn:uuid:b2c3d4e5-f6a7…
active
1.0
2026-01-15
EN (en-PH)
Philippines 🇵🇭
ASEAN Pharma (Philippines) Inc.
Philippine FDA
Composition Metadata
urn:uuid:e8f9a0b1-c2d3…
Amoxicillin 500 mg — Philippines PIL
PIL
active
1.0
EN (en-PH)
Philippines (Appendix 1)
Philippines Template Sections (Appendix 1)
This Composition uses the 21-point section headings for the Philippines Patient Information Leaflet as defined in Appendix 1 of the ASEAN ePI IG. The text is written in layman's terms. Each section maps to a Composition.section entry in the FHIR Bundle.
1. Name of the Product
2. Description of the Product
3. What is in the Medicine?
4. Strength of the Medicine
5. What is this Medicine used for?
6. How much and how often should you use this Medicine?
7. When should you not take this Medicine?
9. Undesirable Effects of this Medicine
14. How should you keep this Medicine?
18. ADR Reporting Statement
(See Composition tab for all 21 sections)
Amoxicillin 500 mg Capsules
In this leaflet:
1) Name of the Product
2) Description of the Product
3) What is in the Medicine?
4) Strength of the Medicine
5) What is this Medicine used for?
6) How much and how often should you use this Medicine?
7) When should you not take this Medicine?
8) Care that should be taken when taking this Medicine?
9) Undesirable Effects of this Medicine
10) What other medicine or food should be avoided while taking this Medicine?
11) What should you do if you miss a dose?
12) Signs and Symptoms of Overdose
13) What to do when you have taken more than the recommended dosage?
14) How should you keep this Medicine?
15) When should you consult your doctor?
16) Name and Address of Marketing Authorization Holder
17) Name and Address of Manufacturer
18) ADR Reporting Statement
19) Registration Number
20) Date of First Authorization/Renewal of the Authorization
21) Date of Revision of Patient Information Leaflet
1) Name of the Product
Amoxicillin (as trihydrate)
2) Description of the Product
Size 0 hard gelatin capsule with a white opaque cap and body, printed with "AMOX 500", containing a white to off-white granular powder.
Each capsule contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin.
5) What is this Medicine used for?
Amoxicillin is an antibiotic belonging to a group of medicines called "penicillins". It is used to kill bacteria that can cause infections. It is used in adults and children to treat infections of the:
Ears, nose, and throat (e.g., severe sore throat, sinusitis, ear infections)
Chest and lungs (e.g., community-acquired pneumonia)
Skin and soft tissue
Urinary tract (bladder and kidneys)
6) How much and how often should you use this Medicine?
Always take this medicine exactly as your doctor or pharmacist has told you.
Adults and adolescents (18 years and older):
Take 1 capsule (500 mg) every 8 hours (three times a day). For severe infections, the doctor may increase the dose to 1,000 mg three times a day.
Swallow the capsule whole with a glass of water. It can be taken before, during, or after meals. Space the doses evenly during the day, at least 4 hours apart.
Important: Keep taking this medicine until the course is finished, even if you feel better. If you stop taking it too soon, the infection may return or the bacteria may become resistant to the antibiotic.
7) When should you not take this Medicine?
Do not take this medicine if you:
Are allergic to amoxicillin, to any other penicillin antibiotic, or to any of the ingredients listed in Section 3.
Have ever had a severe allergic reaction (such as an itchy rash, swelling of the face, or breathing difficulties) to any other antibiotic (like a cephalosporin).
8) Care that should be taken when taking this Medicine?
Tell your doctor before taking this medicine if you:
Have kidney problems. Your dose might need to be lowered.
Have glandular fever (infectious mononucleosis), as this increases the risk of getting a skin rash.
Are pregnant, think you might be pregnant, or are breast-feeding.
If you experience severe diarrhea that contains blood or mucus during or after the treatment, this may be a sign of a serious bowel inflammation. Contact your doctor immediately.
9) Undesirable Effects of this Medicine
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
Mild diarrhea
Feeling sick (nausea) or being sick (vomiting)
Skin rash
Stop taking this medicine and see a doctor straight away if you notice:
Allergic reactions (swelling of the face or throat, sudden wheezing, or difficulty breathing)
Severe skin reactions (blistering, peeling, or a rash targeting the mouth/eyes)
10) What other medicine or food should be avoided while taking this Medicine?
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including:
Probenecid (used to treat gout) – your doctor may adjust your amoxicillin dose.
Methotrexate (used for cancer or severe psoriasis) – amoxicillin can cause a build-up of methotrexate in the body.
Warfarin or other medicines used to prevent blood clots.
11) What should you do if you miss a dose?
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose to make up for a forgotten dose.
12) Signs and Symptoms of Overdose
Taking too much amoxicillin may cause stomach upset (nausea, vomiting or diarrhea) or crystals in the urine, which may be seen as cloudy urine, or problems urinating.
13) What to do when you have taken more than the recommended dosage?
If you or someone else has taken too much medicine, contact your doctor or go to the nearest hospital emergency department immediately. Take the medicine carton or bottle with you to show the doctor.
14) How should you keep this Medicine?
Keep this medicine out of the sight and reach of children.
Store at temperatures not exceeding 25°C.
Store in the original package in order to protect from moisture and light.
Do not use this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to safely dispose of medicines no longer required.
15) When should you consult your doctor?
Consult your doctor immediately if you experience severe allergic reactions (difficulty breathing, swelling of the face or throat), severe blistering skin rashes, or persistent, severe diarrhea with blood during or after your treatment.
16) Name and Address of Marketing Authorization Holder
ASEAN Pharma (Philippines) Inc.
Unit 1205, Medical Tower 2,
Ortigas Center, Pasig City 1605,
Metro Manila, Philippines
17) Name and Address of Manufacturer
Regional Manufacturing Solutions Sdn Bhd
Lot 5, Jalan Industri 3/5,
Taman Perindustrian Rawang,
48000 Rawang, Selangor, Malaysia
18) ADR Reporting Statement
For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph At the first sign of any adverse drug reaction, patient should seek medical attention immediately.
19) Registration Number
DR-XY45678
20) Date of First Authorization / Renewal of the Authorization
15 January 2020
21) Date of Revision of Patient Information Leaflet
15 January 2026
Marketing Authorization Holder (MAH)
ASEAN Pharma (Philippines) Inc.
IdentifierORG-ASEANPHARMA-PHL-001 (OMS)
TypeMAH
AddressUnit 1205, Medical Tower 2, Ortigas Center, Pasig City 1605, Metro Manila
CountryPhilippines 🇵🇭
Manufacturer
Regional Manufacturing Solutions Sdn Bhd
IdentifierORG-RMS-MYS-002 (OMS)
TypeManufacturer
AddressLot 5, Jalan Industri 3/5, Taman Perindustrian Rawang, 48000 Selangor
📅24monthsShelf life of medicinal product as packaged for sale
🌡
Temperature
Store below 25°C
Do not freeze
💧
Humidity
Protect from moisture
Store in original packaging
☀
Light
Protect from light
Use amber glass bottle or keep in carton
👤
Safety
Keep out of reach of children
Marketing Authorization
MA Holder
ASEAN Pharma (Philippines) Inc.
Reg Number
DR-XY45678
Jurisdiction
Philippines 🇵🇭
6
Indications
🎯
2
Contraindications
⛔
3
Interactions
⚡
14
Side Effects
💉
3
Warnings
⚠
2
Dosage Regimens
💊
🎯What is this Medicine used for? (Section 5)6
Indication
Population
ICD-11 Code
Acute bacterial sinusitis
Adults & children ≥2 years
CA0Z
Acute otitis media
Adults & children ≥2 months
AA40
Acute streptococcal tonsillitis & pharyngitis
Adults & children
CA01.0
Community-acquired pneumonia (CAP)
Adults & children ≥3 months
CA40.0Z
Skin and soft tissue infections
Adults & children
1B70
Uncomplicated urinary tract infections
Adults & children ≥3 months
GC08.0
⛔When should you not take this Medicine? (Section 7)2
⊘Allergic to amoxicillin, any penicillin, or any of the inactive ingredients of this medicine.
⊘Previous severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam antibiotic (cephalosporin, carbapenem, or monobactam).
⚡Other medicine or food to avoid (Section 10)3
Interacting Substance
Mechanism
Severity
Clinical Effect
Probenecid
Pharmacokinetic — reduced renal tubular secretion
Moderate
Increased & prolonged amoxicillin plasma levels
Methotrexate
Pharmacokinetic — reduced renal clearance
High
Elevated methotrexate levels; risk of toxicity — monitor closely
Warfarin / oral anticoagulants
Pharmacodynamic — altered gut flora / vitamin K
Moderate
Rare prolongation of prothrombin time; monitor INR
💉Undesirable Effects of this Medicine (Section 9)14
Gastrointestinal disorders
DiarrhoeaVery common (≥1/10)
NauseaCommon (≥1/100)
VomitingCommon (≥1/100)
IndigestionUncommon (≥1/1,000)
Skin and subcutaneous tissue disorders
Skin rash (maculopapular)Common (≥1/100)
UrticariaUncommon (≥1/1,000)
Stevens-Johnson syndromeNot known
Toxic epidermal necrolysisNot known
Nervous system disorders
DizzinessUncommon (≥1/1,000)
Reversible hyperactivityRare (≥1/10,000)
ConvulsionsRare (≥1/10,000)
Renal and urinary disorders
CrystalluriaVery rare (<1/10,000)
Interstitial nephritisNot known
Haemolytic anaemiaVery rare (<1/10,000)
⚠Care that should be taken (Section 8)3
▲Hypersensitivity / Anaphylaxis: Serious and occasionally fatal hypersensitivity reactions have been reported with penicillin therapy. Before initiating therapy, enquire about previous reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, discontinue amoxicillin and institute appropriate therapy immediately.
▲Renal Impairment: Dose reduction is required in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²). Accumulation of amoxicillin may lead to CNS toxicity including convulsions in vulnerable patients.
▲Clostridium difficile-associated diarrhoea (CDAD): CDAD has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhoea to fatal colitis. If CDAD is suspected or confirmed, discontinue amoxicillin and initiate appropriate fluid and electrolyte management.
💊How much and how often should you use this Medicine? (Section 6)2MedicationKnowledge
Adults & Adolescents (≥18 years)Standard
Single dose500 mg
Dose intervalEvery 8 hours (three times daily)
Duration5–10 days depending on infection type
Severe infections1,000 mg three times daily
RouteOral
AdministrationWith or without food; swallow whole with sufficient fluid
📅 Morning🌈 Midday🌑 Evening⚠ Complete full course
FHIR source: MedicationKnowledge/mk-amoxicillin-500mg → dosingGuideline[0].dosage[0] (patientCharacteristic: age ≥18y)
Children & Adolescents (3 months – 17 years)Weight-based
Single dose25 mg/kg/day divided every 8 hours
Maximum single dose500 mg
Maximum daily dose1,500 mg/day (adult dose)
Severe infections40–45 mg/kg/day in 3 divided doses