AMOXICILLIN CAPSULES 250 MG / 500 MG & POWDER FOR ORAL SUSPENSION

🏥 Quality Health Care

PATIENT INFORMATION LEAFLET: INFORMATION FOR THE USER

💊 Active Substance(s)

• Amoxicillin 250 MG Capsules:
  Each capsule contains Amoxicillin Trihydrate equivalent to 250 mg Amoxicillin.

• Amoxicillin 500 MG Capsules:
  Each capsule contains Amoxicillin Trihydrate equivalent to 500 mg Amoxicillin.

• Amoxicillin Powder for Oral Suspension:
  Each 5 ml of the reconstituted suspension contains Amoxicillin Trihydrate equivalent to 125 mg Amoxicillin.

📘 Read Carefully Before Use

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, health care provider or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, health care provider or pharmacist.

📑 This Leaflet Contains:

1. What Amoxicillin Capsules/Suspension is and what it is used for
2. What you should know before you take Amoxicillin Capsules/Suspension
3. How to take Amoxicillin Capsules/Suspension
4. Possible side effects
5. How to store Amoxicillin Capsules/Suspension
6. Further information

1️⃣ WHAT AMOXICILLIN CAPSULES/SUSPENSION IS AND WHAT IT IS USED FOR

Amoxicillin is penicillinase-susceptible penicillin. It exhibits in vitro bactericidal activity against a wide range of gram-negative and gram-positive organisms. It works by killing the bacteria that cause some types of infections.

Indicated for infections caused by susceptible, non-penicillinase-producing organisms including:

• Upper respiratory tract infections
• Skin and soft tissue infections
• Lower respiratory tract infections
• Gonorrhea, otitis media, non-specific urethritis
• Upper urinary tract infections, lower urinary tract infections
• Gastrointestinal tract infections

2️⃣ WHAT YOU SHOULD KNOW BEFORE YOU TAKE AMOXICILLIN CAPSULES/SUSPENSION

❌ Do Not Take If:

• You are allergic (hypersensitive) to Amoxicillin Trihydrate or any of the other ingredients of Amoxicillin Capsules/Suspension
• You are allergic to penicillins or any of the cephalosporins
• You have infectious mononucleosis, lymphatic leukemia, or are being treated with allopurinol (increased risk of skin rashes)

⚠️ Take Special Care If:

• You are a syphilis patient (Jarisch-Herxheimer reaction may occur)
• You or your child has kidney problems, fever (sore throat, swollen glands), or are not urinating regularly
• You are dehydrated or have oliguria (risk of crystalluria)
• Resistance strains may appear—sensitivity testing is recommended

💊 Taking with Other Medicines:

• Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription
• May interact with:
  • Bacteriostatic antibacterials (e.g. chloramphenicol, tetracyclines)
  • Probenecid (prolongs half-life of Amoxicillin)
  • Other drugs due to intestinal flora changes

🍽️ Food and Drink:

• No confirmed effect of food on Amoxicillin
• Avoid alcoholic beverages
• Ask your doctor for personalized advice

🤰 Pregnancy and Breastfeeding:

• Consult your doctor before use
• Amoxicillin is excreted in breast milk in small amounts but is considered compatible with breastfeeding

🚗 Driving and Using Machines:

• No evidence of influence on ability to drive or use machinery
• Avoid machinery if medicine causes drowsiness

🧂 Important Ingredient Information:

• Refer to section 6 for full ingredient list
• Discuss any prior disease conditions with your doctor that may be affected by listed ingredients

3️⃣ HOW TO TAKE AMOXICILLIN CAPSULES/SUSPENSION

Always take Amoxicillin Capsules/Suspension exactly as your doctor or health care provider has told you. Check with them if unsure. Specific doses may vary depending on your condition.

💊 Dosage Guidelines:

• Adults:
  Average daily dose: 750 mg – 1.5 g
  Typically: 250 mg capsule three times daily

• Children (Suspension):

  • 2–10 years: 125 mg (5 ml) three times daily
  • 6 months–2 years: 125 mg (5 ml) three times daily
  • 0–6 months: 62.5 mg (2.5 ml) three times daily

Reconstitution Instructions:
To prepare 100 ml suspension, add 85 ml of water, invert bottle, and shake well until powder is fully dispersed.

🚨 If You Take More Than You Should:

• Contact hospital or doctor immediately
• Bring medicine pack with you
• Symptoms: Rapid onset of side effects, possible anaphylactic reaction
• Treatment: Adrenaline, corticosteroids, antihistamines; supportive care

⏰ If You Forget a Dose:

• Take as soon as remembered unless close to next dose
• Do not double dose

🛑 If You Stop Taking Amoxicillin:

• Consult your doctor or pharmacist if you have questions

4️⃣ POSSIBLE SIDE EFFECTS

Like all medicines, Amoxicillin can cause side effects, although not everyone gets them.

⚠️ Common Side Effects:

• Gastrointestinal disturbances: diarrhea, nausea, vomiting
• Allergic reactions: pruritus, erythematous rash, urticaria
• Maculopapular rash
• Pseudomembranous colitis

🩺 Reporting Side Effects:

• Report any side effects to your doctor, pharmacist, or nurse
• You can also report via the FDA Medsafe app (available on Google Play and Apple Store)

5️⃣ HOW TO STORE AMOXICILLIN

• Keep out of reach and sight of children
• Store in a cool, dark place below 30°C
• Keep in original container and carton box
• Do not use after expiry date (check label, carton, or blister foil)
• Do not use if visible signs of deterioration appear
• Do not dispose via wastewater or household waste—ask pharmacist for proper disposal

6️⃣ FURTHER INFORMATION

💊 What Amoxicillin Contains:

• Active Substance: Amoxicillin Trihydrate
• Capsules Ingredients: Magnesium Stearate, Talc, Sodium Lauryl Sulphate, Starch
• Syrup Ingredients: Sugar, Sodium C.M.C, Sodium Citrate, Talc, Sodium Saccharin, Sodium Benzoate, Orange Flavor, Citric Acid, Sunset Yellow Colour

📦 What It Looks Like:

• Amoxicillin Capsule 250 mg:
  White or almost white powder in yellow body and scarlet cap shell
  Printed: 'LETAP' on cap, 'AMOXYCILLIN 250 mg' on body
  Packed: 50 × 10 capsule blisters or white HDPE jar with 1000 capsules

• Amoxicillin Capsule 500 mg:
  White or almost white powder in maroon cap and yellow body size 'O' shell
  Printed: 'LETAP' on cap, 'AMOXICILLIN 500 mg' on body
  Packed: 10 × 10 capsule blisters

• Amoxicillin Powder for Oral Suspension:
  White or almost white granular powder in 100 ml amber bottle
  White P.P aluminium cap in skillet/carton box
  Reconstituted suspension appears sunset yellow

🗓️ Leaflet Last Approved: June 2021

🏢 Supplier/Manufacturer

Letap Pharmaceuticals Limited
📍 P. O. Box 3346, Plot 107, Graphic Road, Accra, Ghana
📞 +233-0302-225838 / 224613
📠 +233-0302-224693
📧 Letap.group@gmail.com

For any information about this medicinal product, please contact the manufacturer using the details above.