GULAMOX Capsules 250

Country: Tanzania

Language: English

Source: Tanzania Medicinces & Medical Devices Authority

Active ingredient:

Amoxicillin

Available from:

B&O PHARM, FRANCE

ATC code:

Antibacterials for systemic use, beta-lactam anti

INN (International Name):

Amoxicillin

Dosage:

250

Pharmaceutical form:

Capsules

Manufactured by:

Sino Pharma Weiqida Pharmaceuticals Co. Limited, CHINA

Product summary:

Physical description: The filling material is almost white powder or particles; Capsule shell: white body+ red cap; Local technical representative: KITETO DISTRICT COUNCIL (5773)

Authorization status:

Registered/Compliant

Authorization date:

2023-08-15

Patient Information leaflet

CMYK:0/0/0/100
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you (or your child) only. Do
not pass it on to others. It may
harm them even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What GULAMOX capsules are and what they are used for
2. What you need to know before you take GULAMOX capsules
3. How to take GULAMOX capsules
4. Possible side effects
5. How to store GULAMOX capsules
6. Contents of the pack and other information
1. WHAT CAPSULES ARE AND WHAT THEY ARE USED FOR
WHAT GULAMOX CAPSULES ARE
GULAMOX capsules are antibiotics. The active ingredient is
amoxicillin. This belongs to a group of
medicines called ‘penicillin’.
WHAT GULAMOX CAPSULES ARE USED FOR
GULAMOX capsules are used to treat infections caused by bacteria in
different parts of the body.
GULAMOX capsules may also be used in combination with other medicines
to treat stomach ulcers.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GULAMOX CAPSULES
DO NOT TAKE GULAMOX CAPSULES:
- if you are allergic to amoxicillin, penicillin or any of the other
ingredients of this medicine (listed in
section 6).
- if you have ever had an allergic reaction to any antibiotic. This
can include a skin rash or swelling of
the face or throat.
Do not take GULAMOX capsules if any of the above apply. If you are not
sure, talk to your doctor or
pharmacist before taking GULAMOX capsules.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking GULAMOX capsules if
you:
• have glandular fever (fever, sore throat, swollen glands and
extreme tiredness)
• have kidney problems
• are not urinating regularly.
If you are not sure if any of the above apply

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Amoxicillin Capsules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amoxicillin Capsules 250 mg: Each capsule contains Amoxicillin
Trihydrate equivalent to
250
mg
Amoxicillin.
Amoxicillin
chemically
designated
as
R,6R)-6-{[(2R)-2-amino-2-(4-hydroxyphenyl)-acetyl]amino}-3,3-dimethyl-7-oxo-4-thia-1-az
abicyclo[3.2.0]heptane-24-carboxylic acid.
3. DESCRIPTION
The content in the capsule is white or almost white powder or
particles.
4. INDICATIONS
Treatment of Infection: Amoxicillin is a broad spectrum antibiotic
indicated for the treatment
of commonly occurring bacterial infections such as:
Upper respiratory tract infections
Otitis media
Acute and chronic bronchitis
Chronic bronchial sepsis
Lobar and bronchopneumonia
Cystitis, urethritis, pyelonephritis
Bacteriuria in pregnancy
Gynaecological infections including puerperal sepsis and septic
abortion
Gonorrhoea
Peritonitis
Intra-abdominal sepsis
Septicaemia
Bacterial endocarditis
Typhoid and paratyphoid fever
Skin and soft tissue infections
Dental abscess (as an adjunct to surgical management)
Helicobacter pylori eradication in peptic (duodenal and gastric) ulcer
disease.
In children with urinary tract infection the need for investigation
should be considered.
Prophylaxis of endocarditis: Amoxicillin may be used for the
prevention of bacteraemia,
associated with procedures such as dental extraction, in patients at
risk of developing bacterial
endocarditis.
5. DOSAGE AND ADMINISTRATION
Treatment of Infection:
Adult dosage (including elderly patients):
Standard adult dosage: 250 mg three times daily, increasing to 500 mg
three times daily for
more severe infections.
High dosage therapy (maximum recommended oral dosage 6 g daily in
divided doses): A
dosage of 3 g twice daily is recommended in appropriate cases for the
treatment of severe or
recurrent purulent infection of the respiratory tract.
Short course therapy: Simple acute urinary tract infection: two 3 g
doses with 10-12 hours
between the doses. Dent