AFAXIM® ( Cefixime ) Capsule 400 mg

AFAXIM®

Cefixime

Tablet & capsule 200 mg & 400 mg

Powder for oral suspension 100 mg/5mL (50 mL & 100 mL)

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• This medicine has been prescribed for you 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.
• If you have any further questions, ask your doctor or pharmacist.t

it is used f

AFAXIM® is used to treat infections caused by bacteria.

These include infections of the:

Ear, nose, sinuses (such as sinusitis), throat (such as tonsillitis, pharyngitis), chest and lungs (such as bronchitis, pneumonia), urinary system (such as cystitis and kidney infections)

 

Before use this drug, ask your doctor:

• If you are allergic to cefixime, any other cephalosporin antibiotics including penicillin or to any of the other ingredients of this medicine.
• Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of the lips, face, throat and tongue.
• If you have recently taken or might take any other medicines, like warfarin and anticoagulants, carbamazepine.

 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Afaxim®:

• If you have ever had colitis.
• If you have kidney problems.
• If you had previous hypersensitivity reactions to cephalosporins, penicillins, or other drugs.
• If you use anticoagulant

Driving and using machines

This medicine can cause symptoms including fits (convulsions), feeling confused, feeling less alert or aware of things than usual, unusual muscle movements or stiffness. If you experience any of these effects don’t drive or use machinery.

 

Medical Tests

If you require any tests (such as blood or urine tests) while taking this medicine, please make sure your doctor knows that you are taking Afaxim®.

 

Method of administration

• Take this medicine by mouth.
• Swallow tablets whole with a drink of water.
• If you feel the effect of the medicine is too weak or too strong, do not change the dose yourself, but ask your doctor.
• Do not stop taking this medicine without talking to your doctor. You should not stop taking Afaxim® just because you feel better.

 

The medicine should be taken for the prescribed number of days. The recommended dose is:

Adults, Elderly and Children over 10 years or weighing more than 50kg

• Acute Exacerbations of Chronic Bronchitis

400 mg/day PO in single daily dose or divided q12hr

• Otitis Media

400 mg/day PO in single daily dose or divided q12hr

• Pharyngitis/Tonsillitis

400 mg/day PO in single daily dose or divided q12hr

• Uncomplicated Gonorrhea

400 mg PO once plus azithromycin 1 g PO once (preferred) or alternatively doxycycline 100 mg PO q12hr for 7 days

• Uncomplicated Urinary Tract Infections

400 mg/day PO in single daily dose or divided q12hr

Children under 10 years old

Children: 4mg/kg PO q12hr or 8 mg/kg/day

People with kidney problems

• Your doctor may prescribe a lower dose

Reconstitution Directions for Oral Suspension

• Tap the bottle several times to loosen powder contents, then add fresh drinking water in two portions up to the filling mark and shake well after each addition.
• Keep tightly closed.
• Shake well before using.

 

If you take more Afaxim® than you should

If you have too much of this medicine, talk to your doctor straight away.

 

If you forget to take Afaxim®

If you forget to take a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

 

Adverse reactions

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor straight away or go to the nearest hospital casualty department if you notice any of the following serious side effects – you may need urgent medical treatment:

• You have an allergic reaction. The signs may include: a rash, joint pain, swallowing or breathing problems, swelling of your lips, face, throat or tongue
• Blistering or bleeding of the skin around the lips, eyes, mouth, nose and genitals. Also flu-like symptoms and fever. This may be something called ‘Stevens-Johnson’ syndrome.
• Severe blistering rash where layers of the skin may peel off to leave large areas of raw exposed skin over the body. Also a feeling of being generally unwell, fever, chills and aching muscles. This may be something called ‘Toxic epidermal necrolysis’
• You have a skin rash or skin lesions with a pink/red ring and a pale center which may be itchy, scaly or filled with fluid. The rash may appear especially on the palms or soles of your feet. These could be signs of a serious allergy to the medicine called ‘erythema multiform’
• You get infections more easily than usual. This could be because of a blood disorder. This normally gets better after stopping the medicine
• You bruise or bleed more easily than normal. This could be because of a blood disorder. This normally gets better after stopping the medicine.
• If your child gets nose bleeds, bleeding gums, chills, tiredness, pale skin (often with a yellow tinge), and shortness of breath. This may be due to hemolytic anemia.
• Changes in the way the kidneys are working or blood in your child’s urine.
• Fits (convulsions) – Frequency not known
• A brain condition with symptoms including fits (convulsions), feeling confused, feeling less alert or aware of things than usual, unusual muscle movements or stiffness. This may be something called encephalopathy. This side effect is more likely if you have taken an overdose or you already have a problem with your kidneys

Stop taking this medicine and contact your doctor without delay if you get:

• Severe watery diarrhea that will not stop and you are feeling weak and have a fever. This may be something called ‘Pseudomembranous colitis’

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

• Feeling sick (nausea) or being sick (vomiting)
• Stomach pains, indigestion or wind
• Headaches
• Feeling dizzy
• Feeling itchy in the genital or vaginal area

Tell your doctor if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.

 

Special precautions for storage

• Keep this medicine in room temperature, out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and blister pack after EXP:.
• Store dry powder below 25°C, protect from light and moisture.
• After reconstitution, the suspension may be kept for 14 days either at room temperature, or under refrigeration, without significant loss of potency.
• Do not freeze.
• Discard unused portion after 14 days.
• Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

AFAXIM®

Each Capsule contains: 200 mg & 400 mg Cefixime (as trihydrate)

Each Tablet contains: 200 mg & 400 mg Cefixime (as trihydrate)

Each 5 mL of Suspension contains: 100 mg/5mL

 

Manufacture by Afa chemi pharmaceutical co. Tehran-Iran.