Axtrifia contains the active substance cefixime. It belongs to a group of antibiotics called cephalosporins, used to treat infections caused by bacteria in adults and adolescents aged ≥ 12 years, such as:
• Acute ear infection
• Acute infection of the nasal cavity and sinuses
• Acute exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Uncomplicated urinary tract infections
• Acute uncomplicated gonorrhea
You should talk to a doctor if you do not feel better or if you feel worse.

Do not take Axtrifia 400 mg if:
• you are allergic to cefixime or any of the other ingredients of this medicine.

Talk to your doctor or pharmacist before taking Axtrifia.

Pregnancy, lactation and fertility:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Task:
Axtrifia 400 mg should be used during pregnancy only on the advice of your doctor.
If you discover that you are pregnant during treatment, contact your doctor, who is the only person who can decide whether you should continue.
Breastfeeding:
You should not take this medicine while breastfeeding unless clearly indicated by your doctor.
However, if your child develops digestive problems (diarrhoea, infection with a fungus called Candida) or pimples, stop breast-feeding or taking the medicine and contact your doctor immediately. Your doctor will decide whether you should stop breast-feeding or stop/abstain from treatment with Axtrifia 400 mg, taking into account the benefit of breast-feeding for your child and the benefit of treatment for you.

Driving and using machines:
Cefixime may cause dizziness. If affected, you should not drive or use machines.

Axtrifia 400 mg contains sodium:
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially “sodium-free”.

Always take this medicine exactly as your doctor or pharmacist has told you.
Talk to your doctor or pharmacist if you are not sure.

Dosage:
Your doctor will decide the correct dose of Axtrifia 400 mg and tell you how long to take the medicine. The number of Axtrifia 400 mg tablets you should take will depend on your condition. Follow your doctor’s instructions exactly and never change the dose. Ask your doctor or pharmacist if you are not sure how much medicine to take or when to take it.

Adults and adolescents (≥ 12 years):
The recommended dose is 400 mg orally:
1 x 400 mg per day, as a single dose within 24 hours

This medicine should always be taken at the same time of day.

Duration of treatment:
Most infections can be treated within 7 days of treatment. However, in severe cases, Axtrifia 400 mg may be used for 14 days.

Children under 12 years of age:
Please note that Axtrifia 400 mg tablets are not suitable for children, oral suspension can be used instead or you should ask your doctor for more information.

Elderly:
For the elderly, the doses are the same as for adults, provided that kidney function is normal.

Kidney problems:
If you have severe kidney problems or are on dialysis, your doctor will reduce your dose.
There is insufficient data on the use of Axtrifia 400 mg in children with kidney problems.
Therefore, Axtrifia is not recommended for use in these patients. For creatinine clearance values ​​< 20 ml/min, in ambulatory peritoneal dialysis or haemodialysis, the recommended dose is 200 mg once daily.

Impaired liver function
No dose adjustment is necessary in patients with hepatic impairment.

Method of administration
For oral administration.
The tablet should be taken with a sufficient amount of water and the tablets should be swallowed whole.
The score line on the tablet is intended to help you break the tablet if you have difficulty swallowing it whole. The halves should be taken one after the other.
Axtrifia 400 mg can be taken with or without food.

If you have any further questions on this medicine, ask your doctor or pharmacist.

- The active substance is cefixime.
Each film-coated tablet contains 400mg cefixime (as cefixime trihydrate).
- The other components are:
- in the tablet core: calcium hydrogen phosphate, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.
- in the tablet film: macrogol - polyvinyl alcohol copolymer, talc, mono/diglycerides, titanium dioxide (E 171), polyvinyl alcohol.

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

10 film-coated tablets