NEWROXIME

NEWROXIME 250 mg film-coated tablets

NEWROXIME 500 mg film-coated tablets

Cefuroxime

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 or nurse.

– 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 or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1. What NEWROXIME is and what it is used for
2. What you need to know before you take NEWROXIME
3. How to take NEWROXIME
4. Possible side effects
5. How to store NEWROXIME
6. Contents of the pack and other information

1. What NEWROXIME is and what it is used for

NEWROXIME is an antibiotic used in adults and children. It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

NEWROXIME is used to treat infections of:

• the throat
• sinus
• middle ear
• the lungs or chest
• the urinary tract
• the skin and soft tissues.

NEWROXIME can also be used:

• to treat Lyme disease (an infection spread by parasites called ticks).

2. What you need to know before you take NEWROXIME

Do not take NEWROXIME:

• if you are allergic to cefuroxime axetil, any cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6.)
• if you have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

→ If you think this applies to you, don’t take NEWROXIME until you have checked with your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking NEWROXIME.

NEWROXIME is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

You must look out for certain symptoms, such as allergic reactions, fungal infections (such as candida) and severe diahorrea (pseudomembranous colitis) while you are taking NEWROXIME. This will reduce the risk of any problems. See ‘Conditions you need to look out for’ in section 4.

If you need a blood test

NEWROXIME can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test. If you need a blood test:

→Tell the person taking the sample that you are taking NEWROXIME.

Other medicines and NEWROXIME

Tell your doctor or pharmacist if you are taking, have recently taken  or might take any other medicines.

Medicines used to reduce the amount of acid in your stomach (e.g. antacids used to treat heartburn) can affect how NEWROXIME works.

Probenecid

Oral anticoagulants

→Tell your doctor or pharmacist if you are taking any medicine like this.

Contraceptive pills

Cefuroxime  may reduce the effectiveness of the contraceptive pill. If you are taking the contraceptive pill while you are being treated with NEWROXIME you also need to use a barrier method of contraception (such as condoms). Ask your doctor for advice.

Pregnancy, breast-feeding and fertility

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.

Your doctor will consider the benefit of treating you with NEWROXIME against the risk to your baby.

Driving and using machines

NEWROXIME can make you dizzy and have other side effects that make you less alert.

→Don’t drive or use machines if you do not feel well.

NEWROXIME contains propylene glycoll which may cause alcohol-like symptoms.

3. How to take NEWROXIME

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

Take NEWROXIME after food. This will help to make the treatment more effective.

Swallow NEWROXIME tablets whole with some water.

Don’t chew or crush the tablets— this may make the treatment less effective.

The usual dose

Adults

The usual dose of NEWROXIME is 250 mg to 500 mg twice daily depending on the severity and type of infection.

Use in children

The usual dose of NEWROXIME is 10 mg/kg (to a maximum of 125 mg) to 15 mg/kg (to a maximum of 250 mg) twice daily depending on the severity and type of infection.

NEWROXIME is not recommended for children aged under 3 months, as the safety and effectiveness are not known in this age group.

Depending on the illness or how you or your child responds to treatment, the initial dose may be changed or more than one course of treatment may be needed.

Patients with kidney problems

If you have a kidney problem, your doctor may change your dose.

→Talk to your doctor if this applies to you.

If you take more NEWROXIME than you should

If you take too much NEWROXIME you may have neurological disorders, in particular you may be more likely to have fits (seizures).

→Don’t delay. Contact your doctor or your nearest hospital emergency department immediately. If possible, show them the NEWROXIME pack.

If you forget to take NEWROXIME

Do not take a double dose to make up for a forgotte dose. Just take your next dose at the usual time.

If you stop taking this medicine

Don’t stop NEWROXIME without advice.

It is important that you take the full course of NEWROXIME. Don’t stop unless your doctor advises you to – even if you are feeling better. If you don’t complete the full course of treatment, the infection may come back.

4. Possible side effects

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

Conditions you need to look out for

A small number of people taking  NEWROXIME get an allergic reaction or potentially serious skin reaction.

Symptoms of these reactions include:

• severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.
• skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).
• a widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• fungal infections. Medicines like NEWROXIME can cause an overgrowth of yeast (Candida) in the body which can lead to fungal infections (such as thrush). This side effect is more likely if you take NEWROXIME for a long time.
• severe diarrhoea (Pseudomembranous colitis). Medicines like NEWROXIME can cause inflammation of the colon (large intestine), causing severe diarrhoea, usually with blood and mucus, stomach pain, fever.
• Jarisch-Herxheimer reaction. Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with NEWROXIME for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last a few hours or up to one day.

→Contact a doctor or nurse immediately if you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 people:

• fungal infections (such as Candida)
• headache
• dizziness
• diarrhoea
• feeling sick
• stomach pain.

Common side effects that may show up in blood tests:

• an increase in a type of white blood cell (eosinophilia)
• an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

• being sick
• skin rashes.

Uncommon side effects that may show up in blood tests:

• a decrease in the number of blood platelets (cells that help blood to clot)
• a decrease in the number of white blood cells
• positive Coomb’s test.

Other side effects have occurred in a very small number of people, but their exact frequency is unknown:

• severe diarrhoea (pseudomembranous colitis)
• allergic reactions
• skin reactions (including severe)
• high temperature (fever)
• yellowing of the whites of the eyes or skin
• inflammation of the liver (hepatitis).

Side effects that may show up in blood tests:

• red blood cells destroyed too quickly (haemolytic anaemia).

If you get any side effects

→Tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NEWROXIME

Keep this medicine out of the sight and reach of children. Store below 25^oC in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the label and carton.

The expiry date refers to the last day of that month.

Do not use NEWROXIME if the tablets are chipped or there are other visible signs of deterioration.

Don’t throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What NEWROXIME contains:

• The active substance is cefuroxime axetil.
• The other ingredients are: Microcrystaline Cellulose 105, Colloidal Anhydrous Silica Crosscarmellose Sodium, Sodium Lauryl Sulphate, Hydrogenated Vegetable Oil, Hydroxypropyl Methylcellulose (Methocel E5), Propylene Glycol, Titanium dioxide, Talc.

What NEWROXIME looks like and contents of the pack

NEWROXIME 250mg film -coated tablets: White, capsule shaped film -coated tablets, scored on one side

NEWROXIME 500 mg film -coated tablets: White, capsule shaped film -coated tablets, scored on one side.

NEWROXIME 250 and 500 mg film- coated tablets are available in carton boxes with Alu-Alu blisters containing 10 tablets.

Marketing Authorisation Holder

MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

Manufacturer

MEDOCHEMIE LTD, Factory C, 2 Michael Eracleous street, Agios Athanassios Industrial Area, 4101 Agios Athanassios, Limassol

Organization which receives claims from consumers on product quality in the territory of Georgia:

“NEW PHARMA” LTD

Legal address: Georgia, Gori, st. Tsabadze, Bldg. No. 5, sq. 32.

Actual address: Evdoshvili str.18, 0154 Tbilisi, Georgia.

Tel / Fax: +995 (32) 210 88 18.

This leaflet was last revised in 11/2014