Tilexim

Package leaflet: Information for the user

TILEXIM 250 mg film-coated tablets, 500 mg film-coated tablets

Cefuroxime axetil
Please 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 questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Tilexim is and what it is used for

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

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

Tilexim may also be used:

• to treat Lyme disease (an illness transmitted by parasites called ticks).

Your doctor may identify the type of bacteria causing the infection and check whether the bacteria are sensitive to
Tilexim during treatment.

2. What you need to know before taking Tilexim

Do not take Tilexim:

• if you are allergic to d-acetoxymethylcefuroxime or to any antibiotic of the cephalosporin class or to any of the other ingredients of Tilexim (listed in section 6).
• if you have previously experienced a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems).
• if you have developed severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or any other antibiotic of the cephalosporin class.

➔ If you think any of these apply to you, do not take Tilexim before consulting your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tilexim.
Children
Tilexim is not recommended in children under 3 months of age, as safety and efficacy have not been established in this age group.
Be especially careful when taking Tilexim
Severe skin reactions have been reported during treatment with cefuroxime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Seek immediate medical advice if you notice any symptoms related to these serious skin reactions described in section 4.
Pay attention to certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking Tilexim. This will help reduce the risk of potential complications. See 'Conditions requiring caution' in section 4.
If you require blood tests
Tilexim may interfere with blood test results for blood glucose levels or with the blood test known as the Coombs test. If you need blood tests:
➔ Inform the person taking the sample that you are taking Tilexim.
Other medicines and Tilexim
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
Medicines used to reduce stomach acid (for example, antacids used to treat heartburn) may affect the activity of Tilexim.
Probenecid
Oral anticoagulants
➔ Inform your doctor or pharmacist if you are taking any of these medicines.
Oral contraceptives
Tilexim may reduce the effectiveness of oral contraceptives. If you are taking oral contraceptives while being treated with Tilexim, you should also use a barrier method of contraception (such as condoms). Consult your doctor for advice.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Your doctor will assess the benefit of treatment with Tilexim against any potential risk to the unborn or breastfed child.
Driving and using machines
Tilexim may cause dizziness and other adverse effects that may impair alertness.
➔ Do not drive or operate machinery if you do not feel well.
Important information about some of the excipients in Tilexim
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
This medicine contains 0.002 mg of sodium benzoate per 250 mg tablet and 0.005 mg per 500 mg tablet.
This medicine contains 0.44 mg of propylene glycol per 250 mg tablet and 1.11 mg per 500 mg tablet.
Parahydroxybenzoates and their esters
This medicine may cause allergic reactions (including delayed reactions).
➔ Check with your doctor to ensure that Tilexim is suitable for you.

3. How to take Tilexim

Always take Tilexim exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take Tilexim after meals. This will help make the treatment more effective.
Swallow Tilexim tablets whole with water.
Do not chew, crush, or split the tablets – this may make the treatment less effective.

Recommended dose
Adults
The recommended dose of Tilexim is 250 mg to 500 mg twice daily, depending on the severity and
type of infection.

Children
The recommended dose of Tilexim is 10 mg/kg (up to a maximum of 125 mg) to 15 mg/kg (up to a
maximum of 250 mg) twice daily, depending on:

• the severity and type of infection.

Tilexim is not recommended in children under 3 months of age, as safety and efficacy have not been established in this age group.
Depending on the illness or how you or your child respond to treatment, the initial dose may be adjusted, or more than one treatment course may be necessary.

Patients with kidney problems
If you have kidney problems, your doctor may adjust your dose.
➔ Talk to your doctor if this applies to you.

If you take more Tilexim than you should
If you take too much Tilexim, you may experience neurological disturbances; in particular, you are more likely to have seizures.
➔ Do not wait. Contact your doctor or the nearest hospital emergency department immediately.
If possible, show them the Tilexim packaging.

If you forget to take Tilexim
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time.

If you stop taking Tilexim
Do not stop Tilexim without medical advice.
It is important to complete the entire course of Tilexim treatment. Do not stop unless your doctor advises you to, even if you feel better. If you do not complete the full course, the infection may return.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Conditions requiring attention
A small number of people being treated with Tilexim experience an allergic reaction or a potentially serious skin reaction. Symptoms of these reactions include:

• Severe allergic reaction. Signs include a raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty in breathing.
• Skin rash with blister-like lesions resembling "target-like" spots (a dark spot in the centre surrounded by a light area with a dark ring around the edge).
• Widespread rash with blisters and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Widespread rash, high body temperature, swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack caused by an allergy (Kounis syndrome).

Other conditions requiring attention while taking Tilexim include:

• Fungal infections. Medicines like Tilexim can cause an overgrowth of fungi ( Candida ) in the body, leading to fungal infections (such as thrush). This side effect is more likely if Tilexim is taken for a long time.
• Severe diarrhoea ( pseudomembranous colitis ). Medicines like Tilexim may cause inflammation of the colon (large intestine), resulting in severe diarrhoea, usually with blood and mucus, stomach pain, and fever.
• Jarisch-Herxheimer reaction. Some patients may experience high temperature (fever), chills, headache, muscle pain, and skin rash during treatment with Tilexim for Lyme disease. This is known as the Jarisch-Herxheimer reaction. Symptoms usually last for a few hours or up to one day.

➔ Contact your doctor or nurse immediately if you experience any of these symptoms.

Common side effects
These may affect up to 1 in 10 patients:

• Fungal infections (such as Candida)
• Headache
• Dizziness
• Diarrhoea
• Nausea
• Stomach pain

Common side effects that may be detected by blood tests:

• Increase in a type of white blood cells (eosinophilia)
• Increase in liver enzymes

Uncommon side effects
These may affect up to 1 in 100 patients:

• Vomiting
• Skin rashes

Uncommon side effects that may be detected by blood tests:

• Decrease in the number of blood platelets (cells that help blood to clot)
• Decrease in the number of white blood cells
• Positive Coombs test

Other side effects
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 ones)
• High temperature ( fever )
• Yellowing of the whites of the eyes or skin
• Inflammation of the liver ( hepatitis )

Side effects that may be detected by blood tests:

• Too rapid destruction of red blood cells ( haemolytic anaemia )

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Tilexim

Keep this medicine out of the sight and reach of children.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Tilexim contains
The active substance is cefuroxime axetil.
Each film-coated tablet of Tilexim 250 mg contains 300.72 mg of cefuroxime axetil, equivalent to
250 mg of cefuroxime.
Each film-coated tablet of Tilexim 500 mg contains 601.44 mg of cefuroxime axetil, equivalent to
500 mg of cefuroxime.
The excipients are: microcrystalline cellulose, sodium croscarmellose, sodium lauryl sulfate, hydrogenated vegetable oil, anhydrous colloidal silica, hypromellose, propylene glycol, titanium dioxide (E171), sodium benzoate, methyl parahydroxybenzoate, propyl parahydroxybenzoate.

Description of the appearance of Tilexim and contents of the pack
Tilexim 250 mg film-coated tablets: 12 film-coated tablets of 250 mg;
Tilexim 500 mg film-coated tablets: 6 and 12 film-coated tablets of 500 mg.
The tablets are packaged in aluminium-PVC-aluminium blisters.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: I.B.N. Savio S.r.l. – Via del Mare, 36 – Pomezia (RM), Italy
Manufacturer and final controller
Tilexim 250 mg film-coated tablets: Glaxo Wellcome Operations – Harmire Road - Barnard Castle,
United Kingdom
Tilexim 500 mg film-coated tablets: PenCef Pharma GmbH - Schützenanger 9 - 37081 Göttingen - Germany