Oraxim

Package leaflet: Information for the user

Oraxim 125 mg/5 ml granules for oral suspension, 250 mg/5 ml granules for oral suspension, 250 mg granules for oral suspension

cefuroxime
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

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

1. What Oraxim is and what it is used for

Oraxim 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.
Oraxim 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

Oraxim may also be used:

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

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

2. What you need to know before taking Oraxim

Do not take Oraxim:

• if you are allergic to acetoxietilcefuroxime or to any antibiotic of the cephalosporin class, or to any of the other ingredients of Oraxim (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 a severe skin rash, skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or with any other antibiotic of the cephalosporin class.
• If you think any of the above applies to you, do not take Oraxim before consulting your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Oraxim.
Be especially careful with Oraxim
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during treatment with cefuroxime. Contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Children
Oraxim is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.
Be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking Oraxim. This will help reduce the risk of potential complications. See 'Conditions requiring caution' in section 4.
If you need blood tests
Oraxim may interfere with blood test results for blood sugar levels or with the blood test known as the Coombs test. If you require blood tests:
➔ Inform the person taking the sample that you are taking Oraxim.
Other medicines and Oraxim
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 (e.g., antacids used to treat heartburn) may affect the activity of Oraxim.
Probenecid
Oral anticoagulants
➔ Inform your doctor or pharmacist if you are taking any of these medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Oraxim may cause dizziness and other side 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 Oraxim
Oraxim suspension contains sugar (sucrose). If you are diabetic, you must take this into account in your diet.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Oraxim suspension also contains aspartame, which is a source of phenylalanine. This may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot remove it properly.
Oraxim suspension also contains benzyl alcohol (E1519), which may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease, are pregnant, or are breastfeeding (see also the previous section – Pregnancy, breastfeeding and fertility). This is because large amounts of benzyl alcohol may accumulate in your body and cause side effects (called metabolic acidosis). Do not use for more than one week in young children (under 3 years of age), unless advised by your doctor or pharmacist.
Oraxim 125 mg/5 ml oral granules for oral suspension
This medicine contains 0.021 g of aspartame per 5 ml dose
This medicine contains 3.1 g of sucrose per 5 ml dose
This medicine contains 6 mg of propylene glycol (E1520) per 5 ml dose
This medicine contains 4.5 mg of benzyl alcohol (E1519) per 5 ml dose
Oraxim 250 mg/5 ml oral granules for oral suspension
This medicine contains 0.045 g of aspartame per 5 ml dose
This medicine contains 2.3 g of sucrose per 5 ml dose
This medicine contains 4.6 mg of benzyl alcohol (E1519) per 5 ml dose
Oraxim 250 mg oral granules for oral suspension
This medicine contains 0.042 g of aspartame per sachet
This medicine contains 6.1 g of sucrose per single dose. This should be taken into consideration in patients with diabetes mellitus.
This medicine contains 12 mg of propylene glycol (E1520) per sachet. This medicine contains 9 mg of benzyl alcohol (E1519) per sachet
➔ Check with your doctor that Oraxim is suitable for you.

3. How to take Oraxim

Always take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Take Oraxim after meals. This will help make the treatment more effective.

125 mg/5 ml, 250 mg/5 ml oral granules for oral suspension
Shake the bottle well before use.
Oraxim suspension may be diluted in cold fruit juices or milk-based drinks, but must be taken immediately.
Do not mix Oraxim with hot beverages.
For step-by-step instructions on how to prepare Oraxim suspension, see Instructions for reconstitution, at the end of this leaflet.

250 mg granules for oral suspension in sachets
For step-by-step instructions on how to prepare Oraxim sachets, see Instructions for reconstitution, at the end of this leaflet.

Recommended dose

Adults and children weighing 40 kg or more
The recommended dose of Oraxim is 250 mg to 500 mg twice daily, depending on the severity and type of infection.

Children weighing less than 40 kg
Children weighing less than 40 kg should preferably be treated with Oraxim oral suspension or sachets. The recommended dose of Oraxim is 10 mg/kg (up to a maximum of 250 mg) to 15 mg/kg (up to a maximum of 250 mg) twice daily, depending on:

• severity and type of infection
• the child's weight and age, up to a maximum of 500 mg per day.

Oraxim is not recommended for 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 required.

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 Oraxim than you should
If you take too much Oraxim, 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 Oraxim packaging.

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

If you stop taking Oraxim
Do not stop taking Oraxim without consulting your doctor.
It is important to complete the full course of Oraxim treatment. Do not stop unless instructed by your doctor, even if you feel better. If you do not complete the full course, the infection may return.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash with blister-like lesions resembling small targets (a dark spot in the centre surrounded by a pale 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 heart attack caused by an allergy (Kounis syndrome).

Other conditions requiring attention while taking Oraxim include:

• Fungal infections. Medicines like Oraxim can cause overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if Oraxim is taken for a long time.
• Severe diarrhoea (pseudomembranous colitis). Medicines like Oraxim can 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 Oraxim for Lyme disease. This is known as 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 in 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 in 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 in blood tests:

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

Reporting of side effects
➔ If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oraxim

Keep this medicine out of the sight and reach of children.
125 mg/5 ml and 250 mg/5 ml granules for oral suspension
The suspension must always be stored in the refrigerator when not in use.
Do not allow it to freeze. It can be kept in the refrigerator for up to 10 days.
250 mg sachets
The reconstituted suspension must be taken immediately.
Do not use Oraxim if it shows any signs of deterioration.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Oraxim contains
125 mg/5 ml oral suspension granules
The active substance is 125 mg of cefuroxime per 5 ml (present as cefuroxime axetil).
The other components are aspartame (E951), xanthan gum, acesulfame potassium (E950), povidone K30,
stearic acid, sucrose, tutti frutti flavour [containing propylene glycol (E1520) and benzyl alcohol (1519)]
and purified water.

250 mg/5 ml oral suspension granules
The active substance is 250 mg of cefuroxime per 5 ml (present as cefuroxime axetil).
The other components are aspartame (E951), xanthan gum, acesulfame potassium (E950), povidone K30,
stearic acid, sucrose, tutti frutti flavour [contains benzyl alcohol (1519)] and purified water.

250 mg sachets
The active substance is 250 mg of cefuroxime (present as cefuroxime axetil) per sachet.
The other components are aspartame (E951), xanthan gum, acesulfame potassium (E950), povidone K30,
stearic acid, sucrose, tutti frutti flavour [contains propylene glycol (E1520) and benzyl alcohol (1519)] and
purified water.

See section 2 for further important information on some of the excipients of Oraxim.

Description of the appearance of Oraxim and contents of the pack
Oraxim 125 mg/5 ml and 250 mg/5 ml suspension is supplied in a multidose amber glass bottle. The
bottle contains 100 ml of 125 mg/5 ml suspension or 50 ml of 250 mg/5 ml suspension.
This medicine must be prepared with water using the granules provided in the bottle. The bottle is contained in a carton.
The pack may contain, as dosing devices, either a graduated spoon or an oral syringe.
The pack also contains a measuring cup to measure the amount of water required for the suspension.

Oraxim 250 mg suspension is supplied in sachets.
The sachets are contained in a carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: MALESCI Istituto Farmacobiologico S.p.A. – Via Lungo l’Ema, 7 Bagno a Ripoli (FI)
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

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Instructions for reconstitution
125 mg/5 ml and 250 mg/5 ml oral suspension granules
Instructions for preparing the suspension

Please note that the time required to prepare the Oraxim suspension before administering the first dose will take more than one hour. This includes the time required for the suspension to stabilise in the refrigerator.
Follow the instructions below carefully when preparing and storing the Oraxim suspension for your child.

Shake the bottle to disperse the contents. Remove the bottle cap and the heat-sealed membrane. If the membrane is damaged or missing, return the product to the pharmacist.

Add cold water up to the volume line on the provided measuring cup. If the water has been previously boiled, allow it to cool to room temperature before adding. Do not mix Oraxim oral suspension granules with boiling or hot liquids. Cold water should be used to prevent the suspension from becoming too thick.

Pour the entire amount of cold water into the bottle. Replace the cap. Hold the bottle upright to allow the granules to be completely immersed in water; this should take about 1 minute.

Invert the bottle and shake well (for at least 15 seconds) until all granules are mixed with the water.

Turn the bottle upright and shake well for at least 1 minute until all granules are fully mixed with the water.
Immediately store the reconstituted Oraxim suspension in the refrigerator at a temperature between 2 and 8°C (do not freeze) and allow it to stand for at least one hour before administering the first dose.
The reconstituted suspension must always be refrigerated; if stored between 2 and 8°C, the reconstituted suspension can be kept for up to 10 days.
Always shake the bottle well before administering the medicine.

For children who cannot take Oraxim with a spoon, an oral dosing syringe marked at 5 ml may be supplied with the pack. If provided, use the oral dosing syringe to measure the dose accurately:

1. Remove the bottle cap. Keep it safe.
2. Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.
3. Insert the syringe firmly into the adapter.
4. Turn the bottle upside down.
5. Pull back the plunger of the syringe until the syringe contains the first portion of the child's full dose.
6. Return the bottle to an upright position. Remove the syringe from the adapter.
7. Insert the syringe into the child's mouth, placing the tip of the syringe against the inside of the cheek. Slowly push the plunger of the syringe, allowing time for swallowing. Do not push too hard or spray the liquid to the back of the child's throat, as this may cause choking.
8. Repeat steps 3 to 7 in the same way until the entire dose has been administered.
9. Remove the syringe from the bottle and wash it thoroughly with water. Allow it to dry completely before reuse.
10. Close the bottle securely with the cap, leaving the adapter in place.

250 mg oral suspension granules
Instructions for preparing the suspension from sachets

1. Pour the granules from the sachet into a glass.
2. Add a small amount of cold water.
3. Stir well and drink immediately. ➔ Do not mix the suspension or granules with hot drinks.

Patient Information Leaflet: Information for the user

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

cefuroxime
Please read this leaflet carefully before 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

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

1. What Oraxim is and what it is used for

Oraxim 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.
Oraxim 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

Oraxim may also be used:

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

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

2. What you need to know before taking Oraxim

Do not take Oraxim:

• if you are allergic to cefuroxime axetil or to any other antibiotic in the cephalosporin class, or to any of the other ingredients of Oraxim (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 a severe skin rash or skin peeling, blisters, and/or mouth ulcers after treatment with cefuroxime or with any other antibiotic in the cephalosporin class.
• If you think any of the above applies to you, do not take Oraxim before consulting your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Oraxim.
Be especially careful with Oraxim
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 severe skin reactions described in section 4.
Children
Oraxim is not recommended for children under 3 months of age, as safety and efficacy have not been established in this age group.
Be alert for certain symptoms such as allergic reactions, fungal infections (such as Candida), and severe diarrhoea (pseudomembranous colitis) while taking Oraxim. This will help reduce the risk of potential problems. See 'Conditions requiring caution' in section 4.
If you need blood tests
Oraxim may interfere with blood test results for blood glucose levels, or with a blood test known as the Coombs test. If you need blood tests:
➔ Inform the person taking the sample that you are taking Oraxim.
Other medicines and Oraxim
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Medicines used to reduce stomach acid (e.g. antacids used to treat heartburn) may affect the activity of Oraxim.
Probenecid
Oral anticoagulants
➔ Inform your doctor or pharmacist if you are taking any of these medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Oraxim may cause dizziness and other side 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 Oraxim

• This medicine contains 0.00203 mg of sodium benzoate in each 250 mg tablet
• This medicine contains 0.00506 mg of sodium benzoate in each 500 mg tablet
• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'
  ➔ Check with your doctor whether Oraxim is suitable for you.

3. How to take Oraxim

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

Recommended dose
Adults and children weighing 40 kg or more
The recommended dose of Oraxim is 250 mg to 500 mg twice daily, depending on the severity and type
of infection.

Children weighing less than 40 kg
Children weighing less than 40 kg should preferably be treated with Oraxim oral suspension or sachets. The recommended dose of Oraxim is 10 mg/kg (up to a maximum of 250 mg) to 15 mg/kg (up to
a maximum of 250 mg) twice daily, depending on:

• the severity and type of infection.

Oraxim 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 required.

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

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

If you stop taking Oraxim
Do not stop Oraxim without medical advice.
It is important to complete the full course of Oraxim treatment. Do not stop unless instructed by your doctor, 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, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash with blisters resembling small targets (a dark spot in the center surrounded by a pale area and a dark ring around the edge).
• Widespread rash with blisters and skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.)
• Widespread rash, elevated body temperature, swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Chest pain occurring during an allergic reaction, which may be a symptom of heart attack caused by an allergy (Kounis syndrome).

Other conditions requiring attention while taking Oraxim include:

• Fungal infections. Medicines like Oraxim can cause overgrowth of fungi (Candida) in the body, leading to fungal infections (such as thrush). This side effect is more likely if Oraxim is taken for a long time.
• Severe diarrhoea (pseudomembranous colitis). Medicines like Oraxim can 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 Oraxim for Lyme disease. This is known as Jarisch-Herxheimer reaction. Symptoms usually last for a few hours 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 clotting)
• 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)
• 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Oraxim

Keep this medicine out of the sight and reach of children.
Store in the original packaging at a temperature not exceeding 30°C.
Do not use Oraxim if the tablets are chipped or show any other visible signs of deterioration.
Do not use this medicine after the expiry date stated on the pack 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 in use. This will help protect the environment.

6. Contents of the pack and other information

What Oraxim contains
The active substance in each tablet is 250 mg or 500 mg of cefuroxime (present as
axetil cefuroxime).
The other components are microcrystalline cellulose, croscarmellose sodium type A, sodium lauryl sulfate,
hydrogenated vegetable oil, anhydrous colloidal silica, hypromellose, propylene glycol and Opaspray white M-1-7120J
[containing titanium dioxide (E171) and sodium benzoate (E211)].

Description of the appearance of Oraxim and contents of the pack
Oraxim 250 mg tablets are white, film-coated, capsule-shaped tablets, plain on one side and engraved with 'GXES7' on the other. They are packaged in aluminum blisters enclosed in a carton box. Each pack contains 12 tablets.
Oraxim 500 mg tablets are white, film-coated, capsule-shaped tablets, plain on one side and engraved with 'GXEG2' on the other. They are packaged in aluminum blisters enclosed in a carton box. Each pack contains 6 or 12 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: MALESCI Istituto Farmacobiologico S.p.A. – Via Lungo l’Ema, 7 Bagno a Ripoli (FI)
Manufacturer responsible for batch release
Manufacturer:
Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria