Proxedox

Package leaflet: Information for the patient

PROXEDOX 100 mg film-coated tablets, 200 mg film-coated tablets

Cefpodoxime
Equivalent medicine
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 or pharmacist.
• 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. What PROXEDOX is and what it is used for

PROXEDOX is an antibiotic used in adults and adolescents (over 12 years of age) to kill bacteria causing infection in your body. It belongs to a class of antibiotics called "cephalosporins". Your doctor has prescribed PROXEDOX because you have one (or more) of the following types of infections:

• tonsillitis
• acute sinusitis
• acute exacerbation of chronic bronchitis
• pneumonia

2. What you need to know before taking PROXEDOX

DO NOT take PROXEDOX

• if you are allergic (hypersensitive) to cefpodoxime or other cephalosporins, or to any of the other ingredients of this medicine (listed in section 6)
• if you have previously experienced an immediate and/or severe allergic reaction to antibiotics such as penicillins or beta-lactams.

If you think any of these situations apply to you, talk to your doctor before taking PROXEDOX. In such
cases, your doctor will not prescribe PROXEDOX.
Warnings and precautions
Talk to your doctor or pharmacist before using PROXEDOX.
In particular, inform your doctor if:

• you have impaired kidney function and/or are undergoing any kind of treatment (such as dialysis) for renal failure. In this case, your doctor will prescribe a lower dose of cefpodoxime.
• you have ever had an intestinal inflammation called colitis, or other serious diseases affecting the intestine.
• you need to undergo certain blood tests such as cross-matching and Coombs test (tests usually performed before a blood transfusion), as this medicine may alter their results.
• you have diabetes and need to frequently monitor your urine, as this medicine may interfere with urine tests to determine sugar levels (such as Benedict's or Fehling's tests). Your doctor will recommend using alternative tests to monitor diabetes while taking this medicine.
• you develop skin or mucous membrane disorders.
• you have liver disorders and need to monitor your ASAT, ALAT, alkaline phosphatase, and bilirubin levels, as this medicine may alter these test results.

Inform your doctor or pharmacist if any of these situations apply to you.
Other medicines and PROXEDOX
Inform your doctor or pharmacist if you are currently taking or have recently taken any other medicines,
including those obtained without a prescription.
This medicine may interact with other medicines that are eliminated through the kidneys. There are many
medicines that may cause such interactions; therefore, check with your doctor or pharmacist before taking this
medicine.
In particular, inform your doctor or pharmacist if you are taking:

• Antacids (used to treat indigestion)
• Anti-ulcer agents (used to treat ulcers) such as ranitidine and cimetidine
• Diuretics (used to increase urine flow)
• Aminoglycoside antibiotics used to treat infections
• Probenecid (used to treat gout)
• Anticoagulants, e.g., warfarin

Antacids and anti-ulcer agents (such as ranitidine and cimetidine) should be taken 2–3 hours after taking
PROXEDOX. Your doctor is aware of these medicines and will adjust your treatment if necessary.
If you need to undergo any tests (blood tests, urine tests, or diagnostic tests) while taking this
medicine, make sure your doctor knows that you are taking PROXEDOX.
Serious skin reactions have been reported with cefpodoxime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized acute exanthematous pustulosis (GEP). Discontinue use of
cefpodoxime and contact your doctor immediately if you experience any of the symptoms related to these
serious skin reactions described in section 4.
PROXEDOX with food and drink
Always take this medicine with food (see section 3 “How to use PROXEDOX”).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult
your doctor or pharmacist before using this medicine. Your doctor will evaluate the benefit of treatment with PROXEDOX against the potential risk to the unborn or breastfed child.
During breastfeeding, this medicine may be used. If the infant develops symptoms such as diarrhea or mucosal infections, inform your doctor.
Driving and using machines
During treatment with cefpodoxime, dizziness or seizures, confusion, altered consciousness, and movement disorders (symptoms of a condition called encephalopathy) may occur. These effects may impair your ability to drive vehicles (including bicycles) or operate machinery. If you experience these effects, avoid driving and operating machinery.
PROXEDOX film-coated tablets contain lactose, sodium, and the colouring agent sunset yellow FCF (E110)
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
The colouring agent sunset yellow FCF (E110) may cause allergic reactions.

3. How to take PROXEDOX

Always take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Adults, adolescents (over 12 years of age) and elderly patients
The usual recommended dose is:

• Acute sinusitis: 200 mg twice daily.
• Tonsillitis: 100 mg twice daily.
• Acute exacerbation of chronic bronchitis and pneumonia: 200 mg twice daily.

A cefpodoxime-based preparation specifically intended for neonates and children is available on the market.
Adults, adolescents and elderly patients with kidney problems
Depending on the severity of your kidney problems, the usual dose of cefpodoxime for the type of infection you have
may be given once daily instead of twice daily, or even on alternate days. Your doctor will determine the appropriate dose for you.
If you are on dialysis, you may need to take a dose after each dialysis session. Your doctor will tell you how much to take each time.
It is important to take the medicine at the same time every day. You must always take the tablets with food, as food helps the absorption of the tablets.
If you take more PROXEDOX than you should
If you accidentally take too much medicine, contact your doctor or pharmacist, who will advise you on what to do.
If you forget to take PROXEDOX
If you forget to take a dose at the correct time, take it as soon as possible.
However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for the missed one. Simply take the next dose at the regular time and continue as before.
If you stop taking PROXEDOX
Continue taking the medicine until your doctor tells you to stop. Do not stop treatment just because you start to feel better. If you stop taking the medicine prematurely, your condition may return or worsen.
If you have any questions about the use of PROXEDOX, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, PROXEDOX can cause side effects, although not everyone experiences them.
The side effects are listed below according to their frequency.
Stop taking cefpodoxime and contact your doctor immediately if you notice any of the following symptoms:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• A widespread, red, scaly rash with formation of subcutaneous pustules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

STOP immediately taking this medicine and CONTACT your doctor or the nearest emergency
department if you experience any of the following side effects, as they may be serious:

• Severe allergic reaction. Signs include raised, itchy rash, swelling , sometimes of the face or mouth, causing difficulty in breathing.
• Skin rash , with blisters , appearing as small spots (a dark central spot surrounded by a paler area, with 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).
• Severe diarrhoea or blood in diarrhoeal stools (these may be signs of pseudomembranous colitis or Clostridium difficile colitis).

Contact your doctor if you experience any of the following side effects:
Very common side effects (may affect more than 1 in 10 people)

• Headache
• Stomach ache, diarrhoea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Ringing in the ears (tinnitus)
• Stomach swelling, nausea, vomiting, flatulence
• Loss of appetite
• Changes in certain blood test values assessing liver function (increased aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (PAL))
• Rash, lumpy rash (urticaria), itching

Uncommon side effects (may affect up to 1 in 100 people)

• Other allergic reactions of the skin and mucous membranes
• Tingling and numbness (paraesthesia)
• Weakness and general feeling of illness (asthenia)
• Decrease in certain types of white blood cells (neutropenia)
• Intestinal infection (enterocolitis)
• Anaphylactic reactions, bronchospasm
• Mucocutaneous hypersensitivity reactions

Rare side effects (may affect up to 1 in 1,000 people)

• Changes in blood tests assessing liver function (increased bilirubin)
• Anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen)
• Decrease in certain types of white blood cells (leucopenia)
• Increase in certain types of white blood cells (eosinophilia)
• Increase (thrombocytosis) or decrease (thrombocytopenia) in the number of small blood cells (platelets) necessary for blood clotting.

Very rare side effects (may affect up to 1 in 10,000 people)

• Swelling of the face and extremities (angioedema)
• Increased levels of creatinine and urea in the blood
• Liver damage
• A type of anaemia which may be severe and is caused by the breakdown of red blood cells (haemolytic anaemia)
• Skin rash with blisters, appearing as small spots (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• Widespread rash with blisters and skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis).

Side effects with unknown frequency (cannot be estimated from the available data)

• Decrease in a type of white blood cells (agranulocytosis)
• Presence of blood in stools (haematochezia)
• Severe intestinal inflammation (pseudomembranous colitis, Clostridium difficile colitis)
• Impaired kidney function
• Liver damage with accumulation of bile components in the liver (cholestatic liver damage)
• Red-purple skin spots caused by inflammation of blood vessel walls (purpura). Blister formation on the skin (bullous dermatitis)
• A course of cefpodoxime may temporarily increase the risk of infections caused by other types of germs (superinfections)
• Severe allergic reaction (anaphylactic shock)
• Encephalopathy (a disorder that may include seizures, confusion, altered consciousness, movement disorders). Beta-lactam antibiotics, including cefpodoxime, may predispose to encephalopathy, particularly in cases of overdose or impaired renal function.
• Seizures.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system: 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 PROXEDOX

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp". The expiry date refers to the last day of the month.
Store below 25°C.
Do not use PROXEDOX if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PROXEDOX contains

• The active substance is cefpodoxime.
  Each film-coated tablet contains 100 mg of cefpodoxime (as cefpodoxime proxetil).
  Each film-coated tablet contains 200 mg of cefpodoxime (as cefpodoxime proxetil).
• The excipients are:

calcium carmellose, monohydrate lactose, hydroxypropylcellulose, sodium lauryl sulfate, crospovidone (type B),
corn starch, magnesium stearate.
Film coating: hypromellose 6 cp, titanium dioxide (E171), sunset yellow FCF aluminium lake (E110),
aluminium lake of red allura AC (E129) (only in 200 mg tablets), propylene glycol (E1520), yellow iron oxide (E172) (only in 100 mg tablets).

Description of the appearance of PROXEDOX and pack contents
This medicine is a film-coated tablet; the tablets are yellow-orange in colour, elliptical in shape, with "C" engraved on one side and "61" on the other.
This medicine is a film-coated tablet; the tablets are coral-red in colour, elliptical in shape, with "C" engraved on one side and "62" on the other.

Marketing Authorization Holder
So.Se.PHARM S.r.l., Via dei Castelli Romani, 22 – 00071 Pomezia (Rome).

Manufacturer
ACS DOBFAR S.P.A
Via Laurentina km 24,730
00071 Pomezia (RM)

Medical advice / training
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics for you, it is because they are specifically needed for your current illness.
Despite antibiotic treatment, some bacteria may survive or multiply. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You may also help bacteria become more resistant, thereby slowing down recovery or reducing the effectiveness of antibiotics, if you do not follow the appropriate:

• dosage,
• timing,
• duration of treatment.

Therefore, to preserve the effectiveness of this medicine:
1 - Use antibiotics only when prescribed.
2 - Follow the prescription exactly.
3 - Do not reuse an antibiotic without a medical prescription, even if you are treating a similar illness.
4 - Never give your antibiotic to another person; it may not be suitable for their illness.
5 - After completing treatment, return all unused medicines to the pharmacy to ensure they are properly disposed of.

Patient Information Leaflet: Information for the patient
PROXEDOX 40 mg/5 ml granules for oral suspension
Cefpodoxime
Generic medicine

Please read this leaflet carefully before giving this medicine to your child, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for your child. Do not give it to others, even if their symptoms are the same as your child's, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PROXEDOX is and what it is used for
2. What you need to know before giving PROXEDOX to your child
3. How to give PROXEDOX
4. Possible side effects
5. How to store PROXEDOX
6. Package contents and other information

1. What PROXEDOX is and what it is used for

PROXEDOX is an antibiotic used in children up to 11 years of age to kill bacteria causing infection in their body. It belongs to a class of antibiotics called "cephalosporins".
Your doctor may have prescribed PROXEDOX because your child has one (or more) of the following infections:

• Tonsillitis
• Acute sinusitis
• Acute otitis media
• Pneumonia

2. What you should know before giving PROXEDOX to your child

DO NOT give PROXEDOX to your child

• if the child is allergic (hypersensitive) to cefpodoxime or to other cephalosporins or to any of the other ingredients of this medicine (listed in section 6)
• if the child has previously had an immediate and/or severe allergic reaction to antibiotics such as penicillins or beta-lactams

If you think any of these situations applies to your child, talk to the doctor before giving this medicine.
In such cases, the doctor will not prescribe PROXEDOX.
Warnings and precautions
Talk to your doctor or pharmacist before giving PROXEDOX to your child.
In particular, inform the doctor if your child:

• has poorly functioning kidneys and/or is undergoing any type of treatment (such as dialysis) for kidney failure. In this case, the doctor will prescribe a lower dose of cefpodoxime.
• has ever had an intestinal inflammation called colitis or other serious diseases affecting the intestine.
• needs to undergo certain blood tests such as cross-matching and Coombs test (tests generally performed before a blood transfusion), as this medicine may alter their results.
• has diabetes and frequently checks urine, because this medicine may affect urine test results for sugar levels (such as Benedict's or Fehling's tests). The doctor will recommend using alternative tests to monitor diabetes while your child is taking this medicine.
• develops skin or mucous membrane disorders.
• has liver problems and needs to undergo certain blood tests such as monitoring of ASAT, ALAT, alkaline phosphatase, and bilirubin levels, as this medicine may alter their results.

Inform the doctor or pharmacist if any of these situations applies to your child.
Children and adolescents
This medicine is intended for neonates over 28 days of age and for children up to 11 years of age.
Other medicines and PROXEDOX
Inform the doctor or pharmacist if your child is taking or has recently taken any other medicines, including those not requiring a prescription.
This medicine may interact with other medicines that are eliminated via the kidneys. There are many such medicines, so check with the doctor or pharmacist before giving this medicine to your child.
In particular, inform the doctor or pharmacist if your child is taking:

• Antacids (used to treat indigestion)
• Anti-ulcer drugs (used to treat ulcers) such as ranitidine and cimetidine
• Diuretics (used to increase urine flow)
• Aminoglycoside antibiotics used in the treatment of infections
• Probenecid (used in the treatment of gout)
• Anticoagulants such as warfarin

Antacids and anti-ulcer drugs (such as ranitidine and cimetidine) should be taken by your child 2–3 hours after taking PROXEDOX. Your doctor is aware of these medicines and will adjust treatment if necessary.
If your child needs to undergo tests (blood, urine, or diagnostic tests) while taking this medicine, make sure the doctor knows that your child is taking cefpodoxime.
Severe skin reactions have been reported with cefpodoxime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and generalized exanthematous pustulosis (GEP). Discontinue use of cefpodoxime and contact your doctor immediately if your child develops any symptoms related to these severe skin reactions described in section 4.
PROXEDOX with food and drink
This medicine can be taken with or without food (see section 3 “How to take PROXEDOX”).
Driving and using machines
During treatment with cefpodoxime, dizziness or seizures, confusion, altered consciousness, and movement disorders (symptoms of a condition called encephalopathy) may occur. These effects may impair the ability to drive vehicles (such as bicycles) or operate machinery.
If these effects occur, avoid letting your child use vehicles such as bicycles.
PROXEDOX 40 mg/5 ml oral granules for suspension contains lactose, sucrose, and sodium.
If the doctor has diagnosed your child with an intolerance to certain sugars, contact the doctor before giving this medicine. It contains 2.74 g of sucrose (sugar) in 5 ml. This should be taken into account in patients with diabetes mellitus.
This medicine contains 4.58 mg of sodium (the main component of table salt) per 5 ml. This corresponds to 0.2% of the maximum daily recommended dietary intake for an adult.

3. How to take PROXEDOX

Always take PROXEDOX exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Instructions for reconstitution:

Before preparing the suspension, the desiccant silica gel contained in the cap inside the closure must be removed and discarded. To prepare the suspension, first shake the bottle well to dissolve the granules. Add water up to approximately halfway to the 100 ml mark and shake vigorously. Then, add water up to the 100 ml mark on the bottle and shake vigorously until a homogeneous suspension is obtained.

Infants (over 28 days of age) and children (up to 11 years of age)
The recommended average dose is 8 mg/kg per day, administered in two divided doses given 12 hours apart.

The dose to be taken is indicated on the dosing syringe.

The dosing syringe is suitable only for this oral suspension.

The following table indicates the dosing regimen for children according to body weight increments marked on the dosing syringe.

Children weighing at least 25 kg can take 12.5 ml of suspension twice daily or alternatively one 100 mg film-coated tablet twice daily.
Children with kidney problems
Depending on the severity of the kidney problems, your child may need to take cefpodoxime less frequently, for example once daily or on alternate days. Your doctor will decide the appropriate dose.
It is important that the child takes the medicine at the same time each day.
This medicine can be taken with or without food.
If you give your child more PROXEDOX than you should
If you accidentally give your child too much medicine, contact your doctor or pharmacist, who will advise you on what to do.
If you forget to give your child PROXEDOX
If you forget to give your child a dose of the medicine at the scheduled time, give it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not give your child a double dose to make up for the missed dose. Simply take the next dose at the correct time and continue treatment as before.
If you stop your child’s treatment with PROXEDOX
Continue giving your child the medicine until your doctor tells you to stop. Do not stop treatment just because your child starts to feel better. If you stop treatment prematurely, your child’s condition may return or worsen.
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, PROXEDOX can cause side effects, although not everyone experiences them. The side effects are listed below according to frequency.
Stop using cefpodoxime and contact your doctor immediately if you observe any of the following symptoms in your child:

• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome);
• Generalized red, scaly rash with formation of subcutaneous pustules and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

STOP using this medicine IMMEDIATELY and CONTACT your doctor or the nearest emergency department
if your child experiences any of the following side effects, as they may be serious :

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash with blisters, appearing as small spots (a dark central spot surrounded by a paler area, with 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).
• Severe diarrhoea or blood in diarrhoeal stools (these may be signs of pseudomembranous colitis or Clostridium difficile-associated colitis).

Contact your doctor if your child experiences any of the following side effects:
Very common side effects (may affect more than 1 in 10 people)

• Headache
• Stomach ache, diarrhoea

Common side effects (may affect up to 1 in 10 people)

• Dizziness
• Ringing in the ears
• Stomach swelling, nausea, vomiting, flatulence
• Loss of appetite
• Changes in certain blood test values assessing liver function (increased aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (PAL))
• Rash, lumpy rash (urticaria), itching

Uncommon side effects (may affect up to 1 in 100 people)

• Other skin and mucous membrane allergic reactions
• Tingling and numbness
• Weakness and general feeling of malaise
• Decrease in certain types of white blood cells (neutropenia)
• Intestinal infection (enterocolitis)
• Anaphylactic reactions, bronchospasm
• Mucocutaneous hypersensitivity reactions

Rare side effects (may affect up to 1 in 1,000 people)

• Changes in blood tests monitoring liver function (increased bilirubin)
• Anaemia (reduction in haemoglobin in the blood, the substance that carries oxygen)
• Decrease in certain types of white blood cells (leucopenia)
• Increase in certain types of white blood cells (eosinophilia)
• Increase (thrombocytosis) or decrease (thrombocytopenia) in the number of small blood cells (platelets) necessary for blood clotting.

Very rare side effects (may affect up to 1 in 10,000 people)

• Facial and extremity swelling (angioedema)
• Increased levels of creatinine and urea in the blood
• Liver damage
• A type of anaemia that may be severe and caused by the breakdown of red blood cells (haemolytic anaemia)
• Skin rash with blisters, appearing as small spots (a dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
• Widespread rash with blisters and skin peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)

Side effects with unknown frequency (cannot be estimated from the available data)

• Decrease in a type of white blood cells (agranulocytosis)
• Presence of blood in stools (haematochezia)
• Severe intestinal inflammation (pseudomembranous colitis, Clostridium difficile colitis)
• Kidney function disorders
• Liver damage with accumulation of bile components in the liver (cholestatic liver damage)
• Red-purple skin spots caused by inflammation of blood vessel walls (purpura). Blister formation on the skin (bullous dermatitis)
• A course of PROXEDOX treatment may temporarily increase the risk of infections caused by other types of germs (superinfections)
• Severe allergic reaction (anaphylactic shock)
• Encephalopathy (a disorder that may include seizures, confusion, altered consciousness, movement disorders). Beta-lactam antibiotics, including cefpodoxime, may predispose to encephalopathy, particularly in cases of overdose or reduced renal function.
• Seizures

Reporting of side effects
If you notice any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national 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 PROXEDOX

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of the stated month.
Vial containing the granules: Store below 25°C.
Keep in the original packaging to protect the medicine from light.
Reconstituted suspension: Store in the refrigerator (2°C – 8°C) for no more than 10 days.
Discard any remaining liquid after 10 days.
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. Package contents and other information

What PROXEDOX contains
The active substance is cefpodoxime.
Each 5 ml of suspension contains 52.18 mg of cefpodoxime proxetil (equivalent to 40 mg of cefpodoxime).

• The excipients are: monohydrate lactose, corn starch, sodium croscarmellose, yellow iron oxide, hydroxypropylcellulose, dispersible cellulose, anhydrous colloidal silicon dioxide, anhydrous citric acid, sodium citrate, sodium benzoate, banana flavour, sucrose.

Description of the appearance of PROXEDOX and contents of the pack
Granules for oral suspension.
Granular white powder forming a whitish suspension with banana flavour after reconstitution with water.
PROXEDOX 40 mg/5 ml granules for oral suspension are available in HDPE containers with pack sizes of 100 ml of suspension.
A measuring spoon with graduations from 2 ml to 15 ml is supplied with the bottle for accurate dosing.

Marketing Authorization Holder
So.Se.PHARM S.r.l., Via dei Castelli Romani, 22 – 00071 Pomezia (Rome).

Manufacturer
REMEDINA SA
Gounari 23 & Areos Kamatero Attiki
13451 Greece

Medical advice / education
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, it is because you specifically need them for your current illness.
Despite antibiotic treatment, some bacteria may survive and multiply. This phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You can also help bacteria become more resistant, thereby slowing down recovery or reducing antibiotic effectiveness, if you do not follow the appropriate:

• dosages
• timing
• duration of treatment

Therefore, to preserve the effectiveness of this medicine:
1 - Use antibiotics only when prescribed.
2 - Strictly follow the prescribed instructions.
3 - Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.
4 - Never give your antibiotics to another person; they may not be suitable for their condition.
5 - After completing the treatment, return all unused medicines to a pharmacy to ensure they are properly disposed of.