PROXEDOX 100 mg Film-Coated Tablets

Зміст інструкції

1. PROXEDOX 100 mg film-coated tablets, 200 mg film-coated tablets
   1. What is PROXEDOX and what is it used for
   2. What you need to know before you take PROXEDOX
   3. How to take PROXEDOX
   4. Possible side effects
   5. How to store PROXEDOX
   6. Package Contents and Other Information
2. PROXEDOX 40 mg /5 ml granules for oral suspension
   1. What is PROXEDOX and what is it used for
   2. What you need to know before giving PROXEDOX to your child
   3. How to take PROXEDOX
   4. Possible side effects
   5. How to store PROXEDOX
   6. Package contents and other information

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

Cefpodoxime
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is PROXEDOX and what is it used for

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

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

2. What you need to know before you take PROXEDOX

DO NOT take PROXEDOX

• if you are allergic(hypersensitive) to cefpodoximeor other cephalosporins, or to any of the other ingredients of this medicine (listed in section 6)
• if you have had an immediate and/or serious allergic reactionto antibioticssuch as penicillins or beta-lactams.

If you think that any of these cases apply to you talk to your doctorbefore taking PROXEDOX. In these
cases, the doctor will not prescribe PROXEDOX.

Warnings and precautions
Talk to your doctor or pharmacist before using PROXEDOX.
In particular, tell your doctor if:

• your kidneys do not function very well and/or you are undergoing any type of treatment (such as dialysis) for kidney failure. In this case, your doctor will prescribe a lower dose of cefpodoxime.
• you have ever had an inflammation of the intestine called colitis, or other serious diseases that affect the intestine.
• you are to undergo certain blood tests such as cross-matching and the Coombs test (tests that are generally performed before a blood transfusion), as this medicine may alter their results.
• you have diabetes and need to frequently check your urine as this medicine may alter the results of urine analysis to determine sugar levels (such as Benedict or Fehling tests). Your doctor will advise you to use other tests to monitor diabetes while taking this medicine.
• you experience skin or mucous membrane disorders.
• you have liver disorders and need to check ASAT, ALAT, alkaline phosphatase and bilirubin levels, as this medicine may alter their results.

Tell your doctor or pharmacist if any of these cases apply to you.

Other medicines and PROXEDOX
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those available without a prescription.
This medicine may be affected by other medicines that are eliminated through the kidneys. There are
numerous medicines that can cause this, so check with your doctor or pharmacist before
taking this medicine.
In particular, tell 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 in the treatment of infections
• Probenecid (used in the treatment of gout)
• Anticoagulants, for example warfarin

Antacids and anti-ulcer drugs (such as ranitidine and cimetidine) should be taken 2-3 hours after taking
PROXEDOX. Your doctor is aware of these medicines and will change the treatment if he/she considers it
necessary.
If you need to undergo tests (blood tests, urine tests or diagnostic tests) while taking this
medicine, make sure your doctor is aware that you are taking PROXEDOX.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with cefpodoxime-based treatment. Stop using
cefpodoxime and seek immediate medical attention if you experience any of the symptoms related to these
serious skin reactions described in section 4.

PROXEDOX with food and drink
Always use this medicine with meals (see section 3 “How to use PROXEDOX”).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before using this medicine. Your doctor will assess
the benefit of treatment with PROXEDOX, compared to the risk to the baby.
In case of breastfeeding, this medicine can be used. If the infant experiences disturbances
such as diarrhea or mucosal infections, inform your doctor.

Driving and using machines
During treatment with cefpodoxime, dizziness or convulsions, confusion, altered
consciousness, 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
these effects occur, avoid driving vehicles and operating machinery.

PROXEDOX coated tablets contain lactose, sodium and sunset yellow FCF(E110)
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Sunset yellow FCF (E110) may cause allergic reactions.

3. How to take PROXEDOX

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Adults, adolescents (over 12 years of age) and the elderly
The usual recommended dose is:

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

A preparation based on cefpodoxime specifically for newborns and children is commercially available.

Adults, adolescents and the elderly with kidney problems
Depending on the severity of kidney problems, the usual dose of cefpodoxime for the type of infection you have
may be given once a day instead of twice a day or even on alternate days. Your doctor
will decide the dose you need.
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 each day. You should always take the tablets with
meals because food helps the tablets to be absorbed.

If you take more PROXEDOX than you should
If you have accidentally taken too much medicine, contact your doctor or pharmacist, who will tell you how
to proceed.

If you forget to take PROXEDOX
If you forget to take a dose of the medicine at the right 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 dose. Just take the next dose at the right time and continue
as before.

If you stop taking PROXEDOX
Continue to take the medicine until your doctor tells you to stop. Do not stop the
treatment just because you start to feel better. If you stop the treatment with the medicine, your
condition may recur or worsen.
If you have any doubts about using PROXEDOX, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, PROXEDOX can cause side effects, although not everybody gets them.
Side effects are listed according to frequency.
Stop using cefpodoxime and contact your doctor immediately if you experience any of the
following symptoms:

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

STOPusing this medicine immediately and CONTACTyour doctor or the nearest
emergency roomif you experience any of the following side effects because they can be serious:

• Severe allergic reaction. Signs include significant rash and itching, swelling, sometimes of the face or mouth causing difficulty breathing.
• Rash, with blistersand appears as small signs(dark central spot surrounded by a paler area, with a dark ring around the edge).
• Widespread rashwith blistersand skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Severe diarrhea or blood in diarrheal stools(these may be signs of pseudomembranous colitis or colitis from Clostridium difficile).

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 pain, diarrhea

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

• Dizziness
• Ringing in the ears
• Stomach bloating, nausea, vomiting, flatulence
• Loss of appetite
• Changes in certain values during blood tests that check liver function (increased aspartate amino transferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (ALP))
• Rash, lumpy rash (urticaria), itching

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

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

Rare side effects(may affect up to 1 in 1000 people)

• Changes in blood tests that check liver function (increased bilirubin)
• Anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
• Decrease in some types of white blood cells (leukopenia)
• Increase in some types of white blood cells (eosinophilia)
• Increase (thrombocytosis) or decrease (thrombocytopenia) in the number of small cells (platelets) that are needed 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 anemia that can be serious and is caused by the breakdown of red blood cells (hemolytic anemia)
• Rash, with blisters and appears as small signs (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 available data)

• Decrease in a type of white blood cells (agranulocytosis)
• Blood in the stool (hematochezia)
• Severe inflammation of the intestine (pseudomembranous colitis, colitis from Clostridium difficile)
• Kidney function disorders
• Liver damage with accumulation of bile components in the liver (cholestatic liver damage)
• Red-purple skin spots caused by inflammation of the blood vessel walls (purpura) Blistering of the skin (bullous dermatitis)
• A course of cefpodoxime administration may temporarily increase the risk of contracting infections caused by other types of germs (superinfections)
• Severe allergic reaction (anaphylactic shock)
• Encephalopathy (a disorder that can include seizures, confusion, altered consciousness, movement disorders). Beta-lactam antibiotics, including cefpodoxime, predispose to the risk of encephalopathy, especially in cases of overdose or decreased kidney function.
• Seizures.

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

6. Package Contents and Other Information

What PROXEDOX contains

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

Description of the appearance of PROXEDOX and package contents
This medicinal product is a film-coated tablet; the tablets are yellow-orange in colour, elliptical in shape,
with “C” imprinted on one side and “61” on the other side.
This medicinal product is a film-coated tablet, the tablets are coral red in colour, elliptical in shape,
with “C” imprinted on one side and “62” on the other side.

Marketing Authorisation 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, you specifically need them for the current illness.
Despite the administration of antibiotics, some bacteria may survive or grow. This
phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You can also help bacteria become more
resistant and therefore slow down the cure or decrease the effectiveness of antibiotics, if you do not respect the appropriate:

• dosages
• timings
• duration of treatment.

Therefore, to preserve the effectiveness of this medicine:

• 1 - Use antibiotics only under prescription.
• 2 - Follow the prescription strictly.
• 3 - Do not reuse an antibiotic without a doctor's prescription, even if you want to treat a similar illness.
• 4 - Never give your antibiotic to another person; it may not be suitable for their illness.
• 5 - After completing the treatment, return all unused medicines to the pharmacy to ensure they are disposed of correctly.

PROXEDOX 40 mg /5 ml granules for oral suspension

Cefpodoxime
Generic medicine

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 other people, even if they have the same symptoms as your child, as it could be dangerous.
• If your child experiences any side effects, including those not listed in this leaflet, ask 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. Contents of the pack and other information

1. What is PROXEDOX and what is it used for

PROXEDOX is an antibiotic used in children up to 11 years of age to kill bacteria that cause
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 need to know before giving PROXEDOX to your child

DO NOT give PROXEDOX to your child

• if the child is allergic(hypersensitive) to cefpodoximeor other cephalosporins or to any of the other ingredients of this medicine (listed in paragraph 6)
• if the child has had an immediate and/or severe allergic reactionto antibioticssuch as penicillins or beta-lactam antibiotics

If you think that any of these cases applies to your child talk to your doctorbefore giving them this
medicine. In these cases, the doctor will not prescribe PROXEDOX.

Warnings and precautions
Consult your doctor or pharmacist before giving PROXEDOX to your child.
In particular, tell your doctor if the child:

• has kidneys that are not functioning very well 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 to the child.
• has ever had an inflammation of the intestine called colitis or other serious illnesses that affect the intestine.
• needs to undergo certain blood tests such as cross-matching and the Coombs test (tests that are generally performed before a blood transfusion), as this medicine may alter their results.
• has diabetes and needs to frequently check their urine as this medicine may alter the results of urine analysis to determine sugar levels (such as Benedict or Fehling tests). The doctor will advise using other tests to monitor diabetes while the child is taking this medicine.
• experiences skin or mucous membrane disorders.
• has liver problems and needs to undergo certain blood tests such as checking ASAT, ALAT, alkaline phosphatase and bilirubin levels, as this medicine may alter their results.

Inform your doctor or pharmacist if any of these cases applies to your child.

Children and adolescents
This medicine is for infants who are more than 28 days old and for children up to 11 years of age.

Other medicines and PROXEDOX
Tell your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including those available without a prescription.
This medicine may be affected by other medicines that are eliminated through the kidneys. There are
numerous medicines that can cause this, so check with your doctor or pharmacist before
giving this medicine to your child.
In particular, tell your 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 knows these medicines and will change the treatment if they
deem it appropriate.
If your child needs to undergo tests (blood tests, urine tests or diagnostics) while taking
this medicine, make sure your doctor is informed that they are taking cefpodoxime.
Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal
necrosis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized
exanthematous pustulosis (AGEP) have been reported in association with cefpodoxime-based treatment. Stop using
cefpodoxime and contact your doctor immediately if your child develops any of the symptoms
related to these serious skin reactions described in paragraph 4.

PROXEDOX with food and drink
This medicine can be taken with or without food (see paragraph 3 “How to take PROXEDOX”).

Driving and operating machinery
During treatment with cefpodoxime, dizziness or convulsions, confusion, altered
consciousness, movement disorders (symptoms of a condition called encephalopathy) may occur. These effects may
impair the ability to drive vehicles (such as a bicycle) or use machinery.
If these effects occur, avoid letting the child use vehicles such as a bicycle.

PROXEDOX 40 mg /5 ml granules for oral suspension contains lactose, sucrose and sodium.
If your doctor has diagnosed your child with an intolerance to certain sugars, contact them before
taking this medicine. It contains 2.74 g of sucrose (sugar) in 5ml. This should be taken into consideration in
people with diabetes mellitus.
This medicine contains 4.58 mg of sodium (the main component of table salt) per 5ml. This
is equivalent to 0.2% of the recommended maximum daily intake with the diet of an adult.

3. How to take PROXEDOX

Always take PROXEDOX exactly as your doctor has instructed. 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 disposed of. To prepare the suspension, first
shake the bottle well to dissolve the granules. Add
water up to about halfway to the 100 ml line and shake
vigorously. Then add water up to the
100 ml line of the bottle and shake vigorously until
a homogeneous suspension is obtained.

Infants (over 28 days old) and children (up to 11 years)
The recommended average dose is 8 mg/kg per day administered in two separate doses at intervals of 12
hours.
The dose to be taken is indicated on the measuring spoon.
The dosing spoon is only suitable for this oral suspension.
The following table indicates the dosage regimen for children according to the body weight graduations
provided by the measuring spoon.
Children weighing at least 25 kg can take 12.5 ml of suspension twice a day or
alternatively 1 film-coated tablet of 100 mg, twice a day.
Children with kidney problems

Depending on the severity of the kidney problems, your child may need to take cefpodoxime less
frequently, for example once a day or on alternate days. Your doctor will decide the necessary 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 have accidentally given too much medicine to your child, contact your doctor or pharmacist, who will
tell you 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 the child a double dose
to make up for the forgotten dose. Just take the next dose at the right time and
continue therapy as before.

If you stop your child's treatment with PROXEDOX
Continue to give your child the medicine until your doctor has told you to stop. Do not
stop treatment just because your child begins to feel better. If you stop treatment with the
medicine, your child's condition may recur or worsen.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

STOPusing this medicine IMMEDIATELYand CONTACTyour doctor or the nearest emergency roomif your child experiences any of the following side effects because they can be

serious:

• Severe allergic reaction. Signs include significant and itchy rash, swelling, sometimes of the face or mouth causing difficulty breathing.
• Rash, with blistersand appears as small signs(dark central spot surrounded by a paler area, with a dark ring around the edge).
• Widespread rashwith blistersand skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Severe diarrhea or blood in diarrheal stools(these may be signs of pseudomembranous colitis or colitis from Clostridium difficile).

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, diarrhea.

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

• Dizziness
• Ringing in the ears
• Stomach bloating, nausea, vomiting, flatulence
• Loss of appetite
• Changes in some values during blood tests that check liver function (increased aspartate amino transferase (ASAT), alanine aminotransferase (ALAT), alkaline phosphatase (ALP))
• Rash, lumpy rash (urticaria), itching.

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

• Other allergic skin and mucous membrane reactions
• Tingling and numbness
• Weakness and general feeling of discomfort
• Decrease in some 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 that check liver function (increased bilirubin)
• Anemia (reduction of hemoglobin in the blood, a substance that carries oxygen in the blood)
• Decrease in some types of white blood cells (leukopenia)
• Increase in some types of white blood cells (eosinophilia)
• Increase (thrombocytosis) or decrease (thrombocytopenia) in the number of small cells (platelets) that are needed 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 anemia that can be serious and is caused by the breakdown of red blood cells (hemolytic anemia)
• Rash, with blisters and appears as small signs (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 on the basis of available data)

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp.
The expiry date refers to the last day of the month.
Bottle containing the granules: Store at a temperature below 25°C.
Store in the original packaging to protect the medicine from light.
Reconstituted suspension: Store in a refrigerator (2°C – 8°C) for no more than 10 days.
Discard any remaining liquid after 10 days.
Do not dispose of any medicine in 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 ingredient is cefpodoxime
Each 5 ml of suspension contains 52.18 mg of cefpodoxime proxetil (equivalent to 40 mg of cefpodoxime).

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

Description of PROXEDOX and package contents
Granules for oral suspension.
Whitish-coloured granular powder that forms a whitish suspension with a banana flavour, after
reconstitution with water.
PROXEDOX 40 mg/5 ml granules for oral suspension is available in HDPE containers in packs
of 100 ml of suspension.
A measuring device with graduations from 2 ml to 15 ml is supplied with the bottle, for correct dosage .
Marketing Authorisation Holder
So.Se.PHARM S.r.l., Via dei Castelli Romani, 22 – 00071 Pomezia (Roma).

Manufacturer
REMEDINA SA
Gounari 23 & Areos Kamatero Attiki
13451 Greece

Medical advice / training
Antibiotics are used to treat bacterial infections. They are ineffective against viral infections.
If your doctor has prescribed antibiotics, you specifically need them for the current illness.
Despite the administration of antibiotics, some bacteria can survive and grow. This
phenomenon is called resistance: some antibiotic treatments become ineffective.
Improper use of antibiotics increases resistance. You can also help bacteria become more
resistant and therefore slow down the cure or decrease the effectiveness of antibiotics, if you do not respect the appropriate:

• dosages
• timings
• duration of treatment.

Therefore, to preserve the effectiveness of this medicine:

• 1 - Use antibiotics only under prescription.
• 2 - Follow the prescription strictly.
• 3 - Do not reuse an antibiotic without a medical prescription, even if you want to treat a similar illness.
• 4 - Never give your antibiotic to another person; it may not be suitable for their illness.
• 5 - After completing the treatment, return all unused medicines to the pharmacy to ensure they are disposed of correctly.