Polares & Polares-100
Therapy Area
Anti Infective
1.0 Generic Name
Cefpodoxime Oral Suspension IP
2.0 Qualitative and quantitative composition
Polares Dry Suspension
Each 5 ml of reconstituted suspension contains :
Cefpodoxime Proxetil IP
equivalent to Cefpodoxime 50 mg
Excipients q.s
Colour : Quinoline Yellow WS
Polares-100 Dry Suspension
Each 5 ml of reconstituted suspension contains :
Cefpodoxime Proxetil IP
equivalent to Cefpodoxime 100 mg
Excipients q.s.
Colour : Quinoline Yellow WS
3.0 Dosage form and strength
Dry Suspension, 50 / 100 mg
4.0 Clinical particulars
4.1 Therapeutic indication
Acute bronchitis, exacerbations of chronic bronchitis, bronchiolitis pneumonia, sinusitis, recurrent chronic tonsillitis, pharyngitis, acute otitis
4.2 Posology and method of administration
The recommended dosages, durations of treatment, and applicable patient population are as described in the following chart:
Adults and Adolescents (age 12 years and older)
Patients with Renal Insufficiency: For patients with severe renal impairment (<30 mL/min creatinine clearance), the dosing intervals should be increased to every 24 hours. In patients maintained on haemodialysis, the dose frequency should be 3 times/week after hemodialysis. Geriatric use: Dose adjustment in elderly patients with normal renal function is not necessary.
Patients with Hepatic Disease: No dose adjustment is necessary for cirrhotic patients (with or without ascites). Directions for reconstitution Shake the bottle well to loosen the granules. Add freshly boiled and cooled water upto the ring mark on the bottle and shake well. Add more water if necessary to adjust the volume upto the mark. Any unused reconstituted suspension should be discarded after 14 days. Store the constituted oral suspension in a refrigerator.
4.3 Contraindications
• known allergy to cefpodoxime or to the cephalosporin group of antibiotics or to any of the excipients.
• previous history of immediate and / or severe hypersensitivity reaction (anaphylaxis) to penicillin or other betalactam antibiotic.
4.4 Special warnings and precautions for use
Before therapy with cefpodoxime proxetil is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cefpodoxime, other cephalosporin, penicillin, or other drugs. If cefpodoxime is to be administered to penicillin sensitive patients, caution should be exercised because cross hypersensitivity among beta-lactam antibiotics has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to cefpodoxime proxetil occurs, discontinue the drug. Serious acute hypersensitivity reactions may require treatment with epinephrine and other emergency measures, including oxygen, intravenous fluids, intravenous antihistamine, and airway management. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefpodoxime, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated. In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of cefpodoxime proxetil should be reduced because high and prolonged serum antibiotic concentrations can occur in such individuals following usual doses. Cefpodoxime, like other cephalosporin, should be administered with caution to patients receiving concurrent treatment with potent diuretics.
4.5 Drugs interactions
Antacids: Concomitant administration of high doses of antacids (sodium bicarbonate and aluminum hydroxide) or H2 blockers (e.g. ranitidine) reduce peak plasma levels and the extent of absorption but do not alter the rate of absorption. Probenecid: Inhibits renal excretion of Cefpodoxime, resulting in an increase in AUC and peak plasma levels. Nephrotoxic drugs: Close monitoring of renal function is advised when cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential.
4.6 Use in special populations
Pregnancy
Pregnancy Category B There are, however, no adequate and well-controlled studies of cefpodoxime proxetil use in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing mothers
Cefpodoxime is excreted in human milk. Because of the potential for serious reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
4.7 Effects on ability to drive and use machines
Dizziness has been reported during treatment with cefpodoxime and may affect the ability to drive and use machines.
4.8 Undesirable effects
In clinical trials using multiple doses of cefpodoxime proxetil granules for oral suspension, 2128 pediatric patients (93% of whom were less than 12 years of age) were treated with the recommended dosages of cefpodoxime (10 mg/kg/day Q 24 hours or divided Q 12 hours to a maximum equivalent adult dose). There were no deaths or permanent disabilities in any of the patients in these studies. Twenty-four patients (1.1%) discontinued medication due to adverse events thought possibly- or probably-related to study drug. Primarily, these discontinuations were for gastrointestinal disturbances, usually diarrhea, vomiting, or rashes. Adverse events thought possibly- or probably-related, or of unknown relationship to cefpodoxime proxetil for oral suspension in multiple dose clinical trials (N=2128 patients treated with cefpodoxime) were:
Incidence Less Than 1%
Body: Localized abdominal pain, abdominal cramp, headache, monilla, generalized abdominal pain, asthenia, fever, fungal infection. Digestive: Nausea, monilia, anorexia, dry mouth, stomatitis, pseudomembranous colitis. Hemic & Lymphatic: Thrombocythemia, positive direct Coombs' test, eosinophilla, leukocytosis, leukopenia, prolonged partial thromboplastin time, thrombocytopenic purpura. Metabolic & Nutritional: Increased SGPT Musculo-Skeletal: Myalgia. Nervous: Hallucination, hyperkinesia, nervousness, somnolence. Respiratory: Epistaxis, rhinitis, Skin: Fixed drug eruption (FDE), skin moniliasis, urticaria, fungal dermatitis, acne, exfoliative dermatitis, maculopapular rash. Special Senses: Taste perversion. Laboratory Changes Significant laboratory changes that have been reported in adult and pediatric patients in clinical trials of cefpodoxime proxetil, without regard to drug relationship, were: Hepatic: Transient Increases in AST (SGOT), ALT (SGPT), GGT, alkaline phosphatase, bilirubin, and LDH. Hematologic: Eosinophilia, leukocytosis, lymphocytosis, granulocytosis, basophilia, mono- cytosis, thrombocytosis, decreased hemoglobin, decreased hematocrit, leukopenia, neu- tropenia, lymphocytopenia, thrombocytopenia, thrombocythemia, positive Coombs' test, and prolonged PT, and PTT. Serum Chemistry: Hyperglycemia, hypoglycemia, hypoalbuminemia, hypoproteinemia, hyperkalemia, and hyponatremia. Renal: Increases in BUN and creatinine. Most of these abnormalities were transient and not clinically significant.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zuventus.com By reporting side effects, you can help provide more information on the safety of this medicine.
4.9 Overdose
The toxic symptoms following an overdose of beta-lactam antibiotics may include nausea, vomiting, epigastric distress, and diarrhea. In the event of serious toxic reaction from overdosage, hemodialysis or peritoneal dialysis may aid in the removal of cefpodoxime from the body.
5.0 Pharmacological properties
5.1 Mechanism of Action
Cefpodoxime is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Cefpodoxime has activity in the presence of some betalactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.
5.2 Pharmacodynamic properties
Resistance to Cefpodoxime is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability. Cefpodoxime has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections
Gram-positive Bacteria
Staphylococcus aureus (methicillin-susceptible strains, including those producing penicillinases) Staphylococcus saprophyticus Streptococcus pneumoniae (excluding penicillin-resistant isolates) Streptococcus pyogenes
Gram-negative Bacteria
Escherichia coli Klebsiella pneumoniae Proteus mirabilis Haemophilus influenzae (including beta-lactamase producing isolates) Moraxella catarrhalis Neisseria gonorrhoeae (including penicillinase-producing isolates) The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for cefpodoxime. However, the efficacy of cefpodoxime in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.
Gram-positive Bacteria
Streptococcus
agalactiae
Streptococcus spp.
(Groups C, F, G)
Gram-negative Bacteria
Citrobacter diversus
Klebsiella oxytoca
Proteus vulgaris
Providencia rettgeri
Haemophilus parainfluenzae
Anaerobic Gram-positive Bacteria
Peptostreptococcus magnus
5.3 Pharmacokinetic properties
Absorption
Following oral administration of 100 mg of cefpodoxime proxetil to fasting subjects, approximately 50% of the administered cefpodoxime dose was absorbed systemically. Over the recommended dosing range (100 to 400 mg), the rate and extent of cefpodoxime absorption exhibited dose-dependency. Over the recommended dosing range, the Tmaxwas approximately 2 to 3 hours and the T½ ranged from 2.09 to 2.84 hours. Mean Cmax was 1.4 mcg/mL for the 100 mg dose, 2.3 mcg/mL for the 200 mg dose, and 3.9 mcg/mL for the 400 mg dose. In patients with normal renal function, neither accumulation nor significant changes in other pharmacokinetic parameters were noted following multiple oral doses of up to 400 mg Q 12 hours.
Distribution
Protein binding of cefpodoxime ranges from 22 to 33% in serum and from 21 to 29% in plasma.
Skin Blister
Following multiple-dose administration every 12 hours for 5 days of 200 mg or 400 mg cefpodoxime proxetil, the mean maximum cefpodoxime concentration in skin blister fluid averaged 1.6 and 2.8 mcg/mL, respectively.
Tonsil Tissue
Following a single, oral 100 mg cefpodoxime proxetil film-coated tablet, the mean maximum cefpodoxime concentration in tonsil tissue averaged 0.24 mcg/g at 4 hours post-dosing and 0.09 mcg/g at 7 hours post-dosing. These results demonstrated that concentrations of cefpodoxime exceeded the MIC90 of S. pyogenes for at least 7 hours after dosing of 100 mg of cefpodoxime proxetil.
Lung Tissue
Following a single, oral 200 mg cefpodoxime proxetil film coated tablet, the mean maximum cefpodoxime concentration in lung tissue averaged 0.63 mcg/g at 3 hours post-dosing, 0.52 mcg/g at 6 hours post-dosing, and 0.19 mcg/g at 12 hours post-dosing. The results of this study indicated that cefpodoxime penetrated into lung tissue and produced sustained drug concentrations for at least 12 hours after dosing at levels that exceeded the MIC90 for S. pneumoniae and H. influenzae.
Effects of Decreased Renal Function
Elimination of cefpodoxime is reduced in patients with moderate to severe renal impairment (<50 mL/min creatinine clearance). In subjects with mild impairment of renal function (50 to 80 mL/min creatinine clearance), the average plasma half-life of cefpodoxime was 3.5 hours. In subjects with moderate (30 to 49 mL/min creatinine clearance) or severe renal impairment (5 to 29 mL/min creatinine clearance), the half-life increased to 5.9 and 9.8 hours, respectively. Approximately 23% of the administered dose was cleared from the body during a standard 3-hour hemodialysis procedure. Effect of Hepatic Impairment (cirrhosis) Absorption was somewhat diminished and elimination unchanged in patients with cirrhosis. The mean cefpodoxime Trot and renal clearance in cirrhotic patients were similar to those derived in studies of healthy subjects. Pharmacokinetics in Elderly Subjects Elderly subjects do not require dosage adjustments unless they have diminished renal function.
6.0 Nonclinical properties
6.1 Animal Toxicology or Pharmacology
No known animal toxicology data
7.0 Description
Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. The chemical name is (RS)-1(isopropoxycarbonyloxy) ethyl (+)-(6R,7R)-7-[2- (2-amino-4-thiazolyl)-2-{(Z)methoxyimino} acetamido]-3- methoxymethyl-8-oxo-5-thia-1-azabicyclo [4.2.0]oct-2-ene-2- carboxylate. Its structural formula is represented below:
Molecular Formula: C21H27N5O9S2
Molecular Weight: 557.6
8.0 Pharmaceutical particularssuspension
8.1 Incompatibilities
Not Applicable
8.2 Shelf-life
Refer on the pack.
8.3 Packaging information
Polares Dry Suspension : A bottle of 7.5 g / 30 ml.
Polares-100 Dry Suspension : A bottle of 15 g / 30 ml.
8.4 Storage and handing instructions Store below 30°C. Protect from moisture
Keep out of reach of children.
Store the reconstituted oral suspension in a refrigerator (at 2°C to 8°C).
9.0 Patient Counselling Information
Patients should be counseled that antibacterial drugs including Cefpodoxime Proxetil Suspension, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Cefpodoxime Proxetil Suspension, is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may
(1) decrease the effectiveness of the immediate treatment and
(2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefpodoxime Proxetil Suspension, or other antibacterial drugs in the future.
Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible
About leaflet
Read all of this leaflet carefully before you start giving this medicine to your child because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
- If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
- What Polares and Polares-100 dry suspension is and what it is used for
- What you need to know before you give Polares and Polares-100 dry suspension
- How to give Polares and Polares-100 dry suspension
- Possible side effects
- How to store Polares and Polares-100 dry suspension
- Contents of the pack and other information
1. What Polares and Polares-100 dry suspension is and what it is used for
Polares and Polares-100 dry suspension contains cefpodoxime, which is an antibiotic. It belongs to a group of antibiotics that are called cephalosporins. These types of antibiotics are similar to penicillin.
Cefpodoxime kills bacteria and it can be used against various sorts of infections.
Like all antibiotics, cefpodoxime is only effective against some types of bacteria. So, it is only suitable for treating some types of infection.
Polares dry suspension can be used to treat:
- Sinus infections
- Throat infections – e.g. Tonsil infection
- Chest infections such as bronchitis and some types of pneumonia
- Ear infection (acute otitis media)
2. What you need to know before you give Polares and Polares-100 dry suspension
Do not give Polares and Polares-100 dry suspension if your child:
- is allergic to cefpodoxime or to any of the other ingredients of this medicine (listed in section 6).
- is allergic to any other cephalosporin type of antibiotic.
- has ever had a severe allergic reaction to any sort of penicillin antibiotic.
- suffers from phenylketonuria.
- is less than 28 days (4 weeks) old.
- is four weeks to three months of age and has kidney problems.
Not all people who are allergic to penicillins are also allergic to cephalosporins.
However, your child should not be given this medicine if they have ever had a severe allergic reaction to any penicillin. This is because they might also be allergic to this medicine.
If you are not sure about anything, ask your doctor or pharmacist.
Warnings and precautions
Talk to your doctor or pharmacist before giving Polares dry suspension if your child:
- has ever had an allergic reaction to any antibiotic.
- has any other allergies, e.g. hay fever, asthma.
- has ever been told that their kidneys do not work very well. Also, if your child is having any sort of treatment (like dialysis) for kidney failure. Your child may take cefpodoxime but you may need to give a lower dose.
- has ever had inflammation of their bowel, called colitis or any other severe disease affecting their gut.
- has, or has recently had, severe diarrhoea and sickness (vomiting).
- has diabetes and you routinely test their urine, this medicine can alter the results of urine tests for sugar (such as Benedict's or Fehling's tests).
- Other tests may have to be used to monitor their diabetes while they are taking this medicine. – if they have signs of diseases of the skin or mucous.
During treatment
- This medicine can alter the results of some blood tests (such as cross-matching blood and the Coombs' test). It is important to tell the doctor that your child is taking this medicine if they have to have any of these tests.
- Your child’s doctor might have to monitor their blood liver enzymes levels as this medicine may increase their values.
- Talk to your doctor or pharmacist if your child suffers from severe diarrhoea or being sick especially if they are also taking other medicines.
- If your child gets other infections such as thrush, talk to your doctor or pharmacist.
Other medicines and Polares and Polares-100 dry suspension
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
This medicine can be affected by other medicines that are removed by the kidneys. This is especially if these other medicines also affect how well kidneys work. There are many medicines that can do this, so you should check with your doctor or pharmacist before giving this medicine.
In particular, tell your doctor or pharmacist if your child is taking:
- Antibiotics called aminoglycosides (such as gentamicin) or other antibiotics such as chloramphenicol, erythromycin, tetracycline or sulfonamides (e.g. co-trimoxazole).
- Water tablets or injections (diuretics) such as furosemide used to increase the flow of water (urine). It might be necessary to check the kidneys often during treatment. This can be done with blood and urine tests.
- Antacids (used to treat indigestion) and medicines for treating ulcers (such as ranitidine or cimetidine): Give antacids and medicines for ulcers 2-3 hours after this medicine as they may reduce the effect of cefpodoxime when taken at the same time.
- Probenecid as it may slow down the kidneys’ ability to get rid of cefpodoxime.
- Coumarin anti-coagulants such as warfarin (used to thin the blood) as their effect may be increased by cefpodoxime.
Polares and Polares-100 dry suspension with food
Give this medicine with meals. This is because it helps this medicine to be absorbed into the body.
Pregnancy and breast-feeding
This section may not be applicable to children.
If, however, you are an adult taking this medicine, are you pregnant, think you might be pregnant or planning to have a baby? Although this medicine is not known to harm the unborn child, it will only be given to a pregnant woman if it is really necessary.
Are you breast-feeding? This medicine should not be given to women who are breast-feeding. This is because small amounts of it enter the milk. This could cause an allergic reaction or other side effects in the breast-fed baby.
Ask your doctor or pharmacist for` advice before taking any medicine.
Driving and using machines
Your child may get dizzy, light-headed or in more extreme cases experience convulsions, confusion, change of consciousness and movement disorders when taking this medicine. This may affect their ability to ride bikes etc.
3. How to give Polares and Polares-100 dry suspension
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The dispensing label will tell you how much of this medicine you should give and how often you should give it. Please read it carefully. The dose your doctor prescribes depends on the type of infection and how bad the infection is. It also depends on how well the kidneys are working. Your doctor will explain this to you.
Adults: Teenagers and adults who need treatment with cefpodoxime are usually given tablets. Separate patient information leaflets are provided with the tablets.
Children older than four weeks (28 days) up to 11 years: The daily amount is worked out according to the weight of the child.
Give each dose every 12 hours with a meal.
The exact dose will have been worked out by the doctor and shown on the label.
The following table provides a guide to usual doses:
Adults and Adolescents (Age 12 years and older)
| Type of infection | Total daily dose | Dose frequency | Duration |
|---|---|---|---|
| Pharyngitis or tonsillitis | 200 mg | 100 mg every 12 hour | 5 to 10 days |
| Acute-community acquired pneumonia | 400 mg | 200 mg every 12 hour | 14 days |
| Acute exacerbations of chronic bronchitis | 400 mg | 200 mg every 12 hours | 10 days |
| Acute maxillary sinusitis | 400 mg | 200 mg every 12 hours | 10 days |
| Acute otitis media | 10 mg/kg/day | 5mg/kg every 12 hr | 5 days |
| Pharyngitis or tonsillitis | 10 mg/kg/day | 5mg/kg every 12 hr | 5 to 10 days |
| Acute maxillary sinusitis | 10 mg/kg/day | 5mg/kg every 12 hr | 10 days |
How to measure the dose?
Measuring Cap is provided with medicine.
Ask your doctor or pharmacist if you need advice on how to measure out the medicine.
Children under four weeks (28 days) old should not take this medicine.
If your child has kidney problems your doctor may prescribe a different dose than usual. Usually, this means giving doses less often than twice a day.
How to prepare this medicine?
Shake the bottle well to loosen the granules.
Add freshly boiled and cooled water upto the ring mark on the bottle and shake well.
Add more water if necessary to adjust the volume upto the mark.
Any unused reconstituted suspension should be discarded after 14 days.
Store the constituted oral suspension in a refrigerator.
Always remember to shake the bottle before measuring out each dose.
If you give more Polares and Polares-100 dry suspension than you should
If you or your child have taken more of this medicine than you should, talk to your doctor straight away or go to the nearest hospital accident and emergency department. Your child may be unable to concentrate, lack energy and experience a decrease in consciousness. These effects are more likely to occur if your child has kidney problems. Take the medicine with you in the carton, so that staff will know exactly what has been taken.
If you forget to give Polares and Polares-100 dry suspension
If you forget to give a dose of this medicine at the right time, give it as soon as you remember. Do not give a double dose to make up for a forgotten dose.
If you stop giving Polares and Polares-100 dry suspension
It is important that you give this medicine until you finish giving the prescribed course. You should not stop giving the medicine just because your child looks or feels better. If you stop too soon, the infection may start up again. If the person being treated still feels unwell at the end of the prescribed course of treatment, or feels worse during treatment, tell your doctor.
If you have any further questions on 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 gets them.
If you notice any of the following side effects, stop giving this medicine and contact your doctor or take your child to the nearest hospital casualty department straight away:
- A reduction of white blood cells that may cause an increase in the number of new infections that your child gets, such as sore throat or mouth ulcers, or damage to red blood cells, that may cause your child to feel tired and breathless with possible yellowing of the skin.
- Severe allergic reactions which may cause sudden wheeziness and tightness of chest swelling of eyelids, face or lips, loss of consciousness (fainting).
- Severe skin rashes which may include peeling of the skin (Toxic epidermal necrolysis) or that can blister (bullous dermatitis) and may involve the eyes, mouth and throat and genitals (Stevens-Johnson syndrome).
- A course of cefpodoxime can increase the chance that your child gets other types of infection. For example, thrush may occur (white patches on the tongue or a creamy white discharge from the penis or vagina) or severe diarrhoea which may be bloody with stomach pain.
- Liver damage causing jaundice (this may show as a yellowing of the skin or whites of the eyes)
- Sudden severe dull pain around the top of the stomach which radiates to the back, feeling and being sick, which may be due to inflammation of the pancreas.
- A disease that affects the function or structure of your brain (encephalopathy). The symptoms might include among others difficulty with memory or focusing and changes in personality.
Other possible side effects
Very Common (may affect more than 1 in 10 people):
- Headaches.
- Stomach pain.
- Diarrhoea. If you have severe diarrhoea or if you see blood in your diarrhoea you should stop taking this medicine and talk to your doctor immediately.
Common (may affect up to 1 in 10 people):
- Dizziness.
- Bloating, feeling or being sick (nausea, vomiting), flatulence (wind).
- Loss of appetite.
- Changes in blood tests that check how your liver is working.
- Skin rash, hives, itching Ringing in the ears.
Uncommon (may affect up to 1 in 100 people):
- Skin and mucosa skin allergic reactions.
- Pins and needles
Weakness, tiredness and a feeling of generally being unwell.
Rare (may affect up to 1 in 1,000 people):
- Increases in some types of white blood cells, reduced number of small cells that are needed for clotting of the blood, which may cause easy bruising or bleeding.
- Increases in the numbers of small cells that are needed for clotting of the blood, which may show up in blood tests.
- Changes in the way that the kidney is working, which may show up in blood tests.
Very rare (may affect less than 1 in 1,000 people)
- Reduction of red blood cells (haemolytic anaemia)
Not Known (frequency cannot be estimated from the available data)
Fresh, red blood in your stools (haematochezia).
- Purplish-red patches.
- Kidney problems.
During treatment
If your child is having a blood test for any reason, tell the person who is taking their blood sample that you are giving this medicine as it may affect their result.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: Website: www.zuventus.com and click the tab “Safety Reporting” located on the top of the home page.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Polares dry suspension
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 bottle after EXP. The expiry date refers to the last day of that month.
Before being made up into a solution, do not store above 25ºC. Store in the original package.
Once made up into a solution, store the medicine in a refrigerator (2-8 ºC) and do not use any remaining medicine after 14 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Polares dry suspension contains
Polares Dry Suspension
Each 5 ml of reconstituted suspension contains:
Cefpodoxime Proxetil IP equivalent to Cefpodoxime 50 mg
Polares-100 Dry Suspension
Each 5 ml of reconstituted suspension contains:
Cefpodoxime Proxetil IP equivalent to Cefpodoxime 100 mg
What Polares oral suspension looks like and contents of the pack
A bottle of 7.5 g / 30 ml
A bottle of 15 g / 30 ml