CEFIXORAL 400 mg Tabletka Powlekana

Treść ulotki

1. Cefixoral 400mg coated tablets, 400mg dispersible tablets
   1. What is Cefixoral and what is it used for?
   2. What you need to know before you take Cefixoral
   3. How to take Cefixoral
   4. Possible side effects
   5. How to store Cefixoral
   6. Contents of the pack and other information
2. Cefixoral 100mg/5ml granules for oral suspension
   1. What is Cefixoral and what is it used for
   2. What you need to know before you use Cefixoral
   3. How to use Cefixoral
   4. Possible side effects
   5. How to store Cefixoral
   6. Contents of the pack and other information

Cefixoral 400mg coated tablets, 400mg dispersible tablets

Cefixime

Read this leaflet carefully before taking this medicine 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 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 Cefixoral is and what it is used for
• 2. What you need to know before you take Cefixoral
• 3. How to take Cefixoral
• 4. Possible side effects
• 5. How to store Cefixoral
• 6. Contents of the pack and other information

1. What is Cefixoral and what is it used for?

Cefixoral contains cefixime, an antibiotic used to treat infections caused by bacteria.
Cefixoral is indicated in adultsfor the treatment of:

• throat infections (pharyngitis, tonsillitis)
• ear infections (otitis media)
• infections of the bronchi and lungs (bronchitis, pneumonia)
• kidney and urinary tract infections

2. What you need to know before you take Cefixoral

Do not take Cefixoral

• if you are allergic to cefixime, or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to penicillins and cephalosporins (antibiotics).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cefixoral
In particular, tell your doctor if:

• you have previously experienced allergic reactions to cephalosporins, penicillins or other medicines. If any allergic reaction occurs during treatment with Cefixoral, you should also stop treatment;
• you have kidney problems, not only if severe (severe renal insufficiency), or are undergoing a blood purification procedure (hemodialysis or peritoneal dialysis);
• you suffer from or have suffered from stomach or intestinal diseases, especially colitis.
• you experience severe skin reactions; in these cases you should also stop treatment;
• you have previously had a decrease in red blood cells due to damage to blood cells (hemolytic anemia). Prolonged use of Cefixoral may cause the development of germs that are not sensitive and in particular an alteration of the normal intestinal flora.

Other medicines and Cefixoral
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking:

• anticoagulants (medicines that delay blood clotting) such as warfarin,
• medicines that reduce intestinal motility.
• nifedipine, a medicine used to lower blood pressure.
• Oral contraceptives (birth control pill). Laboratory tests and CefixoralCefixoral may alter the results of some blood and urine tests.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
The doctor will prescribe Cefixoral to you only if absolutely necessary.

Pregnancy
During the first three months of pregnancy, it is recommended to avoid the administration of Cefixoral.

Breastfeeding
There is no data on the passage of Cefixoral into breast milk.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

Cefixoral dispersible tablets contains the colourant sunset yellow FCF (E110)
May cause allergic reactions.
Cefixoral 400 mg coated tablets contains less than 1 mmol (23 mg) of sodium per dose, i.e.
essentially ‘sodium-free’.

3. How to take Cefixoral

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose in adults is: one tablet (400 mg) once a day.
The score line on the dispersible tablet is to facilitate breaking it to aid
tablet dispersion and not to divide it into equal doses.

Method of administration:
CEFIXORAL can be taken either close to or away from meals.
The CEFIXORAL coated tablet must be swallowed whole.
The CEFIXORAL dispersible tablet should be dissolved in a glass of water. Mix well until
completely dissolved and drink immediately.

Duration of treatment
Most infections can be treated in 7 days of therapy. However, in more
severe cases, Cefixoral can also be used for 14 consecutive days.

Patients with severe kidney problems:
In case of creatinine clearance values < 20 ml/min, in ambulatory peritoneal dialysis or
in hemodialysis, the recommended dosage is 200 mg once a day.

If you take more Cefixoral than you should
If you accidentally take high amounts of medicine, contact your doctor or go to the
nearest hospital.

If you forget to take Cefixoral
Do not take a double dose to make up for a missed dose.

If you stop taking Cefixoral
Do not stop taking the tablets without consulting your doctor, even if you feel better. It is
important to complete the entire treatment prescribed by your doctor.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience the following side effects during treatment with Cefixoral, contact

immediatelyyour doctor who will STOPthe treatment and initiate appropriate therapies and/or
precautionary measures:

• severe allergic reactions (serum sickness-like reaction and anaphylaxis), facial swelling (facial edema), skin or mucous membrane swelling (angioedema), difficulty breathing (dyspnea);
• severe skin and mucous membrane reactions, including blister formation (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms),
• severe antibiotic-associated diarrhea (pseudomembranous colitis). The following side effects may also occur during treatment:
• bacterial resistance
• inflammation of the tongue (glossitis)
• nausea
• vomiting
• heartburn (gastric pyrosis)
• abdominal pain
• diarrhea
• indigestion (dyspepsia)
• flatulence (passage of gas)
• joint pain (arthralgia)
• drug-induced fever
• alteration of some blood tests (transient increase in transaminases, alkaline phosphatase, total bilirubin, blood urea nitrogen and creatinine)
• reduction in the number of white blood cells (leukopenia, neutropenia, granulocytopenia),
• reduction in the number of platelets (thrombocytopenia),
• increase in the number of white blood cells (eosinophilia, agranulocytosis),
• impaired blood coagulation,
• reduction in the number of red blood cells due to damage to blood cells (hemolytic anemia)
• impaired kidney function (acute renal failure and tubulointerstitial nephritis)
• yellowing of the skin and whites of the eyes (jaundice)
• liver inflammation (hepatitis)
• urticaria
• skin rash
• itching
• genital itching
• dizziness
• headache
• fever
• loss of appetite (anorexia)
• vaginal infection caused by a fungus (Candida vaginitis) Reporting of side effects

If you get any side effects, even if not listed in this leaflet, tell your
doctor. You can also report side effects directly through 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 Cefixoral

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 30°C.
Do not take this medicine after the expiry date which is stated on the pack after Expiry.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Cefixoral contains
CEFIXORAL 400 mg

• The active ingredient is: cefixime (400 mg per tablet)
• The other ingredients are: microcrystalline cellulose, pregelatinized starch, dibasic calcium phosphate dihydrate, magnesium stearate, hypromellose, sodium lauryl sulfate, titanium dioxide (E171), liquid paraffin. CEFIXORAL 400 mg
• The active ingredient is: cefixime (400 mg per tablet)
• The other ingredients are: microcrystalline cellulose, hydroxypropylcellulose, anhydrous colloidal silica, povidone, strawberry aroma FA 15757, strawberry aroma PV 4284, magnesium stearate, calcium saccharin, yellow sunset FCF (E110)(see paragraph “Cefixoral dispersible tablets contains yellow sunset FCF (E110)”)

Description of the appearance of Cefixoral and contents of the pack
Cefixoral 400 mg film-coated tablets
Film-coated tablets in blisters of 5 tablets of 400 mg
Cefixoral 400 mg dispersible tablets
Dispersible tablets in blisters of 5 or 7 tablets of 400 mg
Not all pack sizes may be marketed

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. Via Sette Santi 3, Florence

Manufacturer

• A. Menarini Manufacturing Logistic and Services S.r.l., production site Via di Scandicci 37, Florence ACS DOBFAR S.p.A, production site Via Laurentina Km 24,730 - Pomezia (Rome).

Cefixoral 100mg/5ml granules for oral suspension

Cefixime

Read this leaflet carefully before you start to use this medicine 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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Cefixoral is and what it is used for
• 2. What you need to know before you use Cefixoral
• 3. How to use Cefixoral
• 4. Possible side effects
• 5. How to store Cefixoral
• 6. Contents of the pack and other information

1. What is Cefixoral and what is it used for

Cefixoral contains cefixime, an antibiotic used to treat infections caused by bacteria.
Cefixoral is indicated in children over 6 months of age, in the treatment of:

• throat infections (pharyngitis, tonsillitis)
• ear infections (otitis media)
• infections of the bronchi and lungs (bronchitis, pneumonia)
• infections of the kidneys and urinary tract.

2. What you need to know before you use Cefixoral

Do not use Cefixoral

• if you are allergic to cefixime, or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to penicillins and cephalosporins (antibiotics).

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

• you have previously experienced allergic reactions to cephalosporins, penicillins or other medicines;
• during treatment with Cefixoral, any allergic-type reaction occurs, you should also stop treatment;
• you have kidney problems, even if not severe (severe renal insufficiency), or are undergoing a blood purification procedure (hemodialysis or peritoneal dialysis);
• you suffer from or have suffered from stomach or intestinal diseases, especially colitis;
• you experience severe skin reactions; in these cases you should also stop treatment;
• you have previously had a decrease in red blood cells due to damage to blood cells (hemolytic anemia). Prolonged use of CEFIXORAL may cause the development of germs that are not sensitive and in particular an alteration of the normal intestinal flora,

Other medicines and Cefixoral
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular, tell your doctor if you are taking:

• anticoagulants (medicines that delay blood clotting) such as warfarin,
• medicines that reduce intestinal motility.
• nifedipine, (a medicine used to lower blood pressure).
• oral contraceptives (the pill). Laboratory tests and CefixoralCefixoral may alter the results of some blood and urine tests.

Fertility, pregnancy and breastfeeding

Pregnancy
During the first three months of pregnancy, it is recommended to avoid the administration of Cefixoral.

Breastfeeding
There is no data on the passage of Cefixoral into breast milk.

Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.

Cefixoral contains sucrose
If your doctor has diagnosed you with intolerance to some sugars, contact him before using this
medicine.
Cefixoral contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to use Cefixoral

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose in children over 6 months of age is 8 mg/Kg/day once a day.
The Cefixoral package contains a measuring cup (for older children) and a syringe (for
younger children) to allow for correct dosing of the medicine. The following scheme
facilitates the calculation of the dose to be administered according to the child's body weight.
Safety and efficacy in children under 6 months of age have not been established.

Method of administration:
CEFIXORAL can be taken indifferently with or without meals.

Duration of treatment
Most infections can be treated in 7 days of therapy. However, in more
severe cases, CEFIXORAL can also be used for 14 consecutive days.

Instructions for opening the bottle

• Open the bottle by pressing firmly on the cap and rotating it counterclockwise at the same time.

Instructions for preparing the suspension

• Before adding water to reconstitute the granules, turn the bottle upside down and shake it. This operation facilitates reconstitution in case the powder has become compacted at the bottom of the bottle.
• Completely fill the measuring cup with water.
• Add all the water inside the bottle, close the cap tightly, turn it upside down and shake for a few seconds.
• Let it rest for 1-2 minutes.
• Add water up to the level indicated by the arrow.
• Shake the suspension well until the granules are completely dispersed.
• Let it rest for 1-2 minutes.
• If the suspension level is lower than that indicated by the arrow, add more water to bring the level up to that indicated by the arrow.
• Shake vigorously again until a homogeneous suspension is obtained.
• The suspension thus prepared can be stored at room temperature for up to 14 days.
• Shake vigorously before each use. Patients with severe kidney problems:In case of creatinine clearance values < 20 ml/min, in ambulatory peritoneal dialysis or in hemodialysis), the doctor will adjust the dose.

If you use more Cefixoral than you should
In case of accidental use of high doses of the medicine, consult your doctor or go to the
nearest hospital.

If you forget to use Cefixoral
Do not use a double dose to make up for a missed dose.

If you stop using Cefixoral
Do not stop using Cefixoral without consulting your doctor, even if you feel better. It is
important to complete the entire treatment prescribed by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If the following side effects occur during treatment with Cefixoral, contact

immediatelyyour doctor who will STOPthe treatment and initiate appropriate therapies and/or
precautionary measures:

• severe allergic reactions (reaction similar to serum sickness and anaphylaxis), swelling of the face (facial edema), swelling of the skin or mucous membranes (angioedema), difficulty breathing (dyspnea);
• severe skin and mucous membrane reactions, including blister formation (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug eruption with eosinophilia and systemic symptoms),
• severe antibiotic-associated diarrhea (pseudomembranous colitis). The following side effects may also occur during treatment:
• bacterial resistance
• inflammation of the tongue (glossitis)
• nausea
• vomiting
• heartburn (gastric pyrosis)
• abdominal pain
• diarrhea
• indigestion (dyspepsia).
• emission of intestinal gas (flatulence)
• joint pain (arthralgia)
• drug-induced fever
• alteration of some blood tests (transient increase in transaminases, alkaline phosphatase, total bilirubin, blood urea nitrogen and creatinine)
• reduction in the number of white blood cells (leukopenia, neutropenia, granulocytopenia),
• reduction in the number of platelets (thrombocytopenia),
• increase in the number of white blood cells (eosinophilia, agranulocytosis),
• impaired blood coagulation,
• decrease in the number of red blood cells due to damage to blood cells (hemolytic anemia)
• impaired kidney function (acute renal failure and tubulointerstitial nephritis)
• yellowing of the skin and whites of the eyes (jaundice)
• inflammation of the liver (hepatitis)
• urticaria
• skin rash (rash)
• itching
• genital itching
• dizziness
• headache (cephalalgia)
• fever
• loss of appetite (anorexia)
• vaginal infection caused by a fungus (Candida vaginitis). Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, tell your doctor. You can also report side effects directly through 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 Cefixoral

Keep this medicine out of the sight and reach of children.
Store at a temperature not exceeding 30°C.
The suspension after reconstitution must be stored at a temperature not exceeding 25°C. The
suspension must be used within 14 days. Do not store in the refrigerator.
Do not use this medicine after the expiry date which is stated on the pack after Expiry. The
expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Cefixoral contains

• The active ingredient is: cefixime (20 mg/ml)
• The other ingredients are: sucrose(see section “Cefixoral contains sucrose”), xanthan gum, sodium benzoate, strawberry flavour FA 15757 and strawberry flavour PV4284.

Description of the appearance of Cefixoral and contents of the pack
Oral suspension granules 100mg/5ml, in a 100 ml glass bottle. The bottle is equipped with
a child-resistant closure.
The pack contains a measuring spoon and a dosing syringe.

Marketing Authorisation Holder

• A. Menarini Industrie Farmaceutiche Riunite s.r.l. Via Sette Santi 3, Florence

Manufacturer

• A. Menarini Manufacturing Logistic and Services S.r.l., manufacturing plant Via di Scandicci 37, Florence ACS DOBFAR S.p.A, manufacturing plant Via Laurentina Km 24,730 - Pomezia (Rome).