Cefixoral

Package leaflet: Information for the user

Cefixoral 100mg/5ml granules for oral suspension

Cefixime
Please read all of this leaflet carefully before you start using 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, as it may 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 Cefixoral is and what it is used for
2. What you need to know before taking 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 Cefixoral is and what it is used for

Cefixoral contains cefixime, an antibiotic used to treat infections caused by bacteria.
Cefixoral is indicated in children over 6 months of age for 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 using 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 or cephalosporins (antibiotics).

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

• you have previously experienced allergic reactions to cephalosporins, penicillins, or other medicines.
• you develop any allergic-type reaction during treatment with Cefixoral; in such cases, you must also stop treatment.
• you have kidney problems, not only severe ones (severe renal failure), or are undergoing a blood purification procedure (haemodialysis or peritoneal dialysis).
• you suffer or have suffered from stomach or intestinal diseases, especially colitis.
• you develop severe skin reactions; in such cases, you must also stop treatment.
• you have previously had a reduction in red blood cells due to damage to blood cells (haemolytic anaemia).

Prolonged use of CEFIXORAL may lead to the development of resistant microorganisms and, in particular, to alterations in the normal intestinal flora.
Other medicines and Cefixoral
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform 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 pills).

Laboratory tests and Cefixoral
Cefixoral may alter the results of certain blood and urine tests.
Fertility, pregnancy and breastfeeding
Pregnancy
During the first three months of pregnancy, administration of Cefixoral is not recommended.
Breast-feeding
There are no data on the passage of Cefixoral into breast milk.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Cefixoral contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before using this medicine. It contains 6.07 g of sucrose (sugar) per 12 ml. This should be taken into account in patients with diabetes mellitus.
Cefixoral contains sodium
Cefixoral contains less than 1 mmol (23 mg) of sodium per bottle (100 ml), i.e. essentially 'sodium-free'.
Cefixoral contains sodium benzoate
This medicine contains 6.3 mg of sodium benzoate per 12 ml of medicine.
Cefixoral contains benzyl alcohol
This medicine contains 0.001155 mg of benzyl alcohol per 12 ml of medicine. Benzyl alcohol may cause allergic reactions.
Do not use for more than one week in young children (under 3 years of age) unless otherwise recommended by a doctor or pharmacist.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause undesirable effects (such as metabolic acidosis).
Cefixoral contains sulphites
Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
Cefixoral contains ethanol
This medicine contains 0.020 mg of alcohol (ethanol) in every 12 ml. The amount in 12 ml of this medicine is equivalent to less than 0.0005 ml of beer or 0.0002 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Cefixoral

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose for children over 6 months of age is 8 mg/kg/day once daily.
The Cefixoral package contains a measuring cup (for older children) and a syringe (for
younger children) to accurately measure the correct dose of the medicine. The table below
helps calculate the dose to be administered according to the child's body weight.

The safety and efficacy in children under 6 months of age have not been established.
Administration method:
CEFIXORAL may be taken regardless of meals, either close to or apart from food intake.
Duration of treatment
Most infections can be treated within 7 days of therapy. However, in more severe cases,
CEFIXORAL may be used for up to 14 consecutive days.
Instructions for opening the bottle
➢ Open the bottle by pressing firmly down on the cap while simultaneously turning it counterclockwise.

Instructions for preparing the suspension
➢ Before adding water to reconstitute the granules, invert and shake the bottle. This step facilitates reconstitution if the powder has compacted at the bottom of the bottle.
➢ Completely fill the dosing cup with water.
➢ Add all the water into the bottle, close the cap tightly, invert, and shake for a few seconds.
➢ Let stand for 1–2 minutes.
➢ Add water up to the level indicated by the arrow.
➢ Shake the suspension thoroughly until the granules are completely dispersed.
➢ Let stand for 1–2 minutes.
➢ If the suspension volume appears below the level indicated by the arrow, add more water to bring it up to the level indicated by the arrow.
➢ Shake again vigorously until a homogeneous suspension is obtained.
➢ The reconstituted suspension must be stored in the refrigerator in its original container and used within 14 days. Do not freeze.
➢ Shake vigorously before each use.
Patients with severe kidney problems:
If creatinine clearance values are < 20 ml/min, or if undergoing ambulatory peritoneal dialysis or hemodialysis, the physician will adjust the dosage accordingly.
If you use more Cefixoral than you should
In case of accidental overdose, contact your doctor or go to the nearest hospital.
If you forget to use Cefixoral
Do not take a double dose to make up for the forgotten dose.
If you stop treatment with Cefixoral
Do not stop using Cefixoral without consulting your doctor, even if you feel better. It is important to complete the full course of treatment prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If any of the following side effects occur while being treated with Cefixoral, contact your doctor immediately; the doctor will STOP the treatment and initiate appropriate therapies and/or precautionary measures:

• severe allergic reactions (serum sickness-like reaction and anaphylaxis), facial swelling (facial edema), swelling of the skin or mucous membranes (angioedema), difficulty breathing (dyspnea);
• severe skin and mucous membrane reactions, sometimes with blistering (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms);
• severe antibiotic-associated diarrhoea (pseudomembranous colitis).

The following side effects may also occur during treatment:

• bacterial resistance
• inflammation of the tongue (glossitis)
• nausea
• vomiting
• stomach burning (gastric pyrosis)
• abdominal pain
• diarrhoea
• indigestion (dyspepsia)
• passing of intestinal gas (flatulence)
• joint pain (arthralgia)
• drug-induced fever
• changes in certain blood tests (transient increase in transaminases, alkaline phosphatase, total bilirubin, blood urea nitrogen, and creatinine)
• reduced number of white blood cells (leucopenia, neutropenia, granulocytopenia)
• reduced number of platelets (thrombocytopenia)
• increased number of white blood cells (eosinophilia, agranulocytosis)
• impaired blood coagulation
• decreased number of red blood cells due to damage to blood cells (haemolytic anaemia)
• 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 (rash)
• itching (pruritus)
• genital itching
• dizziness
• headache (cephalalgia)
• fever
• loss of appetite (anorexia)
• fungal vaginal infection (Candida vaginitis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor. You may 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 Cefixoral

Keep this medicine out of the sight and reach of children.
Store the unreconstituted powder in its original intact container at a temperature not exceeding 30 °C.
After reconstitution, the suspension must be stored in the refrigerator in the original container.
The reconstituted suspension must be used within 14 days. Do not freeze.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cefixoral contains

• The active substance is: cefixime (20 mg/ml)
• The other components are: sucrose (see section “Cefixoral contains sucrose”), xanthan gum, sodium benzoate (see section “Cefixoral contains sodium benzoate”), ethanol (see section “Cefixoral contains ethanol”), benzyl alcohol (see section “Cefixoral contains benzyl alcohol”), sulphites (E 220) (see section “Cefixoral contains sulphites”), strawberry flavour 1 and strawberry flavour 2.

Description of the appearance of Cefixoral and contents of the pack
Granules for oral suspension 100 mg/5 ml, in a 100 ml glass bottle. The bottle is equipped with a
safety closure cap.
The pack contains a dosing 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 site Via di Scandicci 37,
Florence
ACS DOBFAR S.p.A, manufacturing site Via Laurentina Km 24,730 - Pomezia (Rome).

Package leaflet: information for the user

Cefixoral 400mg film-coated tablets, 400mg dispersible tablets

Cefixime
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 effect, including any not listed in this leaflet, talk to 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 taking 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 Cefixoral is and what it is used for

Cefixoral contains cefixime, an antibiotic used to treat infections caused by bacteria.
Cefixoral is indicated in adults for 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 taking 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 or cephalosporins (antibiotics).

Warnings and precautions
Talk to your doctor or pharmacist before taking Cefixoral.
In particular, inform 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 must also stop the treatment;
• you have kidney problems, not only severe ones (severe renal failure), or if you are undergoing a blood purification procedure (haemodialysis or peritoneal dialysis);
• you suffer or have suffered from stomach or intestinal diseases, especially colitis;
• you develop severe skin reactions; in such cases, you must also stop the treatment;
• you have previously had a reduction in red blood cells due to damage to blood cells (haemolytic anaemia).

Prolonged use of Cefixoral may lead to the development of resistant microorganisms and, in particular, to alterations of the normal intestinal flora.
Other medicines and Cefixoral
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform 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 pills).

Laboratory tests and Cefixoral
Cefixoral may alter the results of certain blood and urine tests.
Fertility, pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will prescribe Cefixoral only if clearly necessary.
Pregnancy
During the first three months of pregnancy, administration of Cefixoral is not recommended.
Breastfeeding
There are no data available on the passage of Cefixoral into breast milk.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Cefixoral 400 mg film-coated tablets contain sodium
Cefixoral 400 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
Cefixoral 400 mg dispersible tablets contain the colouring agent sunset yellow FCF (E110)
It may cause allergic reactions.
Cefixoral 400 mg dispersible tablets contain sodium
Cefixoral 400 mg dispersible tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
Cefixoral 400 mg dispersible tablets contain benzyl alcohol
This medicine contains 0.000875 mg of benzyl alcohol per tablet. Benzyl alcohol may cause allergic reactions.
Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).
Cefixoral 400 mg dispersible tablets contain sulphites
Rarely, these may cause severe hypersensitivity reactions and bronchospasm.
Cefixoral 400 mg dispersible tablets contain ethanol
This medicine contains 0.015 mg of alcohol (ethanol) in each tablet. The amount in each tablet of this medicine is equivalent to less than 0.0004 ml of beer or 0.0002 ml of wine.
The small amount of alcohol in this medicine will not produce any significant effects.
Cefixoral 400 mg dispersible tablets contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Cefixoral

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose for adults is: one tablet (400 mg) once daily.

The breakline on the dispersible tablet is intended to facilitate breaking the tablet to aid dispersion and is not intended for dividing the tablet into equal doses.

Method of administration:
CEFIXORAL may be taken regardless of meals, either during or apart from meals.
The coated tablet of CEFIXORAL must be swallowed whole.
The dispersible tablet of CEFIXORAL should be dissolved in a glass of water. Mix well until completely dissolved and drink immediately.

Treatment duration:
Most infections can be treated within 7 days of therapy. However, in more severe cases, Cefixoral may be used for up to 14 consecutive days.

Patients with severe kidney problems:
In patients with creatinine clearance values < 20 ml/min, undergoing ambulatory peritoneal dialysis or hemodialysis, the recommended dosage is 200 mg once daily.

If you take more Cefixoral than you should
If you accidentally take a large amount of this 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 the forgotten 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 full course of treatment prescribed by your doctor.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
If you experience any of the following adverse effects while taking Cefixoral, contact your doctor immediately. The doctor will DISCONTINUE treatment and initiate appropriate therapies and/or precautionary measures:

• severe allergic reactions (serum sickness-like reaction and anaphylaxis), facial swelling (facial edema), swelling of the skin or mucous membranes (angioedema), difficulty breathing (dyspnea);
• severe skin and mucous membrane reactions, even with blister formation (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms);
• severe antibiotic-associated diarrhea (pseudomembranous colitis).

The following adverse effects may also occur during treatment:

• bacterial resistance
• inflammation of the tongue (glossitis)
• nausea
• vomiting
• stomach burning (gastric pyrosis)
• abdominal pain
• diarrhea
• indigestion (dyspepsia)
• passage of intestinal gas (flatulence)
• joint pain (arthralgia)
• drug-induced fever
• changes in certain blood tests (transient increase in transaminases, alkaline phosphatase, total bilirubin, blood urea nitrogen, and creatinine)
• reduced number of white blood cells (leukopenia, neutropenia, granulocytopenia)
• reduced number of platelets (thrombocytopenia)
• increased number of white blood cells (eosinophilia, agranulocytosis)
• impaired blood coagulation
• reduced 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 (rash)
• itching
• genital itching
• dizziness
• headache (cephalalgia)
• fever
• loss of appetite (anorexia)
• vaginal fungal infection (Candida vaginitis)

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor. You may also report adverse effects directly via the national reporting system at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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.
Do not use this medicine after the expiry date stated on the packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Cefixoral Contains
CEFIXORAL 400 mg

• The active substance is: cefixime (400 mg per tablet)
• The other components are: microcrystalline cellulose, pregelatinized starch, calcium dibasic phosphate dihydrate, magnesium stearate, hypromellose, sodium lauryl sulfate, titanium dioxide (E171), liquid paraffin. CEFIXORAL 400 mg
• The active substance is: cefixime (400 mg per tablet)
• The other components are: microcrystalline cellulose, hydroxypropylcellulose, anhydrous colloidal silica, povidone, strawberry flavor 1, strawberry flavor 2, magnesium stearate, sucralose, sucrose (see section “Cefixoral 400 mg dispersible tablets contain sucrose”), ethanol (see section “Cefixoral 400 mg dispersible tablets contain ethanol”), sulfites (E 220) (see section “Cefixoral 400 mg dispersible tablets contain sulfites (E 220)”), benzyl alcohol (see section “Cefixoral 400 mg dispersible tablets contain benzyl alcohol”), sunset yellow FCF (E110) (see section “Cefixoral dispersible tablets contain sunset yellow 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 Authorization 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).