GIASION

Package leaflet: Information for the user

Giasion 200 mg film-coated tablets

Cefditoren (pivoxil)
Please read this leaflet carefully before you start 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 those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Giasion 200 mg film-coated tablets are and what they are used for
2. What you need to know before taking Giasion 200 mg film-coated tablets
3. How to take Giasion 200 mg film-coated tablets
4. Possible side effects
5. How to store Giasion 200 mg film-coated tablets
6. Contents of the pack and other information

1. What Giasion 200 mg film-coated tablets are and what they are used for

Giasion belongs to a group of antibiotics called cephalosporins, which works by inhibiting bacterial cell wall synthesis.
Giasion is used in adults for the treatment of the following infections:

• Acute pharyngo-tonsillitis
• Acute maxillary sinusitis
• Acute exacerbation of chronic bronchitis
• Mild to moderate community-acquired pneumonia
• Uncomplicated skin and skin structure infections, such as cellulitis, infected wounds, abscesses, folliculitis, impetigo, and furuncles.

2. What you need to know before taking Giasion 200 mg film-coated tablets

Do not take Giasion:

• If you are allergic to antibiotics, especially penicillins or any other beta-lactam antibiotics, or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to casein, note that this medicine contains sodium caseinate.
• If you have a condition known as primary carnitine deficiency.

Warnings and precautions
Talk to your doctor before taking Giasion:

• If you have liver and/or kidney disease.
• If you are being treated with anticoagulants.
• If you have a history of gastrointestinal disease, particularly colitis.
• If you are concurrently receiving treatment with nephrotoxic active substances such as aminoglycoside antibiotics or potent diuretics (such as furosemide), since these combinations may have undesirable effects on kidney function and have been associated with ototoxicity. Consult your doctor if you experience any of the following during treatment:
• If you experience any allergic reaction during treatment, such as: itching, redness, skin rash, swelling, or difficulty breathing.
• If you develop diarrhoea while taking this medicine or after finishing treatment.

As with other antibiotics, prolonged treatment with Giasion may lead to excessive growth of microorganisms not sensitive to the drug, which might require discontinuation of treatment and administration of appropriate therapy.
Treatment with Giasion may interfere with the results of certain laboratory tests, causing false positives in:

• Direct Coombs test.
• Urine glucose determination.

A false negative result may occur in:

• Plasma or blood glucose determination.

Other medicines and Giasion
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is recommended to leave an interval of at least 2 hours between the administration of antacids and Giasion.
If you take Giasion with probenecid, blood levels of cefditoren increase.
Concomitant use of Giasion with intravenous famotidine is not recommended, as this may make it difficult to achieve appropriate plasma levels.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Giasion is not recommended during pregnancy or while breastfeeding.

Driving and using machines
Giasion may cause dizziness and drowsiness, which may impair your ability to drive vehicles or operate tools or machinery.

3. How to take Giasion 200 mg film-coated tablets

Take this medicine exactly as directed by your doctor. If you have
any doubts, consult your doctor or pharmacist. Do not forget to take your medicine.
Your doctor will indicate the duration of treatment with Giasion.
The tablets should be swallowed whole, with a sufficient amount of water (a
glass of water). The tablets should be taken during meals.
The recommended dose and dosing frequency of this medicine is
indicated below:
Adults and adolescents (over 12 years of age)

• Acute pharyngo-tonsillitis: 1 tablet (200 mg cefditoren) every 12 hours for 10 days.
• Acute maxillary sinusitis: 1 tablet (200 mg cefditoren) every 12 hours for 10 days.
• Acute exacerbation of chronic bronchitis: 1 tablet (200 mg cefditoren) every 12 hours for 5 days.
• Community-acquired pneumonia:
  • in mild cases: 1 tablet (200 mg cefditoren) every 12 hours for 14 days
  • in moderate cases: 2 tablets (400 mg cefditoren) every 12 hours for 14 days
• Uncomplicated skin and skin structure infections: 1 tablet (200 mg cefditoren) every 12 hours for 10 days.

Use in children
The use of Giasion has not been studied in patients under 12 years of age and is therefore not recommended.
Elderly
Dose adjustment is not necessary in elderly patients, unless there is severe renal
and/or hepatic impairment.
Patients with renal impairment
No dose adjustment is required in patients with mild renal impairment.
In patients with moderate renal impairment, the total daily dose should not exceed
one tablet (200 mg cefditoren) every twelve hours. In patients with severe
renal impairment, a single daily dose of 1 tablet (200 mg cefditoren) is recommended. The recommended dose has not been established in patients undergoing dialysis.
Patients with hepatic impairment
No dose adjustments are required in patients with mild to moderate hepatic impairment. In cases of severe hepatic impairment, there are no available data to establish a recommended dose.
If you take more Giasion than you should
If you take more Giasion than prescribed, inform your doctor or pharmacist immediately.
If you forget to take Giasion
If you forget to take a dose, take the next one as soon as possible and then continue as directed in your treatment plan. Do not take a double dose to make up for a missed dose.
If you stop treatment with Giasion
Complete the full course of treatment, as there is a risk that the illness may recur if treatment is stopped prematurely.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are mainly related to the gastrointestinal system.

Very common (more than 1 in 10 users): diarrhoea.

Common (from 1 to 10 in 100 users): headache, nausea, abdominal pain, indigestion, vaginal infection.

Uncommon (from 1 to 10 in 1,000 users):

• Fungal infections
• Anorexia
• Nervousness, dizziness, and sleep disturbances
• Pharyngitis, rhinitis, and sinusitis
• Constipation, flatulence, vomiting, oral candidiasis, eructation, dry mouth, and loss of taste
• Alteration of liver function
• Skin rash, pruritus, and urticaria
• Vaginal inflammation and vaginal discharge
• Fever, weakness, and sweating
• Changes in blood cell count (leucopenia, thrombocytosis) and changes in liver function tests (elevated ALT levels) have been observed.

Rare (from 1 to 10 in 10,000 users):

• Haemolytic anaemia and lymph node disorder
• Dehydration
• Dementia, depersonalisation, emotional weakness, euphoria, hallucinations, increased libido
• Memory loss, lack of coordination, hypertonia, meningitis, and tremor
• Photosensitivity, loss of visual acuity, eye pain, and eyelid inflammation
• Tinnitus
• Changes in heart rhythm, heart failure, and fainting
• Low blood pressure
• Asthma
• Mouth ulcers, haemorrhagic colitis, stomatitis, ulcerative colitis, gastrointestinal haemorrhage, hiccups, inflammation and discoloration of the tongue, Clostridium difficile-associated diarrhoea
• Acne, alopecia, eczema, exfoliative dermatitis (skin cracking and peeling), and herpes simplex
• Muscle pain
• Painful urination, kidney inflammation, changes in urination frequency, incontinence, and urinary tract infection
• Breast pain, menstrual disorders, and erectile dysfunction
• Body odour and chills
• Changes in blood cell counts (eosinophilia, neutropenia, thrombocytopenia), coagulation disorders (prolonged coagulation time, reduced prothrombin time, platelet dysfunction), changes in liver function tests (elevated AST, alkaline phosphatase levels), changes in blood parameters (hyperglycaemia, hypokalaemia, bilirubinaemia, elevated LDH, hypoproteinaemia, increased creatinine), or urine abnormalities (albuminuria) have been observed.

Not known:

• Pneumonia
• Stevens-Johnson syndrome (formation of blisters and erosion of skin and mucous membranes)
• Skin redness
• Toxic epidermal necrolysis (a severe form of Stevens-Johnson syndrome followed by painful skin and detachment of the upper layer of skin)
• Acute kidney failure
• Anaphylactic shock
• Serum sickness (a delayed allergic skin reaction)
• Decreased number of blood cells (agranulocytosis)
• Reduced blood carnitine levels
• Cholestasis (blockage of bile flow from the liver)
• Aplastic anaemia (reduced blood cell counts)
• Liver damage
• Hepatitis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Giasion 200 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton. 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 Giasion 200 mg film-coated tablets contain

• The active substance is cefditoren. Each tablet contains 200 mg of cefditoren (as cefditoren pivoxil).
• The other components are core: Casein sodium salt, Sodium croscarmellose, Mannitol E421, Sodium tripolyphosphate and Magnesium stearate; coating: Opadry Y-1-7000 (Hypromellose, Titanium dioxide E 171, Polyethylene glycol 400) and Carnauba wax; blue OPACODE S-1-20986 ink: Shellac, Brilliant blue lake, Titanium dioxide E 171, Propylene glycol and Concentrated ammonia solution.

Description of the appearance of Giasion and package contents
Giasion 200 mg are film-coated tablets. Each package contains 16, 20 or 500 tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder
ZAMBON ITALIA s.r.l.
Via Lillo del Duca 10
20091 Bresso (MI)
Manufacturer
TEDEC-MEIJI FARMA S.A.
Carretera M-300, km 30,500
28802 Alcalá de Henares – Madrid, SPAIN

Package leaflet: Information for the user

Giasion 400 mg film-coated tablets

Cefditoren (pivoxil)
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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Giasion 400 mg film-coated tablets are and what they are used for
2. What you need to know before taking Giasion 400 mg film-coated tablets
3. How to take Giasion 400 mg film-coated tablets
4. Possible side effects
5. How to store Giasion 400 mg film-coated tablets
6. Contents of the pack and other information

1. What Giasion 400 mg film-coated tablets are and what they are used for

Giasion belongs to a group of antibiotics called cephalosporins, which act by inhibiting bacterial cell wall synthesis.
Giasion is used for the treatment of moderate cases of community-acquired pneumonia in adult patients.

2. What you need to know before taking Giasion 400 mg film-coated tablets

Do not take Giasion:

• If you are allergic to antibiotics, particularly to penicillin or to any other type of beta-lactam antibiotic, or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to casein, please note that this medicine contains sodium caseinate.
• If you suffer from a condition known as primary carnitine deficiency.

Warnings and precautions
Talk to your doctor before taking Giasion:

• If you have liver and/or kidney disease
• If you are being treated with anticoagulants
• If you have a history of gastrointestinal disease, particularly colitis
• If you are concurrently receiving treatment with nephrotoxic active substances such as aminoglycoside antibiotics or potent diuretics (such as furosemide), since these combinations may have undesirable effects on renal function and have been associated with ototoxicity.

Consult your doctor if, during treatment, you experience any of the following:

• If you develop any allergic reaction during treatment such as: itching, redness, skin rash, swelling, or difficulty breathing.
• If you have diarrhoea while taking this medicine or after completing treatment.

As with other antibiotics, prolonged treatment with Giasion may lead to overgrowth of microorganisms not sensitive to it, which may require discontinuation of treatment and administration of appropriate therapy.
Treatment with Giasion may interfere with the results of certain laboratory tests and may cause false positive results in:

• Direct Coombs test
• Urine glucose determination

A false negative result may occur in:

• Plasma or blood glucose determination.

Other medicines and Giasion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is recommended to leave an interval of at least 2 hours between the administration of antacids and Giasion.
If you take Giasion with probenecid, blood levels of cefditoren increase.
Concomitant use of Giasion with intravenous famotidine is not recommended, as this may impair achievement of appropriate plasma levels.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
It is recommended to avoid taking Giasion during pregnancy or while breastfeeding.

Driving and using machines
Giasion may cause dizziness and drowsiness, which may affect your ability to drive or operate tools or machinery.

Giasion contains sodium
Giasion 400 mg film-coated tablets contain approximately 26.2 mg of sodium per dose. This should be taken into consideration by patients on a controlled sodium diet.

3. How to take Giasion 400 mg film-coated tablets

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not forget to take your medicine. Your doctor will determine the duration of treatment with Giasion.
The tablets must be swallowed whole, with a sufficient amount of liquid (a glass of water). The tablets should be taken during meals.
The recommended dose and frequency of administration of this medicine are indicated below:

Adults and adolescents (over 12 years of age)
One tablet (400 mg of cefditoren) every 12 hours for 14 days is recommended.

Use in children
The use of Giasion has not been studied in patients under 12 years of age; therefore, it is not recommended.

Elderly
Dose adjustment is not required in elderly patients, unless there is severe renal and/or hepatic impairment.

Patients with renal impairment
Dose adjustment is not necessary in patients with mild renal impairment.
In patients with moderate renal impairment, the total daily dose must not exceed 200 mg of cefditoren (Giasion 200 mg) every 12 hours. In patients with severe renal impairment, a single daily dose of 200 mg of cefditoren (Giasion 200 mg) is recommended. The recommended dose has not been established in patients undergoing dialysis.

Patients with hepatic impairment
Dose adjustments are not required in patients with mild to moderate hepatic impairment. In cases of severe hepatic impairment, there are no available data to determine a recommended dose.

If you take more Giasion than you should
If you take more Giasion than recommended, inform your doctor or pharmacist immediately.

If you forget to take Giasion
If you miss a dose, take the next dose as soon as possible and then continue as directed in your treatment plan. Do not take a double dose to make up for a missed dose.

If you stop taking Giasion
Complete the full course of treatment, as there is a risk of the infection recurring.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects that may occur are mainly related to the gastrointestinal system.

Very common (more than 1 in 10 users): diarrhoea.

Common (1 to 10 users in 100): headache, nausea, abdominal pain, indigestion, vaginal infection.

Uncommon (1 to 10 users in 1,000):

• Fungal infections
• Anorexia
• Nervousness, dizziness, and sleep disturbances
• Pharyngitis, rhinitis, and sinusitis
• Constipation, flatulence, vomiting, oral candidiasis, eructation, dry mouth, and loss of taste
• Alteration of liver function
• Skin rash, pruritus, and urticaria
• Vaginal inflammation and vaginal discharge
• Fever, weakness, and sweating
• Changes in blood cell count (leukopenia, thrombocytosis) have been observed, as well as changes in liver function tests (elevated ALT levels).

Rare (1 to 10 users in 10,000):

• Haemolytic anaemia and lymph node abnormalities
• Dehydration
• Dementia, depersonalization, emotional weakness, euphoria, hallucinations, increased libido
• Memory loss, lack of coordination, hypertonia, meningitis, and tremor
• Photosensitivity, loss of visual acuity, eye pain, and eyelid inflammation
• Tinnitus
• Changes in heart rhythm, heart failure, and fainting
• Low blood pressure
• Asthma
• Mouth ulcers, haemorrhagic colitis, stomatitis, ulcerative colitis, gastrointestinal haemorrhage, hiccups, inflammation and discoloration of the tongue, Clostridium difficile-associated diarrhoea
• Acne, alopecia, eczema, exfoliative dermatitis (skin cracking and peeling), and herpes simplex
• Muscle pain
• Painful urination, kidney inflammation, changes in urination frequency, incontinence, and urinary tract infection
• Breast pain, menstrual disorders, and erectile dysfunction
• Body odour and chills
• Changes in blood cell count (eosinophilia, neutropenia, thrombocytopenia), coagulation disorders (prolonged coagulation time, reduced prothrombin time, platelet abnormalities), changes in liver function tests (elevated AST and alkaline phosphatase levels), changes in blood parameters (hyperglycaemia, hypokalaemia, bilirubinaemia, elevated LDH, hypoproteinaemia, increased creatinine) or in urine (albuminuria) have been observed.

Not known:

• Pneumonia
• Stevens-Johnson syndrome (blistering and erosion of the skin and mucous membranes)
• Skin redness
• Toxic epidermal necrolysis (a severe form of Stevens-Johnson syndrome followed by painful skin and detachment of the upper layer of skin)
• Acute kidney failure
• Anaphylactic shock
• Serum sickness (a delayed allergic skin reaction)
• Decreased number of blood cells (agranulocytosis)
• Reduced levels of carnitine in the blood
• Cholestasis (blockage of bile flow from the liver)
• Aplastic anaemia (reduced number of blood cells)
• Liver damage
• Hepatitis

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Giasion 400 mg film-coated tablets

Keep this medicine out of the sight and reach of children.
Store in the original packaging.
Do not store above 30°C.
Do not use this medicine after the expiry date stated on the carton. 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 Giasion 400 mg film-coated tablets contain

• The active substance is cefditoren. Each tablet contains 400 mg of cefditoren (as cefditoren pivoxil).
• The other components are core: Casein sodium, Sodium croscarmellose, Mannitol E421, Sodium tripolyphosphate and Magnesium stearate; coating: Opadry Y-1-7000 (Hypromellose, Titanium dioxide E 171, Macrogol 400) and Carnauba wax; blue ink Opacode S-1-20986: Shellac, Brilliant blue lake, Titanium dioxide E 171, Propylene glycol and concentrated ammonia solution.

Description of the appearance of Giasion and package contents
Giasion 400 mg are film-coated tablets. Each pack contains 10 or 500 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder
ZAMBON ITALIA s.r.l.
Via Lillo del Duca 10
20091 Bresso (MI)

Manufacturer
TEDEC-MEIJI FARMA S.A.
Carretera M-300, km 30,500
28802 Alcalá de Henares – Madrid, SPAIN