Unixime

Package leaflet: Information for the user

Unixime 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, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Unixime is and what it is used for
2. What you need to know before taking Unixime
3. How to take Unixime
4. Possible side effects
5. How to store Unixime
6. Contents of the pack and other information

1. What Unixime is and what it is used for

Unixime contains cefixime, an antibiotic used to treat infections caused by bacteria.
Unixime 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 Unixime

Do not take Unixime

• 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 Unixime.
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 Unixime, you must also stop the treatment;
• you have kidney problems, not only severe ones (severe renal failure), or are undergoing a blood purification procedure (hemodialysis 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 (hemolytic anemia).

Prolonged use of Unixime may lead to the development of resistant microorganisms and, in particular, to an alteration of the normal intestinal flora.
Other medicines and Unixime
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 Unixime
Unixime may alter the results of certain blood and urine tests.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will prescribe Unixime only if clearly necessary.
Pregnancy
During the first three months of pregnancy, administration of Unixime is not recommended.
Breastfeeding
There are no data available on the passage of Unixime into breast milk.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
Unixime 400 mg film-coated tablets contain sodium
Unixime 400 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Unixime 400 mg dispersible tablets contain sunset yellow FCF (E110)
This may cause allergic reactions.
Unixime 400 mg dispersible tablets contain sodium
Unixime 400 mg dispersible tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
Unixime 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 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).
Unixime 400 mg dispersible tablets contain sulfites
Rarely, these may cause severe hypersensitivity reactions and bronchospasm.
Unixime 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 significant effects.
Unixime 400 mg dispersible tablets contain sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

3. How to take Unixime

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 in its dispersion, and not for dividing it into equal doses.
Method of administration:
UNIXIME may be taken either with or without food.
The coated tablet of UNIXIME must be swallowed whole.
The dispersible tablet of UNIXIME should be dissolved in a glass of water. Stir well until completely dissolved and take immediately.
Duration of treatment
Most infections can be treated within 7 days of therapy. However, in more severe cases, Unixime may be used for up to 14 consecutive days.
Patients with severe kidney problems:
In patients with creatinine clearance < 20 ml/min, undergoing ambulatory peritoneal dialysis or hemodialysis, the recommended dosage is 200 mg once daily.
If you take more Unixime 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 Unixime
Do not take a double dose to make up for the forgotten dose.
If you stop taking Unixime
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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If you experience any of the following side effects during treatment with Unixime, consult your doctor immediately, who 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-induced skin erythema 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;
• stomach burning (gastric pyrosis);
• abdominal pain;
• diarrhea;
• difficulty in digestion (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);
• reduction in the number of white blood cells (leucopenia, 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 (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 infection of the vagina (Candida vaginitis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor. You may also report side effects directly via the national reporting system at the website 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 Unixime

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 carton after Exp.:
The expiry date refers to the last day of that month.
Do not dispose of medicines via 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 Unixime contains
U 400 mg

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

Description of the appearance of Unixime and contents of the pack
UNIXIME 400 mg film-coated tablets
Film-coated tablets in blisters of 5 tablets of 400 mg
UNIXIME 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
F.I.R.M.A. S.p.A.
Via di Scandicci 37, 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

Unixime 100mg/5ml granules for oral suspension

Cefixime
Please read this leaflet carefully before 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Unixime is and what it is used for
2. What you need to know before using Unixime
3. How to use Unixime
4. Possible side effects
5. How to store Unixime
6. Contents of the pack and other information

1. What Unixime is and what it is used for

Unixime contains cefixime, an antibiotic used to treat infections caused by bacteria.
Unixime 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 Unixime

Do not use Unixime

• 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 Unixime.
In particular, inform your doctor if:

• you have previously experienced allergic reactions to cephalosporins, penicillins, or other medicines;
• you develop any allergic reaction during treatment with Unixime; in such cases, you must also stop the treatment;
• you have kidney problems, not only if severe (severe renal impairment), or if you are undergoing blood purification procedures (hemodialysis 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 (hemolytic anemia).

Prolonged use of Unixime may lead to the development of germs that are not sensitive to the antibiotic, and in particular to alterations of the normal intestinal flora.
Other medicines and Unixime
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;
• drugs that reduce intestinal motility;
• nifedipine (a medicine used to lower blood pressure);
• oral contraceptives (birth control pills).

Laboratory tests and Unixime
Unixime may alter the results of certain blood and urine tests.
Fertility, pregnancy and breastfeeding
Pregnancy
During the first three months of pregnancy, administration of UNIXIME is not recommended.
Breastfeeding
There are no data available on the passage of UNIXIME into breast milk.
Driving and use of machinery
This medicine does not affect the ability to drive or operate machinery.
Unixime contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him 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.
Unixime contains sodium
Unixime contains less than 1 mmol (23 mg) of sodium per bottle (100 ml), i.e., essentially 'sodium-free'.
Unixime contains sodium benzoate
This medicine contains 6.3 mg of sodium benzoate per 12 ml of medicine.
Unixime 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 the 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).
Unixime contains sulfites
Rarely, it may cause severe hypersensitivity reactions and bronchospasm.
Unixime contains ethanol
This medicine contains 0.020 mg of alcohol (ethanol) in each 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 Unixime

Use this medicine exactly as instructed 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, administered once daily.
The Unixime package contains a measuring spoon (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:
UNIXIME may be taken regardless of meal times, either close to or apart from meals.
Treatment duration:
Most infections can be treated within 7 days of therapy. However, in more severe cases, UNIXIME may be used for up to 14 consecutive days.
Instructions for opening the bottle:
➢ Open the bottle by pressing firmly on the cap and 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 in case 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 it 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 it stand for 1–2 minutes.
➢ If the suspension level appears below the level indicated by the arrow, add more water until the level reaches the mark indicated by the arrow.
➢ Shake vigorously again until a homogeneous suspension is obtained.
➢ The prepared 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 Unixime than you should
In case of accidental overdose, contact your doctor or go to the nearest hospital immediately.
If you forget to use Unixime
Do not take a double dose to make up for the missed dose.
If you stop using Unixime
Do not stop using Unixime 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• severe allergic reactions (serum sickness-like reaction and anaphylaxis), facial swelling (facial oedema), swelling of the skin or mucous membranes (angioedema), difficulty breathing (dyspnoea);
• severe skin and mucous membrane reactions, even with blister formation (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced erythema with eosinophilia and systemic symptoms);
• severe diarrhoea caused by antibiotics (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)
• 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)
• reduction in the number of white blood cells (leucopenia, neutropenia, granulocytopenia)
• reduction in the number of platelets (thrombocytopenia)
• increase in the number of white blood cells (eosinophilia, agranulocytosis)
• impaired blood coagulation
• reduction in 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)
• inflammation of the liver (hepatitis)
• urticaria
• skin rash (rash)
• itching (pruritus)
• genital itching
• dizziness
• headache (cephalalgia)
• fever
• loss of appetite (anorexia)
• vaginal fungal infection (Candida vaginitis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system at the website 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 Unixime

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 packaging after "Expiry". 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 Unixime contains

• The active substance is: cefixime (20 mg/ml)
• The other components are: sucrose (see section “Unixime 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 Unixime 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 tamper-evident cap.
The pack contains a dosing spoon and a dosing syringe.
Marketing Authorisation Holder
F.I.R.M.A. S.p.A.
Via di Scandicci 37, 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).