Erythromycin lactobionate FisioPharma

Package leaflet: Information for the user

ERITROMICINA LATTOBIONATO FISIOPHARMA 500 mg/10 ml

powder and solvent for injectable solution
ERITROMICINA LATTOBIONATO FISIOPHARMA 1 g/20 ml
powder and solvent for injectable solution
Generic Medicine
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, ask 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What ERITROMICINA LATTOBIONATO FISIOPHARMA is and what it is used for

ERITROMICINA LATTOBIONATO FISIOPHARMA contains the active substance erythromycin lactobionate, which
belongs to a group of medicines called macrolide antibiotics, used to treat infections caused by
bacteria.
This medicine is indicated for:

• infections of the upper and lower respiratory tract;
• short-term prevention of inflammation of the membrane surrounding the heart, prior to dental or other procedures in individuals who have previously had inflammatory diseases (rheumatic fever) or have a congenital heart condition (congenital heart disease);
• skin and soft tissue infections;
• lung inflammations (atypical primary pneumonia);
• primary syphilis in individuals allergic to antibiotics known as penicillins;
• skin infection (erythrasma);
• diphtheria: administered together with other medicines (antitoxins) to prevent the development of carriers and to eliminate the microorganism in healthy carriers;
• infections of the nose and pharynx;
• prevention of a disease affecting the respiratory tract (whooping cough);
• infections caused by bacteria (strains Legionella (L. pneumophila) and Listeria monocytogenes);
• eye diseases (conjunctivitis) in newborns, lung inflammations (pneumonia) in children, and urinary and genital (urogenital, endocervical) infections in adults.

2. What you need to know before using ERITROMICINA LATTOBIONATO FISIOPHARMA

Do not use ERITROMICINA LATTOBIONATO FISIOPHARMA

• if you are allergic to erythromycin lactobionate, to other macrolide antibiotics, or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if you are taking any of the following medicines:
• terfenadine or astemizole (for allergies);
• cisapride (for stomach disorders);
• pimozide (for the treatment of psychiatric conditions);
• ticagrelor and ranolazine (to make the blood less likely to clot);
• vasoconstrictive alkaloids such as ergotamine and dihydroergotamine (for migraine);
• simvastatin, lovastatin (to lower cholesterol levels in the blood);
• colchicine (for the treatment of gout);
• clarithromycin (for the treatment of certain infections);
• if you have heart problems (QT interval prolongation, cardiac arrhythmia, torsades de pointes);
• if you have severe liver problems associated with kidney problems;
• if you have low levels of potassium (hypokalemia) or magnesium (hypomagnesemia) in the blood;

Warnings and precautions
Talk to your doctor or pharmacist before using ERITROMICINA LATTOBIONATO FISIOPHARMA.
Use this medicine with great caution and inform your doctor in the following cases:

• if you have liver problems (impaired liver function);
• if you are seriously ill and taking a medicine used to lower blood cholesterol (lovastatin), as you may experience severe muscle damage (see section “Other medicines and ERITROMICINA LATTOBIONATO FISIOPHARMA”);
• if you develop an excessive infection caused by bacteria or fungi not sensitive to erythromycin. In this case, treatment with erythromycin lactobionate should be discontinued and replaced with another medicine;
• if you suffer from a disease causing muscle weakness (myasthenia gravis);
• if you have coronary artery disease, heart problems (heart failure, conduction disorders), or if you have a reduced heart rate (clinically significant bradycardia);
• if you have altered levels of certain electrolytes, or if you have low potassium or magnesium levels (hypokalemia or hypomagnesemia);
• if you are taking other medicines that may affect your heart rhythm;
• if you have previously experienced diarrhea following antibiotic use;
• if during treatment you notice vision problems. In addition, stop treatment and contact your doctor if you experience:
• symptoms of liver damage, with or without jaundice (yellowing of the skin and whites of the eyes);
• allergic reactions such as hives;
• inflammation of the intestine (pseudomembranous colitis ranging from mild to life-threatening);
• diarrhea (caused by Clostridium difficile, ranging from mild to fatal (CDAD)).

Children
In this case, the medicine should only be used when strictly necessary and under medical supervision.
If the newborn is the child of a mother treated with erythromycin lactobionate for the treatment of an infectious disease (syphilis), it is recommended to continue therapy with another medicine (penicillin).

Other medicines and ERITROMICINA LATTOBIONATO FISIOPHARMA
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor or pharmacist if you are taking any of the following medicines:

• terfenadine or astemizole (used for allergies);
• cisapride (used for stomach disorders);
• pimozide (used for the treatment of psychiatric conditions);
• ticagrelor and ranolazine (used to make the blood less likely to clot);
• vasoconstrictive alkaloids such as ergotamine and dihydroergotamine (for migraine);
• simvastatin, lovastatin (used to lower cholesterol levels in the blood);
• colchicine (used for the treatment of gout);
• clarithromycin (used for the treatment of certain infections);
• triazolam, alprazolam, midazolam, zopiclone, secobarbital (used for the treatment of sleep disorders);
• digoxin (used to increase the force of heart contraction);
• oral anticoagulants (used to make the blood less likely to clot);
• carbamazepine, phenytoin, valproate (used for the treatment of epilepsy);
• cyclosporine, tacrolimus (immunosuppressant medicines);
• disopyramide, quinidine (used for heart rhythm abnormalities);
• bromocriptine (used for certain types of tumors);
• methylprednisolone (used for the treatment of inflammation);
• cilostazol (used to improve blood circulation);
• vinblastine (an anticancer medicine);
• sildenafil, tadalafil, and vardenafil (used for the treatment of erectile dysfunction);
• colchicine (used for the treatment of gout);
• theophylline (used for the treatment of respiratory diseases);
• verapamil, amlodipine, diltiazem (used for the treatment of blood pressure and heart problems);
• cimetidine (used for the treatment of gastric ulcer);
• fexofenadine (used for the treatment of allergies);
• medicines that inhibit peristalsis.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
If you are pregnant or breastfeeding, do not use ERITROMICINA LATTOBIONATO FISIOPHARMA (see section 2 Do not use ERITROMICINA LATTOBIONATO FISIOPHARMA).
The administration of ERITROMICINA LATTOBIONATO FISIOPHARMA during pregnancy and breastfeeding should only be considered if the expected benefit to the mother outweighs the potential risk to the fetus or infant. Your doctor will prescribe ERITROMICINA LATTOBIONATO FISIOPHARMA only if absolutely necessary.

Driving and using machines
Some adverse effects of erythromycin may affect your ability to drive vehicles or operate machinery.
Current experience shows that erythromycin has negligible effects on the ability to concentrate and react.

3. How to use ERITROMICINA LATTOBIONATO FISIOPHARMA

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine must be administered by direct injection into the muscle (intramuscular route) or into a vein (intravenous route).
The recommended dose is 1–2 g per day, up to a maximum of 4 g per day in more severe infections.

Use in children
Children up to 12 years of age
For children, the recommended dose is 15–50 mg per kg of body weight. The dose should be divided into several administrations per day.
Continue treatment with this medicine for at least 48 hours after symptoms have disappeared and body temperature has returned to normal.
If you have an infection caused by the bacterium Streptococcus, you must continue treatment for at least 10 days.

If you use more ERITROMICINA LATTOBIONATO FISIOPHARMA than you should
The following symptoms may occur after taking an excessive dose of this medicine: hearing disturbances (ototoxicity), hearing loss, liver problems (cholestasis), heart problems (ventricular arrhythmia), abdominal pain (epigastric pain), nausea, vomiting, and diarrhoea.
These symptoms are common when doses between 8 and 12 g per day are used for several days and resolve upon discontinuation of erythromycin treatment.
In case of ingestion/overdose of this medicine, seek immediate medical advice from your doctor or the nearest hospital.

If you forget to use ERITROMICINA LATTOBIONATO FISIOPHARMA
Do not use a double dose to make up for the forgotten dose.
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.
Contact your doctor immediately if you experience a serious skin reaction: red, scaly rash with formation of pustules and blisters (exanthematous pustulosis). The frequency of this reaction is unknown (cannot be estimated based on available data).

The following side effects may occur:
Unknown frequency (frequency cannot be estimated from the available data)

• severe inflammation of the intestine (pseudomembranous colitis);
• infections caused by bacteria or fungi not affected by ERITROMICINA LATTOBIONATO FISIOPHARMA (superinfections, such as oral and vaginal candidiasis);
• loss of appetite (anorexia);
• cramps and abdominal pain;
• nausea;
• vomiting;
• diarrhoea;
• abnormalities in liver function (hepatic dysfunction);
• inflammation of the pancreas (pancreatitis);
• narrowing of the pylorus due to thickening of the muscular tissue in the wall (hypertrophic pyloric stenosis) in newborns;
• skin irritations (urticaria, rashes);
• allergic reactions, even severe ones (rashes, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis, anaphylactic shock);
• fluid accumulation (oedema);
• swelling due to fluid accumulation in the face, larynx, tongue, hands (angioedema);
• itching (pruritus);
• ear problems: reversible hearing loss (reversible deafness) and perception of ringing or noises in the ears (tinnitus);
• vision problems (diplopia and blurred vision);
• increased number of white blood cells in the blood (eosinophilia);
• heart rhythm disorders (cardiac arrhythmias, ventricular tachycardia, QT interval prolongation, torsades de pointes);
• convulsions, hallucinations, dizziness, epileptic seizures, headache, insomnia;
• confusion;
• inflammation of the kidneys (interstitial nephritis);
• inflammation of veins with possible formation of blood clots (thrombophlebitis);
• reduction in blood pressure (hypotension);
• breathing difficulties (dyspnoea, asthma);
• liver problems (reduced liver function, hepatic dysfunction, cholestasis and cholestatic jaundice, hepatitis-like symptoms, hepatomegaly);
• joint problems (swellings);
• pain and/or irritation at the injection site;
• chest pain;
• fever;
• malaise;
• changes in certain urine test values (interference with fluorometric determinations of urinary catecholamines);
• increased levels of ALT, AST, LDH, alkaline phosphatase, γ-GT and bilirubin.

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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ERITROMICINA LATTOBIONATO FISIOPHARMA

Keep this medicine out of the sight and reach of children.
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 store above 30°C.
Keep in the original packaging.
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 ERITROMICINA LATTOBIONATO FISIOPHARMA 500 mg/10 ml powder and solvent for injectable solution contains

• The active substance is erythromycin lactobionate. One vial of powder contains 744.1 mg of erythromycin lactobionate, equivalent to 500 mg of erythromycin.
• The other component is water for injections. One solvent ampoule contains water for injections up to 10 ml.

What ERITROMICINA LATTOBIONATO FISIOPHARMA 1 g/20 ml powder and solvent for injectable solution contains

• The active substance is erythromycin lactobionate. One vial of powder contains 1488.2 mg of erythromycin lactobionate, equivalent to 1000 mg of erythromycin.
• The other component is water for injections. One solvent ampoule contains water for injections up to 20 ml.

Description of the appearance of ERITROMICINA LATTOBIONATO FISIOPHARMA and contents of the pack

Pack containing 1 vial of 500 mg powder and 1 ampoule of 10 ml solvent.
Pack containing 1 vial of 1 g powder and 1 ampoule of 20 ml solvent.

Marketing Authorization Holder and Manufacturer
Fisiopharma S.r.l. – Industrial area – 84020 Palomonte (SA) – Italy.