Erythromycin Panpharma 1 g powder for solution for infusion EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Erythromycin Panpharma 1 g, powder for solution for infusion EFG

Erythromycin (as erythromycin lactobionate)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or nurse.
This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Erythromycin Panpharma is and what it is used for
What you need to know before using Erythromycin Panpharma
How to use Erythromycin Panpharma
Possible side effects
How to store Erythromycin Panpharma
Contents of the pack and other information

The name of this medicine is “Erythromycin Panpharma 1 g, powder for solution for infusion EFG”, but in this leaflet we will refer to it as «Erythromycin Panpharma».

1. What Eritromicina Panpharma is and what it is used for

Eritromicina Panpharma is an antibiotic containing erythromycin (in the form of erythromycin lactobionate), which belongs to a group of antibiotics known as "macrolides", and works by preventing the growth and multiplication of bacteria.

Eritromicina Panpharma is indicated for the treatment of severe bacterial infections in adult and pediatric patients when oral administration of erythromycin is not possible or not sufficient, or in patients who require higher concentrations of erythromycin due to the severity of the infection, or when patients are allergic or hypersensitive to beta-lactam antibiotics (a class of antibiotics), or when these antibiotics are not suitable for other reasons.

Once your doctor has controlled the acute phase of the infection, intravenous erythromycin administration will be replaced with an oral dosage form.

Eritromicina Panpharma is indicated for the treatment of infections such as:

Respiratory tract infections: pneumonia, pertussis.
Ear infections.
Eye infections (conjunctivitis).
Skin and soft tissue infections (such as muscles, blood vessels, tendons, fat).
Gastrointestinal infections.
Urogenital infections (infections of the reproductive and urinary organs).
Lymphogranuloma venereum (a sexually transmitted disease).
Diphtheria (a disease affecting the upper respiratory tract).

2. What you need to know before using Eritromicina Panpharma

Do not use Eritromicina Panpharma:

if you are allergic to erythromycin or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic (or hypersensitive) to other macrolide antibiotics.
if you are taking any of the following medicines:
- Astemizole, terfenadine (medicines used to treat allergic reactions).
- Disopyramide (an antiarrhythmic used in the treatment of ventricular tachycardia).
- Cisapride (used to treat gastroesophageal reflux disease).
- Pimozide (used in the treatment of psychiatric disorders).
- Ergotamine or dihydroergotamine (for migraine).
- Lovastatin, simvastatin, and atorvastatin (medicines to lower blood cholesterol).
- Lomitapide (used to reduce elevated blood fats, such as cholesterol and triglycerides). Taking this medicine together with erythromycin may increase liver enzymes (transaminases), indicating liver stress and potentially causing liver problems.
- Class IA and III antiarrhythmics (used to treat ventricular arrhythmias, to prevent recurrent paroxysmal atrial fibrillation, to treat Wolff-Parkinson-White syndrome, ventricular tachycardias, atrial fibrillation, and atrial flutter).
- Neuroleptics (used to treat psychosis [including delusions, hallucinations, or thought disorders]).
- Tricyclic and tetracyclic antidepressants (used in the treatment of depression).
- Fluoroquinolones (antibiotics used to treat certain infections).
- Arsenic trioxide (used to treat cancer).
- Methadone (used to treat opioid dependence, such as heroin addiction).
- Budipine (an antiparkinsonian agent).
- Antifungals and antimalarials.
if you have liver problems. This is because erythromycin is primarily excreted through the liver (see section 3 "How to use Eritromicina Panpharma").
if you have any heart condition.
if you have any electrolyte imbalance (for example: potassium or magnesium deficiency).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Eritromicina Panpharma:

If you have a heart condition, problems with heart rhythm such as prolongation of the "QT interval" or "ventricular arrhythmia" may occur, so you should consult your doctor, pharmacist, or nurse before using Eritromicina Panpharma.
Severe allergic reactions may occur. Do not use Eritromicina Panpharma if you are allergic or hypersensitive to erythromycin or to other medicines belonging to the macrolide antibiotic group. Consult your doctor, pharmacist, or nurse before using Eritromicina Panpharma.
If you have myasthenia gravis, erythromycin could worsen your symptoms, which could lead to serious breathing problems.
If you are elderly, as you have a higher risk of developing kidney disease. Your doctor will adjust the dose and take into account your kidney function (see section 3 "How to use Eritromicina Panpharma").

Generally, the combined use of erythromycin is not recommended with:

Alfuzosin (used to treat benign prostatic hyperplasia).
Buspirone (used in the treatment of generalized anxiety disorders).
Cyclosporine and tacrolimus (used in organ transplantation to prevent rejection).
Colchicine (used in the treatment of gout).
Ebastine (an antihistamine).
Tolterodine (used in the treatment of urinary incontinence).
Triazolam (used as a sedative to treat severe insomnia).

This medicine will be administered continuously or slowly to avoid pain.

Neonates and children

Contact your doctor immediately if your child vomits (non-bilious projectile vomiting) or has difficulty feeding during treatment with this medicine. Your doctor will determine your child's dose (see section 3 "How to use Eritromicina Panpharma").

Using Eritromicina Panpharma with other medicines

If you need to undergo a urine test, inform your doctor that you are taking erythromycin, as it may alter the results of certain tests.

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

It is not recommended to administer erythromycin simultaneously with:

Warfarin and coumarin derivatives (anticoagulants).
Zopiclone (to induce sleep).
Theophylline (to facilitate breathing).
Sildenafil (used in the treatment of erectile dysfunction and pulmonary arterial hypertension).
Certain cytostatics and vinblastine (used to treat cancer).
Digoxin (used in the treatment of heart problems).
Carbamazepine (used in the treatment of epilepsy and neuropathic pain).
Alfentanil (an anesthetic).
Bromocriptine (used in Parkinson's disease and hyperprolactinemia).
Cilostazol (used in the treatment of intermittent claudication).
Methylprednisolone (a corticosteroid used for its anti-inflammatory effects).
Midazolam (used to induce anesthesia or treat moderate severe insomnia).
Omeprazole (used to reduce gastric acid secretion).
Valproate (an anticonvulsant and mood stabilizer).
Cimetidine (inhibits gastric acid production).
Rifampicin (an antibiotic).
Phenytoin (used as an anticonvulsant).
Phenobarbital (an anticonvulsant).
Benzodiazepines (anxiolytic, anticonvulsant, muscle relaxant, sedative medicines, etc.).
Fexofenadine (used to treat allergic reactions).
St. John's wort (Hypericum perforatum) (a herbal remedy used to treat moderate depression).
Corticosteroids, administered orally, by injection, or inhaled (used to help suppress the body's immune system activity. This is useful for treating a wide range of conditions).
Hydroxychloroquine or chloroquine (used to treat conditions such as rheumatoid arthritis or to treat or prevent malaria). Taking these medicines together with erythromycin may increase the risk of abnormal heart rhythms and other serious heart-related side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

It has been reported that erythromycin crosses the placenta and reaches the fetus.

Erythromycin is excreted in breast milk.

Study data on the risk of congenital malformations are inconsistent, but some studies have reported cardiac abnormalities following the use of Eritromicina Panpharma early in pregnancy.

The decision whether to discontinue breastfeeding or discontinue treatment should be made after considering the benefit of breastfeeding for the child and the benefit of treatment for the mother.

Driving and using machines

The occurrence of adverse effects from Eritromicina Panpharma may affect your ability to drive and use machines.

Experience to date indicates that the effect of erythromycin on the ability to concentrate and react is negligible.

3. How to use Erythromycin Panpharma

Follow exactly the instructions given by your doctor or pharmacist for the administration of this medicine. If in doubt, please consult your doctor or pharmacist again. This medicine will always be administered by a doctor or healthcare professional intravenously (into a vein) over 60 minutes.

Use in adults and children over 12 years of age or weighing more than 40 kg

The recommended dose is 1–2 g per day, equivalent to 25 mg/kg/day given in divided doses (usually 3–4 doses).

This dose may be increased to 4 g per day if the infection is very severe.

It is important that you complete the full course of treatment. Do not stop receiving your infusion treatment prematurely, even if you feel better.

Use in children between 1 month and 12 years of age or weighing ≤ 40 kg

The recommended dose is 15–20 mg/kg body weight, divided into 3–4 doses.

Your doctor will calculate the exact dose your child should receive based on body weight.

Term newborns (from birth up to 1 month of age)

The recommended dose is 10–15 mg/kg, divided into 3 doses.

Your doctor will calculate the exact dose your child should receive based on body weight.

Use in patients with severe kidney disease

Your doctor will calculate the exact dose according to your renal function.

Use in elderly patients

Your doctor will carefully determine your dose and will take into account your renal and hepatic function, as you have a higher risk of developing kidney disease.

If you use more Erythromycin Panpharma than you should

If you think that you or your child has been given more of this medicine than prescribed, contact your doctor immediately. Symptoms of overdose include ototoxicity (ear damage), hearing loss, severe nausea, vomiting, and diarrhea.

If you forget to take Erythromycin Panpharma

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 915 620 420, stating the name of the medicine and the amount ingested.

If you think a dose of this medicine has been missed, contact your doctor or another healthcare professional immediately.

If you stop treatment with Erythromycin Panpharma

Do not stop using this medicine until instructed to do so by your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience an allergic reaction, a rash and swelling of certain parts of the body such as the face and neck may occur, accompanied by difficulty breathing. In such case, you must stop using this medicine and go to the emergency department immediately.

Contact a doctor as soon as possible if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered unknown (cannot be estimated from available data).

The most common side effects are anorexia (loss of appetite), nausea, vomiting, abdominal pain, nausea, flatulence, discomfort, cramps, soft stools or diarrhea.

The following adverse effects have been reported:

Uncommon (may affect up to 1 in 100 people)

Fungal infections (candidiasis) of the mouth, accompanied by whitish patches
Vaginal inflammation
Itching of the vulva in women
Allergic reactions
Widespread skin rash (urticaria)
Itchy skin
Redness of the skin, accompanied by increased blood flow (hyperemia)
Alteration of liver and gallbladder function, detected by blood tests
Pain or irritation at the injection site
Swelling and redness of a vein which will be extremely sensitive to touch

Rare (may affect up to 1 in 1,000 people):

Swelling of certain parts of the body, such as the face and neck (edema or allergic angioedema, anaphylaxis)
Symptoms of loss of appetite (anorexia)
Epigastric pain radiating to the back, accompanied by nausea, vomiting, diarrhea, and loss of appetite (pancreatitis)
Itching accompanied by yellowing of the skin (jaundice), pale stools (cholestasis and cholestatic jaundice)
Swollen joints
Fever
Hives
Skin rashes
Inflammation of the colon, accompanied by severe diarrhea

Very rare (may affect up to 1 in 10,000 people)

Unmasking or worsening of a rare disease associated with muscle weakness (myasthenia gravis)
Ringing in the ears (tinnitus) and hearing loss, usually temporary
Inability of the liver to perform its normal function
Inability of the kidneys to perform their normal function
Severe skin reactions (Stevens-Johnson syndrome and erythema multiforme)
Skin peeling (toxic epidermal necrolysis)

Frequency not known (cannot be estimated from available data):

Chest pain, general malaise
Irregular heartbeat, strong or rapid heartbeats
Chest discomfort, difficulty breathing, abnormally rapid and shallow breathing, pain in the upper part of the spine
Dyspnea (including asthma-like symptoms)
Visual disturbances, including diplopia and blurred vision
Psychiatric disturbances (such as mood changes and altered sense of reality)
Confusion, hallucinations
Dizziness, drowsiness, vertigo
Epileptic seizure, convulsions
Low blood pressure (hypotension)
Blood disorders affecting blood cells, usually detected by blood tests
Headaches

Other adverse effects in neonates and children

Vomiting (non-bilious projectile vomiting) or feeding difficulties and loss of appetite (infantile hypertrophic pyloric stenosis)

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Erythromycin Panpharma

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial and the carton after EXP. The expiry date refers to the last day of the month indicated.

After reconstitution:

Diluted solutions should be used immediately.

Do not freeze the reconstituted solution.

Reconstituted solution: Physical and chemical stability in use has been demonstrated for 24 hours when stored in the refrigerator (2–8°C).

Diluted solution: Physical and chemical stability in use has been demonstrated for 24 hours when stored in the refrigerator (2–8°C).

From a microbiological standpoint, the product should be used immediately.

If not used immediately, the storage conditions and duration prior to use are the responsibility of the user and should not exceed 24 hours in the refrigerator, unless reconstitution or dilution was carried out under controlled and validated sterile conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at the pharmacy or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Erythromycin Panpharma

The active substance is erythromycin lactobionate.

Each vial contains 1 gram of erythromycin.

This medicine does not contain any other component.

Nature of the product and contents of the container

Before reconstitution, Erythromycin Panpharma is a hygroscopic powder for infusion solution, white to light yellow in colour, contained in a glass vial. After reconstitution, the solution is clear and colourless.

Erythromycin Panpharma is available in packs of 1, 10 or 25 glass vials. Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

PANPHARMA

Z.I. DU CLAIRAY

35133 LUITRE

FRANCE

Manufacturer:

PANPHARMA

10 RUE DU CHÊNOT

PARC D’ACTIVITÉ DU CHÊNOT

56380 BEIGNON

FRANCE

PANPHARMA

Z.I du Clairay - Fougeres - F-35133 – France

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Pharmavic Ibérica S.L.,

C/Compositor Lehmberg Ruiz, 6

Edificio Ibiza, Oficina 7

29007 Málaga, Spain

This medicine is authorised in the European Economic Area member states under the following names:

Germany	Erythromycin Panpharma 1000 mg Powder for the preparation of an infusion solution
Denmark	ERYTHROMYCIN PANPHARMA 1 g, powder for infusion solution, solution
Spain	ERITROMYCIN PANPHARMA 1 g, powder for perfusion solution EFG
Finland	Erythromycin Panpharma 1 g, powder for infusion concentrate, for solution
Norway	Erythromycin Panpharma 1 g, powder for infusion solution, solution
Sweden	Erythromycin Panpharma 1 g, powder for infusion solution, solution

Date of the most recent review of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended exclusively for healthcare professionals:

For further information on resistance data, please refer to the Summary of Product Characteristics for erythromycin or Eritromicina Panpharma.

Posology

Use in adults and children over 12 years of age or weighing more than 40 kg

The recommended dose is 1–2 g per day, equivalent to 25 mg/kg/day given in divided doses (usually 3–4 doses).

Severe infections

In cases of severe infections, the dosage regimen may be increased up to 4 g per day, equivalent to 50 mg/kg/day.

The maximum daily dose is 4 g.

Use in children up to 12 years of age or weighing ≤40 kg

From 1 month to 12 years of age: The daily dose for infants and children up to 12 years of age for the treatment of most infections is 15–20 mg of erythromycin/kg body weight, divided into 3–4 doses. This dose may be doubled depending on the indication.

Term newborns (from birth up to 1 month of age)

10–15 mg/kg/day, divided into 3 doses.

Impaired renal or hepatic function

Patients with hepatic impairment:

When liver function is normal, erythromycin concentrates in the liver and is excreted in bile. Although the effect of impaired hepatic function on erythromycin excretion and its half-life in this patient population is unknown, extreme caution should be exercised when administering the antibiotic in such cases, especially in patients with acute hepatic failure receiving high doses of erythromycin. In such cases, monitoring of serum concentrations and dose reduction are required.

Patients with renal impairment:

The low percentage of renal excretion suggests that dosage adjustment may not be necessary in patients with mild to moderate renal impairment (creatinine clearance greater than 10 ml/min).

However, cases of toxicity have been reported in patients with moderate to severe renal impairment, and in such cases dose adjustment is recommended.

Administration of doses ≥4 g/day may increase the risk of erythromycin-induced hearing loss in elderly patients, particularly in those with renal or hepatic impairment.
In cases of moderate to severe renal impairment (serum creatinine levels of 2.0 mg/dl, renal failure associated with anuria), the maximum daily dose for adolescents over 14 years of age and adults (weighing more than 50 kg) is 2 g of erythromycin per day.
In patients with severe renal impairment (creatinine clearance concentrations less than 10 ml/min), the erythromycin dose should be reduced to 50–75% of the usual dose, administered according to the standard treatment regimen. The maximum daily dose should not exceed 2 g.

Erythromycin is not removed by hemodialysis or peritoneal dialysis. Therefore, in patients undergoing regular dialysis, an additional dose is not recommended.

Elderly population

The adult dose should be administered with caution. Elderly patients, particularly those with reduced renal or hepatic function, may have an increased risk of erythromycin-induced hearing loss when administered erythromycin doses of 4 g/day or higher.

Method of administration

Precautions to be taken before handling or administering the medicine

For instructions on reconstitution of the medicine prior to administration, see section 6.6.

Erythromycin may be administered by continuous or intermittent intravenous infusion.

The infusion should be administered over 60 minutes, as rapid infusion may cause local irritation and QT interval prolongation, arrhythmias, or hypotension. In patients with risk factors or a history of arrhythmias, the infusion should be administered over a longer period.

To prepare intravenous solutions for intermittent infusion, a minimum of 200 ml of diluent should be used to minimize the risk of venous irritation.

The concentration of erythromycin should not exceed 5 mg per milliliter, and a concentration of 1 mg/ml (0.1% solution) is recommended.

Erythromycin should only be administered intravenously. Intra-arterial injection is absolutely contraindicated, as it may cause angiospasm accompanied by ischemia. Intramuscular administration and intravenous bolus injection are also contraindicated.

Intravenous treatment should be switched to oral administration after 2 to 7 days. Once symptoms have resolved, treatment with erythromycin should be continued for an additional 2–3 days to ensure complete effectiveness.

Warnings and precautions

Neonates and children

If your child vomits or shows irritability related to feeding, contact your doctor immediately, as there is a risk of hypertrophic pyloric stenosis (HPS), which causes severe, non-bilious projectile vomiting. This medication should not be administered to pediatric populations if the potential benefits do not outweigh the potential risks.

Reconstitution

Each vial is for single use only.

Two steps are required: reconstitution and dilution.

Reconstitution: do not use 0.9% sodium chloride solution in this step.
1. To ensure proper dissolution, gently shake the vial to dislodge the powder content before reconstitution.
2. Prepare an initial solution corresponding to 50 mg/ml of erythromycin base by adding 20 ml of water for injections to the contents of the Eritromicina Panpharma vial. When adding the solvent, ensure it contacts the entire vial wall (e.g., by holding the vial horizontally).
3. Shake vigorously until completely dissolved. Dissolution may be difficult and may take several minutes.

The reconstituted solution may be stored in the refrigerator for 24 hours.

Dilution

Only 0.9% sodium chloride solution or 5% glucose solution should be used.

For intermittent infusion: prepare the solution by mixing the contents of the reconstituted Eritromicina Panpharma vial (20 ml) with 200 ml or 500 ml of one of the diluents, resulting in a final diluted solution concentration of 5 mg/ml or 2 mg/ml, respectively.
For continuous infusion: prepare the solution by mixing the contents of the reconstituted Eritromicina Panpharma vial (20 ml) with 500 ml or 1000 ml of one of the diluents, resulting in a final diluted solution concentration of 2 mg/ml or 1 mg/ml, respectively.

The diluted solution may be stored in the refrigerator for 24 hours. The diluted solution should be administered without adding any other substance.

In pediatric patients, the amount of initial solution to be diluted and the perfusion volume must be adjusted according to the dosing regimen based on the child's weight.

After reconstitution

Diluted solutions should be used immediately.

Any unused medicine and all materials that have come into contact with it should be disposed of in accordance with local regulations.

Incompatibilities

This medicine must not be mixed with other medicinal products except those used for reconstitution.

Erythromycin lactobionate solution should not be mixed with β-lactam antibiotics, aminoglycosides, tetracyclines, chloramphenicol, colistin, aminophylline, barbiturates, phenytoin, heparin, phenothiazines, riboflavin (vitamin B2), vitamin B6, and vitamin C due to pH changes. Therefore, intravenous erythromycin must not be mixed with the listed drugs in an intravenous infusion solution.

The addition of other solutions that alter the pH range of 6–8 reduces the stability of erythromycin lactobionate.

Warning: Sodium chloride solutions or other solutions containing inorganic salts must not be used to prepare the initial solution (see section "Reconstitution"), as precipitates may form.