Leaflet: information for the user

Pantomicina 1g powder for solution for infusion

erythromycin lactobionate

Read this 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isPantomicina 1g powder for solution for infusionand what it is used for

2. What you need to know before you start usingPantomicina 1g powder for solution for infusion

3. How to usePantomicina 1g powder for solution for infusion

4. Possible side effects

5. Storage ofPantomicina 1g powder for solution for infusion

6. Contents of the pack and additional information

Pantomicina 1g powder for solution for infusion contains the active substance erythromycin lactobionate, an antibiotic that belongs to a group called macrolides.

Pantomicina 1g powder for solution for infusion is indicated for the treatment of:

• Pneumonia (lung infection)
• Skin, muscle, tendon, and fat infections
• Intestinal inflammation (enterocolitis) and frequent soft stools (diarrhea)
• Tonsillitis
• Diphtheria (a severe bacterial infection causing sore throat, fever, swollen lymph nodes, and weakness)
• Urethritis (inflammation of the urethra), cervicitis (inflammation of the cervix), or rectal mucosa inflammation (last part of the digestive tract)
• Newborn conjunctivitis caused by Chlamydia trachomatis.
• Lymphogranuloma venereum (a sexually transmitted infection caused by the microorganism Chlamydia trachomatis).

Do not use Pantomicina 1g powder for solution for infusion

• If you are allergic to erythromycin orany of the other components of this medication (listed in section 6).
• If you are allergic to other macrolide antibiotics.
• If you are taking terfenadine or astemizol (antihistamines used to treat allergies), cisapride (used to treat intestinal motility problems), pimozide (antipsychotic), and ergotamine or dihydroergotamine (used to treat migraines).
• If you have abnormally low levels of potassium or magnesium in your blood (hypomagnesemia or hypokalemia).
• If you or a family member has a history of heart rhythm disorders (ventricular arrhythmia or torsades de pointes) or an electrocardiogram (ECG) abnormality called "prolongation of the QT interval".
• If you are currently taking a medication called Lomitapida (used to reduce blood lipid levels, such as cholesterol and triglycerides). Taking this medication with erythromycin may cause an increase in liver enzymes (transaminases) produced by liver cells, indicating liver stress and potentially leading to liver problems.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Pantomicina 1g powder for solution for infusion:

- if you have liver function disorders

- if you have heart problems

- if you are taking other medications known to cause severe heart rhythm disorders

- if you have experienced fever, nausea, vomiting, and muscle pain; this could mean you are having muscle damage symptoms (rhabdomyolysis)

- if you have myasthenia gravis (a disease affecting muscle nerve fibers)

-if you received treatmentfor syphilis(a sexually transmitted disease)whilepregnantor gave birth while receiving the treatment.

-ifyouhave experienceddiarrheaafter previouslyreceivingthemedication.This may indicatediarrheaassociated with Clostridium difficile(CDAD)that is related to the use of antibacterial medications, including erythromycin, and may cause from mild diarrhea to fatal colitis.

-in long-term or repeated treatment,there is a possibility of spreading non-susceptible bacteriaorfungi.If this type of infection appears,the treatment must be stoppedand appropriate measures must be taken.The affected areas may require drainage along with antibacterial therapy.

Children
If a babyor childis receiving antibioticsand is irritableor vomitswhen fed,notify your doctor immediately.There is a risk that thechild may developa severe stomach disorder calledpyloric stenosis.

Use of Pantomicina 1g powder for solution for infusion with other medications

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

It is especially important to inform them if you are taking any of the following medications and treatments.

This is also important if you are taking medications called:

- Corticosteroids, administered orally, by injection, or inhaled (used to help inhibit the body's immune system. This is useful for treating a wide range of pathologies).

- Hydroxychloroquine or chloroquine (used to treat pathologies such as rheumatoid arthritis or to treat or prevent malaria). Taking these medications with erythromycin may increase the risk of abnormal heart rhythms and other severe side effects affecting the heart.

The administration of Pantomicina 1g powder for solution for infusion may increase the effect of:

- Medications for treating anxiety (such as benzodiazepines or hexobarbital)

- Ergot alkaloids (medications for treating migraines)

- Carbamazepine (medication for treating epilepsy)

- Cyclosporine (medication for treating rheumatic diseases and preventing transplant rejection)

- Medications for treating allergies (such as terfenadine, astemizol, and mizolastine)

- Medications for fungal infections (such as fluconazole, ketoconazole, and itraconazole)

- Medications for reducing blood lipid levels (such as lovastatin and simvastatin)

- Rifabutin (medication for treating tuberculosis)

-Anticoagulants, e.g., warfarin, acenocoumarol, and rivaroxaban (used to thin the blood)

- Digoxin (medication for treating heart problems)

- Omeprazole (medication for treating heartburn and indigestion)

- Treatment for reducing reflux (such as cisapride)

- Pimozide (medication used for treating behavioral problems)

- Theophylline (medication for treating asthma and other respiratory problems such as chronic obstructive pulmonary disease (COPD))

- Alfentanil (medication used for anesthetizing patients before surgery)

- Bromocriptine (medication for treating Parkinson's disease)

- Anti-inflammatory medications (such as methylprednisolone)

- Cilostazol (medication for treating lower limb pain caused by poor circulation)

- Vinblastine (medication for treating cancer)

- Sildenafil (medication for treating erectile dysfunction)

- Treatment for heart rhythm disorders or malaria (such as quinidine)

- Colchicine (medication for treating joint problems, such as gout and arthritis)

- Zopiclone (medication for treating sleep disorders)

The following medications may reduce the effect of Pantomicina 1g powder for solution for infusion:

- Rifampicin (for treating some infections),

- Phenobarbital, carbamazepine, and phenytoin (treatment for epilepsy), and

- St. John's Wort (herbal medication for treating depression)

The administration of Pantomicina 1g powder for solution for infusion may decrease the effect of:

- Contraceptives (medications used for birth control)

- HIV treatment medications called protease inhibitors

- Treatment for infections (such as clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, and colistin)

The use of Pantomicina 1g powder for solution for infusion with calcium channel blockers, such as verapamil, may cause low blood pressure, decreased heart rate, or acidosis.

The use of Pantomicina 1g powder for solution for infusion with cimetidine (medication used for treating ulcers) may cause an increase in Pantomicina levels in the blood.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pantomicina 1g powder for solution for infusioncan only be usedduring pregnancyand breastfeedingif your doctorbelieves it is necessary,and followingtheirrecommendations.Erythromycin has not been established as safe during pregnancy. Erythromycin crosses the placental membrane and also appears in breast milk.

The information from studies on the risk of congenital anomalies is not consistent, but some studies have reported heart defects after using Pantomicina 1g powder for solution for infusionat the beginning of pregnancy.It isimportant to useeffective birth control methodsduring treatmentwith the medication(see section "Use of Pantomicina 1g powder for solution for infusion with other medications”).

Driving and operating machinery

The treatment with Pantomicina has a mild influence on the ability to drive or operate machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. This medication will always be administered by a doctor or nurse.

The recommended dose is

For the treatment of severe infections in adults and children, the recommended intravenous dose is 15 to 20 mg/kg/day. In case of very severe infections, higher doses may be used, up to 4 g/day.

For the treatment of "Legionnaires' disease" although optimal doses have not been established, the recommended doses, based on known clinical data, are 1 to 4 g per day in divided doses.

For the treatment of acute inflammatory pelvic disease caused by N. gonorrhoeae, in penicillin-sensitive women, administer 500 mg of lactobionate erythromycin every 6 hours for 3 days, followed by 250 mg of erythromycin orally every 6 hours for 7 days.

Older patients

Older patients usually need lower doses than adult patients. It is more likely that adverse reactions will occur in these patients. Your doctor will give you special information about the precautions, doses, and follow-up needed.

If you are given more Pantomicina 1g powder for solution for infusion than you should

No cases of intoxication have been described with the intravenous administration of erythromycin. If hypersensitivity manifestations occur, treatment should be suspended and appropriate therapy initiated: administration of adrenaline, steroids, etc.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone: 91 562 04 20.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

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

Get in touch with your doctor or pharmacist as soon as possible if you experience the following side effects:

• Unexpected rash, difficulty breathing, and fainting (anaphylactic reaction)
• Pancreatitis, liver inflammation.
• Worsening of a condition called myasthenia gravis.
• Narrowing of the stomach outlet area called the pylorus in children**.
• Diarrhea caused by the use of antibiotics (pseudomembranous colitis).
• Severe skin alterations (conditions known as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme).
• Yellow discoloration of the skin and/or eyes, lack of energy, and loss of appetite (symptoms of liver problems such as hyperbilirubinemia, liver inflammation with cholestasis, jaundice, and liver insufficiency) and liver function alteration.
• Angioedema, a type of skin inflammation.
• Kidney inflammation.
• Abnormal heart rhythms (such as palpitations, faster heart rate, irregular heart rhythm potentially fatal called torsades de pointes or abnormal ECG tracing) or cardiac arrest;
• Contact a doctor immediately if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthema). The frequency of this side effect is considered unknown (cannot be estimated from available data).

The following side effects have been observed with the administration of this medicine:

Very common (may affect more than 1 in 10 people):

Stomach pain

Nausea

Vomiting

Diarrhea

Loss of appetite (anorexia).

Common (may affect up to 1 in 10 people):

Increased liver enzymes and bilirubin

Skin rash.

Uncommon (may affect up to 1 in 100 people):

Allergic reactions in the form ofhives that cause intense itching.

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

Reversible hearing loss*

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

Disorientation

Hallucinations

Seizures

Dizziness

Ear ringing (tinnitus)

State of confusion

Sensation of rotational movement (vertigo)

Unknown frequency(cannot be estimated from available data):

Low white blood cell count (eosinophilia)

Hallucinations

Visual impairment

Deafness

Low blood pressure (hypotension)

Itching

Chest pain

Pain at the injection site ***

Fever

Uncomfortable feeling.

* Eritromycininintravenous perfusionat the highest doses(4gof eritromycinor higherper day) mayrarely cause reversible hearing loss.

**Hypertrrophic pyloric stenosis in children

***In some cases, irritation and pain have been found;if the perfusion is administered slowly, preferablyby continuous or intermittent intravenous perfusionin no less than20 to 60minutes,this effect may be reduced to a minimum.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD.: The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at thelocal SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Pantomicina 1g powder for perfusion solution

• The active principle is erythromycin (in the form of lactobionate).

Appearance of the product and contents of the packaging

Lyophilized powder for perfusion solution in 1 sterile vial

Holder of the Marketing Authorization and responsible for manufacturing

Holder:

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4, Ireland

Local Representative

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona, Spain

Responsible for manufacturing

DELPHARM SAINT REMY

Rue de l'Isle

Saint Remy sur Avre,

28380, – France

Last review date of this leaflet: February 2023

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)