Pantomicina 1 g powder for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Pantomicina 1g powder for solution for infusion

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, pharmacist, 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Pantomicina 1g powder for solution for infusion is and what it is used for

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

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

• Lung infection (such as pneumonia)
• Skin, muscle, tendon, and fat infections
• Inflammation of the gastrointestinal tract (enterocolitis) and frequent loose stools (diarrhea)
• Whooping cough
• Diphtheria (a serious bacterial infection causing sore throat, fever, swollen lymph nodes, and weakness)
• Urethritis (inflammation of the tube draining the bladder), cervicitis (inflammation of the neck of the uterus), or inflammation of the rectal mucosa (last part of the digestive tract)
• Conjunctivitis in newborns caused by Chlamydia trachomatis
• Lymphogranuloma venereum (a sexually transmitted infection caused by a microorganism called Chlamydia trachomatis)

2. What you need to know before using Pantomicina 1g powder for solution for infusion

Do not use Pantomicina 1g powder for solution for infusion

• If you are allergic to erythromycin or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other macrolide antibiotics.
• If you are taking terfenadine or astemizole (antihistamines used to treat allergy), cisapride (used for intestinal motility problems), pimozide (an antipsychotic), or 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 abnormality on the electrocardiogram (ECG) known as "QT interval prolongation syndrome".
• If you are currently taking a medicine called 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.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using Pantomicina 1g powder for solution for infusion:

• if you have liver function disorders
• if you have heart problems
• if you are taking other medicines known to cause serious heart rhythm disturbances
• if you experience fever, nausea, vomiting, and muscle pain; these could indicate symptoms of muscle damage (rhabdomyolysis)
• if you have myasthenia gravis (a disease affecting nerves and muscles)
• if you received treatment for syphilis (a sexually transmitted infection) while pregnant or gave birth during such treatment
• if you have experienced diarrhea after previous use of this medicine. This may indicate Clostridium difficile-associated diarrhea (CDAD), which is linked to the use of antibacterial drugs including erythromycin, and can range from mild diarrhea to fatal colitis
• with long-term or repeated treatment, there is a risk of overgrowth of bacteria not sensitive to the drug or of fungi. If such an infection develops, treatment should be stopped and appropriate measures taken. Localized infection sites may require drainage in addition to antibacterial therapy.

Children If a baby or child receiving antibiotics becomes irritable or vomits during feeding, inform your doctor immediately. There is a risk that the child may develop a serious stomach condition called pyloric stenosis.

Using Pantomicina 1g powder for solution for infusion with other medicines

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might need to use any other medicines.

It is especially important that you inform them if you are taking any of the following medicines or treatments.

This also applies if you are taking medicines known as:

• 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.

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

• Medicines used to treat anxiety (such as benzodiazepines or hexobarbital)
• Ergot alkaloids (medicines used to treat migraine)
• Carbamazepine (a medicine used to treat epileptic seizures)
• Cyclosporine (a medicine used to treat rheumatic diseases and to prevent transplant rejection)
• Medicines used to treat allergies (such as terfenadine, astemizole, and mizolastine)
• Medicines used to treat fungal infections (such as fluconazole, ketoconazole, and itraconazole)
• Medicines used to lower blood lipid levels (such as lovastatin and simvastatin)
• Rifabutin (a medicine used to treat tuberculosis)
• Anticoagulants e.g., warfarin, acenocoumarol, and rivaroxaban (used to thin the blood)
• Digoxin (a medicine used to treat heart problems)
• Omeprazole (a medicine used to treat heartburn and indigestion)
• Medicines to reduce reflux (such as cisapride)
• Pimozide (a medicine used to treat behavioral disorders)
• Theophylline (a medicine used to treat asthma and other respiratory problems such as chronic obstructive pulmonary disease (COPD))
• Alfentanil (a medicine used to anesthetize patients before surgery)
• Bromocriptine (a medicine used to treat Parkinson's disease)
• Anti-inflammatory drugs (such as methylprednisolone)
• Cilostazol (a medicine used to treat leg pain caused by poor circulation)
• Vinblastine (a medicine used to treat cancer)
• Sildenafil (a medicine used to treat erectile dysfunction)
• Medicines for heart rhythm disorders or malaria (such as quinidine)
• Colchicine (a medicine used to treat joint problems such as gout and arthritis)
• Zopiclone (a medicine used to treat sleep disorders)

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

• Rifampicin (used to treat certain infections),
• Phenytoin, carbamazepine, phenobarbital (used to treat seizures), and
• St. John’s wort (a herbal remedy used to treat depression)

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

• Contraceptives (medicines used for birth control)
• Anti-HIV treatments known as protease inhibitors
• Medicines used to treat infections (such as clindamycin, lincomycin, chloramphenicol, streptomycin, tetracyclines, colistin)

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

The use of Pantomicina 1g powder for solution for infusion together with cimetidine (a medicine used to treat ulcers) may lead to increased blood levels of Pantomicina.

Pregnancy, breastfeeding, and fertility

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

Pantomicina 1g powder for solution for infusion may only be used during pregnancy and breastfeeding if your doctor considers it necessary and under their guidance. The safety of erythromycin during pregnancy has not been established. Erythromycin crosses the placental barrier and is also present in breast milk.

Data from studies on the risk of congenital malformations are inconsistent, but some studies have reported cardiac abnormalities following the use of Pantomicina 1g powder for solution for infusion early in pregnancy. It is important to use effective contraceptive methods during treatment with this medicine (see section "Use of Pantomicina 1g powder for solution for infusion with other medicines").

Driving and using machines

Treatment with Pantomicina has a minor influence on the ability to drive or use machines.

3. How to use Pantomicina 1g powder for solution for infusion

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again. This medicine 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 cases 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 according to available clinical data are 1 to 4 g per day given in divided doses.

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

Elderly patients

Elderly patients usually require lower doses than adult patients. Adverse reactions are more likely to occur in these patients. Your doctor will provide you with specific information regarding necessary precautions, dosing, and monitoring.

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

No cases of intoxication have been reported with intravenous administration of erythromycin. If manifestations of hypersensitivity occur, treatment should be discontinued and appropriate therapy initiated (administration of adrenaline, steroids, etc.).

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20.

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

4. Possible adverse effects

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

Contact your doctor or pharmacist immediately if you experience any of the following adverse effects:

• Sudden rash, difficulty breathing, and fainting (anaphylactic reaction)
• Inflammation of the pancreas, inflammation of the liver
• Worsening of a condition called myasthenia gravis
• Narrowing of the stomach outlet area called the pylorus in children**
• Diarrhea caused by antibiotic use (pseudomembranous colitis)
• Serious skin reactions (conditions known as Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme)
• Yellowing of the skin and/or eyes, lack of energy, and loss of appetite (symptoms of liver problems such as hyperbilirubinemia, hepatitis with cholestasis, jaundice, and liver failure), and abnormal liver function
• Skin swelling called angioedema
• Kidney inflammation
• Abnormal heart rhythms (such as palpitations, faster heartbeat, irregular heartbeat potentially life-threatening known as 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 lumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse effect is considered not known (cannot be estimated from available data)

The following adverse effects have been observed with 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 of itchy hives

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

Ringing in the ears (tinnitus)

Confusional state

Sensation of spinning (vertigo)

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

Low levels of white blood cells (eosinophilia)

Hallucinations

Visual impairment

Deafness

Drop in blood pressure (hypotension)

Itching

Chest pain

Pain at injection site ***

Fever

Malaise

• Intravenous infusion of erythromycin at high doses (4 g of erythromycin or more in one day) may rarely cause reversible hearing loss.

** Infantile hypertrophic pyloric stenosis

*** Venous irritation and pain have sometimes occurred; if the infusion is administered slowly, preferably by continuous or intermittent intravenous infusion over no less than 20 to 60 minutes, this effect may be minimized.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

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

5. Storage of Pantomicina 1 g powder for solution for infusion

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the container after the abbreviation CAD.: The expiry date refers to the last day of the month indicated.

Do not use this medicine if the packaging is damaged or shows signs of tampering.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Pantomicina 1g powder for solution for infusion

• The active substance is erythromycin (as lactobionate).

Appearance of the product and contents of the container

Lyophilized powder for infusion solution in 1 sterile vial

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Amdipharm Limited

Unit 17, Northwood House

Northwood Crescent

Northwood, Dublin 9

D09 V504, Ireland

Manufacturer:

DELPHARM SAINT REMY

Rue de l'Isle

Saint Remy sur Avre,

28380, – France

For more information about this medicine, contact the local representative of the Marketing Authorization Holder:

Local representative:

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7th floor

28046 Madrid (Spain)

Tel. +34 900 834 889

[email protected]

Date of the most recent review of this leaflet: February 2023

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