Penilevel 5,000,000 IU powder and solvent for solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Penilevel 5,000,000 IU powder and solvent for injectable solution

Benzylpenicillin sodium

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 others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Penilevel is and what it is used for

Penilevel contains benzylpenicillin sodium, an antibiotic that belongs to a group of medicines called penicillins.

Penilevel is used in the treatment of:

• Skin infections, such as erysipelas.
• Respiratory infections, such as pneumonia, pleuritis (inflammation of the membrane lining the lungs), empyema (presence of pus in the lungs), and lung abscess.
• Bacterial endocarditis (inflammation of the inner lining of the heart).
• Meningitis (inflammation of the membranes covering the brain and spinal cord) and brain abscesses.
• Osteomyelitis (bone infection).
• Genitourinary and gynecological infections.
• Infections of the ear, nose, and mouth, such as tonsillitis (angina), pharyngitis (inflammation of the throat), otitis media (ear infection), or acute sinusitis (inflammation of the nasal sinuses).
• Gastrointestinal and biliary tract infections.
• Peritonitis (inflammation of the membrane lining the abdomen and protecting abdominal organs).
• Sepsis (when bacteria and their toxins circulate in the blood, causing organ damage).

Penilevel is also used in the treatment of the following diseases:

• Anthrax (a bacterial infection that may affect the skin, lungs, and gastrointestinal tract).
• Diphtheria.
• Tetanus.
• Gas gangrene.
• Listeriosis (a foodborne infection that can be severe in pregnant women and elderly individuals).
• Syphilis (in cases of neurological involvement and in newborns).
• Leptospirosis.
• Lyme disease, an illness transmitted by tick bites.
• Pasteurellosis (an infection caused by a bacterium transmitted through bites or scratches from certain animals, primarily cats and dogs).
• Rat-bite fever.
• Vincent's angina (an infection of the mouth and gums caused by bacteria known as spirochetes).
• Actinomycosis, a prolonged bacterial infection usually affecting the face and neck, sometimes causing abscesses, ulcers, and fever.
• Gonorrhea, in complicated cases caused by penicillin-sensitive strains.

2. What you need to know before using Penilevel

Do not use Penilevel

• If you are allergic to sodium benzylpenicillin and/or other beta-lactam antibiotics (penicillins, cephalosporins), or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to use Penilevel:

• If you have ever experienced signs of intolerance after using other antibiotics. Your doctor will decide whether you can use this medicine or not, and whether a hypersensitivity (allergy) test is advisable.
• If you are prone to allergic reactions or have asthma. In such cases, there is an increased risk of allergic reactions.
• If you have heart disease or a severe electrolyte disorder (abnormal levels of sodium, calcium, potassium, or chloride). In these cases, your doctor should monitor your intake of these components, especially potassium.
• If you have impaired liver or kidney function. Your doctor may need to adjust the dose or frequency of administration of this medicine.
• If you have epilepsy, fluid accumulation in the brain (edema), or inflammation of the membranes covering the brain and spinal cord. In these cases, your doctor will monitor you more closely, as there is an increased risk of seizures during treatment.
• If you have mononucleosis (an infectious disease accompanied by fever, sore throat, swollen glands, and extreme fatigue), as there is an increased risk of skin reactions.
• If you have a cancer of the white blood cells known as acute lymphoblastic leukemia, as there is an increased risk of skin reactions.
• If you have a fungal skin infection, as there is an increased risk of developing allergic-type reactions.
• If you are receiving anticoagulant therapy, periodic coagulation monitoring is recommended, and if necessary, your doctor will adjust the dose of your medication.
• If you have diabetes, as absorption of this medicine may be altered when injected into muscle.
• If you are receiving Penilevel for the treatment of Lyme disease (a disease transmitted by tick bites) or for complications of syphilis. In these patients, a transient reaction known as the “Jarisch-Herxheimer reaction” may occur due to the destruction of the bacteria causing the disease. This reaction includes symptoms such as sudden fever, chills, skin redness, headache, muscle and joint pain, fatigue, and exhaustion. These symptoms may last for several days. Consult your doctor on how to relieve them.
• If you develop severe and persistent diarrhea during treatment with Penilevel. This diarrhea may result from intestinal inflammation associated with treatment. Symptoms include watery or bloody-mucous diarrhea, stomach pain, fever, and occasionally a constant, painful urge to defecate. Your doctor will stop treatment immediately and start appropriate therapy.
• If you are receiving prolonged treatment with Penilevel for several weeks. Treatment with Penilevel may lead to overgrowth of other bacteria or yeast-type fungi. Therefore, inform your doctor if you develop diarrhea, skin rashes, or fungal overgrowth on mucous membranes. Additionally, your doctor will perform regular blood tests if treatment lasts longer than 5 days.
• If the medicine is administered to infants via intramuscular injection, local reactions may occur intensely. In this case, intravenous administration is preferred for this patient group.

Interference with diagnostic tests:

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Other medicines and Penilevel

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines. Please note that these instructions may also apply to medicines taken previously or that may be taken in the future.

It is important to inform your doctor if you are taking:

• Methotrexate (used to treat cancer or rheumatoid arthritis), as penicillins may reduce methotrexate elimination, potentially leading to toxic effects.
• Probenecid (used to treat gout), as it reduces penicillin elimination and may increase harmful effects.
• Medicines for inflammation, pain, or fever (such as salicylic acid, indomethacin, or phenylbutazone), as they may reduce penicillin elimination and increase harmful effects.
• Digoxin (used for heart failure or cardiac rhythm disorders), as there is a risk of decreased heart rate.
• Oral anticoagulants, as dose adjustment or more frequent monitoring of coagulation status may be necessary.
• Aminoglycoside antibiotics, as administration of these medicines should be separated by at least 1 hour to avoid interference.
• Certain antibiotics (tetracyclines, chloramphenicol, sulfonamides) may reduce the bactericidal effects of penicillins.

Pregnancy and breastfeeding

If you are pregnant or think you might be pregnant, consult your doctor before using this medicine. Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Penicillins are excreted into breast milk, some in low concentrations. If you breastfeed while using Penilevel, it may cause sensitization, diarrhea, candidiasis, or skin rash in the infant. Consult your doctor if your baby shows any of these symptoms.

Driving and using machines

No effects of Penilevel on the ability to drive or operate machinery have been reported at the recommended doses.

Penilevel contains sodium

This medicine contains 193 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 10% of the maximum daily sodium intake recommended for an adult.

3. How to use Penilevel

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse again.

Recommended dose:

Adults and adolescents (from 12 years of age):

1,000,000–3,000,000 IU/day, administered intravenously or intramuscularly, divided into equal doses every 4 hours.

In case of severe infections, the dose may be increased up to 2,000,000 IU every 2 hours.

Children (up to 12 years of age):

100,000–300,000 IU/kg/day, administered intravenously or intramuscularly, divided into equal doses every 4–6 hours, up to a maximum of 24,000,000 IU/day.

Method of administration

Your doctor or nurse will administer this medicine to you either intramuscularly or intravenously.

The number of days you will receive Penilevel treatment depends on the type of infection you have and how the infection progresses.

If you are given more Penilevel than you should

Penilevel will be administered by a doctor or nurse, so it is unlikely that you will receive an incorrect dose. However, if you think you have been given more Penilevel than you should have, inform your doctor or nurse immediately.

There is no specific antidote for overdose; therefore, treatment should be symptomatic and supportive. Hemodialysis may help remove penicillins from the blood.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or nurse, or contact the Toxicology Information Service, Telephone 91 562 04 20, indicating the product and the amount administered.

If you miss a dose of Penilevel

If you think a dose of Penilevel has not been administered, inform your doctor or nurse immediately.

If you stop using Penilevel

Your doctor will determine the duration of your treatment with Penilevel. Do not stop treatment without consulting your doctor first.

If you have any further questions about the use of this product, 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.

Serious adverse effects

Inform your doctor immediately if you notice any of the following serious adverse effects, as you may require urgent medical treatment:

• Severe allergic reactions (anaphylactic reactions or angioedema), with signs such as skin rash or itching; chest tightness or difficulty breathing; swelling of the eyelids, face or lips; swelling or redness of the tongue; fever; joint pain; swollen lymph nodes.

• Diarrhea that worsens or does not go away, or stools containing blood or mucus. This may occur during treatment or after stopping it. If this happens, do not take medications that slow down or reduce the number of bowel movements.

Other adverse effects

Uncommon: may affect up to 1 in 100 people.

• Allergic reactions: urticaria, asthma, fever, joint pain, gastrointestinal discomfort.
• Nausea and vomiting.
• Diarrhea, which may become severe.
• Inflammation of the tongue.
• Inflammation of the mouth and lips (stomatitis).

Rare: may affect up to 1 in 1,000 people.

• Electrolyte disturbances due to rapid administration of high doses.
• Nervous system disorders, including seizures, in patients with kidney problems or neurological conditions such as epilepsy, fluid accumulation in the brain (edema), or inflammation of the membranes covering the brain and spinal cord.
• Kidney function problems: abnormal presence of protein in the urine, reduced urine output, absence of urine.
• Severe reactions at the intramuscular injection site in infants.

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

• Increase in the number of white blood cells in blood (eosinophilia).
• Decrease in the number of white blood cells in blood (leukopenia, neutropenia, agranulocytosis).
• Decrease in the number of red blood cells in blood (hemolytic anemia).
• Blood coagulation disorders.

Frequency not known: frequency cannot be estimated from the available data.

• Decrease in the number of platelets (thrombocytopenia).
• Prolongation of bleeding time and of the time required for blood to clot in laboratory tests.
• Swelling of the skin and mucous membranes, usually localized in the face, mouth, or tongue (angioedema).
• Hypersensitivity reaction to blood proteins, known as serum sickness, presenting with symptoms such as fever, swollen lymph nodes, redness at the injection site, and itching.
• Jarisch-Herxheimer reaction due to destruction of the bacteria causing the disease. This transient reaction includes symptoms such as sudden fever, chills, skin redness, headache, muscle and joint pain, fatigue, and exhaustion.
• Neurological disorders accompanied by seizures and loss of consciousness (metabolic encephalopathy).
• Inflammation of the liver (hepatitis).
• Impaired flow in the bile duct (cholestasis).
• Pemphigoid (a skin disease characterized by blister formation).
• Itching of the skin.
• Redness and inflammation of the skin (erythema).
• Skin rash resembling measles.
• Maculopapular skin rash (redness and flat areas on the skin).
• Acute generalized exanthematous pustulosis (AGEP): a severe skin reaction that may include redness, pustules, and fever.
• Widespread rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin detachment (toxic epidermal necrolysis).
• Drug reaction with eosinophilia and systemic symptoms (DRESS): presents as a group of flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results, such as increased white blood cells (eosinophilia) or elevated liver enzymes.

Administration by intramuscular route may cause local pain, tenderness, or swelling/induration at the injection site.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Penilevel

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

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Penilevel

• The active substance is sodium benzylpenicillin. Each vial contains 5,000,000 IU of benzylpenicillin, equivalent to 3,000 mg of sodium benzylpenicillin (sodium penicillin G).
• The other components are: solvent ampoule containing 10 ml of water for injection.

Appearance of the product and contents of the pack

Penilevel is supplied as a glass vial containing a white or almost white powder and an ampoule of water for injection. The available pack sizes are:

• Normal pack: 1 vial + 1 solvent ampoule
• Clinical pack: 100 vials + 100 solvent ampoules

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios ERN, S.A.
C/Perú, 228
08020 Barcelona, Spain

Manufacturer

Laboratorios ERN, S.A.
C/Gorchs Lladó, 188
Pol. Ind. Can Salvatella
08210 Barberà del Vallès (Barcelona), Spain

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

Detailed 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.

Method of administration

Penilevel may be administered by intramuscular or intravenous route.

Reconstitute the powder in the vial with the solvent from the ampoule to obtain a homogeneous solution.