Label: information for the user

BENZETACIL2.400.000 UI powder and solvent for injectable suspension

Benzylpenicillin benzathine

BENZETACIL 2.400.000 UIcontainsbenzathine penicillin, an antibiotic that belongs to the family of penicillins.

Benzathine penicillin is indicated for the treatment of infections caused by susceptible germs, including:

• Pharyngitis and tonsillitis.
• Syphilis: primary and secondary.
• Latent syphilis (except neurosyphilis).
• Erysipelas (skin infection).
• Tropical skin infections caused by bacteria of the speciesTreponema, such as yaws or pinta.

Benzathine penicillin is also indicated for the prevention of the following diseases:

• Rheumatic fever.
• Post-streptococcal glomerulonephritis (a specific form of kidney inflammation).
• Erysipelas (skin infection).

BENZETACIL 2.400.000 UI is primarily used for the treatment of syphilis, in which high doses of benzathine penicillin are required.

No use BENZETACIL 2.400.000 UI

If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

If you are allergic (hypersensitive) to penicillins, cephalosporins or soy.

If you have ever had an allergic reaction while taking an antibiotic or other medication. This may include a skin rash or swelling of the face or neck.

Warnings and precautions

Consult your doctor or pharmacist before starting to use BENZETACIL 2.400.000 UI.

-if you have ever had any allergic reaction to other antibiotics such as penicillin or other beta-lactam antibiotics,

-if you have kidney problems (your doctor may need to adjust the dose of this medication),

-if you have liver problems,

-if you are on a low-sodium diet.

BENZETACIL 2.400.000 UI should not be used in tissues with deficient blood flow.

In case of allergic symptoms (e.g. skin rash, itching, shortness of breath), consult your doctor immediately.

A skin test for hypersensitivity should be performed if possible before treatment. If an allergic reaction occurs, your doctor will suspend treatment and, if necessary, initiate appropriate treatment.

If you are allergic to cephalosporins. In hypersensitive patients to cephalosporins, the possibility of cross-allergic reactions should be taken into account.

If you are asthmatic or allergic to hay fever, inform your doctor. Severe immediate allergic reactions may occur when treatment is administered for the first time. In some cases, you may be observed for at least half an hour after administration of the medication in case of acute allergic reaction. In case of allergy, your doctor will take the necessary measures. Treatment with BENZETACIL 2.400.000 UI should be suspended immediately.

When treating syphilis, a reaction of the body to bacterial toxins may occur, which can last for several days (Jarisch-Herxheimer reaction, see section 4). The symptoms are sudden fever (sometimes with chills), paleness, followed by skin redness, headache, muscle and joint pain or fatigue. Your doctor will initiate appropriate treatment to suppress or attenuate a Jarisch-Herxheimer reaction.

If you have severe kidney and/or liver failure, the dose should be adjusted. For long-term treatment (more than 5 days), your doctor may schedule blood counts and examinations to evaluate the functioning of your kidneys.

Like other antibiotics, treatment with BENZETACIL 2.400.000 UI may lead to the proliferation of non-susceptible microorganisms. Contact your doctor if you have an infection caused by a fungus.

If you have ulcerative colitis, Crohn's disease or pseudomembranous colitis (persistent and/or severe diarrhea during or after administration of this medication), you should undergo rigorous clinical monitoring, with periodic analytical determinations.

During antibiotic treatment, including BENZETACIL 2.400.000 UI, diarrhea may occur even several weeks after the end of treatment. In case of severe or persistent diarrhea, or if you notice that your stools contain blood or mucus, inform your doctor immediately to stop treatment. Do not take medications intended to block or delay intestinal transit.

Other medications and BENZETACIL 2.400.000 UI

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

Consult your doctor if you are taking any of the following medications:

• Allopurinol and Probenecid (medications for gout or gouty arthritis)
• Methotrexate (chemotherapy medication)
• Other antibiotics
• Anticoagulants (blood-thinning medications)

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

Use of BENZETACIL 2.400.000 UI with food and beverages

The treatment with BENZETACIL is not affected if it is administered concurrently with food.

Pregnancy, lactation and fertility

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

BENZETACIL 2.400.000 UI should not be used during pregnancy unless the clinical situation of the woman requires treatment with benzylpenicillin benzathine.

Small amounts of benzylpenicillin pass into breast milk. Although no adverse effects have been reported in infants so far, the possibility of sensitization or interference with intestinal flora should be considered. In case of diarrhea, candidiasis or skin rash in the child, consult your doctor immediately. Breastfeeding may be resumed 24 hours after the end of treatment.

Driving and operating machinery

No evidence of effects on the ability to drive vehicles or operate machinery.

BENZETACIL 2.400.000 UI contains Sodium

This medication contains 43.78 mg of sodium per vial, equivalent to 2% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

BENZETACIL 2.400.000 UI contains Soy Lecithin

This medication contains 20.15 mg of soy lecithin per vial. It should not be used in case of allergy to peanuts or soy.

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Follow exactly the administration instructions of this medication as indicated by your doctor.

In case of doubt, consult your doctor or pharmacist again.

BENZETACIL 2.400.000 UI is primarily administered by a healthcare professional.

The recommended dose is:

General treatment:

Adults and adolescents:1.200.000 U.I once a week.

Children over 30 kg of weight:1.200.000 U.I once a week.

Children under 30 kg:600.000 U.I once a week.

Treatment duration:one single dose.

Syphilis treatment:

BENZETACIL 2.400.000 UI is mainly used for:the treatment of syphilis:

• primary and secondary:

Adults and adolescents:2.400.000 UI administered as a single dose.

Children:50.000 UI/kg of weight, not more than 2.400.000 UI.

If clinical symptoms return or laboratory results remain positive, the treatment should be repeated.

Treatment duration:one single dose.

• Latent syphilis:

Adults and adolescents:2.400.000 UI once a week.

Children:50.000 UI/kg of weight, not more than 2.400.000 UI.

Treatment duration: 3 weeks

• Congenital syphilis: without neurological involvement.

Newborns and infants:1 x 50.000 UI/kg of weight.

Treatment duration: one single dose.

Treatment of tropical skin infections (pian, pinta):

Adults and adolescents:1.200.000 U.I as a single dose.

Children over 30 kg of weight:1.200.000 U.I as a single dose.

Children under 30 kg:600.000 U.I as a single dose.

Treatment duration:one single dose.

Prophylaxis of rheumatic fever, post-streptococcal glomerulonephritis, and erysipelas:

Adults and adolescents:1.200.000 UI every 3-4 weeks.

Children over 30 kg of weight:1.200.000 UI every 3-4 weeks.

Children under 30 kg:600.000 U.I every 3-4 weeks.

Treatment duration:

1. Without cardiac involvement: at least 5 years, or until 21 years old.
2. Temporary cardiac involvement: at least 10 years, or until 21 years old.
3. Persistent cardiac involvement: at least 10 years or until 40 years old; sometimes lifelong treatment is necessary.

Children

Foruse in children and for other indications treated with lower doses of benzathine penicillin, BENZETACIL 1.200.000 UI and BENZETACIL 600.000 UI are marketed.

Patients with renal insufficiency and/or hepatic insufficiency

The dose and dosing interval will be determined by your doctor. According to the degree of functioning of your kidneys and/or liver, your doctor may consider adjusting the dose.

Administration form

BENZETACIL 2.400.000 UIis administered exclusively by deep intramuscular injection.

The injection should not be administered in tissues with poor blood flow.

In case of repeated intramuscular administration, the injection site should be changed.

Severe local reactions may occur during intramuscular administration, especially in small children. For this reason, other treatments, such as a different penicillin formulation, may be used whenever possible.

To consult the reconstitution instructions of the medication before administration, see the "Preparation instructions" section at the end of the prospectus.

If you use more BENZETACIL 2.400.000 UI than you should

At extremely high doses, penicillins can cause neuromuscular excitability or convulsions.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 91 562 04 20 indicating the medication and the amount used.

If you forget to use BENZETACIL 2.400.000 UI

Do not use a double dose to compensate for the missed dose. Use the missed dose as soon as possible and then continue with the regular schedule.

If you interrupt the treatment withBENZETACIL 2.400.000 UI

If you have any other doubts 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.

The side effects of this medicine are generally transient and mild. In most cases, side effects are of allergic origin and manifest dermatologically. The toxicological profile of this drug is similar to that of the rest of the penicillins, although allergic manifestations are somewhat more frequent, especially by parenteral route.

Severe allergic reactions (anaphylactic reactions or angioedema) that may occur as:

• skin rash or itching
• difficulty breathing or chest tightness
• swelling of the eyelids, face, or lips
• swelling or redness of the tongue
• fever
• joint pain
• inflamed lymph nodes

In case of allergic reaction, administration will be suspended and treatment with antihistamines (antiallergics) and/or corticosteroids (anti-inflammatory) will be instituted.

The side effects listed below are classified according to their frequency and classification by organs and systems. The frequency categories are defined by the following convention:

Very frequent (affects more than 1 in 10 patients);

Frequent (affects up to 1 in 100 patients);

Rare (affects up to 1 in 1,000 patients);

Rare (affects 1 and 10 in 10,000 patients);

Very rare (affects less than 1 in 10,000 patients);

Unknown frequency (cannot be estimated from available data).

Infections and infestations:

Frequent: fungal infection (candidiasis).

Blood and lymphatic system disorders:

Very rare: alteration of blood cells (eosinophilia, neutropenia, leucopenia, agranulocytosis, granulocytopenia, pancitopenia) and coagulation alterations.

Unknown frequency: Prolongation of bleeding time and prothrombin time.Anemia hemolítica (reduced levels of red blood cells in blood), thrombocytopenia (reduced levels of platelets in blood).

Gastrointestinal disorders:

Frequent: Nausea.

Rare: Inflammation of the oral mucosa (stomatitis) and inflammation of the tongue (glositis), vomiting.

Very rare: Pseudomembranous colitis (inflammation of the colon), diarrhea.

Immune system disorders:

Very rare: Allergic reactions: urticaria (skin rash similar to that caused by a nettle), angioedema (swelling), skin reactions (erythema multiforme, exfoliative dermatitis), fever, joint pain, anaphylactic shock with collapse and anaphylactoid reactions (asthma, skin hemorrhagic lesion called purpura, gastrointestinal disturbances).

Unknown frequency: Serum disease. When treating syphilis, a reaction called Jarisch-Herxheimer may occur, characterized by fever, chills, general and focal symptoms. Allergic reactions may occur in patients with skin mycosis (cutaneous fungus).Angioedema (swelling of the skin, mucosa, and subcutaneous tissue, usually localized in the face, mouth, or tongue).

Nervous system disorders:

Very rare: Neuropathy (affection of the nerves).

Unknown frequency:

Encephalopathy with insomnia, confusion, hallucinations, convulsions, and epileptic state, myoclonia (muscle contraction), and more rarely meningitis and benign intracranial hypertension.

Metabolic encephalopathy (neurological disorders with convulsions and loss of consciousness).

Hepatic disorders:

Unknown frequency: Inflammation of the liver (hepatitis), bile flow disorder (cholestasis).

Skin and subcutaneous tissue disorders:

Frequent: Rashes, exanthems (red rash on the skin), pruritus (itching).

Unknown frequency: AGEP - Generalized Pustular Exanthema with symptoms such as severe skin reactions to medications with or without skin redness, fever, pustules, maculopapular rash (flat and red area on the skin), morbilliform rash (rash that resembles measles), itching, erythema (inflammatory redness of the skin).

Renal and urinary disorders:

Very rare: Kidney disease (nephropathy), interstitial nephritis (inflammation of the kidneys), albuminuria, cylindruria (proteins excreted in urine) and hematuria (blood in urine). Oliguria (decreased urine production), anuria (no urine excretion) may occur at high doses and generally disappear within 48 hours of stopping treatment.

General disorders and administration site conditions:

Frequent: Pain and/or infiltration at the injection site.

Investigations::

Frequent: Modifications of certain tests and investigations such as:

• Direct Coombs test.
• Falsely positive results in urine protein determination, using precipitation techniques (Folin-Ciocalteu-Lowry and biuret methods).
• Falsely positive results in amino acid determination tests.
• Simulation of albuminemia in albumin determination by electrophoretic methods.
• Non-enzymatic tests to detect false positives of glucose in urine and urobilinogen.
• High levels when determining ketosteroids in urine (Zimmermann reaction)

Reporting of suspected adverse reactions:

It is essential to report suspected adverse reactions to the medicine after its authorization. This allows for continuous monitoring of the benefit-risk ratio of the medicine. Healthcare professionals are invited to report suspected adverse reactions through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es

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

The powder for injectable suspension (vial) must be stored in a dry place.

Reconstituted vial: The reconstituted product must be used immediately for intramuscular administration.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the Sigre point of the pharmacy.

If in doubt, ask your pharmacist how to dispose of the containers and unused medications. In this way, you will help protect the environment.

Composition ofBENZETACIL 2.400.000 UI

Vial:

• The active principle isBencilpenicilina benzatina(Penicilina G benzatina). Each vial contains 2.400.000 UIBencilpenicilina benzatina.
• The other components (excipients) are: Tween 80, lecitina, citrato de sodio (E-331).

Ampoule: water for injectable preparations.

Once the vial is reconstituted with 6 ml of water, the final volume is 7.9 ml, containing 2.400.000 UI of Bencilpenicilina benzatina.

There are 400.000 UI of bencilpenicilina benzatina in 1.31 ml of suspension.

Aspect of the product and content of the package

BENZETACIL2.400.000 UI is presented in single-dose packaging: 1 vial and 1 ampoule and in clinical packaging: 100 vials and 100 ampoules.

Holder of the marketing authorization and responsible for the manufacture:

Holder of the marketing authorization:

Laboratorio Reig Jofré, S.A.

Gran Capitán, 10

08970 San Joan Despí (Barcelona)

Responsible for the manufacture:

Laboratorio Reig Jofré, S.A.

Jarama, 111 - Industrial Estate

45007 Toledo

Date of the last review of this leaflet:October 2021.

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

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This information is intended solely for doctors or healthcare professionals:

Medicine:BENZETACIL 2.400.000 UI powder and solvent for injectable suspension

Method of administration:

BENZETACIL 2.400.000 UIis administered exclusively by deep intramuscular injectionin the upper outer quadrant of the gluteus or in the ventro-gluteal area of Hochstetter with the needle pointing towards the iliac crest or according to the Hochstetter method. The puncture must be as perpendicular as possible with respect to the skin surface and the injection as far as possible from the main vessels. In case of repeated doses, change the injection site.

In children, the recommended injection site is in the middle-lateral muscle of the thigh (femoral quadriceps). The deltoid muscle injection is only recommended if the muscle mass is adequate. In this case, attention should be paid to the radial nerve.

In babies and small children, the peripheral area of the upper outer quadrant of the gluteal region should only be used as a site of injection in exceptional cases, to avoid damage to the sciatic nerve.

Before injection, intravascular administration must be excluded by aspiration. In case of repeated doses, change the injection site.

For depot preparations, although it is recommended not to administer more than 5 ml per injection site as a tolerance limit,the entire vial can be administered in one place. In case of excessive pain, the volume can be divided into two injection sites.

The injection should be administered as slowly as possible and only with low pressure.

Avoid pressing and/or rubbing after injection.

Preparation instructions:

To inject BENZETACIL, a long needle of calibre0.9 mmshould be used. Prepare the suspension aseptically by injecting 6 ml of water for injectable preparations from the ampoule provided in the package into the vial.

Shake until a homogeneous suspension is obtained. Aspirate the contents of the vial with the syringe.

1.31 ml of suspension for injection of BENZETACIL 2.400.000 UI, contains 400.000 UI ofbencilpenicilina benzatina after reconstitution with the 6 ml of water from the ampoule.

To inject, insert the needle deeply into the gluteus, place the syringe and aspirate by pulling the plunger of the syringe and checking that no blood comes out to ensure that the needle is not in a blood vessel. Apply as soon as possible to avoid crystallization inside the injection needle and causing the patient more pain.

For single use only. Discard unused suspension.