Benzylpenicillin benzathine 2.4 Million I.U. powder for suspension for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• you are allergic to penicillins or any of the other ingredients of this medicine (listed in section 6).
• you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or neck.

Talk to your doctor or pharmacist before benzylpenicillin benzathine is used if:

• you have ever had an allergic reaction to other antibiotics like penicillin or other beta-lactam antibiotics.
• if you have kidney problems (your doctor may need to adapt the dose of this medicine).
• if you have liver problems.

Benzylpenicillin benzathine should not be used in tissues with poor blood flow.

If allergic symptoms occur (e.g. skin rash, itching, shortness of breath), tell a doctor immediately. Before treatment, a hypersensitivity test should be performed if possible. If an allergic reaction occurs, your doctor will stop your treatment and, if necessary, start appropriate therapy.

As a possible cross-allergy should be considered in patients with hypersensitivity to cephalosporins, please tell your doctor if you have already had a previous allergic reaction to certain antibiotics (cephalosporins).

If you have already been diagnosed with an allergy and/or allergic asthma or hay fever, you should tell your doctor. Severe immediate allergic reactions are possible even when the drug is administered for the first time. Based on general principles, in some cases, you will remain under observation for at least half an hour after the medicine has been administered in case an acute allergic reaction should occur. If an allergy occurs, the doctor will take appropriate measures. Treatment with benzylpenicillin benzathine must be stopped immediately.

When treating syphilis, a reaction to the bacterial toxins may occur, which lasts up to several days (Jarisch-Herxheimer reaction, see section 4). Typical symptoms are sudden fever (sometimes with chills), pale skin; followed by skin redness, headache, painful muscles and joints or tiredness. To suppress or alleviate a Jarisch-Herxheimer reaction, your doctor will start appropriate therapy.

Dose adjustments are necessary in patients with impaired kidney function and in patients with impaired liver function (see section 3).

In long-term treatment (more than a single dose), your doctor may arrange for checks on your blood count and liver and kidney function tests. Please make sure that you attend the check-ups prescribed by the doctor.

As with other antibiotics, therapy with benzylpenicillin benzathine may also lead to the overgrowth of non-susceptible germs. Contact your doctor if you get, for example, a fungal infection.

During treatment with antibiotics, including benzylpenicillin benzathine, diarrhoea may occur, even several weeks after you stopped your therapy. In case of severe or persistent diarrhoea, or if you notice that your stools contain blood or mucus, contact your doctor immediately. The therapy with benzylpenicillin benzathine must be stopped immediately, as it can be life-threatening. Do not take any medications which stop or slow down the bowel movements.

If neurological involvement cannot be ruled out in patients with congenital syphilis, forms of penicillin that reach a higher level in cerebrospinal fluid should be used.

Decreased elimination of povidone (one excipient included in this drug) should be considered in case of impairment of kidney function. It cannot be excluded that in very rare cases an accumulation of povidone or a local deposition and formation of granulomas (inflammation) may occur, which may be confused with tumours.

An effect on laboratory test results should also be considered (see also section 4).

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

Caution should be exercised when administering benzylpenicillin benzathine at the same time as the following medicines:

• probenecid, a medicine used to treat gout.
• methotrexate, a medicine used in chemotherapy. The combination with methotrexate is not recommended.
• anticoagulants: medicines used to thin the blood.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before this medicine is used.

Pregnancy

Benzylpenicillin benzathine can be used during pregnancy after appropriate diagnosis and careful consideration of the benefits and risks by the prescribing doctor.

Breast-feeding

Small amounts of benzylpenicillin benzathine, the active substance, pass into breast milk.

Although no side effects have been reported to date in young infants fed on breast milk, the possibility of sensitisation or interference with the gut flora must nevertheless be considered. In the case of diarrhoea, candidiasis (fungal infection) or rash in the child, immediately ask your doctor for advice, because these disorders in the child could be due to benzylpenicillin benzathine.

In young infants also being fed on baby food, mothers receiving benzylpenicillin benzathine should express and discard their breast milk. They can start breast-feeding again 24 hours after completion of treatment.

This medicine can impair responsiveness and the ability to drive.

Due to the occurrence of possible serious side effects (e.g. anaphylactic shock with collapse and allergic-like reactions (e.g. stomach upsets), see section 4), benzylpenicillin benzathine can have a major influence on the ability to drive and use machines.

This medicine contains phospholipids from soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product. This medicine contains less than 1 mmol sodium (23 mg) per vial 1.2 Million I.U. and 2.4 Million I.U., that is to say essentially ‘sodium-free’.

General treatment:

• Adults and adolescents: 1.2 Million I.U.
• Children (> 30 kg body weight): 1.2 Million I.U.
• Children (<30 kg body weight): 0.6 Million I.U.

Duration of treatment: Single dose

Treatment of syphilis:

• Primary and secondary stage
  • Adults and adolescents: 2.4 Million I.U.
  • Children: 50,000 IU per kg body weight, but not more than 2.4 Million I.U.
    Duration of treatment: Single dose (If clinical symptoms return or laboratory findings remain strongly positive, treatment should be repeated.)
• Late-stage syphilis (latent seropositive syphilis)
  • Adults and adolescents: 2.4 Million I.U.
  • Children: 50,000 IU per kg body weight, but not more than 2.4 Million I.U.
    Duration of treatment: Once weekly for 3 weeks
• Treatment of congenital syphilis (without neurological involvement)
  • Newborns and infants: 50,000 IU / kg body weight
    Duration of treatment: Single dose

Treatment of tropical infectious skin diseases (yaws, pinta):

• Adults and adolescents: 1.2 Million I.U.
• Children (> 30 kg body weight): 1.2 Million I.U.
• Children (< 30 kg body weight): 0.6 Million I.U.

Duration of treatment: Single dose

Prevention of rheumatic fever, poststreptococcal glomerulonephritis and erysipelas:

• Adults and adolescents: 1.2 Million I.U.
• Children (> 30 kg body weight): 1.2 Million I.U.
• Children (< 30 kg body weight): 0.6 Million I.U.

Duration of treatment:

a) without heart involvement: at least 5 years, or up to 21 years of age every 3-4 weeks.

b) temporary heart involvement: at least 10 years, or up to 21 years of age every 3-4 weeks.

c) persistent heart involvement: at least 10 years or up to 40 years of age every 3-4 weeks; life-long treatment is sometimes necessary.

The dosage and dosing interval will be determined by your doctor. If you have any questions on your dosage, please contact your doctor.

The preparation may only be injected into muscle (intramuscular administration).

The injection must not be administered into tissue with poor blood flow. In case of repeated intramuscular application, the site of injection site must be changed.

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

At extremely high doses, penicillins can cause muscular spasms or seizures. If overdose is suspected, talk to a doctor immediately for advice.

If you think that you have not been given a dose, talk to your doctor immediately.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is benzylpenicillin benzathine.

The other ingredients are: soya lecithin; polysorbate 80; carmellose sodium; sodium citrate, anhydrous; and povidone.

Powder in a glass vial for suspension for injection in a carton.

Pack of 1 vial.