Penilente LA Suspension

PENILENTE LA is used for the treatment of infections caused by organisms sensitive to the active ingredient of PENILENTE LA;

• Streptococcal pharyngitis (sore throat);
• Syphilis of less than 1 year duration;
• Uncomplicated cases of erysipeloid (an infection of the upper or outer skin and underlying layers);
• Prophylactic (preventative) use: recurrence of rheumatic fever.

PENILENTE LA should not be administered to you if:

• You are hypersensitive (allergic) to penicillin or cephalosporins or any of the other ingredients of PENILENTE LA (listed in section 6);
• PENILENTE LA must not be given to babies born to mothers who are allergic to penicillin during the neonatal period;
• you have an inflammation of the inner layer of the heart (endocarditis);
• you have inflammation of the peritoneum (peritonitis), the thin tissue that lines the inner wall of the abdomen and covers most of the abdominal organs;
• you have acute inflammation of the protective membranes covering the brain and spinal cord (meningitis).

PENILENTE LA should not be injected into any of your veins.

Warnings and precautions

Tell your doctor or healthcare provider before being given the injection:

• If you have a history of allergic reaction to medicines containing penicillin, cephalosporin or other beta-lactam medicines;
• you have kidney disease (renal impairment), because of the risk of neurotoxicity (nerve toxicity);
• you have liver problems;
• you have congestive heart failure (heart failure).

PENILENTE LA should not be used in tissues with poor blood flow.

You will not be expected to give yourself PENILENTE LA. It will be given to you by a person who is qualified to do so.

Your doctor will tell you how long your treatment with PENILENTE LA will last.

If you have the impression that the effect of PENILENTE LA is too strong or too weak, tell your doctor or pharmacist.

PENILENTE LA is for INTRAMUSCULAR USE ONLY.

You will be administered PENILENTE LA by deep injection into a muscle once a month. PENILENTE LA must NEVER be injected into your veins.

PENILENTE LA can have side effects. Not all side effects reported for PENILENTE LA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving PENILENTE LA, please consult your healthcare provider for advice.

If any of the following happens, stop using PENILENTE LA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing;
• rash or itching;
• fainting;
• chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome).

These are all very serious side effects. If you have them, you may have had a serious reaction to PENILENTE LA. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Fungal infection (candidiasis);
• inflammation of the blood vessels (vasculitis).
• diarrhoea; nausea;
• inflammation of the lining of the mouth (stomatitis) and of the tongue (glossitis);
• being sick (vomiting);
• changes in certain test and investigation results performed by your doctor.

Less frequent side effects:

• Certain blood disorders (so called leukopenia, thrombocytopenia, agranulocytosis);
• sore mouth or tongue and black, hairy tongue;
• kidney disease (nephropathy);
• kidney inflammation (interstitial nephritis).

Side effects with unknown frequency:

• A blood disorder in which red blood cells are destroyed faster than they can be made (haemolytic anaemia);
• an abnormally low count of a type of white blood cell (neutrophils), called neutropenia, prolongation of bleeding time, defective blood platelet function;
• serum sickness (when antigens (substances that trigger an immune response) in certain medications and antiserums cause your immune system to react);
• antibiotic-associated diarrhoea caused by inflammation of the colon/ large intestines (pseudomembranous colitis);
• heartburn;
• liver inflammation (hepatitis);
• impairment of bile flow (cholestasis);
• increases in liver enzymes;

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of PENILENTE LA.

• Store all medicines out of reach of children.
• Store in a cool, dry place.
• Store at or below 25 °C.
• Suspensions must be used within 4 weeks when stored at or below 25 °C.
• PENILENTE LA should not be administered after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
• Any PENILENTE LA which is left over, not used or has passed its expiry date will be disposed of by hospital staff.
• Do not dispose of unused medicine in drains and sewerage systems (e.g., toilets).