Farmaproina 1.200.000 UI powder for injection suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Farmaproina 1,200,000 IU powder for injectable suspension

procaine benzylpenicillin

Package leaflet:

1. What Farmaproina 1,200,000 IU is and what it is used for
2. What you need to know before you start using Farmaproina 1,200,000 IU
3. How to use Farmaproina 1,200,000 IU
4. Possible side effects
5. How to store Farmaproina 1,200,000 IU
6. Contents of the pack and other information

1. What Farmaproina 1,200,000 UI is and what it is used for

Farmaproina 1,200,000 UI contains benzylpenicillin procaine. This medicine belongs to the group of antibiotics. It is available as an injectable suspension and is administered by intramuscular injection. It consists of benzylpenicillin and procaine. Benzylpenicillin, also known as penicillin G, is the antibiotic used to eliminate germs that cause infections, and procaine is an anesthetic that acts by reducing pain at the injection site.

Farmaproina 1,200,000 IU is indicated for the treatment of the following types of infections caused by microorganisms sensitive to penicillin G:

• Ear, nose, and throat infections (such as otitis, sinusitis, pharyngitis, or tonsillitis).

• Dental infections (of the gums, of the mouth).

• Respiratory tract infections (such as diphtheria, bronchitis, pulmonia, pneumonia).

• Heart infections (such as endocarditis).

• Bone infections.

• Skin infections (such as bejel, pinta, yaws, erysipelas, or carbuncle).

• Gastrointestinal infections.

• Gynecological infections.

• Relapsing fever and rat-bite fever.

• Some sexually transmitted diseases (gonorrhea and syphilis).

It is also used to prevent infections prior to undergoing surgical procedures or surgery.

2. What you need to know before using Farmaproina 1,200,000 IU

Do not use Farmaproina 1,200,000 IU

If you are allergic to penicillins, procaine, or any of the other components of this medicine (listed in section 6).

If you are allergic to any beta-lactam type antibiotics, such as cephalosporins.

Do not administer this medicine intravenously, intra-arterially, or near peripheral nerves or blood vessels, as severe and/or irreversible damage may occur.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Farmaproina 1,200,000 IU.

Take special care with Farmaproina 1,200,000 IU

Consult your doctor before starting to use Farmaproina 1,200,000 IU:

• If you have ever had or currently have a tendency towards allergic reactions, or if you suffer from asthma.
• If you have or have had gastrointestinal disorders such as ulcerative colitis, regional enteritis (Crohn's disease), or antibiotic-associated colitis.
• If new infections caused by bacteria or fungi appear during treatment with penicillin.
• If you suffer from a disease called infectious mononucleosis.
• If you have renal insufficiency. The dose will need to be adjusted.
• If minor skin rashes appear during treatment.

Interference with diagnostic tests:

If you are due to have 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 Farmaproina 1,200,000 IU

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

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

• Methotrexate (used to treat cancer or rheumatoid arthritis).
• Probenecid (a medicine for gout and gouty arthritis).
• Digoxin (used for heart failure or cardiac rhythm disorders).
• Medicines used to treat inflammation, pain, or fever.
• Oral anticoagulants (medicines to thin the blood).
• Other antibiotics, especially tetracyclines (chlortetracycline, doxycycline, oxytetracycline).

Inform your doctor that you are taking this medicine, as it may alter the results of blood and urine tests.

Pregnancy and breastfeeding

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. Farmaproina 1,200,000 IU, like most medicines, should not be used during pregnancy or breastfeeding unless your doctor considers it essential.

Driving and using machines:

There is no evidence of effects on the ability to drive or operate machinery.

This medicine contains less than 1 mmol of sodium (23 mg) per vial; hence, it is essentially “sodium-free”.

3. How to use Farmaproina 1,200,000 IU

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

Penicillin G procaine is a drug with low toxicity, so dosage margins are very wide and vary depending on the condition being treated.

Farmaproina 1,200,000 IU is always administered by deep intramuscular injection using a needle of at least 20 gauge. Prior to injection, suspend the powder in the vial with 5 ml of water for injection. Shake until a homogeneous suspension is obtained. Before injecting, pull back the syringe plunger to ensure that the needle is not within the lumen of a blood vessel.

1 ml of prepared suspension contains 240,000 IU of benzylpenicillin procaine, which must be taken into account when administering doses according to patient type and treatment.

Do not stop treatment even if symptoms improve rapidly, as discomfort may reappear.

Your doctor will determine the duration of treatment with Farmaproina 1,200,000 IU and the appropriate dosage based on the infection being treated.

The recommended dose is:

Adults and adolescents: 600,000 IU to 1,200,000 IU every 24 hours.

Maximum dose in adults: 4,800,000 IU every 24 hours.

Children: 50,000 IU per kg every 24 hours.
Usual pediatric dose: 300,000 units per day.

Some infants and children may require up to 100,000 IU per kg every 24 hours, divided into several doses, depending on the type and severity of the infection.

For the treatment of syphilis, the usual dose is 1,200,000 IU every 24 hours for 8 days or for 10 to 15 days, depending on the stage of the disease.

Adults with renal impairment: Your doctor will perform tests to monitor kidney function and adjust the dosage of the medicine if necessary.

If you use more Farmaproina 1,200,000 IU than you should:

In case of overdose, accidental ingestion, or administration to another person, consult your doctor or pharmacist, or call the Toxicology Information Service (Tel. 91 562 04 20), indicating the product and amount administered.

If you forget to use Farmaproina 1,200,000 IU:

Do not use a double dose to make up for missed doses. Take the missed dose as soon as possible, then continue with your regular dosing schedule.

If you interrupt treatment with Farmaproina 1,200,000 IU:

Your doctor will advise you on the duration of your treatment with Farmaproina 1,200,000 IU. 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.

Adverse effects are generally mild and disappear when treatment is discontinued. In most cases, adverse effects are of allergic origin and manifest dermatologically. The toxicological profile of this drug is similar to that of other penicillins, although allergic manifestations occur somewhat more frequently, especially with parenteral administration.

Severe allergic reactions (anaphylactic reactions or angioedema) may occur, such 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; swollen lymph nodes.

Other side effects (the frequency of these side effects is unknown):

AGEP – Acute Generalized Exanthematous Pustulosis, with symptoms such as severe skin reactions to medications with or without skin redness, fever, and pustules.

Maculopapular rash (flat, red area on the skin), morbilliform rash (rash resembling measles), pruritus (itching), erythema (inflammatory redness of the skin), angioedema (swelling of the skin, mucosa, and subcutaneous tissue, usually affecting the face, mouth, or tongue), thrombocytopenia (reduced platelet levels in blood), anemia (reduced red blood cell levels in blood), metabolic encephalopathy (neurological disorders with seizures and loss of consciousness).

The adverse effects listed below are classified according to their frequency and by organ system. Frequency categories are defined as follows:

• Very common (affects more than 1 in 10 people);
• Common (affects up to 1 in 100 people);
• Uncommon (affects up to 1 in 1,000 people);
• Rare (affects between 1 and 10 in 10,000 people);
• Very rare (affects fewer than 1 in 10,000 people);
• Frequency not known (cannot be estimated from available data).

Blood and lymphatic system disorders:

• Uncommon (may affect up to 1 in 100 people): blood disorders such as eosinophilia (abnormal increase in white blood cells), transient neutropenia, leukopenia, thrombocytopenic purpura (decrease in white blood cells or platelets). These reactions are more common with higher doses of penicillin.
• Frequency not known (cannot be estimated from available data): Hemolytic anemia (reduced red blood cell levels in blood), thrombocytopenia (reduced platelet levels in blood), and prolonged bleeding time and clotting time in laboratory tests.

Immune system disorders:

• Common (may affect up to 1 in 10 people): hypersensitivity reactions (allergy) such as redness or inflammation of the skin; in the treatment of syphilis, Jarisch-Herxheimer reaction may occur (acute allergic reaction causing symptoms such as chills, fever, malaise, nausea, headache, or muscle pain).
• Uncommon (may affect up to 1 in 100 people): urticaria (itching), serum sickness (allergic reaction causing fever, urticaria, itching, joint pain, skin rash, swollen lymph nodes, and general discomfort).
• Frequency not known (cannot be estimated from available data): angioedema (swelling of the skin, mucosa, and subcutaneous tissue, usually localized in the face, mouth, or tongue).

Nervous system disorders:

• Rare (may affect up to 1 in 1,000 people): central nervous system effects have been reported, including seizures. These may occur in patients with renal impairment or those receiving high doses of penicillin.
• Frequency not known (cannot be estimated from available data): metabolic encephalopathy (neurological disorders with seizures and loss of consciousness).

Gastrointestinal disorders:

• Common (may affect up to 1 in 10 people): nausea, vomiting, diarrhea, stomach discomfort, and abdominal pain.
• Rare (may affect up to 1 in 1,000 people): pseudomembranous colitis (a serious intestinal disease causing diarrhea, fever, and severe abdominal pain), diarrhea.

Hepatobiliary disorders:

Frequency not known (cannot be estimated from available data): inflammation of the liver (hepatitis), disturbance in bile flow from the gallbladder (cholestasis).

General disorders and administration site conditions:

• Common (may affect up to 1 in 10 people): pain at the injection site.

Psychiatric disorders:

• Uncommon (may affect up to 1 in 100 people): Hoigne syndrome (acute generalized allergic reaction of psychiatric type, with symptoms such as fear of dying, confusion, visual and auditory hallucinations, tachycardia, and/or bluish discoloration of the skin).

Reporting of adverse effects

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

5. Storage of Farmaproina 1,200,000 IU

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

Store in a dry place.

Once reconstituted, the product must be used immediately.

Expiry date:

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point located in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Farmaproina 1,200,000 IU

• Vial:
• The active substance is benzylpenicillin procaine (penicillin G procaine). Each vial contains 1,200,000 IU of benzylpenicillin procaine.
• The medicine does not contain any other ingredient.

The reconstituted vial contains 240,000 IU per ml of suspension.

Appearance of the product and contents of the pack

Farmaproina 1,200,000 IU is available in unit packs containing 1 vial, and in clinical packs containing 100 vials.

Marketing Authorization Holder and Manufacturer:

Laboratorio Reig Jofre, S.A.

Gran Capitán, 10

08970 Sant Joan Despí (Barcelona)

Spain

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

Date of the most recent revision of this leaflet: November 2025