Ospen 750

Leaflet accompanying the packaging: patient information

OSPEN 750, 750,000 IU/5 ml, oral suspension

Benzathine phenoxymethylpenicillin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Ospen 750 is and what it is used for
• 2. Important information before taking Ospen 750
• 3. How to take Ospen 750
• 4. Possible side effects
• 5. How to store Ospen 750
• 6. Contents of the pack and other information

1. What Ospen 750 is and what it is used for

Ospen 750 is an antibiotic belonging to the penicillin group for oral use, with a strong antibacterial effect. It acts bactericidally on sensitive, multiplying microorganisms by inhibiting cell wall synthesis.
Ospen 750 is indicated for:
treatmentof the following infections with a mild to moderate course, caused by microorganisms sensitive to penicillin:

• ear, nose, and throat infections, including streptococcal infections (scarlet fever, pharyngitis, tonsillitis, nasopharyngitis, sinusitis, acute otitis media, Vincent's angina);
• respiratory tract infections: bacterial bronchitis, bacterial pneumonia, bronchopneumonia (except in cases where penicillin should be administered parenterally or as a continuation of injection therapy);
• skin and soft tissue infections: erysipelas, impetigo, purulent skin inflammation (e.g., ecthyma, folliculitis), abscesses, carbuncles; preventionof complications after streptococcal infections, such as: recurrences of rheumatic fever and Sydenham's chorea, rheumatic heart disease, endocarditis, glomerulonephritis; prevention of bacterial endocarditis in patients with congenital or rheumatic heart defects before and after minor surgical procedures, such as tonsillectomy, tooth extraction, etc.

In the treatment of severe pneumonia, lung abscess, sepsis, pericarditis, endocarditis, meningitis, arthritis, and osteomyelitis, penicillin should be administered parenterally in the acute phase of infection.

2. Important information before taking Ospen 750

When not to take Ospen 750:

• if the patient is allergic to penicillin or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to cephalosporins (allergy means that in the past, when taking these medicines, the patient had a skin rash, facial swelling, or difficulty breathing);
• if the patient has gastrointestinal disorders with persistent diarrhea or vomiting, as this may lead to reduced absorption of the medicine.
• if the patient has ever experienced a severe skin rash or exfoliation, blisters, and (or) ulcers of the mouth after treatment with Ospen or other beta-lactam antibiotics.

Warnings and precautions

Before starting to take Ospen 750, the patient should discuss it with their doctor or pharmacist if:
they are allergic to penicillins, cephalosporins, or other substances, as they may also be allergic to Ospen 750;
they currently have or have had asthma or severe allergic reactions;
they are taking Ospen 750 to prevent recurrences of rheumatic fever, as the dose of the medicine may need to be adjusted before a planned surgical procedure (such as tonsillectomy, tooth extraction, etc.);
they have kidney function disorders, especially severe ones, as the dose of the medicine may need to be adjusted or the interval between doses extended, and regular monitoring of kidney function is recommended;
they have infectious mononucleosis, as they may experience a skin rash;
in the past, an antibacterial medicine has caused severe diarrhea in the patient;
they have nausea, vomiting, diarrhea, or have been diagnosed with gastric dilation, disorders of food passage through the esophagus to the stomach (so-called achalasia of the esophagus), or excessive intestinal motility, as this may reduce the absorption of the medicine;
they are going to be vaccinated against typhoid (see "Ospen 750 and other medicines").

Special precautions during Ospen 750 treatment

Severe skin reactions, such as:
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustulosis (AGEP) have been reported during Ospen treatment. If any symptoms associated with severe skin reactions occur, as described in section 4, the patient should stop taking Ospen 750 and contact their doctor immediately.
If severe and persistent diarrhea occurs during or after treatment, the patient should contact their doctor. They should not take anti-diarrheal medicines that inhibit intestinal motility.
During long-term treatment, the doctor will recommend regular blood morphology tests and liver and kidney function tests.
In case of any doubts, the patient should consult their doctor or pharmacist.

Ospen 750 and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. They should especially inform their doctor about the use of the following medicines:
any antibacterial medicines;
medicines with anti-inflammatory, antirheumatic, or antipyretic effects (especially indomethacin, phenylbutazone, and salicylates in high doses);
probenecid and sulfinpyrazone (medicines used to treat gout);
anticoagulant medicines;
methotrexate (a medicine used to treat rheumatic diseases and cancer).
Ospen 750 may inhibit the activity of oral typhoid vaccine. If the patient is going to be vaccinated, they should inform their doctor or nurse about taking Ospen 750.
Effect on laboratory tests
Before performing laboratory tests, the patient should inform their doctor about taking Ospen 750, as it may affect the results of some blood and urine tests, e.g., it may cause false-positive glucose test results in urine or some blood tests.

Taking Ospen 750 with food and drink

The medicine can be taken independently of meals.
Guar gum (a food additive contained in many food products) may reduce the absorption of phenoxymethylpenicillin.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine.
Ospen 750 should not be used during pregnancy.
Phenoxymethylpenicillin and its metabolites pass into breast milk and may affect the breastfed child.

Driving and using machines

The effect of Ospen 750 on the ability to drive and use machines has not been established.

Ospen 750 contains sorbitol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, benzyl alcohol, ethanol, and sodium

Sorbitol

The medicine contains 1666.7 mg of sorbitol in each 5 ml of oral suspension. Sorbitol is a source of fructose.
If the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disease, hereditary fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child.
Sorbitol in large doses may cause gastrointestinal discomfort and have a mild laxative effect.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late-type reactions).

Benzyl alcohol (component of Tutti Frutti Flavor 502814 T aroma)

The medicine contains 0.125 mg of benzyl alcohol in each 5 ml of suspension.
Benzyl alcohol may cause allergic reactions.
Do not give to small children (under 3 years old) for more than a week, unless the doctor recommends otherwise.
Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

Etanol (component of Tutti Frutti Flavor 502814 T aroma)

This medicine contains less than 0.42 µg of ethanol in each 5 ml of suspension.
The amount of ethanol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of ethanol in this medicine will not have noticeable effects.

Sodium

The medicine contains 10.81 mg of sodium in each 5 ml of oral suspension.
If the medicine is used as recommended, the maximum single doses used in children and adolescents contain less than 1 mmol (23 mg) of sodium.
If the medicine is used as recommended, the maximum single dose used in adults contains 28.83 mg of sodium, which corresponds to 1.44% of the WHO-recommended maximum daily intake of 2 g of sodium for adults.
Information for diabetic patients
Ospen 750 is sweetened with artificial sweeteners.

3. How to take Ospen 750

This medicine should always be taken as recommended by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The exact dosage and duration of treatment are determined by the doctor.
Adults and adolescents
2 measuring cups of Ospen 750 oral suspension (1,500,000 IU) three times a day (every 8 hours).
If necessary, the doctor may increase the dose of the medicine.
Children aged 6 to 12 years (with a body weight of 22 to 38 kg):
1 measuring cup of Ospen 750 oral suspension (750,000 IU) three times a day (every 8 hours).
Children aged 1 to 6 years (with a body weight of 10 to 22 kg):
½ measuring cup of Ospen 750 oral suspension (375,000 IU) three times a day (every 8 hours).
Special recommendations for preventive dosing

• Streptococcal infections (e.g., scarlet fever)In case of contact, prophylactic oral penicillin is recommended in therapeutic doses for 10 days after contact. The doctor will determine the exact dose of the medicine.
• Rheumatic feverIn children with a body weight over 30 kg, ½ measuring cup of Ospen 750 is used every 12 hours (twice a day).

Dosing in patients with renal and/or hepatic impairment
Reducing the dose of the medicine in patients with hepatic and/or renal impairment is not usually necessary. However, the doctor will determine the appropriate dose in each individual case.
Duration of treatment
The doctor will determine how long the patient should take the medicine.
As a rule, treatment should be continued for 2 to 3 days after the symptoms have resolved.
To prevent complications (i.e., rheumatic fever, glomerulonephritis), patients with streptococcal infections should take this medicine for at least 10 days.
Method of administration
Ospen 750 can be taken independently of meals.

Taking a higher dose of Ospen 750 than recommended

In case of taking a higher dose of Ospen 750 than recommended, the patient should immediately consult their doctor.
Symptoms of overdose
May include gastrointestinal disorders (nausea, vomiting, abdominal pain, diarrhea) and water-electrolyte balance disorders (e.g., increased potassium levels in the blood).
Significant overdose of the medicine may rarely cause seizures.
If other symptoms occur, it may indicate an allergic reaction.

Missing a dose of Ospen 750

If the patient is unsure whether they have taken a dose of Ospen 750, they should consult their doctor. They should not take a double dose to make up for the missed dose.

Stopping Ospen 750 treatment

The medicine should be taken for as long as the doctor recommends, even if the patient feels better. Premature discontinuation of treatment may lead to a recurrence of the infection.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Ospen 750 can cause side effects, although not everybody gets them.

Severe side effects:

In case of any of the following symptoms, the patient should stop taking Ospen 750 and immediately consult their doctor or go to the hospital:

swelling of the face, lips, throat, or other parts of the body, which may cause difficulty swallowing or breathing (rare - may occur less frequently than in 1 in 1,000 people);
skin rash with itching (hives) (common - may occur less frequently than in 1 in 10 people);
red, non-raised, target-like, or circular spots on the torso, often with centrally located blisters, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) (frequency not known - frequency cannot be estimated from available data);
widespread rash, high fever, and enlarged lymph nodes (DRESS or hypersensitivity syndrome) (frequency not known - frequency cannot be estimated from available data);
red, peeling, widespread rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized pustulosis) (frequency not known - frequency cannot be estimated from available data).
In such cases, immediate medical attention or hospital treatment is necessary.

Side effects observed during Ospen 750 treatment

Common side effects (may occur less frequently than in 1 in 10 people):
allergic reactions (usually skin-related), rash, urticaria, itching, nausea, diarrhea, vomiting, abdominal pain, feeling of fullness in the stomach, oral mucositis, glossitis.
Uncommon side effects (may occur less frequently than in 1 in 100 people):
neuropathy (nerve disorders and symptoms), seizures (especially after taking high doses of the medicine or in patients with impaired renal function), paresthesia (sensory disturbances), which may occur during long-term use, nephropathy (kidney disorders and symptoms) in patients receiving high doses of the medicine parenterally.
Rare side effects (may occur less frequently than in 1 in 1,000 people):
pseudomembranous colitis, severe allergic reactions causing angioedema, laryngeal edema, and anaphylaxis, reactions resembling serum sickness (with fever, chills, joint pain, swelling, fatigue), oral pain, black hairy tongue (superficial, transient brown discoloration of the tongue), desquamative gingivitis.
Very rare side effects (may occur less frequently than in 1 in 10,000 people):
changes in blood count, including thrombocytopenia (reduced platelet count), neutropenia (reduced count of a certain type of white blood cell), leukopenia (reduced white blood cell count), eosinophilia (visible in blood smear as an increased count of acidophilic granulocytes), hemolytic anemia (anemia caused by faster breakdown of red blood cells), agranulocytosis (a severe, life-threatening disease caused by a significant reduction in the count of granulocytes), coagulation disorders (including prolonged bleeding time and disorders of platelet function), hepatitis and jaundice due to bile stasis, interstitial nephritis, positive direct Coombs test.
Side effects with unknown frequency (frequency cannot be estimated from available data):
anaphylactic shock (a severe, life-threatening allergic reaction) with collapse, pseudoanaphylactic reactions (asthma, urticaria, gastrointestinal symptoms), erythema multiforme (polymorphic erythema, sometimes with blisters on the skin in the area of natural body orifices and on the mucous membranes of the mouth).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
phone: +48 22 49 21 301; fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ospen 750

The medicine should be stored out of sight and reach of children.
Store in a temperature range of 2°C to 8°C. Protect from light.
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.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ospen 750 contains

The active substance is benzathine phenoxymethylpenicillin.
Each 5 ml (1 measuring cup) of suspension contains 750,000 IU of benzathine phenoxymethylpenicillin.
The other ingredients are: propyl parahydroxybenzoate, simethicone, sodium saccharin, methyl parahydroxybenzoate, citric acid monohydrate, Tutti Frutti Flavor 502814 T aroma (contains, among others, benzyl alcohol, ethanol, cinnamaldehyde, cinnamyl alcohol, benzyl cinnamate, citral, citronellol, eugenol, farnesol, geraniol, d-limonene, linalool, and methyl heptin carbonate), yellow iron oxide, sodium carmellose, aluminum-magnesium silicate, disodium citrate dihydrate, sorbitol, water.

What Ospen 750 oral suspension looks like and what the pack contains

A dark glass bottle with a cap-to-cap closure, in a cardboard box containing 60 ml or 150 ml of orange-yellow suspension with a characteristic, fruity odor and a sweet-bitter taste. The package includes a polypropylene measuring cup that allows measuring 1.25 ml, 2.5 ml, 5 ml of suspension.

Marketing authorization holder and manufacturer:

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
For more detailed information, please contact:
Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Date of last revision of the leaflet:10/2024
Sandoz logo