Ospen 750

Package leaflet: Information for the patient

OSPEN 750, 750 000 IU/5 ml, oral suspension
Benzathini phenoxymethylpenicillinum
Please read carefully the entire leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 group of penicillins for oral use, with strong antibacterial activity. It exerts a bactericidal effect on susceptible, multiplying microorganisms by inhibiting the synthesis of the bacterial cell wall.

Ospen 750 is indicated:
for the treatment of the following mild to moderate infections caused by microorganisms sensitive to penicillin:

• infections of the ear, nose and throat, including streptococcal infections (erysipelas, pharyngitis, tonsillitis, nasopharyngitis, sinusitis, acute otitis media, Vincent's angina);
• respiratory tract infections: bacterial bronchitis, bacterial pneumonia, bronchopneumonia (except cases where penicillin should be administered parenterally or as continuation of treatment with injectable antibiotics);
• skin and soft tissue infections: erysipelas, erysipeloid, purulent skin infections (e.g. impetigo, folliculitis), abscesses, cellulitis;
  for the prevention of complications following streptococcal infections, such as: recurrent rheumatic fever and Sydenham's chorea, polyarthritis, endocarditis, glomerulonephritis; prevention of bacterial endocarditis in patients with congenital or rheumatic heart disease before and after minor surgical procedures, e.g. tonsillectomy, tooth extraction, etc.

In the treatment of severe pneumonia, empyema, sepsis, pericarditis, endocarditis, meningitis, septic arthritis, and osteomyelitis, penicillin should be administered parenterally during the acute phase of infection.

2. Important information before using Ospen 750

When not to use 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 experienced skin rash, swelling of the face, neck or trunk, or breathing difficulties);
• if the patient has gastrointestinal disorders with persistent diarrhoea or vomiting, as this may lead to reduced absorption of the medicine;
• if the patient has ever experienced severe skin rash, skin peeling, blisters and/or oral mucosal ulcers after treatment with Ospen or other beta-lactam antibiotics.

Warnings and precautions
Before starting treatment with Ospen 750, consult a doctor or pharmacist if:
the patient is allergic to penicillins, cephalosporins or other substances, as they may also be
allergic to Ospen 750;
the patient currently has or has previously had bronchial asthma or severe allergic reactions;
the patient is taking Ospen 750 to prevent recurrence of rheumatic fever, as the dose may need to be appropriately adjusted before planned surgical procedures (such as tonsillectomy or tooth extraction);
the patient has kidney function disorders, especially severe ones, as appropriate dose adjustment or prolonged dosing intervals may be required, along with regular monitoring of kidney function;
the patient has infectious mononucleosis, as skin rash may occur;
in the past, an antibacterial medicine caused the patient severe diarrhoea;
the patient has nausea, vomiting, diarrhoea, or has been diagnosed with gastric dilatation, impaired passage of food from the oesophagus to the stomach (so-called oesophageal achalasia), or excessive intestinal motility, as these may reduce drug absorption;
the patient is scheduled to receive typhoid vaccination (see below “Ospen 750 and other medicines”).

Special caution is required during treatment with Ospen
Severe skin reactions have been reported during treatment with Ospen, including:
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular eruption (AGEP).
If any of the symptoms associated with severe skin reactions described in section 4 occur, Ospen should be discontinued immediately and the patient should contact a doctor without delay.

If the patient develops severe and persistent diarrhoea during or after treatment, they should contact a doctor. Medicines for diarrhoea that inhibit intestinal peristalsis should not be used.

During prolonged treatment, the doctor may recommend regular blood count tests as well as monitoring of liver and kidney function.

If in any doubt, consult a doctor or pharmacist.

Ospen 750 and other medicines
Inform the doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use. In particular, inform about the use of the following medicines:
any antibacterial medicines;
medicines with anti-inflammatory, anti-rheumatic, antipyretic effects (especially indomethacin, phenylbutazone, and high-dose salicylates);
probenecid and sulfinpyrazone (medicines used in the treatment of gout);
anticoagulant medicines;
methotrexate (a medicine used in the treatment of rheumatic and oncological diseases).

Ospen 750 may reduce the effectiveness of oral typhoid vaccine. If the patient is due to be vaccinated, they should inform the doctor or nurse about taking Ospen 750.

Effect on laboratory tests
Before undergoing laboratory tests, inform the laboratory staff about taking Ospen 750, as it may affect the results of certain blood and urine tests, for example, it may cause false-positive results in urine glucose tests or certain blood tests.

Taking Ospen 750 with food and drink
The medicine can be taken regardless of meals.

Guar gum (a food additive present in many food products) may reduce the absorption of phenoxymethylpenicillin.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Ospen 750 should not be used during pregnancy.

Phenoxymethylpenicillin and its metabolites pass into breast milk and may affect the breastfed infant.

Driving and operating machinery
The effect of Ospen 750 on the ability to drive vehicles and operate machinery 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 (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance (a rare genetic disorder in which the patient's body cannot break down fructose), the patient should consult a doctor before taking the medicine or giving it to a child.

High doses of sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).

Benzyl alcohol (component of Tutti Frutti Flavor 502814 T)
The medicine contains 0.125 mg of benzyl alcohol in each 5 ml of suspension.

Benzyl alcohol may cause allergic reactions.

Do not administer to young children (under 3 years of age) for longer than one week unless otherwise directed by a doctor.

Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Ethanol (component of Tutti Frutti Flavor 502814 T)
This medicine contains less than 0.42 µg of alcohol (ethanol) in each 5 ml of suspension.

The amount of alcohol in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Sodium
The medicine contains 10.81 mg of sodium in each 5 ml of oral suspension.

If the medicine is used as directed, the maximum single doses used in children and adolescents contain less than 1 mmol (23 mg) of sodium.

If the medicine is used as directed, the maximum single dose used in adults contains 28.83 mg of sodium, which corresponds to 1.44% of the WHO-recommended maximum daily adult sodium intake of 2 g.

Information for diabetic patients
Ospen 750 is sweetened with artificial sweeteners.

3. How to use Ospen 750

This medicine should always be used exactly as directed by the physician. In case of doubt, consult your doctor or pharmacist.
The exact dosage and duration of treatment are determined by the physician.

Adults and adolescents
2 measuring spoons of Ospen 750 oral suspension (1,500,000 IU) three times daily (every 8 hours).
If necessary, the physician may increase the dose of the medicine.

Children aged 6 to 12 years (with body weight from 22 to 38 kg):
1 measuring spoon of Ospen 750 oral suspension (750,000 IU) three times daily (every 8 hours).

Children aged 1 to 6 years (with body weight from 10 to 22 kg):
½ measuring spoon of Ospen 750 oral suspension (375,000 IU) three times daily (every 8 hours).

Special dosage recommendations for prophylactic use

• Streptococcal infections (e.g. erysipelas) In case of exposure, prophylactic administration of oral penicillin at therapeutic doses for 10 days after exposure is recommended. The physician will determine the exact dosage.
• Rheumatic fever In children with body weight above 30 kg, ½ measuring spoon of Ospen 750 every 12 hours (twice daily) is recommended.

Dosage in patients with renal and/or hepatic impairment
Dosage reduction in patients with hepatic and/or renal impairment is usually not necessary. However, the physician will determine the appropriate dose on an individual basis.

Duration of treatment
The physician will determine how long the medicine should be taken.
As a general rule, treatment should continue for 2 to 3 days after 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 may be taken independently of meals.

Taking more Ospen 750 than prescribed
If more Ospen 750 has been taken than prescribed, seek immediate medical advice.

Symptoms of overdose
Gastrointestinal disturbances (nausea, vomiting, abdominal pain, diarrhoea) and disturbances of water-electrolyte balance (e.g. increased blood potassium concentration) may occur.
Significant overdose may rarely cause seizures.
If other symptoms occur, this may indicate an allergic reaction.

Missing a dose of Ospen 750
If the patient is unsure whether a dose of Ospen 750 has been taken, they should consult the physician. Do not take a double dose to make up for a missed dose.

Stopping Ospen 750 treatment
The medicine should be taken for as long as directed by the physician, even if the patient feels better. Premature discontinuation of treatment may result in recurrence of infection.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions:
If any of the symptoms listed below occur, discontinue taking Ospen immediately and seek medical
advice without delay or go directly to hospital:
swelling of the face, lips, throat or other parts of the body, which may cause difficulty in swallowing
or breathing (rare – may occur in less than 1 in 1,000 people);
itchy skin rash (urticaria) (common – may occur in less than 1 in 10 people);
red, flat, target-like or circular skin lesions on the trunk, often with central blisters, skin peeling,
ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin reactions may be
preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
(frequency unknown – frequency cannot be estimated from available data);
widespread rash, high fever and swollen lymph nodes (DRESS syndrome or drug hypersensitivity
syndrome) (frequency unknown – frequency cannot be estimated from available data);
red, peeling, widespread rash with subcutaneous nodules and blisters, accompanied by fever.
Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis)
(frequency unknown – frequency cannot be estimated from available data).
In such cases, prompt medical attention or hospitalization is required.

Adverse reactions observed during use of Ospen 750
Common adverse reactions (may occur in less than 1 in 10 people):
allergic reactions (usually skin-related), erythematous or maculopapular rash, itching, nausea,
diarrhea, vomiting, abdominal pain, feeling of fullness in the stomach, oral mucositis, glossitis.

Uncommon adverse reactions (may occur in less than 1 in 100 people):
neuropathy (nerve-related disorders and symptoms), seizures (especially after administration of high
doses or in patients with impaired kidney function), paresthesia (sensory disturbances – may occur
during prolonged use), nephropathy (kidney-related disorders and symptoms) in patients receiving
high intravenous doses of the medicine.

Rare adverse reactions (may occur in less than 1 in 1,000 people):
pseudomembranous colitis, severe allergic reactions causing angioedema, laryngeal edema and
anaphylaxis, serum sickness-like reactions (with fever, chills, joint pain, swelling, feeling of exhaustion),
oral pain, black hairy tongue (superficial, transient brownish discoloration of the dorsal surface of the
tongue), exfoliative dermatitis.

Very rare adverse reactions (may occur in less than 1 in 10,000 people):
blood abnormalities, including thrombocytopenia (reduced platelet count), neutropenia (reduced
count of certain white blood cells), leukopenia (reduced white blood cell count), eosinophilia
(increased number of eosinophils visible in blood smear), hemolytic anemia (anemia caused by
accelerated destruction of red blood cells), agranulocytosis (a severe, life-threatening condition caused
by a marked decrease in white blood cells called granulocytes), coagulation disorders (including
prolonged bleeding time and platelet function disorders), hepatitis and cholestatic jaundice,
interstitial nephritis, positive direct Coombs test.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
anaphylactic shock (acute, life-threatening allergic reaction) with collapse, pseudo-anaphylactic
reactions (bronchial asthma, purpura, gastrointestinal symptoms), erythema multiforme (red-blue
erythematous lesions, sometimes with blisters around natural body orifices and on the oral mucosa).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your
doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of
Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301; Fax: +48 22 49 21 309; Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Ospen 750

Keep the medicine out of the sight and reach of children.
Store at a temperature 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

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

What Ospen 750 oral suspension looks like and contents of the pack
An amber 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 odour and sweet-bitter taste. A polypropylene spoon is included in the pack, allowing measurement of 1.25 ml, 2.5 ml and 5 ml of suspension.

Marketing Authorisation Holder and Manufacturer:
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw, Poland
tel. 22 209 70 00