Ospen 1000

Leaflet attached to the packaging: patient information

OSPEN 1000, 1,000,000 IU, coated tablets

OSPEN 1500, 1,500,000 IU, coated tablets

Phenoxymethylpenicillin potassium

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.
• If you have any doubts, consult your 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ospen and what is it used for

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

• Ear, nose, and throat infections, including streptococcal infections (scarlet fever, pharyngitis, tonsillitis, rhinitis, sinusitis, acute otitis media, Vincent's angina);
• Respiratory tract infections: bacterial bronchitis, bacterial pneumonia, bronchopneumonia (as a continuation of treatment with injectable medicines);
• Skin and soft tissue infections: erysipelas, impetigo, purulent skin inflammation (e.g., ecthyma, furunculosis), abscesses, carbuncles; preventionof rheumatic fever.

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

2. Important information before taking Ospen

When not to take Ospen:

• 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, during the use of these medicines, the patient had a skin rash, facial, neck, or torso swelling, or difficulty breathing);
• if the patient has gastrointestinal disorders with persistent diarrhea or vomiting, as this may reduce the absorption of the medicine.
• if the patient has ever had a severe skin rash or exfoliation, blisters, and (or) oral ulcers after treatment with Ospen or other beta-lactam antibiotics.

Warnings and precautions

Before starting to take Ospen, the patient should discuss it with their doctor or pharmacist if:
the patient is allergic to penicillins, cephalosporins, or other substances, as they may also be allergic to Ospen;
the patient currently has or has had asthma or severe allergic reactions;
the patient is taking Ospen to prevent rheumatic fever, as the dose of the medicine may need to be adjusted before a planned surgical procedure (such as tonsillectomy, tooth extraction);
the patient has kidney 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;
the patient has infectious mononucleosis, as they may experience a skin rash;
in the past, an antibacterial medicine has caused the patient severe diarrhea;
the patient has nausea, vomiting, diarrhea, or has been diagnosed with stomach enlargement, 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;
the patient is to be vaccinated against typhoid (see below "Ospen and other medicines").

During treatment with Ospen, special caution should be exercised

In connection with the treatment with Ospen, severe skin reactions have been reported, such as:
Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized pustular psoriasis (AGEP). If any of the symptoms associated with severe skin reactions, described in section 4, are observed, the patient should stop taking Ospen and contact their doctor immediately.
If the patient experiences severe and persistent diarrhea during or after treatment, they should contact their doctor. The patient should not take anti-diarrheal medicines that inhibit intestinal peristalsis.
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 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. In particular, the patient should inform their doctor about the use of the following medicines:
any antibacterial medicines;
medicines with anti-inflammatory, anti-rheumatic, 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 may inhibit the activity of oral typhoid vaccine. If the patient is to be vaccinated, they should inform their doctor or nurse about taking Ospen.
Effect on laboratory tests
Before performing laboratory tests, the patient should inform their doctor about taking Ospen, 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.

Ospen with food and drink

The medicine should be taken 1 hour before a meal.
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 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 on the ability to drive and use machines has not been established.

Ospen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means that the medicine is considered "sodium-free".

3. How to take Ospen

This medicine should always be taken according to the doctor's recommendations. 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, including obese patients, elderly patients, pregnant women
4.5 million IU per day, i.e., 1 Ospen 1500 tablet three times a day (every 8 hours).
If necessary, the doctor may recommend increasing the daily dose of the medicine.
Children and adolescents with a body weight over 40 kg and adults with a body weight under 60 kg
3 million IU per day, i.e., 1 Ospen 1000 tablet three times a day (every 8 hours).
Children over 6 years old
From 1 to 1.5 million IU per day. The doctor will determine the exact dosage.
Prevention of rheumatic fever
Adults should be given at least 1 million IU per day; children should be given Ospen in the form of a suspension.

Dosage in patients with renal and/or hepatic impairment

Reducing the dose of the medicine in patients with liver and/or kidney impairment is not usually necessary. However, the doctor will determine the appropriate dose in each individual case.
Duration of treatment
The doctor will decide how long the patient should take the medicine.
As a rule, treatment should be continued for 3 days after the symptoms have subsided.
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 should be taken 1 hour before a meal. The tablets should be swallowed without chewing, washed down with a glass of water. It is recommended to administer the daily dose in 2 or 3 divided doses.

Taking a higher dose of Ospen than recommended

In case of taking a higher dose of Ospen 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

If the patient has doubts whether they have taken a dose of Ospen, they should consult their doctor.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ospen

The medicine should be taken for as long as the doctor has recommended, even if the patient feels better. Stopping treatment too early may cause the infection to recur.
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 can cause side effects, although not everybody gets them.

Severe side effects:

If any of the following symptoms occur, the patient should stop taking Ospen 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 1000 people);
skin rash with itching (hives) (frequent - less frequently than in 1 in 10 people);
red, flat, 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 the available data);
widespread rash, high fever, and swollen lymph nodes (DRESS or hypersensitivity syndrome) (frequency not known - frequency cannot be estimated from the 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 pustular psoriasis) (frequency not known - frequency cannot be estimated from the available data).
In such cases, immediate medical attention or hospital treatment is necessary.

Side effects observed during treatment with Ospen

Common side effects (may occur less frequently than in 1 in 10 people):
allergic reactions (usually skin), 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 kidney disorders), 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 1000 people):
pseudomembranous colitis, reactions resembling serum sickness (with fever, chills, joint pain, swelling, fatigue), oral pain, black hairy tongue (superficial, transient brown discoloration of the tongue), exfoliative dermatitis.
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 (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 the available data):
anaphylactic shock (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 any side effects occur, including any side effects not listed in this leaflet, the patient should inform 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

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Store in the original packaging.
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. Package contents and other information

What Ospen contains

The active substance is phenoxymethylpenicillin potassium.
1 coated tablet contains 1,000,000 IU (654 mg) or 1,500,000 IU (981 mg) of phenoxymethylpenicillin potassium.
Other ingredients are:magnesium stearate, macrogol 6000, maltodextrin, povidone, talc.
Coating: sodium saccharin, peppermint oil, titanium dioxide, talc, hypromellose.

What Ospen looks like and what the package contains

Ospen 1000: white or slightly creamy, elongated, biconvex coated tablets with a dividing line on both sides.
Ospen 1500: white or slightly creamy, oval, biconvex coated tablets with a dividing line on both sides.
The tablets are packaged in blisters placed in cardboard boxes.
The packages contain 12 or 30 coated tablets.
Hospital packages contain 500 coated tablets.

Marketing authorization holder and manufacturer:

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder:
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
(logo of the marketing authorization holder)