Ospamox

Leaflet accompanying the packaging: patient information

Ospamox, 500 mg, coated tablets

Ospamox, 750 mg, coated tablets

Ospamox, 1000 mg, coated tablets

Amoxicillin

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

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed for a specific person (adult or child). It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ospamox and what is it used for

What is Ospamox

Ospamox is an antibiotic. The active substance of the medicine is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".

What is Ospamox used for

Ospamox is used to treat bacterial infections of various parts of the body. Ospamox can also be used, in combination with other medicines, to treat stomach ulcer disease.

2. Important information before taking Ospamox

When not to take Ospamox

if the patient is allergic to amoxicillin, penicillin or any of the other ingredients of the medicine (listed in section 6);
if the patient has ever been allergic to any other antibiotic. This may include a skin rash or swelling of the face or throat.
If any of these conditions apply to the patient, they should not take Ospamox. In case of doubt, before starting to take the medicine, the patient should consult their doctor or pharmacist.

Warnings and precautions

Before starting to take Ospamox, the patient should discuss it with their doctor or pharmacist if they:
suffer from infectious mononucleosis (fever, sore throat, swollen lymph nodes and extreme fatigue)
have kidney disease
have irregular urination.
In case of doubt whether any of these conditions apply to the patient, before starting to take Ospamox, they should consult their doctor or pharmacist.

Blood and urine tests

If the patient is to have:
urine tests (to detect glucose) or blood tests (to assess liver function)
estriol tests (performed during pregnancy to check if the baby is developing properly),
they should inform their doctor or pharmacist about taking Ospamox, as it may affect the results of these tests.

Ospamox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken or might take.
If the patient is taking allopurinol (used to treat gout) at the same time as Ospamox, they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used to treat gout), their doctor may decide to adjust the dose of Ospamox. Taking probenecid at the same time as Ospamox may reduce the excretion of amoxicillin and is not recommended.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Ospamox, they may need to have additional blood tests.
If the patient is taking other antibiotics (such as tetracycline) at the same time as Ospamox, Ospamox may be less effective.
If the patient is taking methotrexate (a medicine used to treat cancer and severe psoriasis). Penicillins may reduce the excretion of methotrexate, which may increase the risk of side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Ospamox may cause side effects and symptoms (such as allergic reactions, dizziness and convulsions) that may impair the ability to drive or operate machinery.
The patient should not drive or operate machinery unless they feel well.

Ospamox contains sodium

This 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 Ospamox

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
The tablets should be swallowed whole, with a glass of water. The tablets should not be crushed or chewed.
Doses of the medicine should be taken at equal intervals throughout the day, with at least 4-hour intervals.
The usual dose is

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight (in kilograms).
The doctor will recommend the dose of the medicine to be given to the child.
The usual dose is 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly and children with a body weight of 40 kg or more

The usual dose of Ospamox is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection.
Severe infections: 750 mg to 1 g three times a day.
Urinary tract infections: 3 g twice a day for one day.
Lyme disease (borreliosis - tick-borne infection): single migrating erythema (early stage - a pinkish-red spot): 4 g per day.
Systemic symptoms (late stage - more severe symptoms or when the disease affects multiple organs): up to 6 g per day.
Stomach ulcer disease: 750 mg or 1 g twice a day for 7 days in combination with other antibiotics and medicines used to treat stomach ulcers.
Prevention of endocarditis during surgical procedures: the dose may vary depending on the type of surgical procedure. Other medicines may also be given at the same time.
To obtain more detailed information, the patient should consult their doctor, pharmacist or nurse.
The maximum recommended dose is 6 g per day.

Kidney disease

If the patient has kidney disease, the dose of the medicine may be lower than usual.

Taking a higher dose of Ospamox than recommended

If the patient has taken a higher dose of Ospamox than recommended, they may experience gastrointestinal disorders (nausea, vomiting or diarrhea) or crystals in the urine (visible as cloudy urine or difficulty or discomfort when urinating). The patient should consult their doctor as soon as possible. They should take the medicine with them to show it to the doctor.

Missing a dose of Ospamox

If the patient forgets to take a dose, they should take it as soon as they remember.
The patient should not take the next dose too early, but wait about 4 hours before taking it.
The patient should not take a double dose to make up for the missed dose.

How long to take Ospamox

The medicine should be taken for as long as the doctor has prescribed, even if the patient feels better.
All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause a relapse of the infection.
If the patient still does not feel better after finishing the treatment, they should consult their doctor again.
If the patient takes Ospamox for a long time, they may experience thrush (candidiasis - a fungal infection of the mucous membranes, causing local pain, itching and white discharge).
In this case, the patient should consult their doctor.
If the patient takes Ospamox for a long time, their doctor may recommend additional tests to assess kidney, liver and blood function.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Ospamox and contact their doctor immediately, as they may need urgent medical attention.

Very rare side effects(may occur less frequently than 1 in 10,000 patients):
allergic reactions, including itching of the skin or rash, swelling of the face, lips, tongue, body or difficulty breathing; these may be severe symptoms, occasionally leading to death;
rash or punctate, flat, red, round spots under the skin surface or bruising of the skin, which may be a sign of vasculitis due to an allergic reaction;
these may occur with joint pain (arthritis) and kidney function disorders.
late allergic reaction, usually occurring 7 to 12 days after taking Ospamox; symptoms include rash, fever, joint pain and swollen lymph nodes, especially in the armpits;
skin reaction called erythema multiforme, characterized by itchy red-purple patches on the skin, especially on the hands or soles of the feet, swelling of the skin (resembling urticaria), sensitive to touch areas in the mouth, eyes and genitals; fever and a feeling of extreme fatigue may occur;
other severe skin reactions, such as changes in skin color, lumps under the skin, blistering, peeling, redness, pain, itching, flaking of the skin; changes may occur with fever, headache and body aches;
symptoms similar to flu with rash, fever, swollen lymph nodes and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS);
fever, chills, sore throat or other signs of infection or easy bruising; these may be symptoms of blood cell disorders;
Jarisch-Herxheimer reaction, which occurs during the treatment of Lyme disease with amoxicillin and is characterized by fever, chills, headache, muscle pain and skin rash;
colitis, causing diarrhea (sometimes with blood), abdominal pain and fever;
severe liver side effects; these usually occur in patients treated for a long time, men and the elderly
The patient should inform their doctor immediately if they experience:
severe diarrhea with blood
blisters on the skin, redness or bruising
dark urine or pale stools
yellowing of the skin or whites of the eyes (jaundice).
Frequency not known(frequency cannot be estimated from the available data):
chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome)
aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord)
drug-induced colitis (DIES)
DIES occurred mainly in children receiving amoxicillin. It is a type of allergic reaction, the main symptom of which is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure
rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis)
The patient should also read the information below about anemia, which can cause jaundice.
These symptoms may occur during treatment with the medicine or up to several weeks after finishing the treatment.

If the patient experiences any of these symptoms, they should stop taking the medicine and consult their doctor immediately.

Sometimes, less severe skin reactions may occur, such as:

mildly itchy rash (round, pinkish-red patches), resembling urticaria, swelling on the forearms, legs, hands, arms or feet.
These occur not very often (may occur less frequently than 1 in 100 patients).

If the patient experiences any of these symptoms, they should consult their doctor, as they may need to stop taking the medicine.

Other possible side effects
Common side effects(may occur less frequently than 1 in 10 patients):
rash
nausea
diarrhea
Uncommon side effects(may occur less frequently than 1 in 100 patients):
vomiting
Very rare side effects(may occur less frequently than 1 in 10,000 patients):
thrush (fungal infection of the vagina, mouth or skin folds) - the doctor or pharmacist will advise on treatment
kidney function disorders
convulsions (observed in patients receiving high doses or patients with kidney function disorders)
dizziness
excessive activity
crystals in the urine, visible as cloudy urine or difficulty or discomfort when urinating; to reduce the risk of these symptoms, the patient should drink plenty of fluids
change in tongue color to yellow, brown or black (the tongue may look hairy)
excessive breakdown of red blood cells, which can cause anemia; symptoms include:
feeling tired, headaches, shortness of breath, dizziness, pallor and yellowing of the skin and whites of the eyes
decreased white blood cell count
decreased platelet count
prolonged blood clotting time (may be visible in case of nosebleeds or cuts).
Frequency not known(frequency cannot be estimated from the available data):
crystals in the urine leading to acute kidney damage

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 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 Ospamox

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C, protected from moisture.
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. Contents of the packaging and other information

What Ospamox contains

Ospamox, 500 mg
Each coated tablet contains 500 mg of amoxicillin in the form of amoxicillin trihydrate (574 mg).
Ospamox, 750 mg
Each coated tablet contains 750 mg of amoxicillin in the form of amoxicillin trihydrate (861 mg).
Ospamox, 1000 mg
Each coated tablet contains 1000 mg of amoxicillin in the form of amoxicillin trihydrate (1148 mg).
Other ingredients are:
magnesium stearate, povidone (K 25), sodium carboxymethylcellulose, microcrystalline cellulose;
coating:titanium dioxide, talc, methylhydroxypropylcellulose.

What Ospamox looks like and contents of the packaging

Ospamox, 500 mg: white or cream-colored coated tablets, oblong, convex on both sides, with a notch on both sides, measuring 8×18 mm.
Ospamox, 750 mg: white or cream-colored coated tablets, oblong, convex on both sides, with a notch on both sides, measuring 9×20 mm.
Ospamox, 1000 mg: white or cream-colored coated tablets, oblong, convex on both sides, with a notch on both sides, measuring 10×22 mm.
The tablets are packaged in PVC/PVDC/Aluminum blisters, each containing 16 coated tablets, in a cardboard box.

Marketing authorization holder and manufacturer

Sandoz GmbH
Biochemiestrasse 10
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.
ul. Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
(logo of the marketing authorization holder)

Date of last revision of the leaflet:

General advice on the use of antibiotics

Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is the resistance of bacteria to the antibiotic. This means that the bacteria can survive, and even multiply, despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the risk of bacterial resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could reduce the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time and for the correct number of days. The patient should read the instructions in the leaflet and if any of them are unclear, they should ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that has not been prescribed specifically for them and should only use it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. The patient should not give their antibiotics to other people.
• 5. If there are any leftover antibiotics after finishing the treatment as directed by the doctor, the patient should return them to the pharmacy, which will accept them for proper disposal.