OSPAMOX 500 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Ospamox 500 mg, 500 mg, coated tablets
3. Ospamox 750 mg, 750 mg, coated tablets
4. Ospamox 1000 mg, 1000 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
5. What Ospamox is and what it is used for
   1. What Ospamox is
   2. What Ospamox is used for
6. Important information before taking Ospamox
   1. When not to take Ospamox
   2. Warnings and precautions
   3. Blood and urine tests
   4. Ospamox and other medicines
   5. Pregnancy, breastfeeding and fertility
   6. Driving and using machines
   7. Ospamox contains sodium
7. How to take Ospamox
   1. Children weighing less than 40 kg
   2. Adults, elderly and children weighing 40 kg or more
   3. Kidney disease
   4. Overdose of Ospamox
   5. Missed dose of Ospamox
   6. How long to take Ospamox
8. Possible side effects
   1. If you experience any of the following serious side effects, stop taking Ospamox and contact your doctor immediately, as you may need urgent medical attention.
   2. If you experience any of these symptoms, stop taking the medicine and contact your doctor immediately.
   3. Less serious skin reactions can occur, such as:
   4. If you experience any of these symptoms, contact your doctor, as you may need to stop taking the medicine.
   5. Reporting side effects
9. How to store Ospamox
10. Contents of the pack and other information
    1. What Ospamox contains
    2. What Ospamox looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. For more information about this medicine, contact the local representative of the marketing authorization holder:
    5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
    6. General advice on the use of antibiotics

Leaflet attached to the packaging: patient information

Ospamox 500 mg, 500 mg, coated tablets

Ospamox 750 mg, 750 mg, coated tablets

Ospamox 1000 mg, 1000 mg, coated tablets

Amoxicillin

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What Ospamox is and what it is 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 pack and other information

1. What Ospamox is and what it is used for

What Ospamox is

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

What Ospamox is used for

Ospamoxis used to treat infections caused by bacteria that are sensitive to amoxicillin. Ospamoxis used in adults and children to treat the following infections:

• acute bacterial tonsillitis and pharyngitis
• acute bacterial otitis media and acute bacterial sinusitis
• lower respiratory tract infections: exacerbations of chronic bronchitis, pneumonia
• upper and lower urinary tract infections: urinary tract infection (acute cystitis), kidney infection (acute pyelonephritis), asymptomatic bacteriuria during pregnancy
• peritonsillar abscess with spreading cellulitis
• infections related to joint prosthetics
• Lyme disease (borreliosis - infection transmitted by ticks)
• systemic bacterial infections: typhoid and paratyphoid fever
• prevention of bacterial endocarditis
• Ospamoxmay also be used in combination with other medicines to treat gastric ulcer disease caused by Helicobacter pyloribacteria.

2. Important information before taking Ospamox

When not to take Ospamox

if you are allergic to amoxicillin, penicillin or any of the other ingredients of the medicine (listed in section 6);
if you have ever had an allergic reaction to any other antibiotic. This can include a rash, swelling of the face or throat.
If any of these apply to you, do not take Ospamox. If you are not sure, consult your doctor or pharmacist before taking the medicine.

Warnings and precautions

Before taking Ospamox, discuss with your doctor or pharmacist if you:
have infectious mononucleosis (fever, sore throat, swollen lymph nodes and extreme fatigue)
have kidney disease
have irregular urination.
If you are not sure if any of these apply to you, consult your doctor or pharmacist before taking Ospamox.

Blood and urine tests

If you are going to have a urine test (to check for glucose) or a blood test (to check liver function)
a test for estriol levels (performed during pregnancy to check if the baby is developing normally),
tell your doctor or pharmacist that you are taking Ospamox, as it may affect the results of these tests.

Ospamox and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and any you plan to take.
If you are taking allopurinol (for gout), you may be more likely to get a skin rash.
If you are taking probenecid (for gout), it may increase the levels of amoxicillin in the blood and is not recommended. Your doctor may need to adjust your dose of Ospamox.
If you are taking blood-thinning medicines (such as warfarin), you may need to have extra blood tests.
If you are taking other antibiotics (such as tetracycline), Ospamox may be less effective.
If you are taking methotrexate (for cancer or severe psoriasis), penicillins may reduce the excretion of methotrexate, which may increase the risk of side effects.

Pregnancy, breastfeeding and fertility

If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ospamox may cause side effects such as allergic reactions, dizziness and convulsions that can affect your ability to drive or use machines.
Do not drive or use machines unless you feel well.

Ospamox contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which is essentially "sodium-free".

3. How to take Ospamox

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablets with water. Do not crush or chew the tablets.
Take the doses at evenly spaced intervals throughout the day, with at least 4 hours between doses.
The usual dose is

Children weighing less than 40 kg

All doses are given depending on the child's weight (in kilograms).
Your doctor will advise you on the dose to give your child.
The usual dose is 40 mg to 90 mg per kilogram of body weight per day, divided into two or three doses.
The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly and children weighing 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 dose of 4 g per day.
Symptomatic treatment (later stage - more severe symptoms or when the disease affects multiple organs): up to 6 g per day.
Gastric ulcer disease: 750 mg or 1 g twice a day for 7 days in combination with other antibiotics and medicines used to treat gastric ulcers.
Prevention of endocarditis during surgical procedures: the dose may vary depending on the type of surgical procedure. Other medicines may be given at the same time.
For more detailed information, consult your doctor, pharmacist or nurse.
The maximum recommended dose is 6 g per day.

Kidney disease

If you have kidney disease, your dose of Ospamox may be lower than usual.

Overdose of Ospamox

If you take more Ospamox than you should, you may experience gastrointestinal disturbances (nausea, vomiting or diarrhea) or the presence of amoxicillin crystals in the urine (which may appear as cloudy urine or difficulty urinating). Contact your doctor as soon as possible. Take the medicine with you to show the doctor.

Missed dose of Ospamox

If you forget to take a dose, take it as soon as you remember.
Do not take the next dose too early, but wait about 4 hours before taking it.
Do not take a double dose to make up for a forgotten dose.

How long to take Ospamox

Take the medicine for as long as your doctor has told you, even if you feel better.
All the doses of the medicine are needed to get rid of the infection. If some bacteria survive, they can cause the infection to come back.
If you do not feel better after finishing the treatment, consult your doctor again.
If you take Ospamox for a long time, you may get thrush (candidiasis - a fungal infection of the mucous membranes, causing local pain, itching and white discharge).
In this case, consult your doctor.
If you take Ospamox for a long time, your doctor may recommend that you have extra tests to check your kidney, liver and blood function.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking Ospamox and contact your doctor immediately, as you may need urgent medical attention.

Very rare side effects (may occur in less than 1 in 10,000 patients):
allergic reactions, including itching, skin rash or hives, swelling of the face, lips, tongue, body or difficulty breathing; these can be serious and occasionally life-threatening;
a rash or pinpoint, flat, red, round spots under the skin or bruising, which can be a sign of an allergic reaction to the medicine;
these can occur with joint pain (arthritis) and kidney problems;
a late allergic reaction, which usually occurs within 7 to 12 days of taking Ospamox; symptoms include rash, fever, joint pain and swollen lymph nodes, especially in the armpits;
a skin reaction known as erythema multiforme, characterized by itchy, red-purple spots on the skin, especially on the hands or soles of the feet, swelling of the skin (like hives), sensitive areas in the mouth, eyes and genital area; fever and a feeling of general illness may occur;
other serious skin reactions, such as changes in skin color, lumps under the skin, blistering, peeling, redness, pain, itching, scaling of the skin; these can occur with fever, headache and body aches;
symptoms similar to flu, with a rash, fever, swollen lymph nodes and abnormal blood test results [including an increased number of white blood cells (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 can be signs of blood disorders;
Jarisch-Herxheimer reaction, which occurs during treatment of Lyme disease with amoxicillin and is characterized by fever, chills, headache, muscle pain and skin rash;
inflammation of the colon, causing diarrhea (sometimes with blood), abdominal pain and fever;
serious liver side effects; these usually occur in patients who are taking the medicine for a long time, men and the elderly.
Tell your doctor immediately if you 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). Also, read the information below about anemia, which can cause jaundice.
These symptoms can occur during or up to a few weeks after treatment with Ospamox.
chest pain associated with an allergic reaction, which can be a sign of an allergy that can lead to a heart attack (Kounis syndrome). The frequency of this side effect is unknown.
drug-induced enterocolitis syndrome (DIES): drug-induced enterocolitis occurred mainly in children taking amoxicillin. It is a type of allergic reaction, with recurring vomiting (1-4 hours after taking the medicine) as the main symptom. Further symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure. The frequency of this side effect is unknown.
rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis). The frequency of this side effect is unknown.
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis). The frequency of this side effect is unknown.

If you experience any of these symptoms, stop taking the medicine and contact your doctor immediately.

Less serious skin reactions can occur, such as:

mildly itchy rash (round, pink-red spots), like hives
swelling on the forearms, legs, hands, feet or face.
These occur uncommonly (in less than 1 in 100 patients).

If you experience any of these symptoms, contact your doctor, as you may need to stop taking the medicine.

Other possible side effects:
Common side effects(may occur in less than 1 in 10 patients):
rash
nausea
diarrhea
Uncommon side effects(may occur in less than 1 in 100 patients):
vomiting
Very rare side effects(may occur in less than 1 in 10,000 patients):
thrush (fungal infection of the vagina, mouth or skin folds) - your doctor or pharmacist will advise on treatment
kidney problems
convulsions (observed in patients taking high doses or with kidney problems)
dizziness
hyperactivity
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 number of white blood cells
decreased number of platelets (cells that help the blood to clot)
prolonged bleeding time (may be noticeable if you have 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 you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly to the Pharmacovigilance Department, 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
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ospamox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original package to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ospamox contains

The active substance is amoxicillin.
Each Ospamox 500 mg coated tablet contains 500 mg of amoxicillin (as amoxicillin trihydrate).
Each Ospamox 750 mg coated tablet contains 750 mg of amoxicillin (as amoxicillin trihydrate).
Each Ospamox 1000 mg coated tablet contains 1000 mg of amoxicillin (as amoxicillin trihydrate).
The other ingredients are: magnesium stearate, povidone (K25), sodium carboxymethylcellulose (type A), microcrystalline cellulose.
Coating:titanium dioxide (E 171), talc, hypromellose.
See section 2 "Ospamox contains sodium".

What Ospamox looks like and contents of the pack

Ospamox 500 mg
The coated tablets are white or cream-colored, elongated, biconvex, with a dividing line on both sides.
The tablets can be divided into equal halves.
Ospamox 750 mg
The coated tablets are white or cream-colored, oval, biconvex, with a dividing line on both sides.
The tablets can be divided into equal halves.
Ospamox 1000 mg
The coated tablets are white or cream-colored, oval, biconvex, with a dividing line on both sides.
The tablets can be divided into equal halves.
The coated tablets are packaged in PVC/PVDC/Aluminum blisters and placed in a cardboard box.
Pack sizes: 16, 20 or 28 coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

For more information about this medicine, contact the local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
AmoxiHEXAL 500 Filmtabletten
Italy
Amoxicillina Hexal AG
Poland
OSPAMOX 500 mg; COATED TABLETS
OSPAMOX 750 mg; COATED TABLETS
OSPAMOX 1000 mg; COATED TABLETS
(logo of the marketing authorization holder)
Date of last revision of the leaflet: 09/2023

General advice on the use of antibiotics

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria are resistant 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. The careful use of antibiotics can help reduce the risk of bacteria becoming resistant.
The antibiotic prescribed by your doctor is intended only to treat your current illness. Paying attention to the following advice can help prevent the development of resistant bacteria, which could stop the antibiotic from working.
1 It is very important to take the antibiotic at the right dose, at the right time and for the right number of days. Read the instructions in the leaflet and if you do not understand any of them, ask your doctor or pharmacist to explain.
2 Do not take an antibiotic unless it has been prescribed specifically for you and use it only to treat the infection for which it was prescribed.
3 Do not take an antibiotic that was prescribed for someone else, even if they had a similar infection.
4 Do not give your antibiotics to other people.
5 If you have any leftover antibiotics after completing the treatment as directed by your doctor, return them to the pharmacy for proper disposal.