Ospamox 1000 mg
Poland
Table of Contents
Package leaflet: Information for the patient
Ospamox 500 mg, 500 mg, film-coated tablets
Ospamox 750 mg, 750 mg, film-coated tablets
Ospamox 1000 mg, 1000 mg, film-coated tablets
Amoxicillinum
Please read the entire leaflet before using 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 doubts, please consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm someone else, 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 of the leaflet:
- What Ospamox is and what it is used for
- Important information before taking Ospamox
- How to take Ospamox
- Possible side effects
- How to store Ospamox
- Contents of the pack and other information
1. What Ospamox is and what it is used for
What is Ospamox
Ospamox is an antibiotic. The active substance in the medicine is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".
What Ospamox is used for
Ospamox is used to treat bacterial infections in various parts of the body caused by bacteria sensitive to amoxicillin. Ospamox is 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: acute exacerbation of chronic bronchitis, pneumonia
- Upper and lower urinary tract infections: bladder infection (acute cystitis), kidney infection (acute pyelonephritis), asymptomatic bacteriuria during pregnancy
- Periapical abscess with spreading cellulitis
- Infections associated with joint prostheses
- Lyme disease (Lyme borreliosis; infection transmitted by parasites called ticks)
- Systemic bacterial infections: typhoid fever and paratyphoid fever
- Prevention of bacterial endocarditis
- Ospamox may also be used in combination with other medicines in the treatment of peptic ulcer disease caused by Helicobacter pylori bacteria.
2. Important information before using Ospamox
When not to use Ospamox
if the patient is allergic to amoxicillin, penicillin, or to any of the other
components of the medicine (listed in section 6);
if the patient has ever had an allergic reaction to any other antibiotic. This may
include skin rash or swelling of the face or throat.
If any of the above situations apply, the patient should not take Ospamox. If in doubt, consult the doctor or
pharmacist before starting treatment.
Warnings and precautions
Before starting treatment with Ospamox, discuss with the doctor or pharmacist if the patient:
- has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
- has kidney disease
- urinates irregularly.
If in doubt whether any of the above conditions apply, consult the doctor or pharmacist before starting Ospamox.
Blood and urine tests
If the patient is scheduled for:
- urine test (to detect glucose) or blood test (to assess liver function)
- estriol level test (performed during pregnancy to check whether the baby is developing normally),
inform the doctor or pharmacist about taking Ospamox, as it may affect the results of these tests.
Ospamox and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to use.
- If the patient is taking allopurinol (used to treat gout), skin allergic reactions may be more likely when taken together with Ospamox.
- If the patient is taking probenecid (used to treat gout), concomitant use may reduce amoxicillin excretion and is not recommended. The doctor may decide to adjust the dose of Ospamox.
- If Ospamox is taken together with anticoagulant medicines (such as warfarin), additional blood tests may be required.
- If the patient is also taking other antibiotics (such as tetracyclines), Ospamox may be less effective.
- If the patient is taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she is pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Ospamox may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may impair the ability to drive or operate machinery.
The patient should not drive or operate machinery unless feeling well.
Ospamox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".
3. How to use Ospamox
This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The tablets should be swallowed with water. The tablets must not be crushed or chewed.
Doses should be taken at evenly spaced intervals throughout the day, maintaining at least
4-hour intervals between doses.
Usual dosage
Children weighing less than 40 kg
All doses are determined according to the child's body weight (expressed in kilograms).
Your doctor will advise the appropriate dose for your child.
The usual dose is 40 mg to 90 mg per kilogram of body weight per day,
administered in two or three divided doses.
The maximum recommended dose is 100 mg per kilogram of body weight per day.
Adults, elderly patients, and children weighing 40 kg or more
The usual dose of Ospamox is 250 mg to 500 mg three times daily, 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 daily.
Urinary tract infections: 3 g twice daily for one day.
Lyme disease (borreliosis – tick-borne infection):
Migratory erythema (early stage – pink-red rash): 4 g per day.
Systemic symptoms (late stage – more severe symptoms or when multiple organs are involved): up to 6 g per day.
Peptic ulcer disease: 750 mg or 1 g twice daily for 7 days, in combination
with other antibiotics and medications used to treat gastric ulcers.
Prophylaxis of endocarditis during surgical procedures: the dose may vary
depending on the type of surgical procedure. Other medications may also be administered concurrently.
For more detailed information, consult your doctor, pharmacist, or nurse.
The maximum recommended dose is 6 g per day.
Kidney disease
If the patient has kidney disease, the dose of Ospamox may be lower than usual.
Taking more Ospamox than recommended
If a patient takes more Ospamox than recommended, gastrointestinal disturbances
(nausea, vomiting, or diarrhoea) may occur, or amoxicillin crystals may appear in the urine
(observed as cloudy urine or experienced as difficulty in passing urine).
Seek medical advice as quickly as possible. Bring the medicine with you to show the doctor.
If you miss a dose of Ospamox
If a patient forgets to take a dose, they should take it as soon as they remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for a missed dose.
How long to take Ospamox
Continue taking the medicine for as long as your doctor has instructed, even if you start to feel better.
All doses are necessary to eliminate the infection. If some bacteria survive, they may cause a recurrence of the infection.
If you do not feel better after completing the treatment, consult your doctor again.
If Ospamox is used for a prolonged period, fungal infections (candidiasis – yeast infection of mucous membranes causing local pain, itching, and white discharge) may occur.
In such cases, consult your doctor.
If you are taking Ospamox for a prolonged period, your doctor may recommend additional tests to monitor kidney and liver function, as well as blood parameters.
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.
If the patient experiences any of the serious adverse reactions listed below,
treatment with Ospamox must be stopped immediately and medical advice sought, as
immediate medical intervention may be required.
Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
allergic reactions, including skin itching or rash, swelling of the face, lips, tongue, body, or
difficulty breathing; these may be severe symptoms and, rarely, may lead to death;
rash or flat, red, round spots beneath the skin surface or skin bruising, which may indicate
vasculitis due to an allergic reaction; these may occur with joint pain (arthritis) and kidney
function disorders;
delayed-type allergic reaction, usually occurring 7 to 12 days after taking Ospamox; symptoms
include, among others, rash, fever, joint pain, and swollen lymph nodes, especially under the arms;
a skin reaction called erythema multiforme, characterized by itchy, red-purple skin lesions,
especially on the palms or soles of the feet, skin swelling (resembling hives), and tender areas
inside the mouth, eyes, and genital organs; fever and severe fatigue may also occur;
other serious skin reactions, such as skin discoloration, subcutaneous nodules, blister or pustule
formation, skin peeling, redness, pain, itching, or skin desquamation; these changes may be
accompanied by fever, headache, and body aches;
influenza-like symptoms 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 indicate
blood cell disorders;
the Jarisch-Herxheimer reaction, which may occur during amoxicillin treatment for Lyme disease,
and is characterized by fever, chills, headache, muscle pain, and skin rash;
inflammation of the large intestine causing diarrhoea (sometimes with blood), abdominal pain, and
fever;
severe adverse reactions affecting the liver; these usually occur in patients treated for a long time,
in men, and in elderly patients.
Immediately inform the doctor if the patient experiences:
o severe diarrhoea accompanied by bleeding
o blisters on the skin, redness, or bruising
o dark-coloured urine or pale stools
o yellowing of the skin or whites of the eyes (jaundice). Also read the information below
regarding anaemia, which may cause jaundice.
These symptoms may occur during treatment or up to several weeks after treatment has ended.
chest pain related to an allergic reaction, which may be a sign of an allergy leading to heart attack
(Kounis syndrome). The frequency of this adverse reaction is unknown.
drug-induced enterocolitis syndrome (DIES): drug-induced enterocolitis has occurred mainly in
children receiving amoxicillin. This 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, diarrhoea, and low blood pressure. The frequency of this adverse reaction
is unknown.
rash with blisters arranged in a ring-like pattern with central crusts or resembling a string of pearls
(linear IgA dermatosis). The frequency of this adverse reaction is unknown.
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis). The
frequency of this adverse reaction is unknown.
If the patient experiences any of these symptoms, treatment must be stopped immediately and
medical advice sought.
Less severe skin reactions may sometimes occur, such as:
mildly itchy rash (circular, pink-red lesions), or hives-like swelling on the forearms, legs, hands, or
feet.
These occur not very frequently (may occur in fewer than 1 in 100 patients).
If the patient experiences any of these symptoms, medical advice should be sought, as
treatment discontinuation may be necessary.
Other possible adverse reactions:
Common adverse reactions (may occur in fewer than 1 in 10 patients):
rash
nausea
diarrhoea
Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):
vomiting
Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
thrush (yeast infection of the vagina, mouth, or skin folds) – a doctor or pharmacist can advise on
treatment
kidney function disorders
seizures (observed in patients receiving high doses or patients with kidney function disorders)
dizziness
excessive activity
change in tongue colour to yellow, brown, or black (the tongue may appear hairy)
excessive breakdown of red blood cells leading to anaemia; symptoms include fatigue, headache,
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 (blood cells involved in blood clotting)
prolonged blood clotting time (may be noticeable during nosebleeds or minor cuts).
Frequency unknown (frequency cannot be estimated from available data):
crystals in the urine leading to acute kidney injury
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor, pharmacist, or
nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions
of Medicinal Products at the 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 provide more information on the safety of this medicine.
5. How to store Ospamox
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 film-coated tablet contains 500 mg of amoxicillin (as amoxicillin trihydrate).
Each Ospamox 750 mg film-coated tablet contains 750 mg of amoxicillin (as amoxicillin trihydrate).
Each Ospamox 1000 mg film-coated tablet contains 1000 mg of amoxicillin (as amoxicillin trihydrate).
The other ingredients are: magnesium stearate, povidone (K25), sodium carboxymethyl starch (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 film-coated tablets are white or cream-coloured, oblong, biconvex, with a score line on both sides.
The tablets can be divided into equal halves.
Ospamox 750 mg
The film-coated tablets are white or cream-coloured, oval, biconvex, with a score line on both sides.
The tablets can be divided into equal halves.
Ospamox 1000 mg
The film-coated tablets are white or cream-coloured, oval, biconvex, with a score line on both sides.
The tablets can be divided into equal halves.
Film-coated tablets are packed in blisters made of PVC/PVDC/aluminum foil and placed in a cardboard box.
Pack sizes: 16, 20 or 28 film-coated tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
For further information about this medicinal product, contact the local representative of the Marketing Authorisation Holder:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00
This medicinal product is authorised for sale in the European Economic Area under the following names:
Germany AmoxiHEXAL 500 Filmtabletten
Italy Amoxicillina Hexal AG
Poland OSPAMOX 500 mg; FILM-COATED TABLETS
OSPAMOX 750 mg; FILM-COATED TABLETS
OSPAMOX 1000 mg; FILM-COATED TABLETS
(logo of the Marketing Authorisation Holder)
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 bacterial resistance to the administered antibiotic. This means that bacteria can survive, and even multiply, despite antibiotic treatment.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of developing bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could compromise the effectiveness of antibiotics.
-
It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Please read the instructions in this leaflet carefully. If any of them are unclear, ask your doctor or pharmacist for clarification.
-
Do not take an antibiotic unless it has been specifically prescribed for you, and use it only to treat the infection for which it was prescribed.
-
Do not take an antibiotic prescribed for another person, even if their infection seemed similar to yours.
-
Do not give your prescribed antibiotics to other people.
-
If any antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy for proper disposal.