Ospamox
Poland
Table of Contents
Package leaflet: Information for the patient
Ospamox, 500 mg, film-coated tablets
Ospamox, 750 mg, film-coated tablets
Ospamox, 1000 mg, film-coated tablets
Amoxicillinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for you.
- Keep this leaflet for future reference.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual (adult or child). Do not share it with others. This medicine may harm another person, 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
- 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 Ospamox is
Ospamox is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".
Why Ospamox is used
Ospamox is used to treat bacterial infections in various parts of the body. Ospamox may also be used, together with other medicines, in the treatment of peptic ulcer disease.
2. Important information before using Ospamox
When not to use 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 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 with this medicine.
Warnings and precautions
Before starting treatment with Ospamox, discuss with a doctor or pharmacist if the
patient:
- has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue)
- has kidney disease
- passes urine irregularly.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting treatment with Ospamox.
Blood and urine tests
If the patient is due to have:
- a urine test (to detect glucose) or blood test (to assess liver function)
- a test measuring estriol levels (performed during pregnancy to check whether the baby is developing normally),
inform the doctor or pharmacist that the patient is taking Ospamox, as it may affect the results of these tests.
Ospamox and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is taking allopurinol (used to treat gout) together with Ospamox, skin allergic reactions may be more likely.
If the patient is taking probenecid (used to treat gout), the doctor may need to adjust the dose of Ospamox. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
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 in the treatment of cancer and severe psoriasis), penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 they feel well.
Ospamox contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine 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 whole with a glass of water. Do not crush or chew the tablets.
Doses should be taken at regular 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 dose of medicine to be given to the 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 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 (tick-borne borreliosis):
- 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 a day for 7 days, in combination
with other antibiotics and medications used in the treatment of 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 simultaneously.
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 the medicine may be lower than usual.
Taking more Ospamox than recommended
If the patient takes more Ospamox than recommended, gastrointestinal disturbances (nausea, vomiting, or diarrhoea) may occur, or amoxicillin crystals may appear in the urine (perceived as cloudy urine or experienced as difficulty in passing urine). Seek medical advice as quickly as possible. Take the medicine with you to show the doctor.
If you miss a dose of Ospamox
If the 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
Take the medicine for as long as your doctor has instructed, even if the patient feels better.
All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
If the patient still does not feel better after completing the treatment, consult the doctor again.
Prolonged use of Ospamox may lead to fungal infections (candidiasis – a yeast infection of mucous membranes causing local pain, itching, and white discharge).
In such cases, consult your doctor.
If the patient is taking Ospamox for a prolonged period, the doctor may recommend additional tests to monitor kidney, liver, and blood function.
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 a doctor should be consulted, as
immediate medical assistance 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, occasionally leading to death;
rash or small, flat, red, round spots beneath the skin 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 rash, fever, joint pain, and enlarged lymph nodes, especially under the arms;
a skin reaction known as erythema multiforme, characterized by itchy
reddish-purple skin lesions, particularly on the palms or soles of the feet,
skin swelling (resembling hives), tender areas inside the mouth, eyes, and genital organs;
fever and severe fatigue may also occur;
other severe skin reactions, such as skin discoloration, subcutaneous nodules, blistering, pustules, skin peeling, redness, pain, itching, or skin flaking;
these changes may be accompanied by fever, headache, and body aches;
influenza-like symptoms with rash, fever, enlarged 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 may occur during amoxicillin treatment of Lyme disease,
characterized by fever, chills, headache, muscle pain, and skin rash;
inflammation of the large intestine causing diarrhoea (sometimes with blood), pain, and fever;
severe adverse effects affecting the liver; these usually occur in patients treated for a long duration, in men, and in elderly patients.
Immediately inform a doctor if the patient experiences:
o severe diarrhoea associated with 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).
Frequency not known (frequency cannot be estimated from available data):
chest pain associated with an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)
inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
drug-induced enterocolitis (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin.
It is a type of allergic reaction, the main symptom of which is recurrent vomiting (1-4 hours after taking the medicine).
Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Blistering rash arranged in ring-like patterns with scabs in the center or resembling a string of pearls (linear IgA dermatosis).
Please also read the information below regarding anaemia, which may cause jaundice.
The described symptoms may occur during treatment or up to several weeks after treatment has ended.
If the patient experiences any of these symptoms, treatment must be stopped immediately and a doctor should be consulted.
Less severe skin reactions may sometimes occur, such as:
mildly itchy rash (round, pink-red lesions), 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, a doctor should be consulted, as discontinuation of the medicine 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):
fungal infections (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
crystals in urine, visible as urine cloudiness or difficulty or discomfort during urination; to reduce the risk of these symptoms, drink plenty of fluids
yellow, brown, or black discoloration of the tongue (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
reduced number of white blood cells
reduced number of blood platelets (involved in blood clotting)
prolonged blood clotting time (may manifest as nosebleeds or bleeding from cuts).
Frequency not known (frequency cannot be estimated from available data):
urinary crystals leading to acute kidney injury
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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, 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.
Store the medicine below 25 °C and protect from moisture.
Keep 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 stated month.
Medicines should 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 package and other information
What Ospamox contains
Ospamox, 500 mg
Each coated tablet contains 500 mg of amoxicillin as amoxicillin trihydrate (574 mg).
Ospamox, 750 mg
Each coated tablet contains 750 mg of amoxicillin as amoxicillin trihydrate (861 mg).
Ospamox, 1000 mg
Each coated tablet contains 1000 mg of amoxicillin as amoxicillin trihydrate (1148 mg).
The other ingredients are:
magnesium stearate, povidone (K 25), sodium carboxymethyl starch, microcrystalline cellulose;
coating: titanium dioxide, talc, methylhydroxypropylcellulose.
What Ospamox looks like and contents of the pack
Ospamox, 500 mg: white or cream coated tablets, elongated, convex on both sides, with a score line on both sides, measuring 8×18 mm.
Ospamox, 750 mg: white or cream coated tablets, elongated, convex on both sides, with a score line on both sides, measuring 9×20 mm.
Ospamox, 1000 mg: white or cream coated tablets, elongated, convex on both sides, with a score line on both sides, measuring 10×22 mm.
The tablets are packed in PVC/PVDC/Aluminium blisters containing 16 coated tablets, in a cardboard carton.
Marketing Authorisation Holder and Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
For further information about this medicinal product, please 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
(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 use.
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, and if any of them are unclear, ask your doctor or pharmacist for clarification.
- 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.
- Do not take an antibiotic prescribed for someone else, even if their symptoms were similar.
- Do not give your prescribed antibiotics to other people.
- If any antibiotic remains after completing the prescribed course of treatment, return it to a pharmacy for proper disposal.