Ospamox leaflet – Poland

How to use Ospamox

Leaflet attached to the packaging: patient information

Ospamox, 250 mg/5 ml, powder for oral suspension

Ospamox, 500 mg/5 ml, powder for oral suspension

Amoxicillin

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

You should keep this leaflet, so that you can read it again if you need to.
If you have any doubts, you should consult a 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 as yours.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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. It contains the active substance amoxicillin, which belongs to a group of medicines called penicillins.

What Ospamox is used for

Ospamox is 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: exacerbation of chronic bronchitis, pneumonia
urinary tract infections: cystitis (acute cystitis), pyelonephritis (acute pyelonephritis), asymptomatic bacteriuria during pregnancy
peritonsillar abscess with spreading cellulitis
infections related to joint prosthetics
Lyme disease (Lyme disease; infection transmitted by ticks)
systemic bacterial infections: typhoid and paratyphoid
prevention of bacterial endocarditis Ospamoxmay also be used in combination with other medicines to treat peptic ulcer disease caused by Helicobacter pyloribacteria.

2. Important information before taking Ospamox

When not to take Ospamox

Warnings and precautions

Before starting Ospamox, the patient should discuss it with their doctor or pharmacist if they:

Blood and urine tests

Ospamox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

Pregnancy, breastfeeding, and fertility

Driving and using machines

Ospamox may cause side effects and symptoms (such as allergic reactions, dizziness, and seizures) that can impair the ability to drive or operate machinery.
The patient should not drive or operate machinery unless they feel well.
Ospamox contains aspartame, sodium benzoate, benzyl alcohol, benzyl benzoate, ethanol,
sorbitol, sulfur dioxide, glucose, and sodium
This medicine contains 8.5 mg of aspartame in 5 ml of prepared oral suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
This medicine contains 7.1 mg of sodium benzoate (E 211) in 5 ml of prepared oral suspension, which can cause mild skin, eye, and mucous membrane irritation. This medicine contains up to 0.44 mg of benzyl benzoate in 5 ml of prepared oral suspension. Sodium benzoate and benzyl benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
This medicine contains up to 3.0 mg of benzyl alcohol in 5 ml of prepared oral suspension. Benzyl alcohol may cause allergic reactions. Pregnant women, breastfeeding mothers, patients with liver or kidney disease, should consult their doctor or pharmacist, as large amounts of benzyl alcohol may accumulate in their bodies and cause side effects (so-called metabolic acidosis). Do not give to young children (under 3 years) for more than a week without consulting a doctor or pharmacist. Do not give to newborns (up to 4 weeks of age) without consulting a doctor. Administering benzyl alcohol to young children is associated with a risk of serious side effects, including respiratory disorders.

4. weeks of age) without consulting a doctor. Administering benzyl alcohol to young children is associated with a risk of serious side effects, including respiratory disorders.

This medicine contains small amounts of ethanol (less than 100 mg in 5 ml of prepared oral suspension).
This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of prepared oral suspension, i.e., the medicine is considered "sodium-free".
This medicine contains 0.14 mg of sorbitol in 5 ml of prepared oral suspension.
This medicine contains 100 ng of sulfur dioxide, which can rarely cause severe hypersensitivity reactions and bronchospasm.
This medicine contains 0.68 mg of glucose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Ospamox

This medicine should always be taken exactly as advised by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
Before administering each dose, the bottle should always be shaken well.
Doses 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 Ospamox 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 patients, and children with a body weight of 40 kg or more

The usual dose 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 (infection transmitted by ticks): isolated erythema migrans (early stage - red or pink rash around the tick bite): 4 g per day; systemic symptoms (late stage - occurrence of more severe symptoms or spread of the disease in the body): up to 6 g per day.
Peptic ulcer disease: 750 mg or 1 g twice a day for 7 days, along with other antibiotics and medicines used to treat peptic ulcer disease.
Prevention of endocarditis: the dose depends on the type of procedure. The patient may also receive other medicines at the same time. The doctor, pharmacist, or nurse will provide more information on this.
The maximum dose is 6 g per day.

Kidney disease

Taking more Ospamox than recommended

Missing a dose of Ospamox

They should not take the next dose too early, but wait about 4 hours before taking it.
They should not take a double dose to make up for the missed dose.

How long to take Ospamox

The patient should take the medicine for as long as the doctor has prescribed, even if they feel 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 Ospamox is taken for a long time, thrush (candidiasis - a fungal infection of the mucous membranes, causing local pain, itching, and white discharge) may occur. In this case, the patient should consult their doctor.
if the patient takes Ospamox for a long time, the doctor may recommend additional tests to assess kidney, liver, and blood function.

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 can be severe symptoms, occasionally leading to death;
rash or flat, red, round spots under the skin surface or bruising, which can 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 hives), sensitive 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, and flaking of the skin; these 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 signs of blood disorders;
Jarisch-Herxheimer reaction, which occurs during amoxicillin treatment of Lyme disease 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;
severe liver disorders; 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). They should also read the information below about anemia, which can cause jaundice.
These symptoms may occur during or up to a few weeks after treatment.
chest pain associated with an allergic reaction, which can be a sign of an allergy leading 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 receiving amoxicillin. It is a type of allergic reaction, characterized by recurrent vomiting (1-4 hours after taking the medicine). 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 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, red, or pink patches), resembling hives, swelling on the forearms, legs, hands, arms, or feet. These occur uncommonly (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
seizures (observed in patients receiving high doses or patients with kidney function disorders)
dizziness
hyperactivity
tooth discoloration (in children), which can usually be removed by brushing
change in tongue color to yellow, brown, or black (the tongue may look hairy)
excessive breakdown of red blood cells, leading to anemia; symptoms include fatigue, 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 available data):
crystals in the urine leading to acute kidney damage

Reporting side effects

Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ospamox

Keep the medicine out of the sight and reach of children.
Do not use Ospamox after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C. Keep the bottle tightly closed to protect it from moisture.
Prepared suspension: store in the refrigerator (2°C-8°C).
Do not use the prepared suspension for more than 14 days.
Do not use the medicine if, before preparing the suspension, lumps of powder are visible in the bottle.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ospamox contains

The active substance is amoxicillin (in the form of amoxicillin trihydrate).
Each 5 ml of prepared oral suspension contains 250 mg or 500 mg of amoxicillin (in the form of amoxicillin trihydrate).
The other ingredients are: anhydrous citric acid, sodium benzoate, aspartame, talc, anhydrous sodium citrate, guar, silica colloidal, orange flavor [contains glucose, sorbitol (E 420), sulfur dioxide (E 220)], apricot-peach flavor [contains benzyl benzoate, ethanol, sorbitol (E 420), sulfur dioxide (E 220)], orange flavor [contains benzyl alcohol].
See section "Ospamox contains aspartame, sodium benzoate, benzyl alcohol, benzyl benzoate, ethanol, sorbitol, sulfur dioxide, glucose, and sodium".

What Ospamox looks like and contents of the pack

White or slightly yellowish powder with a fruity smell.
The powder for oral suspension is packed in orange glass bottles of 60 ml or 100 ml with a "press-and-turn" cap and protective foil.
Ospamox, 250 mg/5 ml
Package sizes:
6.60 g of powder for preparation of 60 ml of oral suspension
11.0 g of powder for preparation of 100 ml of oral suspension.
Ospamox, 500 mg/5 ml
Package sizes:
12.00 g of powder for preparation of 60 ml of oral suspension
20.0 g of powder for preparation of 100 ml of oral suspension.
Ospamox, 250 mg/5 ml and Ospamox, 500 mg/5 ml
A measuring spoon or syringe (with connector) with a scale of 1.25 ml, 2.5 ml, and 5.0 ml is attached to the packaging.
To measure the correct amount of suspension, the patient should:

Shake the bottle.
Insert the dosing adapter into the bottle.
Insert the tip of the dosing syringe into the adapter.
Turn the bottle upside down.
Pull the syringe plunger to draw the desired dose of medicine.
Turn the bottle right side up, remove the syringe, leaving the adapter on the bottle, and close the bottle.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

To obtain more detailed information about this medicine, the patient should contact their local representative of the marketing authorization holder:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. +48 22 209 70 00

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria
Amoxicillin Hexal 125 mg/5 ml - Powder for oral suspension
Amoxicillin Hexal 250 mg/5 ml - Powder for oral suspension
Amoxicillin Hexal 500 mg/5 ml - Powder for oral suspension
Poland
Ospamox, 250 mg/5 ml, powder for oral suspension
Ospamox 500 mg/5 ml, powder for oral suspension
(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 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 administered 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 patient's current illness. Paying attention to the following advice will help prevent the development of resistant bacteria that could render the antibiotic ineffective.
1 It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. The patient should read the instructions in the leaflet and, if they do not understand any of them, ask their doctor or pharmacist to explain.
2 The patient should not take an antibiotic that has not been prescribed specifically for them, and they should only use it to treat the infection for which it was prescribed.
3 The patient should not take an antibiotic prescribed for someone else, even if they have a similar infection.
4 The patient should not give their antibiotics to others.
5 If, after completing the treatment as recommended by the doctor, there are any leftover antibiotics, the patient should return them to the pharmacy for proper disposal.

Instructions for preparing the medicine for use

Before use, the patient should check if the cap seal is intact.
Turn the bottle upside down and shake it to loosen the powder.
Fill the bottle with boiled, cooled water to a level just below the mark on the bottle. Turn the bottle upside down and shake it thoroughly, then fill it with water exactly to the marked level. Turn the bottle upside down and shake it thoroughly again.
Shake the bottle with the prepared suspension well before each use.
The suspension with a white or slightly yellowish color is ready for use.

Information intended for healthcare professionals only:

After opening the cap, the patient should ensure that the protective foil is intact and tightly adheres to the bottle neck. Do not use the medicine if the protective foil is damaged. Shake the bottle to loosen the powder.
To prepare the suspension, the bottle should be filled with the following amount of water:
250 mg/5 ml
bottle 60 ml: add 55 ml of water
bottle 100 ml: add 92 ml of water
500 mg/5 ml
bottle 60 ml: add 51 ml of water
bottle 100 ml: add 85 ml of water
Shake the bottle again.
The suspension with a white or slightly yellowish color is ready for use.
Do not use the medicine if, after preparation, the suspension is not white or slightly yellowish.
The bottle should be shaken before each use.

Ospamox

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Cystitis treatment

Effective weight loss

ADHD assessment & treatment

Prescription renewal

Migraine treatment