Ospamox

Driving and using machines

Ospamox may cause side effects such as allergic reactions, dizziness, and seizures that can affect 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 the 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 the 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 the 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 the 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 (such as metabolic acidosis). Do not give to small children (under 3 years old) 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 small children is associated with a risk of serious side effects, including respiratory disorders.

• Do not give to small children (under 3 years old) for more than a week without consulting a doctor or pharmacist.

This medicine contains a small amount of ethanol (less than 100 mg in 5 ml of the prepared oral suspension).
This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of the prepared oral suspension, which means the medicine is considered "sodium-free".
This medicine contains 0.14 mg of sorbitol in 5 ml of the 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 consult their doctor before taking the medicine.

3. How to take Ospamox

This medicine should always be taken exactly as directed by the doctor or pharmacist. If the patient has any doubts, they 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 between them.
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 bite): 4 g per day; systemic symptoms (late stage - more severe symptoms or spread of the disease throughout the body): 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 medicines used to treat peptic ulcer disease.
Prevention of endocarditis during surgery: 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

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, they may experience gastrointestinal disturbances (nausea, vomiting, or diarrhea) or amoxicillin crystals in their urine (which may appear as cloudy urine or difficulty urinating). The patient should consult their doctor as soon as possible and take the medicine with them to show the doctor.

Missing a dose of Ospamox

If the patient forgets to take a dose, they should take it as soon as they remember.
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 recommends, even if they feel better.
All doses of the medicine are necessary to combat the infection. If some bacteria survive, they may cause a relapse of the infection.
If the patient 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.
If the patient has any further doubts about taking this medicine, they 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 consult their doctor immediately, as they 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, or body, or difficulty breathing; these can be severe and, in rare cases, life-threatening;
a rash or red, flat, round patches under the skin, or bruising, which can be a sign of an allergic reaction affecting the blood vessels, and may be associated with joint pain and kidney problems.
an allergic reaction known as 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;
colitis (inflammation of the colon), which can cause diarrhea (sometimes with blood), abdominal pain, and fever;
severe liver side effects, which usually occur in patients who have been taking the medicine for a long time, are male, and are elderly.
The patient should consult their doctor immediately if they experience:
severe diarrhea with blooddark urine or pale stools
yellowing of the skin or whites of the eyes (jaundice). The patient should also read the information below about anemia, which can cause jaundice.
These symptoms can occur during or after treatment with Ospamox.
chest pain associated with an allergic reaction, which can be a sign of a heart attack (Kounis syndrome). The frequency of this side effect is unknown.
drug-induced enterocolitis syndrome (DIES): this is a type of allergic reaction, characterized by repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure. The frequency of this side effect is unknown.
a rash with blisters, forming 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.
aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord). The frequency of this side effect is unknown.

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

Less severe skin reactions may also occur, such as:

mildly itchy rash (round, pink or red patches), resembling hives, swelling on the forearms, legs, hands, feet, or face.
These occur uncommonly (in less 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 Ospamox.

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) - the doctor or pharmacist will advise on treatment
kidney problems
seizures (observed in patients taking high doses or with kidney problems)
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, 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 noticeable 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 tell 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, tel: +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 this medicine.

5. How to store Ospamox

Keep the medicine out of the sight and reach of children.
Do not take Ospamox after the expiry date stated on the carton and bottle after EXP. The expiry date refers to the last day of the month stated.
Do not store above 25°C. Keep the bottle tightly closed to protect 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 there are visible lumps of powder in the bottle before preparing the suspension.
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 pack and other information

What Ospamox contains

The active substance is amoxicillin (in the form of amoxicillin trihydrate).
Each 5 ml of the 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)], peach flavor [contains benzyl benzoate, ethanol, sorbitol (E 420), sulfur dioxide (E 220)], lemon 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
Pack sizes:
6.60 g of powder for the preparation of 60 ml of oral suspension
11.0 g of powder for the preparation of 100 ml of oral suspension.
Ospamox, 500 mg/5 ml
Pack sizes:
12.00 g of powder for the preparation of 60 ml of oral suspension
20.0 g of powder for the 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 1.25 ml, 2.5 ml, and 5.0 ml graduations 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 oral 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 on 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 Warszawa
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 – Pulver zur Herstellung einer Suspension zum Einnehmen
Amoxicillin Hexal 250 mg/5 ml – Pulver zur Herstellung einer Suspension zum Einnehmen
Amoxicillin Hexal 500 mg/5 ml – Pulver zur Herstellung einer Suspension zum Einnehmen
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 against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is the development of antibiotic resistance in bacteria. This means that bacteria can survive and even multiply despite the use of antibiotics.
Bacteria can become resistant to antibiotics for many reasons. The careful use of antibiotics can help reduce the risk of antibiotic resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the patient's current illness. The patient should pay attention to the following advice to prevent the development of antibiotic-resistant bacteria:
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 that was prescribed for someone else, even if they have a similar infection.
4 The patient should not give their antibiotics to other people.
5 If there are any leftover antibiotics after completing the treatment as recommended by the doctor, the patient should return them to the pharmacy for proper disposal.

Instructions for preparing the medicine for use

Before use, the patient should check that the cap seal has not been broken.
Turn the bottle upside down and shake to loosen the powder.
Fill the bottle with boiled, cooled water to just below the mark on the bottle. Turn the bottle upside down and shake well, then fill with water to the exact mark on the bottle. Turn the bottle upside down and shake well again.
Shake the bottle with the prepared suspension well before each use.
The suspension, which is white or slightly yellowish in color, is ready for use.

Information intended for healthcare professionals only:

After removing the cap, the patient should ensure that the protective foil is intact and tightly adheres to the bottle rim. Do not use the medicine if the 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 vigorously again.
The suspension, which is white or slightly yellowish in color, is ready for use.
Do not use the medicine if the prepared suspension is not white or slightly yellowish in color.
The bottle should be shaken before each use.