Amoxil

Leaflet attached to the packaging: information for the user

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

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

Amoxicillin

You should carefully read the contents of the leaflet before using 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you as an adult patient (or child). Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Amoxil and what is it used for
• 2. Important information before taking Amoxil
• 3. How to take Amoxil
• 4. Possible side effects
• 5. How to store Amoxil
• 6. Contents of the packaging and other information

1. What is Amoxil and what is it used for

What is Amoxil

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

What is Amoxil used for

Amoxil is used to treat bacterial infections of various parts of the body. Amoxil can also be used, in combination with other medicines, to treat stomach ulcer disease.

2. Important information before taking Amoxil

When not to take Amoxil:

• if the patient is allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever been diagnosed with an allergy to any other antibiotic. This may include a skin rash or swelling of the face or throat.

If the above circumstances apply to the patient, they should not take Amoxil. In case of doubt, the patient should consult their doctor or pharmacist before starting to take Amoxil.

Warnings and precautions

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

• have infectious mononucleosis (fever, sore throat, swollen lymph nodes and extreme fatigue)
• have kidney disease
• have irregular urination.

In case of doubt as to whether the above circumstances apply to the patient, they should consult their doctor or pharmacist before starting to take Amoxil.

Blood and urine tests

If the patient is to undergo:

• urine tests (for glucose) or blood tests to check liver function,
• estriol tests (performed during pregnancy to check if the baby is developing properly), they should inform their doctor or pharmacist that they are taking Amoxil. Amoxil may affect the results of these tests.

Amoxil and other medicines

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

• If the patient takes allopurinol (used to treat gout) at the same time as Amoxil, they may be more likely to experience skin allergic reactions.
• If the patient takes probenecid (used to treat gout) - taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended. The doctor may decide to modify the dose of Amoxil.
• If the patient takes blood-thinning medicines (such as warfarin), additional blood tests may be necessary.
• If the patient takes other antibiotics (such as tetracycline), Amoxil may be less effective.
• If the patient takes methotrexate (used to treat cancer and severe psoriasis)
• penicillins may reduce the excretion of methotrexate, which may increase the risk of side effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Amoxil 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.

Amoxil, 250 mg/5 ml, powder for oral suspension contains aspartame, maltodextrin (containing glucose), sodium, sodium benzoate, and trace amounts of benzyl alcohol.

Amoxil, 500 mg/5 ml, powder for oral suspension contains aspartame, maltodextrin (containing glucose), sodium, sodium benzoate, and trace amounts of benzyl alcohol.

• Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
• This medicine contains maltodextrin. Maltodextrin is absorbed like glucose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
• Sodium benzoate (E 211) can cause mild eye, skin and mucous membrane irritation and may increase the risk of jaundice in newborns.
• This medicine contains trace amounts of benzyl alcohol. Benzyl alcohol may cause allergic reactions.

Amoxil 250 mg/5 ml powder for oral suspension

• This medicine contains 1.4 mg (0.06 mmol) of sodium per 1 ml. This should be taken into account in patients on a low-sodium diet.

Amoxil 500 mg/5 ml powder for oral suspension

• This medicine contains 1.6 mg (0.07 mmol) of sodium per 1 ml. This should be taken into account in patients on a low-sodium diet.

3. How to take Amoxil

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.

• Before administering each dose, the bottle should always be shaken well.
• The measuring spoon provided with the packaging should be used.
• Equal intervals of at least 4 hours should be maintained between doses administered during the day.

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 Amoxil 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 and children with a body weight of 40 kg or more

This oral suspension is not usually recommended for use in adults and children with a body weight of more than 40 kg. However, it may be used in certain situations, especially if the patient is unable to swallow capsules. The oral suspension is available in different strengths. The patient should consult their doctor or pharmacist for advice.

Kidney disease

If the patient has kidney disease, the dose of the medicine may be lower than usual.

Taking a higher dose of Amoxil than recommended

If the patient takes a higher dose of Amoxil than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting or diarrhea) or crystals in the urine, which may be perceived as cloudy urine or problems with urination. The patient should contact their doctor as soon as possible. They should take the medicine with them to show it to the doctor.

Missing a dose of Amoxil

• If the patient forgets to take a dose, they should take it as soon as they remember.
• The patient should not take the next dose too early, they should wait about 4 hours before taking the next dose.
• The patient should not take a double dose to make up for a missed dose.

How long to take Amoxil

• The patient should continue taking Amoxil for as long as their 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 with Amoxil, they should consult their doctor.

In case of long-term use of Amoxil, thrush (candidiasis - fungal infections 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 Amoxil for a long time, their doctor may order additional tests to check kidney, liver and blood function. In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Amoxil and contact their doctor immediately - they may need urgent medical attention:

Very rareside effects (may occur in less than 1 in 10,000 patients)

• allergic reactions, including: itching and skin rash, swelling of the face, lips, tongue, body or difficulty breathing. These symptoms can be severe and, in rare cases, may lead to death.
• rash or patchy, flat, red, round spots under the skin or bruising of the skin, which may be a sign of an allergic reaction causing inflammation of the blood vessels. This may be associated with joint pain (arthritis) and kidney disease.
• late allergic reactions occurring usually 7 to 12 days after taking Amoxil, some of the observed symptoms include: rash, fever, joint pain and swollen lymph nodes, especially in the armpits.
• a 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), irritation around the mouth, eyes or genitals. Fever and a feeling of tiredness may occur.
• other severe skin reactions such as changes in skin color, lumps under the skin, blisters, crusts, peeling of the skin, redness, pain, itching and flaking of the skin. These may be associated with fever, headache and body aches.
• flu-like symptoms with a 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 and other signs of infection or a tendency to bruise. These may be signs of blood cell problems.
• inflammation of the colon, causing diarrhea (sometimes with blood), abdominal pain and fever.
• severe liver side effects. These usually occur in patients treated for a long period, men and the elderly. The patient should immediately inform their doctor if they experience:

severe diarrhea with blood
blistering, redness or bruising of the skin
dark urine or pale stools
yellowing of the skin and whites of the eyes (jaundice). The patient should also read the information below about anemia that may cause jaundice. These symptoms may occur during or up to several weeks after stopping Amoxil. Side effects with unknown frequency(frequency cannot be estimated from the available data)

• Jarisch-Herxheimer reaction. When taking Amoxil to treat Lyme disease (borreliosis), the patient may experience fever, chills, headaches and muscle pain, as well as a rash.
• Chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).
• A red rash usually observed on both sides of the buttocks, the inner upper thighs, under the arms and on the neck [symmetrical, intertriginous and flexural exanthema caused by the drug (SDRIFE)].
• Drug-induced enterocolitis syndrome (DIES) occurred mainly in children receiving amoxicillin. It 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, diarrhea and low blood pressure.

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

Sometimes, less severe skin reactions may occur, such as:

• mildly itchy rash (round, red-pink patches), resembling hives, swelling of the forearms, legs, hands, feet or face. This occurs not very often (may occur in less than 1 in 100 patients).

If the patient experiences any of these symptoms, they should contact their doctor, as it may be necessary to stop taking Amoxil.

Other side effects:
Common side effects(may occur in less than 1 in 10 patients)

• skin 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 infections of the vagina, mouth or skin folds), the doctor or pharmacist will advise on treatment
• kidney problems
• seizures, especially in patients taking high doses or having kidney problems
• dizziness
• excessive activity
• discoloration of teeth (in children), which can usually be removed by brushing
• yellow, brown or black, hairy tongue
• excessive breakdown of red blood cells, which can lead 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 (cells involved in blood clotting)
• blood may take longer to clot than usual. This may be noticeable in case of nosebleeds or cuts.

Side effects with unknown frequency(frequency cannot be estimated from the available data)

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis)
• crystals in the urine leading to acute kidney damage, visible as cloudy urine or causing difficulty or discomfort during urination. To avoid these symptoms, the patient should drink plenty of fluids.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. 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. By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Amoxil

The medicine should be stored out of the sight and reach of children. Do not use this medicine after the expiry date (EXP) stated on the carton. The expiry date refers to the last day of the month stated.

Powder

Do not store above 25°C.

Reconstituted suspension

Do not store above 25°C. The shelf life of the reconstituted suspension is 14 days. Do not use this medicine if signs of deterioration are visible. 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 packaging and other information

What Amoxil contains

• The active substance of the medicine is 250 mg or 500 mg of amoxicillin.
• The other ingredients are: sodium carmellose 12, orange-peach-strawberry flavor (containing maltodextrin and trace amounts of benzyl alcohol), crospovidone (type A), aspartame (E 951), sodium benzoate (E 211), xanthan gum (E 415), colloidal hydrated silica, magnesium stearate.

What Amoxil looks like and contents of the pack

Amoxil, 250 mg/5 ml, powder for oral suspension is a white powder with yellowish granules supplied in glass bottles with a nominal volume of 107 ml (containing powder for the preparation of 60 ml of suspension) or 147 ml (containing powder for the preparation of 100 ml of suspension) with a child-resistant closure. The bottle is placed in a cardboard box with a measuring spoon of 2.5 ml and 5 ml. Amoxil, 500 mg/5 ml, powder for oral suspension is a white powder with yellowish granules supplied in glass bottles with a nominal volume of 107 ml (containing powder for the preparation of 60 ml of suspension) or 147 ml (containing powder for the preparation of 100 ml of suspension) with a child-resistant closure. The bottle is placed in a cardboard box with a measuring spoon of 2.5 ml and 5 ml. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

Manufacturer:

Athlone Laboratories Limited
Ballymurray
Co. Roscommon
F42 EW02
Ireland
or
Glaxo Wellcome Production
Z.I. de la Peyennière
53100 Mayenne
France
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
tel. (22) 576-90-00

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

250 mg/5 ml, powder for oral suspension

Belgium – Clamoxyl
France – Clamoxyl, Amoxicilline Biogaran
Greece – Amoxil
Lithuania – Amoxil
Luxembourg – Clamoxyl
Poland – Amoxil
Portugal – Clamoxyl

500 mg/5 ml, powder for oral suspension

France – Clamoxyl, Amoxicilline Biogaran
Greece - Amoxil
Poland – Amoxil
Portugal – Clamoxyl

Date of last revision of the leaflet: December 2024

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 phenomenon is that bacteria are resistant to the administered antibiotic. This means that bacteria can survive and even multiply despite the use of antibiotics. Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance. The antibiotic prescribed by the doctor is intended solely for the treatment of the current disease. Paying attention to the following tips 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 any of them are unclear, ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that has not been prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. The patient should not give antibiotics prescribed for them to other people.
• 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.

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Instructions for preparing the medicine for use

Before use, the patient should check if the cap seal is intact. The bottle should be turned upside down and shaken to loosen the powder. The bottle should be filled with water to a level just below the mark on the label. The bottle should be turned upside down and shaken carefully, then waited for the foam to dissipate, and finally filled with water exactly to the mark on the label. The bottle should be turned upside down and shaken again carefully. The bottle with the reconstituted suspension should be shaken carefully before each use. The measuring spoon provided with the packaging should be used to administer the medicine.