Amoksiklav

Leaflet attached to the packaging: patient information

Amoksiklav, (400 mg + 57 mg)/5 ml, powder for oral suspension

Amoxicillin + Clavulanic acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for this person. 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Amoksiklav and what is it used for

Amoksiklav is an antibiotic that kills bacteria that cause infections. It contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called penicillins, whose action can sometimes be inhibited (inactivated). The second active substance (clavulanic acid) counteracts this inactivation. Amoksiklav is used in infants and children to treat the following infections: middle ear and sinus infections, respiratory tract infections, urinary tract infections, skin and soft tissue infections, including dental infections, bone and joint infections.

2. Important information before taking Amoksiklav

When not to give Amoksiklav to a child:

if the child is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6); if the child has ever had a severe allergic reaction (hypersensitivity) to any other antibiotic; such a reaction may include a skin rash, swelling of the face or neck; if the child has ever had liver function disorders or jaundice (yellowing of the skin), caused by taking an antibiotic.

If any of the above situations apply to the child, do not give them Amoksiklav.

Amoksiklav.In case of doubt before giving Amoksiklav, consult a doctor or pharmacist.

Warnings and precautions

Before taking this medicine, discuss it with a doctor or pharmacist if the child: has infectious mononucleosis, is being treated for liver or kidney function disorders, does not urinate regularly. In case of doubt whether any of these statements apply to the patient, consult a doctor or pharmacist before taking the medicine. In some cases, the doctor may examine what type of bacteria caused the infection. Depending on the test results, the patient may receive Amoksiklav with a different strength or a different medicine.

Conditions to watch out for

Taking Amoksiklav may worsen the course of some existing diseases or cause severe side effects (such as allergic reactions, seizures, and colitis). To minimize the risk of any problems, while taking Amoksiklav, you should pay attention to whether certain symptoms occur (see "Conditions to watch out for" in section 4).

Blood and urine tests

If the child is to have a blood test (e.g. red blood cell test or liver function tests) or a urine test (for glucose), inform the doctor or nurse that the patient is taking Amoksiklav. The medicine may affect the results of these tests.

Amoksiklav and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription and herbal medicines. If the patient is taking allopurinol (used to treat gout), the risk of a skin allergic reaction may increase. If the patient is taking probenecid (used to treat gout), the doctor may decide to change the dose of Amoksiklav. Taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended. If the patient is taking medicines that reduce blood clotting (such as warfarin), additional blood tests may be necessary. Amoksiklav may affect the action of methotrexate (a medicine 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 child, they should consult a doctor or pharmacist before taking this medicine.

Driving and using machines

Amoksiklav may cause side effects and symptoms that disrupt the ability to drive vehicles. The patient should not drive vehicles or operate machines unless they feel well. Excipients

Amoksiklav contains aspartame (E 951), potassium, and sodium

The medicine contains 16.64 mg of aspartame in each 5 ml of 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. The medicine contains less than 1 mmol (39 mg) of potassium in 5 ml of suspension. The medicine contains 11.7 mg of potassium in each 5 ml of suspension. The medicine contains 1.2 mmol (48.6 mg) of potassium per maximum daily dose (20 ml), which should be taken into account in patients with reduced kidney function and in patients controlling potassium intake in their diet. This medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of suspension, i.e. the medicine is considered "sodium-free".

3. How to take Amoksiklav

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

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

Suspension is not usually recommended for adults and children with a body weight of 40 kg or more. Consult a doctor or pharmacist in this matter.

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 provide information on how much medicine to give to the child. The usual dose is: from (25 mg + 3.6 mg) to (45 mg + 6.4 mg) per kilogram of body weight per day, given in two divided doses. Higher dose: up to (70 mg + 10 mg) per kilogram of body weight per day, given in two divided doses. A measuring spoon or a dosing syringe is attached to the medicine. It should be used to give the child the correct dose of the medicine.

Patients with kidney and liver function disorders

For children with kidney function disorders, the dose may be changed. The doctor may recommend taking a medicine with a different strength or a different medicine. Children with liver function disorders may have more frequent blood tests to monitor liver function.

How to prepare the oral suspension

The instructions for preparing the medicine for use are at the end of this leaflet.

How to take Amoksiklav

Before giving each dose of the medicine, shake the bottle well. The medicine should be given at the beginning of a meal or just before a meal. Equal intervals of at least 4 hours should be maintained between doses given during the day. Do not give 2 doses within 1 hour. Do not give the child Amoksiklav for more than 2 weeks. If the child still feels unwell, consult a doctor again. To ensure that the recommended dose of the medicine has been given to the patient, you can use the table on the outer cardboard packaging. The table indicates the subsequent doses given over 7 days. Each time the medicine is given, push out the cardboard disc with a perforated edge with the number corresponding to the next dose. If the doctor has recommended taking the medicine for more than 7 days, open a new package of the medicine, prepare the suspension, and continue treatment, marking the administration of subsequent doses as described above.

Taking a higher dose of Amoksiklav than recommended

If the patient has taken a higher dose of Amoksiklav than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures may occur. Consult a doctor as soon as possible. Take the cardboard packaging or the bottle of medicine with you to show the doctor.

Missing a dose of Amoksiklav

If a dose of the medicine is missed, give it as soon as you remember. Do not give the next dose too early, but wait about 4 hours before giving the next dose.

Stopping Amoksiklav

Give Amoksiklav until the end of the treatment, even if the child feels better. All doses of the medicine are needed to combat the infection. If some bacteria survive, they may cause a relapse of the infection. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects of this medicine may occur.

Conditions to watch out for

Allergic reactions:

skin rash, vasculitis, which may appear as red or purple raised spots on the skin, but may also affect other parts of the body, fever, joint pain, swelling of lymph nodes in the neck, armpit, or groin, swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing, fainting, chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).

If the child experiences any of these symptoms, consult a doctor immediately. Stop taking Amoksiklav.

Colitis

Colitis, causing watery diarrhea, usually with blood and mucus, stomach pain, and (or) fever.

Acute pancreatitis

If the patient experiences severe and persistent stomach pain, it may be a sign of acute pancreatitis.

Drug-induced colitis (DIES).

Drug-induced colitis occurred mainly in children taking amoxicillin with clavulanic acid. It is a type of allergic reaction, whose leading symptom is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include stomach pain, lethargy, diarrhea, and low blood pressure.

If the child experiences any of these symptoms, consult a doctor immediately.

Common side effects(less than 1 in 10 people)
thrush - a fungal infection of the vagina, mouth (thrush), or skin folds, nausea, especially when taking high doses of the medicine.
→ If nausea occurs, Amoksiklav should be given before meals.
vomiting, diarrhea, uncommon side effects(less than 1 in 100 people)
skin rash, itching, hives (urticaria), indigestion, dizziness, headache, uncommon side effects that may appear in blood test results:
increased activity of certain substances (enzymes) produced in the liver, rare side effects(less than 1 in 1000 people)
skin rash, which may change into blisters and look like small targets (dark spot in the center surrounded by a lighter border with a dark edge - erythema multiforme)

If the child experiences any of these symptoms, consult a doctor immediately.

Rare side effects that may appear in blood test results:
low number of blood cells involved in blood clotting, low number of white blood cells

Other side effects

Other side effects have occurred in a very small number of people, but their exact frequency is not known.
allergic reactions (see above), colitis (see above), severe skin reactions:

• extensive skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form, causing extensive peeling of the skin (covering more than 30% of the body surface - toxic epidermal necrolysis)
• extensive, red skin rash with small blisters filled with pus (bullous exfoliative dermatitis)
• red, scaly rash with thickening under the skin and blisters (pustular psoriasis)
• symptoms similar to flu with a rash, fever, swollen lymph nodes, and abnormal blood test results [including an increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS), crystals in the urine leading to acute kidney damage, rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis), inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

If the child experiences any of the above symptoms, consult a doctor immediately.

liver inflammation, jaundice due to increased bilirubin levels in the blood, which may cause yellowing of the skin and eyes, interstitial nephritis, prolonged blood clotting time, hyperactivity, seizures (in people taking high doses of Amoksiklav or with kidney disease), black hairy tongue, tooth discoloration (in children), which can usually be removed by brushing teeth, development of an infection caused by excessive growth of non-susceptible bacteria, side effects that may appear in blood or urine tests:
significant decrease in the number of white blood cells, low number of red blood cells (hemolytic anemia), crystals in the urine

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a 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 gather more information on the safety of the medicine.

5. How to store Amoksiklav

Keep the medicine out of the sight and reach of children. Dry powder: store at a temperature below 30°C. Prepared suspension: store in a refrigerator at a temperature between 2°C and 8°C and use within 7 days. Before each use, shake the bottle well. After each use, close the bottle tightly. 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 given month. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Amoksiklav contains

The active substances are amoxicillin and clavulanic acid. Each 5 ml of suspension (1 measuring spoon) contains 400 mg of amoxicillin in the form of amoxicillin trihydrate and 57 mg of clavulanic acid in the form of potassium clavulanate. The other ingredients are: colloidal anhydrous silica, xanthan gum, strawberry flavor, crospovidone, aspartame (E 951), sodium carmellose, silicon dioxide.

What Amoksiklav looks like and what the packaging contains

The powder for oral suspension is a white or light yellow powder. The medicine is available in orange glass bottles with a plastic cap with a seal or a plastic cap with a child-resistant seal, containing powder for the preparation of 35 ml, 70 ml, or 140 ml of oral suspension. The bottle is placed in a cardboard box with a plastic dosing syringe or a measuring spoon.

Marketing authorization holder and manufacturer

Sandoz GmbH, Biochemiestrasse 10, A-6250 Kundl, Austria. For more detailed information on this medicine, please contact: Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, tel. +48 22 209 70 00, (logo of the marketing authorization holder)

Date of the last update of the leaflet:

Medical education

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 or multiply despite the use of an antibiotic. Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the likelihood 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 hinder the action of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. Read the instructions in the patient information leaflet and if any of them are unclear, ask the 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. Do not pass on antibiotics prescribed for one patient to others.
• 5. If any leftover antibiotic remains after completing the treatment as directed by the doctor, return it to the pharmacy, which will accept it for proper disposal.

Instructions for preparing the medicine for use

How to prepare the oral suspension

Before opening, check that the bottle seal has not been damaged and is tightly attached to the neck of the bottle. Do not use the medicine if the seal has been damaged. Do not use this product if there are visible lumps of powder in the bottle before preparing the suspension. Shake the bottle to move the powder. 35 ml suspension: Shake the contents of the bottle (powder for oral suspension), fill the bottle with 34 ml of water, and shake well. 70 ml suspension: Shake the contents of the bottle (powder for oral suspension), fill the bottle with 66 ml of water, and shake well. 140 ml suspension: Shake the contents of the bottle (powder for oral suspension), fill the bottle with 132 ml of water, and shake well. The suspension is white or light yellow and is ready for use. Do not use this product if the suspension is a color other than white or light yellow after preparation. Before each use, shake the bottle well. After each use, close the bottle tightly.