Amoksiklav

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 adults 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 take Amoksiklav:

if the patient is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine (listed in section 6); if the patient 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 patient 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 patient, they should not take Amoksiklav.

Amoksiklav.If in doubt before taking Amoksiklav, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before taking this medicine, the patient should discuss it with their doctor or pharmacist if they: have infectious mononucleosis are being treated for liver or kidney disorders do not urinate regularly. If in doubt whether any of these statements apply to the patient, they should 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 when taking Amoksiklav, the patient should pay attention to whether certain symptoms occur (see "Conditions to watch out for" in section 4).

Blood and urine tests

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

Amoksiklav and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking, or have recently taken, and about medicines they plan to take, including those that are available without a prescription and herbal medicines. If the patient is taking allopurinol (used to treat gout) at the same time as Amoksiklav, the likelihood of a skin allergic reaction increases. If the patient is taking probenecid (used to treat gout), the doctor may decide to modify 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) at the same time as Amoksiklav, 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, potentially leading to an increased risk of side effects. If the patient is receiving mycophenolate mofetil (a medicine used to prevent the body from rejecting a transplanted organ), the doctor will closely monitor their health while taking Amoksiklav.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, 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.

Amoksiklav contains sodium and potassium

This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free". The medicine contains 24 mg of potassium, i.e. less than 1 mmol (or 39 mg) per film-coated tablet. The medicine contains 1.85 mmol (72 mg) of potassium per maximum daily dose, which should be taken into account in patients with reduced kidney function and in patients controlling their potassium intake.

3. How to take Amoksiklav

This medicine should always be taken according to the doctor's instructions. If in doubt, the patient should consult a doctor or pharmacist.

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

Usual dose:

• 1 tablet three times a day.

Children with a body weight of less than 40 kg

Children under 6 years of age should preferably receive Amoksiklav in the form of an oral suspension. Before taking Amoksiklav tablets in children with a body weight of less than 40 kg, the patient should consult a doctor or pharmacist.

Patients with kidney and liver diseases

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

How to take Amoksiklav

Tablets should be swallowed whole, with a glass of water, at the beginning of a meal or just before a meal. The patient should maintain equal, at least 4-hour, intervals between doses taken during the day. The patient should not take 2 doses within 1 hour. The patient should not take Amoksiklav for longer than 2 weeks. If the patient still feels unwell, they should contact their doctor again.

Taking a higher dose of Amoksiklav than recommended

If the patient has taken a higher dose of Amoksiklav than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. The patient should contact their doctor as soon as possible. The patient should have the carton of the medicine with them to show the doctor.

Missing a dose of Amoksiklav

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 soon, but wait about 4 hours before taking it.

Stopping treatment with Amoksiklav

The patient should take Amoksiklav until the end of the treatment, even if they feel better. All doses of the medicine are needed to combat the infection. If some bacteria survive, they may cause a relapse of the infection. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

Conditions to watch out for

Allergic reactions:

skin rash vascular inflammation, 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, under the arm or in the 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 patient experiences any of these symptoms, they should contact their doctor immediately. The patient should 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 enterocolitis syndrome (DIES)

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

If the patient experiences any of these symptoms, they should contact their doctor as soon as possible for

advice. Very common side effects(more than 1 in 10 people) diarrhea Common side effects(up to 1 in 10 people) thrush - fungal infection of the vagina, mouth (thrush) or skin folds nausea, especially when taking large doses of the medicine vomiting Uncommon side effects(up to 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 that may change into blisters and looks like small targets (dark spot in the center surrounded by a lighter border with a dark edge - erythema multiforme) → If the patient notices any of these symptoms, they should contact their doctor urgently.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 skin peeling (covering more than 30% of the body surface - toxic epidermal necrolysis [Lyell syndrome]) - extensive, red skin rash with small blisters filled with pus (bullous exfoliative dermatitis) - red, scaly rash with thickening under the skin and blisters (exfoliative dermatitis) - 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 scabs 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 patient experiences any of these symptoms, they should contact their doctor immediately.

liver inflammation yellowing of the skin due to increased bilirubin levels in the blood, which can cause yellowing of the skin and whites of the eyes interstitial nephritis prolonged blood clotting time hyperactivity seizures (in people taking high doses of Amoksiklav or with kidney disease) black hairy tongue development of an infection caused by an overgrowth of non-susceptible bacteria Side effects that may appear in blood or urine test results:significantly reduced number of white blood cells low number of red blood cells (hemolytic anemia) crystals in the urine

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, more information can be gathered on the safety of the medicine.

5. How to store Amoksiklav

The medicine should be stored out of sight and reach of children. Store in a temperature below 25 ° C. Protect from moisture. 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 month. 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 Amoksiklav contains

The active substances are amoxicillin and clavulanic acid. One film-coated tablet contains 500 mg of amoxicillin in the form of amoxicillin trihydrate and 125 mg of clavulanic acid in the form of potassium clavulanate. The other ingredients are: Tablet core:colloidal anhydrous silica, magnesium stearate (E 572), sodium carboxymethylcellulose (type A), microcrystalline cellulose. Tablet coating: hypromellose, ethylcellulose, cetyl alcohol, sodium lauryl sulfate, triethyl citrate, talc, titanium dioxide (E 171).

What Amoksiklav looks like and contents of the pack

White or yellowish, elongated, convex on both sides film-coated tablets with an imprint on one side (GG N6), approximately 10 mm x 21 mm in size. The tablets are packaged in aluminum blisters or soft blisters, placed in a cardboard box, containing 14 or 21 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria Manufacturer Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Lek Pharmaceuticals d.d. Perzonali 47 SI-2391 Prevalje, Slovenia For more detailed information on this medicine, the patient should contact the 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 (logo of the marketing authorization holder)

Date of last revision 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 possibility of bacteria developing resistance. An antibiotic prescribed by a doctor is intended solely for the treatment of the current illness. Paying attention to the following tips will help prevent the development of resistant bacteria that could hinder the effectiveness 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. The patient should read the instructions in the medicine information and if any of them are unclear, they should ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic if it was not prescribed specifically for them. They should only take it for the treatment of an 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 pass on antibiotics prescribed for them 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, which will accept them for proper disposal.