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 may 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, while 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, as well as any 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), the risk 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), additional blood tests may be necessary. Amoksiklav may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis). If the patient is receiving mycophenolate mofetil (a medicine used to prevent the body from rejecting a transplanted organ), while taking Amoksiklav, the doctor will carefully monitor their health.

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.

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 or more

Usual dose: 1 tablet twice a day. Higher 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 more frequent blood tests 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 take the packaging 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, this medicine can cause side effects, although not everybody gets them.

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 any of these symptoms occur, the patient 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 any of these symptoms occur, the patient should contact their doctor as soon as possible.

Very common side effects(more than 1 in 10 people)
diarrhea
Common side effects(less than 1 in 10 people)
candidiasis - fungal infection of the vagina, mouth (thrush), or skin folds
nausea, especially when taking high doses of the medicine
→ If the patient experiences nausea, Amoksiklav should be taken before meals.
vomiting
Uncommon side effects(less than 1 in 100 people)
skin rash, itching
raised, itchy rash (hives)
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 peeling of the skin (covering more than 30% of the body surface - toxic epidermal necrolysis [Lyell's 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)
flu-like symptoms 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 patient experiences any of the above symptoms, they should contact their doctor immediately.

inflammation of the liver
jaundice due to an increase in bilirubin in the blood (a substance produced in the liver), which can cause yellowing of the skin and whites of the eyes
interstitial nephritis
prolonged blood clotting time
restlessness
seizures (in people taking high doses of Amoksiklav or with kidney disease)
black hairy tongue
development of an infection caused by excessive growth of non-susceptible bacteria
Side effects that may appear in blood or urine test results:
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 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 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: 875 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, crospovidone, magnesium stearate, microcrystalline cellulose, talc, povidone. Coating: hypromellose, ethylcellulose, cetyl alcohol, sodium lauryl sulfate, triethyl citrate, talc, titanium dioxide (E 171).

What Amoksiklav looks like and what the pack contains

White or cream-colored, oval, biconvex film-coated tablets with a length of about 22.5 mm and a width of 10.5 mm with a dividing line on both sides, in aluminum blisters placed in a cardboard box, containing 14 or 20 tablets. The dividing line on the tablet is only to facilitate breaking the tablet and does not divide it into equal doses.

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
To obtain more detailed information about 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 the bacteria are resistant to the administered antibiotic. This means that the bacteria can survive or multiply despite the use of the antibiotic. 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 only to treat 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 patient information leaflet and if any of them are unclear, they should ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that was not 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 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.