Amoksiklav

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Amoksiklav (Amoksiklav 2x 1000 mg), (875 mg + 125 mg), film-coated tablets

Amoxicillin + Clavulanic acid
Amoksiklav and Amoksiklav 2x 1000 mg are different trade names for the same medicine.

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 specifically. 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 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 pack 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 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 any of the above situations apply to the patient, they should not take Amoksiklav.In case of doubts 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.

In case of doubts, whether any of these statements apply to the patient, before taking the medicine, they should consult a doctor or pharmacist.
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., 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 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.
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 or rheumatic diseases).
If the patient is receiving mycophenolate mofetil (a medicine used to prevent organ rejection), while taking Amoksiklav, the doctor will closely 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 their 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, which means that 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 recommendations. In case of doubts, 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 in 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.
• Equal, at least 4-hour, intervals should be maintained between doses administered during the day. Do not take 2 doses within 1 hour.
• Do not take Amoksiklav for more 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. They should take the medicine packaging 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. They 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.
To combat the infection, all doses of the medicine are needed. If some bacteria survive, they may cause a relapse of the infection.
In case of any further doubts related to the use of this medicine, the patient 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
• 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.
• 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.

• If the patient experiences any of these symptoms, they should consult 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 - a fungal infection of the vagina, mouth (thrush), or skin folds;
• nausea, especially when taking high doses of the medicine; → If the patient experiences nausea, they should take Amoksiklav before eating.
• 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, which 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 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:
• widespread skin rash with blisters and peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form, causing widespread peeling of the skin (covering more than 30% of the body surface - toxic epidermal necrolysis [Lyell's syndrome])
• widespread, red skin rash with small blisters filled with pus (bullous exfoliative dermatitis)
• red, scaly rash with thickening under the skin and blisters (pustular psoriasis)
• 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) aseptic meningitis.
• If the patient experiences any of the above symptoms, they should contact their doctor immediately.
• hepatitis
• jaundice due to increased bilirubin levels in the blood, which can cause yellowing of the skin and 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 an overgrowth of non-susceptible bacteria.

Side effects that may appear in blood 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 side effects not listed in the 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.
Reporting side effects can help gather more information 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, in the original packaging.
• Do not use this medicine after the expiry date stated on the packaging. 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: colloidal silica anhydrous, crospovidone, magnesium stearate, microcrystalline cellulose, talc, povidone. Tablet 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 tablets.
The dividing line on the tablet is only to facilitate breaking the tablet and does not divide it into equal doses.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Romania, the country of export:

Lek Pharmaceuticals d.d.
Verovškova 57
1526, Ljubljana, Slovenia

Manufacturer:

Sandoz GmbH
Biochemiestraße 10, Kundl, 6250, Austria

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

Prodlekpol Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Authorization number in Romania, the country of export:6354/2006/02
Parallel import authorization number:779/15
Date of leaflet approval: 11.01.2023
[Information about the trademark]

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.
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 action of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the correct 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 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 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.