Amoksiklav

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Amoksiklav

(875 mg + 125 mg), film-coated tablets
Amoxicillin + Clavulanic acid

Before taking the medicine, the patient should carefully read the contents of the leaflet, as it contains important information for the patient.

• The patient should keep this leaflet, so that they can read it again if necessary.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 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.In case of 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.

In case of doubt as to whether any of these statements apply to the patient, they should consult their 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) 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. Concurrent use of probenecid 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).
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 operating 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 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 as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

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

• Usual dose: 1 tablet twice a day.
• Larger 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 their 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.
• Amoksiklav should not be taken for longer than 2 weeks. If the patient still feels unwell, they should consult 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 Amoksiklav treatment

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 recurrence of the infection.
In case of any further doubts related to the use of this medicine, the patient should consult their 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, whose leading symptom 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 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 large doses of the medicine, → In case of nausea, Amoksiklav should be taken 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 look 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 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 skin peeling (affecting more than 30% of the body surface - toxic epidermal necrolysis [Lyell 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),
• kidney stones 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.

• hepatitis,
• jaundice 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,
• 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 insensitive 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 side effects occur, including any not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug 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
By reporting side effects, more information can be collected 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 stated.
• 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 Amoksiklav contains

• The active substances are amoxicillin and clavulanic acid. One tablet contains: 875 mg of amoxicillin in the form of amoxicillin trihydrate and 125 mg of clavulanic acid in the form of potassium clavulanate.
• Other ingredients are: colloidal anhydrous silica, crospovidone, magnesium stearate, microcrystalline cellulose, talc, povidone. Tablet coating: hypromellose, ethyl cellulose, 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 Al/Al 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 not to divide it into equal doses.
For more detailed information, the patient should contact the marketing authorization holder or 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
6250 Kundl
Austria

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Authorization number in Romania, the country of export:
14523/2022/01
14523/2022/02

Parallel import authorization number: 694/15

Date of leaflet approval: 27.12.2023

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 solely for the treatment of the current illness. Paying attention to the following tips will help prevent the development of resistant bacteria that could inhibit 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. 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, after completing the treatment as directed by the doctor, there are any remaining antibiotics, the patient should return them to the pharmacy, which will accept them for proper disposal.

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