Amoksiklav

LEAFLET INCLUDED IN THE PACKAGING: PATIENT INFORMATION

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Amoksiklav

875 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic acid

You should carefully read the contents of this leaflet before taking this 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.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your 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 effect can sometimes be blocked (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 you, you should not take Amoksiklav.

Amoksiklav.If you are in doubt, consult your doctor or pharmacist before taking Amoksiklav.

Warnings and precautions

You should discuss this with your doctor or pharmacist before taking this medicine if you:

• suffer from infectious mononucleosis
• are being treated for liver or kidney disorders
• do not urinate regularly.

If you are in doubt whether any of these statements apply to you, consult your doctor or pharmacist before taking the medicine.
In some cases, your doctor may want to test which type of bacteria is causing the infection. Depending on the results of the test, you may be given 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 you are going to have a blood test (e.g., red blood cell test or liver function tests) or a urine test (for glucose), you should inform your doctor or nurse that you are taking Amoksiklav. The medicine may affect the results of these tests.

Amoksiklav and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as about the medicines you plan to take, including those that are available without a prescription and herbal medicines.
If you are taking allopurinol (used to treat gout) at the same time as Amoksiklav, the likelihood of a skin allergic reaction increases.
If you are taking probenecid (used to treat gout), your doctor may decide to adjust the dose of Amoksiklav. Taking probenecid at the same time may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines that reduce blood clotting (such as warfarin) at the same time as Amoksiklav, you may need to have additional blood tests.
Amoksiklav may affect the action of methotrexate (a medicine used to treat cancer and severe psoriasis).
If you are receiving mycophenolate mofetil (a medicine used to prevent organ rejection), your doctor will closely monitor your health while you are taking Amoksiklav.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoksiklav may cause side effects that can impair your ability to drive or operate machinery. You should not drive or operate machinery unless you 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 exactly as directed by your doctor. If you are in doubt, consult your 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, consult your doctor or pharmacist.

Patients with kidney and liver diseases

• For patients with kidney function disorders, the dose may be changed. Your doctor may prescribe a different strength or a different medicine.
• Patients with liver function disorders may need to have blood tests more frequently to monitor liver function.

How to take Amoksiklav

• Swallow the tablets whole with a glass of water, at the beginning of a meal or just before a meal.
• Keep equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Amoksiklav for more than 2 weeks. If you still feel unwell, consult your doctor again.

Taking a higher dose of Amoksiklav than recommended

If you have taken a higher dose of Amoksiklav than recommended, you may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible. Take the packaging of the medicine with you to show it to your doctor.

Missing a dose of Amoksiklav

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon, but wait about 4 hours before taking it.

Stopping treatment with Amoksiklav

You should take Amoksiklav until the end of the treatment, even if you 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 you have any further doubts about taking this medicine, consult your 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 can appear as red or purple raised spots on the skin, but can 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 can be a sign of an allergy leading to a heart attack (Kounis syndrome).

If you experience any of these symptoms, you should contact your doctor immediately. You should stop taking Amoksiklav.

Colitis

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

Acute pancreatitis

If you experience 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 taking 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 you experience any of these symptoms, you should contact your doctor immediately

for advice.
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 you experience nausea, take Amoksiklav 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, which can 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 you notice any of these symptoms, you should contact your 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:
• 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)
• 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 you experience any of the above symptoms, you should contact your 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 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 you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301 Fax: +48 22 49 21 309 website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoksiklav

• The medicine should be stored out of the 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. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
• Translation of some information on the immediate packaging: LOT/MNF/EXP - batch number/production date/expiry date

1. Contents of the pack 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. The other ingredients are: colloidal anhydrous silica, crospovidone type A, magnesium stearate, microcrystalline cellulose PH-112, talc, povidone K 25 Coating: hypromellose 2910, 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 almost white, elongated, film-coated tablets with beveled edges, with a notch and the marking 875/125 on one side and the marking AMC on the other side, in Al/Al blisters.
The pack contains 14 film-coated tablets.
For more detailed information, please 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:

Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana
Slovenia
Lek Pharmaceuticals d.d.
Perzonali 47
SI-2391 Prevalje
Slovenia

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
IVA Pharm Sp. z o.o.
ul. Drawska 14/1
02-202 Warszawa
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export: 14523/2022/01
Parallel import authorization number: 45/21

Date of leaflet approval: 05.01.2024

[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 your 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 right number of days. Read the instructions in the patient information leaflet and if you do not understand any of them, ask your doctor or pharmacist to explain.
• 2. You should not take an antibiotic that has not been prescribed specifically for you. You should only take it to treat the infection for which the antibiotic was prescribed.
• 3. You should not take an antibiotic that was prescribed for another person, even if they had a similar infection.
• 4. Do not give antibiotics prescribed for you to other people.
• 5. If you have any leftover antibiotic after completing the treatment as directed by your doctor, return it to the pharmacy, which will accept it for proper disposal.