Amoxiclav

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Amoksiklav, (875 mg + 125 mg), film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Amoksiklav is and what it is used for
2. What you need to know 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 Amoksiklav is and what it is used for

Amoksiklav is an antibiotic that kills bacteria causing infections. It contains two different active substances: amoxicillin (in the form of amoxicillin trihydrate) and clavulanic acid (in the form of potassium clavulanate). 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 for the treatment of 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 using Amoksiklav

When not to use Amoksiklav:

• if the patient is allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6);

• if the patient has ever experienced a severe allergic reaction (hypersensitivity) to any other antibiotic; such a reaction may include 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, Amoksiklav must not be taken. If in doubt, consult a doctor or pharmacist before using Amoksiklav.

Warnings and precautions
Before using this medicine, discuss with a doctor or pharmacist if the patient:

• has infectious mononucleosis;
• is being treated for liver or kidney function disorders;
• does not urinate regularly.

If in doubt whether any of these statements apply, consult a doctor or pharmacist before using the medicine.
In some cases, the doctor may test which type of bacteria caused the infection. Depending on the test results, the patient may be prescribed a different strength of Amoksiklav or another medicine.

Conditions to be aware of
Taking Amoksiklav may worsen certain pre-existing conditions or cause serious side effects (such as allergic reactions, seizures, and colitis). To reduce the risk of any problems, pay attention to certain symptoms while taking Amoksiklav (see "Conditions to be aware of" in section 4).

Blood and urine tests
If the patient is due to have blood tests (e.g. red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Amoksiklav. The medicine may affect the results of such tests.

Amoksiklav with other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without prescription and herbal medicines.

If the patient takes allopurinol (used to treat gout) together with Amoksiklav, the risk of developing a skin allergic reaction increases.

If the patient is taking probenecid (used to treat gout), the doctor may decide to adjust the dose of Amoksiklav. Concurrent use of probenecid may reduce the elimination of amoxicillin and is not recommended.

If Amoksiklav is taken together with medicines that reduce blood clotting (such as warfarin), additional blood tests may be required.

Amoksiklav may affect the action of methotrexate (a medicine used in the treatment of cancer and severe psoriasis).

If the patient is receiving mycophenolate mofetil (a medicine used to prevent rejection of a transplanted organ), the doctor will closely monitor the patient's health during treatment with Amoksiklav.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Amoksiklav may cause side effects and symptoms that may impair the ability to drive or operate machinery. Do not drive or operate machinery unless the patient feels well.

Amoksiklav contains sodium and potassium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

The medicine contains less than 1 mmol (39 mg) of potassium per dose, meaning the medicine is considered "potassium-free".

3. How to use Amoksiklav

This medicine should always be used as directed by a doctor. If in doubt, consult a doctor or pharmacist.

Adults and children with body weight of 40 kg or more

• Usual dose: 1 tablet twice daily.
• Higher dose: 1 tablet three times daily.

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

Patients with kidney or liver disease

• For patients with impaired kidney function, the dose may be adjusted. The doctor may recommend a different strength or another medicine.
• Patients with impaired liver function may require more frequent blood tests to monitor liver function.

How to use Amoksiklav

• Swallow the tablets whole with a glass of water, at the beginning of a meal or immediately before a meal.
• Maintain regular intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not use Amoksiklav for longer than 2 weeks. If the patient still feels unwell, contact the doctor again.

Taking more Amoksiklav than recommended
If a patient takes more Amoksiklav than recommended, symptoms such as irritation of the stomach and intestines (nausea, vomiting, or diarrhoea) or seizures may occur. Contact a doctor as soon as possible. Take the medicine packaging along to show the doctor.

If a dose of Amoksiklav is missed
If a patient forgets to take a dose, they should take it as soon as they remember. Do not take the next dose too soon, but wait approximately 4 hours before taking it.

Stopping Amoksiklav treatment prematurely
Continue taking Amoksiklav for the full duration of the prescribed treatment, even if the patient feels better. All doses are needed to eliminate the infection. If some bacteria survive, they may cause the infection to return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Symptoms to be aware of
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, underarm, or groin
• swelling, sometimes of the face or oral cavity (angioedema), causing difficulty in breathing
• fainting
• chest pain associated with an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome)
• If any of these symptoms occur, contact a doctor immediately. You must stop taking Amoksiklav.

Inflammation of the large intestine
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, stomach pain and (or) fever.

Acute pancreatitis
If the patient experiences severe and persistent pain in the abdominal area, this may be a sign of acute pancreatitis.

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

• If any of these symptoms occur, seek medical advice as soon as possible.

Very common adverse reactions (occurring in more than 1 in 10 people)

• diarrhoea

Common adverse reactions (occurring in no more than 1 in 10 people)

• candidiasis – fungal infection of the vagina, mouth (thrush), or skin folds
• nausea, especially when high doses of the medicine are taken → If nausea occurs, Amoksiklav should be taken before meals.
• vomiting

Uncommon adverse reactions (occurring in no more than 1 in 100 people)

• skin rash, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness
• headache

Uncommon adverse reactions that may appear in blood test results:

• increased activity of certain substances (enzymes) produced in the liver

Rare adverse reactions (occurring in less than 1 in 1000 people)

• skin rash which may develop into blisters and resemble target-like lesions (dark spot in the centre surrounded by a lighter ring with a dark border at the edge – erythema multiforme).
• If the patient notices any of these symptoms, contact a doctor urgently.

Rare adverse reactions that may appear in blood test results:

• low number of platelets (cells involved in blood clotting)
• low number of white blood cells

Other adverse reactions
Other adverse reactions occurred in a very small number of people, but their exact frequency is unknown:

• allergic reactions (see above)
• inflammation of the large intestine (see above)
• severe skin reactions:
• widespread skin rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form causing extensive peeling of the skin (affecting more than 30% of body surface – toxic epidermal necrolysis [Lyell’s syndrome])
• widespread red rash with small pustule-filled blisters (bullous exfoliative dermatitis)
• red, scaly rash with subcutaneous nodules and blisters (pustular eruption)
• flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased number of white blood cells (eosinophilia) and increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS)
• crystals in urine leading to acute kidney injury
• blistering rash arranged in ring-like patterns with crusts in the centre or resembling a string of pearls (linear IgA dermatosis)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• If any of the above symptoms occur in the patient, contact a doctor immediately.
• liver inflammation
• jaundice due to increased blood levels of bilirubin (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
• interstitial nephritis
• prolonged blood clotting time
• motor restlessness
• seizures (in patients receiving high doses of Amoksiklav or with kidney disease)
• black hairy tongue
• development of infection caused by overgrowth of resistant bacteria

Adverse reactions that may appear in blood or urine test results:

• marked decrease in white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in urine

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Amoksiklav

• Keep this medicine out of sight and reach of children.
• Store 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 stated month.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Amoksiklav contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains: 875 mg amoxicillin as amoxicillin trihydrate and 125 mg clavulanic acid as potassium clavulanate.
• The other ingredients are: colloidal anhydrous silica, crospovidone type A, magnesium stearate, microcrystalline cellulose PH-112, talc, povidone K 25. Tablet coating: hypromellose 2910, ethylcellulose, cetyl alcohol, sodium lauryl sulfate, triethyl citrate, talc, titanium dioxide (E 171).

What Amoksiklav looks like and contents of the pack
White or almost white, oval, film-coated tablets, with a score line on both sides, approximately
22.5 mm in length and 10.5 mm in width, packed in Al/Al blisters placed in a cardboard box containing 14 tablets.
The score line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dose division.
For more detailed information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Romania, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Romania, country of export: 14523/2022/02
Parallel import authorisation number: 779/15
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 is that bacteria are resistant to the prescribed antibiotic.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics can help reduce the likelihood of bacterial resistance developing.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that could impair the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Please read the instructions provided in the package leaflet, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been specifically prescribed for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any leftover antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy, which will ensure its proper disposal.