Amoxicillin + clavulanic acid aurovitas

Package leaflet: Information for the patient

Amoxicillin + Clavulanic Acid Aurovitas, 875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read carefully all the information in this leaflet before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific person (or child). Do not give it 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, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Amoxicillin + Clavulanic Acid Aurovitas is and what it is used for
2. Important information before taking Amoxicillin + Clavulanic Acid Aurovitas
3. How to take Amoxicillin + Clavulanic Acid Aurovitas
4. Possible side effects
5. How to store Amoxicillin + Clavulanic Acid Aurovitas
6. Contents of the pack and other information

1. What Amoxicillin + Clavulanic Acid Aurovitas is and what it is used for

Amoxicillin + Clavulanic Acid Aurovitas is an antibiotic that kills bacteria causing infections. It contains two different substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins," whose activity may sometimes be inhibited (inactivated). The role of the second component (clavulanic acid) is to prevent this inactivation.
Amoxicillin + Clavulanic Acid Aurovitas 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 Amoxicillin + Clavulanic Acid Aurovitas

When not to use Amoxicillin + Clavulanic Acid Aurovitas

• If the patient is allergic 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 to any other antibiotic. Symptoms may include skin rash or swelling of the face or throat.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) related to antibiotic use.

If any of the above applies to the patient, Amoxicillin + Clavulanic Acid Aurovitas should not be taken. If in doubt, consult your doctor or pharmacist before starting treatment with Amoxicillin + Clavulanic Acid Aurovitas.

Warnings and precautions

Before starting treatment with Amoxicillin + Clavulanic Acid Aurovitas, consult your doctor or pharmacist if:

• The patient has infectious mononucleosis;
• The patient is being treated for liver or kidney disease;
• The patient urinates irregularly.

If in doubt whether any of the above applies, consult your doctor or pharmacist before starting treatment with Amoxicillin + Clavulanic Acid Aurovitas.
In some cases, the doctor may determine which type of bacteria caused the infection. Depending on the results, the patient may receive Amoxicillin + Clavulanic Acid Aurovitas at a different dose or another medicine.

Symptoms to watch for

Treatment with Amoxicillin + Clavulanic Acid Aurovitas may worsen certain conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. Be alert for specific symptoms during treatment with Amoxicillin + Clavulanic Acid Aurovitas to reduce the risk of complications. See "Conditions to watch for" in section 4.

Blood and urine tests

If the patient is scheduled for blood tests (such as complete blood count or liver function tests) or urine tests (to measure glucose levels), inform the doctor or nurse that the patient is taking Amoxicillin + Clavulanic Acid Aurovitas. This medicine may affect the results of such tests.

Amoxicillin + Clavulanic Acid Aurovitas and other medicines

Inform your 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.

• If the patient is taking allopurinol (used for gout), the risk of skin allergic reactions may be increased.
• Probenecid (used in the treatment of gout): concomitant use may reduce the elimination of amoxicillin and is not recommended.
• If the patient is taking anticoagulant medicines (such as warfarin) at the same time as Amoxicillin + Clavulanic Acid Aurovitas, additional blood tests may be required.
• Methotrexate (used in the treatment of cancer and severe psoriasis): penicillins may reduce the elimination of methotrexate, increasing the risk of adverse effects.
• Amoxicillin + Clavulanic Acid Aurovitas may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Amoxicillin + Clavulanic Acid Aurovitas may cause side effects that impair the ability to drive or operate machinery. Do not drive or operate machinery unless the patient feels well.

Amoxicillin + Clavulanic Acid Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Amoxicillin + Clavulanic Acid Aurovitas

Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Recommended dosage:

Adults and children weighing 40 kg or more

• Standard dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

Children weighing less than 40 kg
Children up to 6 years of age should be treated with Amoxicillin + Clavulanic Acid Aurovitas in the form of powder for oral suspension.
Consult your doctor or pharmacist regarding administration of Amoxicillin + Clavulanic Acid Aurovitas tablets to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with kidney or liver disease

• If the patient has kidney disease, the dose may need to be adjusted. The doctor may choose a different dose of Amoxicillin + Clavulanic Acid Aurovitas or another medicine.
• If the patient has liver disease, blood tests may be performed more frequently to monitor liver function.

How to take Amoxicillin + Clavulanic Acid Aurovitas

• Take with food.
• Swallow the tablets whole with a glass of water. Tablets may be broken along the score line to make swallowing easier. Both parts of the tablet should be taken at the same time.
• Maintain at least a 4-hour interval between doses taken during the day. Do not administer two doses within one hour.
• Do not administer Amoxicillin + Clavulanic Acid Aurovitas for longer than 2 weeks. If the patient still does not feel better, contact the doctor again.

Taking more than the recommended dose of Amoxicillin + Clavulanic Acid Aurovitas

If the patient takes more Amoxicillin + Clavulanic Acid Aurovitas than prescribed, symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures. Contact a doctor as soon as possible. Keep the medicine packaging to show the doctor.

Missed dose of Amoxicillin + Clavulanic Acid Aurovitas

If a dose is missed, take it as soon as remembered. Do not take the next dose too early; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.

Stopping treatment with Amoxicillin + Clavulanic Acid Aurovitas

Continue taking Amoxicillin + Clavulanic Acid Aurovitas for the full duration of treatment, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, the infection may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Below is a list of adverse effects that may occur with this medicine.
Conditions to be aware of
Hypersensitivity reactions:

• skin rash;
• vasculitis, which may appear as red or purple raised spots on the skin, but may affect other parts of the body;
• fever, joint pain, swelling of lymph nodes in the neck, armpits or groin;
• swelling, sometimes affecting the face or areas around the mouth (angioedema), causing difficulty in breathing;
• collapse;
• chest pain related to an allergic reaction, which may be a symptom of an allergy leading to myocardial infarction (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice.
Discontinue use of Amoxicillin + Clavulanic Acid Aurovitas immediately.
Colitis
Colitis causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.
If any of these symptoms occur, contact your doctor as soon as possible
for advice.
Acute pancreatitis
If you have severe and persistent pain in the stomach 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.
Very common:
May affect more than 1 in 10 patients

• diarrhoea (in adults).

Common:
May affect up to 1 in 10 patients

• fungal infections (candidiasis – yeast infections of the vagina, mouth or skin folds);
• nausea, particularly when higher doses are taken – if nausea occurs, take Amoxicillin + Clavulanic Acid Aurovitas with food;
• vomiting;
• diarrhoea (in children).

Uncommon:
May affect up to 1 in 100 patients

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

Uncommon adverse effects that may be revealed in blood test results:

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

Rare:
May affect up to 1 in 1000 patients

• skin rash, which may include blisters and appear as target-like lesions (a dark spot in the centre surrounded by a lighter ring and a dark ring around the edge – erythema multiforme). If any of these symptoms are noticed, the patient should contact a doctor urgently.

Rare adverse effects that may appear in blood test results:

• low number of cells involved in blood clotting (thrombocytopenia);
• low number of white blood cells (leukopenia).

Frequency not known (frequency cannot be estimated from the available data):

• hypersensitivity reactions (see above);
• colitis (see above);
• crystals in urine leading to acute kidney injury;
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
• severe skin reactions:
  • widespread skin rash, which may include blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of body surface area – toxic epidermal necrolysis);
  • widespread red skin rash with small pus-filled blisters (bullous exfoliative dermatitis);
  • red scaly rash with subcutaneous nodules and blisters (acute generalized exanthematous pustulosis);
  • flu-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results (including increased white blood cell count (eosinophilia) and increased liver enzyme activity); drug reaction with eosinophilia and systemic symptoms (DRESS);
  • red rash typically observed on both buttocks, inner upper thighs, armpits and neck (symmetrical, drug-related, intertriginous and flexural eruption (SDRIFE));
  • blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis).

If any of these symptoms occur in a patient, seek immediate medical advice.

• hepatitis;
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes;
• inflammation of the kidney tubules;
• prolonged blood clotting time;
• hyperkinesia;
• seizures (in patients receiving high doses of Amoxicillin + Clavulanic Acid Aurovitas or with kidney disease);
• black hairy tongue.

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

• marked decrease in white blood cell count (leukopenia);
• low number of red blood cells (hemolytic anaemia).

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

5. How to store Amoxicillin + Clavulanic Acid Aurovitas

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the specified month.
There are no special requirements regarding the storage temperature of this medicine.
Store in the original packaging to protect from light and moisture.
Do not use this medicine if you notice any changes in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Amoxicillin + Clavulanic Acid Aurovitas contains

• The active substances are amoxicillin and clavulanic acid.

Each film-coated tablet contains 875 mg of amoxicillin (as amoxicillin trihydrate)
and 125 mg of clavulanic acid (as potassium clavulanate).

• Other ingredients:
  Core: Microcrystalline cellulose (E 460), colloidal anhydrous silica, magnesium stearate (E 470b), sodium carboxymethyl starch (type A).
  Coating: Opadry White 06B58855: hypromellose 5 cps, titanium dioxide (E 171), polyethylene glycol 400, hypromellose 15 cps.

What Amoxicillin + Clavulanic Acid Aurovitas looks like and contents of the pack
Film-coated tablets.
Amoxicillin + Clavulanic Acid Aurovitas 875 mg/125 mg is a white, capsule-shaped film-coated tablet,
imprinted with "A" on one side and a line between "6" and "5" on the other side. The line on the tablet is intended only to facilitate breaking for easier swallowing and does not allow division into equal doses.
Amoxicillin + Clavulanic Acid Aurovitas is available in blisters containing 10, 14, 15, 16, 20, 21, 24,
30 and 500 film-coated tablets, and in hospital packs containing 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warsaw
Poland

Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Amoxi-Clavulan PUREN 875 mg/125 mg Filmtabletten
Malta: Amoxicillin/Clavulanic acid Aurobindo 875 mg/125 mg film-coated tablets
Poland: Amoxicillin + Clavulanic Acid Aurovitas
Spain: AMOXICILINA/ACIDO CLAVULANICO AUROVITAS 875 mg/125 mg
COMPRIMIDOS RECUBIERTOS CON PELICULA EFG

Advice / Medical education

Antibiotics are used to treat infections caused by bacteria. They do not work against infections caused by viruses.
Sometimes bacterial infections do not respond to antibiotics. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means they can survive and even multiply despite antibiotic treatment.
Bacteria can become resistant to antibiotics for many reasons. Prudent use of antibiotics can help reduce the risk of bacteria becoming resistant.
When a doctor prescribes an antibiotic, it is intended to treat only the current illness. Paying attention to the following advice can help prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Read the instructions on the label carefully, and if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been prescribed specifically for you, and use it only to treat the infection for which it was prescribed.
3. Do not take antibiotics that have been prescribed for someone else, even if they had a similar infection.
4. Do not give antibiotics prescribed for a specific person to other people.
5. If any antibiotic remains after completing the prescribed course, return the unused portion to a pharmacy for proper disposal.