Amoxicillin + Clavulanic Acid Aurovitas

Leaflet accompanying the packaging: patient information

Amoxicillin + Clavulanic Acid Aurovitas, 875 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic Acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person (or child). 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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Amoxicillin + Clavulanic Acid Aurovitas and what is it 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 packaging and other information

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

Amoxicillin + Clavulanic Acid Aurovitas is an antibiotic that works by killing bacteria that cause infections. It contains two different substances: amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called "penicillins", whose action can sometimes be hindered (inactivated). The task of the second component (clavulanic acid) is to counteract 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 take 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 a skin rash or swelling of the face or throat.
• If the patient has ever had liver problems or jaundice (yellowing of the skin) associated with taking an antibiotic.

If the above applies to the patient, they should not take Amoxicillin + Clavulanic Acid Aurovitas.

Amoxicillin + Clavulanic Acid Aurovitas.In case of doubt, before starting treatment with Amoxicillin + Clavulanic Acid Aurovitas, consult a doctor or pharmacist.

Warnings and precautions

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

• the patient has infectious mononucleosis;
• they are being treated for liver or kidney disease;
• they have irregular urination.

In case of doubt whether the above applies to the patient, consult a doctor or pharmacist before starting treatment with Amoxicillin + Clavulanic Acid Aurovitas.
In some cases, the doctor may check what type of bacteria caused the infection in the patient.
Depending on the results, the patient may receive Amoxicillin + Clavulanic Acid Aurovitas in a different dose or a different medicine.

Symptoms to watch out for

Taking Amoxicillin + Clavulanic Acid Aurovitas may worsen the course of some diseases or cause severe side effects. These include allergic reactions, seizures, and colitis. Pay attention to whether any of these symptoms occur during treatment with Amoxicillin + Clavulanic Acid Aurovitas, in order to minimize the risk of any problems. See "Conditions to watch out for"
in section 4.

Blood and urine tests

If the patient is to have blood tests (such as blood count or liver function tests) or urine tests (to determine glucose levels), they should inform their doctor or nurse that they are taking Amoxicillin + Clavulanic Acid Aurovitas. Amoxicillin + Clavulanic Acid Aurovitas may affect the results of these tests.

Amoxicillin + Clavulanic Acid Aurovitas and other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take.
If the patient is taking allopurinol (used in gout) at the same time as Amoxicillin + Clavulanic Acid Aurovitas, they may be more likely to experience skin allergic reactions.
Probenecid (used in gout treatment), concurrent use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Amoxicillin + Clavulanic Acid Aurovitas, they may need to have additional blood tests.
Methotrexate (used in cancer and severe psoriasis treatment), penicillins may reduce the excretion of methotrexate, potentially leading to increased side effects.
Amoxicillin + Clavulanic Acid Aurovitas may affect the action of mycophenolate mofetil (a medicine used to prevent organ rejection).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.
Consult a doctor or pharmacist before taking any medicine.

Driving and using machines

Amoxicillin + Clavulanic Acid Aurovitas may cause side effects and symptoms that can 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, which is essentially sodium-free.

3. How to take Amoxicillin + Clavulanic Acid Aurovitas

This medicine should always be taken as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
Recommended dosage:

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

• Basic 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 be treated with Amoxicillin + Clavulanic Acid Aurovitas in the form of a powder for suspension.
Consult a doctor or pharmacist for advice on administering Amoxicillin + Clavulanic Acid Aurovitas tablets to children with a body weight of less than 40 kg. Tablets are not suitable for children with a body weight below 25 kg.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Amoxicillin + Clavulanic Acid Aurovitas or a different medicine.
• If the patient has liver disease, they may need to have blood tests more frequently to check how their liver is functioning.

How to take Amoxicillin + Clavulanic Acid Aurovitas

• Take with food.
• Swallow the tablets whole with a glass of water. The tablets can be broken in half to make them easier to swallow. Take both halves of the tablet at the same time.
• Maintain at least 4-hour intervals between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Amoxicillin + Clavulanic Acid Aurovitas for more than 2 weeks. If the patient still does not feel well, they should consult their doctor again.

Taking a higher dose of Amoxicillin + Clavulanic Acid Aurovitas than recommended

If the patient has taken a higher dose of Amoxicillin + Clavulanic Acid Aurovitas than recommended, symptoms may include stomach and intestinal irritation (nausea, vomiting, or diarrhea) or seizures.
Consult a doctor as soon as possible. Have the medicine packaging with you to show the doctor.

Missing a dose of Amoxicillin + Clavulanic Acid Aurovitas

If the patient has missed a dose, they should take it as soon as they remember.
Do not take the next dose too early, wait about 4 hours before taking the next dose. Do not take a double dose to make up for the missed dose.

Stopping treatment with Amoxicillin + Clavulanic Acid Aurovitas

Continue taking Amoxicillin + Clavulanic Acid Aurovitas until the end of the treatment, even if the patient feels better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause a recurrence of the infection.
In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with this medicine.

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 including the face or mouth area (angioedema), causing difficulty breathing;
• anaphylaxis;
• chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).

If any of these symptoms occur, consult a doctor immediately.

Stop taking Amoxicillin + Clavulanic Acid Aurovitas.

Colitis

Colitis, causing watery diarrhea usually with blood and mucus, abdominal pain, and (or) fever.
If any of these symptoms occur, consult a doctor as soon as possible
for advice.

Acute pancreatitis

If you have 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 abdominal pain, lethargy, diarrhea, and low blood pressure.

Very common:

May occur in more than 1 in 10 patients

• diarrhea (in adults).

Common:

May occur in up to 1 in 10 patients

• thrush (candidiasis - fungal infections of the vagina, mouth, or skin folds);
• nausea, especially when taking high doses - if they occur, take Amoxicillin + Clavulanic Acid Aurovitas with food;
• vomiting;
• diarrhea (in children).

Uncommon:

May occur in up to 1 in 100 patients

• 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:

May occur in up to 1 in 1000 patients

• skin rash, which can occur with blisters and look like small targets (dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme). If the patient notices any of these symptoms, they should contact a 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.

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

• allergic reactions (see above);
• colitis (see above);
• crystals in the urine leading to acute kidney damage;
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
• severe skin reactions:
• generalized skin rash, within which blisters and skin peeling may occur, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis);
• generalized, red skin rash, within which small pus-filled blisters may occur (pustular exfoliative dermatitis);
• red, scaly rash with thickening under the skin and blisters (acute generalized exanthematous pustulosis);
• 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);
• rash with blisters arranged in a ring or like a string of pearls (linear IgA dermatosis).

If the patient experiences any of these symptoms, they should contact a doctor immediately.

• hepatitis;
• jaundice, caused by an increase in bilirubin (a substance produced in the liver) in the blood, which can cause yellowing of the skin and whites of the eyes;
• inflammation of the renal tubules;
• prolonged blood clotting;
• restlessness;
• seizures (in people taking high doses of Amoxicillin + Clavulanic Acid Aurovitas or with kidney disease);
• black hairy tongue, which looks like it is hairy.

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

• significantly reduced number of white blood cells;
• low number of red blood cells (hemolytic anemia).

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Amoxicillin + Clavulanic Acid Aurovitas

Keep the medicine out of 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 month.
There are no special storage instructions for 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 should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Amoxicillin + Clavulanic Acid Aurovitas contains

• The active substances of the medicine 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), anhydrous colloidal silica, magnesium stearate (E 470b), sodium carboxymethylcellulose (type A).
Coating:
Opadry White 06B58855: hypromellose 5 cps, titanium dioxide (E 171), macrogol 400, hypromellose 15 cps

What Amoxicillin + Clavulanic Acid Aurovitas looks like and what the pack contains

Film-coated tablets.
Amoxicillin + Clavulanic Acid Aurovitas 875mg/125mg is a white, film-coated tablet in the shape of a capsule, with "A" embossed on one side and a line between "6" and "5" on the other side. The line on the tablet is only to facilitate breaking it, for easier swallowing, and not for dividing into equal doses.
Amoxicillin + Clavulanic Acid Aurovitas is available in blisters of 10, 14, 15, 16, 20, 21, 24, 30, and 500 film-coated tablets, as well as in a clinical package of 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

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 authorized in the Member States of the European Economic Area 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
Portugal
Amoxicilina + Ácido Clavulânico Labesfal
Spain
AMOXICILINA/ACIDO CLAVULANICO AUROVITAS 875 mg/125 mg
COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
Date of last revision of the leaflet:24.08.2023

Advice / medical education

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

• 1. It is very important to take the antibiotic in the correct dose, at the correct time, and for the correct number of days. Read the instructions on the label, and if something is unclear, ask a doctor or pharmacist to explain.
• 2. Do not take an antibiotic unless it has been prescribed specifically for you, and only use it to treat the infection for which it was prescribed.
• 3. Do not take antibiotics that have been prescribed for other people, even if they had a similar infection.
• 4. Do not give antibiotics prescribed for you to other people.
• 5. If you have completed the course as directed by your doctor and have any leftover antibiotic, take the remaining amount to a pharmacy for proper disposal.