AMOXICILLIN/CLAVULANIC ACID Aurovitas Pharma 875 mg / 125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Aurovitas Pharma 875 mg/125 mg Film-Coated Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Amoxicillin/Clavulanic Acid Aurovitas Pharma is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic Acid Aurovitas Pharma
3. How to take Amoxicillin/Clavulanic Acid Aurovitas Pharma
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Aurovitas Pharma
6. Package Contents and Additional Information

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

Amoxicillin/Clavulanic Acid is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medications known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/Clavulanic Acid 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. What you need to know before taking Amoxicillin/Clavulanic Acid Aurovitas Pharma

Do not takeAmoxicillin/Clavulanic AcidAurovitas Pharma

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (listed in section 6),
• if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a mild skin rash or swelling of the face and throat,
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not takeAmoxicillin/Clavulanic Acid Aurovitas Pharma if any of the above applies to you.

If you are unsure, consult your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid Aurovitas Pharma if:

• you have glandular fever or swollen lymph nodes,
• you are being treated for kidney or liver problems,
• you do not urinate regularly,

If you are unsure whether any of the above applies to you, consult your doctor or pharmacist before taking this medication.

In some cases, your doctor may investigate the type of bacteria causing the infection. Based on the results, a different concentration of Amoxicillin/Clavulanic Acid or a different medication may be prescribed.

Situations that need to be monitored

Amoxicillin/Clavulanic Acid may cause existing conditions to worsen or cause severe side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid to reduce the risk of any problems. See "Situations that need to be monitored" in section 4.

Blood and urine tests

Inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid if you need to have blood tests (such as red blood cell tests or liver function tests) or urine tests (glucose tests). This is because Amoxicillin/Clavulanic Acid may affect the results of these tests.

Other medications and Amoxicillin/Clavulanic Acid Aurovitas Pharma

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medications.

If you are taking allopurinol (for gout) with Amoxicillin/Clavulanic Acid, there may be a higher risk of having an allergic skin reaction.

Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If you are taking medications to prevent blood clot formation (such as warfarin) along with Amoxicillin/Clavulanic Acid, additional blood tests may be necessary.

Methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicillin/Clavulanic Acid may affect how mycophenolate mofetil (a medication used to prevent organ transplant rejection) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

Amoxicillin/Clavulanic Acid may have side effects and symptoms that can impair your ability to drive or operate machinery.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Aurovitas Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free).

3. How to take Amoxicillin/Clavulanic Acid Aurovitas Pharma

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more:

The recommended dose is one tablet three times a day.

Children weighing less than 40 kg:

Children under 6 years of age should be treated orally, preferably with a suspension or sachets of amoxicillin/clavulanic acid.

Consult your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid tablets to children weighing less than 40 kg. Tablets are not suitable for children weighing less than 25 kg.

Patients with liver or kidney problems:

• The dose may be changed in case of kidney problems. Your doctor may prescribe a different concentration or medication.
• In case of liver problems, more frequent blood tests may be performed to check that the liver is functioning correctly.

How to take Amoxicillin/Clavulanic Acid Aurovitas Pharma:

• Take with meals.
• Swallow the tablets whole with the help of a glass of water.
• The tablets can be broken along the score line (groove) to make them easier to swallow. You should take both parts of the tablet at the same time.
• Space the doses evenly throughout the day, leaving at least 4 hours between each dose. Do not take 2 doses in 1 hour.
• Do not take Amoxicillin/Clavulanic Acid for more than 2 weeks. Consult your doctor if you still feel unwell.

If you take more Amoxicillin/Clavulanic Acid Aurovitas Pharma than you should

If you took more Amoxicillin/Clavulanic Acid Aurovitas Pharma than you should, you may experience stomach upset (feeling unwell or diarrhea) or seizures. Consult your doctor or pharmacist immediately or contact the Toxicology Information Service, phone 91-562.04.20. Do not forget to take the medication package or bottle with you.

If you forget to take Amoxicillin/Clavulanic Acid Aurovitas Pharma

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

Do not take a double dose to make up for missed doses.

If you stop taking Amoxicillin/Clavulanic Acid Aurovitas Pharma

You should take Amoxicillin/Clavulanic Acid until you complete the treatment, even if you feel better. Each dose is necessary to help fight the infection. If any bacteria survive, the infection may return.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. The following side effects may occur with this medication.

Symptoms to be aware of:

Allergic reactions:

• skin rash,
• inflammation of the veins (vasculitis) that can be seen as red or purple spots on the skin but can affect other parts of the body,
• fever, joint pain, swelling of the lymph nodes in the neck, armpits, or groin,
• inflammation, sometimes of the face or throat (angioedema), causing difficulty breathing,
• collapse,
• chest pain in the context of allergic reactions, which can be a symptom of an allergy-induced heart attack (Kounis syndrome).

• Consult a doctor immediatelyif you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid.

Inflammation of the large intestine:

Inflammation of the large intestine can cause watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• Consult a doctor immediatelyif you experience any of these symptoms.

Very common side effects:

May affect more than 1 in 10 patients

• diarrhea (in adults).

Common side effects:

May affect up to 1 in 10 patients

• thrush (candida - a fungal infection in the vagina, mouth, or skin folds),
• feeling unwell (nausea), especially when taking high doses,

• If affected, take Amoxicillin/Clavulanic Acid with meals

• vomiting
• diarrhea (in children).

Uncommon side effects:

May affect up to 1 in 100 patients

• skin rash, itching,
• raised skin rash with itching (hives or wheals),
• indigestion,
• dizziness,
• headache

Uncommon side effects that may appear in blood tests:

• increased levels of certain substances (enzymes) produced by the liver.

Rare side effects:

May affect up to 1 in 1,000 patients

• skin rash that can lead to blisters and looks like small targets (dark central spots surrounded by a paler area with a dark ring around the edge - erythema multiforme)

• Consult a doctor urgentlyif you experience any of these symptoms.

Rare side effects that may appear in blood tests:

• low number of blood cells responsible for blood clotting,
• low number of white blood cells.

Frequency not known:

Cannot be estimated from available data.

• allergic reactions (see above),
• crystals in the urine that cause acute kidney injury,
• 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 that causes widespread skin peeling (more than 30% of the body surface - toxic epidermal necrolysis),
  • red skin rash with small blisters containing pus (bullous exfoliative dermatitis),
  • scaly red skin rash with bumps under the skin and blisters (pustular exanthematous eruption),
  • flu-like symptoms with skin rash, fever, glandular swelling, and abnormal blood test results (such as increased white blood cell count and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms - DRESS).

• Blistering skin rash arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

Consult a doctor immediatelyif you experience any of these symptoms.

• inflammation of the liver (hepatitis),
• jaundice, caused by an increase in bilirubin (a substance produced by the liver) in the blood, which can cause the skin and the white part of the eyes to turn yellow,
• slower blood clotting,
• hyperactivity,
• seizures (in people taking high doses of amoxicillin/clavulanic acid or with kidney problems),
• black hairy tongue,

Side effects that may appear in blood tests:

• severe reduction in the number of white blood cells in the blood,
• low number of red blood cells in the blood (hemolytic anemia),

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Amoxicillin/Clavulanic Acid Aurovitas Pharma

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton, blister, and bottle label after EXP. The expiration date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin/Clavulanic AcidAurovitas Pharma

The active ingredients of Amoxicillin/Clavulanic Acid Aurovitas Pharma are amoxicillin trihydrate and potassium clavulanate.

One film-coated tablet contains 875 mg of amoxicillin and 125 mg of clavulanic acid.

The other components are:

Core

Microcrystalline cellulose (E460), anhydrous colloidal silica, magnesium stearate (E470b), sodium carboxymethyl starch (type A) (derived from potato starch).

Coating

Hypromellose (E464), macrogol 400, titanium dioxide (E171).

Appearance of the Product and Container Content

Film-coated tablets.

Amoxicillin/Clavulanic Acid Aurovitas Pharma 875 mg/125 mg film-coated tablets EFG are film-coated tablets, capsule-shaped, white in color, engraved with the letter “A” on one side and with a score line between the numbers “6” and “5” on the other.

The score line is intended to facilitate breaking and swallowing, but not to divide into equal doses.

Amoxicillin/Clavulanic Acid Aurovitas Pharma tablets are available in aluminum/aluminum (polyamide/aluminum/PVC-aluminum foil) blisters with 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21, 24, 25, 30, 35, 40, 50, 100, and 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This Medicinal Product is Authorized in the EEA Member States with the Following Names:

Germany Amoxi-Clavulan Aurobindo 875 mg/125 mg Filmtabletten

Austria Amoxicillin/Clavulansäure A-med 875 mg/125 mg Filmtabletten

Denmark Amoxicillin/Clavulansyre Aurobindo

Spain Amoxicillin/Clavulanic Acid Aurovitas Pharma 875 mg/125 mg film-coated tablets EFG

Netherlands Amoxicilline/Clavulaanzuur Aurobindo 875 mg/125 mg, filmomhulde tabletten

Italy Amoxicillina/Acido clavulanico Aurobindo 875 mg/125 mg compresse rivestite con film

Romania AMOXIPLUS 875mg / 125mg, comprimate filmate

Sweden Amoxicillin/Clavulanic acid Aurobindo 875 mg/125 mg filmdragerade tabletter

Date of the Last Revision of this Leaflet:April 2023

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es