Package Leaflet: Information for the User

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

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have similar symptoms to yours, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Amoxicilina/Ácido clavulánico Aurovitasis an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Aurovitasis used in children and adults to treat the following infections:

• Middle ear and nasal sinus infections.
• Respiratory tract infections.
• Urinary tract infections.
• Skin and soft tissue infections, including dental infections.
• Bone and joint infections.

Do not takeAmoxicilina/Ácido clavulánico Aurovitas:

• 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 ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.
• If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

→Do not takeAmoxicilina/Ácido clavulánico Aurovitasif you are in any of the above situations.

Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAmoxicilina/Ácido clavulánico Aurovitasif you:

• Have infectious mononucleosis.
• Are receiving treatment for liver or kidney problems.
• Do not urinate regularly.

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed a different presentation of amoxicillin/clavulanic acid or another medication.

Be aware of the following symptoms

Amoxicilina/Ácido clavulánico Aurovitasmay worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of some symptoms while taking amoxicillin/clavulanic acid to reduce the risk of problems. See “Be aware of the following symptoms” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are takingAmoxicilina/Ácido clavulánico Aurovitas. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Other medications andAmoxicilina/Ácido clavulánico Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are taking allopurinol (used for gout) withamoxicillin/clavulanic acid, you may be more likely to suffer a skin allergic reaction.

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

If you are taking anticoagulants (such as warfarin) withamoxicillin/clavulanic acidyou will need more blood tests.

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

Amoxicillin/clavulanic acidmay affect how micophenolate mofetil (a medication used to prevent organ transplant rejection) works.

Pregnancy, breastfeeding, and fertility

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico Aurovitasmay cause side effects and symptoms that may incapacitate you from driving. Do not drive or operate machinery unless you are feeling well.

Amoxicilina/Ácido clavulánico Aurovitas contains sodium

This medication contains less than 1 mmol ofsodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and children weighing 40 kg or more

Usual dose - 1 tablet administered twice a day.

Higher dose - 1 tablet administered three times a day.

Children weighing less than 40 kg

It is preferable to treat children 6 years old or less with oral suspension of amoxicillin/clavulanic acid or with the sachets.

Consult your doctor or pharmacist when administeringAmoxicilina/Ácido clavulánico Aurovitas tablets to children with a weight less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different presentation or another medication.
• If you have liver problems, you will have more frequent blood tests to check how your liver is functioning.

How to takeAmoxicilina/Ácido clavulánico Aurovitas

• Take with meals.
• Swallow the tablets whole with a glass of water. The tablets can be broken along the notch to make them easier to swallow. You should take the two halves of the tablet at the same time.
• Space out your doses during the day, at least 4 hours apart. Do not take 2 doses in one hour.
• Do not takeAmoxicilina/Ácido clavulánico Aurovitasfor more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

If you take moreAmoxicilina/Ácido clavulánico Aurovitasthan you should

If you take too much Amoxicilina/Ácido clavulánico Aurovitas, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show to your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to takeAmoxicilina/Ácido clavulánico Aurovitas

If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon, wait at least 4 hours before taking the next dose. Do not take a double dose to make up for the missed doses.

If you interrupt the treatment withAmoxicilina/Ácido clavulánico Aurovitas

Continue taking Amoxicilina/Ácido clavulánico Aurovitas until you complete the treatment, even if you feel better. You need to take the full treatment to cure the infection. If any bacteria survive, it may cause the infection to come back.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects listed below may occur with this medicine.

Be aware of these symptoms

Allergic reactions:

• Skin rash.
• Inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body.
• Fever, joint pain, swollen lymph nodes in the neck, armpits, or groin.
• Swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing
• Shock,
• Chest pain in the context of allergic reactions, which can be a symptom of allergic-induced heart attack (Kounis syndrome).

→Contact your doctor immediatelyif you experience any of these symptoms.Stop takingAmoxicilina/Ácido clavulánico Aurovitas.

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have intense and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

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

→Contact your doctor as soon as possibleso they can advise you if you experience these symptoms.

Very common:

May affect more than 1 in 10 people.

• Diarhea (in adults).

Common:

May affect up to 1 in 10 people.

• Thrush (Candida– fungal infection of the vagina, mouth, or mucous membranes).
• Nausea, especially when taking high doses. If this happens to you, take amoxicillin/clavulanate with meals.
• Vomiting.
• Diarhea (in children).

Uncommon:

May affect up to 1 in 100 people.

• Skin rash, itching.
• Increased pruritic rash (urticaria).
• Indigestion.
• Dizziness.
• Headache.

Side effects that may appear in your blood tests

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

Rare:

May affect up to 1 in 1,000 people.

• Skin rash, which may form blisters. They appear as small, dark centers surrounded by a lighter area, with a dark ring around the edge (erythema multiforme).

→If you experience any of these symptoms, contact a doctor urgently.

Side effects that may appear in your blood tests

• Low count of cells involved in blood clotting.
• Low white blood cell count.

Frequency not known

Cannot be estimated from available data.

• Allergic reactions (see above).

• Colitis (see above).
• Crystals in the urine that cause acute kidney injury,
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Severe skin reactions:

• Generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of the body surface –toxic epidermal necrolysis).
• Red, scaly rash with small blisters containing pus (exfoliative bullous dermatitis).
• Red, scaly rash with bumps under the skin and blisters (pustular exanthema).
• Symptoms similar to the flu with rash, fever, swollen lymph nodes, abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)).
• Rashwith blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease).

→Contact a doctor immediately ifyou experience any of these symptoms.

• Liver inflammation (hepatitis).
• Icterus, caused by increased bilirubin in the blood (a substance produced by the liver) that can turn the skin and white of the eyes yellow.
• Inflammation of the kidney tubules.
• Delayed blood clotting.
• Hyperactivity.
• Seizures (in patients taking high doses of amoxicillin/clavulanate or with kidney problems).
• Black tongue that appears hairy.

Side effects that may appear in your blood or urine tests

• Significant reduction in the number of white blood cells.
• Low red blood cell count (hemolytic anemia).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the carton and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special temperature for conservation.

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

Do not use this medication if you notice any change in the appearance of the tablets.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAmoxicilina/Ácido clavulánico Aurovitas

• The active ingredients are amoxicilina trihydrate and potassium clavulanate.

Each film-coated tablet contains amoxicilina trihydrate equivalent to 875 mg of amoxicilina and potassium clavulanate equivalent to 125 mg of clavulanic acid.

• The other components are:

Core:carboxymethylcellulose (E460), colloidal anhydrous silica, magnesium stearate (E470b), sodium carboxymethylcellulose (type A) (from potato starch).

Coating:hypromellose (E464) (5 CP & 15 CP), macrogol 400, titanium dioxide (E171).

Appearance of the product and contents of the package

Amoxicilina/Ácido clavulánico Aurovitas 875 mg/125 mgare film-coated tablets, in capsule shape, white in color, engraved with “A” on one side and with a groove between the numbers “6” and “5” on the other. The groove serves to break and facilitate swallowing, but not to divide into equal doses.

It is available in blister packs with 10, 14, 15, 16, 20, 21,24,30 and 500 film-coated tablets and in clinical packs with 20 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

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 with the following names:

GermanyAmoxi-ClavulanPUREN875 mg/125 mgFilmtabletten

SpainAmoxicilina/Ácido clavulánico Aurovitas 875 mg/125 mg film-coated tablets EFG

MaltaAmoxicillin/Clavulanic acid Aurobindo875 mg/125 mgfilm-coated tablets

PolandAmoxicillin+Clavulanic Acid Aurovitas

PortugalAmoxicilina + Ácido Clavulânico Labesfal

Date of the last review of this leaflet:October 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)