AMOXICILLIN/CLAVULANIC ACID AUROVITAS 875 mg/125 mg FILM-COATED TABLETS

2. What you need to know before you take Amoxicillin/Clavulanic Acid Aurovitas

Do not take Amoxicillin/Clavulanic Acid Aurovitas:

• If you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medicine (listed in section 6).
• If you have ever had a severe allergic reaction to any other antibiotic. This could include a 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 take Amoxicillin/Clavulanic Acid Aurovitas if 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 take Amoxicillin/Clavulanic Acid Aurovitas if 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 formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Aurovitas can worsen existing conditions or cause severe side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of some symptoms while taking amoxicillin/clavulanic acid to reduce the risk of problems. See "Symptoms to be aware of" in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Aurovitas. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

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

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more frequent blood tests will be needed.

Methotrexate (a medicine 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 Aurovitas may affect how mycophenolate mofetil (a medicine used to prevent organ rejection after transplantation) works.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Aurovitas may cause side effects that can affect your ability to drive or use machines. Do not drive or operate machinery unless you are feeling well.

Amoxicillin/Clavulanic Acid Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid Aurovitas

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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 aged 6 years or less with the oral suspension of amoxicillin/clavulanic acid or with sachets.

Consult your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid Aurovitas tablets to children with a weight of less than 40 kg. The tablets are not suitable for children who weigh 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 formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Aurovitas

• Take with meals.
• Swallow the tablets whole with a glass of water. The tablets can be broken along the score line to make them easier to swallow. You should take both halves of the tablet at the same time.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Amoxicillin/Clavulanic Acid Aurovitas for more than 2 weeks. If you are still feeling unwell, you should go back to your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid Aurovitas, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Take the pack with you to show the doctor.

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

If you forget to take Amoxicillin/Clavulanic Acid 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 forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Aurovitas

Continue taking Amoxicillin/Clavulanic Acid Aurovitas until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If some bacteria survive, they can cause the infection to come back.

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

4. Possible side effects

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

Symptoms to be aware of

Allergic reactions:

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

→ Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Aurovitas.

Inflammation of the large intestine

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

Acute inflammation of the pancreas (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 medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

→ Contact your doctor as soon as possiblefor advice if you have these symptoms.

Very common:

May affect more than 1 in 10 people.

• Diarrhea (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, take amoxicillin/clavulanic acid with meals.
• Vomiting.
• Diarrhea (in children).

Uncommon:

May affect up to 1 in 100 people.

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

Uncommon side effects that may appear in your blood tests

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

Rare:

May affect up to 1 in 1,000 people.

• Skin rash that can form blisters. They look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme).

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

Rare side effects that may appear in your blood or urine tests

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

Frequency not known

Cannot be estimated from the available data.

• Allergic reactions (see above).

• Inflammation of the large intestine (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:

• Widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).
• Generalized red skin rash with small blisters containing pus (bullous exfoliative dermatitis).
• Red, scaly rash with bumps under the skin and blisters (pustular exanthematous eruption).
• Symptoms similar to flu with rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

→ Contact a doctor immediately if you have any of these symptoms.

• Inflammation of the liver (hepatitis).
• Jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow.
• Inflammation of the kidney ducts.
• Delayed blood clotting.
• Hyperactivity.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems).
• Black hairy tongue.

Side effects that may appear in your blood or urine tests:

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 medicine.

5. Storing Amoxicillin/Clavulanic Acid Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage temperature.

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

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin/Clavulanic Acid Aurovitas

• The active ingredients are amoxicillin trihydrate and potassium clavulanate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 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) (5 CP & 15 CP), macrogol 400, titanium dioxide (E171).

Appearance of the Product and Container Content

Amoxicillin/Clavulanic Acid Aurovitas 875 mg/125 mg are film-coated tablets, capsule-shaped, white in color, engraved with "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.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Or

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

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

Malta Amoxicillin/Clavulanic Acid Aurobindo 875 mg/125 mg film-coated tablets

Poland Amoxicillin+Clavulanic Acid Aurovitas

Portugal Amoxicillin + Clavulanic Acid Labesfal

Date of Last Revision of this Leaflet:October 2023

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