Leaflet: information for the user

Amoxicillin/Clavulanic Acid Aurovitas Pharma 500 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms as you, 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.

1. What isAmoxicillin/Clavulanic AcidAurovitas Pharma and what it is used for

2. What you need to know before you start takingAmoxicillin/Clavulanic AcidAurovitas Pharma

3. How to takeAmoxicillin/Clavulanic AcidAurovitas Pharma

4. Possible side effects

5. Storage ofAmoxicillin/Clavulanic AcidAurovitas Pharma

6. Contents of the pack and additional informationl

Amoxicilina/Ácido clavulánico is an antibiotic that eliminatesbacteria 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 their effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from occurring.

Amoxicilina/Ácido clavulánico is used in adults and children 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 takeAmoxicillin/Clavulanic AcidAurovitas Pharma

• 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 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 problems with your liver or jaundice (yellow skin) when taking an antibiotic.

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

Consult your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid if you are unsure.

Warnings and precautions

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

• Lymph gland fever,
• Are being treated for kidney or liver problems,
• Do not urinate regularly,

Consult your doctor or pharmacist if you are unsure whether the above applies to you before taking this medicine.

In some cases, your doctor may investigate the type of bacteria causing the infection. Depending on the results, your doctor may prescribe a different concentration of Amoxicillin/Clavulanic Acid or a different medicine.

Monitoring situations

Amoxicillin/Clavulanic Acid may cause some existing situations to worsen or cause severe side effects. These include allergic reactions, convulsions and inflammation of the large intestine. Be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid to reduce the risk of any problems. See “Monitoring situations” 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). This is because Amoxicillin/Clavulanic Acid may affect the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Aurovitas Pharma

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

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

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

If you are taking any medicine to prevent blood clotting (such as warfarin) with Amoxicillin/Clavulanic Acid, additional blood tests may be necessary.

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 may affect the way micophenolate mofetil (a medicine 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 medicine.

Driving and operating machinery

Amoxicillin/Clavulanic Acid may cause side effects and symptoms that incapacitate driving.

Do not drive or operate machinery unless you are feeling well.

Amoxicillin/Clavulanic Acid Aurovitas Pharma contains sodium

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

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

Adults and children with40 kgor more weight:

The recommended dose is one tablet three times a day.

Children with less than40 kgweight:

Children 6 years or younger should be treated orally preferably with suspension or amoxicillin/clavulanate tablets.

Consult your doctor or pharmacist when administering amoxicillin/clavulanate tablets to children with less than40 kgweight. 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. The 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 takeAmoxicilina/Ácido clavulánico 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 to make them easier to swallow. You should take the two 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 one hour.
• Do not take amoxicillin/clavulanate for more than two weeks. Consult your doctor if you still feel unwell.

If you take moreAmoxicilina/Ácido clavulánico Aurovitas Pharmathan you should

If you tookmoreAmoxicilina/Ácido clavulánico Aurovitas Pharmathan you should, you may feel stomach discomfort (nausea or diarrhea) or convulsions. Consult your doctor or pharmacist immediately or the Toxicological Information Service, phone 91-562.04.20. Do not forget to bring the packaging or bottle of the medication.

If you forgot to takeAmoxicilina/Ácido clavulánico 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 4 hours before taking the next dose.

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withAmoxicilina/Ácido clavulánico Aurovitas Pharma

You should takeamoxicillin/clavulanateuntil you complete thetreatment, even if you feel better. Each dose is necessary to help fight the infection. If any bacteria survived the infection, it could come back.

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

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

Symptoms you should be aware of:

Allergic reactions:

• skin rash,
• inflammation of the veins (vasculitis) that may be seen as red or purple patches on the skin but can affect other parts of the body,
• fever, joint pain, inflammation 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 may be a symptom of an allergic-induced heart attack (Kounis syndrome).

• Consult a doctor immediatelyif you experience any of these symptoms. Discontinue treatment withAmoxicilina/Ácido clavulánico.

Colitis:

Colitis may cause 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 reported mainly 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 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

• yeast infections (candidiasis – a fungal infection of the vagina, mouth, or skin folds),
• unpleasant feeling (nausea), especially when taking high doses,

• TakeAmoxicilina/Ácido clavulánicowith meals if you are affected.

• vomiting,
• diarrhea (in children).

Uncommon side effects:

May affect up to 1 in 100 patients

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

Side effects that may appear in blood tests:

• increase in some substances (enzymes) produced by the liver.

Rare side effects:

May affect up to 1 in 1,000 patients

• skin rash that may blister and appear as small, dark spots (eritema multiforme)

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

Side effects that may appear in blood tests:

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

Unknown frequency:

Cannot be estimated from available data.

• allergic reactions (see above),
• colitis (see above),
• kidney stones caused by crystals in the urine that may cause acute kidney damage,
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• inflammation of the bile ducts (colangitis)
• severe skin reactions:
• • widespread rash with blisters and skin 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),
  • widespread red skin rash with small blisters containing pus (exfoliative dermatitis),
  • scaly red rash with bumps under the skin and blisters(pustular psoriasis).
  • flu-like symptoms with skin rash, fever, inflammation of glands, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

• rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease).

• Consult a doctor immediately if you experience any of these symptoms.

• inflammation of the liver (hepatitis),
• jaundice, caused by an increase in bilirubin in the blood that may cause the skin and white part of the eyes to turn yellow,
• inflammation of the renal tubules,
• slower blood clotting,
• hyperactivity,
• seizures (in people taking high doses of amoxicillin/clavulanate or with kidney problems),
• black tongue with a hairy appearance,

Side effects that may appear in blood tests:

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

Reporting of 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 medicationafter the expiration date that appears on the box, blister pack, and label of the bottle after CAD. The expiration date is the last day of the month indicated.

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

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

Composition ofAmoxicillin/Clavulanic AcidAurovitas Pharma

The active ingredients ofAmoxicillin/Clavulanic AcidAurovitas Pharmaare amoxicillin trihydrate and potassium clavulanate.

A film-coated tablet contains 500 mg of amoxicillin and 125 mg of clavulanic acid.

The other components are:

Core

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

Coating

Hydroxypropyl methylcellulose (E464), macrogol 400, titanium dioxide (E171).

Appearance of the product and contents of the pack

Film-coated tablets.

Amoxicillin/Clavulanic Acid Aurovitas Pharma 500 mg/125 mg film-coated tablets EFG are oval-shaped, white film-coated tablets, engraved with the letter “A” on one side and the number “64” on the other.

Amoxicillin/Clavulanic Acid Aurovitas Pharma tablets are available in aluminium/aluminium (polyamide/aluminium/PVC-laminated aluminium) 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.

Holder of the Marketing Authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicinal product is authorized in the Member States of the EEA, under the following names:

GermanyAmoxi-Clavulan Aurobindo 500 mg/125 mg Filmtabletten

AustriaAmoxicillin/Clavulansäure A-med 500 mg/125 mg Filmtabletten

DenmarkAmoxicillin/Clavulansyre Aurobindo

SpainAmoxicilina/Ácido Clavulánico Aurovitas Pharma 500 mg/125 mg film-coated tablets EFG

NetherlandsAmoxicilline/Clavulaanzuur Aurobindo 500 mg/125 mg, filmomhulde tabletten

RomaniaAMOXIPLUS 500mg / 125mg, comprimate filmate

SwedenAmoxicillin/Clavulanic acidAurobindo 500 mg/125 mg filmdragerade tabletter

Last update of this leaflet:April 2023

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