AMOXICILLIN/CLAVULANIC ACID AUROVITAS PHARMA 500 mg / 125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Aurovitas Pharma 500 mg/125 mg Film-Coated Tablets EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amoxicillin/Clavulanic Acid Aurovitas Pharma is and what it is used for
2. What you need to know before you take 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. Pack contents and further 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 medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" which 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 you take 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 ingredients of this medicine (listed in section 6),
• if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This can 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 medicine.

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

Situations that need to be monitored

Amoxicillin/Clavulanic Acid can cause existing conditions to worsen or cause severe side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be alert to 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 (such as glucose tests). This is because Amoxicillin/Clavulanic Acid can affect the results of these tests.

Other medicines and Amoxicillin/Clavulanic Acid Aurovitas Pharma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

If you are taking allopurinol (for gout) with Amoxicillin/Clavulanic Acid, there may be a higher risk of having 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 a medicine to prevent blood clots (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 how the medicine mycophenolate mofetil (used to prevent organ rejection after transplantation) works.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Amoxicillin/Clavulanic Acid may cause side effects that can affect your ability to drive or use machines.

Do not drive or use machines 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".

3. How to take Amoxicillin/Clavulanic Acid Aurovitas Pharma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

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 should be treated with oral 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. The 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 a different medicine.
• In case of liver problems, more frequent blood tests may be performed to check that the liver is working properly.

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 are still feeling unwell.

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

If you have taken more Amoxicillin/Clavulanic Acid Aurovitas Pharma than you should, you may feel stomach upset (feeling sick or diarrhea) or have seizures. Consult your doctor or pharmacist immediately or contact the Toxicology Information Service, telephone 91-562.04.20. Do not forget to take the packaging or container of the medicine with you.

If you forget to take Amoxicillin/Clavulanic Acid Aurovitas Pharma

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 Pharma

You should take Amoxicillin/Clavulanic Acid until you finish the treatment, even if you feel better. Each dose is necessary to help fight the infection. If any bacteria survive, the infection may 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 following side effects may occur with this medicine.

Symptoms to be aware of:

Allergic reactions:

• skin rash,
• inflammation of the veins (vasculitis) which 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,
• swelling, 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 have 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 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.

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

Very common side effects:

May affect more than 1 in 10 people

• diarrhea (in adults).

Common side effects:

May affect up to 1 in 10 people

• thrush (candida - a fungal infection in the vagina, mouth, or skin folds),
• feeling sick (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 people

• skin rash, itching,
• raised itchy rash (hives or urticaria),
• indigestion,
• dizziness,
• headache

Uncommon 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 people

• skin rash that can blister and looks like targets (dark spots in the center, surrounded by a paler area with a dark ring around the edge - erythema multiforme)

• Consult a doctor urgentlyif you have 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 the 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 of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes widespread peeling of the skin (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 psoriasis-like eruption).
  • flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

Consult a doctor immediatelyif you have any of these symptoms.

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 to 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. Storage of Amoxicillin/Clavulanic Acid Aurovitas Pharma

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, blister, and label of the bottle after EXP. The expiry date is the last day of the month stated.

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

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 AcidAurovitas Pharma

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

One 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 carboxymethyl starch (type A) (derived from potato starch).

Coating

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

Appearance and Container Content of the Product

Film-coated tablets.

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

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 under the following names:

Germany Amoxi-Clavulan Aurobindo 500 mg/125 mg Filmtabletten

Austria Amoxicillin/Clavulansäure A-med 500 mg/125 mg Filmtabletten

Denmark Amoxicillin/Clavulansyre Aurobindo

Spain Amoxicillin/Clavulanic Acid Aurovitas Pharma 500 mg/125 mg film-coated tablets EFG

Netherlands Amoxicilline/Clavulaanzuur Aurobindo 500 mg/125 mg, filmomhulde tabletten

Romania AMOXIPLUS 500mg / 125mg, comprimate filmate

Sweden Amoxicillin/Clavulanic acid Aurobindo 500 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