Leaflet: information for the user

Amoxicilina/Ácido clavulánico Aurovitas 875 mg/125 mg powder for oral suspension in EFG sachets

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it 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, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

Amoxicilina/ácido clavulánico Aurovitas is 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 is used in adults and children to treat the following infections:

• Middle ear infections 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 (hypersensitive) to amoxicillin, to clavulanic acid, to penicillins or to any of the other components of this medicine (listed in section 6),
• if you have ever had a severe allergic reaction (hypersensitivity) 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 take amoxicilina/ácido clavulánico if you are included in any of the above points.

Before starting treatment withamoxicilina/ácido clavulánico, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consultyour doctor or pharmacist before starting to take amoxicilina/ácido clavulánico if:

• you have infectious mononucleosis,
• you are receiving treatment for liver or kidney problems,
• you do not urinate regularly.

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking amoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of amoxicilina/ácido clavulánico or another medicine.

Symptoms to be aware of

Amoxicilina/ácido clavulánico may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions and inflammation of the large intestine. You should be aware of certain symptoms while taking amoxicilina/ácido clavulánico to reduce the risk of problems. See “Symptoms to be aware of”in section4.

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 taking amoxicilina/ácido clavulánico. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Other medicines and Amoxicilina/Ácido clavulánico Aurovitas

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

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

If you are taking probenecid (used to treat gout), the concurrent use of probenecid may reduce the excretion of amoxicilina and is not recommended.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be required.

Amoxicilina/ácido clavulánico may affect the action of methotrexate (a medicine used to treat cancer and rheumatic diseases).

Amoxicilina/ácido clavulánico may affect the way micofenolato de mofetilo (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, lactation and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

Amoxicilina/ácido clavulánico may have side effects and symptoms may make you unable to drive. Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Aurovitas contains aspartamo and maltodextrin

This medicine contains 22.5 mg of aspartamo (E951) in each sachet. Aspartamo contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medicine contains maltodextrin (glucose). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

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

Adults and children weighing 40 kg or more

• Usual dose: 1 tablet twice a day.
• Higher dose: 1 tablet three times a day.

Children weighing less than 40 kg

Consult your doctor or pharmacist when administering amoxicillin/clavulanate 875 mg/125 mg oral suspension in sachets to children weighing less than 40 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 take Amoxicillin/Clavulanate Aurovitas

• Just before taking amoxicillin/clavulanate, open the sachet and mix the contents in half a glass of water.
• Take it at the beginning of meals or a little earlier.
• Space out the doses during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take amoxicillin/clavulanate for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanate Aurovitas than you should

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

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

If you forget to take Amoxicillin/Clavulanate 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 withAmoxicillin/Clavulanate Aurovitas

Continue taking amoxicillin/clavulanate until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to have the infection again.

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 following side effects may occur with this medicine.

Symptoms to be aware of:

Allergic reactions:

• Skin rash.
• Swelling 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.
• Collapsing.
• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).

→Contact your doctor immediately if you experience any of these symptoms.Stop taking amoxicillin/clavulanic acid.

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 abdominal area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported in children taking 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 possible for advice, if you experience 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– fungal infection of the vagina, mouth, or mucous membranes).
• Discomfort (nausea), especially when taking high doses.

→ If you experience this, take amoxicillin/clavulanic acid with meals:

• Vomiting.
• Diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 patients):

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

Side effects that may appear in your 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 may form blisters that look like small darts (erythema multiforme).

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

Side effects that may appear in your blood tests:

• Significant reduction in the number of white blood cells.
• Low red blood cell count (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 medication after the expiration date that appears on the package and the box after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid Aurovitas

• The active ingredients are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

• The other components (excipients) are: Crospovidone (Type-A), magnesium stearate, silicon dioxide, and aspartame (E 951).

Composition of strawberry-guarana flavor: maltodextrin from corn, propylene glycol (E1520), flavoring substances, triethyl citrate (E1505), flavoring preparations.

Composition of lemon flavor: natural flavoring substances, flavoring preparations, flavoring substances, maltodextrin from corn, alpha-tocopherol (E307).

Composition of peach flavor: maltodextrin from corn, triacetin (E1518), flavoring substances, flavoring preparations, natural flavoring substances. .

• See section 2 for more important information about any of the components of this medicine.

Appearance of the product and contents of the package

Oral suspension powder in sachets.

White to pale yellow powder.

Amoxicillin/Clavulanic Acid Aurovitas 875 mg/125 mg oral suspension powder is available in sachets.

Package sizes: 8, 12, 20, or 30 sachets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer responsible:

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, Lisboa

Portugal

O

Arrow Génériques

26 Avenue Tony Garnier,

Lyon, Rhone 69007,

France

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Amoxicillin/Clavulanic Acid Aurovitas 875 mg/125 mg oral suspension powder in sachets EFG

France: AMOXICILLINE/ACIDE CLAVULANIQUE ARROW LAB 1 g/125 mg, powder for oral suspension in sachet-dose (amoxicillin/clavulanic acid ratio: 8/1)

Italy: Amoxicillin/Acid Clavulanic Aurobindo Pharma Italia

Malta: Amoxicillin/clavulanic acid Aurobindo 875 mg/125 mg powder for oral suspension in sachet

Last review date of this leaflet:

August 2023

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

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Instructions for reconstitution

Empty the contents of the sachet into a medium-sized glass of water, shake until a suspension is obtained, and take immediately.