Patient Information Leaflet

Amoxicilina/Ácido clavulánico Stada 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Amoxicilina/Ácido clavulánico Stada and what is it used for

2.What you need to know before you start taking Amoxicilina/Ácido clavulánico Stada

3.How to take Amoxicilina/Ácido clavulánico Stada

4.Possible side effects

5.Storage of Amoxicilina/Ácido clavulánico Stada

6.Contents of the pack and additional information

Amoxicilina/Ácido clavulánico Stada 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 and nasal sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections

Do not take Amoxicilina/Ácido clavulánico Stada:

•if you are allergic to amoxicilina, ácido clavulánico, penicilins, or any of the other components of this medication (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 neck

•if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not takeAmoxicilina/Ácido clavulánico Stadaif you fall under any of the above points.Before starting treatment with amoxicilina/ácido clavulánico, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Inform your doctor or pharmacist before taking this medication 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 this medication.

In some cases, your doctor may investigate the type of bacteria causing your infection.

Depending on the results, your doctor may prescribe a different presentation of amoxicilina/ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/ácido clavulánico may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking this medication 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 studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking this medication. This is becausethis medicationmay alter the results of these types of tests.

Use ofAmoxicilina/Ácido clavulánico Stadawith other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those acquired without a prescription and herbal medications.

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 for gout), your doctor may adjust the dose of amoxicilina/ácido clavulánico.

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

This medication may affect the action of methotrexate (a medication used to treat cancer or rheumatic diseases).

This medicationmay affect the action of micofenolato de mofetilo (a medication used to prevent organ transplant rejection).

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.

Driving and operating machinery

Amoxicilina/ácido clavulánico may cause side effects and symptoms that may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Stada contains sodium

This medication contains less than 1 mmol of sodium (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.

Adults and children 40 kg or more

The recommended dose is:

•1 tablet three times a day.

Children under 40 kg

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

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets 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 working.

How to take Amoxicilina/Ácido clavulánico Stada

•Swallow the tablets whole with a glass of water at the beginning of meals or a little before.

•Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.

•Do not take amoxicillin/clavulanic acid for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take moreAmoxicilina/Ácido clavulánico Stadathan you should

If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures.

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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Amoxicilina/Ácido clavulánico Stada

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.

If you stop taking Amoxicilina/Ácido clavulánico Stada

Continue taking amoxicillin/clavulanic acid 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 questions 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.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but canaffect other parts of the body
• fever, joint pain, lymphadenopathy, axillary or inguinal lymphadenopathy
• swelling, sometimes of the face or mouth (angioedema), whichcauses difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of allergic-induced myocardial infarction (Kounis syndrome).

?Contact your doctorimmediatelyif you experience any ofthese symptoms.Stop taking this medicine.

Colitis

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

Acute pancreatitis

If you have had severe and persistent pain in the abdominal area, it may be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children taking amoxicillin. It isa 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 doctoras soon as possibleto advise you, if you have 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– fungal infection of the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

→if this happens, take amoxicillin/clavulanic acidbefore meals

• vomiting
• diarrhea (in children).

Rare side effectsfrequent(may affect 1 in 100 people)

• skin rash, itching
• increased pruritic rash (urticariah)
• indigestion
• dizziness
• headache.

Side effects that may appear in your 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, which may form blisters that appear as small dianas (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)

?If you have any of these symptoms, see a doctor urgently.

Side effectsthat may appear in your blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency isnot known (cannot be estimated from available data):

• Allergic reactions (see above)
• Colitis (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• Rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease)
• Severe skin reactions:

• generalized 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 rash with small blisters with pus (exfoliative bullous dermatitis)
• red exfoliative rash, with bumps under the skin and urticaria (exanthematous pustulosis).
• • flu-like symptoms with skin rash, fever, lymphadenopathy, and abnormal blood test results (such as eosinophilia and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

?Contact your doctor immediately if you have any of these symptoms.

• inflammation of the liver (hepatitis)

• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that may make the skin
• and white of the eyes turn yellow
• inflammation of the renal tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with renal problems)
• black tongue that appears hairy
• stained teeth (in children), which usually disappears with brushing.

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)
• crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist,even if it is a 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 datethat appears on the packaging and in the blister pack. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

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

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will be helping to protect the environment.

Composition of Amoxicilina/Ácido clavulánico Stada

• The active principles are: amoxicilina and ácido clavulánico. Each tablet contains 500 mg of amoxicilina and 125 mg of ácido clavulánico.

• The other components are:

Nucleus of the tablet

Colloidal anhydrous silica, magnesium stearate, carboxymethylcellulose sodium (type A) (from potato), microcrystalline cellulose

Coating of the tablet

Triethyl citrate, hypromellose, talc, ethylcellulose, cetyl alcohol, sodium lauryl sulfate, titanium dioxide (E171).

Appearance of the product and contents of the packaging

Amoxicilina/Ácido clavulánico Stada are film-coated, oblong, white or slightly yellowish tablets (10 mm x 21 mm), marked on one side (GG N6).

Amoxicilina/Ácido clavulánico Stada is presented in Al/Al blisters containing 10, 12, 20, 21, 24 or 30 film-coated tablets.

Only some packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing:

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Sandoz Gesellschaft m.b.H.

Biochemiestrasse 10

A-6250 Kundl

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co. Tipperary

Ireland

Last review date of this leaflet: January 2023

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