Patient Information Leaflet

Amoxicillin/Clavulanic Acid Stada875 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 (or your child) 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 is Amoxicillin/Clavulanic Acid Stadaand what is it used for

2.What you need to know before taking Amoxicillin/Clavulanic AcidStada

3.How to take Amoxicillin/Clavulanic Acid Stada

4.Possible side effects

5.Storage of Amoxicillin/Clavulanic Acid Stada

6.Contents of the pack and additional information

Amoxicilina/Ácido clavulánicoStadais 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 clavulánicoStadais 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 takeAmoxicilina/Ácido clavulánico Stada:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, 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 amoxicillin/clavulanic acid, 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, they may prescribe a different presentation of amoxicillin/clavulanic acid or another medication.

Be aware of the following symptoms

Amoxicillin/clavulanic acid may worsen existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. Be aware of the following symptoms while taking this medication to reduce the risk of problems. See “Be aware of the following symptoms” 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 because this medication may alter the results of these types of tests.

Taking Amoxicilina/Ácido clavulánico Stada with other medications

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

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

If you are taking probenecid (used for gout), your doctor may adjust the dose of amoxicillin/clavulanic acid.

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

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

This medication may affect the action of mycophenolate mofetil (a medication used to prevent organ transplant rejection).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicillin/clavulanic acid may cause side effects and symptoms that may make you unable 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”.

Followexactlytheadministrationinstructionsforthismedicationindicatedbyyourdoctororpharmacist.Incaseofdoubt,consultyourdoctororpharmacistagain.

Adults and children 40 kg or more

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

Children under 40 kg in weight

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 functioning.

How to takeAmoxicillin/Clavulanic Acid Stada

• Swallow the tablets whole with a glass of water at the start 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.
• Thegrooveis only for breaking the tablet if it is difficult to swallow whole.

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicology 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 forget to takeAmoxicillin/Clavulanic Acid 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.Do not take a double dose to make up for the missed doses.

If you stop takingAmoxicillin/Clavulanic Acid Stada

Continue taking amoxicillin/clavulanic acid until you complete the treatment, even if you feel better. You need to complete the treatment to cure the infection. If you do not, the surviving bacteria may cause you to become infected 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 can affect other parts of the body
• fever, joint pain, lymphadenopathy, armpits, or inguinal lymph nodes
• swelling, sometimes of the face or throat (angioedema), which causes difficultybreathing
• collapseor
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome)

?Contact your doctor immediatelyif you experience any of these symptoms.Stop takingthis 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 mainly reported in children taking amoxicillin. It is a certain type of allergic reactionwith 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 possibleto advise you, if youhave these symptoms.

Frequent side effects(may affect more than 1 in10 people)

• diarrhea (in adults).

Frequent side effects(may affect up to 1 in10 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 before meals

• vomiting
• diarrhea (in children).

Rare side effects(may affect 1 in 100 people)

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

Rare 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 eruption, which may form blisters that appear as small dots (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme)

?if you experience any of these symptoms, see a doctor urgently.

Rare side effects that may appear in blood tests:

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

Unknown frequency(frequency 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)
• skin eruption with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• Severe skin reactions:
• • generalized skin eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (more than 30% of the body surface –toxic epidermal necrolysis)
  • generalized skin eruption with small blisters with pus (exfoliative bullous dermatitis)
  • red, exfoliative rash, with subcutaneous nodules and urticaria (pustular exanthema).
  • flu-like symptoms with skin eruption, 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 experience any of these symptoms.

• liver inflammation (hepatitis)

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes 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.

Side effects that may appear in blood or urine tests:

• significantly reduced white blood cell count

• low red blood cell count (hemolytic anemia)
• crystals in the urinethat 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 not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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 packaging and in the blister packaftertheCAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGREpoint of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofAmoxicillin/Clavulanic Acid Stablets

-The active principles are amoxicillin trihydrate and potassium clavulanate.

Each film-coated tablet containsamoxicillintrihydrateequivalent to875 mg of amoxicillinand potassium clavulanate equivalent to125 mg of clavulanic acid.

-The other components are:

Core of the tablet

Colloidal anhydrous silica, magnesium stearate, talc, povidone K25, microcrystalline cellulose, crospovidone.

Coating of the tablet

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

Appearance of the product and contents of the package

Amoxicillin/Clavulanic Acid Stabletsare oval-shaped, white or slightly off-white, scored on both sides film-coated tablets.

The score serves only to break the tablet if it is difficult to swallow whole.

The tablets are packaged in aluminum blisters or aluminum foil strips.

Amoxicillin/Clavulanic Acid Stada is packaged in aluminum blisters (Al/Al blisters) consisting of an aluminum sheet with a PVC coating on the inside and an aluminum sheet on the lid, optionally printed (aluminum 25 µm, hard sheet with a thermoplastic PVC coating on the inside).

Sealed aluminum foil strips consisting of a 30 µm soft aluminum sheet with PE coating, printed, and a 30 µm soft aluminum sheet with PE backing, unprinted.

Packages of 6, 10, 14, 15, 20, 24, 30 film-coated tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Verovškova 57, 1526 Ljubljana

Slovenia

or

Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

STADA Arzneimittel GmbH

Muthgasse 36/2, 1190 Wien

Austria

or

Clonmel Healthcare Ltd.

Waterford Road, Clonmel, Co.Tipperary

Ireland

Revision date of this leaflet: January 2023

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.