Amoxicillin/clavulanic acid STADA 500 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amoxicillin/Clavulanic acid Stada 500 mg/125 mg film-coated tablets EFG

Read the entire 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, and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Amoxicillin/Clavulanic acid Stada is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic acid Stada
3. How to take Amoxicillin/Clavulanic acid Stada
4. Possible side effects
5. How to store Amoxicillin/Clavulanic acid Stada
6. Contents of the pack and other information

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

Amoxicilina/Ácido clavulánico Stada is an antibiotic that kills bacteria causing infections. It contains two different active substances 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

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 taking Amoxicillin/Clavulanic Acid Stada

DO NOT take Amoxicillin/Clavulanic Acid Stada:

• 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 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) while taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Stada if any of the above apply to you. 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 medicine 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 conditions apply to you, inform your doctor or pharmacist before taking this medicine.

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

Depending on the results, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking this medicine to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking this medicine. This is because this medicine may alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid Stada with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal medicines.

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

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

If anticoagulants (such as warfarin) are taken with amoxicillin/clavulanic acid, additional blood tests will be needed.

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

This medicine may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects, and symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Stada contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Stada

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

The recommended dose is:

• 1 tablet three times a day.

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.

Seek advice from your doctor or pharmacist before administering amoxicillin/clavulanic acid tablets to children weighing less than 40 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Stada

• Swallow the tablets whole with a glass of water at the beginning of meals or shortly before.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take amoxicillin/clavulanic acid for longer than 2 weeks. If you still feel unwell, consult your doctor.

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

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Amoxicillin/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.

If you stop taking Amoxicillin/Clavulanic Acid Stada

Continue taking amoxicillin/clavulanic acid for the full duration of treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Symptoms to watch for

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swollen lymph nodes in armpits or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

? Contact your doctor immediately if you experience any of these symptoms. Stop taking this medicine.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhea, usually with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)

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

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being 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 have these symptoms.

Very common adverse effects (may affect more than 1 in 10 people)

• diarrhea (in adults)

Common adverse effects (may affect up to 1 in 10 people)

• oral, vaginal or mucosal fungal infection (candida)
• nausea, especially when high doses are taken

→ if this occurs, take amoxicillin/clavulanic acid before meals

• vomiting
• diarrhea (in children)

Uncommon adverse effects (may affect up to 1 in 100 people)

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

• increase in certain substances (enzymes) produced by the liver

Rare adverse effects (may affect up to 1 in 1,000 people)

• skin rash that may blister and resemble small targets (a dark center surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

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

Rare adverse effects that may appear in blood tests:

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

Other adverse effects

Other adverse effects that have occurred in a very small number of patients and whose frequency is unknown (cannot be estimated from available data):

• Allergic reactions (see above)

• Inflammation of the large intestine (see above)

• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

• Blistering rash arranged in circles with a central crust or resembling a "pearl necklace" (linear IgA disease)

• Severe skin reactions:

• widespread blistering and peeling rash, 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 body surface – toxic epidermal necrolysis)

• widespread blistering rash with pus-filled blisters (exfoliative bullous dermatitis)

• exfoliative red rash with bumps under the skin and hives (exanthematous pustulosis)

  • 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)).

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

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow
• inflammation of kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems)
• black, hairy-looking tongue
• tooth discoloration (in children), which usually resolves with brushing

Adverse effects that may appear in blood or urine tests:

• significant decrease in white blood cell count
• low red blood cell count (hemolytic anemia)
• crystals in urine causing acute kidney injury

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Stada

• The active substances are: amoxicillin and clavulanic acid. Each tablet contains 500 mg of amoxicillin and 125 mg of clavulanic acid.

• The other components are:

Tablet core

Anhydrous colloidal silica, magnesium stearate, sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose

Tablet coating

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

Appearance of the product and contents of the pack

Amoxicillin/Clavulanic Acid Stada are oblong, film-coated tablets, white or slightly yellow (10 mm x 21 mm), marked on one side (GG N6).

Amoxicillin/Clavulanic Acid Stada is available in Al/Al blisters containing 10, 12, 20, 21, 24 or 30 film-coated tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible: 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

Date of the most recent review of this leaflet: January 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.