Amoxicillin/clavulanic acid Stada 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amoxicillin/Clavulanic acid Stada 875 mg/125 mg film-coated tablets EFG

Read this 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 (or for your child) only. Do not give it to other people, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

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 become ineffective (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 treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Amoxicilina/Ácido clavulánico Stada 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, they may prescribe 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, more 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, 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 make it unsafe for you to 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

Take this medicine exactly as prescribed by your doctor or pharmacist. Always follow the instructions in the package leaflet.

• This medicine can be taken at the beginning of a meal or just before a meal.
• Swallow the tablet whole with a glass of water.
• Do not crush or chew the tablet.

Dosage:

The usual dose for adults and children weighing 40 kg or more is:

• One tablet of Amoxicillin/Clavulanic Acid Stada 1000/125 mg every 12 hours, or
• One tablet of Amoxicillin/Clavulanic Acid Stada 500/125 mg every 8 hours.

Your doctor may adjust the dose depending on the severity of the infection.

For patients with kidney problems, your doctor may reduce the dose or extend the dosing interval.

Duration of treatment:

• Continue taking the medicine for the full duration prescribed by your doctor, even if you feel better.
• Do not stop treatment early, as this may lead to incomplete eradication of the bacteria and increase the risk of resistance.

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

Important: Do not share this medicine with others, even if they have similar symptoms. It has been prescribed specifically for you and may not be suitable for others.

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

Adults and children weighing 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

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 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 continue to feel unwell, consult your doctor.
• The score line is intended only for splitting the tablet if you find it difficult to swallow whole.

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

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) 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 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. Do not take a double dose to make up for a missed dose.

If you stop taking Amoxicillin/Clavulanic Acid Stada

Continue taking amoxicillin/clavulanic acid until the end of the treatment, even if you feel better. You need to complete the full course of treatment 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 you should 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 throat (angioedema), causing difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (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 certain 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)

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when high doses are taken

→ if this happens, 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 wheal)
• dyspepsia
• 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 form blisters resembling small targets (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

Frequency not known (frequency 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 forming circular lesions with central crust or resembling a string of pearls (linear IgA disease)
• Serious skin reactions:
  • widespread rash 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 detachment (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread blistering rash with pus-filled blisters (bullous exfoliative 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 experience 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 the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems)
• black, hairy-looking tongue
• stained teeth (in children), which usually disappear with brushing

Adverse effects that may appear in blood or urine tests:

• marked reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the 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 sight and reach of children.

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

Do not store above 30 °C.

Keep in the original packaging to protect from moisture.

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

6. Contents of the container and additional information

Composition of Amoxicillin/Clavulanic Acid Stada

• The active substances are amoxicillin trihydrate and potassium clavulanate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

• Other components are:

Tablet core

Anhydrous colloidal silica, magnesium stearate, talc, povidone K25, microcrystalline cellulose, crospovidone.

Tablet coating

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

Appearance of the medicinal product and content of the container

Amoxicillin/Clavulanic Acid Stada are oval, film-coated tablets, white or slightly whitish, with notches on both sides.

The notch is intended solely for splitting the tablet if you have difficulty swallowing it whole.

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

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

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

Pack sizes of 6, 10, 14, 15, 20, 24, 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

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

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

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

Medical advice/education Antibiotics are used to treat bacterial infections. They are not effective against viral infections. Sometimes, a bacterial infection does not respond to antibiotic treatment. One of the most common reasons this occurs is because the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the presence of the antibiotic. Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood that bacteria will become resistant to them. When your doctor prescribes an antibiotic, it is intended solely for the course of your current illness. Following the advice below will help you prevent the development of resistant bacteria, which could cause the antibiotic to become ineffective. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full number of days. Read the labeling instructions carefully, and if you do not understand something, ask your doctor or pharmacist. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection for which it was prescribed. You should not take antibiotics prescribed for other people, even if they have the same or a similar infection to yours. You should not give antibiotics prescribed for you to other people. If you have any antibiotic left after completing your treatment, return all unused medication to your pharmacy to ensure proper disposal requirements are met.