AMOXICILLIN/CLAVULANIC ACID STADA 875 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Amoxicillin/Clavulanic Acid Stada 875 mg/125 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Amoxicillin/Clavulanic Acid Stada and what is it used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Stada
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 other information

1. What is Amoxicillin/Clavulanic Acid Stada and what is it used for

Amoxicillin/Clavulanic Acid Stada is an antibiotic that eliminates the bacteria that cause 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 the flu or the common cold.

It is important to follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Amoxicillin/Clavulanic Acid 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 you take Amoxicillin/Clavulanic Acid Stada

Do not take Amoxicillin/Clavulanic Acid Stada:

• if you are allergic to amoxicillin, clavulanic acid, 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 a 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 take Amoxicillin/Clavulanic Acid Stada if you are included in any of the above points.Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Tell 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 not sure if any of the above symptoms affect 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 be aware of

Amoxicillin/clavulanic acid can worsen certain existing conditions or cause serious side 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 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 status or liver function tests) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking this medicine. This is because this medicine can alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid Stada with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, 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 amoxicillin/clavulanic acid.

If you are taking anticoagulants (such as warfarin) 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 organ transplant rejection).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may have side effects that can affect your ability to drive or use machines.

Do not drive or operate machinery unless you are feeling well.

Amoxicillin/Clavulanic Acid Stada contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Stada

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

Adults and children over 40 kg

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

Children under 40 kg

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

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets to children who weigh 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 formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Stada

• Swallow the tablets whole with a glass of water at the start of meals or a little before.
• Space out the doses during 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 are still feeling unwell, consult your doctor.
• The score line is only to facilitate breaking 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, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures.

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 medicine and the amount ingested. It is recommended to bring the packaging and the package leaflet of the medicine 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 forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Stada

Continue taking amoxicillin/clavulanic acid until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the bacteria that survive may cause you to become infected again.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can 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 armpits or groin
• swelling, sometimes of the face or throat (angioedema), which can cause difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced 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, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis (inflammation of the pancreas)

If you have severe and persistent stomach pain, 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 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 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 in 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).

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

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

Uncommon 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 that can form blisters, which look like small targets (central dark spot 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 side effects that may appear in your blood tests:

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

Frequency not known(frequency cannot be estimated from the 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)
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)
• Severe skin reactions:
• • widespread 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)
  • widespread rash with small blisters containing pus (bullous exfoliative dermatitis)
  • red, exfoliative rash with bumps under the skin and hives (pustular exanthematous rash)
  • flu-like symptoms with skin rash, fever, gland inflammation, 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) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems)
• black, hairy tongue
• stained teeth (in children), which usually disappears with brushing.

Side 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 side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Do not store above 30°C.

Store in the original packaging to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other 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.

• The other ingredients are:

Core of the tablet

Colloidal anhydrous 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 product and contents of the pack

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

The score line is only to facilitate breaking the tablet if you find it difficult to swallow whole.

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

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

Aluminum foil strips that consist of a soft aluminum foil of 30 µm with a PE coating, printed, and a soft aluminum foil of 30 µm with a PE backing, unprinted.

Pack sizes: 6, 10, 14, 15, 20, 24, 30 film-coated tablets.

Not all 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

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 last revision of this leaflet: January 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.