AMOXICILLIN / CLAVULANIC ACID FARMALIDER 500 mg / 125 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic Acid Farmalider 500 mg/125 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• 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 experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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

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

Amoxicillin/Clavulanic Acid Farmalider is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs 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.

Amoxicillin/Clavulanic Acid Farmalider 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 Farmalider

Do not take Amoxicillin/Clavulanic Acid Farmalider:

• if you are allergic (hypersensitive) to the active substances, to penicillins or to any of the other ingredients of this medicine (listed in section 6.1)
• if you have ever had a severe allergic reaction to any other antibiotic. This could include a skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not take Amoxicillin/Clavulanic Acid Farmaliderif you are included in any of the above points.Before starting treatment with Amoxicillin/Clavulanic Acid Farmalider, if you are not sure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking this medicine if:

• you have infectious mononucleosis
• you are being treated 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 Amoxicillin/Clavulanic Acid Farmalider.

In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be prescribed a different formulation of Amoxicillin/Clavulanic Acid Farmalider or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Farmalider can worsen certain existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid Farmalider 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 studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid Farmalider. This is because Amoxicillin/Clavulanic Acid Farmalider can alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Farmalider

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Farmalider, you may be more likely to suffer an allergic skin reaction.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Farmalider, more frequent blood tests will be needed.

If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

If you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

Amoxicillin/Clavulanic Acid Farmalider may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant or are breastfeeding, talk to your doctor or pharmacist.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Farmalider 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.

3. How to take Amoxicillin/Clavulanic Acid Farmalider

Follow the instructions for administration of Amoxicillin/Clavulanic Acid Farmalider exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist.

Adults and children over 40 kg

The usual dose is:

• 1 tablet three times a day

Children under 40 kg

It is preferable to treat children under 6 years with the oral suspension of Amoxicillin/Clavulanic Acid or sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid Farmalider tablets to children who weigh less than 40 kg. The tablets are not suitable for children who weigh less than 25 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 Farmalider

• Take with meals.
• Swallow the tablets whole with a glass of water.
• 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 Farmalider for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid Farmalider, you may experience symptoms such as stomach upset (nausea, vomiting or diarrhea) or convulsions. Consult your doctor as soon as possible. Take the package with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Farmalider

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 Farmalider

Continue taking Amoxicillin/Clavulanic Acid Farmalider 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 have the infection again.

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

4. Possible side effects

Like all medicines, Amoxicillin/Clavulanic Acid Farmalider 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 glands in the neck, armpits or groin
• swelling, sometimes of the face or mouth (angioedema), which can cause difficulty breathing
• collapse.

• Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Farmalider.

Inflammation of the large intestine

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

• Contact your doctor as soon as possiblefor 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 of the vagina, mouth or mucous membranes)
• nausea, especially when taking high doses

• 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:

• Increased levels of some substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 people.

• skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme)

Rare side effects that may appear in your blood tests:

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

Frequency not known

Frequency cannot be estimated from the available data

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• 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 rash with bumps under the skin and blisters (pustular exanthematous eruption)
  • flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (such as increased white blood cell count (eosinophilia) and elevated liver enzymes (drug reaction with eosinophilia and systemic symptoms (DRESS))).

• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (Kounis syndrome).

• 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.

• Crystals in the urine that cause acute kidney injury.

• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

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

• Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

• Contact a doctor immediatelyif 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
• convulsions (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems)
• black hairy tongue

Side effects that may appear in your blood or urine tests:

• significant reduction in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist or nurse. 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: http://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 Farmalider

Do not store above 25°C.

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

Keep out of the reach and sight of children.

Do not use Amoxicillin/Clavulanic Acid Farmalider after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic AcidFarmalider500 mg/125 mg film-coated tablets

The active ingredients are amoxicillin and clavulanic acid.

Each film-coated tablet contains:

Amoxicillin (as amoxicillin trihydrate).............................. 500 mg

Clavulanic acid (as potassium clavulanate) ...................... 125 mg

The excipients are: Magnesium stearate, anhydrous colloidal silica, crospovidone, microcrystalline cellulose, sodium croscarmellose.

Coating: Triethyl citrate, titanium dioxide (E-171), ethylcellulose, hydroxypropylcellulose, talc, polysorbate 80.

Product Appearance and Container Content

Amoxicillin/Clavulanic Acid Farmalider 500/125 mg is presented in containers containing 12 or 24 film-coated tablets.

Oval, biconvex tablets, white to off-white in color.

Marketing Authorization Holder

Apotex Europe B.V.

Archimedesweg 2,

2333 CN Leiden Netherlands

Manufacturer

Lek Pharmaceuticals d.d

Verovskova 57,

1526 Ljubljana, Slovenia was incorrect, the correct address is: Perzonali, 47, 2391 Prevalje

Perzonali, 47,

2391 Prevalje

Slovenia

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aurovitas Spain S.A.U.

Avda. de Burgos, 16-D

28036 Madrid, Spain

Date of the Last Revision of this Leaflet: April 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/