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

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Tevagen500mg/125mg 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, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack:

1. What Amoxicillin/Clavulanic Acid Tevagen is and what it is used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Tevagen
3. How to take Amoxicillin/Clavulanic Acid Tevagen
4. Possible side effects

5 Storage of Amoxicillin/Clavulanic Acid Tevagen

1. Contents of the pack and other information

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

Amoxicillin/Clavulanic Acid Tevagen 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.

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

It is essential 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 completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Amoxicillin/Clavulanic Acid Tevagen 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 Tevagen

Do not take Amoxicillin/Clavulanic Acid Tevagen:

• if you are allergic (hypersensitive) 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 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid Tevagen 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 Amoxicillin/Clavulanic Acid.

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 Amoxicillin/Clavulanic Acid 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. This is because Amoxicillin/Clavulanic Acid can alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid with other medicines

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

• 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 anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid, more frequent blood tests may be needed.

• 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.

• Probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.

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

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 medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Tevagen may have side effects, and the symptoms can make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Tevagen 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 Tevagen

Follow the instructions for taking this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Adults and children over 40 kg

The recommended dose is:

• 1 tablet administered three times a day

Children under 40 kg

It is preferable to treat children under 6 years of age 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. 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 Tevagen

• 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.

If you take more Amoxicillin/Clavulanic Acid Tevagen 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, also consult the Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take Amoxicillin/Clavulanic Acid Tevagen

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 Tevagen

Continue taking Amoxicillin/Clavulanic Acid Tevagen until you finish the treatment, even if you feel better. You need to complete the full treatment to cure the infection. If you do not, the surviving bacteria may cause the infection to return. 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 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 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 immediatelyif you experience any of these symptoms. Stop takingAmoxicillin/Clavulanic Acid Tevagen.

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

If you have severe and persistent stomach pain, this could 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 immediatelyif you experience any of these symptoms.

Very common side effects

May affect more than 1 in 10 patients

• diarrhea (in adults).

Common side effects

May affect up to 1 in 10 patients

• thrush (candida - fungal infection in 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 patients

• skin rash, itching
• pruritic rash increased (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 patients

• 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)

• Consult your doctor urgentlyif you experience any of these symptoms.

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)
• 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 hives (pustular exanthematous eruption)
• 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)).
• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

• Contact a doctor immediatelyif you experience any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in 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 decrease in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine, which can cause acute kidney injury.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Website: 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 Tevagen

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

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

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to the pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin/Clavulanic Acid Tevagen500 mg/125 mg film-coated tablets

• The active ingredients are amoxicillin and clavulanic acid. Each tablet contains: 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate)
• The other ingredients are: anhydrous colloidal silica, magnesium stearate (E-470 b), sodium carboxymethylcellulose (type A) (derived from potato starch) and microcrystalline cellulose 112 (E460).

Coating: Opadry Oy-S-7300 (containing: Hypromellose 5cps, hypromellose 15 cps, macrogol 4000, macrogol 6000, titanium dioxide (E171)) and dimethicone 500 cps

Appearance of the Product and Container Content

Film-coated, elongated, scored, white tablets with inscription A/C.

Containers containing 30 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, Planta 1ª

Alcobendas, 28108 Madrid

Manufacturer:

Laboratorios Reig Jofré S.A.

C/Jarama 111, Poligono Industrial

45007 Toledo

This leaflet was approved in March 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

---------------------------------------------------------------------------------------------------------------

• 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 for this is that the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.
• Bacteria can become resistant to antibiotics for many reasons. Using antibiotics properly can reduce the chances of bacteria becoming resistant to them.
• When your doctor prescribes an antibiotic, it is only for the course of your illness. Paying attention to the following tips will help you prevent the appearance of resistant bacteria that can make the antibiotic not work.
• 1. It is very important that you take the antibiotic in the correct dose, at the indicated times, and for the correct number of days. Read the label instructions and if you do not understand something, ask your doctor or pharmacist.
• 2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should only use it for the infection for which it was prescribed.
• 3. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
• 4. You should not give antibiotics that have been prescribed for you to other people.
• 5. If you still have antibiotic left after completing the treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.