AMOXICILLIN/CLAVULANIC ACID TEVAGEN 875 mg/125 mg ORAL SUSPENSION POWDER IN SACHETS

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Tevagen 875mg/125mg Powder for Oral Suspension in Sachets 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 pack and other information

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
   1. Storage of Amoxicillin/Clavulanic Acid Tevagen

1. Contents of the pack and further 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 active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" that 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 that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medication. 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 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 neck
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

• Do not takeAmoxicillin/Clavulanic Acid Tevagenif you are included in any of the above points. Before starting treatment with this medicine, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

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

Be particularly careful with Amoxicillin/Clavulanic Acid Tevagen

• if you have infectious mononucleosis
• if you are receiving treatment for liver or kidney problems
• if you do not urinate regularly.

If you are unsure whether 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 which you must pay attention

Amoxicillin/Clavulanic Acid Tevagen may worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You must be attentive to certain symptoms while taking this medicine to reduce the risk of problems. See "Symptoms to which you must pay attention" 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 Tevagen. This is because Amoxicillin/Clavulanic Acid Tevagen may alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid Tevagen withother medicines

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

• 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 anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid, more blood tests will 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 of 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 may make you unfit to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Tevagen 875mg/125mg powder for oral suspension in sachets contains aspartame, sucrose, and glucose

This medicine contains 12.50 mg of aspartame in each sachet.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

It contains 1.14 gm of sucrose per sachet, which should be taken into account in patients with diabetes mellitus.

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Amoxicillin/Clavulanic Acid Tevagen

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

Adults and children over 40kg

• Usual dose - 1 sachet administered twice a day
• Higher dose - 1 sachet administered three times a day

Children under 40kg in weight

Amoxicillin/Clavulanic Acid Tevagen 875 mg/125 mg sachets are not recommended.

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

• Just before taking Amoxicillin/Clavulanic Acid Tevagen, open the sachet and mix the contents in half a glass of water
• Take it at the start of meals or a while 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 Tevagen 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 Tevagen, 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, telephone (91) 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring 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 this medicine until you finish the treatment, even if you feel better. You need to take the complete 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects described below may occur when taking this medicine.

Symptoms to which you must pay attention

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.
• chest pain in the context of allergic reactions, which can be a symptom of an 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 who receive 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 possiblefor advice if you have 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
• • Amoxicillin/Clavulanic Acid Tevagenbefore meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 patients

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

Uncommon side effects that may appear in your blood tests:

• Increased levels of certain 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 have any of these symptoms

Rare side effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (hemolytic anemia)

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)
• severe skin reactions:

• generalized 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 generalized peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)
• generalized rash with small blisters with pus (bullous exfoliative dermatitis)
• red rash, with bumps under the skin and hives (pustular exanthematous)
• 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)).
• rash with blisters arranged in a circle with a central crust or like a necklace (linear IgA disease).

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

• liver inflammation (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 of unknown frequency that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (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 it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System 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

Keep in the original packaging to protect it from moisture. No special storage conditions are required.

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

Do not use Amoxicillin/Clavulanic Acid Tevagen after the expiration date that appears on the packaging and sachet after CAD. The expiration date is the last day of the month indicated.

Do not use Amoxicillin/Clavulanic Acid Tevagen if the sachets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Tevagen 875 mg/125 mg Powder for Oral Suspension in Sachets

• The active ingredients are amoxicillin and clavulanic acid. Each sachet contains: 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate)
• The other components are: Aspartame (E-951) and orange flavoring (contains glucose and sucrose).

Appearance of the Product and Container Content

White to off-white powder.

Packaging of 20 and 30 sachets

Marketing Authorization Holder and Manufacturer

Holder:

Teva Pharma S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st Floor

Alcobendas, 28108 Madrid

Manufacturer:

Laboratorios Reig Jofré, S.A.

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 ineffective.

1. 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.
2. You should not take antibiotics that have been prescribed for other people, even if they have the same or a similar infection to yours.
3. You should not give antibiotics that have been prescribed for you to other people.
4. If you still have antibiotic left after completing treatment, return all unused medication to your pharmacy to ensure that disposal requirements are met.

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Reconstitution Instructions

Pour the contents of the sachet into 10-20 ml of water, shake until a suspension is obtained, and take immediately.