Amoxicillin/clavulanic acid Tevagen 500 mg/125 mg powder for oral suspension in sachets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Tevagen 500mg/125mg powder for oral suspension in sachets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

2. What you need to know before taking Amoxicillin/Clavulanic acid Tevagen

3. How to take Amoxicillin/Clavulanic acid Tevagen

4. Possible side effects

5. How to store Amoxicillin/Clavulanic acid Tevagen

6. 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 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 the instructions regarding dose, dosing interval, and duration of treatment as prescribed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

Amoxicillin/Clavulanic Acid Tevagen is used in adults and children to treat the following infections:

• Middle ear infections 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 Tevagen

Do not take Amoxicillin/Clavulanic Acid Tevagen:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to 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 throat
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 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 Amoxicillin/Clavulanic Acid. This is because Amoxicillin/Clavulanic Acid may alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid Tevagen with other medicines

Inform your doctor or pharmacist if you are using or have recently used any 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 anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid, more blood tests will be needed.

• Methotrexate (a medicine used to treat cancer and severe psoriasis): penicillins may reduce methotrexate excretion and potentially increase adverse effects.

• Probenecid (used to treat gout): concomitant use with probenecid may reduce amoxicillin excretion 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Tevagen may cause adverse effects, and symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Tevagen contains saccharose, glucose and sodium

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

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

3. How to take Amoxicillin/Clavulanic Acid Tevagen

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

Adults and children weighing 40 kg or more

The recommended dose is:

• 1 sachet taken three times a day

Children weighing less than 40 kg

Amoxicillin/Clavulanic Acid 500 mg/125 mg sachets are not recommended.

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

• Just before taking Amoxicillin/Clavulanic Acid, open the sachet and mix the contents in half a glass of water.
• Take it at the beginning of meals or shortly before eating.
• Space the doses evenly 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 still feel unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid Tevagen, symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures may occur.

In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number (91) 562 04 20, indicating 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 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 treatment with Amoxicillin/Clavulanic Acid Tevagen

Continue taking this medicine for the full duration of treatment, even if you feel better. You need to complete the full course 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 product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The adverse effects listed below may occur when taking this medicine.

Symptoms you should be aware of

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing

• collapse

• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)

• Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Tevagen.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Acute pancreatitis

If you have severe and persistent pain in the stomach area, 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 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, diarrhoea, and low blood pressure.

• Contact your doctor as soon as possible so they can advise you if you experience these symptoms.

Very common adverse effects

May affect more than 1 in 10 patients

• diarrhoea (in adults)

Common adverse effects

May affect up to 1 in 10 patients

• thrush (candida – fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when high doses are taken
  • if this occurs, take Amoxicillin/Clavulanic Acid Tevagen before meals
• vomiting
• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 patients

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• 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 patients

• skin rash, which may form blisters resembling small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• if you have any of these symptoms, consult your 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 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:

  • 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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • 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))

• rash with blistering arranged in a circular pattern with a central crust or resembling a string of pearls (linear IgA disease)

• Contact a 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 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:

• significant reduction in the number of white blood cells
• low red blood cell count (haemolytic anaemia)
• crystals in the urine, which may cause acute kidney injury

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: 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 Tevagen

Do not store at temperatures above 25°C.

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

Do not use Amoxicillin/Clavulanic Acid Tevagen after the expiry date stated on the packaging and over CAD. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid Tevagen 500mg/125mg powder for oral suspension in sachets

• The active substances are amoxicillin and clavulanic acid. Each sachet contains: 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• Other components are: silicon dioxide gel (E551), trisodium citrate (E331), sucrose, raspberry flavour (contains glucose), and fruit flavour (contains glucose).

Appearance of the medicine and contents of the pack

Whiteish powder.

Pack containing 30 sachets.

Marketing Authorisation Holder and Manufacturer

Holder:

Teva Pharma S.L.U.

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

Alcobendas, 28108 Madrid, Spain

Manufacturer:

Laboratorios Reig Jofré S.A.

C/Jarama 111, Poligono Industrial

45007 Toledo, Spain

This patient information leaflet was approved in March 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 antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria becoming resistant.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help prevent the development of resistant bacteria, which could make antibiotics ineffective.

1. It is very important to take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the labelling instructions carefully and, if you do not understand something, ask your doctor or pharmacist.
2. Do not take an antibiotic unless it has been specifically prescribed for you, and use it only for the infection it was prescribed for.
3. Do not take antibiotics prescribed for other people, even if they have the same or a similar infection to yours.
4. Do not give antibiotics prescribed for you to other people.
5. If you have any antibiotic left after completing your treatment, return all unused medicines to your pharmacy to ensure proper disposal.

Reconstitution instructions

Pour the contents of the sachet into 10–20 mL of water, shake until a suspension is formed, and take immediately.