Prospecto: information for the user

Amoxicilina/Ácido clavulánico Tevagen500mg/125mg coated tablets EFG

Read this prospect carefully before starting to take the medicine.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, 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 not listed in this prospect. See section 4.

1.What is Amoxicilina/Ácido clavulánico Tevagen and for what it is used

2.What you need to know before starting to take Amoxicilina/Ácido clavulánico Tevagen

3.How to take Amoxicilina/Ácido clavulánico Tevagen

4.Possible adverse effects

5Storage of Amoxicilina/Ácido clavulánico Tevagen

6.Contents of the package and additional information

Amoxicilina/Ácido clavulánico Tevagen is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Tevagen is used in adults and childrento 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.

Do not take Amoxicilina/Ácido clavulánico Tevagen:

• if you are allergic (hypersensitive) to amoxicilina, ácido clavulánico, to penicilins or to any of the other components of this medication (including in the section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of 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 Amoxicilina/Ácido clavulánico Tevagen if:

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

If you are unsure if any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina/Ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, your doctor may prescribe a different presentation of Amoxicilina/Ácido clavulánico or another medication.

Be aware of the following symptoms

Amoxicilina/Ácido clavulánico may worsen certain existing conditions, or cause serious side effects. These include allergic reactions, convulsions and inflammation of the large intestine. Be aware of the following symptoms while taking Amoxicilina/Ácido clavulánico to reduce the risk of problems. See “Be aware of the following symptoms” in the section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are taking Amoxicilina/Ácido clavulánico. This is because Amoxicilina/Ácido clavulánico may alter the results of these types of tests.

Taking Amoxicilina /Ácido clavulánico Tevagen with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

• If you are taking allopurinol (used for gout) with Amoxicilina/Ácido clavulánico, you may be more likely to suffer a skin allergic reaction.

• If you are taking anticoagulants (such as warfarin) with Amoxicilina/Ácido clavulánico, more blood tests may be required.

• Methodrexate (a medication used to treat cancer and severe psoriasis), penicilins may reduce the excretion of methotrexate and cause a potential increase in side effects.

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

• Amoxicilina/Ácido clavulánico may affect the way micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicilina/Ácido clavulánico Tevagen may cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Tevagen contains sodium

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

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

Adults and children 40 kg or more

The recommended dose is:

• 1 tablet administered three times a day

Children under 40 kg of weight

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

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic acid tablets to children weighing less than 40 kg.Tablets are not suitable for children weighing 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 presentation or another medication.
• 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 beginning of meals or a little before.
• Space the doses throughout 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 continue to feel 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 Toxicological Information Service, phone (91) 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot 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 interrupt the treatment with Amoxicillin/Clavulanic acid Tevagen

Continue taking Amoxicillin/Clavulanic acid Tevagen until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause you to have the infection again. If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medicines, Amoxicilina/ Clavulanic Acid may cause side effects, although not everyone will experience them

Symptoms to be aware of

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis) that may 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 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 an allergic-induced heart attack (Kounis syndrome).

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have intense and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has mainly been reported in children taking amoxicilina. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medication). 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

• mouth ulcers (candida– fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses
• • if this occurs, takeAmoxicilina/ Clavulanic Acid Tevagenbefore meals
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect 1 in 100 patients

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

Uncommon side effects that may appear in blood tests:

• increase in certain substances (enzymes) produced by the liver.

Rare side effects

May affect up to 1 in 1,000 patients

• skin rash, which may form blisters that appear as small dots (eritema multiforme)

• if you experience any of these symptoms, consult your doctor urgently

Rare side effects that may appear in blood tests:

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

Frequency not known

The frequency cannot be estimated from the available data.

• allergic reactions (see above)
• colitis (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 widespread peeling of the skin (more than 30% of the body surface –toxic epidermal necrolysis)
• generalized rash with small blisters with pus (exfoliative bullous dermatitis)
• red rash, with lumps under the skin and urticaria (pustular exanthema).
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as elevated eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease).

• Contact your 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) that can turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicilina/ Clavulanic Acid or those with kidney problems)
• black tongue that appears hairy
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low red blood cell count (hemolytic anemia)
• crystals in the urine, which can cause acute kidney damage.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Do not store at a temperature above25ºC.

Store in the original packaging to protect it from humidity.

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

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAmoxicillin/Clavulanate Tevagen500 mg/125 mg film-coated tablets

• The active ingredients are amoxicillin and clavulanate. Each tablet contains: 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanate (as potassium clavulanate)
• The other components 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 contents of the package

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

Packages containing 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, 1st floor

Alcobendas, 28108 Madrid

Responsible for manufacturing:

Laboratorios Reig Jofré S.A.

C/Jarama 111, Industrial Estate

45007 Toledo

This leaflet was approved in March 2023

• The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es

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