Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid TecniGen 875 mg/125 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 (or your child) only. Do not pass it on to others even if they have similar symptoms, as it may harm them.

• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What amoxicillin/clavulanic acid is and what it is used for

2. What you need to know before you start taking amoxicillin/clavulanic acid

3. How to take amoxicillin/clavulanic acid

4. Possible side effects

5. Storage of amoxicillin/clavulanic acid

6. Contents of the pack and additional information

Amoxicillin/clavulanic acid is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medications known as "penicillins" that can sometimes lose its effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/clavulanic acid is used in children and adults to treat the following infections:

• Middle ear infections and nasal sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections

Do not take amoxicillin/clavulanic acid:

•if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (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) when taking an antibiotic.

?Do not take amoxicillin/clavulanic acidif you meet any of the above criteria. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take amoxicillin/clavulanic acid if:

•you have infectious mononucleosis

•you are receiving treatment for liver or kidney problems

•you do not urinate regularly.

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, your doctor may prescribe a different presentation of amoxicillin/clavulanic acid or another medication.

Be aware of these symptoms

Amoxicillin/clavulanic acid may worsen 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 to reduce the risk of problems. See “Be aware of these symptoms” in section 4.

Blood and urine tests

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

Use of amoxicillin/clavulanic acidwith other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you may be more likely to suffer a skin allergy reaction.

If you are taking probenecid (used to treat gout),concomitant use with probenecid may reduce amoxicillin excretion and is not recommended. Your doctor may adjust the dose of amoxicillin/clavulanic acid.

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more blood tests will be needed.

Amoxicillin/clavulanic acid may affect the action of methotrexate (a medication used to treat rheumatic diseases, cancer, and severe psoriasis),penicillins may reduce methotrexate excretion and cause a potential increase in side effects.

Amoxicillin/clavulanic acidmay affect how micophenolate mofetil (a medication 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 medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Amoxicillin/clavulanic acid may cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

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

•Usual dose – 1 tablet administered twice a day.

•Higher dose – 1 tablet administered three times a day.

Children under 40 kg of weight

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

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

• Take with meals
• Swallow the tablets whole with a glass of water. The tablets can be broken along the notch to make it easier to swallow. You should take both halves of the tablet at the same time.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in one 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 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. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take amoxicillin/clavulanic acid

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 the missed doses.

If you interrupt the treatment with amoxicillin/clavulanic acid

Continue taking amoxicillin/clavulanic acid 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 get the infection again.

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

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

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 causes difficulty breathing
• collapse.

Chest pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).

Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported in children taking 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.

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.

Contact your doctor as soon as possible for advice, if you experience 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
• • if this happens, take amoxicillin/clavulanic acid with meals.
• vomiting
• diarrhea (in children).

Uncommon side effects

May affect 1 in 100 people

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

Uncommon side effects that may appear in blood tests:

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

Rare side effects

May affect up to 1 in 1,000 people

• skin eruption, which may form blisters that look like small darts (eritema multiforme).

• If you experience any of these symptoms, consult a 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 protective 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 bumps under the skin and blisters (pustular exanthema)
• rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease)

• acute pancreatitis (see above)

• Contact a doctor immediately if 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 may turn the skin and the white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• convulsions (in patients taking high doses ofamoxicillin/clavulanic acidor who have kidney problems)
• black tongue that appears hairy

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 that 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 Vigilance of Medicines for Human Use:http://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Store below 25°C. Store in the original packaging to protect it from moisture.

Do not use if the tablets are broken or damaged.

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

Composition of Amoxicilina/ácido clavulánico TecniGen 875 mg/125 mg film-coated tablets EFG

• The active principles are amoxicilina and ácido clavulánico. Each tablet contains amoxicilina trihydrate equivalent to 875 mg of amoxicilina and clavulanate potassium equivalent to 125 mg of ácido clavulánico.
• The other components are: Nucleus : microcrystalline cellulose (E460), crospovidone type A (E1202), sodium croscarmellose (E468), anhydrous colloidal silica (E551), magnesium stearate (E470b). Coating: basic butylated methacrylate copolymer, titanium dioxide (E171), talc (E553b), macrogol 6000 .

Appearance of the product and contents of the packaging

Amoxicilina/ácido clavulánico TecniGen 875 mg/125 mg film-coated tablets EFG are white to off-white, oblong, scored film-coated tablets.

They are presented in blister packs containing 20 or 30 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

Edificio América. Polígono Arroyo de la Vega

28108 - Alcobendas (Madrid) España

Responsible for manufacturing:

PenCef Pharma GmbH

Breitenbachstrasse 13-14

13509 Berlin, Germany

Last review date of this leaflet: December 2022

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