AMOXICILLIN/CLAVULANIC ACID TECNIGEN 875 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. What is amoxicillin/clavulanic acid and what is it used for
2. What you need to know before you take 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 other information

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

Amoxicillin/clavulanic acid is an antibiotic that eliminates the bacteria that cause infections. It contains two different medicines 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.

Amoxicillin/clavulanic acid is used in children and adults 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

Do not take amoxicillin/clavulanic acid:

• if you are allergic to amoxicillin, clavulanic acid, 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.

Do not take amoxicillin/clavulanic acid if you are included in any of the above points.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.

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 tests) 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.

Use of amoxicillin/clavulanic acid with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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 probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin 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 medicine used to treat rheumatic diseases, cancer, and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplanted 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.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Amoxicillin/clavulanic acid can have side effects and the symptoms can make you unfit to drive.

Do not drive or operate machinery unless you are feeling well.

3. How to take amoxicillin/clavulanic acid

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

Adults and children over 40 kg

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

Children under 40 kg

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

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

• Take with meals
• Swallow the tablets whole with a glass of water. The tablets can be broken along the score line to make them easier to swallow. You should take both halves of the tablet at the same time.
• 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 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. Take the package with you to show the doctor.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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 forgotten doses.

If you stop taking amoxicillin/clavulanic acid

Continue taking amoxicillin/clavulanic acid until you finish the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the surviving bacteria may cause you to become infected again.

If you have any further 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 listed below can occur with this medicine.

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).

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 immediately if you experience any of these symptoms. Stop takingamoxicillin/clavulanic acid.

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 inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

Contact your doctor as soon as possible for advice if you have 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 in 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 up to 1 in 100 people

• skin rash, itching
• increased pruritic rash (urticarial)
• 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 people

• 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).

• If you have any of these symptoms, consult a doctor urgently.

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 protective 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 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 blisters (pustular exanthematous)
• Blisters arranged in a circle with a central crust or like a necklace (linear IgA disease)

• Acute inflammation of the pancreas (see above)

• Contact a doctor immediately if you have 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

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)
• crystals in the urine that 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 them directly through the Spanish Medicines Monitoring System for Human Use: http://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

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

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of the month stated.

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

Do not use if the tablets are broken or damaged.

Medicines should not be disposed of via wastewater or household waste. Return the packages and medicines you no longer need to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of packages and medicines no longer needed. This will help protect the environment.

6. Contents of the pack and other information

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

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

Appearance of the product and pack contents

Amoxicillin/Clavulanic Acid TecniGen 875 mg/125 mg Film-Coated Tablets EFGare white to off-white, oblong, and scored tablets.

They are available in blister packs of 20 or 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

Edificio América. Polígono Arroyo de la Vega

28108 - Alcobendas (Madrid) Spain

Manufacturer:

PenCef Pharma GmbH

Breitenbachstrasse 13-14

13509 Berlin, Germany

Date of last revision of this leaflet: December 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es