Amoxicillin/clavulanic acid Tecnigen 875 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/clavulanic acid TecniGen 875 mg/125 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

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

Leaflet contents

1. What amoxicillin/clavulanic acid is and what it is used for
2. What you need to know before taking amoxicillin/clavulanic acid
3. How to take amoxicillin/clavulanic acid
4. Possible adverse effects
5. How to store amoxicillin/clavulanic acid
6. Contents of the pack and other information

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

Amoxicillin/clavulanic acid 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.

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

• Middle ear and nasal 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

Do not take amoxicillin/clavulanic acid:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a serious 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.

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

Warnings and precautions

Talk to your doctor or pharmacist before taking 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 conditions apply to 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, 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 amoxicillin/clavulanic acid 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 with other medicines

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

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

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

If anticoagulants (such as warfarin) are taken 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 methotrexate excretion and potentially increase adverse effects.

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning 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 may cause adverse effects, and symptoms may make it unsafe for you to drive.

Do not drive or operate machinery unless you feel well.

3. How to take amoxicillin/clavulanic acid

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

Adults and children weighing 40 kg or more

• Usual dose – 1 tablet taken twice daily.
• Higher dose – 1 tablet taken three times daily.

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.

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

• Take with food.
• Swallow the tablets whole with a glass of water. The tablets can be split along the score line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one 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 than you should

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show the doctor.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine 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 a missed dose.

If you stop treatment with amoxicillin/clavulanic acid

Continue taking amoxicillin/clavulanic acid until the end of the prescribed course, 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 medicine, 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 with this medicine.

Symptoms to watch for

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 throat (angioedema), causing difficulty breathing
• collapse

Chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered 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 being 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 taking amoxicillin/clavulanic acid.

Inflammation of the large intestine

Inflammation of the large intestine, causing 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 pain in the stomach area, this could be a sign of acute pancreatitis.

Contact your doctor as soon as possible for advice if you have these symptoms.

Very common adverse effects

May affect more than 1 in 10 people

• diarrhea (in adults)

Common adverse 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 food.
• vomiting
• diarrhea (in children)

Uncommon adverse effects

May affect up to 1 in 100 people

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

Uncommon adverse effects that may appear in your blood tests:

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

Rare adverse effects

May affect up to 1 in 1,000 people

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

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

Rare adverse effects that may appear in your 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 protective membranes surrounding the brain and spinal cord (aseptic meningitis)

• severe skin reactions:

  • widespread blistering rash with peeling 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 blistering rash with pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • rash with blisters arranged in a ring with a central crust or resembling a string of pearls (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 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 the 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

Adverse effects that may appear in your blood or urine tests:

• significant decrease in white blood cell count
• low red blood cell count (hemolytic anemia)
• crystals in urine leading to acute kidney injury

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: http://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

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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

Do not use if the tablets are broken or damaged.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps 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 substances 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.
• Other components 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 EFG are white to off-white, oblong, film-coated tablets with a score line.

They are supplied in blister packs containing 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 the most recent revision of this package leaflet: December 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es