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

Introduction

Package Leaflet: Information for the User

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

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

amoxicillin/clavulanic acid cinfa is an antibiotic that eliminates the bacteria that cause 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 lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

amoxicillin/clavulanic acid cinfa 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 cinfa

Do not take amoxicillin/clavulanic acid cinfa:

• 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 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 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 cinfa 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.

Other medicines and amoxicillin/clavulanic acid cinfa

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.

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 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 transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may have side effects, and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you are feeling well.

amoxicillin/clavulanic acid cinfa contains sodium

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

3. How to take amoxicillin/clavulanic acid cinfa

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, check with your doctor or pharmacist.

Adults and children over 40 kg

• Usual recommended dose – 1 tablet twice a day.
• Higher dose – 1 tablet 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 cinfa

• Take with food

• Swallow the tablets whole with a glass of water. The tablets can be broken along the score line. The score line is only to help you break the tablet if you have difficulty swallowing it whole. 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 cinfa 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 pack with you to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take amoxicillin/clavulanic acid cinfa

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 cinfa

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 bacteria that survive may cause you to become infected again.

If you have any further questions on 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 may 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.

→ 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, which causes watery diarrhea, usually with blood and mucus,

stomach pain and/or fever.

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 food.

• Vomiting.
• Diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 people):

• Skin rash, itching.
• Increased itchy rash (urticarial rash).
• Indigestion.
• Dizziness.
• Headache.

Uncommon side effects that may appear in your blood tests:

• Increased levels of 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 tests:

• Low count of cells involved in blood clotting.
• Low white blood cell count.

Frequency not known(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, exfoliative rash, with bumps under the skin and blisters (pustular exanthematous rash).
• flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased white blood cell count and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms - DRESS).

• 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 a doctor immediately if you have any of these symptoms.

• Crystals in the urine that cause acute kidney injury.
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).
• Acute pancreatitis (inflammation of the pancreas)

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

→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 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.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://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 cinfa

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 after EXP. The expiry date refers to the last day of the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of amoxicillin/clavulanic acid cinfa

• The active substances are amoxicillin and clavulanic acid. Each tablet contains 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other ingredients (excipients) are:

Core: magnesium stearate (E-470b), anhydrous colloidal silica (E-551), sodium carboxymethyl starch (type A) (from potato), microcrystalline cellulose (E-460).

Coating: titanium dioxide (E-171), hypromellose 5cps (E-464), hypromellose 15cps (E-464), macrogol 4000 (E-1521), macrogol 6000 (E-1521), dimethicone 500.

Appearance of the product and pack contents

White or almost white, oval, film-coated tablets, scored and marked with the code "A C".

They come in Alu/Alu-polyamide-PVC blister packs, in packs of 20, 30, or 500 (clinical pack) film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer:

LABORATORIOS REIG JOFRÉ, S.A.

C/Jarama, 111. Pol Industrial

45007 Toledo

Spain

Date of last revision of this leaflet:April 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

You can access detailed and up-to-date information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/67892/P_67892.html

QR code to: https://cima.aemps.es/cima/dochtml/p/67892/P_67892.html