AMOXICILLIN/CLAVULANIC ACID CINFAMED 500 mg/125 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

amoxicillin/clavulanic acid cinfamed 500 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 cinfamed is and what it is used for
2. What you need to know before you take amoxicillin/clavulanic acid cinfamed
3. How to take amoxicillin/clavulanic acid cinfamed
4. Possible side effects
5. Storage of amoxicillin/clavulanic acid cinfamed
6. Contents of the pack and other information

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

amoxicillin/clavulanic acid cinfamed 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" that can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin/clavulanic acid is used in adults and children 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 cinfamed

Do not take amoxicillin/clavulanic acid cinfamed:

• 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 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 cinfamed 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 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 cinfamed

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 can make you unfit to drive.

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

amoxicillin/clavulanic acid cinfamed 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 cinfamed

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

Adults and children over 40 kg

The recommended dose is 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.

Ask your doctor or pharmacist for advice when administering amoxicillin/clavulanic acid tablets to children who weigh less than 40 kg. The tablets are not suitable for children who weigh less than 25 kg.

Patient 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 cinfamed

• Take with meals.
• Swallow the tablets whole with a glass of water.
• The score line is only to facilitate breaking the tablet if you find it difficult to swallow it whole. You should take both parts 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 cinfamed 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.

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

If you forget to take amoxicillin/clavulanic acid cinfamed

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 cinfamed

Continue taking amoxicillin/clavulanic acid until you finish the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the bacteria that survive may cause you to have the infection 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.

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 immediatelyif 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 immediatelyif you experience any of 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

• 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 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 your doctor urgently.

Rare side effects that may appear in blood tests:

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

Frequency not known

Cannot be estimated from the available data.

• allergic reactions (see above)
• 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 rash)
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as elevated liver enzymes and eosinophilia) (drug reaction with eosinophilia and systemic symptoms - DRESS).

• Chest pain in the context of allergic reactions, which can be a symptom of allergy-induced myocardial infarction (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.

• 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 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 blood or urine tests:

• significant reduction in the number of white blood cells
• low count of red blood cells (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 through 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 cinfamed

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 packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy. 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 cinfamed

• The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other ingredients (excipients) are:

Core: colloidal anhydrous silica, magnesium stearate, sodium starch glycolate (type A), and microcrystalline cellulose.

Coating: Opadry Oy-S-7300 (contains hypromellose 5 cP (E-464), hypromellose 15 cP (E-464), macrogol 4000 (E-1521), macrogol 6000 (E-1521), titanium dioxide (E-171)), dimethicone 500, and purified water.

Appearance of the product and pack contents

White, elongated, scored tablets with the inscription A/C.

Available in Alu/Alu-polyamide-PVC blisters and in packs of 20 or 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorio REIG JOFRE, S.A.

C/Jarama 111. Pol Industrial

45007 Toledo - Spain

Date of last revision of this leaflet:April 2023

Detailed 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 updated information about 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/66765/P_66765.html.

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