Leaflet: information for the user

amoxicillin/clavulanic acid cinfa 875 mg/125 mg film-coated tablets

Read this leaflet carefully before you start to take this medicine, becauseit contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, 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.

amoxicillin/clavulanic acid cinfa 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 cinfa 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.

Do not take amoxicillin/clavulanic acid cinfa:

→Do not take amoxicillin/clavulanic acid if you are included in any of the above points. Before starting treatment withamoxicillin/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:

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, they may prescribe a different presentation of amoxicillin/clavulanic acid or another medicine.

Be aware of the following symptoms

Amoxicillin/clavulanic acid may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while taking amoxicillin/clavulanic acid to reduce the risk of problems. See “Be aware of the following symptoms” in section4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) 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 alter the results of these types of tests.

Other medicines and amoxicillin/clavulanic acid cinfa

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

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), the 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 micophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

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.

Amoxicillin/clavulanic acid cinfa contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

• Recommended 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 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 functioning.

How to take amoxicillin/clavulanic acid cinfa

• Take with meals

• Swallow the tablets whole with a glass of water. The tablets can be broken by the notch. The notch is only for breaking the tablet if it is difficult to swallow it whole. 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 cinfa than you should

If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Bring the packaging with you to show to your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or 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 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 the missed doses.

If you interrupt the treatment withamoxicillin/clavulanic acid cinfa

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 doubts 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.
• Shock.

→Contact your doctor immediately if you experience any of these symptoms.Stop taking amoxicillin/clavulanic acid.

Colitis:

Colitis, 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 patients):

• Diarrhea (in adults).

Common side effects(may affect up to 1 in 10 patients):

• 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 up to 1 in 100 patients):

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

Side effects that may appear in your blood tests:

• Increased levels of certain substances (enzymes) produced by the liver.

Rare side effects(may affect up to 1 in 1,000 patients):

• Skin rash, which may form blisters that look like small darts (erythema multiforme).

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

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 available data):

• Allergic reactions (see above).
• Colitis (see above).
• Menigitis (inflammation of the protective membranes surrounding the brain and spinal cord).
• 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 (toxic epidermal necrolysis).
• Generalized rash with small blisters with pus (exfoliative dermatitis).
• Red exfoliative rash, with lumps under the skin and blisters (pustular exanthema).
• Symptoms similar to the flu, with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

• Chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES):

DIES has mainly been 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.

• Crystals in the urine that cause acute kidney injury.
• Rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease).
• Acute pancreatitis.

If you have intense and persistent pain in the abdominal area, this could be a sign of acute pancreatitis.

→Contact a doctor immediately if you have any of these symptoms.

• Acute hepatitis.
• Icterus, caused by increased 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.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems).
• Black tongue that appears hairy.

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

• Significant reduction 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 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 Medicinal Products for Human Use:https://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 after CAD. 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of amoxicillin/clavulanic acid cinfa

• The active principles 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 components (excipients) are:

Core: magnesium stearate (E-470b), anhydrous colloidal silica (E-551), sodium carboxymethylcellulose (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 contents of the packaging

Oval-shaped tablets with a white or almost white film coating, scored, and marked with the code “A C”.

Presented in Alu/Alu-poliamida-PVC blisters, in packaging of 20, 30, or 500 (clinical packaging) oval-shaped tablets with a white or almost white film coating.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing:

LABORATORIOS REIG JOFRÉ, S.A.

Jarama Street, 111.Industrial Park

45007 Toledo

Spain

Last review date of this leaflet:April 2023

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

You can access detailed and updated information on this medication 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