Patient Information Leaflet: Package Insert

Amoxicilina / Acido Clavulánico Bluefish 875/125 mg Film-Coated Tablets EFG

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

Read this 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 only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. This is because side effects are not listed in this leaflet. See section 4.

Amoxicilina / Acido clavulánico Bluefish is an antibiotic that eliminates the bacteria that cause infections. It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from occurring.

Amoxicilina / Acido clavulánico Bluefishis 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 Amoxicilina / Acido clavulánico Bluefish

• If you are allergic (hypersensitive) to amoxicilina, ácido clavulánico or any of the other components of this medication (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 know you are allergic to penicillin (or any other antibiotic).
• If you have ever had liver problems or jaundice (yellow discoloration of the skin) when taking an antibiotic

Do not take Amoxicilina / Acido clavulánico Bluefish if you include any of the above points. If you are unsure, consult your doctor or pharmacist before takingAmoxicilina / Acido clavulánico Bluefish.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAmoxicilina / Acido clavulánico Bluefishif:

• You are receiving treatment for liver or kidney problems
• You have infectious mononucleosis
• You do not urinate regularly

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking amoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation ofAmoxicilina / Acido clavulánico Bluefishor another medication.

Be aware of the following symptoms

Amoxicilina / Acido clavulánico Bluefishmay worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions and inflammation of the large intestine.

You should be aware of certain symptoms while takingAmoxicilina / Acido clavulánico Bluefishto reduce the risk of problems. See “Be aware of the following symptoms” in section 4.

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 takingAmoxicilina / Acido clavulánico Bluefish. This is becauseAmoxicilina / Acido clavulánico Bluefishmay alter the results of these types of tests.

Other medications and Amoxicilina / Acido clavulánico Bluefish

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

If you are taking allopurinol (used for gout) withAmoxicilina / Acido clavulánico Bluefish, you may be more likely to suffer a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose ofAmoxicilina / Acido clavulánico Bluefish.

If you are taking anticoagulants (such as warfarin) withAmoxicilina / Acido clavulánico Bluefishyou will need more blood tests.

Amoxicilina / Acido clavulánico Bluefishmay affect the action of methotrexate (a medication used to treat cancer or rheumatic diseases).

Amoxicilina/Ácido clavulánico may affect the functioning of micofenolato mofetilo (a medication used to prevent organ transplant rejection).

Taking Amoxicilina / Acido clavulánico Bluefish with food and drinks and alcohol

Amoxicilina / Acido clavulánico Bluefishshould be taken just before meals, swallow whole and with water. Do not chew

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicilina / Acido clavulánico Bluefishmay cause side effects and symptoms that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina / Acido clavulánico Bluefish contains potassium

This medication contains 0.64 mmol (25 mg) of potassium per tablet, which should be taken into account in patients with renal insufficiency or in patients with low-potassium diets.

Amoxicilina / Acido clavulánico Bluefish contains sodium

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

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

Adults and children 40 kg or more

Usual dose – 1 tablet twice a day.

Higher dose – 1 tablet three times a day

Use in children and adolescents

Consult your doctor or pharmacist when administering Amoxicilina / Acido clavulánico Bluefish tablets to children weighing less than 40 kg.

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 Amoxicilina / Acido clavulánico Bluefish

• Swallow the tablets whole with a glass of water, at the beginning of meals or a little before.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses in one hour.
• Do not take Amoxicilina / Acido clavulánico Bluefish for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina / Acido clavulánico Bluefish than you should:

If you take too much Amoxicilina / Acido clavulánico Bluefish, you may experience symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the packaging with you to show the doctor.

You can also call the Toxicological Information Service, phone 91 5620420, indicating the medication and the amount ingested.

If you forget to take Amoxicilina / Acido clavulánico Bluefish:

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 Amoxicilina / Acido clavulánico Bluefish treatment

Continue taking Amoxicilina / Acido clavulánico Bluefish 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 have the infection again.

If you have any other questions about the use of this medication, ask your doctor or pharmacist

Like all medicines, this medicine can have side effects, although not everyone will experience them.

Symptoms to be aware of

• 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
• collapse
• chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

Contact your doctor immediatelyif you experience any of these symptoms.Stop taking Amoxicilina / Acido clavulánico Bluefish

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Drug-induced enterocolitis syndrome (DIES)

DIES has been mainly 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 medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

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

Contact your doctor as soon as possibleso they can advise you if you experience 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)

• mouth ulcers (Candida– fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses

→if this happens, takeAmoxicilina / Acido clavulánico Bluefishwith meals

• vomiting
• diarrhea (in children)

Uncommon side effects (may affect 1 in 100 people)

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

• dizziness
• headache
• indigestion

Uncommon side effects that may appear in blood tests:

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

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

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

If you haveanyof these symptoms, consult your doctor urgently.

Uncommon side effects that may appear in blood tests:

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

Unknown frequency (frequency cannot be estimated from available data)

• allergic reactions (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• colitis (see above)
• 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 (more than 30% of the body surface –toxic epidermal necrolysis)
• generalized rash with small blisters with pus (exfoliative bullous dermatitis)
• red rash, with lumps under the skin and blisters (pustular exanthema)
• flu-like symptoms, with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

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

• Rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease)

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses ofAmoxicilina / Acido clavulánico Bluefishor who have kidney problems)
• black tongue that looks hairy
• stained teeth (in children), which usually disappears with brushing

Side effects that may appear in your 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 that cause acute kidney damage.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, 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 Pharmacovigilance of Medicines for Human Use: http://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 store at a temperature above 25 °C.

Do not use this medication after the expiration date that appears on the label, carton, or bottle after CAD. The expiration date is the last day of the month indicated..

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

Composition of Amoxicilina / Acid clavulanic Bluefish:

The active principles are Amoxicilina and Acid clavulanic.

Each tablet contains: 875 mg of amoxicilina as amoxicilina trihydrate and 125 mg of acid clavulanic as potassium clavulanate.

The other components are: microcrystalline cellulose (E460) (AVICEL Ph 102), sodium croscarmellose, purified talc, magnesium stearate, hypromellose (E-15), titanium dioxide, hydroxypropylcellulose, ethylcellulose, and propylene glycol.

Appearance of the product and content of the container:

Amoxicilina / Acid clavulanic Bluefish 875mg/125mg tablets are white, elongated, film-coated tablets, scored on both sides, supplied in a PVC/Al blister sealed in aluminum cells with 7, 10, 12, 14, 20, 21, 24, and 30 tablets. Some package sizes may only be marketed.

Marketing Authorization Holder and Responsible for Manufacturing:

Marketing Authorization Holder:

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm

Sweden

Responsible for Manufacturing:

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Branch 36

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Amoxicilina / Acid clavulanic Bluefish 875 mg/125 mg film-coated tablets EFG

Ireland: Co-amoxiclav Bluefish Film Coated Tablets

Poland: Co-amoxiclav Bluefish

Last review date of this leaflet: January 2025

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