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

2. What you need to know before taking Amoxicillin/Clavulanic Acid Bluefish

Do not take Amoxicillin/Clavulanic Acid Bluefish

• If you are allergic (hypersensitive) to amoxicillin, clavulanic acid, 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 a 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 (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Bluefish if you are included in any of the above points. If you are not sure, consult your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Bluefish.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid Bluefish if:

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

If you are not sure 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 Bluefish or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Bluefish may worsen certain 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 taking Amoxicillin/Clavulanic Acid Bluefish 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 Bluefish. This is because Amoxicillin/Clavulanic Acid Bluefish may affect the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Bluefish

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 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 of Amoxicillin/Clavulanic Acid Bluefish.

If you are taking anticoagulants (such as warfarin) with Amoxicillin/Clavulanic Acid Bluefish, more blood tests will be needed.

Amoxicillin/Clavulanic Acid Bluefish may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases).

Amoxicillin/Clavulanic Acid may affect the functioning of mycophenolate mofetil (a medicine used to prevent organ rejection after transplantation).

Taking Amoxicillin/Clavulanic Acid Bluefish with food, drinks, and alcohol

Amoxicillin/Clavulanic Acid Bluefish should be taken just before meals, swallowed whole, and with water. Do not chew them.

Pregnancy, breastfeeding, and fertility

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 Bluefish 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 Bluefish contains potassium

This medicine 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.

Amoxicillin/Clavulanic Acid Bluefish contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Bluefish

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

Adults and children over 40 kg

Usual dose – 1 tablet twice a day.

Higher dose – 1 tablet three times a day.

Use in children and adolescents

Ask your doctor or pharmacist for advice when giving Amoxicillin/Clavulanic Acid Bluefish tablets to children who weigh 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 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 Bluefish

• Swallow the tablets whole with a glass of water, at the start of meals or a little before.
• 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 Bluefish for more than 2 weeks. If you are still feeling unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid Bluefish than you should:

If you take too much Amoxicillin/Clavulanic Acid Bluefish, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions. Consult your doctor as soon as possible. Take the pack with you to show the doctor.

You can also call the Toxicology Information Service, telephone 91 5620420, stating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid 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 forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Bluefish

Continue taking Amoxicillin/Clavulanic Acid Bluefish 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.

Symptoms to be aware of

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

Contact your doctor immediatelyif you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Bluefish

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

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.

Acute pancreatitis (inflammation of the pancreas)

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

Contact your doctor as soon as possiblefor 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 Bluefish with meals

• vomiting
• diarrhea (in children)

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

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

• dizziness
• headache
• indigestion

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 (frequency cannot be estimated from the available data)

• allergic reactions (see above)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• inflammation of the large intestine (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, gland inflammation, and abnormal blood test results (such as increased white blood cells (eosinophilia) 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 like a string of pearls (linear IgA disease)

• inflammation of the liver (hepatitis)
• jaundice, caused by increased 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
• convulsions (in patients taking high doses of Amoxicillin/Clavulanic Acid Bluefish or with kidney problems)
• black hairy tongue
• stained teeth (in children), which usually disappears with brushing

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

• significant decrease in the number of white blood cells
• low count of red blood cells (hemolytic anemia)
• crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: http://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 Bluefish

Keep this medicine out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the label, carton, or bottle after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Place the empty pack and any remaining medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the pack and any remaining medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Amoxicillin/Clavulanic Acid Bluefish:

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 clavulanate potassium.

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

Appearance of the product and pack contents:

Amoxicillin/Clavulanic Acid Bluefish 875mg/125mg tablets are white, elongated, film-coated, scored on both sides, and supplied in a PVC/Al blister pack with 7, 10, 12, 14, 20, 21, 24, and 30 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB

P.O. Box 49013,

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

You can obtain further information on this medicine by contacting the local representative of the marketing authorization holder:

Bluefish Pharma S.L.U

AP 36007

2832094 Madrid, Branch 36

This medicine is authorized in the Member States of the European Economic Area under the following names:

Spain: Amoxicillin/Clavulanic Acid Bluefish 875 mg/125 mg film-coated tablets EFG

Ireland: Co-amoxiclav Bluefish Film Coated Tablets

Poland: Co-amoxiclav Bluefish

Date of the last revision of this leaflet:January 2025

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/