CO-AMOXICLAV 500 mg/125 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Co-amoxiclav Bluefish, 500 mg + 125 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is Co-amoxiclav Bluefish and what is it used for
4. Important information before taking Co-amoxiclav Bluefish
   1. When not to take Co-amoxiclav Bluefish
   2. If the above circumstances apply to the patient, they should not take Co-amoxiclav Bluefish.
   3. Warnings and precautions
   4. Conditions to be aware of
   5. Blood and urine tests
   6. Co-amoxiclav Bluefish and other medicines
   7. Co-amoxiclav Bluefish with food, drink, and alcohol
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Co-amoxiclav Bluefish contains potassium
   11. Co-amoxiclav Bluefish contains sodium
5. How to take Co-amoxiclav Bluefish
   1. Adults and children with a body weight of 40 kg or more
   2. Use in children and adolescents
   3. Patients with kidney and liver diseases
   4. How to take Co-amoxiclav Bluefish
   5. Taking a higher dose of Co-amoxiclav Bluefish than recommended
   6. Missing a dose of Co-amoxiclav Bluefish
   7. Stopping the use of Co-amoxiclav Bluefish
6. Possible side effects
   1. Conditions to be aware of
   2. Stop taking Co-amoxiclav Bluefish.
   3. Colitis
   4. Drug-induced enterocolitis syndrome (DIES)
   5. Acute pancreatitis
   6. Very common side effects (may occur in more than 1 in 10 people)
   7. Common side effects (may occur in up to 1 in 10 people)
   8. Uncommon side effects (may occur in up to 1 in 100 people)
   9. Rare side effects (may occur in up to 1 in 1,000 people)
   10. Side effects with unknown frequency (frequency cannot be estimated from available data)
   11. If the patient experiences any of these symptoms, they should contact their doctor immediately
   12. Reporting side effects
7. How to store Co-amoxiclav Bluefish
8. Contents of the pack and other information
   1. What Co-amoxiclav Bluefish contains
   2. What Co-amoxiclav Bluefish looks like and contents of the pack
   3. Marketing authorization holder and importer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Leaflet attached to the packaging: information for the user

Co-amoxiclav Bluefish, 500 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic Acid

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Co-amoxiclav Bluefish and what is it used for
• 2. Important information before taking Co-amoxiclav Bluefish
• 3. How to take Co-amoxiclav Bluefish
• 4. Possible side effects
• 5. How to store Co-amoxiclav Bluefish
• 6. Contents of the pack and other information

1. What is Co-amoxiclav Bluefish and what is it used for

Co-amoxiclav Bluefish is an antibiotic that works bactericidally on bacteria that cause infections. Co-amoxiclav Bluefish contains two different medicines: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose action may sometimes be inhibited (inactivated). The second active ingredient (clavulanic acid) counteracts this inactivation. Co-amoxiclav Bluefish 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. Important information before taking Co-amoxiclav Bluefish

When not to take Co-amoxiclav Bluefish

• If the patient is allergic to amoxicillin, clavulanic acid, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had severe allergic reactions (hypersensitivity) to any other antibiotic. They may include skin rash or swelling of the face or neck.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) related to the use of an antibiotic.

If the above circumstances apply to the patient, they should not take Co-amoxiclav Bluefish.

Bluefish.In case of doubts, before starting to take Co-amoxiclav Bluefish, consult your doctor or pharmacist.

Warnings and precautions

Before taking Co-amoxiclav Bluefish, discuss it with your doctor or pharmacist

• if the patient is being treated for liver disease or kidney disease
• if the patient has infectious mononucleosis
• if the patient has irregular urination.

In case of doubts whether any of the above statements apply to the patient, before taking Co-amoxiclav Bluefish, consult your doctor or pharmacist. In some cases, the doctor may examine what type of bacteria caused the patient's infection. Depending on the results, the patient may receive Co-amoxiclav Bluefish in a different dose or another medicine.

Conditions to be aware of

Taking Co-amoxiclav Bluefish may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. Pay attention to whether the patient experiences certain symptoms during the use of Co-amoxiclav Bluefish to minimize the risk of any problems. See "Conditions to be aware of" in section 4.

Blood and urine tests

If the patient is to have blood tests (such as red blood cell tests or liver function tests) or urine tests (for glucose), they should inform their doctor or nurse that they are taking Co-amoxiclav Bluefish. Co-amoxiclav Bluefish may affect the results of these tests.

Co-amoxiclav Bluefish and other medicines

Tell your doctor about all medicines you are taking now or have taken recently, as well as any medicines you plan to take. If you are taking allopurinol (used in gout) at the same time as Co-amoxiclav Bluefish, you may be more likely to experience skin allergic reactions. If you are taking probenecid (used in gout), your doctor may decide to modify the dose of Co-amoxiclav Bluefish. If you are taking blood thinners (such as warfarin) at the same time as Co-amoxiclav Bluefish, you may need to have additional blood tests. Co-amoxiclav Bluefish may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases). Co-amoxiclav Bluefish may affect the action of mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs).

Co-amoxiclav Bluefish with food, drink, and alcohol

Co-amoxiclav Bluefish tablets should be taken directly before a meal, swallowing them whole and washing them down with water. The tablets should not be chewed.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Co-amoxiclav Bluefish may cause side effects and symptoms that can impair the ability to drive vehicles. Do not drive vehicles or operate machines unless you feel well.

Co-amoxiclav Bluefish contains potassium

Each 500 mg + 125 mg tablet of Co-amoxiclav Bluefish contains 25 mg (i.e., 0.64 mmol) of potassium.

Co-amoxiclav Bluefish contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 500 mg + 125 mg tablet, which means the medicine is considered "sodium-free".

3. How to take Co-amoxiclav Bluefish

This medicine should always be taken as directed by your doctor. In case of doubts, consult your doctor or pharmacist.

Adults and children with a body weight of 40 kg or more

The usual dose is:

• 1 tablet three times a day.

Use in children and adolescents

Consult your doctor or pharmacist before giving Co-amoxiclav Bluefish tablets to children with a body weight below 40 kg.

Patients with kidney and liver diseases

• If the patient has kidney disease, the dose of the medicine may be changed. The doctor may choose a different dose of Co-amoxiclav Bluefish or another medicine.
• If the patient has liver disease, blood tests may be performed more frequently to check liver function.

How to take Co-amoxiclav Bluefish

• Swallow the tablets whole, washing them down with a glass of water. The medicine should be taken at the beginning of a meal or shortly before a meal.
• Keep equal intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour.
• Do not take Co-amoxiclav Bluefish for longer than 2 weeks. If the patient still does not feel well, they should contact their doctor again.

Taking a higher dose of Co-amoxiclav Bluefish than recommended

If the patient has taken a higher dose of Co-amoxiclav Bluefish than recommended, they may experience symptoms such as stomach and intestine irritation (nausea, vomiting, or diarrhea) or seizures. They should contact their doctor as soon as possible. They should have the carton of the medicine with them to show it to the doctor.

Missing a dose of Co-amoxiclav Bluefish

If the patient forgets to take a dose, they should take it as soon as they remember. They should not take the next dose too early; they should wait about 4 hours before taking the next dose. They should not take a double dose to make up for the missed dose.

Stopping the use of Co-amoxiclav Bluefish

The patient should continue taking Co-amoxiclav Bluefish until the end of the treatment, even if they feel better. All doses of the medicine are necessary to combat the infection. If some bacteria survive, they may cause a relapse of the infection. In case of any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Conditions to be aware of

• skin rash;
• vasculitis, which may appear as red or purple, raised spots on the skin, but may also affect other organs;
• fever, joint pain;
• swelling of the glands in the neck, under the arm, or in the groin;
• swelling, sometimes including the face or mouth (angioedema), causing difficulty breathing;
• anaphylaxis;
• chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).

If any of these symptoms occur, contact a doctor immediately.

Stop taking Co-amoxiclav Bluefish.

Colitis

Colitis causing watery diarrhea, usually with blood and mucus, abdominal pain, and (or) fever.

Drug-induced enterocolitis syndrome (DIES)

Drug-induced enterocolitis syndrome occurred mainly in children receiving amoxicillin with clavulanic acid. It is a type of allergic reaction, whose leading symptom is repeated vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Acute pancreatitis

If you have severe and persistent stomach pain, it may be a symptom of acute pancreatitis. If any of these symptoms occur, contact your doctor as soon as possible for advice.

Very common side effects (may occur in more than 1 in 10 people)

• diarrhea (in adults).

Common side effects (may occur in up to 1 in 10 people)

• thrush (candidiasis - a yeast infection of the vagina, mouth, or skin folds);
• nausea (especially when taking high doses). If they occur, take Co-amoxiclav Bluefish with a meal.
• vomiting;
• diarrhea (in children).

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

• skin rash, itching;
• raised, itchy rash (hives);
• dizziness;
• headache;
• indigestion; Uncommon side effects that may appear in blood or urine test results:
• increased activity of certain substances (enzymes) produced in the liver.

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

• skin rash, which may be accompanied by blisters and look like small targets (a dark spot in the center surrounded by a lighter border with a dark ring around the edge - erythema multiforme). If the patient notices any of these symptoms, they should contact their doctor urgently. Rare side effects that may appear in blood test results:
• low number of blood cells involved in blood clotting
• low number of white blood cells.

Side effects with unknown frequency (frequency cannot be estimated from available data)

• hypersensitivity reactions (see above)
• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord);
• colitis (see above);
• severe skin reactions:
• -widespread skin rash, which may be accompanied by blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin peeling (more than 30% of the body surface - toxic epidermal necrolysis)
• -widespread red skin rash, which may be accompanied by small pus-filled blisters (bullous exfoliative dermatitis)
• -red, scaly rash with thickening under the skin and blisters (exfoliative dermatitis)
• -flu-like symptoms, with a rash, fever, swollen lymph nodes, and abnormal blood test results [including an increased number of white blood cells (eosinophilia) and increased liver enzyme activity] [drug reaction with eosinophilia and systemic symptoms (DRESS)]
• -red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, neck (SDRIFE, Symmetrical Drug-Related Intertriginous and Flexural Exanthema)

If the patient experiences any of these symptoms, they should contact their doctor immediately

• rash with blisters arranged in a ring or like a string of pearls (linear IgA dermatosis);
• hepatitis;
• jaundice, caused by an increased level of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and eyes;
• interstitial nephritis;
• prolonged blood clotting time;
• restlessness;
• seizures (in people taking high doses of Co-amoxiclav Bluefish or with kidney disease);
• black hairy tongue;
• tooth discoloration (in children), which can usually be removed by brushing teeth

Side effects that may appear in blood or urine test results:

• significant decrease in the number of white blood cells
• low number of red blood cells (hemolytic anemia)
• crystals in the urine leading to acute kidney damage.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Co-amoxiclav Bluefish

Keep the medicine out of sight and reach of children. Do not store above 25°C. Do not use this medicine after the expiry date stated on the blister and carton after "Expiry Date (EXP)". The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Co-amoxiclav Bluefish contains

The active substances of the medicine 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 are cellulose, microcrystalline (AVICEL pH 102), croscarmellose sodium, purified talc, magnesium stearate, coating: hypromellose, ethylcellulose, titanium dioxide, suspension [Opaspray K-1-7000): SDA 3 A Alcohol 27 CRF (ethanol, methanol), titanium dioxide (E 171), hydroxypropylcellulose], propylene glycol.

What Co-amoxiclav Bluefish looks like and contents of the pack

Co-amoxiclav Bluefish, 500 mg + 125 mg, is available in the form of white or almost white oval film-coated tablets, packaged in PVC/Aluminum blisters. The packs contain 14 tablets (2 blisters of 7), 21 tablets (3 blisters of 7), or 30 tablets.

Marketing authorization holder and importer

Bluefish Pharmaceuticals AB
P.O. Box 49013,
100 28 Stockholm
Sweden

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

Ireland:
Co-amoxiclav Bluefish Film Coated Tablets
Poland:
Co-amoxiclav Bluefish
Date of last revision of the leaflet:January 2025