CO-AMOXICLAV 875 mg/125 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Co-amoxiclav Bluefish, 875 mg + 125 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before using 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. Bluefish.
   4. Warnings and precautions
   5. Conditions to watch out for
   6. Blood and urine tests
   7. Co-amoxiclav Bluefish and other medicines
   8. Co-amoxiclav Bluefish with food, drink, and alcohol
   9. Pregnancy, breastfeeding, and fertility
   10. Driving and using machines
   11. Co-amoxiclav Bluefish contains potassium
   12. 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 treatment with Co-amoxiclav Bluefish
6. Possible side effects
   1. Conditions to watch out for
   2. The patient should stop taking Co-amoxiclav Bluefish.
   3. Colitis
   4. Drug-induced enterocolitis syndrome (DIES)
   5. Acute pancreatitis
   6. Very common side effects (may affect more than 1 in 10 people)
   7. Common side effects (may affect up to 1 in 10 people)
   8. Uncommon side effects (may affect up to 1 in 100 people)
   9. Rare side effects (may affect 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, 875 mg + 125 mg, film-coated tablets

Amoxicillin + Clavulanic Acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness 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 (inactivation). 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, including penicillins. These 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) associated with the use of an antibiotic.

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

Bluefish.

In case of doubt, before starting to take Co-amoxiclav Bluefish, the patient should consult their doctor or pharmacist.

Warnings and precautions

• Before starting to take Co-amoxiclav Bluefish, the patient should discuss it with their doctor or pharmacist if they are being treated for liver or kidney disease
• if the patient has infectious mononucleosis
• if the patient has irregular urination.

In case of doubt as to whether any of the above statements apply to the patient, before taking Co-amoxiclav Bluefish, they should consult their doctor or pharmacist.
In some cases, the doctor may test 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 a different medicine.

Conditions to watch out for

Taking Co-amoxiclav Bluefish may worsen the course of some diseases or cause severe side effects, including allergic reactions, seizures, and colitis. The patient should pay attention to whether certain symptoms occur during the use of Co-amoxiclav Bluefish to reduce the risk of any problems. See "Conditions to watch out for" 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

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking allopurinol (used in gout) at the same time as Co-amoxiclav Bluefish, they may be more likely to experience skin allergic reactions.
If the patient is taking probenecid (used in gout), their doctor may decide to modify the dose of Co-amoxiclav Bluefish.
If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Co-amoxiclav Bluefish, they 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. The patient should not drive vehicles or operate machines unless they feel well.

Co-amoxiclav Bluefish contains potassium

Each 875 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, i.e., the medicine is considered "sodium-free".

3. How to take Co-amoxiclav Bluefish

This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.

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

• Usual dose - 1 tablet twice a day.
• Larger dose - 1 tablet three times a day.

Use in children and adolescents

The patient should consult their doctor or pharmacist before taking Co-amoxiclav Bluefish tablets in 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 a different medicine.
• If the patient has liver disease, blood tests may be performed more frequently to check liver function.

How to take Co-amoxiclav Bluefish

• The line on the tablet is only to facilitate breaking and not to divide into equal doses.
• The tablets should be swallowed 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.
• The patient should maintain equal intervals of at least 4 hours between doses taken during the day. They should not take 2 doses within 1 hour.
• The patient should not take Co-amoxiclav Bluefish for more than 2 weeks. If they still do 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 intestinal 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 treatment with 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 needed 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, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

Conditions to watch out for

• 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 involving the face or mouth (angioedema), causing difficulty breathing;
• excessive sweating, rapid heartbeat, or loss of consciousness;
• 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, the patient should contact their doctor immediately.

The patient should 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, the leading symptom of which 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 the patient has severe and persistent stomach pain, it may be a sign of acute pancreatitis.
If any of these symptoms occur, the patient should contact their doctor as soon as possible for advice.

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

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

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

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

• skin rash, which may be accompanied by blisters and look like small targets (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)
• meningitis (aseptic meningitis);
• 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 widespread 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)]

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

• blistering rash, which may be arranged in a ring or like a string of pearls (linear IgA dermatosis);
• hepatitis;
• jaundice, caused by an increase in the level of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, it is possible to gather more information on the safety of the medicine.

5. How to store Co-amoxiclav Bluefish

The medicine should be stored 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. 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 875 mg of amoxicillin as amoxicillin trihydrate and 125 mg of clavulanic acid as potassium clavulanate.
The other ingredients are cellulose, microcrystalline (E 460) (AVICEL pH 102), croscarmellose sodium, purified talc, magnesium stearate, and coating: hypromellose (E-15), titanium dioxide suspension [Opaspray K-1-7000): SDA 3 A Alkohol 27 CRF (ethanol, methanol), titanium dioxide (E 171), hydroxypropylcellulose] and propylene glycol.

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

Co-amoxiclav Bluefish, 875 mg + 125 mg, is available in the form of white or almost white oval film-coated tablets, with a line on both sides, packaged in PVC/Aluminum blisters.
The packs contain 14 tablets (2 blisters) 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:

Spain:
Co-amoxiclav Bluefish 875 mg/125 mg Film Coated Tablets
Ireland:
Co-amoxiclav Bluefish 875 mg/125 mg Film Coated Tablets
Poland:
Co-amoxiclav Bluefish
Date of last revision of the leaflet:January 2025