CO-AMOXICLAV BLUEFISH

Package leaflet: Information for the user

Co-amoxiclav Bluefish, 500 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

Co-amoxiclav Bluefish is an antibiotic with bactericidal activity against bacteria causing infections. Co-amoxiclav Bluefish contains two different active substances: amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", whose activity 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 using Co-amoxiclav Bluefish

When not to use 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. These may include skin rash or swelling of the face or neck area.
• If the patient has ever had liver function disorders or jaundice (yellowing of the skin) associated with the use of an antibiotic.

If any of the above situations apply, the patient should not take Co-amoxiclav Bluefish.
If in doubt, consult the patient's doctor or pharmacist before starting treatment with Co-amoxiclav Bluefish.
Warnings and precautions
Before starting treatment with Co-amoxiclav Bluefish, discuss this with a doctor or pharmacist:

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

If in doubt whether any of the above conditions apply to the patient, consult a doctor or pharmacist before using Co-amoxiclav Bluefish.
In some cases, the doctor may test which type of bacteria caused the patient's infection. Depending on the results, the patient may receive Co-amoxiclav Bluefish at a different dose or another medicine.
Conditions to be aware of
Treatment with Co-amoxiclav Bluefish may worsen certain diseases or cause serious adverse effects, including allergic reactions, seizures, and colitis. It is important to monitor whether the patient develops specific symptoms during treatment with Co-amoxiclav Bluefish to reduce the risk of complications. See "Conditions to be aware of" in section 4.
Blood and urine tests
If the patient is due to have blood tests (such as red blood cell count or liver function tests) or urine tests (for glucose), inform the doctor or nurse that the patient is taking Co-amoxiclav Bluefish. Co-amoxiclav Bluefish may affect the results of such tests.
Co-amoxiclav Bluefish and other medicines
Inform the doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If the patient is taking allopurinol (used for gout) at the same time as Co-amoxiclav Bluefish, skin allergic reactions may be more likely.
If the patient is taking probenecid (used for gout), the doctor may decide to adjust the dose of Co-amoxiclav Bluefish.
If the patient is taking anticoagulant medicines (such as warfarin) together with Co-amoxiclav Bluefish, additional blood tests may be necessary.
Co-amoxiclav Bluefish may affect the action of methotrexate (a medicine used in the treatment of cancer or rheumatic diseases).
Co-amoxiclav Bluefish may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Co-amoxiclav Bluefish, food, drink, and alcohol
Co-amoxiclav Bluefish tablets should be taken just before a meal, swallowed whole with water. Do not chew the tablets.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
Co-amoxiclav Bluefish may cause adverse effects and symptoms that impair the ability to drive or operate machinery. Do not drive or operate machinery unless the patient feels well.
Co-amoxiclav Bluefish contains potassium
Each 500 mg + 125 mg Co-amoxiclav Bluefish tablet 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, meaning the medicine is considered "sodium-free".

3. How to use Co-amoxiclav Bluefish

This medicine should always be taken exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
The usual dose is:

• 1 tablet three times a day.

Use in children and adolescents
Seek advice from your doctor or pharmacist before using Co-amoxiclav Bluefish tablets in children weighing less than 40 kg.
Patients with kidney or liver disease

• If the patient has kidney problems, the dose of this medicine may need to be adjusted. Your doctor may prescribe a different dose of Co-amoxiclav Bluefish or another medicine.
• If the patient has liver problems, blood tests may be performed more frequently to monitor liver function.

How to take Co-amoxiclav Bluefish

• Swallow the tablets whole with a glass of water. Take the medicine at the beginning of a meal or shortly before a meal.
• Maintain regular intervals of at least 4 hours between doses taken during the day. Do not take 2 doses within 1 hour of each other.
• Do not take Co-amoxiclav Bluefish for longer than 2 weeks. If the patient still does not feel better, they should contact their doctor again.

Taking more Co-amoxiclav Bluefish than prescribed
If the patient takes more Co-amoxiclav Bluefish than prescribed, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Keep the cardboard packaging of the medicine to show it to the doctor.
If you miss a dose of Co-amoxiclav Bluefish
If the patient forgets to take a dose, take it as soon as they remember. Do not take the next dose too early; wait approximately 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
Stopping treatment with Co-amoxiclav Bluefish
Continue taking Co-amoxiclav Bluefish for the full duration of treatment, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, the infection may return.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Symptoms to be aware of

• Skin rash;
• Vasculitis (inflammation of blood vessels), which may appear as red or purple raised spots on the skin, but may also affect other organs;
• Fever, joint pain;
• Swelling of glands in the neck, underarm, or groin;
• Swelling, sometimes affecting the face or mouth (angioedema), causing difficulty in breathing;
• Collapse;
• Chest pain related to an allergic reaction, which may be a sign of an allergy leading to heart attack (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice.
Stop taking Co-amoxiclav Bluefish immediately.
Colitis
Inflammation of the large intestine causing watery diarrhoea, usually with blood and mucus, abdominal pain and (or) fever.
Drug-induced enterocolitis syndrome (DIES)
Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin with clavulanic acid. This is a type of allergic reaction, the main symptom of which is recurrent vomiting (1 to 4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
Acute pancreatitis
If you have severe and persistent pain in the stomach area, this may be a sign of acute pancreatitis.
If any of these symptoms occur, contact your doctor immediately for advice.
Very common adverse reactions (may affect more than 1 in 10 people)

• Diarrhoea (in adults).

Common adverse reactions (may affect up to 1 in 10 people)

• Fungal infections (candidiasis – yeast infection of the vagina, mouth or skin folds);
• Nausea, especially when high doses are used. If nausea occurs, take Co-amoxiclav Bluefish with food.
• Vomiting;
• Diarrhoea (in children).

Uncommon adverse reactions (may affect up to 1 in 100 people)

• Skin rash, itching;
• Raised, itchy rash (urticaria);
• Dizziness;
• Headache;
• Indigestion.
  Uncommon adverse reactions that may appear in blood test results:
• Increased activity of certain substances (enzymes) produced in the liver.

Rare adverse reactions (may affect up to 1 in 1000 people)

• Skin rash, possibly with blisters and resembling target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring at the edge – erythema multiforme). If any of these symptoms are noticed, contact a doctor urgently.
  Rare adverse reactions that may appear in blood test results:
• Low number of blood platelets (thrombocytopenia);
• Low number of white blood cells (leukopenia).

Adverse reactions with unknown frequency (frequency cannot be estimated from available data)

• Hypersensitivity reactions (see above);
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
• Colitis (see above);
• Severe skin reactions:
  • Widespread skin rash, possibly with blisters and skin peeling, particularly around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (over 30% of body surface – toxic epidermal necrolysis);
  • Widespread red rash with small pus-filled blisters (bullous exfoliative dermatitis);
  • Red, scaly rash with subcutaneous nodules and blisters (pustular eruption);
  • Influenza-like symptoms with rash, fever, swollen lymph nodes and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity] [drug reaction with eosinophilia and systemic symptoms (DRESS)];
  • Red rash commonly seen on both buttocks, inner upper thighs, armpits, neck (SDRIFE – Symmetrical Drug-Related Intertriginous and Flexural Exanthema).

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

• Blistering rash arranged in a ring-like or "pearl necklace" pattern (linear IgA dermatosis);
• Hepatitis (liver inflammation);
• Jaundice, caused by increased bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes;
• Inflammation of the kidney tubules;
• Prolonged blood clotting time;
• Restlessness;
• Seizures (in people receiving high doses of Co-amoxiclav Bluefish or with kidney disease);
• Black, hairy-looking tongue;
• Tooth discoloration (in children), which can usually be removed by brushing teeth.

Adverse reactions that may appear in blood or urine tests:

• Marked decrease in white blood cells (leukopenia);
• Low number of red blood cells (haemolytic anaemia);
• Crystals in urine leading to acute kidney injury.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Co-amoxiclav Bluefish

Keep this 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 pack and the cardboard
carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated 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 in this medicine are amoxicillin and clavulanic acid.
Each coated tablet contains 500 mg of amoxicillin in the form of amoxicillin trihydrate and
125 mg of clavulanic acid in the form of potassium clavulanate.
The other ingredients are microcrystalline cellulose (AVICEL pH 102), sodium croscarmellose, 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 a white or almost white, oval, film-coated tablet, packed in PVC/Aluminium blisters. The packs contain 14 tablets (2 blisters of 7 tablets), 21 tablets (3 blisters of 7 tablets), or 30 tablets.

Marketing Authorisation Holder and Importer
Bluefish Pharmaceuticals AB
P.O. Box 49013,
100 28 Stockholm
Sweden

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Ireland: Co-amoxiclav Bluefish Film Coated Tablets
Poland: Co-amoxiclav Bluefish