Co-amoxiclav bluefish

Package leaflet: Information for the user

Co-amoxiclav Bluefish, 875 mg + 125 mg, film-coated tablets
Amoxicillinum + Acidum clavulanicum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

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

Table of contents:

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 component (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, including penicillins. These may include skin rash or swelling of the face or neck.
• If the patient has ever experienced liver function disorders or jaundice (yellowing of the skin) associated with taking an antibiotic.

If any of the above situations apply, the patient must not take Co-amoxiclav Bluefish.
If in doubt, consult the doctor or pharmacist before starting treatment with Co-amoxiclav Bluefish.

Warnings and precautions

• Before starting treatment with Co-amoxiclav Bluefish, discuss with a doctor or pharmacist if the patient:
  • is being treated for liver or kidney disease
  • has infectious mononucleosis
  • urinates irregularly.

If in doubt whether any of the above apply, consult a doctor or pharmacist before taking Co-amoxiclav Bluefish.
In some cases, the doctor may investigate which type of bacteria caused the infection. Depending on the results, the patient may be prescribed 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 inflammation of the large intestine. 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 these 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 takes allopurinol (used for gout) at the same time as Co-amoxiclav Bluefish, skin allergic reactions may be more likely.
If the patient takes probenecid (used for gout), the doctor may decide to adjust the dose of Co-amoxiclav Bluefish.
If the patient takes anticoagulant medicines (such as warfarin) at the same time as Co-amoxiclav Bluefish, additional blood tests may be necessary.
Co-amoxiclav Bluefish may affect the action of methotrexate (a medicine used in 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 with 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 may 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 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, 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 with body weight of 40 kg or more

• Usual dose – 1 tablet twice daily.
• Higher dose – 1 tablet three times daily.

Use in children and adolescents
Please consult your doctor or pharmacist before using Co-amoxiclav Bluefish tablets in children with body weight below 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 an alternative medicine.
• If the patient has liver problems, blood tests may be performed more frequently to monitor liver function.

How to take Co-amoxiclav Bluefish

• The score line on the tablet is only intended to facilitate swallowing by allowing the tablet to be broken, but does not allow for division into equal doses.
• 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.
• Do not take Co-amoxiclav Bluefish for longer than 2 weeks. If the patient still does not feel better, he/she should contact the doctor again.

Taking more Co-amoxiclav Bluefish than recommended
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.

Missing a dose of Co-amoxiclav Bluefish
If the patient forgets to take a dose, it should be taken as soon as remembered. 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, they may cause the infection to return.

If you have any further questions 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 will experience them.
Symptoms that require attention

• 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 involving the face or mouth (angioedema), causing difficulty in breathing;
• excessive sweating, rapid heartbeat, or loss of consciousness;
• chest pain related to an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome).

If any of these symptoms occur, seek immediate medical advice.
Stop taking Co-amoxiclav Bluefish immediately.
Inflammation of the large intestine (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 syndrome has mainly occurred 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 as soon as possible for advice.
Very common side effects (may affect more than 1 in 10 people)

• diarrhoea (in adults).

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

• fungal infections (candidiasis – yeast infection of the vagina, mouth or skin folds);
• nausea, particularly when higher doses are used. If this occurs, take Co-amoxiclav Bluefish with food.
• vomiting;
• diarrhoea (in children).

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

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

Rare side effects (may affect up to 1 in 1000 people)

• skin rash, possibly with blisters and appearing as target-like lesions (dark spot in the centre surrounded by a lighter ring and a dark ring around the edge – erythema multiforme). If any of these symptoms occur, contact your doctor urgently.
  Rare side effects that may be seen in blood test results:
• low number of cells involved in blood clotting (thrombocytopenia);
• low number of white blood cells (leucopenia).

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

• hypersensitivity reactions (see above);

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);

• inflammation of the large intestine (colitis) (see above);

• severe skin reactions:

  • widespread skin rash, 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 peeling (more than 30% of body surface area – toxic epidermal necrolysis);
  • widespread red rash with small pustules (pemphigoid bullous dermatitis);
  • red, scaly rash with subcutaneous nodules and blisters (pustular eruption);
  • flu-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)];

• if any of these symptoms occur, contact your doctor immediately:

• blistering rash arranged in a ring-like pattern or like a string of pearls (linear IgA dermatosis);

• hepatitis (liver inflammation);

• jaundice, caused by increased levels of 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.

Side effects that may be observed in blood or urine tests:

• marked decrease in white blood cells;
• low number of red blood cells (haemolytic anaemia);
• crystals in urine leading to acute kidney injury.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Co-amoxiclav 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 stated on the blister pack and the cardboard
box 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 are amoxicillin and clavulanic acid.
Each film-coated tablet contains 875 mg amoxicillin as amoxicillin trihydrate and 125 mg clavulanic acid as potassium clavulanate.
The other ingredients are: microcrystalline cellulose (E 460) (AVICEL pH 102), sodium croscarmellose, purified talc, magnesium stearate, and for the coating: hypromellose (E 15), titanium dioxide dispersion [Opaspray K-1-7000: SDA 3 A Alcohol 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 a white or almost white, oval, film-coated tablet, scored on both sides, packed in PVC/Aluminium blisters.
Pack sizes contain 14 tablets (2 blisters) 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 European Economic Area countries 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