Amoxicillin/clavulanic acid Bluefish 875/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

Read the entire leaflet carefully before you start taking this medicine,

because it contains important information for you.

• Keep this leaflet as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Amoxicillin/Clavulanic Acid Bluefish is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic Acid Bluefish
3. How to take Amoxicillin/Clavulanic Acid Bluefish
4. Possible side effects
5. How to store Amoxicillin/Clavulanic Acid Bluefish
6. Contents of the pack and other information

1. What Amoxicillin/Clavulanic Acid Bluefish is and what it is used for

Amoxicillin / Clavulanic Acid Bluefish is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

Amoxicillin / Clavulanic Acid Bluefish is used in children and adults 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. 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 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) while taking an antibiotic.

Do not take Amoxicillin / Clavulanic Acid Bluefish if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin / Clavulanic Acid Bluefish.

Warnings and precautions

Consult your doctor or pharmacist before starting 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 unsure whether any of the above conditions apply to 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 watch for

Amoxicillin / Clavulanic Acid Bluefish may worsen certain pre-existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine.

You should be aware of certain symptoms while taking Amoxicillin / Clavulanic Acid Bluefish to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin / Clavulanic Acid Bluefish. This is because Amoxicillin / Clavulanic Acid Bluefish may alter the results of these types of tests.

Other medicines and Amoxicillin / Clavulanic Acid Bluefish

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking allopurinol (used for gout) with Amoxicillin / Clavulanic Acid Bluefish, you may be more likely to develop a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of Amoxicillin / Clavulanic Acid Bluefish.

If anticoagulants (such as warfarin) are taken with Amoxicillin / Clavulanic Acid Bluefish, additional 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 function of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

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

Amoxicillin / Clavulanic Acid Bluefish should be taken just before meals, swallowed whole 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin / Clavulanic Acid Bluefish may cause adverse effects, and the symptoms may mean you should not drive.

Do not drive or operate machinery unless you feel 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 impairment or those on potassium-restricted diets.

Amoxicillin / Clavulanic Acid Bluefish contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Bluefish

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

Usual dose – 1 tablet twice daily.

Higher dose – 1 tablet three times daily.

Use in children and adolescents

Seek advice from your doctor or pharmacist before giving Amoxicillin/Clavulanic Acid Bluefish tablets to children weighing less than 40 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how well your liver is working.

How to take Amoxicillin/Clavulanic Acid Bluefish

• Swallow the tablets whole with a glass of water, at the beginning of meals or shortly before.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid Bluefish for longer than 2 weeks. If you continue to feel unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid Bluefish, symptoms such as stomach upset (nausea, vomiting or diarrhoea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor.

You may also call the Toxicology Information Service at telephone number 91 5620420, indicating the medicine and the amount ingested.

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 a missed dose.

If you stop taking Amoxicillin/Clavulanic Acid Bluefish:

Continue taking Amoxicillin/Clavulanic Acid Bluefish until the end of the prescribed treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Symptoms to watch for

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

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

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES)

DIES has mainly been reported in children receiving amoxicillin. It is a type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

Acute inflammation of the pancreas (acute pancreatitis)

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

Contact your doctor as soon as possible for advice if you have these symptoms.

Very common adverse effects (may affect more than 1 in 10 people)

• diarrhoea (in adults)

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

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when high doses are taken

→ if this happens, take Amoxicillin / Clavulanic Acid Bluefish with food

• vomiting
• diarrhoea (in children)

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

• skin rash, itching
• increased itchy rash (urticarial wheals )
• dizziness
• headache
• indigestion

Uncommon adverse effects that may appear in blood tests:

• increase in certain substances (enzymes ) produced by the liver

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

• skin rash, which may form blisters resembling small targets (a dark central 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 adverse effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Frequency not known (frequency cannot be estimated from 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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis )

• widespread rash with small pus-filled blisters (exfoliative bullous dermatitis )

• red rash with bumps under the skin and blisters (exanthematous pustulosis )

• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and increased 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 ring with a central crust or resembling 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), which may cause the skin and whites of the eyes to turn yellowish
• inflammation of the kidney tubules
• delayed blood clotting
• hyperactivity
• seizures (in patients taking high doses of Amoxicillin / Clavulanic Acid Bluefish or who have kidney problems)
• black, hairy-looking tongue
• stained teeth (in children), which usually disappear with brushing

Adverse effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low red blood cell count (haemolytic anaemia )
• crystals in the urine causing acute kidney injury.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaRAM.es. By reporting adverse 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 stated on the label, carton, or bottle after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and any unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and any unused medicines. This will help protect the environment.

6. Package contents and other 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 potassium clavulanate.

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

Appearance of the product and contents of the pack:

The Amoxicillin / Clavulanic Acid Bluefish 875 mg/125 mg tablets are white, elongated, film-coated tablets, scored on both sides. They are supplied in PVC/Al blisters sealed in aluminum pockets containing 7, 10, 12, 14, 20, 21, 24 and 30 tablets. Only certain 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U
P.O. Box 36007
2832094 Madrid, Branch Office 36
Spain

This medicinal product 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 most recent review of this leaflet: January 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/