Amoxicillin and clavulanic acid Biopharma
ItalyTable of Contents
PATIENT LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA 875 mg/125 mg Film-coated tablets, Oral suspension powder
amoxicillin/clavulanic acid
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 questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you personally (or for your child). Do not give it to others, even if their symptoms are the same as yours, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- What AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA is and what it is used for
- What you need to know before taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
- How to take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
- Possible side effects
- How to store AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
- Contents of the pack and other information
1. WHAT AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA IS AND WHAT IT IS USED FOR
AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as “penicillins”, whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening. AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA is used in adults and children to treat the following infections:
- ear and nasal sinus infections
- respiratory tract infections
- urinary tract infections
- skin and soft tissue infections, including dental infections
- bone and joint infections
2. WHAT YOU SHOULD KNOW BEFORE TAKING AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
Do not take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA:
- if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the other components of AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA (listed in section 6)
- if you have previously had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck
- if you have previously experienced liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
Do not take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA if any of the above apply to you.
If you have any doubts, speak with your doctor or pharmacist before taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine if you:
- have infectious mononucleosis
- have previously been treated for liver or kidney problems
- do not urinate regularly.
If you are unsure whether any of the conditions listed above apply to you, discuss them with your doctor or pharmacist before taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of amoxicillin/clavulanic acid or a different medicine.
Conditions requiring your attention
AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA may worsen certain pre-existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms while taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA in order to minimize any risk. See “Conditions requiring your attention” in section 4.
Blood and urine tests
If you are scheduled for blood tests (such as tests for red blood cells or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA. This is because AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA may affect the results of these tests.
Other medicines and AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA, you are at increased risk of developing a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA.
If you are taking medicines such as warfarin (which help prevent blood clots) together with AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA, additional blood tests may be required.
AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA may affect how methotrexate (a medicine used to treat tumours or rheumatic diseases) works.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA may cause adverse effects, and symptoms may impair your ability to drive.
Do not drive or operate machinery unless you feel well.
Important information about excipients in AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
Oral suspension powder contains sucrose: if you are known to have sugar intolerance, consult your doctor before taking this medicine.
3. HOW TO TAKE AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
Take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA exactly as prescribed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
875 mg/125 mg film-coated tablets
- Usual dose – 1 tablet twice daily
- Higher dose – 1 tablet three times daily
875 mg/125 mg powder for oral suspension in sachets
- Usual dose – 1 sachet twice daily
- Higher dose – 1 sachet three times daily
Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid oral suspension or pediatric sachets.
875 mg/125 mg film-coated tablets
Consult your doctor or pharmacist for advice on administering AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA tablets to children weighing less than 40 kg.
875 mg/125 mg powder for oral suspension
AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA sachets are not recommended.
Patients with kidney or liver problems
- If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
- If you have liver problems, you may require more frequent blood tests to monitor liver function.
How to take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
- Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
- Do not take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA for longer than 2 weeks. If you continue to feel unwell, return to your doctor.
Film-coated tablets
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Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before.
Powder for oral suspension in sachets -
Just before taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA, open the sachet and mix the contents with half a glass of water.
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Take at the beginning of a meal or immediately before.
If you take more AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA than you should
If you take too much AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as possible.
Bring the medicine packaging to show your doctor.
If you forget to take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; instead, wait approximately 4 hours before taking the next dose.
If you stop treatment with AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
Continue taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA until the treatment course is complete, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA may cause adverse reactions, although not everybody experiences them.
Conditions you should pay attention to
Allergic reactions:
- skin rashes
- inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
- fever, joint pain, swelling of the glands in the neck, armpits or groin
- swelling, sometimes of the face or mouth ( angioedema ), causing difficulty in breathing
- collapse. Contact your doctor immediately if you experience any of these symptoms. Stop taking AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever. If you experience these symptoms, contact your doctor as soon as possible 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
- thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
- nausea, especially when taking high doses: if this occurs, take AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA before food
- vomiting
- diarrhoea (in children)
Uncommon adverse reactions
May affect up to 1 in 100 people
- skin rash, itching
- raised itchy rash ( urticaria )
- indigestion
- dizziness
- headache
Uncommon adverse reactions may be detected through blood tests: - increase in certain proteins ( enzymes ) produced by the liver
Rare adverse reactions
May affect up to 1 in 1,000 people
- skin rashes, which may appear as blisters and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme ). If you notice any of these symptoms, contact your doctor urgently.
Rare adverse reactions may be detected through blood tests:
- low number of cells involved in blood clotting
- low number of white blood cells
Frequency not known
- Allergic reactions (see above)
- Intestinal inflammation (see above)
- Severe skin reactions:
- widespread rash with blisters and peeling, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin peeling (more than 30% of body surface, toxic epidermal necrolysis )
- widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis )
- red, scaly rash with raised areas under the skin and blisters ( exanthematous pustulosis )
- flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes). (Drug reaction with eosinophilia and systemic symptoms). If you experience any of these symptoms, contact your doctor immediately.
- inflammation of the liver ( hepatitis )
- 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
- blood takes longer to clot
- hyperactivity
- seizures (in people taking high doses of AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA or who have kidney problems)
- black hairy tongue
- tooth staining (in children), usually removable by brushing
Adverse reactions that may be detected through blood or urine tests:
- severe reduction in the number of white blood cells
- low number of red blood cells ( haemolytic anaemia )
- crystals in the urine
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. HOW TO STORE AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA
Store in the original packaging to protect the product from light and moisture, at a temperature not exceeding 25°C.
Keep this medicine out of the sight and reach of children.
Do not use AMOXICILLIN AND CLAVULANIC ACID BIOPHARMA after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What AMOXICILLINA E ACIDO CLAVULANICO BIOPHARMA contains
AMOXICILLINA E ACIDO CLAVULANICO BIOPHARMA 875 mg/125 mg Film-coated tablets
Each tablet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: Colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone.
AMOXICILLINA E ACIDO CLAVULANICO BIOPHARMA 875 mg/125 mg Powder for oral suspension
Each sachet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: Colloidal silica, lemon flavour, strawberry flavour, xanthan gum, sucrose.
Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO BIOPHARMA and contents of the package
Film-coated tablets: Carton containing 12 tablets.
Powder for oral suspension: Carton containing 12 sachets.
Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER:
Marketing Authorization Holder: Biopharma S.r.l. – Via Paolo Mercuri, 8 - 00193 Rome - Italy
RESPONSIBLE MANUFACTURER FOR BATCH RELEASE
Biopharma S.r.l. – Via delle Gerbere, 22/30 - 00134 S. Palomba (RM) - Italy
Laboratorio Reig Jofré, S.A. - C/Jarama s/n, Poligono Industrial - 45007 Toledo - Spain
MARKETING AUTHORISATION HOLDER:
EG S.p.A. Via Pavia 6, 20136 MILAN
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, a bacterial infection does not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice to help prevent the development of bacterial resistance, which may lead to failure of antibiotic therapy.
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It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package leaflet and, if anything is unclear, ask your doctor or pharmacist for clarification.
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Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
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Do not use antibiotics that have been prescribed for other people, even if you have a similar infection.
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Do not give your prescribed antibiotics to other people.
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If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.