Amoxicillin and clavulanic acid Mylan Generics

Package leaflet: Information for the patient

AMOXICILLIN AND CLAVULANIC ACID MYLAN GENERICS

875 mg/125 mg film-coated tablets
amoxicillin / clavulanic acid
Generic medicine
Please read this leaflet carefully before you (or your child) take 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 or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not pass it on to others, even if their symptoms seem identical to yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this leaflet contains:

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

1. What Amoxicillin and Clavulanic Acid Mylan Generics is and what it is used for

Amoxicillin and Clavulanic Acid Mylan Generics is an antibiotic that works by killing bacteria that cause infections. It contains two active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," whose activity can sometimes be interrupted (rendering it ineffective). The other component (clavulanic acid) prevents this from happening. Amoxicillin and Clavulanic Acid Mylan Generics is used in adults and children to treat the following infections:

• middle ear infection and sinus infection
• 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 and Clavulanic Acid Mylan Generics

Do not take Amoxicillin and Clavulanic Acid Mylan Generics:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, cephalosporins, or any of the other ingredients of this medicine (listed in section 6).
• if you have had severe allergic reactions to any other antibiotic. These may include skin rashes and swelling of the face or neck.
• if you have previously experienced liver problems or jaundice (yellowing of the skin) while taking antibiotics. Do not take Amoxicillin and Clavulanic Acid Mylan Generics if any of the above conditions apply to you. If you are unsure, speak with your doctor or pharmacist before taking this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you:

• suffer from glandular fever (infectious mononucleosis)
• have been treated for liver or kidney problems
• do not urinate regularly

If you are not sure whether any of these conditions apply to you, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Mylan Generics.
In some cases, your doctor may investigate the type of bacteria causing your infection.
Depending on the results, you may be prescribed a different dosage of amoxicillin/clavulanic acid or a different medicine.

Conditions requiring monitoring

Amoxicillin and Clavulanic Acid Mylan Generics may worsen certain pre-existing conditions or cause serious side effects. These include allergic reactions, seizures (epileptic fits), and inflammation of the bowel. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic Acid Mylan Generics to reduce the risk of complications. See section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell counts) or urine tests (for glucose), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may affect the results of these tests.

Other medicines and Amoxicillin and Clavulanic Acid Mylan Generics

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines you can buy without a prescription or herbal medicines.

Amoxicillin/clavulanic acid may affect how mycophenolate mofetil (a medicine used to prevent organ transplant rejection) works.

If you are taking allopurinol (used for gout) together with amoxicillin/clavulanic acid, you may be more likely to develop a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of Amoxicillin and Clavulanic Acid Mylan Generics.

If you are taking medicines to help prevent blood clots (such as warfarin) together with amoxicillin/clavulanic acid, additional blood tests may be needed.

Amoxicillin/clavulanic acid may affect how methotrexate (a medicine used to treat cancer or rheumatic disorders) 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 Mylan Generics may cause possible side effects such as dizziness or seizures (epileptic fits), and these symptoms may impair your ability to drive.
Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin and Clavulanic Acid Mylan Generics

Always take this medicine exactly as instructed by your doctor.
If you have any doubts, consult your doctor or pharmacist.

Use in adults and children weighing 40 kg or more
Usual dose – 1 tablet twice daily
Higher doses – 1 tablet three times daily

Use in children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets.
Ask your doctor or pharmacist for advice regarding when to give amoxicillin/clavulanic acid tablets to children weighing less than 40 kg. The tablets are not suitable for use in children weighing less than 25 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 dosage or a different medicine.
• If you have liver problems, you should have blood tests more frequently to monitor how well your liver is functioning.

How to take Amoxicillin and Clavulanic Acid Mylan Generics

• Take the tablets with a glass of water during a meal. The tablets can be split along the break line to make swallowing easier. You must take both parts of the tablet at the same time.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin and Clavulanic Acid Mylan Generics for longer than 2 weeks. If you still do not feel better, return to see your doctor.

If you take more Amoxicillin and Clavulanic Acid Mylan Generics than you should
If you have taken too much Amoxicillin and Clavulanic Acid Mylan Generics, symptoms may include stomach upset (nausea, vomiting, or diarrhoea) or seizures (epileptic fits). Speak to your doctor as soon as possible. Take the packaging with you to show the doctor.

If you forget to take Amoxicillin and Clavulanic Acid Mylan Generics
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. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Amoxicillin and Clavulanic Acid Mylan Generics
Continue treatment with Amoxicillin and Clavulanic Acid Mylan Generics even if you feel better. You need to take all the doses to fully treat the infection. If some bacteria survive, they may cause the infection to return.

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

4. Possible side effects

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

Conditions requiring immediate attention

Allergic reactions:

• Skin rash
• Inflammation of blood vessels (vasculitis), which may appear as raised 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

If you experience any of these symptoms, contact your doctor immediately. Stop treatment with Amoxicillin and Clavulanic Acid Mylan Generics immediately.

Severe skin reactions:

• Widespread rash with blisters and peeling, particularly 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 blisters containing pus (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 white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms - DRESS)
• Skin rash, which may blister, appearing as small "target" lesions (dark central spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

Contact your doctor immediately if you experience any of these symptoms.

Inflammation of the large intestine:

• Inflammation of the large intestine, causing watery diarrhoea usually containing blood and mucus, stomach pain and/or fever. If you have these symptoms, contact your doctor as soon as possible for advice.

Other possible serious side effects

• 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
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Seizures (in people taking high doses of amoxicillin/clavulanic acid or who have kidney problems)
• Severe reduction in the number of white blood cells (agranulocytosis), which may lead to increased risk of infections such as sore throat, mouth ulcers, fever, etc.
• Low number of red blood cells (haemolytic anaemia), which may cause fatigue, shortness of breath, and unusually pale skin. Contact your doctor immediately for advice if you experience these symptoms.

Other possible side effects

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)

• Thrush (candidiasis – a fungal infection of the vagina, mouth, or skin folds)
• Feeling unwell (nausea), especially when taking high doses (if affected, take Amoxicillin and Clavulanic Acid Mylan Generics with food)
• Vomiting
• Diarrhoea (in children)

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

• Rash
• Itching
• Raised, itchy rash (urticaria)
• Indigestion
• Dizziness
• Headache

Uncommon side effects that may be detected in blood tests:

• Increased levels of certain substances (enzymes) produced by the liver

Rare side effects (may affect up to 1 in 1,000 people) that may be detected in blood tests:

• Low number of blood cells involved in clotting (thrombocytes)
• Low number of white blood cells

Not known (frequency cannot be estimated from the available data)
These side effects have been reported in a small number of people, but their exact frequency is unknown.

• Blood takes longer to clot
• Hyperactivity
• Dark, "hairy" looking tongue

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

• Crystals in the urine

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep in the original packaging.
Do not use this medicine after the expiry date, which is stated on the carton 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. 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 Amoxicillin and Clavulanic Acid Mylan Generics contains

• The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• Other excipients: colloidal silicon dioxide, magnesium stearate (E572), talc, povidone, sodium croscarmellose, microcrystalline cellulose. The tablet coating contains: triethyl citrate, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, hypromellose, talc, titanium dioxide (E171).

Description of the appearance of Amoxicillin and Clavulanic Acid Mylan Generics and contents of the
package
The tablets are: oblong, white to pale yellow, with a break line.
Amoxicillin and Clavulanic Acid Mylan Generics is available in blisters containing 6, 8, 10, 12, 14, 15, 16, 20, 40,
50, 100 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124, Milan
Italy

Manufacturer responsible for Batch Release
Sandoz GmbH
Biochemiestrasse 10, 6250 Kundl - Austria
McDermott Laboratories Ltd (t/a Gerard Laboratories)
Baldoyle Industrial Estate, Grange Road – Dublin 13 – Ireland
Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL – United Kingdom
Mylan S.p.A.
Viale dell’innovazione, 3 – 20126 Milan - Italy

This medicinal product has been authorized in the Member States of the European Economic Area under the
following names
Austria CombAmox 1g filmtabletten
Belgium Amoxiclav Mylan 875mg filmomhulde tabletten
Germany Amoxidura plus 875/125mg filmtabletten
Iceland Amoclav Mylan 875/125 mg filmuhuouo
Portugal Amoxicilina E Acido Clavulanico Mylan Genericos 875mg / 125mg Comprimidos
Revestidos
Italy Amoxicillina e Acido clavulanico Mylan Generics
Sweden Amoclav Mylan

This leaflet was last updated in
Advice/Medical education
Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.
Sometimes, a bacterial infection does not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotics being taken. This means they can survive and even multiply despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the chance that bacteria become resistant.
When your doctor prescribes an antibiotic, it is intended for the treatment of your current illness only. Paying attention to the following advice will help you prevent the emergence of bacterial resistance, which could interfere with the effectiveness of antibiotics.

1. It is very important that you take the antibiotic at the correct dose, at the correct time, and for the correct number of days. Read the instructions on the label and, if you do not understand something, ask your doctor or pharmacist to explain it to you.
2. You must not take antibiotics unless they have been specifically prescribed for you, and you should only use them to treat infections for which they were prescribed.
3. You must not take antibiotics that have been prescribed for other people, even if they have an infection similar to yours.
4. You must not give antibiotics prescribed for you to other people.
5. If you have leftover antibiotics after completing a course as prescribed by your doctor, you should return the remaining medication to the pharmacy for proper disposal.