Amoxicillin and clavulanic acid Mylan

Package leaflet: Information for the patient

AMOXICILLIN AND CLAVULANIC ACID MYLAN

875 mg + 125 mg film-coated tablets
amoxicillin and clavulanic acid
Generic medicine
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What AMOXICILLIN AND CLAVULANIC ACID MYLAN is and what it is used for
2. What you need to know before taking AMOXICILLIN AND CLAVULANIC ACID MYLAN
3. How to take AMOXICILLIN AND CLAVULANIC ACID MYLAN
4. Possible side effects
5. How to store AMOXICILLIN AND CLAVULANIC ACID MYLAN
6. Contents of the pack and other information

1. What AMOXICILLINA E ACIDO CLAVULANICO MYLAN is and what it is used for

AMOXICILLINA E ACIDO CLAVULANICO MYLAN contains two active substances, amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called antibiotics (beta-lactam antibiotics or penicillins) used to treat infections caused by bacteria. Clavulanic acid, on the other hand, prevents amoxicillin from being rapidly broken down and rendered ineffective.
This medicine is indicated in adults and children for the treatment of:

• infections of the nasal sinuses (acute bacterial sinusitis) and of the ear (acute otitis media);
• respiratory tract infections at the level of the bronchi (acute exacerbations of chronic bronchitis) or lungs (community-acquired pneumonia);
• urinary tract infections (cystitis, pyelonephritis);
• skin or other soft tissue infections (cellulitis, animal bites), including dental infections (severe dental abscess with diffuse cellulitis);
• bone and joint infections (osteomyelitis).

2. What you need to know before taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN

Do not take AMOXICILLINA E ACIDO CLAVULANICO MYLAN

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6);
• if you have had a severe allergic reaction to any other antibiotic. This may include rash or swelling of the face or throat;
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take AMOXICILLINA E ACIDO CLAVULANICO MYLAN if any of these cases apply to you.
If you have any doubts, speak with your doctor or pharmacist before taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN.
Speak with your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis;
• you have previously been treated for liver or kidney problems;
• you do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN.
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 AMOXICILLINA E ACIDO CLAVULANICO MYLAN or a different medicine.
Conditions you should monitor
AMOXICILLINA E ACIDO CLAVULANICO MYLAN may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN in order to reduce any risks. See “Conditions you should monitor” in section 4.
Blood and urine tests
If you are scheduled to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN. This is because AMOXICILLINA E ACIDO CLAVULANICO MYLAN may affect the results of these types of tests.
Other medicines and AMOXICILLINA E ACIDO CLAVULANICO MYLAN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking allopurinol (used for gout) together with AMOXICILLINA E ACIDO CLAVULANICO MYLAN, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of AMOXICILLINA E ACIDO CLAVULANICO MYLAN.
If you are taking medicines such as warfarin (which help prevent blood clots) together with AMOXICILLINA E ACIDO CLAVULANICO MYLAN, additional blood tests may be required.
AMOXICILLINA E ACIDO CLAVULANICO MYLAN may affect how methotrexate (a medicine used to treat tumors or rheumatic diseases) works.
AMOXICILLINA E ACIDO CLAVULANICO MYLAN may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
AMOXICILLINA E ACIDO CLAVULANICO MYLAN may cause side effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
AMOXICILLINA E ACIDO CLAVULANICO MYLAN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take AMOXICILLINA E ACIDO CLAVULANICO MYLAN

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• usual dose – 1 tablet twice daily;
• higher dose – 1 tablet three times daily.

Children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with amoxicillin and clavulanic acid oral suspension or sachets.
Ask your doctor or pharmacist for advice on administering AMOXICILLINA E ACIDO CLAVULANICO MYLAN tablets to children weighing less than 40 kg. The tablets are not suitable for 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 alternative medicine.
• If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take AMOXICILLINA E ACIDO CLAVULANICO MYLAN

• Take with meals.
• Swallow the tablet whole with a glass of water. The tablets may be divided along the break line to make swallowing easier. Both tablet parts should be taken together.
• Space doses evenly throughout the day, at intervals of at least 4 hours. Do not take 2 doses within 1 hour.
• Do not take AMOXICILLINA E ACIDO CLAVULANICO MYLAN for longer than 2 weeks. If you still do not feel better, consult your doctor.

If you take more AMOXICILLINA E ACIDO CLAVULANICO MYLAN than you should
If you take too much AMOXICILLINA E ACIDO CLAVULANICO MYLAN, symptoms may include stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible.
Bring the medicine package to show your doctor.

If you forget to take AMOXICILLINA E ACIDO CLAVULANICO MYLAN
If you forget a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours.
Do not take a double dose to make up for a forgotten dose.

If you stop taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN
Continue taking AMOXICILLINA E ACIDO CLAVULANICO MYLAN until the full course is completed, even if you feel better. You need every dose to 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 or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects listed below may occur with this medicine.

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 lymph glands in the neck, armpits or groin,
• swelling, sometimes of the face or throat ( angioedema ), causing difficulty in breathing,
• collapse;
• chest pain occurring during 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 AND CLAVULANIC ACID MYLAN .

Intestinal inflammation
Intestinal inflammation causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine).
Further 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 these symptoms occur.

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)

• oral, vaginal or skin fold fungal infection ( candidiasis );
• nausea, especially when taking high doses: → if affected, take AMOXICILLIN AND CLAVULANIC ACID MYLAN with meals;
• vomiting;
• diarrhoea (in children).

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

• skin rash, itching;
• raised, itchy rash ( urticaria );
• indigestion;
• dizziness;
• headache.

Uncommon side effects may be detected in blood tests:

• increased levels of certain proteins ( enzymes ) produced by the liver.

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

• skin rashes, which may appear as blisters and resemble "target" lesions (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 side effects may be detected in blood tests:

• low number of cells involved in blood clotting (platelets);
• low number of white blood cells.

Frequency not known (frequency cannot be estimated from the available data)

• allergic reactions (see above);
• intestinal inflammation (see above);
• inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis);
• severe skin reactions:
• widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin detachment (more than 30% of body surface - toxic epidermal necrolysis );
• widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis );
• rash, red with crusts, swellings under the skin and blisters ( pustular exanthema );
• 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));
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous Flexural Exanthema (SDRIFE)).

→ If you experience any of these symptoms, contact your doctor immediately.

• Rash with blistering arranged in circles with a central crust or resembling a string of pearls (linear IgA diseases);
• inflammation of the liver ( hepatitis );
• jaundice, caused by increased levels of bilirubin (a substance produced by 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 MYLAN or who have kidney problems);
• black hairy tongue.

Side effects that may be detected in 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 leading to kidney damage.

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store AMOXICILLIN AND CLAVULANIC ACID MYLAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the
last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AMOXICILLINA E ACIDO CLAVULANICO MYLAN contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• The other components are: anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.

Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO MYLAN and contents of the
pack
Pack of 12 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy
Manufacturer
Elpen SA
95 Marathonos Avenue
19009 Pikermi Attika
Greece