Amoxicillin and clavulanic acid Krka

Package leaflet: Information for the patient

Amoxicillin and Clavulanic Acid Krka 875 mg/125 mg film-coated tablets

Amoxicillin/Clavulanic acid
Generic medicine
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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Amoxicillin and Clavulanic Acid Krka is an antibiotic that works by killing the bacteria causing 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 Krka 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. What you need to know before taking Amoxicillin and Clavulanic Acid Krka

Do not take Amoxicillin and Clavulanic Acid Krka:

• if you are allergic to amoxicillin, clavulanic acid, or to any of the other ingredients of this medicine (listed in section 6),
• if you have 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 had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin and Clavulanic Acid Krka if any of the conditions described above apply to you or your
child. If you have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid
Krka.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Krka 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 above conditions apply to you, consult your doctor or pharmacist before
taking Amoxicillin and Clavulanic Acid Krka.
In some cases, your doctor may perform tests to identify the type of bacteria causing your infection or your
child's infection. Based on the results, a different dosage of Amoxicillin and Clavulanic Acid Krka or a different
medicine may be prescribed for you or your child.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid Krka may worsen certain pre-existing conditions or cause serious adverse
effects. These may include allergic reactions, seizures (epileptic fits), and inflammation of the bowel. You should
be aware of certain symptoms while you or your child are taking Amoxicillin and Clavulanic Acid Krka, in order
to reduce any risk.
See “Conditions to which you should pay attention” in Section 4.
Blood and urine tests
If you or your child are due to have blood tests (for example, checks on red blood cells or liver function tests) or
urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Krka.
This is because Amoxicillin and Clavulanic Acid Krka may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Krka
Inform your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other
medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Krka, you are much
more likely to develop 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 Krka.
If you are taking medicines that help prevent blood clots (such as warfarin) together with Amoxicillin and
Clavulanic Acid Krka, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Krka may affect how methotrexate (a medicine used to treat cancers or
rheumatic diseases) works.
Amoxicillin and Clavulanic Acid Krka may affect how mycophenolate mofetil (a medicine used to prevent organ
rejection after transplantation) works.
Amoxicillin and Clavulanic Acid Krka with food and drink
Take Amoxicillin and Clavulanic Acid Krka at the beginning of a meal or just before a meal, and swallow the
tablets whole with a glass of water.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Krka may cause adverse effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.

3. How to take Amoxicillin and Clavulanic Acid Krka

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

Use in children
Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension.
Consult your doctor or pharmacist for advice on administering Amoxicillin and Clavulanic Acid Krka 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 or your child have kidney problems, the dose may need to be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you or your child have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Amoxicillin and Clavulanic Acid Krka

• Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before.
• Space the 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 Krka for longer than 2 weeks. If you or your child continue to feel unwell, you must return to the doctor.

If you take more Amoxicillin and Clavulanic Acid Krka than you should
If you take too much Amoxicillin and Clavulanic Acid Krka, symptoms may include stomach upset (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine pack or container with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Krka
Do not take a double dose to make up for the missed dose. If you forget a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
If you stop taking Amoxicillin and Clavulanic Acid Krka
Continue taking Amoxicillin and Clavulanic Acid Krka for the full duration of treatment, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, the infection may 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 everyone gets them.

Conditions you should watch for

Allergic reactions:

• skin rash
• 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 Krka.

Inflammation of the intestine
Inflammation of the intestine, 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.

M very common: may affect more than 1 in 10 people

• diarrhoea (in adults)

Common: may affect up to 1 in 10 people

• thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
• feeling unwell (nausea), especially when taking high doses

If this occurs, take Amoxicillin and Clavulanic Acid Krka before food.

• vomiting
• diarrhoea (in children)

Uncommon: may affect up to 1 in 100 people

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

Uncommon side effects that may be detected in blood tests:

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

Rare: may affect up to 1 in 1,000 people

• skin rash, which may appear as blistering lesions resembling 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 side effects that may be detected in blood tests:

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

Frequency not known: frequency cannot be estimated from the available data

• Allergic reactions (see above)
• Inflammation of the intestine (see above)
• Inflammation of the protective membrane surrounding the brain (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 )
• red rash with crusts, swellings under the skin and blisters ( pustular exanthem )
  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 Krka or who have kidney problems)
• black, hairy-looking tongue

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

• severe reduction in white blood cell count
• low red blood cell count ( haemolytic anaemia )
• crystals in the urine

Reporting of side effects
If you get any side effects, 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 http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Krka

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

6. Package contents and other information

What Amoxicillin and Clavulanic Acid Krka contains

• The active substances are amoxicillin and clavulanic acid. Each film-coated tablet contains 875 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• The other components (excipients) are microcrystalline cellulose (E460), sodium starch glycolate (type A), anhydrous colloidal silica (E551), magnesium stearate (E470b) in the tablet core, and titanium dioxide (E171), hypromellose (E464) and macrogol 400 in the film coating.

Description of the appearance of Amoxicillin and Clavulanic Acid Krka and package contents
White, capsule-shaped, film-coated tablets, marked with "I 07" on one side and smooth on the other side. Tablet length: 21.70 ± 0.10 mm.
Amoxicillin and Clavulanic Acid Krka is available in boxes containing 10, 12, 14, 16, 20, 21, 24, 30, 100 or 500 film-coated tablets, in strips.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against infections
caused by viruses.
Sometimes, bacterial infections do 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 can survive and even multiply despite the presence of the
antibiotic.
Bacteria can become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes you 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 leads to loss of antibiotic effectiveness.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration indicated. If you have any doubts, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not take antibiotics prescribed for other people, even if you believe your infection is similar.
4. Do not give to others antibiotics that have been specifically prescribed for you.
5. If you have leftover antibiotic after completing your treatment, return it to the pharmacist for proper disposal.