TUVRAHAZ 875 mg/125 mg Tabletki Powlekane

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1. Tuvrahaz 875 mg /125 mg film-coated tablets
   1. What is Tuvrahaz and what is it used for
   2. What you need to know before taking Tuvrahaz
   3. How to take Tuvrahaz
   4. Possible side effects
   5. How to store Tuvrahaz
   6. Package contents and other information

Tuvrahaz 875 mg /125 mg film-coated tablets

Amoxicillin/clavulanic acid
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 for your child) only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Tuvrahaz and what is it used for

Tuvrahaz is an antibiotic that works by killing the bacteria that cause infections. It contains two different
medicines, called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines
called “penicillins”, whose activity can sometimes be blocked (i.e. the medicines become inactive).
The other active ingredient (clavulanic acid) prevents this from happening.
Tuvrahaz is used in adults and children to treat the following infections:

• infections of the middle ear and sinuses
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• infections of the bones and joints

2. What you need to know before taking Tuvrahaz

DO NOT take Tuvrahaz:

• if you are allergic to amoxicillin, to clavulanic acid, to penicillin or to any of the other ingredients of this medicine (listed in section 6)
• if you have had a severe allergic reaction (hypersensitive) to any other antibiotic in the past. These reactions may include skin rash or swelling of the face or throat
• if you have had problems with your liver or jaundice (yellowing of the skin) when taking an antibiotic. ► If any of these applies to you, DO NOT take Tuvrahaz.If you have doubts, consult your doctor or pharmacist before taking Tuvrahaz.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tuvrahaz if:

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

If you are not sure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Tuvrahaz.
In some cases, your doctor may perform an investigation to identify the type of bacteria that caused the infection. Depending on the results, they may prescribe you a different dosage of Tuvrahaz, or another medicine.

Conditions to pay attention to
Tuvrahaz may worsen some existing conditions, or cause serious side effects.
These may include allergic reactions, convulsions and inflammation of the colon. While taking Tuvrahaz, you should pay attention to certain specific symptoms, in order to reduce the risk of any problems. See Conditions to pay attention toin section 4.

Blood and urine tests
If you need to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for blood sugar), tell your doctor or nurse that you are taking Tuvrahaz. This is because Tuvrahaz can affect the results of these types of tests.

Other medicines and Tuvrahaz
Tell 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 Tuvrahaz, you are very likely to develop an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to change your dose of Tuvrahaz.
If you are taking medicines that help prevent blood clots (such as warfarin) together with Tuvrahaz, further blood tests may be necessary.
Tuvrahaz may affect the way methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Tuvrahaz may affect the way mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs) works.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Tuvrahaz may cause side effects, the symptoms of which may make you unfit to drive.
Do not drive vehicles or use machines unless you feel well.
Tuvrahaz contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially “sodium-free”.

3. How to take Tuvrahaz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.

Adults and children weighing 40 kg or more

• Normal dose - one tablet twice a day
• High dose - one tablet three times a day

Children weighing less than 40 kg
Children aged 6 years or less should preferably be treated with amoxicillin/clavulanic acid oral
suspension or sachets.
Regarding the administration of this medicine to children weighing less than 40 kg, ask
your doctor or pharmacist for advice. The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney and liver problems

• If you have kidney problems, the dose may be modified. Your doctor may prescribe a different dosage, or a different medicine.
• If you have liver problems, you may need to undergo blood tests more frequently, to check liver function.

How to take Tuvrahaz

• Take the tablets with a glass of water, with a meal.
• Space out the intakes evenly during the day, at a distance of at least 4 hours from each other. Do not take 2 doses within one hour.
• Do not take Tuvrahaz for more than 2 weeks. If you continue to feel unwell, you will need to consult your doctor again.
• The tablet can be divided into equal doses.

If you take more Tuvrahaz than you should
If you take too much Tuvrahaz, the signs may include stomach upset (nausea, vomiting or diarrhoea) or
convulsions. Consult your doctor as soon as possible. Bring the medicine packaging with you,
to show it to the doctor.

If you forget to take Tuvrahaz
If you forget to take a dose, take it as soon as you remember. However, you should not take the next
dose too soon: you should wait about 4 hours before taking the next dose. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Tuvrahaz
Continue to take Tuvrahaz until the end of the treatment cycle, even if you feel better. To
fight the infection you need all the doses. If some bacteria survive, they can cause the
infection to return.
If you have any doubts 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 gets them.
manifest.

Conditions to pay attention to
Allergic reactions:

• skin rash
• inflammation of the blood vessels ( vasculitis), which may appear as red or purple raised spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema), which causes difficulty breathing
• collapse.

► If you experience any of these symptoms, contact a doctor immediately. Stop taking Tuvrahaz.

Inflammation of the large intestine
Inflammation of the large intestine, which causes watery diarrhea, usually containing blood and mucus, stomach pain
and/or fever.
► If you experience these symptoms, consult your doctor as soon as possible.

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

• diarrhea (in adults).

Common side effects(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 → in this case, take Tuvrahaz with food
• vomiting
• diarrhea (in children).

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

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

Uncommon side effects that may be highlighted by blood tests:

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

Rare side effects(may affect up to 1 in 1000 people)

• skin rash, with possible blistering, which appears as small “targets” (dark central spots surrounded by lighter areas, with a dark circle around the edge - erythemamultiforme) ► if you notice any of these symptoms, contact a doctor urgently.

Rare side effects that may be highlighted by blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells.

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

• allergic reactions (see above)
• inflammation of the large 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, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome) and a more severe form, which causes extensive skin detachment (more than 30% of the body surface area - toxic epidermal necrolysis)
• widespread red rash, with small blisters containing pus ( exfoliative bullous dermatitis)
• red and scaly rash with bumps under the skin and blisters ( pustular exanthematous rash)
• 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 (DRESS)).

► If you experience any of these symptoms, contact a doctor immediately.

• inflammation of the liver ( hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver), which can give the skin and whites of the eyes a yellowish tinge
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in patients taking high doses of Tuvrahaz or who have kidney problems)
• black tongue that appears covered in hair

Side effects that may be highlighted by blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells ( hemolytic anemia)
• presence of crystals in the urine.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tuvrahaz

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 blister and the package after “Exp.”.
The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in 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 Tuvrahaz contains
The active ingredients are amoxicillin trihydrate and potassium clavulanate.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and
potassium clavulanate equivalent to 125 mg of clavulanic acid.
The other ingredients are:
Tablet core:
Colloidal anhydrous silica, magnesium stearate, talc (E 553), povidone K25, microcrystalline cellulose,
crospovidone (E 1202)
Coating:
Triethyl citrate (E 1505), hypromellose (E 464), talc (E 553), titanium dioxide (E 171), ethylcellulose, cetyl alcohol,
sodium lauryl sulfate,

Description of Tuvrahaz and package contents
The film-coated tablets are oval, from white to cream in color, with a fracture line on both
sides (10.5 mm x 22.5 mm)
Aluminum blisters (Alu/alu blister) consisting of an aluminum foil with a PVC coating on the
inner side and a closing aluminum foil, possibly printed (aluminum foil 25 μm with a
plastic coating based on PVC on the inner side)
Package: 12 film-coated tablets

Marketing authorization holder and manufacturer
Marketing authorization holder
Hexal A/S
Edvard Thomsens Vej, 14
2300 Copenhagen
Denmark

Manufacturer
Sandoz GmbH
Biochemiestrasse, 10
6250 Kundl
Austria
Lek Pharmaceuticals d.d.
Verovskova ulica 57
1526 Ljubljana
Slovenia

This medicinal product is authorized in the EEA Member States with the following denominations
Austria Amcladoz 875 mg/125 mg - Filmtabletten
Italy Tuvrahaz

Recommendations/medical education
Antibiotics are used to treat infections caused by bacteria. They are not effective
against infections caused by viruses.
Sometimes an infection caused by bacteria does not respond to a course of treatment with an
antibiotic: one of the most common reasons is that the bacteria causing the infection are
resistant to the antibiotic being administered. This means that the bacteria can
survive, and even multiply, despite the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. By using antibiotics
carefully and appropriately, the risk of bacteria becoming resistant to them can be reduced.
When the doctor prescribes antibiotic therapy, this is indicated only for the current illness.
Pay attention to the following recommendations, so as to prevent the emergence of resistant bacteria,
which cause the blocking of the antibiotic's activity.

• 1. It is very important that you take the antibiotic at the right dose, at the right time and for the right number of days. Read the instructions on the label and, if something is not clear, ask your doctor or pharmacist.
• 2. Do not take an antibiotic unless it has been specifically prescribed for you; use the antibiotic only to treat the infection for which it was prescribed.
• 3. Do not use antibiotics that have been prescribed to other people, even if their infection is similar to yours.
• 4. Do not give others antibiotics that have been expressly prescribed for you.
• 5. If, once you have finished the treatment cycle prescribed by the doctor, you have some antibiotics left over, return them to the pharmacy so that they can be disposed of properly.