AMOXICILLINA 875 mg/125 mg Tabletki Powlekane

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1. Amoxicillina e Acido clavulanico PENSA PHARMA 875 mg/125 mg compresse
   1. What Amoxicillina and Acido clavulanico PENSA PHARMA is and what it is used for
   2. What you need to know before taking Amoxicillina e Acido clavulanico PENSA PHARMA
   3. How to take Amoxicillina and Acido clavulanico PENSA PHARMA
   4. Possible side effects
   5. How to store Amoxicillina e Acido clavulanico PENSA PHARMA
   6. Package contents and other information
2. Amoxicillina e Acido clavulanico PENSA PHARMA 875 mg/125 mg powder for suspension
   1. What Amoxicillina and Acido clavulanico PENSA PHARMA is and what it is used for
   2. What you need to know before taking Amoxicillina e Acido clavulanico PENSA
   3. How to take Amoxicillina and Acido clavulanico PENSA PHARMA
   4. Possible side effects
   5. How to store Amoxicillina e Acido clavulanico PENSA PHARMA
   6. Contents of the pack and other information

Amoxicillina e Acido clavulanico PENSA PHARMA 875 mg/125 mg compresse

film-coated tablets
Amoxicillin/clavulanic acid
Generic medicine

Read this leaflet carefully before 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 only. Do not pass it on to others, even if they have the same symptoms as you, as it may 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 Amoxicillina e Acido clavulanico PENSA PHARMA is and what it is used for
• 2. What you need to know before you take Amoxicillina e Acido clavulanico PENSA PHARMA
• 3. How to take Amoxicillina e Acido clavulanico PENSA PHARMA
• 4. Possible side effects
• 5. How to store Amoxicillina e Acido clavulanico PENSA PHARMA
• 6. Contents of the pack and other information

1. What Amoxicillina and Acido clavulanico PENSA PHARMA is and what it is used for

Amoxicillina and Acido clavulanico PENSA PHARMA 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. rendered inactive). The other active ingredient (clavulanic acid) prevents this from happening.
Amoxicillina and Acido clavulanico PENSA PHARMA is used in adults and children to treat the
following infections:

• 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 Amoxicillina e Acido clavulanico PENSA PHARMA

Do not take Amoxicillina e Acido clavulanico PENSA PHARMA:

• if you are allergic to amoxicillin, clavulanic acid, penicillin or to 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 can include a skin rash or swelling of the face or throat

• if you have had problems with your liver or jaundice (yellowing of the skin) when you have taken an antibiotic. → Do not take Amoxicillina e Acido clavulanico PENSA PHARMAif any of these apply to you. If you are unsure, talk to your doctor or pharmacist before taking Amoxicillina e Acido clavulanico PENSA PHARMA.

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

• have infectious mononucleosis
• have been treated for problems with your liver or kidneys
• do not urinate regularly.

If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before taking Amoxicillina e Acido clavulanico PENSA PHARMA.
In some cases, the doctor may perform an investigation to assess the type of bacteria that caused your infection.
Based on the results, they may prescribe a different dosage of Amoxicillina e Acido clavulanico PENSA PHARMA or a different medicine.

Conditions you should pay attention to
Amoxicillina e Acido clavulanico PENSA PHARMA can worsen some existing conditions or cause serious side effects.
These can include allergic reactions, convulsions and inflammation of the intestine. You should pay attention to certain symptoms while taking Amoxicillina e Acido clavulanico PENSA PHARMA, in order to reduce any risk. See “ Conditions you should pay attention to” in Section 4.

Blood and urine tests
If you are about to have blood tests (such as those related to red blood cells or liver function) or urine tests (for glucose), tell your doctor or nurse that you are taking Amoxicillina e Acido clavulanico PENSA PHARMA. This is because Amoxicillina e Acido clavulanico PENSA PHARMA can affect the results of these types of tests.

Other medicines and Amoxicillina e Acido clavulanico PENSA PHARMA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
If you are taking allopurinol (used for gout) with Amoxicillina e Acido clavulanico PENSA PHARMA, you are very likely to have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of Amoxicillina e Acido clavulanico PENSA PHARMA.
If you are taking medicines (such as warfarin) that help prevent blood clots together with Amoxicillina e Acido clavulanico PENSA PHARMA, you may need to have additional blood tests.
Amoxicillina e Acido clavulanico PENSA PHARMA can affect the mechanism of action of methotrexate (a medicine used to treat tumors or rheumatic diseases).
Amoxicillina e Acido clavulanico PENSA PHARMA can affect the functioning of Mycophenolate Mofetil (a drug used to prevent rejection of transplanted organs).

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
Amoxicillina e Acido clavulanico PENSA PHARMA can have side effects and the symptoms may make you unfit to drive.
Do not drive or use machines unless you feel well.

Amoxicillina e Acido clavulanico PENSA PHARMAcontains sodium

• This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Amoxicillina and Acido clavulanico PENSA PHARMA

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

Adults and children weighing 40 kg or more

• Usual dose - 1 tablet twice a day
• Highest dose - 1 tablet three times a day

Children weighing less than 40 kg
Amoxicillina and Acido clavulanico PENSA PHARMA is not recommended in children weighing less than
40 Kg.
Ask your doctor or pharmacist for advice on administering formulations based on
Amoxicillina and Acido clavulanico suitable for the treatment of children weighing less than 40 kg.

Patients with kidney or liver problems

• If you have kidney problems, the dose may be changed. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, your doctor will closely monitor you and you may be subject to more regular liver function tests.

How to take Amoxicillina and Acido clavulanico PENSA PHARMA

• Take with meals.
• Swallow the tablet whole with a glass of water. The tablets can be divided along the fracture line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• Space the doses regularly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillina and Acido clavulanico PENSA PHARMA for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

If you take more Amoxicillina and Acido clavulanico PENSA PHARMA than you should
If you take too much Amoxicillina and Acido clavulanico PENSA PHARMA, the signs may include
stomach upset (nausea, vomiting or diarrhoea) or convulsions. Tell your doctor as soon as possible.
Bring the medicine packaging or the bottle to show your doctor.

If you forget to take Amoxicillina and Acido clavulanico PENSA PHARMA
If you forget to take a dose, take it as soon as you remember. You should not take the next dose
too soon, but wait about 4 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillina and Acido clavulanico PENSA PHARMA
Continue to take Amoxicillina and Acido clavulanico PENSA PHARMA until the treatment is
finished, even if you feel better. You need every dose to fight the infection. If some bacteria
survive, they can cause the infection to return.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Conditions you should pay attention to
Allergic reactions:

• skin rashes
• inflammation of the blood vessels ( vasculitis) which may be visible as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swollen lymph nodes in the neck, armpits or groin swelling, sometimes of the face or mouth ( angioedema), which causes difficulty breathing
• collapse. → Contact your doctor immediatelyif you experience any of these symptoms. Stop takingAmoxicillina e Acido clavulanico PENSA PHARMA.

Intestinal inflammation
Intestinal inflammation, which causes watery diarrhea generally with blood and mucus, stomach pain
and/or fever.

→If you experience these symptoms, contact your doctor as soon as possiblefor advice.

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 → if you experience this, take Amoxicillina e Acido clavulanico PENSA PHARMA before meals
• vomiting
• diarrhea (in children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised rash, itchy (urticaria)
• indigestion
• dizziness
• headache. Uncommon side effects can be seen from blood tests:
• increase in some proteins ( enzymes) produced by the liver.

Rare side effects
May affect up to 1 in 1000 people

• skin rashes, which may appear as blisters and look like small targets (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 can be seen from blood tests:

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

Frequency not known
The frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• 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 that causes extensive skin peeling (more than 30% of the body surface, 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)

→If you experience any of these symptoms contact your 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 make the skin and whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Amoxicillina e Acido clavulanico PENSA PHARMA or who have kidney problems)
• black tongue that appears covered in hair
• stains on teeth (in children), usually removed by brushing.

Side effects that can be seen from blood or urine tests:

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system at 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 Amoxicillina e Acido clavulanico PENSA PHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25°C.
Store in the original container to protect from moisture
Do not use the tablets if chipped or damaged.
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. Package contents and other information

What contains Amoxicillina e Acido clavulanico PENSA PHARMA
The active ingredients are amoxicillin and clavulanic acid.
Each tablet contains:
amoxicillin trihydrate corresponding to 875 mg of amoxicillin and potassium clavulanate corresponding to 125
mg of clavulanic acid.
The other ingredients are:
Tablet core: Magnesium stearate, Colloidal anhydrous silica, Microcrystalline cellulose,
Croscarpovidone, Sodium croscarmellose
Tablet coating: Basic butyl methacrylate copolymer (Eudragit E 12.5), Titanium dioxide (E171),
Talc, Macrogol

Description of the appearance of Amoxicillina e Acido Clavulanico PENSA PHARMA and contents of the
packageAmoxicillina e Acido Clavulanico PENSA PHARMA 875 mg/125 mg - film-coated tablets
with a colour from white to off-white, oblong with a fracture line.
Tablet dimensions: 22 mm x 10 mm
They are packaged in:

• Blisters in OPA/Al/PVC, contained in a cardboard box. Each package contains 12 film-coated tablets. Not all packages may be marketed

Marketing authorisation holder and manufacturer
Marketing authorisation holder
TOWA PHARMACEUTICAL S.P.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturer
PenCef Pharma Berlin GmbH
Breitenbachstrasse 13-14
13509 Berlin – GERMANY

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective for viral infections.
Sometimes an infection caused by bacteria does not respond to antibiotic therapy. The most common reason for
this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately
can reduce the emergence of bacterial resistance.
When your doctor prescribes antibiotic therapy, it is indicated only for the illness you have.
Pay attention to the following advice, in order to avoid the emergence of bacterial resistance which causes the
blockage of antibiotic activity.

• 1. It is very important that you take the antibiotic at the correct dose, at the scheduled times and for the right

to your doctor or pharmacist.

• 2. Do not take antibiotics if they have not been expressly prescribed for you and use them only for the infection for which they have been prescribed.
• 3. Do not use antibiotics that have been prescribed to other people, even if you have a similar infection to theirs.
• 4. Do not give antibiotics that have been expressly prescribed for you to others.
• 5. If you have any antibiotic left over at the end of the treatment, return it to the pharmacist so that it can be disposed of properly.

Amoxicillina e Acido clavulanico PENSA PHARMA 875 mg/125 mg powder for suspension

oral in sachets
Amoxicillin/clavulanic acid
Generic medicine

Read this leaflet carefully before 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 only for you (or for your child). Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4

Contents of this leaflet:

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

1. What Amoxicillina and Acido clavulanico PENSA PHARMA is and what it is used for

Amoxicillina and Acido clavulanico PENSA PHARMA 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. rendered inactive). The other active ingredient (clavulanic acid) prevents this from happening.
Amoxicillina and Acido clavulanico PENSA PHARMA 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 Amoxicillina e Acido clavulanico PENSA

PHARMA Do not take Amoxicillina e Acido clavulanico PENSA PHARMA:

• 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 can include a 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. → Do not take Amoxicillina e Acido clavulanico PENSA PHARMAif any of these apply to you. If you are unsure, talk to your doctor or pharmacist before taking Amoxicillina e Acido clavulanico PENSA PHARMA.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine if you:

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

If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before
taking Amoxicillina e Acido clavulanico PENSA PHARMA.
In some cases, the doctor may perform an investigation to assess the type of bacteria that caused your infection.
Based on the results, they may prescribe a different dosage of Amoxicillina e Acido clavulanico PENSA
PHARMA or a different medicine.

Conditions you should pay attention to
Amoxicillina e Acido clavulanico PENSA PHARMA can worsen some existing conditions
or cause serious side effects.
These may include allergic reactions, convulsions and inflammation of the intestines. You should pay
attention to certain symptoms while taking Amoxicillina e Acido clavulanico PENSA PHARMA, in order to
reduce any risk. See “ Conditions you should pay attention to” in Section 4.

Blood and urine tests
If you are about to have blood tests (such as for red blood cell counts or liver function tests) or urine tests (for glucose), tell your doctor or nurse that you are taking
Amoxicillina e Acido clavulanico PENSA PHARMA. This is because Amoxicillina e Acido clavulanico
PENSA PHARMA can affect the results of these types of tests.

Other medicines and Amoxicillina e Acido clavulanico PENSA PHARMA
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) with Amoxicillina e Acido clavulanico PENSA PHARMA,
you are very likely to have an allergic skin reaction.
If you are taking probenecid (used for gout), your doctor may decide to change your dose of
Amoxicillina e Acido clavulanico PENSA PHARMA.
If you are taking medicines (such as warfarin) that help prevent blood clots together with Amoxicillina e Acido clavulanico PENSA PHARMA, you may need to have
additional blood tests.
Amoxicillina e Acido clavulanico PENSA PHARMA can affect the mechanism of action of
methotrexate (a medicine used to treat tumors or rheumatic diseases).
Amoxicillina e Acido clavulanico PENSA PHARMA can affect the function of Mycophenolate
Mofetil (a drug used to prevent organ rejection after transplantation).

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

Driving and using machines
Amoxicillina e Acido clavulanico PENSA PHARMA may have side effects and the symptoms may
make you unfit to drive vehicles.
Do not drive vehicles or use machines unless you feel well.

Amoxicillina e Acido clavulanico PENSA PHARMA contains aspartame, maltodextrine and benzyl alcohol

• Amoxicillina e Acido clavulanico PENSA PHARMA contains 20 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to build up because the body cannot process it properly.
• Amoxicillina e Acido clavulanico PENSA PHARMA contains maltodextrine (glucose). If you know you are intolerant to certain sugars, ask your doctor before taking this medicine.
• Amoxicillina e Acido clavulanico PENSA PHARMA contains 0.0013 mg of benzyl alcohol per sachet. Benzyl alcohol can cause allergic reactions. Ask your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can build up in the body and cause side effects (such as metabolic acidosis). Ask your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol can build up in the body and cause side effects (such as metabolic acidosis).

3. How to take Amoxicillina and Acido clavulanico PENSA PHARMA

Always take this medicine exactly as your doctor or pharmacist has told you. If you have
any doubts, ask your doctor or pharmacist.

Adults and children weighing 40 kg or more
875 mg/125 mg oral suspension powder in sachets

• Recommended dose - 1 sachet twice a day
• Highest dose - 1 sachet three times a day

Children weighing less than 40 kg
Amoxicillina e Acido clavulanico PENSA PHARMA 875 mg/125 mg sachets are not recommended in
children weighing less than 40 kg.
Ask your doctor or pharmacist for advice on administering formulations based on
Amoxicillina e Acido clavulanico suitable for the treatment of children weighing less than 40 kg.

Patients with kidney and liver problems

• If you have kidney problems, the dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, more frequent blood tests may be required to check how your liver is working.

How to take Amoxicillina and Acido clavulanico PENSA PHARMA

• Immediately before taking Amoxicillina and Acido clavulanico PENSA PHARMA, open the sachet and mix the contents with half a glass of water.
• Take with meals.
• Space the doses regularly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Amoxicillina and Acido clavulanico PENSA PHARMA for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

If you take more Amoxicillina and Acido clavulanico PENSA PHARMA than you should
If you take too much Amoxicillina and Acido clavulanico PENSA PHARMA, symptoms may include
stomach upset (nausea, vomiting or diarrhoea) or convulsions. Tell your doctor as soon as possible.
Bring the medicine packaging or the bottle to show to the doctor.

If you forget to take Amoxicillina and Acido clavulanico PENSA PHARMA
If you forget to take a dose, take it as soon as you remember. You should not take the next dose
too soon, but wait about 4 hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Amoxicillina and Acido clavulanico PENSA PHARMA
Continue to take Amoxicillina and Acido clavulanico PENSA PHARMA until the treatment is
finished, even if you feel better. You need every dose to fight the infection. If some bacteria
survive, they can cause the infection to return.
If you have any questions about using 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.
The side effects that may occur with this medicine are listed below.

Conditions you should pay attention to
Allergic reactions:

• skin rashes
• inflammation of the blood vessels (vasculitis) which may be visible as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swollen lymph nodes in the neck, armpits or groin swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing
• collapse. → Contact your doctor immediatelyif you experience any of these symptoms. Stop takingAmoxicillina e Acido clavulanico PENSA PHARMA.

Intestinal inflammation
Intestinal inflammation, which causes watery diarrhea generally with blood and mucus, stomach pain
and/or fever.

→If you experience these symptoms, contact your doctor as soon as possiblefor advice.

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 → if you suffer from this, take Amoxicillina e Acido clavulanico PENSA PHARMA before meals
• vomiting
• diarrhea (in children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised rash, with itching (urticaria)
• indigestion
• dizziness
• headache. Uncommon side effects can be seen from blood tests:
• increase in some proteins (enzymes) produced by the liver.

Rare side effects
May affect up to 1 in 1000 people

• skin rashes, which may appear as blisters and look like small targets (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 can be seen from blood tests:

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

Other side effects
Other side effects occur in a very limited number of people, but their exact frequency
is unknown.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• 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 that causes extensive skin peeling (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).
• 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 an increase in bilirubin in the blood (a substance produced by the liver) which can cause the skin and whites of the eyes to appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of Amoxicillina e Acido clavulanico PENSA PHARMA or who have kidney problems)
• black tongue that appears covered in hair
• stains on teeth (in children), usually removed by brushing.

Side effects that can be seen from blood or urine tests:

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

Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Amoxicillina e Acido clavulanico PENSA PHARMA

Keep out of sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Store at a temperature not exceeding 25°C.
Store in the original container to protect from moisture.
Do not use this medicine if the sachet is broken or damaged.
Medicines should not be disposed of via drains 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 pack and other information

What contains Amoxicillina e Acido clavulanico PENSA PHARMA

• The active ingredients are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate corresponding to 875 mg of amoxicillin and potassium clavulanate corresponding to 125 mg of clavulanic acid.

The other excipients are: magnesium stearate, crospovidone, colloidal silicon dioxide, aspartame (E951), strawberry aroma
(containing maltodextrins, benzyl alcohol).

• See paragraph 2 for further information regarding one of the excipients of Amoxicillina e Acido clavulanico PENSA PHARMA

Description of the appearance of Amoxicillina e Acido clavulanico PENSA PHARMA and contents of the
pack
Powder of colour from whitish to yellowish for oral suspension.
Each pack contains 12 sachets in PET/Al/PE
Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
TOWA PHARMACEUTICAL S.P.A.
Via Enrico Tazzoli, 6
20154 Milan
Italy

Manufacturer
PenCef Pharma Berlin GmbH
Breitenbachstrasse 13-14
13509 Berlin – GERMANY