Amoxicillin and clavulanic acid Pensapharma: detailed information

Package leaflet: Information for the user

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

Amoxicillin/clavulanic acid
Equivalent medicine
Read this leaflet carefully before you 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 only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

What this leaflet contains:

What Amoxicillin and Clavulanic Acid PENSA PHARMA is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid PENSA PHARMA
How to take Amoxicillin and Clavulanic Acid PENSA PHARMA
Possible side effects
How to store Amoxicillin and Clavulanic Acid PENSA PHARMA
Contents of the pack and other information

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

Amoxicillin and Clavulanic Acid PENSA PHARMA is an antibiotic that works by killing the bacteria that cause 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 (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening. Amoxicillin and Clavulanic Acid 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 Amoxicillin and Clavulanic Acid PENSA PHARMA

Do not take Amoxicillin and Clavulanic Acid PENSA PHARMA:

if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other
components of this medicine (listed in section 6)
if you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or throat
if you have previously had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.
→ Do not take Amoxicillin and Clavulanic Acid PENSA PHARMA if any of these apply to you.
If in doubt, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid PENSA PHARMA.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine 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 PENSA PHARMA.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Amoxicillin and Clavulanic Acid PENSA PHARMA or a different medicine altogether.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid PENSA PHARMA may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic Acid PENSA PHARMA in order to minimize any risks. See “Conditions to which you should pay attention” in Section 4.
Blood and urine tests
If you are due 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 Amoxicillin and Clavulanic Acid PENSA PHARMA. This is because Amoxicillin and Clavulanic Acid PENSA PHARMA may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid PENSA PHARMA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid PENSA PHARMA, you are 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 PENSA PHARMA.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid PENSA PHARMA, additional blood tests may be required.
Amoxicillin and Clavulanic Acid PENSA PHARMA may affect how methotrexate (a medicine used to treat tumours or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid PENSA PHARMA may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid PENSA PHARMA may cause side effects that could affect your ability to drive.
Do not drive or operate machinery unless you feel well enough to do so.
Amoxicillin and Clavulanic Acid PENSA PHARMA contains sodium

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

3. How to take Amoxicillin and Clavulanic Acid PENSA PHARMA

Take this medicine exactly as directed 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 a day
Higher dose – 1 tablet three times a day

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid PENSA PHARMA is not recommended in children weighing less than 40
kg.
Please consult your doctor or pharmacist for advice on formulations containing
Amoxicillin and Clavulanic Acid suitable for treating children weighing less than 40 kg.
Patients with kidney or liver problems

If you have kidney problems, your dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
If you have liver problems, your doctor will monitor you closely and you may undergo more frequent liver function tests.

How to take Amoxicillin and Clavulanic Acid PENSA PHARMA

Take with meals.
Swallow the tablet whole with a glass of water. Tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken at the same time.
Space 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 PENSA PHARMA for longer than 2 weeks. If you still do not feel better, you must see your doctor again.

If you take more Amoxicillin and Clavulanic Acid PENSA PHARMA than you should
If you take too much Amoxicillin and Clavulanic Acid PENSA PHARMA, symptoms may include
gastrointestinal disturbances (nausea, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible.
Bring the medicine pack or container with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid PENSA PHARMA
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid PENSA PHARMA
Continue taking Amoxicillin and Clavulanic Acid PENSA PHARMA 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everyone experiences 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 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, swollen 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 Amoxicillina e Acido clavulanico PENSA PHARMA.

Intestinal inflammation
Intestinal inflammation 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.

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 ( candida – a fungal infection of the vagina, mouth or skin folds)
nausea, especially when taking high doses → if affected, take Amoxicillina e Acido clavulanico PENSA PHARMA before meals
vomiting
diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects may be detected through blood tests:

increase in 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 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 may be detected through blood tests:

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

Frequency not known
Frequency cannot be estimated based on 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, 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 area, toxic epidermal necrolysis )
- widespread red rash with small pus-filled blisters ( 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 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 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 Amoxicillina e Acido clavulanico PENSA PHARMA or who have kidney problems)
black, hairy-looking tongue
tooth staining (in children), usually removable by brushing

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

severe reduction in the number of white blood cells
low number of red blood cells ( haemolytic anaemia )
crystals in 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.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 Amoxicillin and Clavulanic Acid 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 below 25°C.
Keep in the original container to protect from moisture.
Do not use the tablets if chipped or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Amoxicillina e Acido clavulanico PENSA PHARMA 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:
Tablet core: Magnesium stearate, Anhydrous colloidal silica, Microcrystalline cellulose,
Crospovidone, 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 the contents of the
package
Amoxicillina e Acido Clavulanico PENSA PHARMA 875 mg/125 mg - film-coated tablets - white to off-white, oblong, with a break line.
Tablet dimensions: 22 mm x 10 mm
Packaged in:

Blister packs made of OPA/Al/PVC, contained in a cardboard carton. Each package contains 12 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 against viral infections.
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 survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic, it is intended solely for the illness you currently have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
Do not use antibiotics that have been prescribed for other people, even if you think you have a similar infection.
Do not give your antibiotics to other people, even if they have the same symptoms.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Package leaflet: Information for the user

Amoxicillin and Clavulanic Acid PENSA PHARMA 875 mg/125 mg powder for oral suspension in sachets

Oral suspension in sachets
Amoxicillin/Clavulanic acid
Equivalent medicine
Please 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, consult your doctor or pharmacist.
This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amoxicillin and Clavulanic Acid PENSA PHARMA is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid PENSA PHARMA
How to take Amoxicillin and Clavulanic Acid PENSA PHARMA
Possible side effects
How to store Amoxicillin and Clavulanic Acid PENSA PHARMA
Contents of the pack and other information

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

Amoxicillin and Clavulanic Acid PENSA PHARMA is an antibiotic that works by killing bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active ingredient (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid 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 should know before taking Amoxicillin and Clavulanic Acid PENSA PHARMA

Do not take Amoxicillin and Clavulanic Acid PENSA PHARMA:

if you are allergic to amoxicillin, clavulanic acid, penicillins, or to any of the excipients of this medicine (listed in section 6)
if you have had a severe allergic reaction to any other antibiotic. This may include a skin 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 Amoxicillin and Clavulanic Acid PENSA PHARMA if any of these apply to you. If you are in doubt, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid PENSA PHARMA.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking this medicine 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 PENSA PHARMA.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dosage of Amoxicillin and Clavulanic Acid PENSA PHARMA or a different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid PENSA PHARMA may worsen certain pre-existing conditions or cause serious adverse effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic Acid PENSA PHARMA, in order to reduce any risk. See “Conditions to which you should pay attention” in section 4.
Blood and urine tests
If you are scheduled for blood tests (such as 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 PENSA PHARMA. This is because Amoxicillin and Clavulanic Acid PENSA PHARMA may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid PENSA PHARMA
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid PENSA PHARMA, 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 Amoxicillin and Clavulanic Acid PENSA PHARMA.
If you are taking medications (such as warfarin) that help prevent blood clots together with Amoxicillin and Clavulanic Acid PENSA PHARMA, additional blood tests may be required.
Amoxicillin and Clavulanic Acid PENSA PHARMA may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).
Amoxicillin and Clavulanic Acid PENSA PHARMA may affect the effectiveness of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid PENSA PHARMA may cause adverse effects, and symptoms may make you unfit to drive or operate machinery.
Do not drive or use machinery unless you feel well.
Amoxicillin and Clavulanic Acid PENSA PHARMA contains aspartame, maltodextrin and benzyl alcohol

Amoxicillin and Clavulanic Acid 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 causing phenylalanine to accumulate in the body due to inability to metabolize it properly.
Amoxicillin and Clavulanic Acid PENSA PHARMA contains maltodextrin (glucose). If you know you are intolerant to certain sugars, consult your doctor before taking this medicine.
Amoxicillin and Clavulanic Acid PENSA PHARMA contains 0.0013 mg of benzyl alcohol per sachet. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis). Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (such as metabolic acidosis).

3. How to take Amoxicillin and Clavulanic Acid PENSA PHARMA

Always 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
875 mg/125 mg powder for oral suspension in sachets

Recommended dose – 1 sachet twice daily
Higher dose – 1 sachet three times daily

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid PENSA PHARMA 875 mg/125 mg sachets are not recommended for
children weighing less than 40 kg.
Please consult your doctor or pharmacist for advice on formulations containing
Amoxicillin and Clavulanic Acid suitable for treating children weighing less than 40 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 an alternative medicine.
If you have liver problems, more frequent blood tests may be required to monitor liver function.

How to take Amoxicillin and Clavulanic Acid PENSA PHARMA

Just before taking Amoxicillin and Clavulanic Acid PENSA PHARMA, open the sachet and mix the contents with half a glass of water.
Take with meals.
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 PENSA PHARMA for longer than 2 weeks. If you continue to feel unwell, you should see your doctor again.

If you take more Amoxicillin and Clavulanic Acid PENSA PHARMA than you should
If you take too much Amoxicillin and Clavulanic Acid PENSA PHARMA, symptoms may include
stomach disturbances (nausea, vomiting, or diarrhoea) or seizures. Inform your doctor as soon as possible.
Bring the medicine packaging or container to show your doctor.
If you forget to take Amoxicillin and Clavulanic Acid PENSA PHARMA
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid PENSA PHARMA
Continue taking Amoxicillin and Clavulanic Acid PENSA PHARMA until the treatment is complete, even if you start to 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, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this one can cause side effects, although not everyone experiences 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 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, swollen 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 PENSA PHARMA.

Intestinal inflammation
Intestinal inflammation, 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.

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 or vaginal thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
nausea, especially when taking high doses → if affected, take Amoxicillin and Clavulanic Acid PENSA PHARMA before meals
vomiting
diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects may be detected through 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 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 may be detected through 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, 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 pus-filled blisters ( 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)

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

inflammation of the liver ( hepatitis )
jaundice, caused by increased levels of bilirubin in the blood (a substance produced in the liver), 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 PENSA PHARMA or who have kidney problems)
black hairy tongue, appearing as if covered in hair
tooth staining (in children), usually removable by brushing

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

severe decrease in white blood cell count
low number of red blood cells ( haemolytic anaemia )
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.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 Amoxicillin and Clavulanic Acid PENSA PHARMA

Keep out of sight and reach of children.
Do not use this medicine after the expiry date ( E X P ) stated on the packaging. The expiry date refers to the last day of the month.
Store below 25°C.
Keep in the original container to protect from moisture.
Do not use this medicine if the sachet is torn 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 Amoxicillina e Acido clavulanico PENSA PHARMA contains

The active substances are amoxicillin and clavulanic acid. Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

The other excipients are: magnesium stearate, crospovidone, colloidal silicon dioxide, aspartame (E951), strawberry flavour (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

White to yellowish powder for oral suspension.

Each pack contains 12 sachets in PET/Al/PE.

It is possible that not all pack sizes are 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