Amoxicillin and clavulanic acid P-Care: detailed information

Package leaflet: Information for the user

Amoxicillina e Acido Clavulanico P-Care 875 mg/125 mg film-coated tablets

amoxicillin + clavulanic acid
Generic medicine
Please read all of 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, pharmacist, or nurse.
This medicine has been prescribed for you (or your child) only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Amoxicillina e Acido Clavulanico P-Care is and what it is used for
What you need to know before taking Amoxicillina e Acido Clavulanico P-Care
How to take Amoxicillina e Acido Clavulanico P-Care
Possible side effects
How to store Amoxicillina e Acido Clavulanico P-Care
Contents of the pack and other information

1. What Amoxicillin and Clavulanic Acid P-Care is and what it is used for

Amoxicillin and Clavulanic Acid P-Care is an antibiotic that works by killing the bacteria causing infections.
It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin is an antibiotic belonging 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 P-Care 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 P-Care

Do not take Amoxicillin and Clavulanic Acid P-Care:

if you are allergic to amoxicillin, clavulanic acid, penicillins, 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 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 P-Care if any of these apply to you.
If you have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid P-Care.
1 of 6
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid P-Care.
Speak with your doctor or pharmacist before taking this medicine if:

you have infectious mononucleosis (commonly known as “kissing disease”, which causes fever and swollen glands (lymph nodes) in the neck)
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, discuss this with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid P-Care.
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 P-Care or a different medicine.
Conditions to be aware of
Amoxicillin and Clavulanic Acid P-Care 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 alert to certain symptoms while taking Amoxicillin and Clavulanic Acid P-Care in order to reduce any risk. See “Conditions to be aware of” in section 4.
Blood and urine tests
If you 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 P-Care. This is because Amoxicillin and Clavulanic Acid P-Care may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid P-Care
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 Amoxicillin and Clavulanic Acid P-Care, 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 P-Care.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid P-Care, additional blood tests may be needed.
Amoxicillin and Clavulanic Acid P-Care may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid P-Care 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 might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid P-Care may cause side effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well enough.
Amoxicillin and Clavulanic Acid P-Care 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 P-Care

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults and children weighing 40 kg or more

The recommended dose is 1 tablet twice daily.
The maximum dose is 1 tablet three times daily.

Use in children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with amoxicillin and clavulanic acid
oral suspension.
Ask your doctor or pharmacist for advice on administering Amoxicillin and Clavulanic Acid P-Care
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 a different medicine.
If you have liver problems, you may require more frequent blood tests to monitor your liver function.

How to take Amoxicillin and Clavulanic Acid P-Care

Take with food.
Swallow the tablet whole with a glass of water.
Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within one hour.
Do not take Amoxicillin and Clavulanic Acid P-Care for longer than 2 weeks. If you continue to feel unwell, you should see your doctor.

If you take more Amoxicillin and Clavulanic Acid P-Care than you should
If you take too much Amoxicillin and Clavulanic Acid P-Care, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures. Inform your doctor as soon as possible. Bring the medicine package to show your doctor.
If you forget to take Amoxicillin and Clavulanic Acid P-Care
If you forget to take 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 missed dose.
If you stop taking Amoxicillin and Clavulanic Acid P-Care
Continue taking Amoxicillin and Clavulanic Acid P-Care until the treatment is complete, 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 following side effects may occur with this medicine.

Conditions to pay attention to:

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 throat ( angioedema ), causing difficulty in breathing
collapse (sudden drop in blood pressure)
chest pain during an allergic reaction, which may be a symptom of an allergy-induced heart attack ( Kounis syndrome ).

→ Contact your doctor immediately if you experience any of these symptoms. Stop taking
Amoxicillin and Clavulanic Acid P-Care.

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 mainly reported 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). Additional 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 may 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)

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 P-Care with 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 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 present 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 in blood tests:

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

Not known (frequency cannot be estimated from the available data)

allergic reactions (see above)
intestinal inflammation (see above)
inflammation of the 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 pus-filled blisters ( exfoliative bullous dermatitis )
- red rash with crusts, swellings under the skin, and blisters ( pustular eruption )
- 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 and Flexural Eruption (SDRIFE)).

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

Rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)
inflammation of the liver (hepatitis)
jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may 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 Amoxicillin and Clavulanic Acid P-Care or who have kidney problems)
black hairy 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 leading to acute kidney injury

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid P-Care

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 container to protect the medicine from light and moisture.
Do not store above 25°C.
Do not dispose of medicines 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 Amoxicillin and Clavulanic Acid P-Care contains
Amoxicillin and Clavulanic Acid P-Care 875 mg + 125 mg film-coated tablets

The active substances are amoxicillin trihydrate, corresponding to 875 mg amoxicillin, and potassium clavulanate, corresponding to 125 mg 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 Amoxicillin and Clavulanic Acid P-Care and pack contents
Film-coated tablets: carton containing 12 tablets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare Srl, Via Marghera, 29 - 20149 Milan, Italy
Distribution Licensee:
ACCORD HEALTHCARE ITALIA S.R.L.
Viale Monza, 265 - 20126 Milan – Italy
Manufacturer
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika (Greece)
Behavioral hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes a bacterial infection 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 bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the development of bacterial resistance.
When your doctor prescribes you an antibiotic, it is intended only for the illness you currently have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to the loss of antibiotic effectiveness.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. 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 prescribed for other people, even if you believe you have a similar infection.
Do not give your antibiotics to other people, even if they appear to have the same condition as you.
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 P-Care 875 mg/125 mg powder for oral suspension

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, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you (or your child) 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 side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Amoxicillina e Acido Clavulanico P-Care is and what it is used for

Amoxicillina e Acido Clavulanico P-Care is an antibiotic that works by killing bacteria causing infections.
It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin is an antibiotic belonging to the group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillina e Acido Clavulanico P-Care is used in adults and children to treat the following infections:

middle ear and nasal 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 P-Care

Do not take Amoxicillin and Clavulanic Acid P-Care:

if you are allergic to amoxicillin, clavulanic acid, penicillins, 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 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 P-Care if any of the above apply to you. If you are in doubt,
speak to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid P-Care.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid P-Care.
Speak to your doctor or pharmacist before taking this medicine if:

you have infectious mononucleosis (commonly known as “kissing disease”, which causes fever and swollen glands (lymph nodes) in the neck)
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 Amoxicillin and Clavulanic Acid P-Care.
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 P-Care or
a different medicine.
Conditions you should be aware of
Amoxicillin and Clavulanic Acid P-Care 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 P-Care, in order to
minimize any risk. See “Conditions you should be aware of” in section 4.
Blood and urine tests
If you are about 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 P-Care. This is because Amoxicillin and Clavulanic Acid P-Care may
affect the results of these types of tests.
Other medicines and Amoxicillin and Clavulanic Acid P-Care
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 Amoxicillin and Clavulanic Acid P-Care, you are at increased risk of developing 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 P-Care.
If you are taking medicines (such as warfarin) that help prevent blood clots together with Amoxicillin and Clavulanic Acid P-Care, additional blood tests may be required.
Amoxicillin and Clavulanic Acid P-Care may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).
Amoxicillin and Clavulanic Acid P-Care 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 are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid P-Care may cause side effects, and the symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid P-Care contains aspartame (E951).
This medicine contains 12.5 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 in the body because it cannot be properly eliminated.

3. How to take Amoxicillin and Clavulanic Acid P-Care

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
Use in adults and children weighing 40 kg or more

The recommended dose is 1 sachet twice a day.
The higher dose is 1 sachet three times a day.

Use in children weighing less than 40 kg
Amoxicillin and Clavulanic Acid P-Care 875 mg/125 mg sachets are not recommended.
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 a different medicine.
If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Amoxicillin and Clavulanic Acid P-Care

Just before taking Amoxicillin and Clavulanic Acid P-Care, open the sachet and mix the contents with half a glass of water.
Take 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 P-Care for longer than 2 weeks. If you still do not feel better, you should see your doctor again.

If you take more Amoxicillin and Clavulanic Acid P-Care than you should
If you take too much Amoxicillin and Clavulanic Acid P-Care, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible and take the medicine pack with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid P-Care
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop treatment with Amoxicillin and Clavulanic Acid P-Care
Continue taking Amoxicillin and Clavulanic Acid P-Care until the treatment course is complete, 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 that may occur with this medicine are listed below.

Conditions to pay attention to:

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 throat ( angioedema ), causing difficulty in breathing
collapse or chest pain occurring during an allergic reaction, 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 P-Care.

Intestinal inflammation
Inflammation of the intestine 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). Additional 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 this occurs, take Amoxicillin and Clavulanic Acid P-Care before 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 also 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 rash, 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 also be detected through blood tests:

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

Not known ( frequency cannot be estimated from the available data ):

allergic reactions (see above)
intestinal inflammation (see above)
inflammation of the 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 pus-filled blisters ( exfoliative bullous dermatitis )
- skin rash, red with crusts, swellings under the skin and blisters ( pustular eruption )
- 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 buttocks, upper inner thighs, armpits and neck (Symmetrical Drug-Related Intertriginous Flexural Erythema (SDRIFE)).

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

skin rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA bullous disease)
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 P-Care or who have kidney problems)
black hairy tongue
tooth staining (in children), usually removable by brushing

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

severe reduction in white blood cell count
low number of red blood cells (haemolytic anaemia)
crystals in the urine leading to acute kidney injury

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid P-Care

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 used. This will help protect the environment.

6. Package contents and other information

What Amoxicillina e Acido Clavulanico P-Care contains
Amoxicillina e Acido Clavulanico P-Care 875 mg/125 mg Powder for oral suspension

The active substances are amoxicillin and potassium clavulanate. Each sachet contains amoxicillin trihydrate equivalent to 875 mg amoxicillin and potassium clavulanate equivalent to 125 mg clavulanic acid.
The other components are: hydrated colloidal silica, orange flavour, aspartame.

Description of the appearance of Amoxicillina e Acido Clavulanico P-Care and the contents of the pack
Powder for oral suspension: carton containing 12 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl, Via Marghera, 29 – 20149 - Milan - Italy
Distribution Licensee:
ACCORD HEALTHCARE ITALIA S.R.L.
Viale Monza, 265 - 20126 Milan – Italy
Manufacturer
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attica (Greece)
LA.FA.RE. S.r.l. – Via S. Benedetto Cozzolino, 77 – 80056 Ercolano (NA) (Italy)

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do 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 bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can help reduce the emergence of bacterial resistance.
When your doctor prescribes 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 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 exact number of days indicated. Read the instructions in the package 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 believe you have a similar infection.
Do not give your prescribed antibiotics to anyone else.
If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.