Amoxicillin and clavulanic acid Pharmacare: detailed information

Package leaflet: Information for the user

AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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 or pharmacist.
This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE is and what it is used for
What you need to know before taking AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
How to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
Possible side effects
How to store AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
Contents of the pack and other information

1. What AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE is and what it is used for

AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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 (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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

PHARMACARE
Do not take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE:

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 (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck;
if you have previously had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

→ Do not take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE if any of
these apply to you. If you are unsure, speak to your doctor or pharmacist before taking
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
Speak to your doctor or pharmacist before taking this medicine if:

you have infectious mononucleosis;
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 PHARMACARE.
In some cases, your doctor may perform 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 PHARMACARE or a different medicine.
Conditions to be aware of
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking AMOXICILLIN AND CLAVULANIC ACID PHARMACARE in order to reduce any risks. See “Conditions to be aware of” in section 4.
Blood and urine tests
If you are scheduled 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 PHARMACARE.
This is because AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may affect the results of these tests.
Other medicines and AMOXICILLIN AND CLAVULANIC ACID PHARMACARE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with AMOXICILLIN AND CLAVULANIC ACID PHARMACARE, you are more likely to experience allergic skin reactions.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
If you are taking medicines such as warfarin (which help prevent blood clots) together with AMOXICILLIN AND CLAVULANIC ACID PHARMACARE, additional blood tests may be required.
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
If you are pregnant, think you might 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 PHARMACARE may cause side effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE

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

Adults and children weighing 40 kg or more
Recommended dose: 1 tablet of 875 mg + 125 mg, twice daily.
Higher dose: 1 tablet of 875 mg + 125 mg, three times daily.

Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid oral suspension.
Ask your doctor or pharmacist for advice on administering AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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 liver function.

How to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before.
Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
Do not take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE for longer than 2 weeks.
If you continue to feel unwell, you should see your doctor again.

If you take more AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE than you should
If you take too much AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine package with you to show the doctor.

If you forget to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
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 before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
Continue taking AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE until the treatment is complete, even if you feel better. You need every dose to help 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 medicine can cause side effects, although not everyone gets them. The side effects that may occur with this medicine are listed below.

Conditions to 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, swelling of the lymph nodes in the neck, armpits, or groin;
swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing;
collapse;
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 PHARMACARE.

Intestinal inflammation
Intestinal inflammation causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

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.

Drug-induced enterocolitis syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a specific type of allergic reaction with the main symptom being recurrent vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
→ 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, vaginal or skin fungal infections (candidiasis), nausea, especially when taking high doses: if affected, take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE 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 through blood tests:

increased levels of certain liver-produced proteins (enzymes).

Rare side effects
May affect up to 1 in 1,000 people

skin rash, 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 through blood tests:

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

Frequency 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 blistering rash with peeling 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 the body surface – toxic epidermal necrolysis);
widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis);
a red rash with crusts, swellings under the skin, and blisters (pustular exanthema);
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 Flexural Exanthema (SDRIFE)).

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

Skin rash with ring-shaped blisters with a central crust or resembling a string of pearls (linear IgA disease);
liver inflammation (hepatitis);
jaundice, caused by increased bilirubin levels 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 PHARMACARE or who have kidney problems);
black hairy tongue (a condition where the tongue appears black and hairy);

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 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 may also report side effects directly via the national reporting system at https://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 PHARMACARE

Keep in the original packaging to protect the medicine from light and moisture.
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Scad". The shelf life applies to the product in unopened packaging, correctly stored.
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE contains
Each tablet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.

Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE and contents of the pack
Film-coated tablets: Carton containing 12 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milano
Italy

Manufacturer
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika (Greece).
LABORATORIO REIG JOFRE' SA. Calle Jarama S/N Poligono Industrial, Toledo 45007 (Spain).

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, a bacterial infection does 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 antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice to help prevent the development of bacterial resistance, which can lead to failure of antibiotic activity.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. 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 have a similar infection.
Do not give your prescribed antibiotics to other people.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Patient Information Leaflet: Information for the user

AMOXICILLIN AND CLAVULANIC ACID PHARMACARE 875 mg + 125 mg

powder for oral suspension
amoxicillin + clavulanic acid
Generic 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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AMOXICILLIN AND CLAVULANIC ACID PHARMACARE is and what it is used for
What you need to know before taking AMOXICILLIN AND CLAVULANIC ACID PHARMACARE
How to take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE
Possible side effects
How to store AMOXICILLIN AND CLAVULANIC ACID PHARMACARE
Contents of the pack and other information

7. What AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE is and what it is used for

AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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 (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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

8. What you need to know before taking AMOXICILLIN AND CLAVULANIC ACID

PHARMACARE
Do not take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE:

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 (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck;
if you have previously experienced liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

→ Do not take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE if any of
these situations apply to you. If you are unsure, speak with your doctor or pharmacist before taking
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
Speak with your doctor or pharmacist before taking this medicine if:

you have infectious mononucleosis;
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 PHARMACARE.
In some cases, your doctor may perform 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 PHARMACARE or a different medicine.
Conditions requiring attention
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE 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 PHARMACARE in order to reduce any potential risk. See “Conditions requiring attention” in section 4.
Blood and urine tests
If you are scheduled for blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
This is because AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may affect the results of these types of tests.
Other medicines and AMOXICILLIN AND CLAVULANIC ACID PHARMACARE
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those available without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with AMOXICILLIN AND CLAVULANIC ACID PHARMACARE, you are at increased risk of developing skin allergic reactions.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of AMOXICILLIN AND CLAVULANIC ACID PHARMACARE.
If you are taking medicines such as warfarin (which help prevent blood clots) together with AMOXICILLIN AND CLAVULANIC ACID PHARMACARE, additional blood tests may be required.
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may affect how methotrexate works, a medicine used to treat cancers or rheumatic diseases.
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
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 PHARMACARE may cause side effects, and symptoms may make you unfit to drive or operate machinery.
Do not drive or operate machinery unless you feel well.
AMOXICILLIN AND CLAVULANIC ACID PHARMACARE contains aspartame (E951)
This medicine contains 12.5 mg of aspartame (E951) 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 because it cannot be properly metabolized.

9. How to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE

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

Adults and children weighing 40 kg or more
Recommended dose: 1 sachet of 875 mg + 125 mg, twice daily.
Higher dose: 1 sachet of 875 mg + 125 mg, three times daily.

Children weighing less than 40 kg
AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE 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 an alternative medicine.
If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
Open the sachet and mix the contents with half a glass of water immediately before administration.
Take at the beginning of a meal or just before a meal.
Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
Do not take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE for longer than 2 weeks.
If you continue to feel unwell, you must return to your doctor.

If you take more AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE than you should
If you take too much AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine pack with you to show the doctor.

If you forget to take AMOXICILLINA E ACIDO CLAVULANICO PHARMACARE
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 before taking the next dose. Do not take a double dose to make up for a forgotten dose.

If you have any questions about the use of this medicine, ask your doctor or pharmacist.

10. 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 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 glands in the neck, armpits or groin;
swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing;
collapse;
chest pain during allergic reactions, 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 PHARMACARE.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

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.

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.
→ 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 (candidiasis – a fungal infection of the vagina, mouth or skin folds), nausea, especially when taking high doses: if you experience nausea, take AMOXICILLIN AND CLAVULANIC ACID PHARMACARE with food;
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 be detected in blood tests:

increase in certain liver-produced proteins (enzymes).

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 in blood tests:

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

Frequency 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 peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis);
widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis);
a red rash with crusts, swellings under the skin and blisters (pustular exanthema);
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 Erythema (SDRIFE)).

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

Rash with blistering 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 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 PHARMACARE or who have kidney problems);
black hairy tongue, appearing covered with hair-like projections;
tooth staining (in children), usually removable by brushing.

Side effects that may be detected in 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

11. How to store AMOXICILLIN AND CLAVULANIC ACID PHARMACARE

Store in the original packaging to protect the medicine from light and moisture.
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month and applies to the product in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

12. Package contents and other information

What AMOXICILLIN AND CLAVULANIC ACID PHARMACARE contains
Each sachet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: hydrated colloidal silica, orange-flavoured aroma, aspartame.

Description of the appearance of AMOXICILLIN AND CLAVULANIC ACID PHARMACARE and package contents
Oral suspension powder: Carton containing 12 sachets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy

Manufacturers
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika (Greece).
LABORATORIO REIG JOFRE' SA. Calle Jarama S/N Poligono Industrial, Toledo 45007 (Spain).
LA.FA.RE. S.r.l., (Via Sacerdote 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 antibiotic treatment.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.

When your doctor prescribes an antibiotic treatment, it is specifically indicated for your current illness. Please pay attention to the following advice to help prevent the emergence of bacterial resistance, which can lead to 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 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 prescribed for other people, even if you believe you have a similar infection.
Do not give your prescribed antibiotics to other people.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.