Clavulin

Patient Information Leaflet: Information for the User

Clavulin 875 mg/125 mg film-coated tablets

Amoxicillin/clavulanic acid
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or your child) only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Clavulin is and what it is used for

Clavulin 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 component (clavulanic acid) prevents this from happening.
Clavulin 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 Clavulin

Do not take Clavulin:

• 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 previously had a severe allergic reaction to any other antibiotic. This may include 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 Clavulin if any of these apply to you. If you are unsure, speak with your doctor or
pharmacist before taking Clavulin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clavulin if you:

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

If you are uncertain whether any of the conditions listed above apply to you, discuss this with your doctor or pharmacist before taking Clavulin.
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 Clavulin or an alternative medicine.
Conditions you should monitor
Clavulin may worsen certain pre-existing conditions or cause serious adverse effects.
These may include allergic reactions, seizures, and inflammation of the bowel. You should pay attention to certain symptoms while taking Clavulin in order to reduce any risks. See “Conditions you should monitor” 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 Clavulin.
This is because Clavulin may affect the results of these types of tests.
Other medicines and Clavulin
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Clavulin, 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 Clavulin.
If you are taking medicines together with Clavulin (such as warfarin) that help prevent blood clots, additional blood tests may be required.
Clavulin may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Clavulin may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Clavulin may cause adverse effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Clavulin contains sodium

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

3. How to take Clavulin

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 daily
• Higher dose - 1 tablet three times daily

Children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with Clavulin oral suspension or sachets.
Ask your doctor or pharmacist for advice regarding administration of Clavulin 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 Clavulin

• Take with meals.
• Swallow the tablet whole with a glass of water. The tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken immediately.
• Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Clavulin for longer than 2 weeks. If you still do not feel better, you should return to your doctor.

If you take more Clavulin than you should
If you take too much Clavulin, symptoms may include gastrointestinal disturbances (nausea, vomiting or diarrhoea)
or seizures. Speak to your doctor as soon as possible. Take the medicine pack with you to show the doctor.
If you forget to take Clavulin
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 forgotten dose.
If you stop taking Clavulin
Continue taking Clavulin until the 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 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 everyone will experience them. The following side effects may occur with this medicine.

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 the glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty in breathing
• collapse
• chest pain occurring 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 Clavulin.

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 reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is 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

• thrush (candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses ➝ if affected, take Clavulin 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:

• 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 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 blisters containing pus (exfoliative bullous dermatitis)
• red rash with crusts and 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 (Symmetric Drug-Related Intertriginous Flexural Exanthema (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 beads (linear IgA disease)
• liver inflammation (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 Clavulin or who have kidney problems)
• black hairy tongue

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 the urine leading to acute kidney damage

Reporting of side effects
If you experience any side effects, 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://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 Clavulin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the pack. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep in the original container to protect from moisture.
Do not use the tablets if chipped or damaged.
Do not dispose of any medicine 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 Clavulin 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, sodium carboxymethylstarch A, anhydrous colloidal silica, microcrystalline cellulose. Tablet coating – titanium dioxide (E171), hypromellose, macrogol (4000, 6000), and silicone oil (dimethicone).

Description of the Appearance of Clavulin and Contents of the Package
Clavulin 875 mg/125 mg – film-coated tablets – white to off-white, capsule-shaped tablets
with "AC" printed on both sides and a break line on one side.
They are packaged in:

• Blister packs, contained in a cardboard carton. Each pack contains 12 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona – Italy
Selling Agent: SAVIO Pharma Italia Srl - Via del Mare, 36 - Pomezia (RM)
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria – Augmentin
Belgium – Augmentin
Bulgaria – Augmentin
Cyprus – Augmentin
Czech Republic – Augmentin
Estonia – Augmentin
Germany – Augmentan
Greece – Augmentin
Hungary – Augmentin Duo
Ireland – Augmentin
Italy – Augmentin-Clavulin
Latvia – Augmentin
Lithuania – Augmentin
Luxembourg – Augmentin
Malta – Augmentin
Netherlands – Augmentin
Poland – Augmentin
Portugal – Augmentin Duo
Romania – Augmentin
Slovakia – Augmentin
Slovenia – Augmentin
Spain – Augmentine, Clavumox
United Kingdom – Augmentin

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 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 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 follow these recommendations to help prevent the development of bacterial resistance, which can lead to loss of antibiotic effectiveness.

1. 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 the package leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you have a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Package leaflet: Information for the user

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

Amoxicillin/clavulanic acid
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, 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 appear to be 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:

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

1. What Clavulin is and what it is used for

Clavulin is an antibiotic that works by killing 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.
Clavulin is used in adults and children to treat the following infections:

• middle ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. What you need to know before taking Clavulin

Do not take Clavulin:

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or 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 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 Clavulin if any of these apply to you. If in doubt, speak to your doctor or
pharmacist before taking Clavulin.
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 Clavulin.
In some cases, your doctor may carry out an investigation to identify the type of bacteria causing your infection.
Based on the results, they may prescribe a different dose of Clavulin or a different medicine altogether.
Conditions to which you should pay attention
Clavulin 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 Clavulin in order to reduce 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 (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
Clavulin. This is because Clavulin may affect the results of these tests.
Other medicines and Clavulin
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 Clavulin, you are much 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
Clavulin.
If you are taking Clavulin together with medicines such as warfarin (which help prevent blood clots), additional blood tests may be required.
Clavulin may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).
Clavulin 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 to become pregnant, or are breastfeeding, please consult your doctor or pharmacist before using this medicine.
Driving and using machines
Clavulin 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.
Clavulin contains aspartame and maltodextrin

• Clavulin contains aspartame (E951), a source of phenylalanine. It may be harmful for patients with phenylketonuria.
• Clavulin contains maltodextrin (glucose). If you know you are intolerant to certain sugars, consult your doctor before taking this medicine.

3. How to take Clavulin

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

• Recommended dose - 1 sachet twice daily
• Higher dose - 1 sachet three times daily

Children weighing less than 40 kg
Clavulin 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, more frequent blood tests may be required to monitor your liver function.

How to take Clavulin

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

If you take more Clavulin than you should
If you take too much Clavulin, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea)
or seizures. Speak to your doctor as soon as possible. Take the medicine pack with you to show the doctor.
If you forget to take Clavulin
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 forgotten dose.
If you stop treatment with Clavulin
Continue taking Clavulin for the full duration of treatment, 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, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

Conditions you should 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
• chest pain occurring as part of an allergic reaction, which may be a sign of an allergy-triggered heart attack ( Kounis syndrome ). Contact your doctor immediately if you experience any of these symptoms. Stop taking Clavulin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually containing 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 whose main symptom is 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

• thrush ( candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses → if affected, take Clavulin 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 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 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 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 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)
• a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits and neck (Symmetric Drug-Related Intermtriginous Flexural Exanthema (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 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 Clavulin 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 the number of white blood cells
• low number of red blood cells ( haemolytic anaemia )
• crystals in the urine leading to acute kidney damage

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 Clavulin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the pack. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Clavulin 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), peach-lemon-strawberry flavour (containing maltodextrins).
• See section 2 for further information regarding one of the excipients of Clavulin.

Description of the appearance of Clavulin and contents of the pack
Clavulin 875 mg/125 mg - oral suspension powder in sachets contains a white to off-white powder for oral suspension.
The sachets are contained in a carton. Each pack contains 12 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Distributor for sale: SAVIO Pharma Italia Srl - Via del Mare, 36 - Pomezia (RM)
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)
This medicinal product is authorised in the European Economic Area countries under the following
names:
Italy – Augmentin, Clavulin
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 antibiotic.
Bacteria become resistant to antibiotics for several reasons. By using antibiotics appropriately, the development of bacterial resistance can be reduced.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have.
Please follow the advice below to help prevent the emergence of bacterial resistance, which leads to loss of antibiotic effectiveness.

1. 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.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you have an infection similar to theirs.
4. Do not give your prescribed antibiotics to other people.
5. If you have any leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.

---

Instructions for reconstitution
The contents of the sachets must be dissolved in half a glass of water before administration.

Package leaflet: Information for the user

Clavulin Children 400 mg/57 mg oral suspension powder in sachets

Amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine to your child, as it contains
important information for your child.

• 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 your child only. Do not give it to others, even if their symptoms are the same as your child's, as it could be harmful.
• If any adverse effects occur, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Clavulin is and what it is used for
2. What you need to know before giving Clavulin
3. How to give Clavulin
4. Possible side effects
5. How to store Clavulin
6. Package contents and other information

1. What Clavulin is and what it is used for

Clavulin is an antibiotic that works by killing 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.
Clavulin 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 giving Clavulin to your child

Do not give Clavulin to your child:

• if he or she is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients of this medicine (listed in section 6)
• if he or she has had a severe allergic reaction to any other antibiotic. This may include skin rash or swelling of the face or throat
• if he or she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Clavulin if any of these cases apply to your child. If you have any doubts, speak with the doctor or
pharmacist before giving Clavulin.
Warnings and precautions
Talk to the doctor, pharmacist, or nurse before giving Clavulin to your child if:

• he or she has infectious mononucleosis
• he or she has been treated for liver or kidney problems
• he or she does not urinate regularly.

If you are unsure whether any of the above conditions apply to your child, consult the doctor or pharmacist
before giving Clavulin.
In some cases, the doctor may carry out tests to identify the type of bacteria causing your child’s infection.
Based on the results, the doctor may prescribe a different dose of Clavulin or a different medicine.
Conditions to be aware of
Clavulin may worsen certain pre-existing conditions or cause serious side effects.
These may include allergic reactions, seizures, and inflammation of the bowel. You should watch for certain symptoms while your child is taking Clavulin, in order to reduce any risk. See “Conditions to be aware of” in section 4.
Blood and urine tests
If your child is due to have blood tests (such as checks on red blood cells or liver function tests) or urine tests (for glucose), inform the doctor or nurse that your child is taking Clavulin. This is because Clavulin may affect the results of these tests.
Other medicines and Clavulin
Inform the doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines.
If your child is taking allopurinol (used for gout) together with Clavulin, it is highly likely that your child may develop a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of Clavulin.
If your child is taking medicines (such as warfarin) that help prevent blood clots, additional blood tests may be needed.
Clavulin may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Clavulin may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If your daughter who is taking this medicine is pregnant, suspects she might be pregnant, plans to become pregnant, or is breastfeeding, please consult the doctor or pharmacist before using this medicine.
Driving and using machines
Clavulin may cause side effects, and the symptoms may make you unfit to drive or operate machinery.
Do not drive or operate machinery unless you feel well.
Clavulin contains aspartame and maltodextrins

• Clavulin contains aspartame (E951), which is a source of phenylalanine. It may be harmful for patients with phenylketonuria.
• Clavulin contains maltodextrins (glucose). If you know your child has an intolerance to certain sugars, consult your doctor before giving this medicine.

3. How to use Clavulin

Always use 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

• The sachets are not recommended for adults and children weighing 40 kg or more. If you have any doubts, consult your doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms.

• Your doctor will advise you on the dose of Clavulin to give to your child.
• Recommended dose – from 25 mg/3.6 mg up to 45 mg/6.4 mg per kg of body weight per day, administered in two divided doses.
• Higher dose – up to 70 mg/10 mg per kg of body weight per day, administered in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be reduced. Your doctor may choose a different dosage or a different medicine.
• If your child has liver problems, more frequent blood tests may be required to monitor liver function.

How to give Clavulin

• Just before giving Clavulin, open the sachet and mix the contents with half a glass of water.
• Give the resulting mixture to your child with meals.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not give your child two doses within one hour.
• Do not give Clavulin to your child for longer than 2 weeks. If your child does not feel better, you must return to the doctor.

If you give more Clavulin than you should
If your child takes too much Clavulin, symptoms may include stomach disturbances (nausea, vomiting, or
diarrhea) or seizures. Speak to your doctor as soon as possible. Bring the medicine packaging or the
bottle to show the doctor.

If you forget to give Clavulin
If you forget to give a dose to your child, give it as soon as you remember. Do not give the next dose too early; wait approximately 4 hours. Do not give a double dose to make up for a forgotten dose.

If your child stops treatment with Clavulin
Continue giving Clavulin to your child until the treatment is finished, even if your child seems to be feeling better. Your child needs every dose to fight the infection. If some bacteria survive, they may cause the infection to return.

If you have any doubts about using this medicine, consult your doctor, pharmacist, or nurse.

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, swelling of the glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing
• collapse
• chest pain during allergic reactions, which may be a symptom of an allergy-induced heart attack (Kounis syndrome). Contact your doctor immediately if your child experiences any of these symptoms. Stop taking Clavulin.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually containing 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 whose main symptom is repeated vomiting (1-4 hours after taking the medicine). Further 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

• thrush (candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses → if affected, take Clavulin with 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:

• 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

Frequency not known
Frequency cannot be estimated from 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 blisters containing pus (exfoliative bullous dermatitis)
• 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 number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)
• 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 your child experiences 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 Clavulin 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 the number of white blood cells
• low number of red blood cells (haemolytic anaemia)
• crystals in the urine leading to acute kidney damage

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 Clavulin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Store 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Clavulin contains

• The active substances are amoxicillin and clavulanic acid. Each sachet contains: amoxicillin trihydrate equivalent to 400 mg amoxicillin and potassium clavulanate equivalent to 57 mg clavulanic acid.
• The other excipients are: magnesium stearate, crospovidone, colloidal silicon dioxide, aspartame (E951), peach-lemon-strawberry flavour (containing maltodextrins).
• See section 2 for further information on one of the excipients of Clavulin.

Description of the appearance of Clavulin and contents of the pack
Clavulin paediatric 400 mg/57 mg powder for oral suspension in sachets contains a white or almost white powder for oral suspension.
The sachets are packed in a carton. Each pack contains 12 sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura 7 - 37135 Verona - Italy
Selling Agent: SAVIO Pharma Italia Srl - Via del Mare, 36 - Pomezia (RM)
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)
This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
400 mg/57 mg powder for oral suspension in sachets
Italy – Augmentin, Clavulin
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 may become resistant to antibiotics for several reasons. By using antibiotics appropriately, you can help 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 may lead to antibiotics becoming ineffective.

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

---

Instructions for reconstitution
The contents of the sachets must be dissolved in half a glass of water before administration.

Package leaflet: Information for the user

Clavulin Children 400 mg/57 mg/5 ml powder for oral suspension (mixed fruit flavour)

amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine to your child, 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, pharmacist, or nurse.
• This medicine has been prescribed for children. Never give it to others. It may be harmful to other people, even if their symptoms are the same as your child's.
• If your child experiences any side effect, contact your doctor, pharmacist, or nurse. This includes any side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Clavulin is and what it is used for
2. What you need to know before using Clavulin
3. How to use Clavulin
4. Possible side effects
5. How to store Clavulin
6. Package contents and other information

1. What Clavulin is and what it is used for

Clavulin 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 component (clavulanic acid) prevents this from happening.
Clavulin 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 using Clavulin

Do not give Clavulin to your child:

• if he/she is allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients in this medicine (listed in section 6)
• if he/she has had an allergic reaction to any other antibiotic. This may include rash or swelling of the face or throat
• if he/she has had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Clavulin to your child if any of these cases apply to your child. If you have any doubts,
speak with your doctor or pharmacist before giving Clavulin.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before giving Clavulin to your child if:

• he/she has infectious mononucleosis
• he/she has been treated for liver or kidney problems
• he/she does not urinate regularly.

If you are unsure whether any of the conditions listed above apply to your child, consult your doctor or pharmacist before
giving Clavulin.
In some cases, the doctor may perform tests to determine the type of bacteria causing your
child’s infection.
Based on the results, he/she may prescribe a different dose of Clavulin or a different medicine.
Conditions you should watch for
Clavulin may worsen certain pre-existing conditions or cause serious adverse effects.
These may include allergic reactions, seizures, and inflammation of the intestine. You should pay
attention to certain symptoms while your child is taking Clavulin, in order to reduce any
risk. See “Conditions you should watch for” in Section 4.
Blood and urine tests
If your child is about to have blood tests (for example, tests related to red blood cells or
liver function tests) or urine tests (for glucose), inform the doctor or nurse that he/she is
taking Clavulin. This is because Clavulin may affect the results of these types of tests.
Other medicines and Clavulin
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take
any other medicines.
If your child is taking allopurinol (used for gout) together with Clavulin, he/she is very likely to develop
a skin allergic reaction.
If your child is taking probenecid (used for gout), the doctor may decide to adjust the dose of
Clavulin.
If your child is taking medicines (such as warfarin) that help prevent blood clots along with Clavulin,
additional blood tests may be required.
Clavulin may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Clavulin may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If your daughter is pregnant or breastfeeding, or if she suspects she may be pregnant or is planning a
pregnancy, consult your doctor or pharmacist before giving this medicine.
Driving and using machines
Clavulin may cause adverse effects, and symptoms may impair the ability to drive.
Do not drive or operate machinery until you feel well again.
Clavulin contains aspartame, benzyl alcohol, and maltodextrins

• This medicine contains 2.5 mg of aspartame per ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.
• Clavulin contains traces of benzyl alcohol. Benzyl alcohol may cause allergic reactions.
• Clavulin contains maltodextrins (glucose). If you are aware that your child has an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Clavulin

Always give this medicine exactly as your doctor or pharmacist has told you. If you are unsure,
consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• This suspension is not recommended for adults and children weighing 40 kg or more. If you have any doubts, consult your doctor or pharmacist.

Children weighing less than 40 kg
All doses are calculated based on the child's body weight expressed in kilograms. Your doctor will
advise you on the appropriate dose of Clavulin for your child.

• You must use an oral dosing syringe. You will use it to give your child the correct dose. Instructions on how to use the dosing syringe are provided at the end of this leaflet.
• Recommended dose – from 25 mg/3.6 mg/kg/day (0.4 ml of suspension/kg/day) up to 45 mg/6.4 mg/kg/day (0.6 ml of suspension/kg/day), given in two divided doses.
• Higher dose – up to 70 mg/10 mg/kg/day (1.0 ml of suspension/kg/day), given in two divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may need to be reduced. Your doctor may choose a different dosage or an alternative medicine.
• If your child has liver problems, more frequent blood tests may be needed to monitor liver function.

How to use Clavulin

• Always shake the bottle well before withdrawing each dose.
• Administer the dose at the beginning of a meal or just before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not give two doses within one hour.
• Do not let your child take Clavulin for longer than 2 weeks. If your child does not feel better, you should contact your doctor.

If you give more Clavulin than you should
If your child takes too much Clavulin, symptoms may include stomach problems (nausea, vomiting or
diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine pack or the
bottle with you to show the doctor.
If you forget to give Clavulin
If you forget to give a dose to your child, give it as soon as you remember. Do not give the next dose too soon; wait approximately 4 hours. Do not give a double dose to make up for a missed dose.
If your child stops treatment with Clavulin
Continue giving Clavulin to your child until the full course is completed, even if your child seems to be feeling better. Your child needs 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, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Conditions you should pay attention to

Allergic reactions:

• 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
• chest pain during allergic reactions, which may be a symptom of an allergy-triggered heart attack ( Kounis syndrome ). Contact your doctor immediately if your child experiences any of these symptoms. Stop giving Clavulin.

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 reported mainly in children treated with amoxicillin/clavulanic acid. It is a type of allergic reaction whose main symptom is 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

• thrush ( candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when taking high doses → if this affects you, take Clavulin with meals
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects that may be detected by 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 that may be detected by blood tests:

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

Frequency not known
Frequency cannot be estimated from 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 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 (Symmetric Drug-Related Intertriginous Flexural Exanthema (SDRIFE))

If your child experiences any of these symptoms, contact your doctor immediately.

• rash with blistering arranged in circles, 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 Clavulin 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 by 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://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 Clavulin

Keep this medicine out of the sight and reach of children.
Dry powder
Store in the original container to protect from moisture.
Store at a temperature not exceeding 25°C.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Reconstituted suspension
Store in the refrigerator (2°C – 8°C).
Do not freeze.
The reconstituted suspension must be used within 7 days.
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.

6. Package contents and other information

What Clavulin contains

• The active substances are amoxicillin and clavulanic acid. Each ml of suspension contains amoxicillin trihydrate equivalent to 80 mg of amoxicillin and potassium clavulanate equivalent to 11.4 mg of clavulanic acid.

The other components are aspartame (E951), xanthan gum, silicon dioxide, anhydrous colloidal silica,
hypromellose, succinic acid, orange flavour 1* (contains benzyl alcohol), orange flavour 2*, raspberry flavour*,
and Golden syrup flavour*.
* also contains maltodextrins.

• See also section 2 for important information on aspartame, benzyl alcohol and maltodextrins in Clavulin.

Description of the appearance of Clavulin and contents of the pack
Clavulin paediatric 400 mg/57 mg/5 ml (mixed fruit flavour) powder for oral suspension is a whitish powder
in a transparent glass bottle.
Once reconstituted, the bottle contains 35, 70 or 140 ml of a white to light brown liquid known as a suspension.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
GlaxoSmithKline S.p.A. - Viale dell’Agricoltura, 7 - 37135 Verona - Italy
Selling Agent: SAVIO Pharma Italia Srl - Via del Mare, 36 - Pomezia (RM)
Manufacturer
Glaxo Wellcome Production - Manufacturing site Mayenne (France)
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, an infection caused by bacteria does not respond to antibiotic therapy. The most common reason
for this is that the bacteria causing the infection are resistant to the antibiotic being used.
This means that 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 development of bacterial resistance.

When your doctor prescribes 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
failure of antibiotic treatment.

1. 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.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for someone else, even if you have an infection similar to theirs.
4. Do not give your antibiotics to others, even if they appear to have the same condition as you.
5. If you have any antibiotic left over after completing your course of treatment, return it to your pharmacist for proper disposal.

---

Instructions for reconstitution
Remove the cap. Before use, check that the protective seal on the bottle is intact.
Close the bottle with the cap.

1. Shake the bottle to loosen the powder.

2. Remove the cap from the bottle.

3. Remove the protective film.

4. Add the volume of water (as indicated below). Close the bottle, invert and shake well.

Alternatively, fill the vial with water just below the level indicated on the vial label.

Close the vial with the cap, invert and shake well, then fill with water exactly to the level.

Close the vial with the cap, invert and shake well again.

5. Store in the refrigerator and always shake well before use. The reconstituted oral suspension must be used within 7 days.

Instructions for the use of the syringe

A syringe is provided for administering Clavulin
The syringe must be used only for the administration of Clavulin and must not be used to administer other medicines, as the markings are specific to this product. The syringe is supplied with an adapter that allows attachment to the bottle.
The dose on the oral dosing syringe is indicated in millilitres (ml). The dose to be given to your child must be the one recommended by your doctor.
Check the cleanliness of the syringe and adapter before use; rinse with clean water if necessary.

1. Shake the suspension in the bottle well before each administration.

2. Remove the adapter from the syringe. Hold the bottle firmly and insert the adapter into the neck of the bottle (the adapter should remain securely in place).

3. Insert the syringe into the adapter, ensuring it is properly seated.

4. Invert the bottle, keeping the syringe in place, and draw up the required dose as prescribed by the doctor.

5. Return the bottle to an upright position and remove the syringe.

6. To administer the dose, carefully insert the tip of the syringe into the mouth and slowly push down the plunger of the syringe (repeat steps 3, 4, 5 and 6 if more than one syringe is needed to deliver the full dose).

7. Rinse the syringe thoroughly with clean water. Allow the syringe to dry completely before next use.

8. Close the bottle with the cap.

9. Store in the refrigerator and always shake well before use. The suspension, once reconstituted, must be used within 7 days.