Neoduplamox

Package leaflet: Information for the user

Neoduplamox Children 400 mg/57 mg powder for oral suspension in sachets

Amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine
because 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, because it could be harmful.
• If any side effect occurs, including any not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Neoduplamox is and what it is used for

Neoduplamox is an antibiotic that works by killing bacteria causing infections. It contains
two different medicines 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.
Neoduplamox is used in 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 Neoduplamox to your child

Do not give Neoduplamox to your child:

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

➔ Do not give Neoduplamox if any of these apply to your child.
If you are unsure, speak to your doctor or pharmacist before giving Neoduplamox.
Take special care with Neoduplamox
Talk to your doctor or pharmacist before giving this medicine to your child if:

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

If you are not sure whether any of the above conditions apply to your child, consult your doctor or pharmacist before giving Neoduplamox.
In some cases, the doctor may carry out tests to identify the type of bacteria causing your child's infection.
Based on the results, he/she may prescribe a different dose of Neoduplamox or a different medicine.
Conditions to watch for
Neoduplamox may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should monitor for certain symptoms while your child is taking Neoduplamox, in order to reduce any risk. See “Conditions to watch for” in section 4.
Blood and urine tests
If your child is due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform the doctor or nurse that your child is taking Neoduplamox. This is because Neoduplamox may affect the results of these tests.
Other medicines and Neoduplamox
Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those available without a prescription and herbal products.
If your child is taking allopurinol (used for gout) together with Neoduplamox, it is highly likely that your child may develop a skin allergic reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If Neoduplamox is taken together with medicines such as warfarin (which help prevent blood clots), additional blood tests may be required.
Methotrexate (used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing side effects.
Neoduplamox may affect how methotrexate works.
Neoduplamox 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 may be pregnant, is planning to become pregnant, or is breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Neoduplamox may cause side effects, and symptoms may make your child unfit to drive or operate machinery.
Do not drive or operate machinery unless your child feels well.
Neoduplamox contains aspartame and maltodextrin

• This medicine contains 11 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate in the body because it cannot be properly metabolized.
• Neoduplamox contains maltodextrin (glucose). If your doctor has diagnosed your child with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to use Neoduplamox

Always use this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• 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 appropriate dose of Neoduplamox for your newborn or 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 use Neoduplamox

• Immediately before administering Neoduplamox, open the sachet and mix the contents with half a glass of water.
• Have your child take the suspension immediately before a meal.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not administer two doses within one hour.
• Do not let your child take Neoduplamox for longer than 2 weeks. If your child does not feel well, return to the doctor.

If you give more Neoduplamox than you should
If your child takes too much Neoduplamox, symptoms may include stomach problems (nausea, vomiting) or intestinal problems (diarrhea), or seizures. Inform your doctor as soon as possible. Bring the medicine package or bottle to show the doctor.
If you forget to give Neoduplamox
If you forget to give your child a dose, give it as soon as you remember. Do not give the next dose too early; wait approximately 4 hours before giving the next dose.
If your child stops treatment with Neoduplamox
Continue giving Neoduplamox to your child until the treatment is complete, even if your child seems to feel 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 the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Conditions you should pay attention to

Allergic reactions:

• skin rashes
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpits or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• collapse
• chest pain occurring in the context of 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 the symptoms listed above.
Stop giving Neoduplamox.

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 mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

➔ If your child experiences 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 less than 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses; if this occurs, take Neoduplamox before food
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect less than 1 in 100 people

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

Uncommon side effects may be revealed by blood tests:

• increase in certain proteins (enzymes) produced by the liver

Rare side effects
May affect less than 1 in 1,000 people

• skin rashes, which may appear as blisters and look like 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 revealed by blood tests:

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

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

• 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)
  • rash with blistering arranged in a ring-like pattern with a central crust or resembling a string of pearls (linear IgA disease)

➔ If your child experiences any of the symptoms listed above, contact your doctor immediately.

• inflammation of the liver (hepatitis)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Neoduplamox or who have kidney problems)
• black, hairy-looking tongue
• tooth staining (in children), usually removable by brushing

Side effects that may be revealed by 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 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 Neoduplamox

Keep this medicine out of the sight and reach of children.
Do not use Neoduplamox after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store below 25°C.
Keep in the original container to protect from moisture.
Do not use Neoduplamox if the sachet is torn or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information
What Neoduplamox 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, silicon dioxide, aspartame (E951), peach-lemon-strawberry flavour (containing maltodextrins).
• See section 2 for information regarding aspartame and maltodextrins in Neoduplamox.

Description of the appearance of Neoduplamox and package contents
Neoduplamox Bambini 400 mg/57 mg powder for oral suspension in sachets contains a white to off-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
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)

This medicine is authorised in the Member States of the European Economic Area under the following names:
Italy: Neoduplamox Bambini 400 mg/57 mg powder for oral suspension in sachets

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 the bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately 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 failure of antibiotic therapy:

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 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 a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.

---

Instructions for reconstitution

The contents of the sachet should be dissolved in half a glass of water before administration.

Package leaflet: Information for the user

Neoduplamox bambini 400 mg/57 mg/5 ml powder for oral suspension (mixed fruits flavour)

amoxicillin/clavulanic acid
Please read this leaflet carefully before giving this medicine to your child because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child. Never give it to others. It may be harmful to others, even if their symptoms are the same as your child's.
• If your child experiences any side effect, contact your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Neoduplamox is and what it is used for

Neoduplamox is an antibiotic that works by killing bacteria that cause infections. It contains
two different medicines 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.
Neoduplamox is used in infants 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 Neoduplamox

➔ Do not give Neoduplamox 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 (hypersensitivity) to any other antibiotic. This may include skin 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 Neoduplamox to your child if any of the above conditions apply. If you
have doubts, speak with your doctor or pharmacist before giving Neoduplamox.
Warnings and precautions
Talk to your doctor or pharmacist before giving this medicine 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 Neoduplamox.
In some cases, the doctor may carry out tests to identify the type of bacteria causing
your child's infection.
Based on the results, he/she may prescribe a different dose of Neoduplamox or a different
medicine.
Conditions you should monitor
Neoduplamox may worsen certain pre-existing conditions or cause serious
adverse effects. These may include allergic reactions, seizures, and inflammation
of the bowel. You should watch for certain symptoms during treatment with
Neoduplamox in order to minimize any risk. See “Conditions you should monitor” in
Section 4.
Blood and urine tests
If your child is due to have blood tests (such as red blood cell counts or liver function tests) or urine tests (for glucose), inform the doctor that he/she is taking Neoduplamox. This is because Neoduplamox may affect the results of these tests.
Other medicines and Neoduplamox
Inform your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription and herbal products.
If your child is taking allopurinol (used for gout) with Neoduplamox, he/she is very likely to develop a skin allergic reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If your child is taking medicines such as warfarin (which help prevent blood clots) together with Neoduplamox, additional blood tests may be required.
Methotrexate (used to treat cancer and severe psoriasis): penicillins can reduce the excretion of methotrexate, potentially increasing its side effects.
Neoduplamox may affect how methotrexate works.
Neoduplamox 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, breastfeeding, suspects she may be pregnant, or is planning a pregnancy, consult your doctor or pharmacist before giving this medicine.
Driving and operating machinery
Neoduplamox may cause adverse effects, and symptoms may impair the ability to drive.
Do not drive or operate machinery until you feel well.
Neoduplamox contains aspartame, benzyl alcohol and maltodextrin.

• This medicine contains 2.5 mg of aspartame (E951) per ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly eliminate it.
• This medicine contains traces of benzyl alcohol. Benzyl alcohol may cause allergic reactions.
• This medicine contains maltodextrin (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to use Neoduplamox

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

• 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 Neoduplamox to give to your infant or child.

• You must use the oral dosing syringe supplied in the package to give your infant or child the correct dose. Instructions for using 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), administered in two divided doses.
• Higher dose – up to 70 mg/10 mg/kg/day (1.0 ml of suspension/kg/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 an alternative medicine.
• If your child has liver problems, more frequent blood tests may be required to monitor liver function.

How to use Neoduplamox

• Always shake the bottle well before withdrawing each dose.
• Administer the dose at the beginning of a meal or immediately before eating.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not administer two doses within one hour.
• Do not give Neoduplamox to your child for longer than 2 weeks. If your child does not feel better, you must consult your doctor again.

If you give more Neoduplamox than you should
If your child takes too much Neoduplamox, symptoms may include stomach problems (nausea,
vomiting) or intestinal problems (diarrhea), or seizures. Inform your doctor as soon as possible. Bring the medicine packaging or the bottle to show the doctor.
If you forget to give Neoduplamox
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 before administering the next dose. Do not give a double dose to make up for a forgotten dose.
If your child stops treatment with Neoduplamox
Continue giving Neoduplamox to your child until the full course of treatment is completed, even if your child appears to be feeling better. Your child needs every dose to fully eliminate the infection. If some bacteria survive, they may cause the infection to return.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome). ➔ Contact your doctor immediately if your child experiences any of these symptoms. Stop giving Neoduplamox.

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 mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after administration of the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
➔ If your child experiences these symptoms, contact your doctor as soon as possible for advice.
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 this occurs, take Neoduplamox before meals
• vomiting
• diarrhoea

Uncommon side effects
May affect up to 1 in 100 people

• rashes, itching
• raised, itchy rash ( urticaria )
• indigestion
• dizziness
• headache. Uncommon side effects that may be detected by 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 that may be detected by blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells.

Frequency not known

• 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 white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
  • rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)

➔ If your child experiences any of the symptoms listed above, contact your doctor immediately.

• inflammation of the liver ( hepatitis )
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Neoduplamox 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 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
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 Neoduplamox

Keep 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 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 no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Neoduplamox 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, succinic acid, hypromellose, orange flavour 1* (contains benzyl alcohol), orange flavour
2*, raspberry flavour*, golden syrup flavour*
*containing maltodextrins
See also section 2 for important information on aspartame, benzyl alcohol and
maltodextrins in Neoduplamox

Description of the appearance of Neoduplamox and contents of the pack
Neoduplamox paediatric 400 mg/57 mg/5 ml powder for oral suspension is a whitish powder,
contained in a transparent glass bottle closed with a child-resistant cap.
Once reconstituted, the bottle contains 35 ml, 70 ml or 140 ml of a white to light brown liquid called suspension.
The pack is supplied with an oral dosing syringe.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy

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:
Italy – Neoduplamox

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 the bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for several reasons. By using antibiotics appropriately, you
can help reduce the emergence of antibiotic resistance.
When your doctor prescribes an antibiotic, it is intended only for the specific illness you have.
Please pay attention to the following advice to help prevent the development of bacterial resistance,
which can 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 duration of treatment. 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 think you have a similar infection.
4. Do not give your antibiotics to other people, even if they have the same symptoms.
5. If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.

---

Instructions for reconstitution
Remove the cap. Before use, check the integrity of the tamper-evident seal consisting of a protective
film on the bottle. Close the bottle with the cap.

1. Shake the bottle to disperse the powder.

2. Remove the child-resistant cap.

3. Before use, check the integrity of the protective film. Remove the protective film.

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

Alternatively,
shake the bottle to disperse the powder, fill the bottle with water just below the level indicated on
the label of the bottle, close the bottle, invert and shake well, and let it stand for a few minutes. Then
fill with water exactly up to the level indicated on the label of the bottle, close the bottle again,
invert and shake well once more.
Store in the refrigerator and always shake well before use.
The suspension, once reconstituted, must be used within 7 days.
1.
2.

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

PACKAGE LEAFLET: INFORMATION FOR THE USER

Neoduplamox 875 mg/125 mg film-coated tablets

Amoxicillin/clavulanic acid
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor 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 side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Neoduplamox is and what it is used for

Neoduplamox is an antibiotic that works by killing the 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.
Neoduplamox 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 Neoduplamox

Do not take Neoduplamox:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of Neoduplamox (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or throat
• if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. → Do not take Neoduplamox if any of these cases apply to you. If you have any doubts, speak with your doctor or pharmacist before taking Neoduplamox.

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

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

If you are unsure whether any of the above conditions apply to you, discuss this with your doctor or pharmacist before taking Neoduplamox.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dosage of Neoduplamox or a different medicine.
Conditions you should be aware of
Neoduplamox may worsen certain pre-existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should be alert to certain symptoms while taking Neoduplamox in order to minimize any risks. See “Conditions you should be aware of ” 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 Neoduplamox. This is because Neoduplamox may affect the results of these tests.
Other medicines and Neoduplamox
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 Neoduplamox, you are very likely to develop a skin allergic reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Neoduplamox, additional blood tests may be required.
Methotrexate (used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing its side effects. Neoduplamox may affect how methotrexate works.
Neoduplamox may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Neoduplamox may cause adverse effects, and symptoms may impair your ability to drive or operate machinery.
Do not drive or use machines unless you feel well.
Sodium content of Neoduplamox
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Neoduplamox

Always take this medicine exactly as instructed by your doctor. 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 aged 6 years and younger should preferably be treated with Neoduplamox oral suspension or pediatric sachets.
Ask your doctor or pharmacist for advice on administering Neoduplamox 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 an alternative medicine.
• If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Neoduplamox

• Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before. The tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken at the same time.
• Space doses evenly throughout the day, with at least 4 hours between doses. Do not take two doses within one hour.
• Do not take Neoduplamox for longer than 2 weeks. If you still do not feel better, you should return to your doctor.

If you take more Neoduplamox than you should
If you take too much Neoduplamox, you may experience stomach problems (nausea, vomiting) or intestinal issues (diarrhea), or seizures. Inform your doctor as soon as possible. Take the medicine package with you to show to the doctor.

If you forget to take Neoduplamox
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 missed dose.

If you stop taking Neoduplamox
Continue taking Neoduplamox 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

Conditions 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 breathing
• collapse
• chest pain occurring during an allergic reaction, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).

➔ Contact your doctor immediately if you experience any of these symptoms. Stop taking Neoduplamox.

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 mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
➔ If you experience these symptoms, contact your doctor as soon as possible for advice.

Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common side effects
May affect up to 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses: if affected, take Neoduplamox before meals
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects may 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 rash, which may appear as blisters and look like 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 pustules (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)
  • rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)

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

• inflammation of the liver (hepatitis)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, which may 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 Neoduplamox or who have kidney problems)
• black hairy tongue

Side effects that may be revealed by blood or urine tests:

• severe decrease in white blood cell count
• 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, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Neoduplamox

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

What Neoduplamox contains
875/125 mg film-coated tablets
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, colloidal anhydrous silica, microcrystalline cellulose.
Tablet coating: titanium dioxide (E171), hypromellose, macrogol (4000, 6000) and silicone oil (dimethicone).

Description of the appearance of Neoduplamox and contents of the pack
NEODUPLAMOX 875 mg/125 mg - film-coated tablets - are white to off-white, capsule-shaped tablets, with "AC" imprinted on both sides and a score line on one side.
The tablets are packed in blisters contained in a cardboard carton.
The pack contains 12 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NEOPHARMED GENTILI S.p.A – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)

This medicinal product is authorized in the European Economic Area Member States under the following names:
Italy - Neoduplamox

This patient information leaflet was last approved on: ……

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.
Bacteria become resistant to antibiotics for several 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 therapy.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration indicated. 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 prescribed for other people, even if you believe 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.

NEODUPLAMOX Patient Information Leaflet: Information for the User

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

Amoxicillin/clavulanic acid
Please read this leaflet carefully before taking this medicine
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What Neoduplamox is and what it is used for

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

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

2. What you should know before taking Neoduplamox

Do not take Neoduplamox:

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

→ Do not take Neoduplamox if any of these cases apply to you. If you have any doubts, speak with your doctor or pharmacist before taking Neoduplamox.
Take special care with Neoduplamox
Talk to your doctor or pharmacist before taking this medicine if you:

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

If you are unsure whether any of the above conditions apply to you, talk to your doctor or pharmacist before taking Neoduplamox.
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 Neoduplamox or a different medicine.
Conditions you should be aware of
Neoduplamox 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 taking Neoduplamox, in order to minimize any risk. See “Conditions you should be aware of” 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 Neoduplamox. This is because Neoduplamox may affect the results of these tests.
Other medicines and Neoduplamox
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with Neoduplamox, you are very likely to develop a skin allergic reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce amoxicillin excretion and is not recommended.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Neoduplamox, additional blood tests may be required.
Methotrexate (used to treat cancer and severe psoriasis): penicillins may reduce methotrexate excretion, potentially increasing side effects. Neoduplamox may affect how methotrexate works.
Neoduplamox 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, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Neoduplamox may cause adverse effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Neoduplamox contains aspartame and maltodextrins
This medicine contains 24 mg of aspartame per sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder causing accumulation of phenylalanine due to the body's inability to process it properly.
Neoduplamox contains maltodextrins (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Neoduplamox

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
875 mg/125 mg powder for oral suspension in sachets

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

Children weighing less than 40 kg
Neoduplamox 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 how your liver is functioning.

How to take Neoduplamox

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

If you take more Neoduplamox than you should
If you take too much Neoduplamox, you may experience stomach problems (nausea, vomiting), intestinal problems (diarrhoea), or seizures. Inform your doctor as soon as possible. Take the medicine package or container with you to show the doctor.
If you forget to take Neoduplamox
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon; wait approximately 4 hours before taking the next dose.
If you stop taking Neoduplamox
Continue taking Neoduplamox 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, consult your doctor or pharmacist.

4. Possible side effects

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

Conditions you should pay attention to
Allergic reactions:

• skin rashes
• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the lymph glands in the neck, armpits or groin
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• collapse
• chest pain occurring in the context of allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

➔ Contact your doctor immediately if you experience any of the symptoms listed above. Stop taking Neoduplamox.

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 mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after drug administration). 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 less than 1 in 10 people

• oral or vaginal thrush (candida – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when high doses are taken; if affected, take Neoduplamox before meals
• vomiting
• diarrhoea (in children)

Uncommon side effects
May affect less than 1 in 100 people

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

Uncommon side effects may also be revealed by blood tests:

• increased levels of certain proteins (enzymes) produced by the liver

Rare side effects
May affect less than 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 also be revealed by blood tests:

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

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

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the 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)
  • 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 number of white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms)
  • rash with blistering arranged in rings with central crusts or resembling a string of pearls (linear IgA disease)

➔ If you experience any of the symptoms listed above, contact your doctor immediately.

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

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

5. How to store Neoduplamox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Store below 25°C.
Keep in the original container to protect from moisture.
Do not use this medicine if the sachet is torn or damaged.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Neoduplamox 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, silicon dioxide, aspartame (E951), peach-lemon-strawberry flavour (containing maltodextrins).
• See section 2 for information regarding aspartame and maltodextrins in Neoduplamox.

Description of the appearance of Neoduplamox and contents of the pack
NEODUPLAMOX 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
NEOPHARMED GENTILI S.p.A. – Via San Giuseppe Cottolengo 15 – 20143 Milan, Italy
Manufacturer
Glaxo Wellcome Production - Manufacturing site: Mayenne (France)
This medicinal product is authorised in the European Economic Area Member States under the following names:
Italy – Neoduplamox 875 mg/125 mg oral suspension powder in sachets

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. By using antibiotics appropriately, you can help reduce the emergence of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice to help prevent the development of bacterial resistance, which may lead to failure of antibiotic therapy.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
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 believe your infection is similar.
4. Do not give your prescribed antibiotics to other people.
5. If you have any leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

---

Instructions for reconstitution

The contents of the sachets must be dissolved in a small amount of water before administration.