Mondex

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONDEX 875 mg/125 mg Film-coated Tablets, 875 mg/125 mg Powder for Oral Suspension

Amoxicillin + Clavulanic Acid
Generic medicine
Please read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you 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 or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT MONDEX IS AND WHAT IT IS USED FOR

Mondex 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.
Mondex 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 SHOULD KNOW BEFORE TAKING MONDEX

Do not take Mondex:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6).

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• if you have had a severe allergic reaction (hypersensitivity) 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 Mondex if any of these cases apply to you. If you have any doubts, speak with your
doctor or pharmacist before taking Mondex.
Warnings and precautions
Exercise particular caution with Mondex
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, discuss this with your
doctor or pharmacist before taking Mondex.
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 Mondex or a different medicine.
Conditions to which you should pay attention
Mondex may worsen certain pre-existing conditions or cause serious side effects. These may
include allergic reactions, seizures, and inflammation of the intestine. You should watch for
certain symptoms while taking Mondex, in order to reduce any risks. See “Conditions to which you should pay attention ” in Section 4.
Blood and urine tests
If you are scheduled for blood tests (such as checks for red blood cells or liver function tests)
or urine tests (for glucose), inform your doctor or nurse that you are taking Mondex. This is
because Mondex can affect the results of these types of tests.
Other medicines and Mondex
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 Mondex, you are more likely to
develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Mondex.
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If you are taking medications (such as warfarin) that help prevent blood clots while also
taking Mondex, additional blood tests may be required.
Mondex may affect how methotrexate (a medicine used to treat cancers or rheumatic
diseases) works.
Mondex may affect the action of mycophenolate mofetil (a drug used to prevent rejection of
transplanted organs).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are
breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Mondex may cause side effects, and symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
MONDEX 875 mg/125 mg powder for oral suspension in sachets contains 3.6 g of sucrose
per sachet; patients with rare hereditary fructose intolerance, glucose-galactose malabsorption,
or sucrase-isomaltase deficiency must not take this medicine. This should be taken into account
in patients with diabetes mellitus.
MONDEX 875 mg/125 mg powder for oral suspension in sachets contains 0.63 mmol (24.6 mg)
of potassium per sachet. This should be taken into account in patients with impaired renal
function or those on a low-potassium diet.
MONDEX 875 mg/125 mg film-coated tablets contain less than 1 mmol (23 mg) of sodium per
tablet, i.e. essentially “sodium-free”.
MONDEX 875 mg/125 mg film-coated tablets contain 0.63 mmol (24.6 mg) of potassium per
tablet. This should be taken into account in patients with impaired renal function or those on
a low-potassium diet.

3. HOW TO TAKE MONDEX

Take this medicine exactly as prescribed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
Adults, including elderly patients, and children weighing 40 kg or more

• Recommended dose – 1 tablet or 1 sachet twice daily
• Higher dose – 1 tablet or 1 sachet three times daily

Children weighing less than 40 kg
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Children aged 6 years or younger should preferably be treated with amoxicillin and
clavulanic acid oral suspension or pediatric sachets.
875 mg/125 mg Film-coated tablets
Consult your doctor or pharmacist for advice on administering Mondex tablets to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.
875 mg/125 mg Powder for oral suspension
Mondex 875 mg/125 mg sachets are not recommended.
Patients with kidney or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or an alternative medicine.
• If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Mondex
Tablet
Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before.
Sachet
Open the sachet and mix the contents with a glass of water; drink the suspension at the beginning of a meal or immediately before.

• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Mondex for longer than 2 weeks. If you continue to feel unwell, you should return to your doctor.

If you take more Mondex than you should
If you take too much Mondex, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhea) or seizures. Speak to your doctor as soon as possible. Take the medicine packaging with you to show the doctor.
If you forget to take Mondex
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too soon, but 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 treatment with Mondex
Continue taking Mondex until the full course is completed, 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.
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4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Mondex can cause adverse reactions, although not everyone experiences them. The following adverse reactions may occur with this medicine.

Conditions to which you should pay attention

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis), which may appear as raised 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-triggered heart attack (Kounis syndrome).

Contact your doctor immediately if any of these symptoms occur. Stop taking Mondex.

Inflammation of the large intestine (colitis)
Inflammation of the large intestine, causing watery diarrhoea, usually accompanied by blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being recurrent vomiting (1-4 hours after taking the medicine). Additional symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
Contact your doctor as soon as possible for advice if you experience these symptoms.

Very common adverse reactions
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common adverse reactions
May affect up to 1 in 10 people

• thrush (candida – a fungal infection of the vagina, mouth, or skin folds)
• nausea, especially when high doses are taken: if affected, take Mondex before food
• vomiting 5/9
• diarrhoea (in children)

Uncommon adverse reactions
May affect up to 1 in 100 people

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

Uncommon adverse reactions may be detected through blood tests:

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

Rare adverse reactions
May affect up to 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 adverse reactions may be detected through blood tests:

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

Frequency not known
Frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Inflammation of the protective membrane surrounding the brain and spinal cord (aseptic meningitis)
• Severe skin reactions:
  • widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
  • a skin rash, red, 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 (Symmetrical Drug-Related Intertriginous Flexural Erythema (SDRIFE)).

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

• rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease)
• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin levels in the blood (a substance produced in the liver), which may cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Mondex or who have kidney problems)
• black hairy tongue
• tooth staining (in children), usually removable by brushing

Adverse reactions that may be detected through blood or urine tests:

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

If you experience adverse reactions
If any of the adverse reactions worsen or become bothersome, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONDEX

Keep in the original packaging to protect the product from light and moisture,
at a temperature not exceeding 25°C.
Keep this medicine out of the sight and reach of children.
Do not use Mondex after the expiry date stated on the carton after Exp. The expiry date refers to the last day of the month.
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. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

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What Mondex contains
Film-coated tablets
Each tablet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone.

Oral suspension powder
Each sachet contains:
Active substances: amoxicillin trihydrate corresponding to 875 mg amoxicillin, potassium clavulanate corresponding to 125 mg clavulanic acid.
Excipients: colloidal silicon dioxide, lemon flavour, strawberry flavour, xanthan gum, sucrose.

Description of the appearance of Mondex and contents of the pack
Carton containing 12 film-coated tablets
Carton containing 12 sachets

Marketing Authorization Holder
S.F. GROUP s.r.l. – Via Tiburtina No. 1143, 00156 Rome, Italy

Manufacturer
Laboratorio Reig Jofré, S.A. - C/Jarama s/n, Poligono Industrial - 45007 Toledo - Spain

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Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections. Sometimes a bacterial infection does not respond to antibiotic treatment. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that bacteria survive and multiply despite the antibiotic.

Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, the development of bacterial resistance can be reduced.

When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice in order to help prevent the emergence 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 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 believe your infection is similar.

4. Do not give antibiotics prescribed specifically for you to anyone else.

5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

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