Aveggio

FI

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aveggio 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, consult your doctor or pharmacist. This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist.
• Contents of this leaflet:
  1. What Aveggio is and what it is used for
  2. What you need to know before taking Aveggio
  3. How to take Aveggio
  4. Possible side effects
  5. How to store Aveggio
  6. Package contents and other information

1. WHAT AVEGGIO IS AND WHAT IT IS USED FOR

Aveggio is an antibiotic that works by killing the 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 (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Aveggio 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 AVEGGIO

Do not take Aveggio:

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

Do not take Aveggio if any of these apply to you. If you are in doubt, speak with your doctor or pharmacist before taking Aveggio.

Take special care with Aveggio
Talk to your doctor or pharmacist 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, discuss this with your doctor or pharmacist before taking Aveggio. In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection. Based on the results, they may prescribe a different dose of Aveggio or a different medicine.

Conditions to be aware of
Aveggio may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should pay attention to certain symptoms while taking Aveggio in order to reduce any risk. See "Conditions to be aware of" in section 4.

Blood and urine tests
If you are about to have blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Aveggio. This is because Aveggio may affect the results of these tests.

Taking other medicines
Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal products.

If you are taking allopurinol (used for gout) together with Aveggio, 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 Aveggio.

If you are taking medicines such as warfarin (which help prevent blood clots) together with Aveggio, additional blood tests may be required.

Aveggio may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are breastfeeding, inform your doctor or pharmacist. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Aveggio may cause side effects, and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you feel well.

3. HOW TO TAKE Aveggio

Always take Aveggio 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 film-coated tablets

• Usual dose – 1 tablet twice daily
• Higher dose – 1 tablet three times daily

875 mg/125 mg oral suspension powder

• Usual dose – 1 sachet twice daily
• Higher dose – 1 sachet three times daily

Children weighing less than 40 kg
875 mg/125 mg film-coated tablets
Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or sachets. Please consult your doctor or pharmacist for advice on administering Aveggio tablets to children weighing less than 40 kg.

875 mg/125 mg oral suspension powder in sachets
Aveggio 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 liver function.

How to take Aveggio

• Swallow the tablet whole with a glass of water at the beginning of a meal or just before.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Aveggio for longer than 2 weeks. If you still do not feel better, you should see your doctor again.

If you take more Aveggio than you should
If you take too much Aveggio, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the medicine pack or bottle with you to show the doctor.

If you forget to take Aveggio
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.

If you stop taking Aveggio
Continue taking Aveggio for the full duration of treatment, even if you start to 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 using this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Aveggio can cause adverse reactions, although not everybody experiences them.
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 mouth (angioedema), causing difficulty in breathing
• collapse. Contact your doctor immediately if you experience any of these symptoms. Stop taking Aveggio.

Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.
FI
If you experience these symptoms, contact your doctor as soon as possible for advice.
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 (candidiasis – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses: if this occurs, take Aveggio before food
• vomiting
• 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 by blood tests:
• increased levels of 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 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 adverse reactions may be detected by blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells Other adverse reactions Other adverse reactions occur in a very limited number of people, but their exact frequency is unknown.
• Allergic reactions (see above)
• Intestinal inflammation (see above)
• 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)
  • a red rash with crusts, swellings under the skin and blisters (pustular exanthema).

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 cause yellowing of the skin and whites of the eyes
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity

FI

• seizures (in people taking high doses of Aveggio or who have kidney problems)
• black, hairy-looking tongue
• tooth staining (in children), usually removable by brushing.

Adverse reactions 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. 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. The oral suspension powder contains sucrose: if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

5. HOW TO STORE Aveggio

Keep this medicine out of the sight and reach of children.
Store in the original packaging to protect the medicine from light and moisture, at a temperature not exceeding 25°C.
Do not use Aveggio after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
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 Aveggio contains
   AVEGGIO 875 mg + 125 mg - 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 anhydrous silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone.

AVEGGIO 875 mg + 125 mg – 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 anhydrous silica, lemon flavour, strawberry flavour, xanthan gum, sucrose.

Description of Aveggio and contents of the pack
AVEGGIO 875 mg + 125 mg - film-coated tablets: carton pack containing 12 tablets
AVEGGIO 875 mg + 125 mg – oral suspension powder: carton pack containing 12 sachets

Marketing Authorisation Holder
AGIPS FARMACEUTICI S.r.l – via Amendola, 4 - 16035 RAPALLO (Genoa) - Italy

Manufacturer
Tablets:
Laboratorio Reig Jofrè, S.A. – C/Jarama n. 111, Poligono industrial – 45007 Toledo (Spain)
Next Pharma – Pencef Pharma GMBH – Breitenbachstr. 13, D-13509 Berlin (Germany)
Sachets:
Laboratorio Reig Jofrè, S.A. – C/Jarama n. 111, Poligono industrial – 45007 Toledo (Spain)
FI

This leaflet was last revised in: April 2013

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 can become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the development of bacterial resistance.

When your doctor prescribes an antibiotic treatment, 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 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 have a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have any antibiotic left over after completing your treatment, return it to your pharmacist for proper disposal.