Abba

PACKAGE LEAFLET: Information for the user

ABBA 875 mg / 125 mg film-coated tablets, 875 mg / 125 mg powder for oral suspension

amoxicillin and clavulanic acid
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Abba is and what it is used for

Abba is an antibiotic that works by killing bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of antibiotic medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive). Clavulanic acid prevents this from happening.
This medicine is used in adults and children to treat the following infections:

• infections of the ear and sinuses (acute otitis media, acute bacterial sinusitis)
• respiratory tract infections (acute exacerbations of chronic bronchitis, community-acquired pneumonia)
• urinary tract infections (cystitis, pyelonephritis)
• skin and soft tissue infections (particularly cellulitis, animal bites, severe dental abscess with diffuse cellulitis)
• bone and joint infections (osteomyelitis).

2. What you should know before taking Abba

Do not take Abba

• if you are allergic to amoxicillin trihydrate, to other similar medicines (penicillins), to potassium clavulanate, or to any of the ingredients of this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic in the same family (beta-lactam antibiotics). This may include a skin rash or swelling of the face or neck
• if you have had liver problems or have experienced jaundice (yellowing of the skin and whites of the eyes) when taking this type of antibiotic.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Do not take this medicine for a prolonged period, as antibiotic-resistant organisms may develop.
Take this medicine with caution and inform your doctor in the following cases:

• if you have a viral infection called mononucleosis and have symptoms such as fever, fatigue, and general malaise
• if you have or have had liver or kidney problems
• if you have difficulty urinating
• if you develop severe diarrhoea during treatment. In this case, stop treatment and inform your doctor, as it may be due to inflammation of the intestine (colitis).

In some cases, your doctor may perform tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dose of amoxicillin and clavulanic acid or a different medicine.
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 this medicine, because Abba may affect the results of these tests.
Behavioural hygiene
Abba may worsen existing conditions or cause serious adverse effects. These may include allergic reactions, seizures, and intestinal inflammation. You should pay attention to certain symptoms while taking this medicine in order to reduce any risk (see section 4 “Possible side effects”).
Antibiotics are used to treat bacterial infections. They are not effective against infections caused by viruses. Sometimes a bacterial infection does not respond to treatment because 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.
Use antibiotics appropriately to reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended only for the illness you currently have.
Pay attention to the following advice to help prevent the emergence of bacterial resistance, which can lead to loss of antibiotic effectiveness.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package leaflet, 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 antibiotics to other people.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

Children
The use of Abba 875 mg / 125 mg oral suspension powder is not recommended in children weighing less than 40 kg, who should preferably be treated with oral amoxicillin and clavulanic acid suspension or paediatric sachets.
Other medicines and Abba
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:

• allopurinol, a medicine used for gout, because it may cause a skin allergic reaction
• probenecid, a medicine used for gout. In this case, your doctor may decide to adjust your dose of Abba
• oral anticoagulants (medicines that help prevent blood clots, such as warfarin). In this case, additional blood tests may be required
• methotrexate, a medicine used to treat tumours or rheumatic diseases
• Abba 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.
If you are pregnant or breastfeeding, take this medicine only if absolutely necessary and under close medical supervision.
Driving and using machines
This medicine may cause side effects such as allergic reactions, dizziness, and seizures. Do not drive or operate machinery if you experience these symptoms.
Abba 875 mg / 125 mg oral suspension powder contains aspartame
This medicine contains 12.5 mg of aspartame per sachet. 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 eliminate it properly.
Abba 875 mg / 125 mg film-coated tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Abba

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the contents of the sachet or one tablet at the beginning of a meal or just before.
To take the contents of the sachet, first dissolve it in half a glass of water.
Take subsequent doses at least 4 hours apart to avoid overdose. Do not take two doses
within the same hour.
The recommended dose in adults and children weighing 40 kg or more is 1 sachet or
1 tablet twice daily.
In more severe cases, the dose may be increased to 1 sachet or 1 tablet three times daily.
Do not take Abba for longer than 2 weeks. If you continue to feel unwell, you must see your doctor again.

Use in children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin and clavulanic acid oral suspension or paediatric sachets.
Ask your doctor or pharmacist for advice on the administration of Abba tablets.
Abba sachets are not recommended.

Use in patients with kidney or liver problems

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

If you take more Abba than you should
If you (or someone else) have taken an excessive dose of Abba or if you suspect that a child may have taken this medicine, contact your doctor immediately or go to the nearest hospital emergency department.
Symptoms of overdose include stomach problems such as nausea, vomiting or diarrhoea, and seizures.
Inform your doctor as soon as possible. Take the medicine packaging or sachet with you to show the doctor.

If you forget to take Abba
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 forgotten dose.

If you stop taking Abba
Continue taking Abba for the full duration of treatment, even if you feel better. If you decide to stop taking the medicine, discuss this first with your doctor or pharmacist.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Conditions to pay attention to
Stop treatment with this medicine and inform your doctor immediately if you notice the onset of allergic reactions and experience any of the following symptoms and/or signs:

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

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

• 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 mainly reported in children treated with amoxicillin/clavulanate. It is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after drug administration). 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.

Other possible side effects include:
Very common (may affect more than 1 in 10 people):

• diarrhoea (in adults)

Common (may affect up to 1 in 10 people):

• oral, vaginal or skin fungal infections (e.g. thrush or candidiasis)
• nausea, especially when taking high doses (If affected, take Abba before food)
• vomiting
• diarrhoea (in children)

Uncommon (may affect up to 1 in 100 people):

• skin rashes, itching
• raised, itchy skin rash (urticaria)
• indigestion
• dizziness and headache
• increased levels of certain liver proteins (enzymes: AST, ALT)

Rare (may affect up to 1 in 1,000 people):

• skin rashes, which may appear as blisters with a dark central area surrounded by a paler area and a dark ring at the edge (erythema multiforme). Contact your doctor if you notice these signs
• low number of cells involved in blood clotting (platelets) (thrombocytopenia)
• low number of white blood cells in the blood (leucopenia)

Frequency not known (frequency cannot be estimated from available data):

• development of antibiotic-resistant bacteria
• severe reduction in white blood cells (agranulocytosis)
• low number of red blood cells due to excessive destruction (haemolytic anaemia)
• blood takes longer to clot (prolonged bleeding time and prothrombin time)
• reversible hyperactivity
• seizures (in people taking high doses of Abba or who have kidney problems)
• black hairy tongue, appearing covered with elongated filiform papillae (black hairy tongue)
• liver inflammation (hepatitis)
• yellowing of the skin and whites of the eyes (jaundice)
• widespread skin 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 area – toxic epidermal necrolysis)
• widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
• red, crusted skin rash with swellings under the skin and blisters (exanthematous pustulosis)
• flu-like symptoms with skin 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)
• kidney inflammation (interstitial nephritis)
• problems with urination and presence of crystals in the urine leading to acute kidney injury
• tooth discoloration (in children), usually removable by brushing
• Skin rash with blistering arranged in a ring-shaped pattern with central crusting or resembling a string of pearls (linear IgA disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

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

5. How to store Abba

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture, at a temperature not exceeding 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Abba 875 mg / 125 mg film-coated tablets contains

• The active substances are Amoxicillin and Clavulanic acid. Each tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.
• The other components are: anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hypromellose, talc, titanium dioxide, diethyl phthalate, dimethicone.

What Abba 875 mg / 125 mg oral suspension powder 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 components are: hydrated colloidal silica, aspartame, orange flavour.

Description of the appearance of Abba and package contents
Abba 875 mg / 125 mg film-coated tablets
Carton pack containing 12 tablets
Abba 875 mg / 125 mg powder for oral suspension
Carton pack containing 12 sachets of powder for oral suspension.

Marketing Authorization Holder
Fidia farmaceutici S.p.A.
Via Ponte della Fabbrica, 3/A - Abano Terme (PD)

Manufacturers
Elpen Pharmaceutical Co. Inc.
95 Marathonos Avenue - 19009 Pikermi Attika (Greece)
For tablets only:
Reig Jofrè SA
Calle Jarama s/n - Poligono Industrial - Toledo (Spain)
For sachets only:
La.Fa.Re. S.r.l.
Via Sacerdote Benedetto Cozzolino 77, 80056 – Ercolano (NA)