ABBA 875 mg/125 mg Film-Coated Tablets

Зміст інструкції

1. ABBA 875 mg / 125 mg film-coated tablets, 875 mg / 125 mg oral suspension powder
   1. What is Abba and what is it 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

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

amoxicillin and clavulanic acid
Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you (or for your child) only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even if 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 you take 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 is Abba and what is it used for

Abba 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 antibiotic medicines called “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:

• ear and sinus infections (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 (in particular cellulitis, animal bites, severe dental abscess with widespread cellulitis)
• bone and joint infections (osteomyelitis).

2. What you need to 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 of the same family (beta-lactam antibiotics). This may include a skin rash or swelling of the face or neck
• if you have had problems with your liver or if you have suffered from jaundice (yellowing of the skin and the whites of your eyes) when you have taken this type of antibiotic.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine.
Do not take this medicine for a long period of time because organisms resistant to the antibiotic may develop.
Take this medicine with cautionand inform your doctor in the following cases:

• if you have an infection caused by a virus, called mononucleosis and present symptoms such as fever, fatigue and general malaise
• if you have or have had problems with your liver or kidneys
• if you have problems with urination
• if you develop severe diarrhea 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, the doctor may perform an investigation to evaluate the type of bacterium that caused your infection.
Based on the results, they may prescribe a different dose of amoxicillin and clavulanic acid or a different medicine.

Blood and urine tests
If you are about to have blood tests (such as those related to red blood cells or liver function tests) or urine tests (for glucose), tell your doctor or nurse that you are taking this medicine, because Abba can affect the results of these types of tests.

Behavioral hygiene
Abba may worsen some existing conditions or cause serious side effects. These may include allergic reactions, convulsions and inflammation of the intestine. You should pay attention to some 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 for infections caused by viruses. Sometimes an infection caused by bacteria does not respond to therapy because the bacteria causing the infection are resistant to the antibiotic being used. This means that the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons.
Use antibiotics appropriately to reduce the emergence of bacterial resistance.
When your doctor prescribes antibiotic therapy, it is indicated only for the illness you have.
Pay attention to the following advice, in order to avoid the emergence of bacterial resistance that causes the blocking of antibiotic activity.

• 1. It is very important that you take the antibiotic at the right dose, at the scheduled times and for the right

explanations to your doctor or pharmacist.

• 2. Do not take antibiotics if they have not been expressly prescribed for you and use them only for the infection for which they have been prescribed.
• 3. Do not use antibiotics that have been prescribed to other people even if you have a similar infection to theirs.
• 4. Do not give antibiotics to others that have been expressly prescribed for you.
• 5. If you have any antibiotic left at the end of the treatment, return it to the pharmacist so that it can be disposed of appropriately.

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 amoxicillin and clavulanic acid oral suspension or pediatric sachets.

Other medicines and Abba
Tell 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 can cause an allergic skin reaction
• probenecid, a medicine used for gout. In this case, your doctor may decide to change your dose of Abba
• oral anticoagulants (medicines that help prevent blood clots, such as warfarin). In this case, additional blood tests are necessary
• methotrexate, a medicine used to treat tumors or rheumatic diseases
• Abba can affect the functioning of mycophenolate mofetil (a drug used to prevent organ rejection after transplantation).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you are pregnant or breastfeeding, take this medicine only if absolutely necessary and under strict medical supervision.

Driving and operating machinery
The use of this medicine can cause side effects such as allergic reactions, dizziness and convulsions.
Do not drive vehicles or operate machinery if you experience these symptoms.

Abba 875 mg / 125 mg powder for oral suspension 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 a build-up of phenylalanine because the body cannot process it correctly.

Abba 875 mg / 125 mg film-coated tablets contains 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 following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
Take the contents of the sachet or one tablet at the beginning of the meal or immediately before.
To take the contents of the sachet, you must first dissolve it in half a glass of water.
Take subsequent doses at least 4 hours apart, to avoid an overdose. Do not take two doses
in the same hour.
The recommended dosein adults and in children weighing 40 kg or more is 1 sachet or 1
tablet twice a day.
In more severe cases, the dose may be increased to 1 sachet or 1 tablet three times a day.
Do not take Abba for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

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

Use in patients with kidney and liver problems

• if you have kidney problems, the dose may be changed. Your doctor may choose a different dosage or a different medicine.
• if you have liver problems, you may need to have more frequent blood tests to check how your liver is working.

If you take more Abbathan you should
If you (or someone else) have taken an excessive dose of Abba or if you think a child may have
taken this medicine, inform your doctor immediately or go to the Accident and Emergency department of the
nearest hospital.
Symptoms of overdose include stomach problems such as nausea, vomiting or diarrhoea and convulsions.
Tell your doctor as soon as possible. Bring the medicine packaging or the 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 about 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 to take Abba until the treatment is finished, even if you feel better. If you decide to
stop taking the medicine, talk to your doctor or pharmacist first.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Conditions to watch out for
Stop treatment with this medicine and tell your doctor immediately if you notice the
appearance of allergic reactionsand experience the following symptoms and/or signs:

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

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

• Inflammation of the large intestine: 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 enterocolitic syndrome (DIES): DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a certain type of allergic reaction with the symptom

main symptom of repetitive vomiting (1-4 hours after taking the medicine). Further symptoms
may include abdominal pain, lethargy, diarrhoea and low blood pressure.
Contact your doctor as soon as possible for advice if these symptoms occur
The following side effects may also occur:

Very common(may affect more than 1 in 10 people):

• diarrhoea (in adults).

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

• thrush or candida, a fungal infection of the vagina, mouth or skin folds
• nausea, especially when taking high doses (If you experience this, take Abba with food)
• vomiting
• diarrhoea (in children).

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

• skin rashes, itching
• raised, itchy rash (urticaria)
• indigestion
• dizziness and headache
• increase in some proteins (enzymes: AST, ALT) produced by the liver.

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

• skin rashes, which may appear as blisters with a dark area in the centre surrounded by a paler area, with a dark ring around 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 (leukopenia).

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

• development of antibiotic-resistant bacteria
• severe reduction in the number of white blood cells (agranulocytosis)
• low number of red blood cells following their excessive destruction (hemolytic anemia)
• blood takes longer to clot (prolongation of bleeding time and Prothrombin time)
• reversible hyperactivity
• seizures (in people taking high doses of Abba or who have kidney problems)
• black tongue appearing covered with filamentous papillae (villous black tongue)
• inflammation of the liver (hepatitis)
• yellowing of the skin and whites of the eyes (jaundice)
• a widespread rash with blisters and detachment of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form, causing extensive detachment of the skin (more than 30% of the body surface area - toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus (exfoliative pustulosis)
• 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).
• inflammation of the kidneys (interstitial nephritis)
• problems with urination and the presence of crystals in the urine leading to acute kidney damage
• stains on teeth (in children), usually removed by brushing
• Rash with blisters arranged in a circle with a crusty centre or like a string of pearls (linear IgA disease)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting ofside effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 the sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “ Scad.”.
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and humidity at a temperature not
exceeding 25 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

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

• The active ingredients are Amoxicillin and Clavulanic acid. Each sachet contains amoxicillin trihydrate corresponding to 875 mg of amoxicillin and potassium clavulanate corresponding to 125 mg of clavulanic acid.
• The other ingredients 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 ingredients are Amoxicillin and Clavulanic acid. Each sachet contains amoxicillin trihydrate corresponding to 875 mg of amoxicillin and potassium clavulanate corresponding to 125 mg of clavulanic acid.
• The other ingredients are: hydrated colloidal silica, aspartame, orange flavour.

Description of the appearance of Abba and contents of the pack

Abba 875 mg / 125 mg film-coated tablets
Pack of 12 tablets

Abba 875 mg / 125 mg oral suspension powder
Pack of 12 sachets of oral suspension powder.

Marketing Authorisation 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)