Amoxicillin and clavulanic acid Alter: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMOXICILLIN AND CLAVULANIC ACID ALTER 875 mg / 125 mg

Film-coated tablets
AMOXICILLIN AND CLAVULANIC ACID ALTER 875 mg / 125 mg
Powder for oral suspension
Amoxicillin/clavulanic acid
Generic Medicine
Please 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Amoxicillin and Clavulanic Acid ALTER is and what it is used for
What you need to know before taking Amoxicillin and Clavulanic Acid ALTER
How to take Amoxicillin and Clavulanic Acid ALTER
Possible side effects
How to store Amoxicillin and Clavulanic Acid ALTER
Contents of the pack and other information

1. What Amoxicillina e Acido Clavulanico Alter is and what it is used for

Amoxicillina e Acido Clavulanico Alter 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 (i.e. rendered inactive).
The other active component (clavulanic acid) prevents this from happening.
Amoxicillina e Acido Clavulanico Alter is used in adults and children to treat the following infections:

middle ear and nasal 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 Amoxicillin and Clavulanic Acid Alter

Do not take Amoxicillin and Clavulanic Acid Alter:

if you are allergic to amoxicillin, clavulanic acid, penicillin, or to any of the other ingredients of this medicine (listed in section 6).
if you have had a severe allergic reaction 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 Amoxicillin and Clavulanic Acid Alter if any of the above apply to you. If you
have any doubts, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic
Acid Alter.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Alter 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 conditions listed above apply to you, discuss this with your
doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Alter.
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 Amoxicillin and Clavulanic Acid or a
different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid Alter may worsen certain pre-existing conditions or cause
serious side effects. These may include allergic reactions, seizures, and inflammation of the
intestine. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic
Acid Alter, in order to reduce any risk. See “Conditions to which you should pay attention ” in Section 4.
Blood and urine tests
If you are due to have blood tests (for example, checks on red blood cells or liver function tests)
or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and
Clavulanic Acid Alter. This is because Amoxicillin and Clavulanic Acid Alter may affect the
results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Alter
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Alter,
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
Amoxicillin and Clavulanic Acid Alter.
If you are taking medicines (such as warfarin) that help prevent blood clots together with
Amoxicillin and Clavulanic Acid Alter, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Alter may affect how methotrexate (a medicine used to treat
cancer or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid Alter 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, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Alter may cause side effects, and symptoms may make you
unsuitable for driving.
Do not drive or operate machinery unless you feel better.
Amoxicillin and Clavulanic Acid Alter 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 causing
phenylalanine to accumulate because the body cannot eliminate it properly.
Amoxicillin and Clavulanic Acid Alter 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 Amoxicillin and Clavulanic Acid Alter

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
Amoxicillin and Clavulanic Acid Alter 875 mg/125 mg film-coated tablets

Recommended dose – 1 tablet twice daily
Higher dose – 1 tablet three times daily

Amoxicillin and Clavulanic Acid Alter 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
Amoxicillin and Clavulanic Acid Alter 875 mg/125 mg sachets are not recommended.
Children up to 6 years of age should preferably be treated with amoxicillin and clavulanic acid oral suspension.
Consult your doctor or pharmacist for advice on administering Amoxicillin and Clavulanic Acid Alter 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 a different medicine.
If you have liver problems, you may require more frequent blood tests to monitor liver function.

How to take Amoxicillin and Clavulanic Acid Alter
Amoxicillin and Clavulanic Acid Alter 875 mg/125 mg film-coated tablets

Take with meals
Swallow the tablet whole with a glass of water.
Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.

Amoxicillin and Clavulanic Acid Alter 875 mg/125 mg sachets
Just before taking Amoxicillin and Clavulanic Acid Alter, open the sachet and mix the contents with half a glass of water.

Take with meals
Drink at the beginning of a meal or just before
Space doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.

Do not take Amoxicillin and Clavulanic Acid Alter for longer than 2 weeks. If you continue to feel unwell, you should see your doctor.
If you take more Amoxicillin and Clavulanic Acid Alter than you should
If you take too much Amoxicillin and Clavulanic Acid Alter, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Inform your doctor as soon as possible. Take the medicine pack with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Alter
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours. Do not take a double dose to make up for a missed dose.
If you stop treatment with Amoxicillin and Clavulanic Acid Alter
Continue taking Amoxicillin and Clavulanic Acid Alter until the treatment is complete, even if you feel better. You need every dose to 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 medicine can cause side effects, although not
everyone experiences them. The following side effects may occur with this
medicine.
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 throat ( angioedema ), causing difficulty in breathing
collapse
chest pain in the context of allergic reactions, 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 Amoxicillin and Clavulanic Acid Alter.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually with blood and mucus,
stomach pain and/or fever.
Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It
is a type of allergic reaction whose main symptom is repeated vomiting (1-4 hours after
administration of the medicine). Additional symptoms may include
abdominal pain, lethargy, diarrhoea, and low blood pressure.
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.
➔ Contact your doctor as soon as possible for advice if these symptoms occur.
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 Amoxicillin and Clavulanic Acid Alter with meals
vomiting
diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects may be detected through blood tests:

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

Rare side effects
May affect up to 1 in 1,000 people

skin rashes, which may present 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 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 pus-filled blisters ( exfoliative bullous dermatitis )
- rash, red 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 - DRESS )
- a red rash commonly observed on both sides of the buttocks, upper inner thighs, armpits, and neck

( Symmetrical Drug-Related Intertriginous Flexural Erythema - SDRIFE ).
→ If you experience any of these symptoms, contact your doctor immediately .

Skin 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 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 Amoxicillin and Clavulanic Acid Alter or who have kidney problems)
black hairy tongue
tooth staining (in children), usually removable by brushing.

Side effects that may be detected through 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,
please consult your doctor or pharmacist. You may also report side effects directly
via the national reporting system at the website
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 Amoxicillin and Clavulanic Acid Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP.) stated on the packaging.
The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original container to protect the product from light and moisture.
Do not use the tablets if chipped or damaged.
Do not use this medicine if the blister pack is broken or damaged.
Do not dispose of any medicine 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 Amoxicillina e Acido Clavulanico Alter 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, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.

Each sachet contains:
amoxicillin trihydrate equivalent to 875 mg of amoxicillin and potassium clavulanate
equivalent to 125 mg clavulanic acid.
The other components are: hydrated colloidal silica, orange-flavoured aroma, aspartame (E951).
See section 2 for further information regarding one of the excipients of Amoxicillina e Acido Clavulanico Alter.

Description of the appearance of Amoxicillina e Acido Clavulanico Alter and contents of the pack
Amoxicillina e Acido Clavulanico Alter 875 mg / 125 mg - film-coated tablets, whitish in colour, elongated, biconvex.
They are packaged in blisters contained in a cardboard carton. Each pack contains 12 tablets.

Amoxicillina e Acido Clavulanico Alter 875 mg / 125 mg - powder for oral suspension in sachets – contains a white to off-white powder. The sachets are contained in a carton. Each pack contains 12 sachets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratori Alter S.r.L. – Via Egadi 7 – 20144 Milano

Manufacturer
For tablets and powder for oral suspension:
Elpen Pharmaceutical Co. Inc – 95 Marathonos Avenue – 19009 Pikermi Attiki – Greece
For oral suspension:
LA.FA.RE. S.r.L. – via Sacerdote Benedetto Cozzolino, 77 – 80056 Ercolano (NA) - Italy

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 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 various reasons. By using antibiotics appropriately, you can 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 can lead to loss of antibiotic effectiveness.

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 the package leaflet and, if anything is unclear, ask your doctor or pharmacist for clarification.
Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
Do not use antibiotics that have been prescribed for other people, even if you believe your infection is similar.
Do not give antibiotics prescribed for you to other people.
If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.