AMOXICILLINA 875 mg/125 mg Proszek Do Sporządzania Zawiesiny Doustnej

Treść ulotki

1. What is Amoxicillina e Acido Clavulanico Almus Generici and what is it used for
2. What you need to know before taking Amoxicillina e Acido Clavulanico Almus Generici
3. How to take Amoxicillina and Acido Clavulanico Almus Generici
4. Possible side effects
5. How to store Amoxicillina e Acido Clavulanico Almus Generici
6. Package Contents and Other Information

Amoxicillina e Acido Clavulanico Almus Generici 875 mg/125 mg powder for oral suspension
Equivalent 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, pharmacist or nurse.
• This medicine has been prescribed only for you (or for your child). Do not give it to other people, even if their symptoms are the same as yours, as it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:
1 What is Amoxicillina e Acido Clavulanico Almus Generici and what it is used for
2 What you need to know before you take Amoxicillina e Acido Clavulanico Almus Generici
3 How to take Amoxicillina e Acido Clavulanico Almus Generici
4 Possible side effects
5 How to store Amoxicillina e Acido Clavulanico Almus Generici
6 Contents of the pack and other information

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

Amoxicillina e Acido Clavulanico Almus Generici is an antibiotic that works by killing the bacteria
that cause infections. It contains two different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines called "penicillins", whose activity can sometimes
be blocked (i.e. rendered inactive). The other active ingredient (clavulanic acid) prevents
this from happening.
Amoxicillina e Acido Clavulanico Almus Generici is used in adults and children weighing 40 kg or
more to treat the following infections:

• middle 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 need to know before taking Amoxicillina e Acido Clavulanico Almus Generici

Do not take Amoxicillina e Acido Clavulanico Almus Generici:

• if you are allergic to amoxicillin, clavulanic acid, penicillin or 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 can include skin rash or swelling of the face or throat
• if you have had problems with your liver or jaundice (yellowing of the skin) when you have taken an antibiotic.

→Do not take Amoxicillina e Acido Clavulanico Almus Generici if any of these applies to you.
If you are unsure, talk to your doctor or pharmacist before taking Amoxicillina e Acido
Clavulanico Almus Generici.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking this medicine if you:

• have infectious mononucleosis
• have been treated for problems with your liver or kidneys
• do not urinate regularly. If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Amoxicillina e Acido Clavulanico Almus Generici.

In some cases, the doctor may perform an investigation to assess the type of bacteria that caused your
infection. Based on the results, they may prescribe a different dosage of Amoxicillina e Acido
Clavulanico Almus Generici or a different medicine.

Conditions you should pay attention to
Amoxicillina e Acido Clavulanico Almus Generici may worsen some existing conditions
or cause serious side effects. These can include allergic reactions, seizures
and inflammation of the intestine. You should pay attention to certain symptoms while taking
Amoxicillina e Acido Clavulanico Almus Generici, in order to reduce any risk. See
“Conditions you should pay attention to” in Section 4.

Blood and urine tests
If you are about to have blood tests (such as for red blood cell counts or
liver function tests) or urine tests (for glucose), tell your doctor or nurse that you are
taking Amoxicillina e Acido Clavulanico Almus Generici. This is because Amoxicillina e Acido
Clavulanico Almus Generici can affect the results of these types of tests.

Other medicines and Amoxicillina e Acido Clavulanico Almus Generici
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicine.
If you are taking allopurinol(used for gout) with Amoxicillina e Acido Clavulanico Almus
Generici, you are very likely to have an allergic skin reaction.
If you are taking probenecid(used for gout), your doctor may decide to change your dose of
Amoxicillina e Acido Clavulanico Almus Generici.
If you are taking medicines (such as

warfarin) that help prevent blood clots, you may need to
have additional blood tests.
Amoxicillina e Acido Clavulanico Almus Generici can affect the mechanism of action of

methotrexate(a medicine used to treat tumors or rheumatic diseases).
Amoxicillina e Acido Clavulanico Almus Generici 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 may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
Amoxicillina e Acido Clavulanico Almus Generici may have side effects and the symptoms
may make you unfit to drive vehicles. Do not drive vehicles or operate machinery unless you
feel better.

Amoxicillina e Acido Clavulanico Almus Generici 875 mg/125 mg oral suspension powder
contains 20 mg of aspartame (E951)per sachet.
Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare
genetic disorder that causes a buildup of phenylalanine because the body cannot eliminate it
correctly .
The strawberry flavor included in Amoxicillina e Acido Clavulanico Almus Generici 875 mg/125 mg
oral suspension powdercontains maltodextrin (glucose). If your doctor has diagnosed you with
an intolerance to certain sugars, contact them before taking this medicine.
The strawberry flavor included in Amoxicillina e Acido Clavulanico Almus Generici 875 mg/125 mg
oral suspension powder contains 0.024% benzyl alcoholper equivalent dose of 0.0031
mg per sachet. Benzyl alcohol can cause allergic reactions.
Ask your doctor or pharmacist if you have a liver or kidney condition, or if you are pregnant or
breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause
adverse effects (such as metabolic acidosis).

3. How to take Amoxicillina and Acido Clavulanico Almus Generici

Always take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, ask your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Recommended dose - 1 sachet twice a day
• Highest dose - 1 sachet three times a day.

Children weighing less than 40 kg
Amoxicillina and Acido Clavulanico Almus Generici is not recommended in children weighing less than
40 kg.
Ask your doctor or pharmacist for advice on suitable amoxicillin/clavulanic acid formulations for the treatment of children weighing less than 40 kg.

Patients with kidney and liver problems

• If you have kidney problems, the dose may 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 check how your liver is working.

How to take Amoxicillina and Acido Clavulanico Almus Generici

• Immediately before taking Amoxicillina and Acido Clavulanico Almus Generici, open the sachet and mix the contents with half a glass of water
• Take with meals
• Space the doses regularly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour
• Do not take Amoxicillina and Acido Clavulanico Almus Generici for more than two weeks. If you continue to feel unwell, you should return to your doctor.

If you take more Amoxicillina and Acido Clavulanico Almus Generici than you should
If you take too much Amoxicillina and Acido Clavulanico Almus Generici, symptoms may include
stomach upset (nausea, vomiting or diarrhoea) or convulsions. Tell your doctor as soon as
possible. Bring the medicine packaging to show to the doctor.

If you forget to take Amoxicillina and Acido Clavulanico Almus Generici
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. Do not take a double dose to make up for
forgetting a dose.

If you stop taking Amoxicillina and Acido Clavulanico Almus Generici
Continue to take Amoxicillina and Acido Clavulanico Almus Generici until the treatment is
finished, even if you feel better. You need every dose to fight the infection. If some
bacteria survive, they can cause the infection to return.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects that may occur with this medicine are listed below.

Conditions you should pay attention to
Allergic reactions:

• 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 Amoxicillina e Acido Clavulanico Almus GenericiInflammation of the large intestineInflammation 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 area of the stomach, this could be a sign of
acute pancreatitis.

Drug-induced enterocolitic syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanic acid. It is a
certain type of allergic reaction with the main symptom of repetitive vomiting (1-4 hours after
administration of the drug). Further symptoms may include abdominal pain, lethargy,
diarrhoea and low blood pressure.

• If you experience these symptoms, contact your doctor as soon as possible for advice.

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 you suffer from this, take Amoxicillina e Acido Clavulanico Almus Generici with meals
• vomiting
• diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects can be seen from blood tests:

• increase in some proteins (enzymes) produced by the liver.

Rare side effects
May affect up to 1 in 1000 people

• skin rashes, which may appear as blisters and look like small targets (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 urgentlyRare side effects can be seen from blood tests:
• low number of cells involved in blood clotting
• low number of white blood cells.

Other side effects with unknown frequency
Frequency cannot be estimated on the basis of 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 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, toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus (exfoliative bullous dermatitis)
• red rash, with scabs and swellings under the skin and blisters (pustulous 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).
• If you experience any of these symptoms, contact your doctor immediately.
• Inflammation of the liver (hepatitis)
• Jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) which can cause the skin and whites of the eyes to appear yellow
• Inflammation of the kidney tubules
• Blood takes longer to clot
• Hyperactivity
• Convulsions (in people taking high doses of Amoxicillina e Acido Clavulanico Almus Generici or who have kidney problems)
• Black tongue that appears covered in hair
• Stains on teeth (in children), usually removed by brushing
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease)

Side effects that can be seen from blood or urine tests:

• Severe reduction in the number of white blood cells
• Low number of red blood cells (hemolytic anemia)
• Crystals in the urine leading to acute kidney injury.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system at
https://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 Amoxicillina e Acido Clavulanico Almus Generici

Keep this medicine out of the 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.
Do not store at a temperature above 25°C. Store in the original packaging to protect
the medicine from moisture.
Do not dispose of any medicine in 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

• 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: crospovidone (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b), aspartame (E951), strawberry aroma (containing corn maltodextrins andbenzyl alcohol).

Description of the appearance of Amoxicillina e Acido Clavulanico Almus Generici and package contents
Amoxicillina e Acido Clavulanico Almus Generici 875 mg/125 mg - oral suspension powder:
whitish to yellowish powder in sachets of polyethylene terephthalate/aluminium/polyethylene
(PET/AL/PE).
Each pack contains 12 sachets in a cardboard box.

Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
E-mail: [email protected]

Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13-14
13509 Berlin, Germany

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective for viral
infections.
Sometimes an infection caused by bacteria 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 the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes antibiotic therapy, it is indicated only for the illness you have
currently. Pay attention to the following advice, in order to avoid the emergence of bacterial resistance
which causes the blocking of antibiotic activity.

• 1. It is very important that you take the antibiotic at the correct dose, at the scheduled times and for the duration indicated by 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 prescribed expressly for you to others.
• 5. If you have any antibiotic left over at the end of the treatment, return it to the pharmacist so that it can be disposed of properly.

Instructions for reconstitution
The contents of the sachets must be dissolved in half a glass of water before
administration.