Amoxicillin and clavulanic acid Almus Generici: detailed information

Package leaflet: Information for the user

Amoxicillin and Clavulanic Acid Almus Generics 875 mg/125 mg powder for oral suspension
Generic medicine
Please read all of this leaflet carefully before you (or your child) take this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you (or your child) only. Do not give it to other people, 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, tell your doctor, pharmacist, or nurse. See section 4.

What this leaflet contains:
1 What Amoxicillin and Clavulanic Acid Almus Generics is and what it is used for
2 What you need to know before taking Amoxicillin and Clavulanic Acid Almus Generics
3 How to take Amoxicillin and Clavulanic Acid Almus Generics
4 Possible side effects
5 How to store Amoxicillin and Clavulanic Acid Almus Generics
6 Contents of the pack and other information

1. What Amoxicillin and Clavulanic Acid Almus Generics is and what it is used for

Amoxicillin and Clavulanic Acid Almus Generics is an antibiotic that works by killing bacteria causing infections. It contains two 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 ineffective). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Almus Generics 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 should know before taking Amoxicillin and Clavulanic Acid Almus Generics

Do not take Amoxicillin and Clavulanic Acid Almus Generics:

if you are allergic to amoxicillin, clavulanic acid, penicillin, or to any of the excipients in 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 Almus Generics if any of the above apply to you.
If you are in doubt, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Almus Generics.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse 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, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Almus Generics.

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 dosage of Amoxicillin and Clavulanic Acid Almus Generics or a different medicine.

Conditions to which you should pay attention

Amoxicillin and Clavulanic Acid Almus Generics 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 Almus Generics, in order to reduce any risk. See "Conditions to which you should pay attention" in section 4.

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 Amoxicillin and Clavulanic Acid Almus Generics. This is because Amoxicillin and Clavulanic Acid Almus Generics may affect the results of these tests.

Other medicines and Amoxicillin and Clavulanic Acid Almus Generics

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.

If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Almus Generics, 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 Almus Generics.

If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Almus Generics, additional blood tests may be required.

Amoxicillin and Clavulanic Acid Almus Generics may affect the action of methotrexate (a medicine used to treat cancers or rheumatic diseases).

Amoxicillin and Clavulanic Acid Almus Generics may affect the effectiveness 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 using this medicine.

Driving and using machines

Amoxicillin and Clavulanic Acid Almus Generics may cause side effects, and symptoms may impair your ability to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin and Clavulanic Acid Almus Generics 875 mg/125 mg powder for oral suspension 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 causing phenylalanine to accumulate in the body because it cannot be properly metabolized.

The strawberry flavour included in Amoxicillin and Clavulanic Acid Almus Generics 875 mg/125 mg powder for oral suspension contains maltodextrins (glucose). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

The strawberry flavour included in Amoxicillin and Clavulanic Acid Almus Generics 875 mg/125 mg powder for oral suspension contains 0.024% benzyl alcohol per dose, equivalent to 0.0031 mg per sachet. Benzyl alcohol may cause allergic reactions.

Ask your doctor or pharmacist for advice if you have liver or kidney disease, are pregnant, or are breastfeeding. This is because large amounts of benzyl alcohol may accumulate in the body and cause unwanted effects (such as metabolic acidosis).

3. How to take Amoxicillin and Clavulanic Acid Almus Generics

Always take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

Recommended dose – 1 sachet twice a day
Higher dose – 1 sachet three times a day.

Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid Almus Generics is not recommended in children weighing less than
40 kg.
Please consult your doctor or pharmacist for advice on amoxicillin/clavulanic acid formulations suitable for treating children weighing less than 40 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, more frequent blood tests may be required to monitor how your liver is functioning.

How to take Amoxicillin and Clavulanic Acid Almus Generics

Just before taking Amoxicillin and Clavulanic Acid Almus Generics, open the sachet and mix the contents with half a glass of water.
Take during meals.
Space the 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 Almus Generics for longer than two weeks. If you continue to feel unwell, you should see your doctor again.

If you take more Amoxicillin and Clavulanic Acid Almus Generics than you should
If you take too much Amoxicillin and Clavulanic Acid Almus Generics, symptoms may include
gastrointestinal disturbances (nausea, vomiting or diarrhoea) or seizures. Inform your doctor as soon as
possible. Take the medicine pack with you so you can show it to the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Almus Generics
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 forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid Almus Generics
Continue taking Amoxicillin and Clavulanic Acid Almus Generics 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 doubts about how to use this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

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

Conditions requiring your attention

Allergic reactions:

Skin rashes
Inflammation of blood vessels (vasculitis), which may appear as raised 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, armpit or groin
Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Collapse
Chest pain during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).

Contact your doctor immediately if any of these symptoms occur. Stop taking Amoxicillin and Clavulanic Acid Almus Generici.

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 enterocolitis syndrome (DIES)
DIES has been reported mainly in children treated with amoxicillin/clavulanic acid. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Additional 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 (candidiasis, a fungal infection of the vagina, mouth or skin folds)
Nausea, especially when taking high doses. If affected, take Amoxicillin and Clavulanic Acid Almus Generici with food
Vomiting
Diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

Skin rash, 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 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 side effects may be detected through 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 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)
Red rash 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 white blood cell count (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms – DRESS)

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
Seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Almus Generici or who have kidney problems)
Black hairy tongue (appearing covered in hair)
Tooth staining (in children), usually removable by brushing
Skin rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease)

Side effects that may be detected through blood or urine tests:

Severe reduction in white blood cell count
Low number of red blood cells (haemolytic anaemia)
Crystals in urine leading to acute kidney damage

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

5. How to store Amoxicillin and Clavulanic Acid Almus Generics

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 above 25°C. Keep in the original packaging to protect the medicine from moisture.
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 Amoxicillina e Acido Clavulanico Almus Generici 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.
Other components are: crospovidone (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b), aspartame (E951), strawberry flavour (containing maize maltodextrins and benzyl alcohol).

Description of the appearance of Amoxicillina e Acido Clavulanico Almus Generici and the contents of the
pack
Amoxicillina e Acido Clavulanico Almus Generici 875 mg/125 mg - powder for oral suspension:
whiteish to yellowish powder in sachets made of polyethylene terephthalate/aluminum/polyethylene
(PET/AL/PE).
Each pack contains 12 sachets in a cardboard box.
Marketing Authorization Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa, Italy
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 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 help reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely 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.

It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. Read the instructions in this leaflet carefully 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 your prescribed antibiotics to anyone else.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.

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