Amoxicillin and clavulanic acid Teva Generics: detailed information

Package leaflet: Information for the user

Amoxicillin and Clavulanic Acid Teva Generics 875 mg + 125 mg film-coated tablets
Amoxicillin and Clavulanic Acid Teva Generics 875 mg + 125 mg powder for oral suspension
Generic medicine

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 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

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

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

Amoxicillin and Clavulanic Acid Teva Generics is an antibiotic that works by killing bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid.
Amoxicillin is an antibiotic belonging to the group of medicines known as “penicillins”, whose activity can sometimes be blocked (rendered ineffective). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Teva Generics is used in adults and children 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 Amoxicillin and Clavulanic Acid Teva Generics

Do not take Amoxicillin and Clavulanic Acid Teva Generics

if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6);
if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include a skin rash or swelling of the face or neck;
if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. Do not take Amoxicillin and Clavulanic Acid Teva Generics if any of these apply to you. If you are in doubt, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Teva Generics.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Teva Generics.
Speak with your doctor or pharmacist before taking this medicine if:

you have infectious mononucleosis (commonly known as "kissing disease", characterized by fever and swollen glands (lymph nodes) in the neck);
you have previously been treated for liver or kidney problems;
you do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, discuss this with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Teva Generics.
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.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid Teva 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 Teva 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 due to have blood tests (such as checks for 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 Teva Generics. This is because Amoxicillin and Clavulanic Acid Teva Generics may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Teva Generics
Inform 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 Teva Generics, you are very 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 Teva Generics.
If you are taking medicines such as acenocoumarol or warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Teva Generics, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Teva Generics may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid Teva Generics may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy and breastfeeding
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.
Driving and using machines
Amoxicillin and Clavulanic Acid Teva Generics may cause side effects, and the symptoms may affect your ability to drive or operate machinery.
Do not drive or operate machinery unless you feel well.
Amoxicillin and Clavulanic Acid Teva Generics 875 mg + 125 mg film-coated tablets
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
Amoxicillin and Clavulanic Acid Teva Generics 875 mg + 125 mg oral suspension powder in sachets contains aspartame (E951).
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.

3. How to take Amoxicillin and Clavulanic Acid Teva Generics

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Use in adults and children weighing 40 kg or more
Amoxicillin and Clavulanic Acid Teva Generics 875 mg/125 mg film-coated tablets

The recommended dose is 1 tablet twice daily.
The maximum dose is 1 tablet three times daily. Amoxicillin and Clavulanic Acid Teva Generics 875 mg/125 mg powder for oral suspension
The recommended dose is 1 sachet twice daily.
The maximum dose is 1 sachet three times daily.

Use in children weighing less than 40 kg
875 mg/125 mg powder for oral suspension in sachets
Amoxicillin and Clavulanic Acid Teva Generics 875 mg/125 mg sachets are not recommended.
875 mg/125 mg film-coated tablets
Children weighing less than 40 kg should preferably be treated with amoxicillin and clavulanic acid oral suspension or pediatric sachets with lower dosages.
Ask your doctor or pharmacist for advice on administering Amoxicillin and Clavulanic Acid Teva Generics 875 mg/125 mg film-coated 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 Teva Generics
Tablets:

Take with food.
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.
Do not take Amoxicillin and Clavulanic Acid Teva Generics for longer than 2 weeks. If you continue to feel unwell, you must return to your doctor.

Sachets:

Take with food.
Just before taking Amoxicillin and Clavulanic Acid Teva Generics, open the sachet and mix the contents with half a glass of water.
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 Teva Generics for longer than 2 weeks. If you continue to feel unwell, you must return to your doctor.

If you take more Amoxicillin and Clavulanic Acid Teva Generics than you should
If you take too much Amoxicillin and Clavulanic Acid Teva Generics, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Speak to 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 Teva Generics
If you forget to take a dose, take it as soon as you remember, but only if at least four hours have passed since the last dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid Teva Generics
Continue taking Amoxicillin and Clavulanic Acid Teva Generics for the full duration of treatment, even if you feel better. You need every dose to help 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 or pharmacist.

4. Possible side effects

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

Conditions you should pay attention to
Allergic reactions:

skin rash (appearance of red spots on the skin);
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 mouth ( angioedema ), causing difficulty in breathing;
collapse (drop in blood pressure);
chest pain during allergic reactions, which may be a symptom of heart attack triggered by allergy (Kounis Syndrome). Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin and Clavulanic Acid Teva Generics.

Intestinal inflammation
Intestinal inflammation causing watery diarrhoea, usually with 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/clavulanate. It is a type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine).
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.

Tell your doctor if any of the following side effects occur:

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

diarrhoea.

Common (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 this affects you, take Amoxicillin and Clavulanic Acid Teva Generics before food;
vomiting.

Uncommon (may affect up to 1 in 100 people)

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

Uncommon side effects that may be detected by blood tests:

increase in certain proteins ( enzymes ) produced by the liver.

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

skin rash, which may appear as blisters and look like 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 that may be detected by blood tests:

low number of cells involved in blood clotting;
low number of white blood cells.

Other side effects
Other side effects occur in a very small number of people, but their exact frequency is not known (the 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, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin peeling (more than 30% of body surface – toxic epidermal necrolysis );
widespread red rash with small blisters containing pus ( bullous dermatitis and exfoliative dermatitis );
a red, scaly rash with raised areas under the skin and blisters ( generalised acute exanthematous 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);
skin rash with blisters arranged in a circular pattern with a central crust or resembling a string of pearls (linear IgA disease).

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;
reversible hyperactivity;
seizures (in people taking high doses of Amoxicillin and Clavulanic Acid Teva Generics or who have kidney problems);
black hairy tongue, appearing covered with hair-like projections (aspergillosis: a type of fungus);
tooth staining (in children), usually removable by brushing.

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

severe, reversible reduction in the number of white blood cells ( leucopenia );
low number of red blood cells ( haemolytic anaemia );
crystals in the urine leading to acute kidney damage.

Reporting of side effects
If you get any side effects, including ones 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin and Clavulanic Acid Teva Generics

Do not store above 25°C.
Keep in the original packaging to protect the medicine from light and moisture.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp. The expiry date refers to the last day of that month.
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 Amoxicillin and Clavulanic Acid Teva Generics contains
Amoxicillin and Clavulanic Acid Teva Generics 875 mg + 125 mg film-coated tablets

The active substances are amoxicillin trihydrate, corresponding to 875 mg amoxicillin, and potassium clavulanate, corresponding to 125 mg clavulanic acid.
The other components are anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.

Amoxicillin and Clavulanic Acid Teva Generics 875 mg + 125 mg powder for oral suspension

The active substances are amoxicillin trihydrate, corresponding to 875 mg amoxicillin, and potassium clavulanate, corresponding to 125 mg clavulanic acid.
The other components are hydrated colloidal silica, orange flavour, aspartame.

Description of the appearance of Amoxicillin and Clavulanic Acid Teva Generics and contents of the
pack
Film-coated tablets: Carton containing 12 tablets.
Powder for oral suspension: Carton containing 12 sachets.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano
Manufacturer
For “Film-coated tablets” and “Powder for oral suspension”
Elpen Pharmaceutical Co Inc. - 95 Marathonos Avenue - 19009 Pikermi, Attiki – (Greece)
Only for “Powder for oral suspension”
LA.FA.RE. S.r.l.
Via S. Benedetto Cozzolino, 77
80056 Ercolano (NA) - Italy
Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective against viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. 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 presence of the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the development 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 emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

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 antibiotics prescribed for you to other people.
If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.