Amoxicillin and clavulanic acid Doc Generici

AMOXICILLIN AND CLAVULANIC ACID DOC Generici 875 mg + 125 mg
film-coated tablets
AMOXICILLIN AND CLAVULANIC ACID DOC Generici 875 mg + 125 mg
powder for oral suspension
Generic medicine
Please read this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you personally (or for your child). Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
• If any of the side effects worsens, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

1. What AMOXICILLIN AND CLAVULANIC ACID DOC Generici is and what it is used for
2. Before taking AMOXICILLIN AND CLAVULANIC ACID DOC Generici
3. How to take AMOXICILLIN AND CLAVULANIC ACID DOC Generici
4. Possible side effects
5. How to store AMOXICILLIN AND CLAVULANIC ACID DOC Generici
6. Further information

1. WHAT AMOXICILLIN AND CLAVULANIC ACID DOC Generici IS AND WHAT IT IS USED FOR

AMOXICILLIN AND CLAVULANIC ACID DOC Generici is an antibiotic that works by killing the bacteria causing infections. It contains two different active ingredients called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (rendered inactive).
The other active component (clavulanic acid) prevents this from happening.
AMOXICILLIN AND CLAVULANIC ACID DOC Generici is used in adults and children to treat the following infections:

• ear and sinus infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections

2. BEFORE TAKING AMOXICILLIN AND CLAVULANIC ACID DOC Generici

Do not take AMOXICILLIN AND CLAVULANIC ACID DOC Generici:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to any of the excipients of AMOXICILLIN AND CLAVULANIC ACID DOC Generici (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 DOC Generici if any of these
situations apply to you. If you are in doubt, speak with your doctor or pharmacist before taking AMOXICILLIN AND
CLAVULANIC ACID DOC Generici.
Take special care with AMOXICILLIN AND CLAVULANIC ACID DOC Generici
Talk to your doctor or pharmacist before taking this medicine if:

• you have infectious mononucleosis
• you have 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, consult your doctor or pharmacist before
taking AMOXICILLIN AND CLAVULANIC ACID DOC Generici.
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
medication.
Conditions to which you should pay attention
AMOXICILLIN AND CLAVULANIC ACID DOC Generici may worsen certain pre-existing
conditions or cause serious adverse effects. These may include allergic reactions, seizures, and intestinal
inflammation. You should be aware of certain symptoms while taking AMOXICILLIN AND
CLAVULANIC ACID DOC Generici 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 DOC Generici. This is because AMOXICILLIN AND CLAVULANIC ACID DOC Generici may affect the results of these tests.
Taking AMOXICILLIN AND CLAVULANIC ACID DOC Generici with other medicines
Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription and herbal products.
If you are taking allopurinol (used for gout) together with AMOXICILLIN AND CLAVULANIC ACID DOC Generici, you are very likely to develop a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust the dose of AMOXICILLIN AND CLAVULANIC ACID DOC Generici.
If you are taking medicines (such as warfarin) that help prevent blood clots together with AMOXICILLIN AND CLAVULANIC ACID DOC Generici, additional blood tests may be required.
AMOXICILLIN AND CLAVULANIC ACID DOC Generici may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, or are breastfeeding, inform your doctor or pharmacist.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
AMOXICILLIN AND CLAVULANIC ACID DOC Generici may cause adverse effects, and symptoms may impair your ability to drive.
Do not drive or operate machinery unless you feel well.
Important information about excipients in AMOXICILLIN AND CLAVULANIC ACID DOC Generici
AMOXICILLIN AND CLAVULANIC ACID DOC Generici 875 mg + 125 mg powder for oral suspension contains aspartame (E951), a source of phenylalanine. It may be harmful for patients suffering from phenylketonuria.

3. HOW TO TAKE AMOXICILLIN AND CLAVULANIC ACID DOC Generici

Always take AMOXICILLIN AND CLAVULANIC ACID DOC Generici exactly as directed by your
physician. If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
AMOXICILLIN AND CLAVULANIC ACID DOC Generici 875 mg + 125 mg film-coated tablets

• Usual dose – 1 tablet twice daily
• Higher dose – 1 tablet three times daily

AMOXICILLIN AND CLAVULANIC ACID DOC Generici 875 mg + 125 mg powder for oral suspension

• Usual dose – 1 sachet twice daily
• Higher dose – 1 sachet three times daily

Children weighing less than 40 kg
Children aged 6 years or younger should preferably be treated with amoxicillin/clavulanic acid oral suspension or pediatric sachets.
Film-coated tablets
Consult your doctor or pharmacist for advice on administering AMOXICILLIN AND CLAVULANIC ACID DOC Generici film-coated tablets to children weighing less than 40 kg.
Powder for oral suspension
The sachets of AMOXICILLIN AND CLAVULANIC ACID DOC Generici are not recommended.
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 DOC Generici
Film-coated tablets:

• Swallow the tablet whole with a glass of water at the beginning of a meal or immediately before.

• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
  Powder for oral suspension:

• Just before taking AMOXICILLIN AND CLAVULANIC ACID DOC Generici, open the sachet and mix the contents with half a glass of water.

• Take at the beginning of a meal or immediately before.

• Space your 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 DOC Generici for longer than 2 weeks. If you
continue to feel unwell, you should return to your doctor.
If you take more AMOXICILLIN AND CLAVULANIC ACID DOC Generici than you should
If you take too much AMOXICILLIN AND CLAVULANIC ACID DOC Generici, symptoms may
include gastrointestinal disturbances (nausea, vomiting, or diarrhea) or seizures. Contact your doctor as soon as
possible. Take the medicine packaging along to show your doctor.
If you forget to take AMOXICILLIN AND CLAVULANIC ACID DOC Generici
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; instead, wait approximately 4 hours before taking the next dose.
If you stop taking AMOXICILLIN AND CLAVULANIC ACID DOC Generici
Continue taking AMOXICILLIN AND CLAVULANIC ACID DOC Generici until the treatment is
complete, even if you feel better. Each dose is necessary to help you fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, AMOXICILLIN AND CLAVULANIC ACID DOC Generics may cause adverse reactions, although not everyone experiences them.

Conditions to which you should pay attention

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 glands in the neck, armpits, or groin
• swelling, sometimes of the face or mouth ( angioedema ), causing difficulty breathing
• collapse

Contact your doctor immediately if you experience any of these symptoms.
Stop taking AMOXICILLIN AND CLAVULANIC ACID DOC Generics.

Intestinal inflammation
Intestinal inflammation causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.
If you experience these symptoms, contact your doctor as soon as possible for advice.

Very common adverse effects
May affect more than 1 in 10 people

• diarrhoea (in adults)

Common adverse 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 DOC Generics before food
• vomiting
• diarrhoea (in children)

Uncommon adverse effects
May affect up to 1 in 100 people

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

Uncommon adverse effects may be detected in blood tests:

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

Rare adverse 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 adverse effects may be detected in blood tests:

• low number of cells involved in blood clotting
• low white blood cell count

Other adverse effects
Other adverse effects occur in a very limited number of people, but their exact frequency is unknown.

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Severe skin reactions:
  • widespread rash with blisters and peeling, particularly 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 area, toxic epidermal necrolysis )
  • widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis )
  • red, scaly rash with raised areas under the skin and blisters ( exanthematous pustulosis )
  • 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)
    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 make the skin and whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of AMOXICILLIN AND CLAVULANIC ACID DOC Generics or who have kidney problems)
• black hairy tongue
• tooth staining (in children), usually removable by brushing

Adverse effects that may be detected in blood or urine tests:

• severe reduction in white blood cell count
• low red blood cell count ( haemolytic anaemia )
• crystals in the urine

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AMOXICILLINA E ACIDO CLAVULANICO DOC Generici

Keep out of the reach and sight of children.
Store this medicine in its original packaging to protect the product from light and moisture, at a temperature not exceeding 25°C.
Do not use AMOXICILLINA E ACIDO CLAVULANICO DOC Generici after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What AMOXICILLINA E ACIDO CLAVULANICO DOC Generici contains

• The active substances are amoxicillin trihydrate and potassium clavulanate.
• The excipients are:
  Film-coated tablets: Anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.
  Oral suspension powder: Hydrated colloidal silica, orange-flavouring, aspartame.

Description of the appearance of AMOXICILLINA E ACIDO CLAVULANICO DOC Generici and contents of the pack
Film-coated tablets. Oral suspension powder.
AMOXICILLINA E ACIDO CLAVULANICO DOC Generici 875 mg + 125 mg film-coated tablets: oval, biconvex, almost white, film-coated tablet, marked on one side.
AMOXICILLINA E ACIDO CLAVULANICO DOC Generici 875 mg + 125 mg oral suspension powder: white to almost white powder.
The film-coated tablets are packed in blisters of 12 tablets.
The oral suspension powder is packed in sachets. Each pack contains 12 sachets.

Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.

Manufacturers
Elpen SA
95 Marathonos Avenue
19009 Pikermi Attika
Greece
Laboratorio Reig Jofrè S.A.
Calle Jarama s/n
Polígono Industrial
45007 Toledo
Spain

This patient information leaflet was last approved in December 2012.

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 the bacteria survive and multiply despite the presence of the antibiotic.
Bacteria can 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, 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.

1. It is very important that you take the antibiotic at the correct dose, at the specified times, and for the exact number of days prescribed. Read the instructions in this leaflet carefully and, if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you believe you have a similar infection.
4. Do not give your antibiotics to other people, even if they appear to have the same condition as you.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.