Amoxicillin and clavulanic acid Teva

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin Clavulanic Acid Teva 1000 mg + 200 mg powder for solution for injection or infusion
Amoxicillin Clavulanic Acid Teva 2000 mg + 200 mg powder for solution for infusion
Amoxicillin/Clavulanic Acid
Generic medicine
Please read all of this leaflet carefully before you start 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, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4. Contents of this leaflet:
  1. What Amoxicillin Clavulanic Acid Teva is and what it is used for
  2. What you need to know before taking Amoxicillin Clavulanic Acid Teva
  3. How to take Amoxicillin Clavulanic Acid Teva
  4. Possible side effects
  5. How to store Amoxicillin Clavulanic Acid Teva
  6. Contents of the pack and other information

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

Amoxicillin Clavulanic Acid Teva is an antibiotic that works by killing bacteria causing 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 (rendered inactive).
The other active component (clavulanic acid) prevents this from happening.
Amoxicillin Clavulanic Acid Teva is used in adults and children to treat the following infections:

• severe ear, nose and throat infections
• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections, including dental infections
• bone and joint infections
• intra-abdominal infections
• genital infections in women

Amoxicillin Clavulanic Acid Teva is used in adults and children for the prevention of infections associated with major surgical procedures.

2. What you should know before taking Amoxicillin Clavulanic Acid Teva

Do not use Amoxicillin Clavulanic Acid Teva:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or to any of the excipients of this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include a skin rash or swelling of the face or neck
• if, when taking an antibiotic, you experienced liver problems or jaundice (yellowing of the skin)

Do not use Amoxicillin Clavulanic Acid Teva if any of these cases apply to you. If you have any doubts, speak with your
doctor, pharmacist, or nurse before taking this medicine.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Amoxicillin Clavulanic Acid Teva:

• if you have glandular fever
• if you have been treated for liver or kidney problems
• if you do not urinate regularly.

If you are unsure whether any of the above conditions apply to you, discuss this with your doctor, pharmacist,
or nurse before using Amoxicillin Clavulanic Acid Teva.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dose of Amoxicillin Clavulanic Acid Teva or a
different medicine.
Conditions you should be aware of
Amoxicillin Clavulanic Acid Teva may worsen certain pre-existing conditions or cause serious adverse effects.
These may include allergic reactions, seizures, and inflammation of the large intestine. You should pay attention
to certain symptoms while taking Amoxicillin Clavulanic Acid Teva in order to reduce any risks. See “Conditions
you should be aware of ” 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 Clavulanic Acid Teva. This is because Amoxicillin
Clavulanic Acid Teva may affect the results of these types of tests.
Other medicines and Amoxicillin Clavulanic Acid Teva
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines,
including those available without a prescription and herbal products.

• If you are taking allopurinol (used for gout) together with Amoxicillin Clavulanic Acid Teva, you may be more 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 Clavulanic Acid Teva.
• If you are taking medicines (such as warfarin) that help prevent blood clots together with Amoxicillin Clavulanic Acid Teva, additional blood tests may be required.
• Amoxicillin Clavulanic Acid Teva may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
• Amoxicillin Clavulanic Acid Teva may affect how mycophenolate mofetil (a medicine used after kidney transplantation) works.

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 taking this medicine.
Driving and using machines
Amoxicillin Clavulanic Acid Teva may cause side effects, and the symptoms may make you unfit to drive. Do not
drive or operate machinery unless you feel well.
Amoxicillin Clavulanic Acid Teva contains sodium and potassium

• The sodium content in the 1000 mg+200 mg Powder is 3.4 mmol. The potassium content is 1 mmol.
• The sodium content in the 2000 mg+200 mg Powder is 6.8 mmol. The potassium content is 1 mmol. This should be taken into account for patients with kidney problems or for patients on a diet controlled for potassium and sodium content.

3. How to take Amoxicillin Clavulanic Acid Teva

Never take this medicine on your own initiative. This medicine will be administered by a
qualified person, such as a doctor or nurse.
The recommended doses are:
500 mg/50 mg, 1000 mg/100 mg, 2000 mg/200 mg powder for injection/infusion.
Adults and children weighing equal to or more than 40 kg

Children weighing less than 40 kg

• All doses are calculated based on the child's body weight expressed in kilograms.

500 mg/100 mg, 1000 mg/200 mg powder for injection/infusion
Adults and children weighing equal to or more than 40 kg

Children weighing less than 40 kg

• All doses are calculated based on the child's body weight expressed in kilograms.

Patients with kidney and 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 well your liver is working.

How Amoxicillin Clavulanic Acid Teva will be administered to you

• Amoxicillin Clavulanic Acid Teva will be administered to you by intravenous injection or intravenous infusion.
• Make sure you drink an adequate amount of fluids while receiving Amoxicillin Clavulanic Acid Teva.
• Do not take Amoxicillin Clavulanic Acid Teva for longer than 2 weeks unless your doctor has instructed otherwise.

If you receive more Amoxicillin Clavulanic Acid Teva than you should
It is very unlikely that this will happen, but if you think an excessive amount of Amoxicillin Clavulanic Acid Teva has been administered, contact your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

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 which 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

If you experience any of these symptoms, contact your doctor immediately. Stop taking
Amoxicillin Clavulanic Acid Teva.

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.

Inflammation of the meninges
Symptoms may include neck stiffness, headache, nausea or vomiting, fever or confusion.
If you experience these symptoms, contact your doctor as soon as possible for advice.

Common (may affect up to 1 in 10 people):

• oral, vaginal or skin fold fungal infection ( candidiasis )
• diarrhoea

Uncommon (may affect up to 1 in 100 people):

• skin rash, itching
• raised, itchy rash ( urticaria )
• nausea, especially when taking high doses; if affected, take Amoxicillin Clavulanic Acid Teva before meals
• vomiting
• indigestion
• dizziness
• headache

Uncommon side effects that may be detected by blood tests:

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

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

• skin rash, which may present as blisters and resemble "target" lesions (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
• swelling and redness along a vein, with pain becoming more pronounced when touched

Rare side effects that may be detected by blood tests:

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

Not known (frequency cannot be estimated from the available data):

• allergic reactions (see above)
• intestinal inflammation (see above)
• inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• severe skin reactions: either a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), or a more severe form causing extensive skin detachment (more than 30% of body surface - toxic epidermal necrolysis ), or a widespread red rash with small pus-filled blisters ( exfoliative bullous dermatitis ), or a red rash with crusts, swellings under the skin, and blisters ( pustular exanthema ), or flu-like symptoms with a 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.
• liver inflammation (hepatitis)
• jaundice, caused by increased 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
• seizures (in people taking high doses of Amoxicillin Clavulanic Acid Teva or who have kidney problems)

Side effects that may be detected by 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

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: www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amoxicillin Clavulanic Acid Teva

Keep this medicine out of the sight and reach of children.
Do not store at temperatures above 25°C. Store in the original packaging. Do not transfer to
another container.
Do not use this medicine after the expiry date stated on the carton and label after Exp. The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
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. Package contents and other information

What Amoxicillina Acido clavulanico Teva contains

• The active substances are amoxicillin and clavulanic acid.
• Each vial contains 1000 mg of amoxicillin (as the sodium salt) and 200 mg of clavulanic acid (as the potassium salt). The sodium content per vial is 3.4 mmol. The potassium content per vial is 1.0 mmol.
• Each vial contains 2000 mg of amoxicillin (as the sodium salt) and 200 mg of clavulanic acid (as the potassium salt). The sodium content per vial is 6.8 mmol. The potassium content per vial is 1.0 mmol.
• It does not contain any other excipients.

Description of the appearance of Amoxicillina Acido clavulanico Teva and contents of the pack

• Amoxicillina Acido clavulanico Teva is a white or almost white crystalline powder for injectable/infusion solution.
• The product is available in packs of 1 or 10 vials.

Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
MARKETING AUTHORIZATION HOLDER
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milano, Italy
Manufacturer
Pharmachemie B.V. – Swensweg, 5 – 2031 GA Haarlem (The Netherlands)
Reig Jofré S.A. – Jarama s/n Poligono Industrial – 45007 Toledo (Spain)
This medicinal product is authorized in the Member States of the European Economic Area under the
following names:
1000 mg/200 mg:
Netherlands: Amoxicilline/Clavulaanzuur 1000/200 PCH, poeder voor oplossing voor injectie
United Kingdom: Co-Amoxiclav 1000/200 mg Powder for Solution for Injection/Infusion
Italy: Amoxicillina Acido Clavulanico Teva 1000 mg+200 mg polvere per soluzione iniettabile o per infusione
Ireland: Co-Amoxiclav TEVA 1000/200 mg Powder for Solution for Injection
2000 mg/200 mg:
Netherlands: Amoxicilline/Clavulaanzuur 2000/200 PCH, poeder voor oplossing voor intraveneuze infusie
Italy: Amoxicillina Acido Clavulanico Teva 2000 mg+200 mg polvere per soluzione per infusione

The following information is intended exclusively for physicians or healthcare professionals.
Refer to the Summary of Product Characteristics for further information.
Administration
Amoxicillina Acido clavulanico Teva may be administered by slow intravenous injection over a period of 3 to 4 minutes directly into the vein, or by intravenous infusion over a period of 30 to 40 minutes.
Amoxicillina Acido clavulanico Teva is not suitable for intramuscular administration.
Reconstitution
Preparation of solutions for intravenous injection

*
Amoxicillin Clavulanic Acid Teva powder for injectable solution must be dissolved in 20–50 ml of solvent as indicated in the table above, yielding a single-dose solution which must be administered within 15 minutes after reconstitution.
Amoxicillin Clavulanic Acid Teva 2000 mg + 200 mg powder for infusion solution is not suitable for bolus injection. Administration must be performed by intravenous infusion.

Preparation of solutions for intravenous infusion

1000 mg/200 mg:
Vials containing 1000 mg + 200 mg should be diluted with 50 ml or up to 100 ml of water for injections or the following fluids: physiological saline, sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.

2000 mg/200 mg:
Vials containing 2000 mg + 200 mg should be diluted with 100 ml of water for injections or the following fluids: physiological saline, sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution. If the product is dissolved in water for injections as specified, this solution may be mixed with the following diluents: water for injections, physiological saline, sodium lactate 167 mmol/l, Ringer's solution, Hartmann's solution.

Intravenous infusion solutions must be administered in their entirety within 60 minutes of preparation. After dissolution, a light yellow coloration may be observed.
Stability of prepared solutions
Prepared solutions must be used immediately. If not used immediately, the times and conditions of storage are under the responsibility of the user.