Amoxicillin and clavulanic acid Zentiva Lab

Package leaflet: Information for the user

Amoxicillin and Clavulanic Acid Zentiva Lab 875 mg/125 mg powder for oral suspension

in sachets
Generic Medicine
Read all of this leaflet carefully before taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally (or for your child). Do not give it to others, 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 or pharmacist.

Contents of this leaflet:

1. What Amoxicillin and Clavulanic Acid Zentiva Lab is and what it is used for
2. What you need to know before taking Amoxicillin and Clavulanic Acid Zentiva Lab
3. How to take Amoxicillin and Clavulanic Acid Zentiva Lab
4. Possible side effects
5. How to store Amoxicillin and Clavulanic Acid Zentiva Lab
6. Contents of the pack and other information

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

Amoxicillin and Clavulanic Acid Zentiva Lab is an antibiotic that works by killing bacteria causing 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 (rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Zentiva Lab 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. Before taking Amoxicillin and Clavulanic Acid Zentiva Lab

Do not take Amoxicillin and Clavulanic Acid DSM Sinochem:

• if you are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or to 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 Zentiva Lab if any of the above apply to you. If you are unsure, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid DSM Sinochem.

Warnings and precautions

Talk to your doctor or pharmacist 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 conditions listed above apply to you, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid DSM Sinochem.

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 and Clavulanic Acid Zentiva Lab or a different medicine.

Conditions to which you should pay attention

Amoxicillin/clavulanic acid 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/clavulanic acid 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 (for example, checks on 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 DSM Sinochem. This is because amoxicillin/clavulanic acid may affect the results of these tests.

Other medicines and Amoxicillin and Clavulanic Acid DSM Sinochem

Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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 DSM Sinochem, 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 DSM Sinochem.

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

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

Amoxicillin and Clavulanic Acid Zentiva Lab may affect the action 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, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amoxicillin and Clavulanic Acid Zentiva Lab may cause side effects, and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin and Clavulanic Acid Zentiva Lab contains aspartame (E951), a source of phenylalanine. It may be harmful for patients with phenylketonuria.

3. How to take Amoxicillina e Acido clavulanico Zentiva Lab

Always take Amoxicillina e Acido clavulanico Zentiva Lab exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

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

Children weighing less than 40 kg

• Amoxicillina e Acido clavulanico Zentiva Lab 875 mg/125 mg sachets 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, more frequent blood tests may be needed to monitor liver function.

How to take Amoxicillina e Acido clavulanico Zentiva Lab

• Just before taking Amoxicillina e Acido clavulanico DSM Sinochem, open the sachet and mix the contents with half a glass of water. Stir well and take immediately.
• Take at the beginning of a meal or immediately before a meal.
• Space doses evenly throughout the day, at intervals of at least 4 hours. Do not take two doses within one hour.
• Do not take Amoxicillina e Acido clavulanico Zentiva Lab for longer than two weeks. If you continue to feel unwell, you must return to your doctor.

If you take more Amoxicillina e Acido clavulanico Zentiva Lab than you should
If you take too much Amoxicillina e Acido clavulanico DSM Sinochem, symptoms may include gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine package or container with you to show the doctor.

If you forget to take Amoxicillina e Acido clavulanico Zentiva Lab
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 before taking the next dose.

If you stop taking Amoxicillina e Acido clavulanico Zentiva Lab
Continue taking Amoxicillina e Acido clavulanico Zentiva Lab for the full duration of treatment, even if you start to 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amoxicillin and Clavulanic Acid Zentiva Lab can cause side effects, although not everybody gets 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 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

Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin and Clavulanic Acid DSM Sinochem.

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 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 affected, take Amoxicillin and Clavulanic Acid Zentiva Lab before meals
• Vomiting
• Diarrhoea (in children)

Uncommon side effects
May affect up to 1 in 100 people

• Skin rashes, itching
• Raised, itchy 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 white blood cell count

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

• Allergic reactions (see above)
• Intestinal inflammation (see above)
• Severe skin reactions:
• A widespread rash with blistering 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 blisters containing pus (exfoliative bullous dermatitis)
• A red rash with crusts, swellings under the skin and blisters (pustular exanthem)
• 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 Zentiva Lab or who have kidney problems)
• Black, hairy-looking tongue
• Tooth staining (in children), usually removable by brushing

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

• Severe reduction in white blood cell count
• Low red blood cell count (haemolytic anaemia)
• Crystals in the urine

If you get any side effects
If any of the side effects worsen or become troublesome, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Reporting of side effects
If you get any side effects, 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 and Clavulanic Acid Zentiva Lab

Do not store above 25°C. Keep in the original packaging to protect the medicine from moisture.
Keep out of sight and reach of children.
Do not use Amoxicillin and Clavulanic Acid Zentiva Lab after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 DSM Sinochem contains:

• The active substances are amoxicillin trihydrate and clavulanic acid.
• The other excipients are: crospovidone (E1202), anhydrous colloidal silica (E551), magnesium stearate (E470b), aspartame (E951), strawberry flavouring.

Description of the appearance of Amoxicillina e Acido clavulanico Zentiva Lab and contents of the
package
Amoxicillina/acido clavulanico Zentiva Lab 500/125 mg powder for oral suspension in
sachets:
White to yellowish powder in a sachet made of polyethylene terephthalate/aluminium/polyethylene (PET/ALU/PE).
Pack: 12 sachets in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zentiva Italia Srl
Viale Luigi Bodio 37/B
20158 Milano, Italy
Manufacturer
PenCef Pharma GmbH
Breitenbachstrasse 13
13509 Berlin, Germany
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands
Amoxicilline/Clavulaanzuur Zentiva Lab 875 mg/125 mg powder for oral suspension in sachet
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 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 antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice to help prevent the development of bacterial resistance, which can lead to loss of antibiotic effectiveness.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the correct number of days. Read the instructions in the package 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 have an infection similar to theirs.
4. Do not give your antibiotics to other people, even if they seem to have the same infection as you.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist for proper disposal.