Amoxicillin and clavulanic acid Aurobindo
Italy
Table of Contents
Patient Information Leaflet: Information for the User
Amoxicillin and Clavulanic Acid Aurobindo 875 mg/125 mg film-coated tablets
Generic medicine
Please read 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 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, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Amoxicillin and Clavulanic Acid Aurobindo is and what it is used for
- What you need to know before taking Amoxicillin and Clavulanic Acid Aurobindo
- How to take Amoxicillin and Clavulanic Acid Aurobindo
- Possible side effects
- How to store Amoxicillin and Clavulanic Acid Aurobindo
- Contents of the pack and other information
1. What Amoxicillin and Clavulanic Acid Aurobindo is and what it is used for
Amoxicillin and Clavulanic Acid Aurobindo is an antibiotic that works by killing the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called "penicillins", which sometimes can be blocked in their action (rendered inactive). The other active substance (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Aurobindo is used in adults and children to treat the following infections:
- Sinus and middle ear 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 Aurobindo
Do not take Amoxicillin and Clavulanic Acid Aurobindo
- 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 previously had a severe allergic reaction to any other antibiotic. This reaction may include a skin rash or swelling of the face or throat;
- if you have previously had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
→ Do not take Amoxicillin and Clavulanic Acid Aurobindo if any of the above apply to you.
If you are unsure, speak with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Aurobindo.
Warnings and precautions
Tell your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Aurobindo:
- if you have glandular fever;
- if you are being treated for liver or kidney problems;
- if you do not urinate regularly.
If you are unsure whether any of the above apply to you, discuss this with your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Aurobindo.
In some cases, your doctor may test for the type of bacteria causing your infection. Depending on the results, you may be prescribed a different dose of Amoxicillin and Clavulanic Acid Aurobindo or a different medicine.
Conditions to be aware of
Amoxicillin and Clavulanic Acid Aurobindo may worsen certain pre-existing conditions or cause serious side effects. These include allergic reactions, seizures (fits), and inflammation of the large intestine. You should be alert to certain symptoms while taking Amoxicillin and Clavulanic Acid Aurobindo to reduce the risk of complications. See also “Conditions to monitor” in section 4.
Blood and urine tests
If you are having blood tests (e.g. tests for red blood cell status or liver function) or urine tests (for glucose), inform your doctor or nurse that you are taking Amoxicillin and Clavulanic Acid Aurobindo. This medicine may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Aurobindo
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
If you are taking allopurinol (used for gout) together with Amoxicillin and Clavulanic Acid Aurobindo, you may be more likely to develop a skin allergic reaction.
Probenecid (used to treat gout): concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
If you are taking medicines to thin the blood or treat blood clots (e.g. warfarin) together with Amoxicillin and Clavulanic Acid Aurobindo, additional blood tests may be required.
Methotrexate (used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate, potentially increasing side effects.
Amoxicillin and Clavulanic Acid Aurobindo 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, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Aurobindo may cause side effects that could affect your ability to drive.
Do not drive or operate machinery until you feel better.
Amoxicillin and Clavulanic Acid Aurobindo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
3. How to take Amoxicillin and Clavulanic Acid Aurobindo
Take this medicine exactly as directed by your doctor or pharmacist. If you
are unsure, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
875 mg/125 mg film-coated tablets
The recommended dose is:
- usual dose – 1 tablet twice daily.
- high dose – 1 tablet 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 sachets.
Consult your doctor or pharmacist when administering Amoxicillin and Clavulanic Acid Aurobindo 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, the dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
- If you have liver problems, you may need more frequent blood tests to monitor liver function.
How to take Amoxicillin and Clavulanic Acid Aurobindo
- Take with food.
- Swallow the tablets whole with a glass of water. The tablets may be divided along the break line to make swallowing easier. Both parts of the tablet must be taken at the same time.
- 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 Aurobindo for longer than 2 weeks. If you still do not feel better, you should see your doctor.
If you take more Amoxicillin and Clavulanic Acid Aurobindo than you should
If you take too much Amoxicillin and Clavulanic Acid Aurobindo, symptoms may include stomach
upset (nausea, vomiting or diarrhoea) or seizures. Contact your doctor as soon as possible. Take the
medicine pack or container with you to show the doctor.
If you forget to take Amoxicillin and Clavulanic Acid Aurobindo
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait at least 4 hours before taking the next dose. Do not take a double dose to make up for a missed dose.
If you stop taking Amoxicillin and Clavulanic Acid Aurobindo
Continue taking Amoxicillin and Clavulanic Acid Aurobindo for the full duration of treatment,
even if you feel better. You need all the doses to fight the infection. If any bacteria
survive, the infection may 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 everybody will experience them. The side effects listed below may occur with this medicine.
Conditions to watch for
Allergic reactions:
- Rash.
- 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, swollen glands in the neck, under the arms, and in the groin.
- Swelling, sometimes of the face or throat (angioedema), causing breathing difficulties.
- Collapse.
- Chest pain occurring during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome).
→ Contact a doctor immediately if you experience any of these symptoms and stop taking Amoxicillin and Clavulanic Acid Aurobindo.
Inflammation of the large intestine
Inflammation of the large intestine, 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 stomach pain, this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES)
DIES has been mainly reported in children treated with amoxicillin. 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.
→ Consult your doctor as soon as possible if you experience these symptoms.
Very common side effects
These side effects may affect more than 1 in 10 people.
- Diarrhoea (in adults).
Common side effects
These side effects may affect up to 1 in 10 people.
- Candidiasis (candida – an infection of the vagina, mouth, or skin folds);
- Feeling unwell (nausea), especially when taking high doses; → if this symptom occurs, take Amoxicillin and Clavulanic Acid Aurobindo with meals.
- Vomiting;
- Diarrhoea (in children).
Uncommon side effects
These side effects may affect up to 1 in 100 people.
- Skin rash, itching;
- Raised itchy rash (urticaria);
- Indigestion;
- Dizziness;
- Headache.
Uncommon side effects that may show up in blood tests:
- Increased levels of certain substances (enzymes) produced by the liver.
Rare side effects
These side effects may affect up to 1 in 1,000 people.
- Skin rash that may develop into pustules and appear as small target-like spots (central dark spots surrounded by a lighter 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 show up in blood tests:
- Low number of cells involved in blood clotting (platelets);
- Low number of white blood cells.
Side effects with unknown frequency
The frequency cannot be estimated from the available data.
- Allergic reactions (see above);
- Inflammation of the large intestine (see above);
- Crystals in the urine leading to acute kidney injury;
- Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis);
- Severe skin reactions:
- Widespread erythema with pustules and skin 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 – toxic epidermal necrolysis);
- Widespread erythema and redness of the skin with small pus-filled pustules (exfoliative bullous dermatitis);
- Scaly red erythema with subcutaneous nodules and pustules (exanthematous pustulosis);
- Flu-like symptoms with skin 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));
- A red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (symmetrical drug-related intertriginous flexural erythema (SDRIFE));
- Rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease).
→ Contact a doctor immediately if you develop any of these symptoms.
- 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/clavulanic acid or who have kidney problems);
- Black, hairy-looking tongue.
Side effects that may be detected in blood tests:
- Severe reduction in the number of white blood cells;
- Reduced number of red blood cells (haemolytic anaemia).
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Aurobindo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and vial after 'EXP'. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
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 Aurobindo contains
- The active substances are amoxicillin trihydrate and potassium clavulanate.
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin
and potassium clavulanate equivalent to 125 mg of clavulanic acid.
- The other components are:
Tablet core: Microcrystalline cellulose (E460), anhydrous colloidal silica, magnesium stearate (E470b), sodium starch glycolate (type A).
Coating:
Hypromellose (E464), macrogol 400, titanium dioxide (E171).
Description of the appearance of Amoxicillin and Clavulanic Acid Aurobindo and contents of the
pack
Film-coated tablets
Amoxicillin and Clavulanic Acid Aurobindo 875/125 mg tablets are white, capsule-shaped, film-coated tablets with the letter 'A' marked on one side and a break line between '6' and '5' on the other side.
The break line is intended only to facilitate tablet splitting for easier swallowing and does not allow division into equal doses.
Amoxicillin and Clavulanic Acid Aurobindo tablets are available in aluminium/aluminium blisters (polyamide/aluminium/PVC-aluminium foil) containing 4, 5, 6, 7, 8, 10, 12, 14, 15, 16, 20, 21, 24, 25, 30, 35, 40, 50, 100 and 500 film-coated tablets. Not all pack sizes may be commercially available.
Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe 102
21047 Saronno (VA)
Italy
Manufacturer
APL Swift Services (Malta) Limited
HF 26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria Amoxicillin/Clavulansäure A-med 875 mg/125 mg Filmtabletten
Denmark Amoxicillin/Clavulansyre Aurobindo
Germany Amoxi-Clavulan Aurobindo 875 mg/125 mg Filmtabletten
Italy Amoxicillina e Acido clavulanico Aurobindo
Netherlands Amoxicilline/Clavulaanzuur Aurobindo 875 mg/125 mg, filmomhulde tabletten
Romania Amoxiplus 875 mg/125 mg, comprimate filmate
Spain Amoxicilina/Ácido clavulánico Aurovitas Pharma 875 mg/125 mg comprimidos recubiertos con película
Sweden Amoxicillin/Clavulanic acid Aurobindo 875 mg/125 mg filmdragerade tabletter
Medical advice/public health information
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 bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately 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 pay attention to the following advice to help prevent the emergence of bacterial resistance, which can lead to loss of antibiotic effectiveness.
- It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. 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 prescribed for other people, even if you appear to have a similar infection.
- Do not give your prescribed antibiotics to other people.
- If you have leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.