Amoxicillin and clavulanic acid Mylan Generics Italia
ItalyTable of Contents
Patient Information Leaflet
Amoxicillin and Clavulanic Acid Mylan Generics Italia 875 mg/125 mg
oral suspension powder
amoxicillin / clavulanic acid
Generic Medicine
Please read all of this leaflet carefully before taking this medicine, as 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 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, contact your doctor, pharmacist or nurse. See section 4.
What this leaflet contains
- What Amoxicillin and Clavulanic Acid Mylan Generics Italia is and what it is used for
- What you need to know before taking Amoxicillin and Clavulanic Acid Mylan Generics Italia
- How to take Amoxicillin and Clavulanic Acid Mylan Generics Italia
- Possible side effects
- How to store Amoxicillin and Clavulanic Acid Mylan Generics Italia
- Contents of the pack and other information
1. What Amoxicillin and Clavulanic Acid Mylan Generics Italia is and what it is used for
Amoxicillin and Clavulanic Acid Mylan Generics Italia is an antibiotic that works by killing bacteria that cause 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 ineffective).
The other active ingredient (clavulanic acid) prevents this from happening.
Amoxicillin and Clavulanic Acid Mylan Generics Italia 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 Mylan Generics Italia
Do not take Amoxicillin and Clavulanic Acid Mylan Generics Italia:
- if you are allergic to amoxicillin, clavulanic acid, penicillin, 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 throat.
- if you have had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
Do not take Amoxicillin and Clavulanic Acid Mylan Generics Italia if any of the above apply to you.
If you are unsure, speak to your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Mylan Generics Italia.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse 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 not sure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Amoxicillin and Clavulanic Acid Mylan Generics Italia. In some cases, your doctor may carry out 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 Mylan Generics Italia or a different medicine.
Conditions to which you should pay attention
Amoxicillin and Clavulanic Acid Mylan Generics Italia may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the bowel. You should be aware of certain symptoms while taking Amoxicillin and Clavulanic Acid Mylan Generics Italia in order to reduce any risks. See “Conditions to which you should pay attention” in Section 4.
Blood and urine tests
If you are about to have blood tests (for example, tests related to 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 Mylan Generics Italia. This is because Amoxicillin and Clavulanic Acid Mylan Generics Italia may affect the results of these tests.
Other medicines and Amoxicillin and Clavulanic Acid Mylan Generics Italia
Tell 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 Mylan Generics Italia, 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 Mylan Generics Italia.
If you are taking medicines such as warfarin (which help prevent blood clots) together with Amoxicillin and Clavulanic Acid Mylan Generics Italia, additional blood tests may be required.
Amoxicillin and Clavulanic Acid Mylan Generics Italia may affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.
Amoxicillin and Clavulanic Acid Mylan Generics Italia may affect the effectiveness 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, consult your doctor or pharmacist before using this medicine.
Driving and using machines
Amoxicillin and Clavulanic Acid Mylan Generics Italia 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 Mylan Generics Italia contains aspartame
This medicine contains 12.5 mg of aspartame per sachet, equivalent to 0.25 mg/kg. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to build up in the body because it cannot be properly metabolized.
3. How to take Amoxicillin and Clavulanic Acid Mylan Generics Italia
Always take Amoxicillin and Clavulanic Acid Mylan Generics Italia exactly as directed by your doctor.
If you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more
875 mg/125 mg powder for oral suspension in sachets
- Recommended dose – 1 sachet twice daily
- Higher dose – 1 sachet three times daily
Children weighing less than 40 kg
Amoxicillin and Clavulanic Acid Mylan Generics Italia 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 required to monitor liver function.
How to take Amoxicillin and Clavulanic Acid Mylan Generics Italia
- Just before taking Amoxicillin and Clavulanic Acid Mylan Generics Italia, open the sachet and mix the contents with half a glass of water.
- Take with meals.
- 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 Mylan Generics Italia for longer than 2 weeks. If you continue to feel unwell, you should see your doctor again.
If you take more Amoxicillin and Clavulanic Acid Mylan Generics Italia than you should
If you take too much Amoxicillin and Clavulanic Acid Mylan Generics Italia, symptoms may include
gastrointestinal 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 Mylan Generics Italia
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early; wait approximately 4 hours. Do not take a double dose to make up for a forgotten dose.
If you stop taking Amoxicillin and Clavulanic Acid Mylan Generics Italia
Continue taking Amoxicillin and Clavulanic Acid Mylan Generics Italia for the full duration of treatment, even if you 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 using this medicine, consult your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them. The side effects that may occur with this medicine are listed below.
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 throat (angioedema), causing difficulty breathing
- collapse
- chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).
→ Contact your doctor immediately if you experience any of these symptoms. Stop taking
Amoxicillin and Clavulanic Acid Mylan Generics Italia.
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.
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 Mylan Generics Italia with meals
- vomiting
- diarrhoea (in children)
Uncommon side effects
May affect up to 1 in 100 people
- skin rash, itching
- raised, itchy skin 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 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 may be detected through blood tests:
- low number of cells involved in blood clotting
- low number of white blood cells
Frequency 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:
- widespread rash with blisters 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 area, toxic epidermal necrolysis)
- widespread red rash with small pus-filled blisters (exfoliative bullous dermatitis)
- red rash with crusts, swellings under the skin and blisters (pustular eruption)
- 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)
- Skin rash with ring-shaped blisters 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 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 Mylan Generics Italia or who have kidney problems)
- black hairy tongue, appearing covered in hair-like projections
- 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 number of red blood cells (haemolytic anaemia)
- crystals in the urine leading to acute kidney damage
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 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 Mylan Generics Italia
Keep in the original packaging to protect the product from light and moisture.
Store at a temperature not exceeding 25°C.
Keep this medicine out of the sight and reach of children.
Do not use Amoxicillin and Clavulanic Acid Mylan Generics Italia after the expiry date (EXP) 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. Package contents and other information
What Amoxicillin and Clavulanic Acid Mylan Generics Italia contains
The active substances are amoxicillin and clavulanic acid.
Each sachet contains amoxicillin trihydrate equivalent to 875 mg of amoxicillin, potassium clavulanate
equivalent to 125 mg of clavulanic acid.
The other components are: hydrated colloidal silica, orange flavour, aspartame.
Description of the appearance of Amoxicillin and Clavulanic Acid Mylan Generics Italia and pack contents
Powder for oral suspension.
The powder is white or almost white. The suspension is uniform, white or almost white, with an orange odour.
Carton box containing 12 sachets AIC No. 036744011
Marketing Authorization Holder and Manufacturer
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan, Italy
Manufacturers
Laboratorio Reig Jofré S.A., Calle Jarama S/N, Poligono Industrial, 45007 Toledo, Spain
LA.FA.RE. S.r.l., Via Sacerdote Benedetto Cozzolino, 77, 80056 – Ercolano (NA), Italy
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 therapy. 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. By using antibiotics appropriately, you can reduce the emergence of bacterial resistance, which leads to the loss of antibiotic effectiveness.
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 development of bacterial resistance, which can result in the failure of antibiotic therapy.
- 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 the package 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 think you have a similar infection.
- Do not give your antibiotics, prescribed specifically for you, to other people.
- If you have any leftover antibiotic after completing your treatment, return it to your pharmacist for proper disposal.