Amoxicillin Sandoz: detailed information

Package leaflet: Information for the patient

Amoxicillina Sandoz 250 mg/5 ml powder for oral suspension

Equivalent medicine
Please read all of 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 (or your child) 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 effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amoxicillina Sandoz is and what it is used for
What you need to know before taking Amoxicillina Sandoz
How to take Amoxicillina Sandoz
Possible side effects
How to store Amoxicillina Sandoz
Contents of the pack and other information

1. What Amoxicillina Sandoz is and what it is used for

What Amoxicillina Sandoz is
Amoxicillina Sandoz is an antibiotic. Its active ingredient, called amoxicillin, belongs to a group of medicinal substances known as "penicillins".
Amoxicillina Sandoz is used to treat bacterial infections in various parts of the body.
Amoxicillina Sandoz may also be used in combination with other medicines for the treatment of gastric ulcers.

2. What you need to know before taking Amoxicillina Sandoz

Do not take Amoxicillina Sandoz:

if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).
if you have previously had an allergic reaction to any antibiotic. This also includes skin rash or development of swelling of the face or throat.

Do not take Amoxicillina Sandoz if any of the above situations apply to you. If you
have any doubts, consult your doctor or pharmacist before taking Amoxicillina Sandoz.
Warnings and precautions
Talk to your doctor or pharmacist before taking Amoxicillina Sandoz if:

you have glandular fever (fever, sore throat, swollen glands and extreme tiredness)
you have kidney problems
you do not urinate regularly.

If you are unsure whether any of the points listed above apply to you, consult your doctor or pharmacist
before taking Amoxicillina Sandoz.
Blood and urine tests
If you are undergoing:

urine tests (for glucose) or blood tests for liver function
tests for estriol (used during pregnancy to check normal fetal development), inform your doctor or pharmacist that you are taking Amoxicillina Sandoz, as this medicine may alter the results of these tests.

Other medicines and Amoxicillina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine.

If you are taking allopurinol (a medicine used to treat gout) together with Amoxicillina Sandoz, you may have a higher chance of developing an allergic skin reaction.
If you are taking probenecid (a medicine used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended. Your doctor may decide to adjust the dose of Amoxicillina Sandoz.
If you are taking medicines to prevent blood clots (e.g. warfarin), you may need additional blood tests.
If you are taking other antibiotics (e.g. tetracyclines), the effectiveness of Amoxicillina Sandoz may be reduced.
If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, potentially increasing its side effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Amoxicillina Sandoz may cause side effects whose symptoms (such as allergic reactions, dizziness and
seizures) may interfere with your ability to drive.
Do not drive or operate machinery if you do not feel well.
Amoxicillina Sandoz 250 mg/5 ml oral suspension powder contains sucrose, sodium
benzoate and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this
medicine.
This medicine contains 10 mg of sodium benzoate per 5 ml, equivalent to 2 mg/ml.
Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborns up to 4
weeks of age.
This medicine contains less than 1 mmol (23 mg) of sodium per 5 ml, i.e. essentially ‘sodium-free’.

3. How to take Amoxicillin Sandoz

Take this medicine exactly as prescribed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.

Shake the bottle well before taking a dose.
Take the doses at regular intervals throughout the day, spaced at least 4 hours apart.

Usual dose:
Children weighing less than 40 kg
All doses are calculated according to the child's body weight in kilograms.

Your doctor will tell you how much Amoxicillin Sandoz to give your child.
The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more
This suspension is generally not prescribed for adults and children weighing 40 kg or more.
Please consult your doctor or pharmacist.
Kidney problems
If you have kidney problems, your dose may be lower than usual.
If you take more Amoxicillin Sandoz than you should
If you take too much Amoxicillin Sandoz, symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhea), presence of crystals in the urine (possibly causing cloudy urine), or difficulty urinating may occur. Contact your doctor as soon as possible, and bring the medicine with you to show it to them.
If you forget to take Amoxicillin Sandoz

If you miss a dose, take it as soon as you remember.
Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
Do not take a double dose to make up for the missed dose.

How long should you take Amoxicillin Sandoz?

Continue taking Amoxicillin Sandoz for the length of time prescribed by your doctor, even if you start feeling better. It is important to take all prescribed doses to fully treat the infection. The infection may return if some bacteria survive.
If you still do not feel well after completing the treatment, contact your doctor again.

Prolonged use of Amoxicillin Sandoz may lead to the development of candidiasis (a fungal infection caused by yeast, affecting moist areas of the body and causing irritation, itching, and white discharge). If this occurs, consult your doctor.
If you take Amoxicillin Sandoz for a prolonged period, your doctor may carry out additional tests to monitor your kidney, liver, and blood function.
If you stop treatment with Amoxicillin Sandoz
If you have any questions 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 gets them.
Stop taking Amoxicillina Sandoz and consult a doctor immediately if you experience
any of the following serious side effects, as urgent medical treatment may be required:

Chest pain occurring in the context of allergic reactions, which may be a symptom of myocardial infarction triggered by allergy (Kounis syndrome)
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). Further symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

The following side effects are very rare (may affect up to 1 in 10,000 people):

Allergic reactions, accompanied by signs such as skin itching or rash, swelling of the face, lips, tongue or body, or breathing difficulties. These effects can be severe and, in some cases, have been fatal
Skin rash or appearance of small, round, flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels caused by an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
Delayed allergic reaction, usually occurring 7-12 days after taking Amoxicillina Sandoz, accompanied by signs such as skin rash, fever, joint pain, and swollen lymph nodes, particularly under the arm
A skin reaction known as “erythema multiforme”, with itchy, reddish-purple patches on the skin, particularly on the palms of the hands or soles of the feet, areas of skin swelling similar to hives, or painful areas on the surface of the mouth, eyes, and genitals. This may be accompanied by fever and a feeling of extreme fatigue
Other severe skin reactions may include changes in skin colour, formation of lumps under the skin, blistering, pustules, peeling, redness, pain, itching, and skin shedding. These may be associated with fever, headache, and widespread body aches
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)
Fever, chills, sore throat or other signs of infection, or a tendency to bruise easily. These may be signs of a blood cell disorder
The Jarisch-Herxheimer reaction, which may occur during treatment of Lyme disease with Amoxicillina Sandoz, causing fever, chills, headache, muscle pain, and skin rash
Inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), pain, and fever
Severe side effects affecting the liver may occur, observed mainly in patients treated for long periods, in men, and in elderly people. Inform your doctor urgently if you notice: severe diarrhoea with bleeding or blisters, skin redness or bruising, dark urine, pale stools, or yellowing of the skin or the white part of the eye (jaundice). See also the entry on anaemia below as a possible cause of jaundice.

These effects may occur during treatment with the medicine or even several weeks later.
If any of the above-listed effects occur, stop taking the
medicine and contact your doctor immediately.
Sometimes less severe skin reactions may occur, such as:

A slightly itchy skin rash (roundish pinkish-red patches), localized swelling similar to hives on the forearms, legs, palms of the hands, hands or feet. This is an uncommon effect (may affect up to 1 in 100 people).

If any of these side effects occur, contact your doctor, as treatment with Amoxicillina Sandoz will need to be discontinued.
Other possible side effects are:
Common (may affect up to 1 in 10 people)

Skin rash
Nausea
Diarrhoea.

Uncommon (may affect up to 1 in 100 people)

Vomiting.

Very rare (may affect up to 1 in 10,000 people)

Candidiasis (yeast infection of the vagina, mouth or skin folds); your doctor or pharmacist will prescribe appropriate treatment
Kidney problems
Seizures, observed in patients treated with high doses or with kidney problems
Dizziness
Hyperactivity
Presence of crystals in the urine (which may lead to acute kidney damage), possibly causing cloudy urine, difficulty urinating, or discomfort during urination. Make sure to drink plenty of fluids to reduce the risk of developing these symptoms
Teeth may appear stained, but usually return to their normal appearance with brushing (this effect has been documented in children)
The tongue may become yellowish, brownish or blackish in colour and have a hairy appearance
Excessive destruction of red blood cells, leading to a type of anaemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness, and yellowing of the skin and the white part of the eye
Reduction in the number of white blood cells
Reduction in the number of cells involved in blood clotting
Prolonged blood clotting time compared to normal. This effect may become apparent with nosebleeds or when sustaining a cut. Not known
- Skin rash with blisters arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (IgA linear disease)
- Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Reporting of side effects
If you experience 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 http://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 Amoxicillina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack. The expiry date refers to the last day of that month.
Dry powder
Keep in the original packaging to protect the medicine from moisture.
Liquid suspension
Once prepared, the suspension must be used within 7 days if stored at a temperature below 25°C.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine 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 Sandoz contains

Each 5 ml dose of suspension contains 250 mg of amoxicillin as the active substance.
The other components are: tutti-frutti flavour, sodium carmellose, sucrose, anhydrous colloidal silica, sodium benzoate.

Description of the appearance of Amoxicillina Sandoz and contents of the pack
Amoxicillina Sandoz 250 mg/5 ml powder for oral suspension is a white powder presented in amber glass bottles. The bottles are packed in a box together with a dosing spoon.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio (VA) - Italy
Manufacturer
MITIM S.r.l.
Via Cacciamali, 34/38
25125 Brescia
General recommendation on the use of antibiotics
Antibiotics are used to treat bacterial infections and have no effect against infections caused by viruses.
It may happen that a bacterial infection does not respond to a course of antibiotic therapy. Most often this is due to the fact that the bacteria causing the infection are resistant to the administered antibiotic and are therefore able to survive and multiply despite treatment.
There are several reasons why bacteria can become resistant to antibiotics. Correct use of antibiotics can help reduce the likelihood of bacteria developing resistance.
The prescription of an antibiotic course is intended solely to treat the current illness. By following the recommendations below, you can help prevent the development of resistant bacteria, which could undermine the effectiveness of antibiotic therapy.

It is very important that antibiotics are taken at the correct dose, at the right times, and for the prescribed number of days. It is important to read the instructions accompanying the medicine and, if they are difficult to understand, to ask your doctor or pharmacist for clarification.
Antibiotics should not be taken unless they have been specifically prescribed for you, and should only be used to treat the infection for which they were prescribed.
Do not take antibiotics prescribed for other people, even if the infection appears similar.
Do not give your prescribed antibiotics to other people.
If, after completing the treatment course as directed by your doctor, you have leftover antibiotic, it should be returned to a pharmacy for proper disposal.

Instructions for reconstitution
Check that the cap seal is intact before use.
Invert and shake the bottle to loosen the powder.
Fill the bottle with water up to just below the mark on the bottle.
Invert and shake thoroughly, then add more water up to the mark on the bottle. Invert and shake again.
Shake well before taking each dose.