Sievert

Package leaflet: Information for the user

SIEVERT 1 g dispersible tablets

Amoxicillin
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 (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 effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Sievert is and what it is used for

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

2. What you need to know before taking Sievert

Do not take Sievert:

• 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 includes skin rash or development of swelling of the face or throat.

Do not take Sievert if any of the above situations apply to you. If you have any doubts,
consult your doctor or pharmacist before taking Sievert.
Warnings and precautions
Consult your doctor or pharmacist before taking Sievert 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 above points apply to you, consult your doctor or
pharmacist before taking Sievert.
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 monitor normal fetal development),
  inform your doctor or pharmacist that you are taking Sievert, as this medicine may alter the results of these tests.

Other medicines and Sievert
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 Sievert, you may have a higher risk of developing an allergic skin reaction.
• If you are taking probenecid (a medicine used to treat gout), your doctor may decide to adjust the dose of Sievert.
• If you are taking medicines to reduce blood clot formation (e.g., warfarin), you may need additional blood tests.
• If you are taking other antibiotics (e.g., tetracyclines), the effectiveness of Sievert may be reduced.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), Sievert may cause an increase in side effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Sievert may cause side effects whose symptoms (such as allergic reactions, dizziness, and
seizures) could impair your ability to drive. Do not drive or operate machinery if you do not feel well.

3. How to take Sievert

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

• Add the tablet to a glass of water and stir until completely dissolved. Then drink immediately.
• Take the doses at regular intervals throughout the day, at least 4 hours apart.

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

• Your doctor will tell you how much Sievert to give your child.
• The usual dose is 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
The usual dose of Sievert is 250–500 mg three times a day or 750 mg–1 g every 12 hours, depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g three times a day.
• Urinary tract infections: 3 g twice a day for one day.
• Lyme disease (infection caused by a parasite called tick): isolated erythema migrans (early stage – circular reddish or pinkish skin rash): 4 g per day; systemic manifestations (late stage – with more severe symptoms or when the disease spreads to other parts of the body): up to 6 g per day.
• Gastric ulcers: one 750 mg dose or one 1 g dose twice daily for 7 days, together with other antibiotics and medicines for treating gastric ulcers.
• Prevention of heart infections during surgical procedures: the dose will vary depending on the type of surgery. Other medicines may also be administered simultaneously. Your doctor, pharmacist, or nurse will provide more detailed information.
• The maximum recommended dose is 6 g per day.

Kidney problems
If you have kidney problems, your dose may be lower than usual.
If you take more Sievert than you should
If you take too much Sievert, symptoms such as gastrointestinal disturbances (nausea, vomiting, or diarrhoea) or presence of crystals in the urine may occur, possibly causing cloudy urine or difficulty urinating. Contact your doctor as soon as possible, and bring the medicine with you to show it.

If you forget to take Sievert

• If you forget 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 a forgotten dose.

How long should you take Sievert?

• Continue taking Sievert for the length of time prescribed by your doctor, even if you feel better. It is necessary to take all prescribed doses to fight the infection. The infection may return if some bacteria survive.
• If you still do not feel well after completing the treatment, consult your doctor again.

Long-term use of Sievert may lead to the development of candidiasis (a fungal infection caused by yeast affecting moist areas of the body, causing irritation, itching, and whitish discharge). If this occurs, consult your doctor.
If you take Sievert for a prolonged period, your doctor may carry out additional tests to monitor your kidneys, liver, and blood.
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 everyone will experience them.
Stop taking Sievert and consult a doctor immediately if you notice any of the following serious
side effects, as urgent medical treatment may be required:
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 reactions 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 accompanied by joint pain (arthritis) and kidney problems
• a delayed allergic reaction, usually occurring 7–12 days after taking Sievert, accompanied by symptoms such as skin rash, fever, joint pain and swollen lymph nodes, particularly those 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 hive-like skin swelling, 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 serious skin reactions may include changes in skin colour, formation of lumps under the skin, appearance of blisters, pustules, peeling, redness, pain, itching and shedding, and may be associated with fever, headache and widespread body aches
• 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)
• 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 Sievert, causing fever, chills, headache, muscle pain and skin rash
• inflammation of the large intestine (colon) with diarrhoea (sometimes containing blood), abdominal pain and fever
• severe liver-related side effects, mainly observed in patients undergoing long-term treatment, in men and in elderly people. Contact 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 effects occur, stop taking the medicine and contact your doctor immediately.
Less severe skin reactions may sometimes occur, such as:

• a slightly itchy rash (roundish pinkish-red patches), localized swelling resembling 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, consult your doctor, as treatment with Sievert will need to be stopped.
Other possible side effects include:
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 who have kidney problems
• dizziness
• hyperactivity
• presence of crystals in the urine, possibly causing cloudy urine, difficulty urinating or discomfort during urination. Make sure you drink plenty of fluids to reduce the risk of developing these symptoms
• teeth may appear stained, but usually regain their normal appearance with brushing (this effect has been reported 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
• decreased number of white blood cells
• decreased number of cells involved in blood clotting
• prolonged blood clotting time compared to normal. This effect may become noticeable in case of nosebleeds or cuts.

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
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 Sievert

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store this medicine above 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Sievert contains

• Each tablet contains 1 g of amoxicillin as the active substance.
• The other ingredients are: microcrystalline cellulose, crospovidone, sodium lauryl sulfate, magnesium stearate, sodium saccharin, strawberry flavor

Description of the appearance of Sievert and package contents
Sievert 1 g tablets are white, oval-shaped tablets.
The tablets are packaged in blisters, packed in a box containing 12 tablets.
Marketing Authorization Holder:
TECNOPHARMA SRL Via Sestri 29 A/3 - 16154 Genoa – Italy
Manufacturer:
LA.FA. RE. S.r.l., Via Sac. Benedetto Cozzolino, 77 - 80056 Ercolano (Naples)
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 prescribed antibiotic,
and thus are 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.
A prescribed course of antibiotics is intended solely to treat the current illness.
By following the recommendations below, you can help prevent the development of resistant bacteria,
which could otherwise undermine the effectiveness of antibiotic therapy.

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