SIEVERT 1 G Soluble tablet

Зміст інструкції

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

SIEVERT 1 g soluble tablets

Amoxicillin
Generic Medicine

Read 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 (or for your child) only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even 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 you take 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 is Sievert and what is it used for

What is Sievert
Sievert is an antibiotic. Its active ingredient, called amoxicillin, belongs to a group of
medicinal substances known as “penicillins”.

What is Sievert used for
Sievert is used to treat infections caused by bacteria in different parts of the body. Sievert can
also be used in association 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 had an allergic reaction to any antibiotic in the past. This also includes a skin rash or the development of swelling of the face or throat.

Do not take Sievert if you recognise yourself in any of the situations above. If you have any doubts,
ask your doctor or pharmacist before taking Sievert.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sievert if:

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

If you are unsure whether any of the points above apply to you, ask your doctor or
pharmacist before taking Sievert.

Blood and urine tests
If you are undergoing:

• urine tests (for glucose) or blood tests to check liver function
• tests for oestriol (used in pregnancy to check the normal development of the foetus) tell your doctor or pharmacist that you are taking Sievert, as this medicine may alter the results of these tests.

Other medicines and Sievert
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

• If you are taking allopurinol (a medicine used to treat gout) together with Sievert, you may be more likely to develop 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 clotting (e.g. warfarin) you may need to have 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 to become pregnant, or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Sievert can cause side effects whose symptoms (such as allergic reactions, dizziness and
convulsions) may interfere with the ability to drive vehicles. Do not drive vehicles and do not operate
machinery if you do not feel well.

3. How to take Sievert

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask 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.

The usual dose is:

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

• Your doctor will tell you how much Sievert to give to your child.
• The usual dose ranges from 40 mg to 90 mg per kilogram of body weight per day, to be administered in two or three separate 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:from 750 mg to 1 g three times a day.
• Urinary tract infection:3 g twice a day for one day.
• Lyme disease (infection caused by a parasite called a tick): isolated erythema migrans (early stage - circular reddish or rosy skin rash): 4 g per day, systemic manifestations (late stage - when more severe symptoms are present or when the disease spreads to other parts of the body): up to 6 g per day.
• Gastric ulcers:a dose of 750 mg or a dose of 1 g twice a day for 7 days together with other antibiotics and medicines for the treatment of gastric ulcers.
• Prevention of cardiac infections during surgery:the dose will vary depending on the type of surgery. Other medicines may also be administered at the same time. Your doctor, pharmacist or nurse will provide you with more detailed information.
• The maximum recommended dose is 6 g per day.

Kidney problems
If you have kidney problems, the dose may be lower than usual.

If you take more Sievert than you should
If you take an excessive amount of Sievert, symptoms such as gastrointestinal disorders (nausea, vomiting or diarrhea) or the presence of crystals in the urine, with possible clouding of the urine, or problems with urination may appear. Seek medical attention as soon as possible, bringing 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 soon, wait about 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 to take Sievert for the time indicated by your doctor, even if you feel better. To fight the infection, it is necessary to take all the prescribed doses. The infection may return if some bacteria survive.
• If, once the treatment is finished, you continue to feel unwell, consult your doctor again.

The use of Sievert for long periods can lead to the development of candidiasis (an infection caused by a yeast that affects the moist areas of the body, causing irritation, itching and whitish discharge). If this happens, consult your doctor.
If you take Sievert for long periods, your doctor may perform additional tests to check that everything is normal with your kidneys, liver and blood.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Sievert and consult your doctor immediately if you notice any of the following serious side effects, as urgent medical treatment may be needed:
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 difficulty breathing. These effects can be severe and, in some cases, have been fatal
• rash or the appearance of small, pinpoint, round and flat, reddish spots under the skin surface, or skin bruising. This is due to inflammation of the blood vessel walls due to an allergic reaction. It may be accompanied by joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur, usually 7-12 days after taking Sievert, accompanied by signs such as rash, fever, joint pain and swollen lymph nodes, especially those under the arm
• a skin reaction defined as “erythema multiforme”, with itchy, reddish-purple patches on the skin, especially 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. It may be accompanied by fever and a feeling of extreme fatigue
• other serious skin reactions may include changes in skin color, formation of bumps under the skin, appearance of blisters, pustules, exfoliation, redness, pain, itching and scaling, and may be associated with fever, headache and widespread pain
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (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. These may be signs of a blood cell problem
• the Jarisch-Herxheimer reaction, which may occur during the treatment of Lyme disease with Sievert, causing fever, chills, headache, muscle pain and rash
• inflammation of the large intestine (colon) with diarrhea (sometimes containing blood), pain and fever
• serious liver effects may occur, observed mainly in subjects treated for long periods, in men and in the elderly. Inform your doctor urgently if you notice the appearance of: o severe diarrhea with bleeding o blisters, redness or bruising of the skin o dark urine o pale stools o yellowing of the skin or the white of the eye (jaundice). See also the entry on anemia 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 consult your doctor immediately.
Sometimes less serious skin reactions may occur, such as:

• a slightly itchy rash (pinkish-reddish round patches), localized swelling similar to hives on 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 are:

Common(may affect up to 1 in 10 people)

• rash
• nausea
• diarrhea.

Uncommon(may affect up to 1 in 100 people)

• vomiting.

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

• candidiasis (infection of the vagina, mouth or skin folds caused by a yeast); your doctor or pharmacist will prescribe appropriate treatment
• kidney problems
• seizures, observed in patients treated with high doses or with kidney problems
• dizziness
• hyperactivity
• crystals may form in the urine, with possible clouding of the 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 black and have a hairy appearance
• excessive destruction of red blood cells, responsible for causing a type of anemia. Signs include: fatigue, headache, shortness of breath, dizziness, paleness and yellowing of the skin and the white of the eye
• decreased number of white blood cells
• decreased number of cells involved in blood clotting
• increased time required for blood to clot compared to normal. This effect may be noticed in case of nosebleeds or if you get a cut.

Reporting of side effects
If you get any side effects, even those not listed in this
leaflet, tell your doctor or pharmacist. You can also report side effects
directly through 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.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store this medicine at a temperature above 25°C.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sievert contains

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

Description of the appearance of Sievert and contents of the pack
Sievert 1 g tablets are presented in the form of oval, white tablets
The tablets are packaged in blisters contained in a box of 12 tablets.

Marketing Authorisation Holder:
TECNOPHARMA SRL Via Sestri 29 A/3 - 16154 Genova – Italy

Manufacturer:
LA.FA. RE. S.r.l., Via Sac. Benedetto Cozzolino, 77 - 80056 Ercolano (Napoli)
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 of the
time this is due to the fact that the bacteria responsible for the infection are resistant to the antibiotic
administered and are therefore able to survive and proliferate despite the treatment.
There are various reasons why bacteria can become resistant to antibiotics. Correct use
of antibiotics can help reduce the likelihood that bacteria will develop resistance. The
prescription of a course of antibiotics is intended to treat only the current illness.
By following the advice below, you will help prevent the development of resistant bacteria that
could negate 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, ask your doctor or pharmacist for clarification.
• 2. Antibiotics should not be taken if they have not been specifically prescribed for you and should be used only to treat the infection for which they have been prescribed.
• 3. You should not take antibiotics prescribed to other people, even if the infection seems similar.
• 4. You should not give antibiotics prescribed to you to other people.
• 5. If, once the treatment course according to the doctor's instructions is completed, there is any unused antibiotic remaining, this must be taken to the pharmacy for correct disposal.