BALZIDE 750 mg Капсулы Твердые
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Инструкция по применению BALTSIDE
Содержание инструкции
Balzide 750 mg hard capsules
Balsalazide disodium
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 pass it on to others, even if they have the same symptoms as you, 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 Balzide is and what it is used for
- 2. What you need to know before you take Balzide
- 3. How to take Balzide
- 4. Possible side effects
- 5. How to store Balzide
- 6. Contents of the pack and other information
1. What is Balzide and what is it used for
Balzide is a medication capable of releasing a substance called mesalazine, which acts as an
intestinal anti-inflammatory with a local action on the inner lining (mucosa) of the large
intestine (colon).
Ulcerative colitis is a disease characterized by inflammation of the mucous membranes of the large
intestine (colon) and rectum. Balzide acts locally reducing inflammation (treatment in the active phase).
After the disappearance of symptoms, Balzide can be used to prevent further flare-ups of
symptoms (maintenance phase treatment).
Balzide 750 mg capsules are used in the treatment of ulcerative colitis, of mild or
moderate severity, both in the active phase and as maintenance therapy.
Balzide is indicated for adults.
2. What you need to know before taking Balzide
Do not take Balzide:
- if you are allergic to balsalazide or mesalazine or any of the excipientsof this medicine (listed in section 6).
- if you are allergic (hypersensitive) to acetylsalicylic acid and its derivatives.
- if you are pregnant or breastfeeding.
- if you suffer from moderate or severe kidney disorders
- if you suffer from severe liver disorders
Warnings and precautions
Talk to your doctor or pharmacist before taking Balzide if:
you have liver diseases or mild kidney problems.
you suffer from asthma
you experience bleeding
you have an active peptic ulcer
If any of these conditions apply to you, inform your doctor before taking Balzide.
Liver, kidney and blood tests
Before starting treatment with Balzide, it will be necessary to perform urine and blood tests in
order to assess the functioning of your kidneys and any signs of blood alterations. During the
treatment, the doctor will periodically analyze blood and urine samples in order to monitor the
functioning of the liver, kidneys and blood.
Immediately stop treatment if you suspect a blood alteration, based on the results
of the blood test or for the presence of symptoms that may include, for example, one or more of the
following: unexplained bleeding, bruising, sore throat, fever, malaise or reddish/pustular spots
on the skin (purpura).
Children and adolescents (under 18 years of age)
The use of Balzide is not recommended in children.
Other medicines and Balzide
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those without a prescription.
The effect of the treatment may be affected by other medicines, if taken together with Balzide. It may
be necessary to reduce the dosage, take other precautions or, in some cases, stop taking
one of the medicines. This applies to any medicine, even those without a prescription,
especially:
digitalis (digoxin), a medicine for the heart, whose levels in the blood may be reduced in
methotrexate, a medicine used to treat some forms of arthritis, tumors and psoriasis, the
elimination of which by the kidney may be reduced in patients undergoing concomitant treatment with
Balzide
Balzide with food and drink
Balzide should be taken with a full stomach.
Pregnancy and breastfeeding
Do not take Balzide during pregnancy and breastfeeding.
Driving and using machines
No relevant effects of Balzide are known
3. How to take Balzide
Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Ulcerative colitis – Treatment in the active phase:the dose is 3 capsules of Balzide (2.25 grams) 3
times a day (6.75 grams/day) until the disappearance of symptoms or for a maximum of 12 weeks. If
necessary, corticosteroids may be administered simultaneously
Ulcerative colitis – Maintenance treatment phase:the recommended initial dose is 2
capsules of Balzide (1.5 grams) 2 times a day (3 grams/day). There may be further benefit
using a dose of up to 8 capsules per day (6 grams).
Elderly
Balzide can also be used by people aged 65 years or older without any adjustment
of the dosage.
happens, ask your doctor for further explanation.
Make sure to drink enough fluids while taking the medicine to maintain
hydration, especially after severe or prolonged episodes of vomiting and/or diarrhea, high fever or heavy
sweating. This is to avoid kidney problems.
Balzide capsules must be swallowed whole with a full stomach.
If you take more Balzide than you should
If you have taken too many capsules, contact your doctor, pharmacist or hospital immediately.
If you forget to take Balzide
Do not take a double dose to make up for the missed dose.
If you stop taking Balzide
Stopping treatment with Balzide may worsen your condition. Do not
stop using the medicine unless advised by your doctor.
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 treatment and immediately inform your doctor if:
- you experience allergic reactions such as skin redness (skin rashes), breathing difficulties (bronchospasm), allergic pneumonia (with symptoms including shortness of breath, dyspnea, and dry cough accompanied by chills, sweating and pain)
- you have blood disorders with symptoms such as unexplained bleeding, bruising, spots/pustules on the skin (purpura), sore throat, fever, malaise or if you have changes in blood tests indicating blood alterations (decrease in white blood cells, red blood cells and platelets)
- you have skin signs such as facial redness with skin peeling, pain and redness of the inner mucous membrane of the mouth (lupus erythematosus-like syndrome)
The most common side effects are:
- headache
- gastrointestinal disorders (abdominal pain, diarrhea, nausea and vomiting)
Less frequently, the following have been reported:
- gallstones
- worsening of colitis symptoms (e.g. drastic change in bowel movement frequency, watery diarrhea with blood, mucus and/or pus)
- kidney inflammation (nephritis) with fever, increased urine output, cloudy urine or with traces of blood, abdominal pain and fatigue as possible symptoms
- pancreas inflammation (acute pancreatitis) with nausea, vomiting, fever, sweating and yellowing of the skin as possible symptoms
- liver inflammation (hepatitis) with fatigue, fever, loss of appetite, nausea or vomiting, muscle and joint pain, yellowing of the skin and eyes as possible symptoms
- heart inflammation (myocarditis and pericarditis) with chest pain, palpitations, fatigue, difficulty breathing as possible symptoms
- joint pain
- muscle pain
- peripheral nerve disorders (neuropathy) for example with a sensation of tingling or burning, pain and numbness
- hair loss
If any of these side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at the address: www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Balzide
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 packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Store in the original packaging.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in 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 Balzide contains
- The active ingredient is balsalazide disodium 750 mg corresponding to balsalazide 612.8 mg and mesalazine 262.5 mg.
- The excipients are:
- Capsule content: magnesium stearate, anhydrous colloidal silica
- Capsule shell: gelatin, shellac, black iron oxide (E172), titanium dioxide (E171), indigotine (E132)
Description of the appearance of Balzide and package contents
Balzide are white and blue gelatin capsules. The capsules are available in polyethylene bottles,
equipped with a screw cap with child-resistant safety closure, containing 56, 112, 130, 224 (2x112), 260 (2x130), 672 (6x112) and 780 (6x130) capsules.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A. - 1, Avenue de la Gare, L-1611 Luxembourg.
Sales representative: Malesci Istituto Farmacobiologico S.p.A., Via Lungo l’Ema, 7, Bagno a
Ripoli - Florence.
Manufacturer
Doppel Farmaceutici s.r.l., Via Volturno, 48, Quinto De Stampi – Rozzano (Milan)
- A. Menarini Manufacturing Logistics & Services s.r.l., Campo di Pile, L’Aquila.
This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
United Kingdom: Balzide
Italy: Balzide
For further information on this medicine, contact the marketing authorisation holder.
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- Страна регистрации
- Форма выпускаHard capsule, 750 MG
- Код АТХA07EC04
- Действующее вещество
- Отпускается по рецептуДа
- Производитель
- Информация на этой странице носит справочный характер и не является медицинской консультацией. Перед началом приема лекарства обязательно проконсультируйтесь с врачом.
- Аналоги BALTSIDEФорма выпуска: Enteric-coated tablet, 400 MGДействующее вещество: месалазинаПроизводитель: DICOFARM S.P.A.Отпускается по рецептуФорма выпуска: Enteric-coated tablet, 400 MGДействующее вещество: месалазинаПроизводитель: GIULIANI SPAОтпускается по рецептуФорма выпуска: Rectal suspension, 2 GДействующее вещество: месалазинаПроизводитель: CHIESI FARMACEUTICI S.P.A.Отпускается без рецепта
Аналоги BALTSIDE в других странах
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Аналог BALTSIDE в Испания
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Часто задаваемые вопросы
BALTSIDE требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество BALTSIDE — balsalazide. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
BALTSIDE производится компанией MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.. Упаковка и торговое название могут отличаться в зависимости от дистрибьютора.
Врачи, включая Семейные врачи, Психиатры, Дерматологи, Кардиологи, Эндокринологи, Гастроэнтерологи, Пульмонологи, Нефрологи, Ревматологи, Гематологи, Инфекционисты, Аллергологи, Гериатры, Педиатры, Онкологи, могут оценить целесообразность применения BALTSIDE с учетом вашей ситуации и местных правил. Вы можете записаться на онлайн-консультацию, чтобы обсудить возможные варианты.
Польша имеет хорошо развитую систему здравоохранения в крупных городах, таких как Варшава, Краков, Вроцлав и Гданьск. Аптеки широко доступны и работают в соответствии с действующим законодательством, обеспечивая доступ к рецептурным препаратам.
Вы можете купить BALTSIDE в Варшаве, Кракове, Вроцлаве или Гданьске в любой аптеке при наличии действующего рецепта.
Чтобы получить рецепт, вы можете воспользоваться Oladoctor:
Другие лекарства с тем же действующим веществом (balsalazide) включают ARGONAL, ASAKOL, ASALEX. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
