Инструкция по применению SKOPOLAMINA BUTILBROMURO KALKEKS
Содержание инструкции
Scopolamina butilbromuro Kalceks 20 mg/ml injectable solution
joscine butylbromide
Generic medicine
Read this leaflet carefully before using 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, pharmacist or nurse.
- 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 may be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What Scopolamina butilbromuro Kalceks is and what it is used for
- 2. What you need to know before you receive Scopolamina butilbromuro Kalceks
- 3. How Scopolamina butilbromuro Kalceks is administered
- 4. Possible side effects
- 5. How to store Scopolamina butilbromuro Kalceks
- 6. Contents of the pack and other information
1. What is Scopolamina butilbromuro Kalceks and what is it used for
Scopolamina butilbromuro Kalceks contains the active ingredient butylscopolamine. It belongs to
a group of medicines called “antispasmodics”. These medicines provide relief from spasms
(cramplike contractions) of the internal organs and alleviate the associated spastic pain.
This medicine is used for the relief of spasms of the smooth muscles of the gastrointestinal and
genitourinary tract (stomach, intestines, bile ducts, pancreas and urinary tract).
Scopolamina butilbromuro Kalceks can also be used in medical diagnostic procedures.
2. What you need to know before you receive Scopolamina butilbromuro Kalceks
Do not use Scopolamina butilbromuro Kalceks
- if you are allergic to butylscopolamine or any of the other ingredients of this medicine (listed in section 6)
- if you have glaucoma (eye disease)
- if you have an enlarged prostate and find it difficult or painful to urinate
- if you have problems with intestinal blockage
- if you have an abnormally enlarged intestine (megacolon)
- if you have an increased heart rate
- if you have a condition called “myasthenia gravis” (characterized by extreme muscle weakness).
You should not be given an injection of butylscopolamine into the muscle if you are taking
medicines for the prevention of blood clots (blood thinners), as a hematoma (bruise) may occur.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before you are given
this medicine:
- if you have unexplained abdominal pain that persists or worsens, or that is accompanied by fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, low blood pressure, dizziness or blood in your stools
- if your intestines are no longer functioning properly (intestinal atony)
- if you have inflammation of the esophagus associated with reflux (this happens when stomach acids come back up and enter the esophagus)
- if you have a severe inflammation of the colon that recurs frequently (ulcerative colitis)
- if you have impaired liver or kidney function
- if you have an overactive thyroid (this gland produces too much thyroid hormone)
- if you have chronic bronchitis (inflammation of the bronchi).
You must see your doctor immediatelyif you experience eye pain and redness with
loss of vision after injection of butylscopolamine. This could be a sign of
high pressure inside the eye, due to acute angle-closure glaucoma that has not yet
been diagnosed and therefore not yet treated.
Allergic reactions have been observed after injection of butylscopolamine (see
section 4). Therefore, you will be monitored after injection of butylscopolamine and
will receive appropriate treatment if such reactions occur.
Other medicines and Scopolamina butilbromuro Kalceks
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This includes medicines obtained without a prescription and
herbal remedies.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- medicines for depression called “tricyclic antidepressants” or “tetracyclic antidepressants”
- medicines for the treatment of allergies (antihistamines)
- medicines for the treatment of mental illnesses
- medicines for the treatment of heart failure or asthma (beta-mimetics)
- medicines for the treatment of heart rhythm disorders (quinidine or disopyramide)
- amantadine (used to treat Parkinson's disease)
- medicines for the treatment of respiratory disorders (such as tiotropium, ipratropium, medicines similar to atropine)
- metoclopramide (used to treat nausea, vomiting or gastrointestinal disorders).
If you are not sure if any of the above applies to you, ask your doctor or pharmacist before
you are given this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding with
breast milk, ask your doctor for advice before receiving this medicine.
Pregnancy
Data on the use of the product in pregnant women and breastfeeding mothers are limited. Consequently, for safety reasons, the use of this medicine is not recommended during
pregnancy. During pregnancy, the use of the medicine is only possible after consulting a
doctor who will assess the benefit/risk ratio.
Breastfeeding
During breastfeeding, the use of the medicine is only possible after consulting a doctor who
will assess the benefit/risk ratio.
Driving and operating machinery
Some people may experience blurred vision or dizziness after treatment with this
medicine. If you experience these effects, wait until your vision returns to normal or the dizziness
stops before driving vehicles or operating machinery.
Scopolamina butilbromuro Kalceks contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially ‘sodium-free’.
3. How Scopolamina butilbromuro Kalceks is administered
Scopolamina butilbromuro Kalceks will be administered to you by a doctor or nurse as a
slow injection into a vein, a muscle, or under the skin. The dose will be determined by a doctor.
This medicine should not be used continuously every day, or for long periods of
time, without ascertaining the cause of the abdominal pain.
Adults and children over 12 years of age
The dose is 20 40 mg (1 2 vials) several times a day. The maximum daily dose is 100 mg (5 vials).
Use in children
In severe cases, in infants and children, a dose of 0.3 0.6 mg/kg of body weight can be used several
times a day. The maximum daily dose of 1.5 mg/kg of body weight must not be exceeded.
If you have been given too much Scopolamina butilbromuro Kalceks
If you think you have been given too much medicine, contact your doctor or
nurse immediately. The following symptoms may occur: dry mouth, flushed skin, difficulty urinating,
increased heart rate, and visual disturbances.
If you miss a dose of Scopolamina butilbromuro Kalceks
You will not receive a double dose to make up for a missed dose. You will receive the next dose only if
required based on your health condition.
If stopping the use of Scopolamina butilbromuro Kalceks
The doctor will administer an injection only in acute conditions. If it is necessary to continue the
treatment, the doctor will switch you to treatment with joscine butylbromide
tablets.
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.
Many of the side effects listed are attributable to the anticholinergic properties of
joscine butylbromide. Usually, the anticholinergic side effects of joscine butylbromide
are mild and transient.
The side effects are listed according to the following frequency convention:
Very common may affect more than 1 in 10 people
Common may affect up to 1 in 10 people
Uncommon may affect up to 1 in 100 people
Rare may affect up to 1 in 1,000 people
Very rare may affect up to 1 in 10,000 people
Not known frequency cannot be estimated from available data
Immune system disorders
Not known:anaphylactic shock (a severe, sudden allergic reaction that manifests with shortness of breath,
circulatory failure and swelling, including cases with fatal outcome, anaphylactic reactions, shortness
of breath, skin reactions (such as urticaria, rash, reddened skin, itching), other
hypersensitivity reactions.
Psychiatric disorders
Not known: mental confusion in the elderly, excitability, irritability.
Eye disorders
Common:accommodation disorder (difficulty focusing).
Not known:dilated pupils, increased pressure inside the eye, reduced tear secretion.
Cardiac disorders
Common:increased heart rate.
Not known: palpitations.
Vascular disorders
Common:dizziness.
Not known:low blood pressure, flushing.
Respiratory disorders
Not known: thickening of bronchial secretions.
Gastrointestinal disorders
Common:dry mouth.
Not known: constipation.
Skin and subcutaneous tissue disorders
Not known:impaired sweat secretion.
Renal and urinary disorders
Not known:difficulty urinating.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national 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 Scopolamina butilbromuro Kalceks
Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is reported on the cardboard box and on the vial
after Exp. The expiry date refers to the last day of that month.
Shelf life after opening the vial: the medicine must be used immediately.
Shelf life after dilution: chemical and physical stability during use has been demonstrated
for 24 hours at 25 ºC and at 2-8 ºC.
From a microbiological point of view, the medicine must be used immediately, unless the
opening/dilution method precludes the risk of microbial contamination. If not used
immediately, the storage times and conditions during use are the responsibility
of the user.
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 Scopolamina butilbromuro Kalceks contains
- The active ingredient is joscine butylbromide. Each vial (1 ml) contains 20 mg of joscine butylbromide.
- The other ingredients are sodium chloride, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.
Description of the appearance of Scopolamina butilbromuro Kalceks and contents of the pack
Injectable solution (injectable).
Clear, colorless or practically colorless solution, free from visible particles.
1 ml transparent Type I glass vials.
The vials are packaged in PVC blisters. The blisters are placed in a cardboard box.
Pack sizes: 5 or 10 vials
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AS KALCEKS
Krustpils iela 71E, Rīga, LV-1057, Latvia
Tel.: +371 67083320
E-mail: [email protected]
Manufacturer
AS “Kalceks”
Krustpils iela 71E, Rīga, LV-1057, Latvia
This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Czech Republic Butylscopolaminium bromid Kalceks
Austria Butylscopolaminiumbromid Kalceks 20 mg/ml Injektionslösung
Belgium Scopolamine butylbromide Kalceks 20 mg/ml solution injectable
Scopolamine butylbromide Kalceks 20 mg/ml oplossing voor injectie
Scopolamine butylbromide Kalceks 20 mg/ml Injektionslösung
Bulgaria Scopolamine butylbromide Kalceks 20 mg/ml injection solution
France SCOPOLAMIE BUTYLBROMURE KALCEKS 20 mg/mL, solution injectable
Italy Scopolamina butilbromuro Kalceks
Latvia Hyoscine butylbromide Kalceks 20 mg/ml šķīdums injekcijām
Norway Skopolaminbutylbromid Kalceks
Poland Scopolamine butylbromide Kalceks
Portugal Butilescopolamina Kalceks
Slovakia Scopolamine butylbromide Kalceks 20 mg/ml injekčný roztok
Spain Butilescopolamina Kalceks 20 mg/ml solución inyectable EFG
Sweden Hyoscine butylbromide Kalceks
Netherlands Scopolamine butylbromide Kalceks 20 mg/ml oplossing voor injectie
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The following information is intended only for healthcare professionals:
Route of administration
For intravenous, intramuscular or subcutaneous injection.
Instructions for use and handling
For single use only. Any unused portion must be discarded after opening.
The medicinal product must be visually inspected before use. Only clear solutions free from particles must be used.
Dilution can be carried out with dextrose or 0.9% sodium chloride solution for injection.
Instructions for opening the vial
- 1) Hold the vial with the colored dot facing upwards. If there is solution in the upper part of the vial, gently tap with your finger to allow all the solution to flow to the bottom.
- 2) Use both hands to open; holding the bottom of the vial with one hand, detach the top with the other in the opposite direction to the colored dot (see the following images).

Unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.

- Страна регистрации
- Форма выпускаInjectable solution, 20 MG/ML
- Код АТХA03BB01
- 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 SKOPOLAMINA BUTILBROMURO KALKEKSФорма выпуска: Coated tablet, 10 MGДействующее вещество: бутилбромид гиосцинаОтпускается без рецептаФорма выпуска: Suppository, 10 MGДействующее вещество: бутилбромид гиосцинаПроизводитель: OPELLA HEALTHCARE ITALY S.R.L.Отпускается без рецептаФорма выпуска: Coated tablet, 10 MGДействующее вещество: бутилбромид гиосцинаПроизводитель: AUROBINDO PHARMA (ITALIA) S.R.L.Отпускается без рецепта
Аналоги SKOPOLAMINA BUTILBROMURO KALKEKS в других странах
Лекарства с тем же действующим веществом, доступные в других странах.
Аналог SKOPOLAMINA BUTILBROMURO KALKEKS в Польша
Аналог SKOPOLAMINA BUTILBROMURO KALKEKS в Украина
Аналог SKOPOLAMINA BUTILBROMURO KALKEKS в Испания
Врачи онлайн по SKOPOLAMINA BUTILBROMURO KALKEKS
Обсудите применение SKOPOLAMINA BUTILBROMURO KALKEKS и возможные следующие шаги — по оценке врача.
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Заполните форму за 2 минуты
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Получите в любой аптеке
Электронный рецепт отправляется на вашу почту — действителен по всей Польше.
Часто задаваемые вопросы
SKOPOLAMINA BUTILBROMURO KALKEKS требует рецепта в Италия. Вы можете уточнить у врача онлайн, подходит ли это лекарство для вашей ситуации.
Действующее вещество SKOPOLAMINA BUTILBROMURO KALKEKS — бутилбромид гиосцина. Эта информация помогает определить лекарства с тем же составом под другими торговыми названиями.
SKOPOLAMINA BUTILBROMURO KALKEKS производится компанией AS KALCEKS. 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 SKOPOLAMINA BUTILBROMURO KALKEKS 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 SKOPOLAMINA BUTILBROMURO KALKEKS 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 (бутилбромид гиосцина) включают ADDOFIX, BUSKOPAN, BUTILSKOPOLAMINA AUROBINDO. Они могут отличаться торговым названием или формой выпуска, но содержат одинаковый терапевтический компонент. Перед изменением лечения рекомендуется проконсультироваться с врачом.
















