Scopolamine butylbromide kalceks

Package leaflet: Information for the user

Scopolamine butylbromide Kalceks, 20 mg/ml, solution for injection
Hyoscini butylbromidum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist or nurse immediately. See section 4.

Table of contents

1. What Scopolamine butylbromide Kalceks is and what it is used for
2. Important information before using Scopolamine butylbromide Kalceks
3. How to use Scopolamine butylbromide Kalceks
4. Possible side effects
5. How to store Scopolamine butylbromide Kalceks
6. Contents of the pack and other information

1. What Scopolamine butylbromide Kalceks is and what it is used for

Scopolamine butylbromide Kalceks contains the active substance hyoscine butylbromide. It belongs to a group of medicines called "antispasmodics". These medicines reduce muscle tension (spasms) in internal organs and relieve associated spastic pain.
This medicine is used to relieve spasms of smooth muscles in the gastrointestinal tract and the genitourinary system (stomach, intestines, bile ducts, pancreas and urinary tract).
Scopolamine butylbromide Kalceks may also be used during diagnostic medical procedures.

2. Important information before using Scopolamine butylbromide Kalceks

When not to use Scopolamine butylbromide Kalceks

• if the patient is allergic to scopolamine butylbromide or any of the other ingredients of this medicine (listed in section 6);
• if the patient has glaucoma (an eye disease);
• if the patient has benign prostatic hyperplasia and experiences difficulty or pain when passing urine;
• if the patient has intestinal obstruction;
• if the patient has abnormally enlarged intestine (colonic dilation);
• if the patient has a rapid heartbeat;
• if the patient has a condition called myasthenia gravis (characterized by extreme muscle weakness).

Do not administer an injection of scopolamine butylbromide into the muscle if the patient is taking medicines that prevent blood clotting (anticoagulant medicines), as bruising (haematomas) may occur.

Warnings and precautions

Before starting treatment with this medicine, discuss with your doctor, pharmacist or nurse:

• if the patient has abdominal pain of unknown cause that persists or worsens, or occurs with fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, low blood pressure, feeling of weakness, or blood in the stool;
• if the patient's intestines are no longer functioning properly (intestinal atony);
• if the patient has inflammation of the oesophagus associated with reflux (when stomach acid flows back into the oesophagus);
• if the patient has severe, frequently recurring inflammation of the large intestine (ulcerative colitis);
• if the patient has impaired liver or kidney function;
• if the patient has hyperthyroidism (the thyroid gland produces too many hormones);
• if the patient has chronic bronchitis (inflammation of the bronchioles).

The patient should seek immediate medical advice if, after injection of scopolamine butylbromide, painful redness of the eye with loss of vision occurs. This may indicate increased intraocular pressure due to previously undiagnosed and therefore untreated narrow-angle glaucoma.

Allergic reactions have been observed after administration of scopolamine butylbromide. Therefore, the patient will be monitored after the injection, and appropriate treatment will be provided if such reactions occur.

Scopolamine butylbromide Kalceks and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This includes also medicines taken without prescription and herbal medicines.

In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• antidepressant medicines known as "tricyclic antidepressants" or "tetracyclic antidepressants";
• medicines used to treat allergies (antihistamines);
• medicines used to treat psychiatric disorders;
• medicines used to treat heart failure or asthma (beta-agonists);
• medicines used to treat heart rhythm disorders (quinidine or disopyramide);
• amantadine (a medicine used to treat Parkinson's disease);
• medicines used to treat breathing disorders (such as tiotropium, ipratropium, anticholinergic-like medicines);
• metoclopramide (a medicine used to treat nausea, vomiting or gastrointestinal disorders).

If the patient is unsure whether any of the above apply, talk to a doctor or pharmacist before using this medicine.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor before using this medicine.

Pregnancy

Data on the use of this medicine in pregnant and breastfeeding women are limited. Therefore, for safety reasons, the use of this medicine during pregnancy is not recommended. During pregnancy, this medicine may be used only under the supervision of a doctor who will assess the benefit-risk ratio.

Breastfeeding

During breastfeeding, this medicine may be used only under the supervision of a doctor who will assess the benefit-risk ratio.

Driving and operating machinery

In some patients, treatment with this medicine may cause visual disturbances or dizziness. If these symptoms occur, the patient should wait until vision returns to normal or dizziness resolves before driving or operating machinery.

Scopolamine butylbromide Kalceks contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Scopolamine butylbromide Kalceks

Scopolamine butylbromide Kalceks will be administered to the patient by a doctor or nurse as a slow intravenous, intramuscular or subcutaneous injection. The dosage will be determined by the doctor.
This medicine should not be used continuously, daily or for prolonged periods without investigating the cause of abdominal pain.
Adults and children over 12 years of age
The recommended dose is 20–40 mg (1–2 ampoules) several times a day. The maximum daily dose is 100 mg (5 ampoules).
Use in children
In severe cases, infants and children may be given a dose of 0.3–0.6 mg/kg body weight several times a day. The maximum daily dose of 1.5 mg/kg body weight must not be exceeded.
Use of a higher than recommended dose of Scopolamine butylbromide Kalceks
If the patient suspects that too much medicine has been administered, they should immediately consult a doctor or nurse. The following symptoms may occur: dry mouth, skin redness, difficulty in urinating, increased heart rate and visual disturbances.
Missed dose of Scopolamine butylbromide Kalceks
Do not use a double dose to make up for a missed dose. The next dose should be given only if required due to the patient's clinical condition.
Discontinuation of Scopolamine butylbromide Kalceks
The doctor will decide to administer this medicine by injection only in acute conditions. If continued treatment is necessary, the doctor will recommend using hyoscine butylbromide tablets.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Many of the adverse reactions listed can be attributed to the anticholinergic properties of
butylbromide scopolamine. Anticholinergic adverse effects of butylbromide scopolamine are usually
mild and transient.
The following classification has been used to define the frequency of adverse reactions:
Very common: may affect more than 1 in 10 patients
Common: may affect up to 1 in 10 patients
Uncommon: may affect up to 1 in 100 patients
Rare: may affect up to 1 in 1,000 patients
Very rare: may affect up to 1 in 10,000 patients
Frequency not known: cannot be estimated from the available data

Immune system disorders
Frequency not known: anaphylactic shock (sudden, severe allergic reaction characterized by
breathing difficulties, circulatory failure, and swelling, including cases resulting in death),
anaphylactic reactions, dyspnea, skin reactions (e.g. urticaria, rash, erythema, pruritus), other hypersensitivity reactions.

Psychiatric disorders
Frequency not known: confusion in elderly patients, restlessness, irritability.

Eye disorders
Common: accommodation disorders (focusing problems) of the eye.
Frequency not known: pupil dilation, increased intraocular pressure, reduced tear secretion.

Cardiac disorders
Common: increased heart rate.
Frequency not known: palpitations.

Vascular disorders
Common: dizziness.
Frequency not known: hypotension, skin flushing.

Respiratory system disorders
Frequency not known: thickening of bronchial secretions.

Gastrointestinal disorders
Common: dry mouth.
Frequency not known: constipation.

Skin and subcutaneous tissue disorders
Frequency not known: impaired sweating.

Renal and urinary disorders
Frequency not known: difficulty in urination.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse.
Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Scopolamine butylbromide Kalceks

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this medicine.
Do not use this medicine after the expiry date stated on the cardboard packaging
and ampoule after: "Expiry date (EXP)" and on the ampoule after: "EXP". The expiry date refers to the last
day of the stated month.
Period of use after opening the ampoule: The medicine should be used immediately.
Period of use after dilution: Chemical and physical stability has been demonstrated for 24 hours
at 25°C and at 2-8°C.
From a microbiological point of view, unless the method of opening/dilution excludes the risk of
microbiological contamination, the medicine should be used immediately. If not used immediately,
the user is responsible for the storage duration and conditions prior to use.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Scopolamine butylbromide Kalceks contains

• The active substance is hyoscine butylbromide. Each ampoule (1 ml) contains 20 mg of hyoscine butylbromide.
• The other components are sodium chloride, hydrochloric acid concentrated (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

What Scopolamine butylbromide Kalceks looks like and contents of the pack
Injection solution (liquid for injection).
A clear, colourless or almost colourless solution free from visible particles.
Ampoules made of colourless glass of type I with a capacity of 1 ml.
The ampoules are packed in PVC blisters. The blisters are packed in a cardboard box.
Pack sizes: 5 or 10 ampoules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
AS KALCEKS
Krustpils iela 71E
LV-1057 Rīga
Latvia
Tel.: +371 67083320
E-mail: [email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic Butylskopolaminium 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 SCOPOLAMINE 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

Information intended exclusively for medical professionals:

Administration method
For intravenous, intramuscular or subcutaneous injection.
Instructions for use and disposal
For single use only. After opening, any unused portions must be discarded.
The medicinal product should be inspected visually before use. Only clear, particle-free solution should be administered.
It may be diluted with glucose or 0.9% sodium chloride for injection.

Instructions for opening the ampoule

1. Turn the ampoule with the coloured dot facing upwards. If there is solution in the upper part of the ampoule, gently tap with a finger to move all the solution to the lower part.
2. Use both hands to open the ampoule; hold the lower part of the ampoule in one hand and, with the other hand, snap off the top part of the ampoule away from the coloured dot (see image below).

Any unused portions of the medicinal product or waste materials must be disposed of in accordance with local regulations.