Scopolamine butilbromide Kalceks

Package Leaflet: Information for the User

Scopolamine butylbromide Kalceks, 20 mg/ml, Solution for Injection

Hyoscine butylbromide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Contents of the Package Leaflet

• 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 the tension (spasms) of internal organs and the associated spastic pain.

This medicine is used to relieve spasms of smooth muscles in the gastrointestinal and urinary tracts (stomach, intestines, bile ducts, pancreas, and urinary tract).

Scopolamine butylbromide Kalceks may also be used in medical diagnostic procedures.

2. Important information before using Scopolamine butylbromide Kalceks

When not to use Scopolamine butylbromide Kalceks

• if you are allergic to hyoscine butylbromide or any of the other ingredients of this medicine (listed in section 6);
• if you have glaucoma (eye disease);
• if you have prostate enlargement and experience difficulty or pain when urinating;
• if you have intestinal obstruction;
• if you have a condition called 'megacolon' (enlarged colon);
• if you have a rapid heart rate;
• if you have a condition called 'myasthenia gravis' (characterized by extreme muscle weakness).

Do not inject hyoscine butylbromide into a muscle if you are taking medicines to prevent blood clotting (blood thinners), as this may cause bruising.

Warnings and precautions

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

• if you have abdominal pain of unknown cause, which 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 your intestines are not working properly (intestinal atony);
• if you have esophageal inflammation associated with reflux (when stomach acid flows back into the esophagus);
• if you have severe ulcerative colitis (which often recurs);
• if you have impaired liver or kidney function;
• if you have hyperthyroidism (your thyroid gland produces too many thyroid hormones);
• if you have chronic bronchitis (inflammation of the bronchi).

You should immediately consult a doctorif, after injection of hyoscine butylbromide, you experience painful eye redness with vision loss. This may indicate increased pressure within the eye due to previously undiagnosed and untreated glaucoma with a narrow angle.

After injection of hyoscine butylbromide, allergic reactions have been observed (see section 4). Therefore, after injection of hyoscine butylbromide, you will be monitored and, if such reactions occur, treated accordingly.

Scopolamine butylbromide Kalceks and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• antidepressant medicines called 'tricyclic' or 'tetracyclic' antidepressants;
• medicines used to treat allergies (antihistamines);
• medicines used to treat mental disorders;
• medicines used to treat heart failure or asthma (beta-mimetics);
• medicines used to treat irregular heart rhythms (quinidine or disopyramide);
• amantadine (a medicine used to treat Parkinson's disease);
• medicines used to treat respiratory disorders (such as tiotropium, ipratropium, atropine-like medicines);
• metoclopramide (a medicine used to treat nausea, vomiting, or gastrointestinal disorders).

If you are unsure whether any of the above applies to you, talk to your doctor or pharmacist before using this medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Pregnancy

Data on the use of the medicine in pregnant women are limited. Therefore, for safety reasons, the use of this medicine is not recommended during pregnancy. During pregnancy, the medicine should only be used on the advice of a doctor who will weigh the benefits and risks.

Breastfeeding

During breastfeeding, the medicine should only be used on the advice of a doctor who will weigh the benefits and risks.

Driving and using machines

Some patients may experience vision disturbances or dizziness after treatment with this medicine. If you experience these symptoms, wait until your vision returns to normal or the dizziness has passed before driving or operating machinery.

Scopolamine butylbromide Kalceks contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to use Scopolamine butylbromide Kalceks

Scopolamine butylbromide Kalceks will be administered to you by a doctor or nurse by slow intravenous, intramuscular, or subcutaneous injection. The dose will be determined by your doctor.

This medicine should not be used continuously, daily, or for a long time 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, in infants and children, a dose of 0.3-0.6 mg/kg body weight may be used several times a day. Do not exceed the maximum daily dose of 1.5 mg/kg body weight.

If you use more Scopolamine butylbromide Kalceks than you should

If you think you have been given too much of this medicine, contact your doctor or nurse immediately. The following symptoms may occur: dry mouth, skin redness, difficulty urinating, rapid heart rate, and vision disturbances.

If you miss a dose of Scopolamine butylbromide Kalceks

Do not use a double dose to make up for a missed dose. You will only receive the next dose if it is necessary for your medical condition.

If you stop using Scopolamine butylbromide Kalceks

Your doctor will decide whether to administer this medicine by injection only in acute conditions. If continued treatment is necessary, your doctor will prescribe hyoscine butylbromide in tablets.

If you have any further questions about using 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 can be attributed to the anticholinergic properties of hyoscine butylbromide. Anticholinergic side effects of hyoscine butylbromide are usually mild and transient.

The following convention has been used for the classification of frequencies:

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

Frequency not known

cannot be estimated from the available data

Immune system disorders

Frequency not known: anaphylactic shock (a sudden, severe allergic reaction with symptoms such as difficulty breathing, circulatory failure, and swelling, including cases that were fatal), anaphylactic reactions, shortness of breath, skin reactions (e.g., hives, rash, redness, itching), other hypersensitivity reactions.

Psychiatric disorders

Frequency not known: confusion in the elderly, restlessness, irritability.

Eye disorders

Common: accommodation disorders (focusing problems).

Frequency not known: pupil dilation, increased intraocular pressure, decreased tear production.

Cardiac disorders

Common: rapid heart rate.

Frequency not known: palpitations.

Vascular disorders

Common: dizziness.

Frequency not known: low blood pressure, skin redness.

Respiratory 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: sweating disorders.

Renal and urinary disorders

Frequency not known: difficulty urinating.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or nurse.

Side effects can also be reported directly to the Pharmacovigilance Department of the 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Scopolamine butylbromide Kalceks

Keep this medicine out of the sight and reach of children.

No special precautions for storage are necessary.

Do not use this medicine after the expiry date stated on the carton and ampoule after 'EXP'. The expiry date refers to the last day of that month.

Shelf life after opening the ampoule: the medicine should be used immediately.

Shelf life after dilution: chemical and physical stability has been demonstrated for 24 hours at 25°C and 2-8°C.

From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These 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 ingredients are sodium chloride, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What Scopolamine butylbromide Kalceks looks like and contents of the pack

Solution for injection (injectable solution).

Clear, colorless or almost colorless solution free from visible particles.

Ampoules made of colorless glass type I with a capacity of 1 ml.

Ampoules are packed in PVC blisters. Blisters are packed in a cardboard box.

Pack sizes: 5 or 10 ampoules

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AS KALCEKS

Krustpils iela 71E

LV-1057 Rīga

Latvia

Tel.: +371 67083320

Email: [email protected]

This medicine is authorized in the Member States of the European Economic Area 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 мг/мл инжекционен разтвор

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

Date of last revision of the package leaflet: 10/2022

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Information intended for healthcare professionals only:

Method of administration

For intravenous, intramuscular, or subcutaneous injection.

Instructions for use and disposal

For single use only. After opening, any unused contents should be discarded.

The medicinal product should be inspected visually before use. Only a clear and particle-free solution should be administered.

It can be diluted with dextrose or 0.9% sodium chloride injection solution.

Instructions for opening the ampoule

• 1) Turn the ampoule with the colored point upwards. If there is a solution in the upper part of the ampoule, gently tap with your finger to transfer all the solution to the lower part of the ampoule.
• 2) Use both hands to open the ampoule; holding the lower part of the ampoule in one hand, with the other hand, break off the upper part of the ampoule in the direction away from the colored point (see picture below).

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.