Package Leaflet: Information for the User

Butilescopolamine Kalceks 20mg/ml Injectable Solution EFG

butilescopolamina bromuro

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1. What Butilescopolamine Kalceks is and what it is used for

2. What you need to know before you are given Butilescopolamine KalceksButilescopolamine Kalceks

3. How Butilescopolamine Kalceks will be given to you

4. Possible side effects

5. Storage of Butilescopolamine Kalceks

6. Contents of the pack and additional information

Butilescopolamina Kalceks contains the active substance butilescopolamina bromide. This belongs to a group of medicines called antispasmodics. These medicines relieve spasms (contractions similar to cramps) of internal organs and relieve the pain that comes from them.

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

Butilescopolamina Kalceks may also be used in medical diagnostic procedures.

No useButylescopolamine Kalceks

• If you are allergic to butylescopolamine bromide or any of the other components of this medication (listed in section6)
• If you have glaucoma (eye disease)
• If you have an enlarged prostate and experience difficulty or pain urinating
• If you have intestinal obstruction
• If you have an abnormally enlarged intestine (megacolon)
• If you have an increased heart rate
• If you have a disease called myasthenia gravis (characterized by extreme muscle weakness)

Do not receive any butylescopolamine bromide injections into the muscle if you are taking medications to prevent blood clot formation (anticoagulants), as it may cause a hematoma (bruise).

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before administering this medication to:

• If you experience persistent or worsening abdominal pain, or if it appears with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, dizziness, or presence of blood in stool
• If your intestine stops functioning correctly (intestinal atony)
• If you have inflammation of the esophagus associated with acid reflux (when stomach acid rises and enters the esophagus)
• If you have a severe and recurring inflammation of the colon (ulcerative colitis)
• If you have liver or kidney problems
• If you have hyperthyroidism (when the thyroid gland produces too many thyroid hormones)
• If you have chronic bronchitis (inflammation of the bronchi)

You must see a doctor immediately, if after the butylescopolamine bromide injection, you experience eye pain and redness with vision loss. This may be a sign of increased pressure inside the eye due to a previously undiagnosed and untreated narrow-angle glaucoma.

Allergic reactions have been observed after butylescopolamine bromide injection (see section4). Therefore, you will be monitored after the butylescopolamine bromide injection, and treated appropriately if such reactions occur.

Other Medications and Butylescopolamine Kalceks

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications and herbal supplements.

Especially inform your doctor or pharmacist if you are taking any of the following:

• Medications for depression called tricyclic antidepressants or tetracyclic antidepressants
• Medications for allergies (antihistamines)
• Medications for mental health conditions
• Medications for heart failure or asthma (beta-mimetics)
• Medications for heart rhythm disturbances (quinidine or disopyramide)
• Amantadine (medication for Parkinson's disease treatment)
• Medications for respiratory disorders (such as tiotropium, ipratropium, and atropine-like medications)
• Metoclopramide (used to treat nausea, vomiting, or gastrointestinal disorders)

If you are unsure if any of the above situations apply to you, speak with your doctor or pharmacist before receiving this medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant, breastfeeding, or think you may be pregnant, consult your doctor before receiving this medication.

Pregnancy

The available data on the use of the product in pregnant women or breastfeeding women are limited. Therefore, for safety reasons, it is not recommended to use this medication during pregnancy.

During pregnancy, the medication can only be used under the advice of a doctor who will evaluate the risk-benefit ratio.

Breastfeeding

During breastfeeding, the medication can only be used under the advice of a doctor who will evaluate the risk-benefit ratio.

Driving and Operating Machines

Some people may experience vision disturbances and dizziness after being treated with this medication. If you experience these effects, do not drive or operate machines until your vision returns to normal or you no longer feel dizzy.

Butylescopolamine Kalceks contains sodium

This medication contains less than 23 mg of sodium (1mmol); it is essentially "sodium-free."

Butilescopolamina Kalceks will be administered by a doctor or nurse as a slow injection into a vein, muscle, or under the skin. The dose will be determined by the doctor.

This medication should not be administered continuously on a daily basis or for prolonged periods of time without investigating the cause of abdominal pain.

Adults and children over 12 years old

The dose is 20 to 40 mg (1-2 ampoules) administered several times a day. The maximum daily dose is 100 mg (5 ampoules).

Use in children

In severe cases in infants and children, the dose is 0.3 to 0.6 mg/kg of body weight, administered several times a day. The maximum daily dose should not exceed 1.5 mg/kg of body weight.

If you have been administered an excessive amount of Butilescopolamina Kalceks

If you think you have been given an excessive amount, inform your doctor or nurse immediately. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or go to a medical center, or call the Toxicological Information Service, Tel. 91 562 04 20 indicating the medication and the amount ingested.

The following symptoms may occur: dry mouth, skin redness, difficulty urinating, rapid heartbeats, and vision disturbances.

If you forget a dose of Butilescopolamina Kalceks

You will not receive a double dose to compensate for the missed dose. You will only receive the next dose if necessary according to your health status.

If the use of Butilescopolamina Kalceks is interrupted

Your doctor will administer an injection only in acute cases. If further treatment is necessary, your doctor will switch you to butilescopolamina bromide in tablets.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Many of the adverse reactions can be associated with the anticholinergic properties of butylescopolamine bromide, which are generally mild and transient.

Adverse reactions have been tabulated using the following frequency convention:

Very commonmay affect more than 1in 10people

Commonmay affect up to 1in 10people

Uncommonmay affect up to 1in 100people

Raremay affect up to 1in 1,000people

Very raremay affect up to 1in 10,000people

Frequency not knowncannot be estimated from available data

Immune system disorders

Frequency not known: anaphylactic shock (severe and sudden allergic reaction, which manifests with difficulty breathing, circulatory insufficiency, and swelling, and can be fatal), anaphylactic reactions, difficulty breathing, skin reactions (e.g., urticaria, hives, skin redness, itching), other hypersensitivity reactions.

Mental health disorders

Frequency not known:confusion in elderly people, excitability, irritability.

Eye disorders

Common:visual accommodation (focusing) disorders.

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: decreased blood pressure, flushing.

Respiratory disorders

Frequency not known:thickened bronchial secretions.

Gastrointestinal disorders

Common:dry mouth.

Frequency not known:constipation.

Skin and subcutaneous tissue disorders

Frequency not known: abnormal sweating.

Renal and urinary disorders

Frequency not known: difficulty urinating.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and on the ampule after CAD. The expiration date is the last day of the month indicated.

Shelf life once the ampule is opened:The administration of the medication should take place immediately.

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

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

Medications should not be disposed of through the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Butilescopolamina Kalceks

• The active ingredient is butilescopolamina bromide.

Each ampoule (1ml) contains 20mg of butilescopolamina bromide.

• The other components are sodium chloride, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injectable preparations.

Appearance of Butilescopolamina Kalceks and packaging contents

Injectable solution.

Transparent, colorless or almost colorless solution without visible particles.

Transparent type I glass ampoules of 1ml.

The ampoules are placed in a PVC tray. The trays are packaged in cardboard boxes.

Packaging sizes: 5 or 10ampoules

Only some packaging sizes may be commercially available.

Marketing Authorization Holder

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057,

Latvia

Tel.: +371 67083320

E-mail:[email protected]

Responsible for manufacturing

Akciju sabiedriba “Kalceks”

Krustpils iela 71E, Riga, LV-1057, Latvia

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Republic of CzechiaButylskopolaminium bromid Kalceks

AustriaButylscopolaminiumbromid Kalceks 20mg/ml Injektionslösung

BelgiumScopolamine butylbromide Kalceks 20mg/ml solution injectable

Scopolamine butylbromide Kalceks 20mg/ml oplossing voor injectie

Scopolamine butylbromide Kalceks 20mg/ml Injektionslösung

BulgariaScopolamine butylbromide Kalceks 20??/????????????????????

FranceSCOPOLAMINE BUTYLBROMURE KALCEKS 20 mg/mL, solution injectable

ItalyScopolamina butilbromuro Kalceks

LatviaHyoscine butylbromide Kalceks 20mg/ml škidums injekcijam

PolandScopolamine butylbromide Kalceks

PortugalButilescopolaminaKalceks

NorwaySkopolaminbutylbromid Kalceks

SlovakiaScopolamine butylbromide Kalceks20 mg/ml injekcný roztok

SpainButilescopolaminaKalceks20mg/ml solución inyectable EFG

SwedenHyoscine butylbromide Kalceks

NetherlandsScopolamine butylbromide Kalceks20mg/ml oplossing voor injectie

Last review date of this leaflet:October 2022.

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

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This information is intended solely for healthcare professionals:

Administration route

Intravenous, intramuscular or subcutaneous injection.

Instructions for use, disposal and other manipulations

For single use only. Once opened, the unused solution must be discarded.

The medicinal product must be visually inspected before use. It should only be used if the solution is transparent and free of particles.

It can be used diluted with dextrose or with a 0.9% sodium chloride injectable solution.

Instructions for opening the ampoule:

1)Turn the ampoule with the color point upwards. If there is any solution left at the top of the ampoule, gently tap it with your finger to bring all the solution down to the bottom of the ampoule.

2)Use both hands to open; while holding the bottom of the ampoule with one hand, separate the top of the ampoule in the opposite direction to the color point (see the images below).

The disposal of unused medicinal product and all materials that have come into contact with it will be carried out in accordance with local regulations.