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BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION

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About the medicine

How to use BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Butilescopolamina Kalceks 20mg/ml solution for injection EFG

butilescopolamine bromide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this 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 signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

  1. What is Butilescopolamina Kalceks and what is it used for
  2. What you need to know before you are given Butilescopolamina Kalceks
  3. How Butilescopolamina Kalceks is given
  4. Possible side effects
  5. Storage of Butilescopolamina Kalceks
  6. Contents of the pack and other information

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

Butilescopolamina Kalceks contains the active substance butilescopolamine 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 tract).

Butilescopolamina Kalceks may also be used in medical diagnostic procedures.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you are given Butilescopolamina Kalceks

Do not useButilescopolamina Kalceks

  • if you are allergic to butilescopolamine bromide 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 have difficulty or pain when 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).

You should not receive any injection of butilescopolamine bromide into the muscle if you are taking medicines to prevent blood clot formation (anticoagulants), as a hematoma (bruise) may occur.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using this medicine:

  • if you have abdominal pain of unknown origin that persists or worsens, or appears with symptoms such as fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, decreased blood pressure, fainting, or blood in the stool
  • if the intestine stops working properly (intestinal atony)
  • if you have esophageal inflammation associated with acid reflux (when stomach acid rises and enters the esophagus)
  • if you have severe colon inflammation that recurs frequently (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 should go to the doctor immediately, if after the injection of butilescopolamine bromide, pain and redness of an eye with vision loss appear. 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 the injection of butilescopolamine bromide (see section 4). Therefore, you will be monitored after the injection of butilescopolamine bromide and treated accordingly if such reactions occur.

Other medicines and Butilescopolamina Kalceks

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription, including herbal medicines.

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

  • medicines for treating depression called tricyclic or tetracyclic antidepressants
  • medicines for treating allergies (antihistamines)
  • medicines for treating mental illnesses
  • medicines for treating heart failure or asthma (betamimetics)
  • medicines for treating heart rhythm disorders (quinidine or disopyramide)
  • amantadine (medicine for the treatment of Parkinson's disease)
  • medicines for treating respiratory disorders (such as tiotropium, ipratropium, and atropine-like substances)
  • metoclopramide (used to treat nausea, vomiting, or gastrointestinal disorders).

If you are not sure if any of the above situations apply to you, talk to your doctor or pharmacist before you are given this medicine.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Pregnancy

There is limited experience with the use of this product in pregnant or breast-feeding women. Consequently, for safety reasons, the use of this medicine during pregnancy is not recommended.

During pregnancy, the medicine should only be used under the advice of a doctor who will evaluate the risk/benefit ratio.

Breast-feeding

During breast-feeding, the medicine should only be used under the advice of a doctor who will evaluate the risk/benefit ratio.

Driving and using machines

Some people may experience vision changes and dizziness after being treated with this medicine. If you experience these effects, do not drive or use machines until your vision returns to normal or you stop feeling dizzy.

Butilescopolamina Kalceks contains sodium

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

3. How Butilescopolamina Kalceks is given

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

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

Adults and children over 12years

The dose is 20 to 40 mg (1-2 ampoules) given 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 body weight, given several times a day. The maximum daily dose should not exceed 1.5 mg/kg body weight.

If you have been given too muchButilescopolamina Kalceks

If you think you have been given too much, tell 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 Toxicology Information Service, Tel. 91 562 04 20 indicating the medicine and the amount taken.

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

If you miss a dose of Butilescopolamina Kalceks

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

If you stop using Butilescopolamina Kalceks

Your doctor will give you an injection only in acute cases. If it is necessary to continue treatment, your doctor will switch you to butilescopolamine bromide in tablets.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Adverse reactions have been tabulated using 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

Frequency not known cannot be estimated from the available data

Disorders of the immune system

Frequency not known: anaphylactic shock (severe and sudden allergic reaction, which manifests with difficulty breathing, insufficient blood circulation, and swelling, and can be fatal), anaphylactic reactions, difficulty breathing, skin reactions (such as hives, rash, skin redness, itching), other hypersensitivity reactions.

Psychiatric disorders

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

Eye disorders

Common:disorders of visual accommodation (focusing).

Frequency not known: pupil dilation, increased pressure inside the eye, 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: thickening of bronchial secretions.

Gastrointestinal disorders

Common:dry mouth.

Frequency not known: constipation.

Disorders of the skin and subcutaneous tissue

Frequency not known: abnormal sweating.

Renal and urinary disorders

Frequency not known: difficulty urinating.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Health Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Butilescopolamina Kalceks

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton and on the ampoule after EXP. The expiry date is the last day of the month shown.

Shelf-life after opening of the ampoule: The administration of the medicine 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 opening/dilution precludes the risk of microbial contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Butilescopolamina Kalceks

  • The active substance is butilescopolamine bromide.

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

  • The other ingredients are sodium chloride, concentrated hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), water for injections.

Appearance of Butilescopolamina Kalceks and pack contents

Solution for injection (injectable).

Clear, colorless or almost colorless solution, without visible particles.

1 ml glass ampoules of type I.

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

Package sizes: 5 or 10 ampoules

Not all pack sizes may be marketed.

Marketing authorization holder

AS KALCEKS

Krustpils iela 71E, Riga, LV-1057,

Latvia

Tel.: +371 67083320

E-mail: [email protected]

Manufacturer

Akciju sabiedriba “Kalceks”

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

You can request moreinformation about this medicine from the local representative of the marketing authorization holder

EVER Pharma Therapeutics Spain SL

c/ Toledo 170

28005 Madrid

Spain

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 ??/?? ??????????? ???????

France SCOPOLAMINE BUTYLBROMURE KALCEKS 20 mg/mL, solution injectable

Italy Scopolamina butilbromuro Kalceks

Latvia Hyoscine butylbromide Kalceks 20 mg/ml škidums injekcijam

Poland Scopolamine butylbromide Kalceks

Portugal Butilescopolamina Kalceks

Norway Skopolaminbutylbromid Kalceks

Slovakia Scopolamine butylbromide Kalceks 20 mg/ml injekcný 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 this leaflet:October 2022.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

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This information is intended only for healthcare professionals:

Method of administration

Intravenous, intramuscular, or subcutaneous injection.

Instructions for use, disposal, and other handling

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

The medicine should be visually inspected before use. It should only be used if the solution is clear and free of particles.

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

Instructions for opening the ampoule:

  1. Turn the ampoule with the colored point upwards. If some solution remains in the top part of the ampoule, gently tap with your finger to make the solution go 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 part of the ampoule in the opposite direction to the colored point (see the images below).

Hand holding a medicine vial with a connected needle preparing for injection

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

Online doctors for BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION

Discuss questions about BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

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  • General internal medicine concerns and initial health assessment.
  • Acute symptoms such as fever, cough, infections, pain, or weakness.
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Dr Okeke is known for his clear communication, calm approach, and cultural awareness. He listens carefully, explains medical decisions in a structured way, and supports patients in making informed choices about their health.

Online consultations with Dr Chikeluo Okeke offer reliable internal medicine care without geographic limitations, focused on medical relevance, clarity, and patient comfort.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
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  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
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Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

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Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
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He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

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Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

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Frequently Asked Questions

Is a prescription required for BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION?
BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION?
The active ingredient in BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION is butylscopolamine. This information helps identify medicines with the same composition but different brand names.
How much does BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION cost in pharmacies?
The average pharmacy price for BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION is around 4.06 EUR. Prices may vary depending on the manufacturer and dosage form.
Who manufactures BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION?
BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION is manufactured by Kalceks As. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to BUTYLSCOPOLAMINE KALCEKS 20 mg/ml INJECTABLE SOLUTION?
Other medicines with the same active substance (butylscopolamine) include BUSCAPINA 10 mg FILM-COATED TABLETS, BUSCOPRESC 20 mg INJECTABLE SOLUTION, BUTILESCOPOLAMINA AUROVITAS 10 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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