Scopolamine butylbromide Kalceks

Package leaflet: Information for the user

Scopolamine butylbromide Kalceks 20 mg/ml injection solution

butylbromide of hyoscine
Equivalent medicine
Please read all of this leaflet carefully before you use this medicine because 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Scopolamine butylbromide Kalceks is and what it is used for
2. What you need to know before receiving Scopolamine butylbromide Kalceks
3. How Scopolamine butylbromide Kalceks is administered
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 butylbromide of hyoscine. It belongs to
a group of medicines called "antispasmodics". These medicines relieve spasms (cramp-like contractions)
of internal organs and alleviate the associated spastic pain.
This medicine is used to relieve spasms of the smooth muscles of the gastrointestinal and genitourinary tract
(stomach, intestine, biliary tract, pancreas, and urinary tract).
Scopolamine butylbromide Kalceks may also be used during diagnostic medical procedures.

2. What you need to know before receiving Scopolamine butylbromide Kalceks

Do not 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 (an eye disease)
• if you have an enlarged prostate and find it difficult or painful to urinate
• if you have intestinal obstruction problems
• if you have an abnormally enlarged bowel (megacolon)
• if you have an increased heart rate
• if you have a condition called “myasthenia gravis” (characterized by extreme muscle weakness).

An intramuscular injection of hyoscine butylbromide must not be administered if you are taking
medicines to prevent blood clots (blood thinners), as this may cause
a haematoma (bruising).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before this
medicine is administered to you:

• if you have unexplained abdominal pain that persists or worsens, or that is associated with fever, nausea, vomiting, changes in bowel movements, abdominal tenderness, low blood pressure, feeling faint or presence of blood in the stools
• if your bowel is not functioning properly (intestinal atony)
• if you have inflammation of the oesophagus associated with reflux (this occurs when stomach acids flow back into the oesophagus)
• if you have a severe, frequently recurring inflammation of the colon (ulcerative colitis)
• if you have impaired liver or kidney function
• if you have an overactive thyroid (this gland produces excessive thyroid hormones)
• if you have chronic bronchitis (inflammation of the bronchi).

You must contact your doctor immediately if eye pain and redness with
loss of vision occur after the injection of hyoscine butylbromide. This could be a sign of
high pressure inside the eye due to undiagnosed and therefore untreated
acute angle-closure glaucoma.
Allergic reactions have been observed after hyoscine butylbromide injection (see
section 4). Therefore, you will be monitored after the injection of hyoscine butylbromide and
will receive appropriate treatment if such reactions occur.
Other medicines and Scopolamine butylbromide 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, inform your doctor or pharmacist if you are taking any of the following medicines:

• antidepressant medicines known as “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-agonists)
• 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, atropine-like medicines)
• metoclopramide (used to treat nausea, vomiting or gastrointestinal disorders).

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before
this medicine is administered to you.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding,
please consult your doctor before receiving this medicine.
Pregnancy
Data on the use of this product in pregnant and breastfeeding women are limited. Therefore,
for safety reasons, the use of this medicine is not recommended during
pregnancy. During pregnancy, the medicine may be used only on the advice of a
doctor who will assess the benefit-risk balance.
Breastfeeding
During breastfeeding, the use of this medicine is possible only on the advice of a
doctor who will assess the benefit-risk balance.
Driving and using machines
Some people may experience vision problems or dizziness after treatment with this
medicine. If these effects occur, wait until your vision returns to normal or the dizziness stops before driving or operating machinery.
Scopolamine butylbromide 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 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 a physician.
This medicine must not be used continuously every day or for long periods of time without identifying the cause of 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, infants and children may receive 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.

If you have been given more Scopolamina butilbromuro Kalceks than you should have
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
Do not receive a double dose to make up for a missed dose. You will receive the next dose only if required based on your medical condition.

If treatment with Scopolamina butilbromuro Kalceks is stopped
Your doctor will administer an injection only in acute conditions. If continued treatment is necessary, your doctor will switch you to treatment with butylbromide of hyoscine tablets.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Many of the listed side effects are attributable to the anticholinergic properties of hyoscine butylbromide. Usually, the anticholinergic side effects of hyoscine butylbromide are mild and transient.
The side effects are listed below 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 the available data

Immune system disorders
Not known: anaphylactic shock (sudden severe allergic reaction presenting with shortness of breath, circulatory failure, and swelling, including cases with fatal outcome), anaphylactic reactions, dyspnoea, skin reactions (such as urticaria, rash, reddened skin, pruritus), other hypersensitivity reactions.

Psychiatric disorders
Not known: mental confusion in the elderly, excitability, irritability.

Eye disorders
Common: accommodation disorders (difficulty focusing).
Not known: dilated pupils, increased intraocular pressure, reduced lacrimal secretion.

Cardiac disorders
Common: increased heart rate.
Not known: palpitations.

Vascular disorders
Common: dizziness.
Not known: drop in 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: disturbance in sweating.

Renal and urinary disorders
Not known: difficulty urinating.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or nurse. You may also report side effects directly via 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 Scopolamine butylbromide 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 stated 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 °C and at 2–8 °C.
From a microbiological standpoint, the medicine should be used immediately, unless the method of opening/dilution prevents the risk of microbial contamination. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.
Do not dispose of any medicine via 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 Scopolamine butylbromide Kalceks contains

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

Description of the appearance of Scopolamine butylbromide Kalceks and package contents
Injectable solution (injection).
Clear, colourless or practically colourless solution, free from visible particles.
Clear glass vials of Type I, 1 ml.
The vials are packed 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 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 injekčný roztok
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

The following information is intended for healthcare professionals only:

Method of administration
For intravenous, intramuscular, or subcutaneous injection.

Instructions for use and handling

For single use only. After opening, any unused portion must be discarded.
The medicine should be inspected visually before use. Only clear solutions free from particles should be used.
Dilution may be performed with dextrose or 0.9% sodium chloride for injection.

Instructions for opening the vial

1. Hold the vial with the coloured mark facing upwards. If any solution is present in the upper part of the vial, gently tap with the finger to allow all the solution to flow down to the lower part.
2. Use both hands to open; hold the lower part of the vial with one hand and, with the other hand, break off the top part in the direction away from the coloured mark (see the following images).

Any unused medicine and waste material resulting from this medicine must be disposed of in accordance with local regulations.