Scopolan

Leaflet attached to the packaging: patient information

Scopolan

Hyoscine butylbromide

10 mg, suppositories

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Scopolan and what is it used for

Scopolan is a medicine that contains hyoscine butylbromide, which relieves smooth muscle spasms in the abdominal cavity. The antispasmodic effect helps to alleviate painful spasms of the digestive tract, bile ducts, and the urinary and genital systems.

Indications for use

Scopolan is used for painful conditions associated with spasms:

• of the digestive tract (e.g., stomach cramps, intestinal colic, irritable bowel syndrome),
• of the bile ducts (e.g., biliary colic),
• of the urinary and genital system (e.g., renal colic, spasms associated with ureteral stones, painful menstruation).

2. Important information before using Scopolan

When not to use Scopolan

You should not use Scopolan if you are allergic to the active substance, hyoscine butylbromide, or any of the other ingredients of this medicine (listed in section 6). You should not use Scopolan if you have:

• an allergy to tropane alkaloids (e.g., atropine) and their derivatives,
• glaucoma with a narrow angle of filtration (an eye disease characterized by increased intraocular pressure),
• prostate enlargement (prostatic hyperplasia),
• atomic constipation,
• paralytic ileus (obstruction of the movement of intestinal contents),
• esophageal, gastric, or duodenal stenosis,
• urethral stenosis,
• tachycardia (heart rhythm disorder with accelerated heart rate),
• myasthenia gravis (a disease characterized by impaired muscle function and significant muscle weakness),
• pathological dilation of the large intestine (megacolon). Scopolan should not be used in children under 6 years of age.

Warnings and precautions

Before starting to use Scopolan, you should discuss it with your doctor or pharmacist. This medicine should only be taken as needed (when symptoms occur) and in the recommended indications. If you experience sudden abdominal pain of unknown cause and also have: fever, nausea, vomiting, changes in bowel movements (e.g., diarrhea), abdominal tenderness, decreased blood pressure, fainting, or blood in the stool, you should not take the medicine without consulting a doctor. To investigate the cause of the symptoms, the doctor will recommend appropriate diagnostic tests. You should discuss the use of Scopolan with your doctor if you have:

• gastroesophageal reflux disease (gastroesophageal reflux),
• ulcerative colitis,
• ischemic heart disease,
• mitral stenosis (one of the heart valves). You should be particularly cautious in elderly patients. If you experience any vision disturbances or eye pain caused by increased intraocular pressure, you should stop taking the medicine and consult a doctor. Due to the possible reduction in sweat production, the medicine should be used with caution in patients with fever.

Children

Do not use in children under 6 years of age. Use in older children - see section 3.

Scopolan and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Before starting to use Scopolan, you should consult a doctor if you are taking:

• tricyclic antidepressants - e.g., clomipramine, amitriptyline (medicines used to treat depression),
• neuroleptics (antipsychotic medicines) from the phenothiazine derivative group - e.g., chlorpromazine, flufenazine; as well as clozapine and olanzapine,
• monoamine oxidase inhibitors (MAOIs) - e.g., selegiline, moclobemide (some medicines used to treat depression and Parkinson's disease),
• antihistamines - e.g., dimenhydrinate, clemastine,
• amantadine (a medicine used to treat Parkinson's disease),
• pethidine (a medicine used to treat severe and prolonged pain),
• disopyramide (an antiarrhythmic medicine used to treat irregular heart rhythm),
• other cholinolytic medicines, such as ipratropium or tiotropium (medicines used to treat chronic obstructive pulmonary disease) or other atropine-like medicines,
• medicines that block dopamine receptors - e.g., metoclopramide (a medicine used to treat gastrointestinal disorders),
• beta-adrenergic medicines (used to treat shortness of breath and asthma).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult a doctor or pharmacist before using this medicine. Pregnancy There are no clinical studies confirming the safety of hyoscine butylbromide during pregnancy. The medicine should not be used during pregnancy unless the doctor considers it absolutely necessary. Breastfeeding There is no data on the penetration of hyoscine butylbromide into breast milk. Medicines from this group may inhibit milk production, so it is not recommended to use Scopolan during breastfeeding. Fertility The effect on fertility is unknown.

Driving and using machines

During treatment, you should not drive vehicles or operate machines, as the medicine may cause impaired psychophysical performance and vision disturbances.

3. How to use Scopolan

This medicine should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist. The medicine should only be used as needed (when symptoms occur). Before use, you should tear off the triangular end of the foil, remove the suppository from the blister, and insert it into the rectum. The recommended dose is: Adults and adolescents over 12 years old:

• rectally 1 to 2 suppositories 2 to 3 times a day. Children from 6 to 12 years old:
• rectally 1 suppository 2 to 3 times a day.

Do not use in children under 6 years of age. You should always use the smallest effective dose. If symptoms persist for more than 3 days from the start of treatment or worsen despite using the medicine, you should stop using the medicine and consult a doctor.

Using a higher dose of Scopolan than recommended

If you have taken a higher dose of Scopolan than recommended, you should immediately consult a doctor. In humans, no severe poisoning symptoms have been observed after a single acute overdose. You may experience symptoms such as urinary retention, dry mouth, tachycardia (accelerated heart rate), dizziness, and transient vision disturbances.

Missing a dose of Scopolan

You should not take a double dose to make up for a missed dose.

Stopping the use of Scopolan

Scopolan should only be used as needed and should be stopped after the symptoms have subsided. If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Scopolan can cause side effects, although not everybody gets them. The medicinal product used in recommended therapeutic doses is well-tolerated, and any side effects that may occur are of moderate severity. Side effects of Scopolan are presented according to the classification of organs and systems and the frequency of occurrence: uncommon (occurring less frequently than in 1 in 100 patients, but more frequently than in 1 in 1000 patients); rare (occurring less frequently than in 1 in 1000 patients, but more frequently than in 1 in 10,000 patients); unknown (cannot be determined based on available data). During the use of Scopolan, the following side effects may occur: skin and subcutaneous tissue disorders: flushing, skin burning, itching, rash, urticaria, edema - uncommon; gastrointestinal disorders: dry mouth, constipation - uncommon; cardiac disorders: tachycardia (accelerated heart rate) - uncommon; vascular disorders: hypotension (low blood pressure) - uncommon; renal and urinary disorders: anuria (urinary retention) - rare; eye disorders: vision disturbances - rare; immune system disorders: anaphylactic reactions (allergic), anaphylactic shock (a sudden and severe allergic reaction characterized by difficulty breathing, significant drop in blood pressure, swelling, rash) - frequency unknown. If you experience any of the above symptoms, you should immediately stop using the medicine and consult a doctor.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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 gather more information on the safety of the medicine.

5. How to store Scopolan

Store in a temperature below 25°C. The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month. Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Scopolan contains

• The active substance of the medicine is hyoscine butylbromide. One suppository contains 10 mg of hyoscine butylbromide.
• The excipients are: solid fat, polysorbate 80, liquid paraffin, purified water.

What Scopolan looks like and what the packaging contains

Scopolan is a white or cream-colored suppository. Packaging: a blister pack of PVC/PE film in a cardboard box. Pack size: 6 suppositories.

Marketing authorization holder and manufacturer

Wrocławskie Zakłady Zielarskie "Herbapol" SA, 50-951 Wrocław, ul. św. Mikołaja 65/68, Tel.: +48 71 33 57 225, Fax: +48 71 37 24 740, e-mail: [email protected]. For more detailed information about this medicine, you should contact the marketing authorization holder - tel. 71 321 86 04 ext. 123.

Date of the last update of the leaflet: