Package leaflet: Information for the patient

Scopolan
Hyoscini butylbromidum
10 mg, coated tablets
Please read carefully the entire 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
a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.

Table of contents

What Scopolan is and what it is used for
Important information before taking Scopolan
How to take Scopolan
Possible side effects
How to store Scopolan
Contents of the pack and other information

1. What Scopolan is and what it is used for

Scopolan is a medicine containing butylbromide of hyoscine, which relieves spasm of smooth muscles in the abdominal cavity. The spasmolytic effect helps alleviate painful spasms of the gastrointestinal tract, biliary passages, and the urogenital system.
Indications
Scopolan is indicated for painful conditions associated with spasms:

of the gastrointestinal tract (e.g. stomach spasms, intestinal colic, irritable bowel syndrome),
of the biliary passages (e.g. biliary colic),
of the urogenital system (e.g. renal colic, spasms associated with ureteric stones, painful menstruation).

2. Important information before using Scopolan

When not to use Scopolan
Do not use Scopolan if the patient is allergic to the active substance - hyoscyne butylbromide - or any of the other ingredients of this medicine (listed in section 6).
Do not use Scopolan if the patient has:

allergy to tropane alkaloids (e.g. atropine) and their derivatives,
narrow-angle glaucoma (an eye condition characterized by increased intraocular pressure),
benign prostatic hyperplasia (enlargement of the prostate gland),
atonic constipation,
paralytic ileus (intestinal obstruction due to lack of intestinal motility),
stricture of the esophagus, pylorus or gastric outlet,
urethral stricture,
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 colon (megacolon).

Warnings and precautions
This medicine should be taken only on an as-needed basis (when symptoms occur) and only for the recommended indications.
If abdominal pain occurs suddenly and its cause is unknown, and is accompanied by fever, nausea, vomiting, changes in bowel habits (e.g. diarrhea), tenderness upon touching the abdomen, low blood pressure, fainting, or presence of blood in stool, the patient should not take this medicine without first consulting a physician. The doctor will recommend appropriate diagnostic tests to determine the cause of symptoms.
The use of Scopolan should be discussed with a doctor if the patient suffers from:

gastroesophageal reflux disease (backflow of stomach contents into the esophagus),
ulcerative colitis,
ischemic heart disease,
mitral valve stenosis (narrowing of one of the heart valves).

Special caution is required when administering this medicine to elderly patients. If any disturbances in visual acuity or eye pain due to increased intraocular pressure occur, the use of the medicine should be discontinued and medical advice sought immediately. Due to the possibility of reduced sweating, Scopolan should be used with caution in patients with fever.

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

Scopolan and other medicines
Inform your doctor about all medicines currently used or recently taken, as well as any medicines planned for future use.
Consult your doctor before taking Scopolan if you are using:

tricyclic antidepressants - clomipramine, amitriptyline (medicines used to treat depression),
neuroleptics (antipsychotic medicines) of the phenothiazine derivatives group, e.g. chlorpromazine, fluphenazine; as well as clozapine and olanzapine,
monoamine oxidase inhibitors (MAO inhibitors), e.g. selegiline, moclobemide (some medicines used in the treatment of depression and Parkinson's disease),
antihistamines (antiallergic medicines), e.g. dimenhydrinate, clemastine,
amantadine (a medicine used in the treatment of Parkinson's disease),
pethidine (a medicine used for severe and prolonged pain),
disopyramide (an antiarrhythmic medicine used to treat irregular heart rhythms),
other anticholinergic medicines such as ipratropium or tiotropium (medicines used in chronic obstructive pulmonary disease) or other agents similar to atropine,
dopamine receptor blockers, e.g. metoclopramide (a medicine used for gastrointestinal motility disorders),
beta-adrenergic blockers (used in the treatment of shortness of breath and asthma).

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
There are no clinical studies confirming the safety of hyoscyne butylbromide during pregnancy. This medicine should not be used during pregnancy unless the physician considers it absolutely necessary.

Breastfeeding
There are no data on the passage of hyoscyne butylbromide into human breast milk. Medicines in this group may inhibit milk production; therefore, the use of Scopolan is not recommended during breastfeeding.

Effect on fertility
The effect on fertility is unknown.

Driving and operating machinery
Patients should not drive or operate machinery during treatment, as the medicine may impair psycho-physical performance and cause visual disturbances.

Scopolan contains monohydrate lactose and sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Scopolan

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine should only be used on an as-needed basis (when symptoms occur).
Recommended dose:
Adults:

Orally, 1 to 2 coated tablets 3 to 5 times daily.

Use in children and adolescents
Adolescents over 12 years of age:

Orally, 1 to 2 coated tablets 3 to 5 times daily.

Children aged 6 to 12 years:

Orally, 1 coated tablet twice daily. Scopolan should not be used in children under 6 years of age.

Always use the lowest effective dose.
If symptoms persist for more than 3 days after starting treatment or worsen despite taking the medicine, the patient should stop using the medicine and consult a doctor.
Use of a higher than recommended dose of Scopolan
In case of overdose, seek medical advice immediately.
Severe symptoms of poisoning have not been observed in humans following a single acute overdose.
Symptoms may include urinary retention, dry mouth, tachycardia (increased heart rate), dizziness, and transient visual disturbances.
Missed dose of Scopolan
Do not take a double dose to make up for a missed dose.
Stopping Scopolan
Scopolan should only be taken when needed and should be discontinued once symptoms have resolved.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, Scopolan may cause adverse reactions, although not everyone experiences them. The medicinal product, when used at recommended therapeutic doses, is well tolerated, and any possible adverse symptoms are of moderate intensity.
The adverse reactions of the medicinal product are presented according to organ systems and frequency of occurrence: not very common (occurring in fewer than 1 in 100 patients but more than 1 in 1000 patients); rare (occurring in fewer than 1 in 1000 patients but more than 1 in 10,000 patients); unknown (cannot be estimated from available data).
The following adverse reactions may occur during treatment with Scopolan:
Skin and subcutaneous tissue disorders: erythema, burning sensation of the skin, pruritus, rash, urticaria, swelling – not very common;
Gastrointestinal disorders: dry mouth, constipation – not very common;
Cardiac disorders: tachycardia (increased heart rate) – not very common;
Vascular disorders: hypotension (low blood pressure) – not very common;
Renal and urinary disorders: anuria (retention of urine) – rare;
Eye disorders: visual disturbances – rare;
Immune system disorders: anaphylactic (allergic) reactions, anaphylactic shock (sudden and severe allergic reaction characterized by breathing difficulties, significant drop in blood pressure, swelling, rash) – frequency unknown.
If any of the above symptoms occur, treatment with the medicinal product should be stopped immediately and medical advice should be sought.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicinal product.

5. How to store Scopolan

Store below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Scopolan contains

The active substance is hyoscine butylbromide (Hyoscini butylbromidum) - 10 mg
The other ingredients are: potato starch, lactose monohydrate, arabic gum, sucrose, talc, magnesium stearate.

What Scopolan looks like and contents of the pack
Scopolan is a white coated tablet.
Packaging: Aluminium/PVC blister in a cardboard box.
Pack sizes: 10 or 30 coated tablets.

Marketing Authorisation Holder and Manufacturer
Wrocławskie Zakłady Zielarskie „Herbapol” SA
50-951 Wrocław, ul. św. Mikołaja 65/68
Tel.: + 48 71 33 57 225
Fax: + 48 71 372 47 40
e-mail: [email protected]

For further information about this medicine, please contact the Marketing Authorisation Holder - tel. 71 321 86 04 ext.123