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SCOPOLAN® compositum

Dear Patient.
Prescription drugs may be prescribed by a doctor.
If you have lost a leaflet from the drug, here you can get a copy of it.
In medical matters concerning dosage, consult your doctor.


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SCOPOLAN® compositum

Hyoscini butylbromidum + Metamizolum natricum monohydricum
coated tablets, 10 mg + 250 mg

Active substances:
Hyoscine butylbromide            – 10 mg
Metamizole sodium monohydrate    – 250 mg

Auxiliary substances: talc, Arabic gum, gelatin, glycerin, potato starch, magnesium stearate, sucrose, titanium dioxide E-171.

Package contains 10 coated tablets.

Entity responsible:
Wrocławskie Zakłady Zielarskie „Herbapol” S.A.
50-951 Wrocław, ul. Św. Mikołaja 65/68

In this leaflet:

  1. What is the drug SCOPOLAN Compositum and what it is used for
  2. Before you take SCOPOLAN Compositum
  3. How to take SCOPOLAN Compositum
  4. Possible adverse effects
  5. Storing SCOPOLAN Compositum
  6. Other necessary information about the drug SCOPOLAN Compositum

1. What is the drug SCOPOLAN Compositum and what it is used for

Scopolan Compositum is a drug consisting of hyoscine butylbromide of diastolic action on the smooth muscles of the gastrointestinal tract, biliary and genitourinary tract and metamizole sodium monohydrate having analgesic, antipyretic and anti-inflammatory effects.

Indications for use:
Pain in spastic conditions of the gastrointestinal tract (abdominal cramps, irritable bowel syndrome), bile ducts (biliary colic), genitourinary system (renal colic, menstrual cramps, detrusor hyperreflexia).

2. Before you take SCOPOLAN Compositum

Do not use if you are hypersensitive to pyrazolones and other no steroidal anti-inflammatory drugs, allergic to tropane alkaloids, have stomach ulcers and duodenal ulcers, changes in the image morphology of blood: leukopenia, granulocytopenia, anemia, congenital glucose-6-phosphate dehydrogenase deficiency, acute hepatic porphyria, acute renal or liver failure, glaucoma, benign prostatic hyperplasia, paralytic intestinal obstruction, atonic constipation, during pregnancy and lactation.

Caution should be used:

  • in gastroesophageal reflux disease,
  • in pylorostenosis,
  • in heart rhythm problems with tachycardia, in ischaemic heart disease.

Application of Scopolan compositum in children:
Not recommended for use in children and adolescents up to 18 years.

Pregnancy:
The drug should not be used during pregnancy.

Breast-feeding:
The drug should not be used during breast-feeding.

Driving vehicles and using machines:
Scopolan Compositum can cause impairment of psychophysical efficiency, so patients should not drive or operate machinery during treatment.

Taking other medicines:
Tricyclic antidepressants, neuroleptics of phenothiazine derivatives group and clozapine and olanzapine, antihistamines of 1st generation, amantadine, pethidine and disopyramide may potentiate the cholinolytic effects of the preparation.
Prokinetic drugs: metoclopramide, cisapride may reduce the effect of the drug.
Metamizole sodium monohydrate contained in the product, like aminophenazone can displace oral anticoagulants, oral antidiabetics, phenytoin and sulfonamides from the protein binding.
Metamizole sodium monohydrate increases the metabolism of cyclosporine, which leads to a reduction of its concentration in the blood serum.
The drug should not be used concomitantly with other drugs from the group of pyrazolone derivatives.

Tell your doctor about all the recently taken drugs, even those that are obtained without a prescription.

3.  How to take SCOPOLAN Compositum

Adults: orally 1 to 2 coated tablets at one time.  The drug should be used as needed.  In case of severe pain dosage can be increased, taking 1 to 2 coated tablets 3 times a day.  Do not administer to children and adolescents up to 18 years.

If you take more than the recommended dose
Symptoms of overdose are the result of the central and peripheral actions of metamizole sodium monohydrate and peripheral of hyoscine butylobromide.
The following symptoms can occur on the part of the central nervous system: dizziness, tinnitus, hearing impairment, psychomotor agitation, and after taking of very high doses disturbances of consciousness, coma and convulsions.
Peripheral symptoms, apart from the disorders characteristic for hyoscine butylobromide such as: dry mouth, blurred vision, tachycardia, drop in blood pressure, difficulty swallowing, painful pressure on the bladder, also include severe abdominal pain, nausea and vomiting induced by metamizole sodium monohydrate.
In the case of symptoms of overdose, discontinue the drug and contact your doctor immediately.

If you miss a dose of Scopolan Compositum do not take a double dose to make up for a missed dose.

4.   Possible adverse effect

Like all medicines, Scopolan Compositum can cause adverse effects.  The following may occur rarely: a feeling of dry mouth, atonic constipation and tachycardia, in large doses also blurred vision, agitation. Due to metamizole sodium monohydrate content disorders of the gastrointestinal tract (nausea, vomiting), kidney and liver damage (in case of long-term use) may occur. There are reports in the literature about the risk of damage to the bone marrow of allergic origins (leading to agranulocytosis and other hematological complications: thrombocytopenia and anemia, which can be fatal).  In addition, there may be allergic skin reactions rarely.
If you experience these or other adverse effects not listed in this leaflet, please inform your doctor.

5.  Storage of SCOPOLAN Compositum

Store at the temperature not exceeding 25°C.

Store the drug in a place out of reach and sight of children.
Do not use after expiry date printed on the package.

6.  Other information

For more detailed information, please contact the local representative of the Marketing Authorization holder – phone (+48) 71 321 86 04 ext. 123

Wrocławskie Zakłady Zielarskie „Herbapol” S.A.
Poland, 50-951 Wrocław, ul. Św. Mikołaja 65/68

Date of leaflet preparation: 02.10.2013

In the text of the leaflet approved by the Ministry of Health on 29.10.2008 the names of active substances were corrected to comply with the monograph Ph.Eur. and with marketing authorization of 10.02.2013.