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Scopolan (czopki)

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.


PATIENT LEAFLET: INFORMATION FOR THE USER

Scopolan

10 mg, suppositories
Hyoscini butylbromidum

Please read the package leaflet before using the drug.

Keep this leaflet as you may need to read it again.
Ask your doctor or pharmacist if you need advice or any further information.
This medicine has been prescribed for you personally and you should not pass it on to others, as it can harm them, even if their symptoms are the same.
If you notice any of the adverse effects or adverse effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

  1. What is SCOPOLAN and what it is used for
  2. Before you use Scopolan
  3. How to use Scopolan
  4. Possible adverse effects
  5. How to store Scopolan Other information

 

1. WHAT IS SCOPOLAN AND WHAT IT IS USED FOR

Scopolan is a medicine containing hyoscine butylbromide with relaxant effect on smooth muscle of the gastrointestinal tract, biliary tract and urogenital system.

Indications for application                                           

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 – over reactive bladder or urinary incontinence caused by urgent vesical tenesmus).

2. BEFORE YOU USE SCOPOLAN

Do not take Scopolan:
Do not use Scopolan if you are allergic to tropane alkaloids and their derivatives, have narrow angle glaucoma, prostatic hyperplasia, atonic constipation, paralytic intestinal obstruction, narrowing of the esophagus, cardia or pylorus, bladder neck stenosis, cardiac arrhythmias (tachycardia), myasthenia gravis (myasthenia gravis), pathological extension of the large intestine (megacolon).

Take special care with Scopolan

Caution should be exercised in patients with gastroesophageal reflux disease, ulcerative colitis, arrhythmias with rapid ventricular action, coronary heart disease with mitral stenosis (one of the valves in the heart) and in elderly patients.
The drug should be taken only temporarily in spastic conditions of the gastrointestinal tract and urinary tract.
In case of any disturbances in visual acuity or ocular pain caused by an increase in intraocular pressure discontinue taking the drug and contact your doctor.
Due to the possibility of reducing perspiration the drug should be used with caution in patients with fever.

Taking other medicines with Scopolan

You should tell your doctor about all the recently taken drugs, even those without a prescription.
Tricyclic antidepressants, (clomipramine, amitriptiline); neuroleptics of phenothiazine derivative group (chlorpromazine, flufenazine); clozapine and olanzapine; some antihistamines (anti-allergic drugs – e.g. dimenhydrynate, clemastine); amantadine, pethidine and disopyramide may potentiate the cholinolytic effects of Scopolan.
Metoclopramide, cisapride may decrease the inhibitory effect of the drug Scopolan on the digestive tract.
Taking Scopolan with MAO inhibitors (certain medicines used in psychiatry and Parkinson’s disease) may cause increased adverse effects.

Pregnancy
Before taking any medicine, consult your doctor.
There are no clinical studies to support the safety of using hyoscine butylbromide during pregnancy.  The drug should not be used during pregnancy unless your doctor considers it absolutely necessary

Breast-feeding
Before taking any medicine, consult your doctor.
There is no data on the penetration of hyoscine butylobromide into human milk.  The drugs of this group can inhibit the secretion of milk, therefore it is not recommended to apply Scopolan during breast-feeding.

Application in children
Do not use in children under the age of 3 years.
Use in older children – see section 3.

Driving vehicles and using machine
During treatment, do not drive or operate machines because the drug may cause psychophysical efficiency impairment and blurred vision.

3. HOW TO USE SCOPOLAN

Scopolan should only be used as prescribed by the doctor.  If in doubt, check with your doctor.
Suppository out of the blister should be introduced into the rectum.
Rectally, adults and children over 12 years:  1 to 2 suppositories 2 to 3 times a day.
Children from 6 to 12 years:  1 suppository 2 to 3 times a day.
Children from 3 to 6 years: ¾ of suppository once a day.

Taking higher than recommended dose of the drug Scopolan

In humans, so far no severe symptoms of poisoning after a single acute overdose have been observed.
However, if you develop symptoms such as urinary retention, dry mouth, tachycardia (increased heart rate), dizziness, and transient vision disturbances, immediately contact your doctor.

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

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Scopolan can cause adverse effects, although not everybody experiences them.
Adverse reactions which are uncommon (less than 1 in 100 people) – allergic skin reactions (urticaria), dry mouth, atonic constipation, increased heart rate, decreased blood pressure.
Rare side effects (less than 1 in 1,000 people) – problems with urination, blurred vision.
Adverse reactions of indeterminate incidence – hypersensitivity to the active substance, anaphylactic shock.
In case of any of the above symptoms stop taking the drug and contact your doctor.

5. HOW TO STORE SCOPOLAN

Do not store at the temperature exceeding 25°C.
Keep out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the package.

6. OTHER INFORMATION

What Scopolan contains:
The active substance is hyoscine butylbromide – 10 mg
The other ingredients are: solid fat, polysorbate 80, liquid paraffin, purified water.

What does Scopolan look like and contents of the pack:
The drug Scopolan are white or cream suppositories in a blister of PVC/PE.
Suppository mass 2 g.

The package contains 6 suppositories.

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

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

Date of leaflet approval: 04.03.2010