Spasticol

Leaflet attached to the packaging: patient information

SPASTICOL, (15 mg + 40 mg)/1.5 g, suppositories
Belladonnae folii extractum siccum normatum + Papavrini hydrochloridum

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

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any further doubts, please consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Spasticol and what is it used for
• 2. Important information before using Spasticol
• 3. How to use Spasticol
• 4. Possible side effects
• 5. How to store Spasticol
• 6. Package contents and other information

1. What is Spasticol and what is it used for

Spasticol is a combined medicine with a spasmolytic effect. The medicine is used in spastic conditions within the abdominal cavity, in renal and biliary colic.

2. Important information before using Spasticol

When not to use Spasticol

Spasticol should not be used if the patient has:

• hypersensitivity (allergy) to papaverine or atropine;
• hypersensitivity (allergy) to any other component of this medicine (listed in section 6);
• prostatic hyperplasia;
• intestinal obstruction or atony (decreased intestinal motility);
• urinary bladder atony;
• ulcerative colitis;
• pyloric stenosis;
• glaucoma with a narrow angle of filtration.

Warnings and precautions

Caution should be exercised when using Spasticol in patients with elevated body temperature, reflux disease, after myocardial infarction, in patients with hypertension and other cardiovascular diseases, as well as in patients with conditions accompanied by tachycardia (rapid heart rate), such as hyperthyroidism, heart failure.
Before starting to use Spasticol, the patient should discuss it with their doctor.

Children and adolescents

There is no data confirming the safety of use. The medicine should be used only on the doctor's prescription. When using Spasticol in children, particular caution should be exercised due to the possible increased sensitivity to side effects.

Patients over 65 years of age

Particular caution should be exercised when using Spasticol in patients over 65 years of age, due to the possible increased sensitivity to side effects.

Spasticol and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, the patient should inform their doctor about taking:

• first-generation antihistamines used in allergic diseases;
• neuroleptics derived from phenothiazine, used in schizophrenia;
• tricyclic antidepressants, used in depression;
• trihexyphenidyl, biperiden, used in Parkinson's disease;
• quinidine, disopyramide, propafenone, used in cardiac arrhythmia. The inhibition of gastrointestinal motility caused by Spasticol may affect the absorption of other medicines.

Pregnancy and breastfeeding

The use of Spasticol is not recommended during pregnancy and breastfeeding.

Driving and operating machinery

The medicine contains atropine. Due to the vision disturbances it causes, the patient should not drive vehicles or operate machinery during treatment.

3. How to use Spasticol

Spasticol should be used in accordance with the doctor's recommendations.
The medicine is intended for rectal administration. Unless the doctor recommends otherwise, adults should use 1 suppository 1 to 3 times a day.
In case of doubts about the use of the medicine, the patient should consult their doctor.

Using a higher dose of Spasticol than recommended

The following symptoms may occur:

• rapid heart rate;
• elevated body temperature;
• rapid breathing;
• excitement, disorientation, and hallucinations. If a higher dose of the medicine than recommended is taken, the patient should immediately consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Spasticol can cause side effects, although not everybody gets them. During treatment with the medicine, the following may occur:

• gastrointestinal disorders: dry mouth, constipation, vomiting;
• renal and urinary disorders: difficulty urinating;
• cardiac disorders: slowed or rapid heart rate;
• vascular disorders: decreased blood pressure;
• skin and subcutaneous tissue disorders: dryness and redness of the skin, facial redness, skin rash, increased sweating;
• nervous system disorders: headaches and dizziness, drowsiness;
• eye disorders: vision disturbances.

In case of any side effects, the patient should stop using the medicine. Side effects can be reported to a healthcare professional, the marketing authorization holder, or the President of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products [current address, phone number, and fax number, email address].

5. How to store Spasticol

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
Do not use after the expiry date stated on the packaging.

6. Package contents and other information

What Spasticol contains

The active substances of the medicine are standardized dry extract of belladonna leaves and papaverine hydrochloride.
The excipient is cocoa oil.

What Spasticol looks like and what the package contains

The medicine is in the form of suppositories packaged in blisters and a cardboard box.
The package contains 10 suppositories.

Marketing authorization holder and manufacturer

Farmina sp. z o.o.
ul. Lipska 44

• 30-721 Kraków [Logo]

Date of the last update of the leaflet: