Spastina
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How to use Spastina
Package Leaflet: Information for the Patient
SPASTYNA
40 mg, tablets
Drotaverine hydrochloride
Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.
- This package leaflet should be kept in case it needs to be read again.
- If advice or additional information is needed, a pharmacist should be consulted.
- If the patient experiences any side effects, including any not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
- If there is no improvement or the patient feels worse after 10 days, a doctor should be consulted.
Table of Contents of the Package Leaflet
- 1. What is SPASTYNA and what is it used for
- 2. Important information before taking SPASTYNA
- 3. How to take SPASTYNA
- 4. Possible side effects
- 5. How to store SPASTYNA
- 6. Package contents and other information
1. What is SPASTYNA and what is it used for
The active substance of SPASTYNA is drotaverine hydrochloride. This substance is used for smooth muscle spasms of both nervous and muscular origin. The spasmolytic effect of drotaverine does not depend on the type of innervation and the location of the smooth muscles (gastrointestinal tract, genitourinary system, cardiovascular system, and bile ducts). The medicine is metabolized in the liver and excreted mainly in the urine and to a lesser extent in the feces.
Indications
SPASTYNA is used for:
spastic conditions of smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, and papillitis;
spastic conditions of smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, and painful urination;
and as an adjunct:
in spastic conditions of smooth muscles of the gastrointestinal tract: gastric and duodenal ulcer disease, gastritis, enteritis, colitis, and spastic conditions of the pylorus and cardia, irritable bowel syndrome, spastic constipation, and intestinal bloating;
in gynecological disorders: dysmenorrhea.
If there is no improvement or the patient feels worse after 10 days, a doctor should be consulted.
2. Important information before taking SPASTYNA
When not to take SPASTYNA:
if the patient is allergic to drotaverine or any of the other ingredients of this medicine (listed in section 6);
if the patient has severe liver, kidney, or heart failure;
if the patient has a second- or third-degree atrioventricular block;
do not use in children under 6 years of age.
Warnings and precautions
Before starting to take SPASTYNA, the doctor or pharmacist should be consulted.
Due to the presence of lactose, the medicine may cause gastrointestinal disorders in patients with lactose intolerance.
The medicine should be used with caution in patients with hypotension.
Care should be taken when using the medicine in pregnant women and children from 6 years of age.
The medicine should not be used during labor.
SPASTYNA and other medicines
The doctor or pharmacist should be informed about all medicines currently or recently taken by the patient, as well as any planned to be taken.
Care should be taken when using the medicine with levodopa (a medicine used in Parkinson's disease) due to reduced antiparkinsonian effect and increased tremors and stiffness.
Children
The medicine should not be used in children under 6 years of age.
SPASTYNA with food and drink
The medicine can be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Drotaverine crosses the placenta. The medicine should not be used during labor.
It is not known whether drotaverine passes into breast milk. The use of this medicine is not recommended during breastfeeding.
Driving and using machines
At therapeutic doses, the medicine does not affect the ability to drive or operate machinery when taken orally.
In case of dizziness, driving or operating machinery should be avoided.
SPASTYNA contains lactose monohydrate
If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine.
3. How to take SPASTYNA
This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
The medicine is taken orally.
Adults: the daily dose is 120 to 240 mg, in 2 to 3 divided doses.
The maximum daily dose is 240 mg of drotaverine (6 tablets).
Children:
Clinical trials have not been conducted in children. The medicine should not be used in children under 6 years of age.
Care should be taken when using the medicine in children from 6 years of age.
If the medicine needs to be used in children, the daily dose is:
for children from 6 to 12 years of age - 80 mg, in 2 divided doses (the maximum daily dose of drotaverine is 80 mg),
for children over 12 years of age - 160 mg, in 2 to 4 divided doses (the maximum daily dose of drotaverine is 160 mg).
If there is no improvement or the patient feels worse after 10 days, a doctor should be consulted.
Taking a higher dose of SPASTYNA than recommended
There are no reports of overdose with the medicine.
In case of taking a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.
Missing a dose of SPASTYNA
In case of missing a dose of the medicine, it should be taken as soon as possible, unless it is close to the time for the next dose.
Two doses of the medicine should not be taken at the same time or in a short period.
A double dose should not be taken to make up for a missed dose.
In case of any further doubts about taking this medicine, a doctor or pharmacist should be consulted.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects (in 1 to 10 patients out of 10,000):
nausea, constipation,
headache, dizziness, insomnia,
palpitations, decreased blood pressure,
allergic reactions (angioedema, urticaria, rash, pruritus).
Reporting side effects
If any side effects occur, including any not listed in the package leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.
5. How to store SPASTYNA
Store in the original package, protected from light, at a temperature below 25°C.
The medicine should be kept out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.
6. Package contents and other information
What SPASTYNA contains
- The active substance is drotaverine hydrochloride. One tablet contains 40 mg of drotaverine hydrochloride.
- The other ingredients (excipients) are: lactose monohydrate, maize starch, povidone K 30, magnesium stearate.
What SPASTYNA looks like and contents of the package
SPASTYNA is a round, biconvex tablet with a smooth surface and yellow color. One package of the medicine contains 20 or 40 tablets.
Marketing authorization holder and manufacturer
“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel.: 22 742 00 22
e-mail: [email protected]
Date of last revision of the package leaflet:
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- ImporterPrzedsiębiorstwo Produkcji Farmaceutycznej HASCO-LEK S.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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