Spastina Max

Leaflet attached to the packaging: patient information

SPASTYNA MAX

80 mg, tablets

Drotaverine hydrochloride

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is SPASTYNA MAX and what is it used for
• 2. Important information before taking SPASTYNA MAX
• 3. How to take SPASTYNA MAX
• 4. Possible side effects
• 5. How to store SPASTYNA MAX
• 6. Package contents and other information

1. What is SPASTYNA MAX and what is it used for

The active substance of SPASTYNA MAX is drotaverine hydrochloride. This substance is used for smooth muscle spasms of both nervous and muscular origin, most often manifested by abdominal pain. The spasmolytic effect of drotaverine does not depend on the type of innervation and the location of smooth muscles (gastrointestinal tract, genitourinary system, circulatory 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 MAX is used in:
spastic conditions of smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, papillitis;
spastic conditions of smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, painful urination;
and as an adjunct:
in spastic conditions of smooth muscles of the gastrointestinal tract: gastric and duodenal ulcer disease, gastritis, enteritis, colitis, spastic conditions of the gastric inlet and pylorus, irritable bowel syndrome, spastic constipation and intestinal bloating, pancreatitis;
in gynecological disorders: painful menstruation.
If after 7 days there is no improvement or the patient feels worse, they should consult a doctor.
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2. Important information before taking SPASTYNA MAX

When not to take SPASTYNA MAX

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,
in children under 12 years of age.

Warnings and precautions

Before taking SPASTYNA MAX, the patient should discuss it with their doctor or pharmacist.
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 over 12 years of age.
The medicine should not be used during labor.

SPASTYNA MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Care should be taken when using the medicine with levodopa (a medicine used in Parkinson's disease) due to the reduced antiparkinsonian effect and increased tremors and stiffness.

Children

The medicine should not be used in children under 12 years of age.

SPASTYNA MAX with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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

In therapeutic doses, the medicine does not affect the ability to drive vehicles or operate machines.
In case of dizziness, the patient should avoid driving vehicles or operating machines.

SPASTYNA MAX contains lactose monohydrate

If the patient has previously been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take SPASTYNA MAX

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This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
The recommended dose is:
Adults: the daily dose is 120 to 240 mg in 2 to 3 divided doses.
The maximum daily dose is 240 mg of drotaverine (3 tablets).
Children:
Clinical trials have not been conducted in children. The medicine should not be used in children under 12 years of age.
Care should be taken when using the medicine in children over 12 years of age.
If the product SPASTYNA MAX is to be used in children over 12 years of age, the daily dose is 160 mg, in 2 to 4 divided doses.
The maximum daily dose of drotaverine in this age group is 160 mg.
The medicine SPASTYNA MAX should not be used for more than 7 days without consulting a doctor.

Overdose of SPASTYNA MAX

There are no reports of overdose with this medicine.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missed dose of SPASTYNA MAX

In case of missing a dose, the patient should take it as soon as possible, unless it is close to the time of the next dose.
The patient should not take two doses of the medicine at the same time or at short intervals.
The patient should not take a double dose to make up for a missed dose.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist or nurse.

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, itching).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. 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.
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Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store SPASTYNA MAX

Store in a temperature below 25°C.
Store in the original packaging to protect from light.
The medicine should be kept out of the 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What SPASTYNA MAX contains

• The active substance of the medicine is drotaverine hydrochloride. One tablet contains 80 mg of drotaverine hydrochloride.
• The other ingredients (excipients) are: lactose monohydrate, maize starch, povidone K 30, magnesium stearate.

What SPASTYNA MAX looks like and what the package contains

SPASTYNA MAX is an oval, biconvex tablet with a smooth surface and yellow color. The tablets have a score line for dividing the tablet into two equal doses.
One package of the medicine contains 20 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: informacjaoleku@hasco-lek.pl

Date of last update of the leaflet:

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