SPASTYNA MAX

Package leaflet: Information for the patient

SPASTYNA MAX
80 mg, tablets
Drotaverini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents

1. What SPASTYNA MAX is and what it is 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. Contents of the package and other information

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

The active substance in SPASTYNA MAX is drotaverine hydrochloride. This substance is used in spasms of smooth muscles of both neural and muscular origin, most commonly manifesting as abdominal pain. The spasmolytic effect of drotaverine does not depend on the type of innervation or the location of the smooth muscles (gastrointestinal tract, urinary and genital system, circulatory system, and biliary ducts). The drug is metabolized in the liver and is excreted mainly in urine and to a lesser extent in feces.

Indications
SPASTYNA MAX is indicated for:
spastic conditions of smooth muscles associated with biliary tract diseases: biliary calculi, cholecystitis, pericholecystitis, cholangitis, inflammation of the Vater's papilla;
spastic conditions of the urinary tract smooth muscles: nephrolithiasis, ureteric calculi, pyelitis, cystitis, painful urge to urinate;
and additionally, as supportive treatment:
spastic conditions of gastrointestinal smooth muscles: peptic ulcer of the stomach and duodenum, gastritis, enteritis, colitis, spasms of the stomach inlet and pylorus, irritable bowel syndrome, spastic constipation and intestinal meteorism, pancreatitis;
gynecological disorders: dysmenorrhea.

If there is no improvement after 7 days, or if you feel worse, consult your doctor.
1/4

2. Information before using SPASTYNA MAX

When not to use 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 second- or third-degree atrioventricular block,
in children under 12 years of age.

Warnings and precautions
Before starting treatment with SPASTYNA MAX, consult your doctor or pharmacist.
Due to the presence of lactose, this medicine may cause gastrointestinal symptoms in patients with lactose intolerance.
Use SPASTYNA MAX with caution in patients with hypotension.
Exercise caution when using the medicine in pregnant women and children over 12 years of age.
Do not use the medicine during labour.

SPASTYNA MAX and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Exercise caution when using SPASTYNA MAX concomitantly with levodopa (a medicine used in Parkinson's disease), as it may reduce its antiparkinsonian effect and worsen tremors and rigidity.

Children
Do not use this medicine in children under 12 years of age.

SPASTYNA MAX with food and drink
This medicine may be taken with or without food.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Drotaverine crosses the placenta. Do not use the medicine during labour.
It is not known whether drotaverine passes into human breast milk. Use of this medicine during breastfeeding is not recommended.

Driving and operating machinery
At therapeutic doses, SPASTYNA MAX does not affect the ability to drive or operate machinery.
However, if dizziness occurs, driving or operating machinery should be avoided.

SPASTYNA MAX contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use SPASTYNA MAX

2/4
This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for oral use.
Recommended dosage:
Adults: The daily dose is 120 to 240 mg, divided into 2 to 3 doses.
The maximum daily dose is 240 mg of drotaverine (3 tablets).
Children:
Clinical studies have not been conducted in children. SPASTYNA MAX should not be used in children under 12 years of age.
Caution should be exercised when using SPASTYNA MAX in children over 12 years of age.
If use of SPASTYNA MAX is necessary in children over 12 years of age, the daily dose is 160 mg, divided into 2 to 4 doses.
The maximum daily dose of drotaverine in this age group is 160 mg.
Do not use SPASTYNA MAX for longer than 7 days without consulting a doctor.
Taking more SPASTYNA MAX than recommended
There are no reports on overdose of this medicine.
If you take more than the recommended dose, contact your doctor or pharmacist immediately.
If you miss a dose of SPASTYNA MAX
If you miss a dose, take it as soon as possible, unless it is almost time for your next dose.
Do not take a double dose or two doses close together.
Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions occurring rarely (in 1 to 10 patients per 10,000):
nausea, constipation,
headache, dizziness, insomnia,
palpitations, decreased blood pressure,
allergic reactions (angioedema, urticaria, rash, itching).
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
3/4
By reporting adverse reactions, additional information regarding the safety of the medicine can be collected.

5. How to store SPASTYNA MAX

Store below 25°C.
Keep in the tightly closed original packaging to protect from light.
Keep 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 specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What SPASTYNA MAX contains

• The active substance is drotaverine hydrochloride. One tablet contains 80 mg of drotaverine hydrochloride.
• Other components (excipients) are: monohydrate lactose, pregelatinized corn starch, povidone K 30, magnesium stearate.

What SPASTYNA MAX looks like and contents of the pack
SPASTYNA MAX is an oval, biconvex tablet with a smooth surface and yellow colour. The tablets have a break line on one side, allowing division into two equal doses.
One pack contains 20 tablets.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medical information
tel.: 22 742 00 22
e-mail: [email protected]
4/4