No-spa Max

Package Leaflet: Information for the User

NO-SPA Max,80 mg, coated tablets
Drotaverine hydrochloride
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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 the package leaflet or as directed by a doctor, pharmacist, or nurse.

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

Table of Contents of the Leaflet

• 1. What is No-Spa Max and what is it used for
• 2. Important information before taking No-Spa Max
• 3. How to take No-Spa Max
• 4. Possible side effects
• 5. How to store No-Spa Max
• 6. Contents of the pack and other information

1. What is No-Spa Max and what is it used for

No-Spa Max is a spasmolytic medicine that reduces pain (painful spasms) in the abdominal and pelvic cavities, i.e., in the digestive tract (stomach and intestines), bile ducts, and urinary tract, as well as in the female reproductive system.
No-Spa Max contains drotaverine hydrochloride as the active substance. 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 the smooth muscles (digestive tract, urinary system, circulatory system, and bile ducts).
The medicine is metabolized in the liver and excreted mainly in the urine and to a lesser extent through the digestive tract.

No-Spa Max is used:

• for spastic conditions of the smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, papillitis
• for spastic conditions of the smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, painful urination

and as an adjunct:

• for spastic conditions of the smooth muscles of the digestive 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
• for gynecological disorders: dysmenorrhea.

2. Important information before taking No-Spa Max

When not to take No-Spa Max:

• if the patient is allergic to drotaverine, peanuts, soy, or any other component of this medicine (listed in section 6).
• if the patient has severe liver, kidney, or circulatory failure.
• if the patient has a second- or third-degree atrioventricular block.
• in children under 12 years of age.

Warnings and precautions

Before taking No-Spa Max, the patient should discuss it with their doctor or pharmacist.
Caution should be exercised when taking the medicine:

• in patients with hypotension
• in pregnant women
• in children over 12 years of age

No-Spa Max 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.
Caution should be exercised when taking No-Spa Max with levodopa (a medicine used for Parkinson's disease) due to reduced antiparkinsonian effect and increased tremors and stiffness.

No-Spa 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 taken during labor.
It is not recommended to take this medicine during breastfeeding.

Driving and using machines

In therapeutic doses, No-Spa Max does not affect the ability to drive or operate machinery.
If dizziness occurs, the patient should avoid potentially hazardous activities, such as driving or operating machinery.

No-Spa Max contains lactose monohydrate, quinoline yellow, and soy lecithin

Each tablet contains 104 mg of lactose monohydrate, 1.04 mg of quinoline yellow lake (E 104), and 0.294 mg of soy lecithin. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Due to the presence of quinoline yellow, the medicine may cause allergic reactions.

• The medicine contains soy lecithin. It should not be taken in case of known hypersensitivity to peanuts or soy.

The medicine contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

No-Spa Max contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take No-Spa Max

This medicine should always be taken exactly as described in the package leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.
Recommended dose

• Adults:1 coated tablet 2 or 3 times a day; the daily dose is 120 to 240 mg.

Use in children:
Clinical trials have not been conducted in children. Caution should be exercised when taking No-Spa Max in children over 12 years of age.
If it is necessary to use the medicinal product No-Spa Max in children over 12 years of age:

• 1 coated tablet 1 or 2 times a day; the maximum daily dose for children is 160 mg.

Without consulting a doctor, the medicine can be taken for a maximum of 7 days.
The dividing line on the tablet is not intended for dividing the tablet into two equal doses.

Taking a higher dose of No-Spa Max than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of No-Spa Max

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

4. Possible side effects

Like all medicines, No-Spa Max can cause side effects, although not everybody gets them.
Rare(affect 1 to 10 in 10,000 patients):

• allergic reactions (angioedema, urticaria, rash, pruritus)
• peripheral (vestibular) headache and dizziness, insomnia
• palpitations, decreased blood pressure
• nausea, constipation.

Frequency not known(cannot be estimated from the available data):

• central dizziness.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 or its representative in Poland.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store No-Spa Max

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging to protect from light.
Do not take the medicine after the expiry date stated on the packaging.
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. Contents of the pack and other information

What No-Spa Max contains

• The active substance is drotaverine. Each coated tablet contains 80 mg of drotaverine hydrochloride.
• The other ingredients are: tablet core: lactose monohydrate, corn starch, povidone, magnesium stearate, talc. Coating:Opadry II yellow 85G32207: polyvinyl alcohol, talc, quinoline yellow lake (E 104), macrogol, titanium dioxide (E 171), soy lecithin, yellow iron oxide (E 172), red iron oxide (E 172).

What No-Spa Max looks like and contents of the pack

The pack contains 10, 20, 24, 40, 48, 50, or 60 coated tablets.
The coated tablets are yellow, oblong, and biconvex. One side of the tablet has the inscription "NOSPA", and the other side has a dividing line that is not intended for dividing the tablet into two equal doses.
The coated tablets are packaged in blisters of PA/Al/PVC/Al or PVC/Al foil in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Opella Healthcare Commercial Ltd.
Váci út 133. "E" épület 3. Emelet,

• 1138 - Budapest, Hungary

Manufacturer
Opella Healthcare Poland Sp. z o. o.
Rzeszów Branch
ul. Lubelska 52
35-233 Rzeszów
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of last revision of the leaflet: