No-spa

Leaflet attached to the packaging: information for the user

NO-SPA 40 mg, tablets
Drotaverine hydrochloride
{logo}

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, 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 side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 10 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

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

No-Spa 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 contains drotaverine hydrochloride as the active substance. 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 (digestive tract, urogenital 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 is used:

• for spastic conditions of the smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, and papillitis
• for spastic conditions of the smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, and painful urination and as an adjunct:
• for spastic conditions of the smooth muscles of the digestive tract: gastric and duodenal ulcers, gastritis, enteritis, colitis, and spastic conditions of the pylorus and cardia, irritable bowel syndrome, spastic constipation, and intestinal bloating, pancreatitis
• for gynecological disorders: dysmenorrhea.

2. Important information before taking No-Spa

When not to take No-Spa:

• 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 6 years of age

Warnings and precautions

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

• in patients with hypotension
• in children aged 6 and over (see section 3)
• in pregnant women

No-Spa should not be taken during labor.

No-Spa 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 with levodopa (a medicine used for Parkinson's disease) due to the reduced effect of levodopa and increased tremors and stiffness.

No-Spa 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 baby, they should consult their doctor before taking this medicine.
Drotaverine crosses the placental barrier.
No-Spa should not be taken during labor.
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.
In case of dizziness, the patient should avoid potentially hazardous activities, such as driving or operating machinery.

No-Spa contains lactose monohydrate

Each tablet contains 52 mg of 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 No-Spa

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, the patient should consult their doctor, pharmacist, or nurse.
Adults:
Daily dose: 120 to 240 mg, in 2 to 3 divided doses.
Children:
Clinical trials have not been conducted in children. Caution should be exercised when taking No-Spa in children aged 6 and over.
If No-Spa needs to be taken in children:

• daily dose for children aged 6 to 12: 80 mg, in 2 divided doses
• daily dose for children over 12: 160 mg, in 2 to 4 divided doses.

If there is no improvement after 10 days or the patient feels worse, they should contact their doctor.

Taking a higher dose of No-Spa 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

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 two doses at the same time or in a short period.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

• 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 side effects not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 collected on the safety of the medicine.

5. How to store No-Spa

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton or blister.
The expiry date refers to the last day of the month.
The shelf life after opening the container is 12 months (packaging of 60 tablets).
Store below 25°C. Protect from light.
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 No-Spa contains

• The active substance of the medicine is drotaverine. Each tablet contains 40 mg of drotaverine hydrochloride.
• The other ingredients are: corn starch, lactose monohydrate, magnesium stearate, talc, povidone.

What No-Spa looks like and what the package contains

The tablets are yellow, round, and convex with a greenish or orange tint. On one side of the tablet, the inscription "spa" is present.
The package contains 10, 20, 24, 30, 40, 48, or 60 tablets in Al/PVC blisters in a cardboard box or 60 tablets in a PE container with a PP cap and a desiccant (silica gel) in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów
To obtain more detailed information, the patient should contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00
Date of last revision of the leaflet:April 2024