No-spa Comfort

Package Leaflet: Information for the User

NO-SPA Comfort, 40 mg, coated tablets

Drotaverine hydrochloride
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Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this package leaflet for the patient 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 tell their doctor or pharmacist. See section 4.
• If after 10 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

No-Spa Comfort is a spasmolytic medicine that reduces pain (painful spasms) in the abdominal and pelvic organs, i.e., the digestive tract (stomach and intestines), bile and urinary tract, and in women, also the reproductive tract.
No-Spa Comfort 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 action of drotaverine does not depend on the type of innervation and the location of smooth muscles (digestive tract, urinary and reproductive 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 Comfort is used:

• in spastic conditions of the smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, papillitis
• in spastic conditions of the smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, painful urination and as an adjunct:
• in spastic conditions of the smooth muscles of the digestive tract: gastric and duodenal ulcer disease, gastritis, enteritis, colitis, in spastic conditions

of the pylorus and cardia of the stomach, irritable bowel syndrome, spastic constipation and intestinal bloating, pancreatitis

• in gynecological disorders: painful menstruation.

2. Important information before using No-Spa Comfort

When not to use No-Spa Comfort:

• if the patient is allergic (hypersensitive) to drotaverine, soy, peanuts, or any of the other ingredients of the 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 starting to use No-Spa Comfort, the patient should discuss it with their doctor.
Caution should be exercised when using No-Spa Comfort:

• in patients with hypotension
• in children from 6 years of age (see section 3)
• in pregnant women.

The medicine should not be used during labor.

No-Spa Comfort 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.
Caution should be exercised when administering No-Spa Comfort with levodopa (a medicine used in Parkinson's disease) due to the reduced anti-Parkinsonian effect and increased tremors and stiffness.

No-Spa Comfort 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 before using this medicine.
Drotaverine crosses the placenta.
The medicine should not be used during labor.
It is not recommended to use this medicine during breastfeeding.

Driving and using machines

At therapeutic doses, the medicine does not affect the ability to drive vehicles or operate machinery when taken orally.
In case of dizziness, the patient should avoid potentially hazardous activities, such as driving or operating machinery.

No-Spa Comfort contains lactose monohydrate, tartrazine (E 102), and soy lecithin.

Each tablet contains 52 mg of lactose monohydrate, 0.007 mg of tartrazine (E 102), and 0.245 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 tartrazine (E 102), the medicine may cause allergic reactions.
Due to the presence of soy lecithin, the medicine should not be used in case of known hypersensitivity to peanuts or soy.

3. How to use No-Spa Comfort

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
The medicine is administered orally.
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 using No-Spa Comfort in children from 6 years of age.
In case of necessity to use No-Spa Comfort in children:

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

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

Using a higher dose of No-Spa Comfort 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 Comfort

In case of missing a dose of the medicine, 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.
In case of any further doubts about using the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, No-Spa Comfort can cause side effects, although not everybody gets them.
Rare(may affect up to 1 in 1000 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products, ul. 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 Comfort

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the carton or blister.
The expiry date refers to the last day of the month.
Store in a temperature below 25°C. Store in the original package to 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What No-Spa Comfort contains

• The active substance of the medicine is drotaverine. Each coated tablet contains 40 mg of drotaverine hydrochloride.
• The other ingredients of the medicine are: tablet core: lactose monohydrate, corn starch, povidone, magnesium stearate, talc. tablet coating: Opadry II pink 85G34397, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soy), carmine (E 120), tartrazine (E 102).

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

The pack contains 20, 30, 40, or 60 coated tablets.
Blisters of PA/Al/PVC/Al or PVC/Al foil 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, please 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