No-spa comfort

Patient Information Leaflet

NO-SPA Comfort, 40 mg, coated tablets
Drotaverini hydrochloridum
{logo}
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
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 10 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

1. What NO-SPA Comfort is and what it is used for

NO-SPA Comfort is an antispasmodic medicine that reduces pain (painful spasms) in the abdominal and pelvic organs, including the gastrointestinal tract (stomach and intestines), biliary and urinary tracts, and in women, also the genital organs.
NO-SPA Comfort contains drotaverine hydrochloride as the active substance. This substance is used in smooth muscle spasms of both nervous and muscular origin, which most commonly manifest 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, urogenital system, circulatory system, or biliary tract).
The drug is metabolized in the liver and is excreted mainly in the urine and to a lesser extent via the gastrointestinal tract.
NO-SPA Comfort is indicated for:

• Spasms of smooth muscles associated with biliary tract diseases: biliary colic, cholecystitis, pericholecystitis, cholangitis, papillitis of Vater's papilla

• Spasms of smooth muscles of the urinary tract: renal colic, ureteric colic, pyelitis, cystitis, painful urgency to urinate and additionally as supportive treatment:

• Spasms of smooth muscles of the gastrointestinal tract: peptic ulcer disease of the stomach and duodenum, gastritis, enteritis, colitis, spasms of the gastric inlet and outlet (cardia and pylorus), irritable bowel syndrome, spastic constipation and intestinal bloating, pancreatitis

• Gynecological conditions: dysmenorrhea (painful menstruation).

2. 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 second- or third-degree atrioventricular block,
• children under 6 years of age.

Warnings and precautions
Before starting treatment with No-Spa Comfort, consult your doctor.
Exercise caution when using No-Spa Comfort:

• in patients with hypotension,
• in children aged 6 years and older (see section 3),
• in pregnant women.

Do not use the medicine during childbirth.
No-Spa Comfort and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently used, as well as any medicines you plan to take.
Exercise caution when administering concomitantly with levodopa (a medicine used in Parkinson's disease), due to reduced anti-Parkinson activity and increased tremors and rigidity.
No-Spa Comfort with food and drink
The medicine can be taken with food or independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
Drotaverine crosses the placenta.
Do not use the medicine during childbirth.
Use of this medicine is not recommended during breastfeeding.
Driving and operating machinery
At therapeutic doses, the orally administered medicine does not affect the ability to drive or operate machinery.
If dizziness occurs, potentially hazardous activities such as driving or operating machinery should be avoided.
No-Spa Comfort contains monohydrate lactose, tartrazine (E 102) and soy lecithin.
Each tablet contains 52 mg of monohydrate lactose, 0.007 mg of tartrazine (E 102) and 0.245 mg of soy lecithin.
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should contact a doctor before taking the medicine.
Due to the presence of tartrazine (E 102), the medicine may cause allergic reactions.
Because of the presence of soy lecithin, the medicine should not be used if hypersensitivity to peanuts or soy has been diagnosed.

3. How to use No-Spa Comfort

This medicine should always be taken exactly as described in this patient information leaflet or as
advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor,
pharmacist, or nurse.
This medicine is for oral use.
Adults:
Daily dose: 120 to 240 mg, in 2 to 3 divided doses.
Children:
Clinical studies have not been conducted in children. Caution should be exercised when
administering No-Spa to children aged 6 years and older.
If use of No-Spa Comfort is necessary in children:

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

If there is no improvement after 10 days of treatment, or if the patient feels worse, contact a
doctor.
Taking more No-Spa Comfort than recommended
If you take more medicine than recommended, seek immediate advice from your doctor or
pharmacist.
Missed dose of No-Spa Comfort
If you miss a dose, take it as soon as possible, unless it is almost time for your next dose.
Do not take two doses at the same time or within a short interval.
If you have any further questions about the use of this medicine, consult your
doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine may cause adverse reactions, although not everybody experiences them.
Rare (may occur in no more than 1 in 1,000 people):

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

Frequency unknown (cannot be estimated based on available data):

• central origin dizziness.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 4921301, Fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl. Adverse reactions can also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store NO-SPA Comfort

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What No-Spa Comfort contains

• The active substance is drotaverine. Each coated tablet contains 40 mg of drotaverine hydrochloride.
• Other components of the medicine are: tablet core: monohydrate lactose, maize starch, povidone, magnesium stearate, talc.
  Coating of the tablet: Opadry II pink 85G34397, polyvinyl alcohol, talc, titanium dioxide (E171), macrogol, lecithin (soya), 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 made of PA/Al/PVC/Al or PVC/Al in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information, please contact:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00