No-spa

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
NO-SPA
40 mg, tablets
Drotaverini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because 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, so that you can read it again if necessary.
• 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, consult your doctor.

Contents of the leaflet

1. What No-Spa is and what it is 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. Contents of the pack and other information

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

No-Spa is a spasmolytic medicine that reduces pain (painful spasms) in the abdominal organs and the pelvic cavity, i.e. in the gastrointestinal tract (stomach and intestines), biliary and urinary tracts, and in women also in the genital tract.
No-Spa contains drotaverine hydrochloride as the active substance. This substance is used in smooth muscle spasms of both neural and muscular origin. 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 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 is indicated:

• in smooth muscle spasm associated with biliary tract diseases: biliary calculi, cholecystitis, pericholecystitis, cholangitis, inflammation of the Vater's papilla;
• in smooth muscle spasm of the urinary tract: nephrolithiasis, ureteric calculi, pyelitis, cystitis, painful urge to urinate; and additionally, as supportive treatment:
• in smooth muscle spasm of the gastrointestinal tract: 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;
• in gynecological disorders: dysmenorrhea.

2. Important information before using No-Spa

When not to use 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 second- or third-degree atrioventricular block;
• in children under 6 years of age.

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

• 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 with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be used.
Exercise caution when administering concomitantly with levodopa (a medicine used in Parkinson's disease), due to reduced antiparkinsonian effect and increased tremors and rigidity.
No-Spa 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 become pregnant, 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, orally administered No-Spa has no influence on the ability to drive or operate machinery.
However, if dizziness occurs, potentially hazardous activities such as driving or operating machinery should be avoided.
No-Spa contains monohydrate lactose
Each tablet contains 52 mg of monohydrate lactose.
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use NO-SPA

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.

Adults:
Daily dose: 120 mg 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 in children aged 6 years and older.

If use of NO-SPA 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 or if the patient feels worse after 10 days, consult a doctor.

Taking more NO-SPA than recommended
In case of taking more than the recommended dose, seek immediate advice from a doctor or pharmacist.

Missing a dose of NO-SPA
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose.
Do not take a double dose or two doses close together.

If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although they do not occur in everyone.
Rare (may occur in up to 1 in 1,000 people):

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

Frequency unknown (cannot be estimated from available data):

• central dizziness.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects 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, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store NO-SPA

Keep the medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
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 packaging and other information

What No-Spa contains

• The active substance is drotaverine (in the form of drotaverine hydrochloride). Each tablet contains 40 mg of drotaverine hydrochloride.
• Other ingredients are: maize starch, monohydrate lactose, magnesium stearate, talc, povidone.

What No-Spa looks like and contents of the pack
The pack contains 24 tablets in Al/PVC blisters in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
UAB „Sanofi-Aventis Lietuva”
A. Juozapavičiaus g. 6/2
LT-09310 Vilnius
Lithuania
Manufacturer:
Opella Healthcare Hungary Ltd.
(Opella Healthcare Hungary Limited Liability Company)
2112 Veresegyház, Lévai utca 5
Hungary
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Lithuania, country of export: LT/1/96/0784/005
Parallel import authorization number: 282/17