No-spa

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

NO-SPA

40 mg, tablets

Drotaverine hydrochloride

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should 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 and what is it used for
• 2. Important information before using No-Spa
• 3. How to use No-Spa
• 4. Possible side effects
• 5. How to store No-Spa
• 6. Contents of the packaging 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 ulcer disease, gastritis, enteritis, colitis, and spastic conditions of the gastric cardia and pylorus, irritable bowel syndrome, spastic constipation, and intestinal bloating, pancreatitis;
• for 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 a second- or third-degree atrioventricular block;
• in children under 6 years of age.

Warnings and precautions

Before starting to use No-Spa, you should discuss it with your doctor.
You should be cautious when using No-Spa:

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

Do not use the medicine during labor.

No-Spa and other medicines

You should tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
You should be cautious when using 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Drotaverine passes through the placenta.
Do not use the medicine 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 or use machines when taken orally.
In case of dizziness, you should avoid potentially hazardous activities such as driving or using machines.

No-Spa contains lactose monohydrate

Each tablet contains 52 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the 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 you are unsure, you should consult your 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. You should be cautious when using No-Spa in children aged 6 years.
If No-Spa needs to be used in children:

• daily dose for children aged 6 to 12 years: 80 mg, in 2 divided doses
• daily dose for children over 12 years: 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 than recommended

If you have taken more than the recommended dose of the medicine, you should immediately consult your doctor or pharmacist.

Missing a dose of No-Spa

If you miss a dose of the medicine, you should take it as soon as possible, unless it is almost time for the next dose.
You should not take two doses of the medicine at the same time or in a short period.
If you have any further questions about using this medicine, you should consult your 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 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 you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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.
By reporting side effects, you can help provide more information on the safety of the medicine.

5. How to store No-Spa

The medicine should be stored out of 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What No-Spa contains

• The active substance of the medicine is drotaverine (in the form of drotaverine hydrochloride). 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 contents of the packaging

The packaging contains 24 tablets, in an Al/PVC blister pack in a cardboard box.
For more detailed information, you should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian marketing authorization number, in the country of export:LT/1/96/0784/005
Parallel import authorization number:282/17
Date of leaflet approval: 29.08.2022
[Information about the trademark]