Package leaflet: Information for the patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
NO-SPA Forte
80 mg, tablets
Drotaverini hydrochloridum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is NO-SPA Forte and what is it used for
Important information before taking NO-SPA Forte
How to take NO-SPA Forte
Possible side effects
How to store NO-SPA Forte
Contents of the pack and other information

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

NO-SPA Forte is a spasmolytic medicine that reduces pain (painful spasms) in the organs of the
abdominal cavity and the pelvic region, i.e. in the gastrointestinal tract (stomach and intestines),
biliary and urinary tracts, and in women also in the genital tract.
NO-SPA Forte contains drotaverine hydrochloride as the active substance.
This substance is used in smooth muscle spasms of both nervous and muscular origin.
The spasmolytic effect of drotaverine does not depend on the type of innervation or the location
of smooth muscles (gastrointestinal tract, urogenital 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 Forte is indicated:

in spastic conditions of smooth muscles associated with biliary tract diseases: biliary calculi, cholecystitis, pericholecystitis, cholangitis, papillitis of Vater's papilla,
in spastic conditions of smooth muscles of the urinary tract: nephrolithiasis, ureteric calculi, pyelitis, cystitis, painful urge to urinate, and as adjunctive therapy:
in spastic conditions of smooth muscles of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, enteritis, colitis, spasms of the pylorus and gastric orifice, irritable bowel syndrome, spastic constipation and intestinal flatulence, pancreatitis,
in gynecological disorders: dysmenorrhea,
in tension-type headaches.

2. Important information before using No-Spa Forte

When not to use No-Spa Forte:

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 cardiac insufficiency,
if the patient has second- or third-degree atrioventricular block,
in children under 12 years of age.

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

in patients with hypotension,
in children over 12 years of age (see section 3),
in pregnant women.

Do not use the medicine during childbirth.
No-Spa Forte and other medicines
Inform your doctor 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 the risk of reduced antiparkinsonian effect and worsening of tremors and rigidity.
No-Spa Forte with food and drink
No-Spa Forte may 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 her doctor before using this medicine.
Drotaverine crosses the placenta.
Do not use the medicine during childbirth.
Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
At therapeutic doses, orally administered drotaverine does not affect 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 Forte contains lactose monohydrate
Each tablet contains 104 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use NO-SPA Forte

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor.
The package contains 24 or 48 tablets.
1 tablet contains 80 mg of drotaverine hydrochloride.
Adults:
The daily dose is 120 to 240 mg in 2 to 3 divided doses.
Use in children:
Clinical studies have not been conducted in children.
If use of NO-SPA Forte 80 mg in children is necessary:

the daily dose for children over 12 years of age is 160 mg, in 2 to 4 divided doses. Caution should be exercised when using NO-SPA Forte in children over 12 years of age.

Taking more than the recommended dose of NO-SPA Forte
If more than the recommended dose is taken, seek immediate advice from a doctor or
pharmacist.
Missed dose of NO-SPA Forte
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Rare (may occur in up to 1 in 1,000 people):

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

Frequency not known (cannot be estimated from available data):

central origin dizziness.

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

5. How to store NO-SPA Forte

Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect the
environment.

6. Contents of the packaging and other information

What No-Spa Forte contains

The active substance in No-Spa Forte is drotaverine (in the form of drotaverine hydrochloride).

One No-Spa Forte tablet contains 80 mg of drotaverine hydrochloride.

Other excipients: magnesium stearate, talc, povidone, maize starch, lactose monohydrate.

What No-Spa Forte looks like and contents of the pack
The pack contains 24 or 48 tablets of 80 mg.
Yellow, elongated, convex tablets with a greenish or orange tint. On one side of the tablet there is the inscription "NOSPA", on the other side there is a break line.
For further information, please contact the responsible party or the parallel importer.
Responsible party in Lithuania, country of export:
Opella Healthcare France SAS
157 Avenue Charles De Gaulle
92200 Neuilly-sur-Seine
France
Manufacturer:
Opella Healthcare Hungary Limited Liability Company
(Opella Healthcare Hungary Ltd.)
Lévai utca 5
2112 Veresegyhaz
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/1/99/0784/007
Parallel import authorization number: 217/22