No-spa Forte

Leaflet attached to the packaging: patient information

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

NO-SPA Forte

80 mg, tablets

Drotaverine hydrochloride

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• 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.

Table of contents of the leaflet

• 1. What is No-Spa Forte and what is it used for
• 2. Important information before taking No-Spa Forte
• 3. How to take No-Spa Forte
• 4. Possible side effects
• 5. How to store No-Spa Forte
• 6. Package contents 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 abdominal and pelvic cavities, i.e., in the digestive tract (stomach and intestines), bile and urinary tracts, and in women, also in the reproductive tract.
No-Spa Forte 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 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 Forte is used:

• for spastic conditions of the smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, papillitis of Vater,
• for spastic conditions of the smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, 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, spastic conditions of the gastric inlet and pylorus, irritable bowel syndrome, spastic constipation and intestinal bloating, pancreatitis,
• for gynecological disorders: painful menstruation,
• for tension headaches.

2. Important information before taking No-Spa Forte

When not to take 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 circulatory failure,
• if the patient has a second- or third-degree atrioventricular block,
• in children under 12 years of age.

Warnings and precautions

Before starting to take No-Spa Forte, discuss it with your doctor.
Caution should be exercised when taking No-Spa Forte:

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

Do not take the medicine during childbirth.

No-Spa Forte and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Caution should be exercised when taking No-Spa Forte with levodopa (a medicine used for Parkinson's disease) due to reduced anti-Parkinsonian effect and increased tremors and stiffness.

No-Spa Forte with food and drink

No-Spa Forte can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine.
Drotaverine passes through the placenta.
Do not take the medicine during childbirth.
It is not recommended to take this medicine during breastfeeding.

Driving and using machines

In therapeutic doses, drotaverine taken orally does not affect the ability to drive vehicles and operate machines.
If dizziness occurs, avoid potentially hazardous activities, such as driving or operating machines.

No-Spa Forte contains lactose monohydrate

Each tablet contains 104 mg of lactose monohydrate.
If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take No-Spa Forte

Take this medicine always as directed by your doctor. If you are unsure, 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 trials have not been conducted in children.
If No-Spa Forte needs to be used, 80 mg for children:

• the daily dose for children over 12 years of age is: 160 mg, in 2 to 4 divided doses. Caution should be exercised when taking No-Spa Forte in children over 12 years of age.

Taking a higher dose of No-Spa Forte than recommended

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

Missing a dose of No-Spa Forte

Do not take a double dose to make up for a missed dose.
If you have any further doubts about taking this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, No-Spa Forte 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 headache, dizziness
• 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 this leaflet, 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 this 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 package.
Do not use this medicine after the expiry date stated on the package.
The expiry date refers to the last day of the specified month.
Medicines should 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. Package contents and other information

What No-Spa Forte contains

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

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

• The other excipients are: magnesium stearate, talc, povidone, corn starch, lactose monohydrate.

What No-Spa Forte looks like and what the package contains

The package contains 24 or 48 tablets of 80 mg each.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Opella Healthcare France SAS
82 Avenue Raspail
94250 Gentilly
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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Lithuanian, country of export marketing authorization number: LT/1/99/0784/007

Parallel import authorization number: 217/22 Date of leaflet approval: 16.05.2022

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