No-spa ampuvki

Package Leaflet: Information for the Patient

NO-SPA Ampoules, 20 mg/ml, Solution for Injection

Drotaverine Hydrochloride
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Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is No-Spa Ampoules and what is it used for
• 2. Important information before using No-Spa Ampoules
• 3. How to use No-Spa Ampoules
• 4. Possible side effects
• 5. How to store No-Spa Ampoules
• 6. Contents of the pack and other information

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

No-Spa Ampoules is a solution for subcutaneous, intramuscular, and intravenous injection, containing the active substance drotaverine. Drotaverine belongs to the group of antispasmodic drugs. It is used in smooth muscle spasm of both nervous and muscular origin. The spasmolytic effect of drotaverine does not depend on the type of innervation and localization of smooth muscles (gastrointestinal tract, urogenital system, cardiovascular system, and bile ducts).

No-Spa Ampoules are used:

• in spastic conditions of smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis,
• in spastic conditions of smooth muscles of the urinary tract: kidney stones, pyelonephritis, cystitis, painful urination, as an adjunct:
• in spastic conditions of smooth muscles of the gastrointestinal tract: in gastric and duodenal ulcer disease, in spastic conditions of the pylorus and cardia of the stomach, irritable bowel syndrome, spastic constipation, and intestinal bloating,
• in gynecological disorders: painful menstruation.

2. Important information before using No-Spa Ampoules

When not to use No-Spa Ampoules:

• if you are allergic to drotaverine or any of the other ingredients of this medicine (listed in section 6) (especially - hypersensitivity to sodium metabisulfite),
• if you have severe renal and hepatic impairment,
• if you have severe heart failure (low output syndrome),
• in children.

Warnings and precautions

Before starting to use No-Spa Ampoules, discuss it with your doctor.
Caution should be exercised when administering No-Spa Ampoules:

• in patients with hypotension. Due to the risk of syncope, the drug should be administered intravenously to a lying patient.
• in pregnant women.

The medicine contains sodium metabisulfite, which may cause severe hypersensitivity reactions, including anaphylactic symptoms and bronchospasm. This applies especially to sensitive patients, particularly those with asthma and allergy in their history. In case of hypersensitivity to sodium metabisulfite, avoid parenteral administration of the medicine.

No-Spa Ampoules and other medicines

Tell your doctor about all the medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Phosphodiesterase inhibitors, such as papaverine (a smooth muscle relaxant of internal organs) and its derivatives, reduce the antiparkinsonian effect of levodopa (a medicine used in Parkinson's disease). When drotaverine and levodopa are used together, the patient may experience increased tremors and stiffness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Drotaverine crosses the placenta.
Do not use the medicine during labor.
The use of this medicine is not recommended during breastfeeding.

Driving and using machines

After parenteral administration, especially intravenous, avoid potentially hazardous activities, such as driving or operating machinery.

No-Spa Ampoules contain sodium metabisulfite

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

No-Spa Ampoules contain alcohol (ethanol)

3. How to use No-Spa Ampoules

This medicine should always be used as directed by your doctor or pharmacist.
If you are unsure, ask your doctor or pharmacist.
The medicine is for subcutaneous, intramuscular, or intravenous use.
The daily dose is 40 to 240 mg and should be administered in 1 to 3 divided doses, subcutaneously or intramuscularly.
In case of acute bile duct or kidney colic, 40 to 80 mg of drotaverine is administered slowly (approx. 30 seconds) intravenously.
In other spastic abdominal pains, 40 to 80 mg of drotaverine is administered intramuscularly or subcutaneously. If necessary, the dose of the medicine can be repeated up to 3 times a day.
If you feel that the effect of No-Spa Ampoules is too strong or too weak, ask your doctor.

Using more than the recommended dose of No-Spa Ampoules

In case of overdose, contact your doctor immediately.

Missing a dose of No-Spa Ampoules

If you miss a dose, take it as soon as possible, unless it is close to the time of the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor.

4. Possible side effects

Like all medicines, No-Spa Ampoules can cause side effects, although not everybody gets them.
Side effects during treatment with drotaverine are rare.
Rare(may affect up to 1 in 1000 people):

• allergic reactions (angioedema, urticaria, rash, pruritus)
• peripheral headache, dizziness, insomnia
• palpitations, decreased blood pressure
• nausea, constipation, and reactions at the injection site.

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

• central dizziness.

In patients treated with drotaverine in the form of a solution for injection, anaphylactic shock may occur, with an unknown frequency, which can lead to death.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store No-Spa Ampoules

Keep the medicine out of the sight and reach of children.
Store the medicine at a temperature below 25°C. Protect from light.
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What No-Spa Ampoules contain

• The active substance of the medicine is drotaverine hydrochloride. 2 ml (1 ampoule) contains 40 mg of drotaverine hydrochloride. 1 ml of the solution for injection contains 20 mg of drotaverine hydrochloride.
• The other excipients are: sodium metabisulfite, ethanol 96%, water for injections.

What No-Spa Ampoules look like and what the pack contains

The pack contains 5 or 25 ampoules of orange glass, 2 ml each, in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder
Opella Healthcare Commercial Ltd.
Váci út 133. „E” épület 3. Emelet,

• 1138 - Budapest, Hungary

Manufacturer
CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd.
3510 Miskolc
Csanyikovölgy
Hungary
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00

Date of last revision of the leaflet: