NO-SPA AMPOULES

Package leaflet: Information for the patient

NO-SPA Ampoules, 20 mg/ml, solution for injection
Drotaverini hydrochloridum
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Please read all of this leaflet carefully before use, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents

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

No-Spa Ampoules is available as a solution for subcutaneous, intramuscular, and intravenous injection, containing the active substance drotaverine hydrochloride. Drotaverine belongs to a group of medicines known as antispasmodics. It is used to relieve smooth muscle spasms of both nervous and muscular origin. The spasmolytic effect of drotaverine is independent of the type of innervation and the location of smooth muscles (gastrointestinal tract, urinary and genital systems, circulatory system, and bile ducts).

No-Spa Ampoules is used:

• in smooth muscle spasms associated with biliary tract diseases: biliary calculi, cholecystitis,
• in smooth muscle spasms of the urinary tract: renal calculi, pyelitis, cystitis, painful urge to urinate; additionally:
• in smooth muscle spasms of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, spasms of the gastric inlet and pylorus, irritable bowel syndrome, spastic constipation and intestinal flatulence,
• in gynaecological disorders: dysmenorrhoea.

2. Important information before using No-Spa Ampoules

When not to use No-Spa Ampoules:

• if the patient is allergic to drotaverine or any of the other ingredients of this medicine (listed in section 6) (especially - sensitivity to sodium metabisulfite),
• if the patient has severe renal or hepatic insufficiency,
• if the patient has severe heart failure (low-output syndrome),
• in children.

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

• in patients with arterial hypotension. Due to the risk of collapse, the intravenous administration should be given to a patient lying down.
• in pregnant women.

This medicine contains sodium metabisulfite, which may cause severe allergic reactions, including
anaphylactic symptoms and bronchospasm. This particularly affects sensitive patients, especially
those with a history of asthma or allergy. In case of hypersensitivity to sodium metabisulfite, avoid
parenteral administration of the drug.
No-Spa Ampoules and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the
patient plans to take.
Phosphodiesterase inhibitors, such as papaverine (a smooth muscle relaxant of internal organs) and its derivatives, reduce the antiparkinsonian effect of levodopa (a drug used in Parkinson's disease). When drotaverine and levodopa are used concomitantly, the patient may experience increased tremors and rigidity.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a
child, she should consult a doctor before using this medicine.
Drotaverine crosses the placenta.
Do not use this medicine during labour.
Use of this medicine is not recommended during breastfeeding.
Driving and operating machinery
After parenteral administration, especially intravenous, potentially hazardous activities such as
driving or operating machinery should be avoided.
No-Spa Ampoules contain sodium metabisulfite
This medicine may rarely cause severe allergic reactions and bronchospasm.
No-Spa Ampoules contain alcohol (ethanol)

3. How to use NO-SPA ampułki

This medicine should always be used as directed by a physician or pharmacist.
In case of doubt, consult a physician or pharmacist.
This medicine is for subcutaneous, intramuscular, or intravenous administration.
The daily dose ranges from 40 to 240 mg, administered in 1 to 3 divided doses, subcutaneously or intramuscularly.
In the case of an acute attack of biliary or renal colic, 40 to 80 mg of drotaverine should be administered slowly (approximately 30 seconds) intravenously.
For other spastic abdominal pains, 40 to 80 mg of drotaverine should be administered intramuscularly or subcutaneously. If necessary, the dose may be repeated up to a maximum of 3 times per day.
If you feel that the effect of NO-SPA ampułki is too strong or too weak, consult your physician.
Use of a higher than recommended dose of NO-SPA ampułki
In case of overdose, seek immediate medical advice.
Missed dose of NO-SPA ampułki
If a dose is missed, take it as soon as possible, unless it is almost time for the next dose.
Do not administer a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your physician.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions during the use of drotaverine occur rarely.
Rare (may occur in up to 1 in 1000 people):

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

Frequency not known (cannot be estimated based on available data):

• central dizziness.

In patients treated with drotaverine in the form of an injection solution, anaphylactic shock of unknown frequency may occur, which may lead to death.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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
Adverse reactions can also be reported to the responsible entity or the representative of the responsible entity in Poland.
Reporting adverse reactions enables the collection of further information on the safety of using the medicine.

5. How to store NO-SPA ampułki

Keep this medicine out of 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 indicated.
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 package and other information

What No-Spa Ampoules contains

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

What No-Spa Ampoules looks like and contents of the pack
The pack contains 5 or 25 amber glass ampoules with 2 ml each, in a cardboard box.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Opella Healthcare Commercial Ltd.
Váci út 133. „E” building, 3rd floor,
1138 Budapest
Hungary
Manufacturer
CHINOIN Pharmaceutical and Chemical Works Private Co. Ltd.
3510 Miskolc
Csanyikovölgy
Hungary
For more detailed information, please contact the representative of the Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Tel.: +48 22 280 00 00