NO-SPA MAX

Package leaflet: Information for the user

NO-SPA Max, 80 mg, coated tablets
Drotaverini hydrochloridum
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Please read the entire leaflet carefully before taking this medicine, because it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the doctor, pharmacist, or nurse.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Table of contents of the leaflet

1. What NO-SPA Max is and what it is used for
2. Important information before taking NO-SPA Max
3. How to take NO-SPA Max
4. Possible side effects
5. How to store NO-SPA Max
6. Contents of the pack and other information

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

NO-SPA Max is a spasmolytic medicine that reduces pain (painful spasms) in the organs of the abdominal cavity and the pelvic region, including the gastrointestinal tract (stomach and intestines), biliary and urinary tracts, and in women, also the genital tract.
NO-SPA Max contains drotaverine hydrochloride as the active substance. This substance is used in smooth muscle spasms of both neural and muscular origin, which most commonly manifest as abdominal pain. The spasmolytic effect of drotaverine is independent of the type of innervation and the location of smooth muscles (gastrointestinal tract, urinary and genital 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 Max is indicated for use in:

• smooth muscle spasms associated with biliary tract diseases: biliary calculosis, cholecystitis, pericholecystitis, cholangitis, and Vater's papillitis

• smooth muscle spasms of the urinary tract: nephrolithiasis, ureteric calculosis, pyelitis, cystitis, and painful micturition

as well as adjunctively in:

• smooth muscle spasms of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, enteritis, colitis, spasms of the stomach inlet and pylorus, irritable bowel syndrome, spastic constipation and intestinal distension, pancreatitis

• gynecological disorders: dysmenorrhea.

2. Information before using No-Spa Max

When not to use No-Spa Max:

• if the patient is allergic to drotaverine, peanuts, soya, 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 Max, consult your doctor or
pharmacist.
Exercise caution when using this medicine:

• in patients with hypotension
• in pregnant women
• in children over 12 years of age

No-Spa Max with other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.
Exercise caution when administering concomitantly with levodopa (a medicine used in Parkinson's disease), as this may reduce its anti-Parkinsonian effect and worsen tremors and rigidity.
No-Spa Max with food and drink
This medicine may be taken with or without food.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist 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
At therapeutic doses, No-Spa Max does not affect the ability to drive or operate machinery.
If dizziness occurs, avoid potentially hazardous activities such as driving or operating machinery.
No-Spa Max contains monohydrate lactose, quinoline yellow, and soya lecithin
Each tablet contains 104 mg monohydrate lactose, 1.04 mg quinoline yellow lake (E 104), and 0.294 mg soya lecithin.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Due to the presence of quinoline yellow, this medicine may cause allergic reactions.
This medicine contains soya lecithin. Do not use if the patient has been diagnosed with hypersensitivity to peanuts or soya.
No-Spa Max contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use NO-SPA Max

This medicine should always be taken exactly as described in the patient leaflet or
as advised by your doctor, pharmacist, or nurse. If in doubt, consult your
doctor, pharmacist, or nurse.

Recommended dose

Adults:

• 1 coated tablet 2 or 3 times daily; the daily dose ranges from 120 to 240 mg.

Use in children:
Clinical studies have not been conducted in children. Caution should be exercised
when using NO-SPA Max in children above 12 years of age.
If use of NO-SPA Max is necessary in children above 12 years of age:

• 1 coated tablet 1 or 2 times daily; the maximum daily dose for children is 160 mg.

Without consulting a doctor, this medicine may be used for a maximum of 7 days.
The tablet breakline is not intended for splitting the tablet.

Taking more NO-SPA Max than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.

Missing a dose of NO-SPA Max
If you miss a dose, take it as soon as possible, unless it is almost time for your next dose.
Do not take a double dose to make up for a missed dose.

If you have any further doubts about the use of this medicine, consult your
doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not
occur in everyone.
Rare (occur in 1 to 10 out of 10,000 patients):

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

Frequency unknown (cannot be estimated based on available data):

• central dizziness.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet,
please inform your doctor or pharmacist. Adverse effects can be reported directly to the Department for Monitoring 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 effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting adverse effects, additional information on the safety of this medicine can be collected.

5. How to store NO-SPA Max

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the container.
The expiry date refers to the last day of the stated month.
Medicines should 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 package and other information

What No-Spa Max contains

• The active substance is drotaverine. Each coated tablet contains 80 mg of drotaverine hydrochloride.
• The other ingredients are: tablet core: monohydrate lactose, corn starch, povidone, magnesium stearate, talc. Tablet coating: Opadry II yellow 85G32207: polyvinyl alcohol, talc, quinoline yellow lake (E 104), macrogol, titanium dioxide (E 171), lecithin (soya), yellow iron oxide (E 172), red iron oxide (E 172).

What No-Spa Max looks like and contents of the pack
The pack contains 10, 20, 24, 40, 48, 50 or 60 coated tablets.
The coated tablets are yellow, oblong-shaped and convex. On one side of the tablet there is
the imprint "NOSPA", on the other side there is a break line which does not serve to divide the tablet into two equal doses.
The coated tablets are packed in blisters made of PA/Al/PVC/Al or PVC/Al foil in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Opella Healthcare Commercial Ltd.
Váci út 133. „E” épület 3. Emelet,
1138 - Budapest
Hungary

Manufacturer
Opella Healthcare Poland Sp. z o.o.
Branch in Rzeszów
ul. Lubelska 52
35-233 Rzeszów

For more detailed information, contact the representative of the Marketing Authorisation Holder:
Opella Healthcare Poland Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warszawa
Tel.: +48 22 280 00 00