📌 Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:
- Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after some days.
📑 What is in this leaflet:
- What No-Spa is and what it is used for
- What you need to know before you take No-Spa
- How to take No-Spa
- Possible side effects
- How to store No-Spa
- Contents of the pack and other information
1️⃣ WHAT NO-SPA IS AND WHAT IT IS USED FOR
No-Spa is a spasmolytic medicine, and may be used in the following conditions:
- Smooth muscle spasm in diseases of biliary origin: gallstones, inflammation of the gallbladder or bile ducts
- Smooth muscle spasm of urinary tract origin: urinary (renal or ureteral) stone, pyelitis, cystitis, urinary bladder
- Gastrointestinal smooth muscle spasm: stomach or duodenal ulcer, stomach mucosal inflammation, spasm of the sphincter muscle of gastric cardia or pylorus, inflammation of small or large intestines
- Gynaecologic diseases: painful menstruation or period cramps
2️⃣ WHAT YOU NEED TO KNOW BEFORE YOU TAKE NO-SPA
❌ Do not take No-Spa:
- If you are allergic to drotaverine or any of the other ingredients (listed in section 6)
- If you suffer from severe impairment of your liver, kidney, or heart
⚠️ Warnings and precautions:
- Talk to your doctor or pharmacist before taking No-Spa
- In patients with low blood pressure, administration of this medicine should be done with caution
💊 Other medicines and No-Spa:
- Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines
- Levodopa: When used concomitantly, drotaverine weakens the effect of levodopa in reducing symptoms of Parkinson’s disease and may amplify skeletal muscle rigidity and tremor
🤰 Pregnancy, breast-feeding, and fertility:
- Pregnancy: Based on animal experiments and human studies, no harmful effects were detected during pregnancy. However, your doctor will decide on use individually
- Lactation: Due to lack of clinical data, administration during lactation is not recommended
- Fertility: No data are available on human fertility
🚗 Driving and using machines:
- Usual doses of No-Spa have no effect on the ability to drive or use machines
- If dizziness occurs after taking the tablet, avoid activities performed in unsafe environments
🧁 No-Spa contains lactose:
- If your doctor has told you that you have intolerance to some sugars, talk to your doctor before taking this medicine
3️⃣ HOW TO TAKE NO-SPA
- Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you
- Check with your doctor or pharmacist if you are not sure
💊 Recommended dose:
- Adults: 3 to 6 tablets daily, divided into 2 to 3 doses
👶 Use in children and adolescents:
- Children aged 6 to 12 years: Not more than 80 mg daily, in 2 doses
- Children over 12 years: Not more than 160 mg daily, in 2 to 4 doses
- Children under 6 years: No data available
⚠️ If you take more No-Spa than you should:
- Contact your doctor or the nearest medical service immediately
- Overdose may cause heart rhythm and conduction disorders, which may be fatal
- Take the box of the medicine with you to show the doctor
❗ If you forget to take No-Spa:
- Do not take a double dose to make up for a forgotten dose
4️⃣ POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
🚨 Serious side effects (rare):
- Angioedema: rapid swelling of subcutaneous tissues involving throat, eyelids, lips, and genitals
🧠 Other side effects:
- Allergic skin reactions: urticaria, rash, itching
- Headache
- Dizziness
- Insomnia
- Palpitations
- Fall in blood pressure
- Nausea
- Constipation
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.
5️⃣ HOW TO STORE NO-SPA
- Store below 30°C
- Keep in the original package
- Keep out of the sight and reach of children
- Do not use this medicine after the expiry date stated on the box
- Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment.
6️⃣ CONTENTS OF THE PACK AND OTHER INFORMATION
💊 What No-Spa 40 mg tablet contains:
- Active substance: Drotaverine hydrochloride 40 mg
- Other ingredients: Magnesium stearate, talc, povidone, maize starch, lactose monohydrate
🟡 What No-Spa 40 mg tablet looks like:
- Yellow coloured, round, biconvex tablets with a shade of greenish or orange tint
- One face of the tablet is engraved with the sign "spa"
📦 Pack sizes:
- 20, 24 or 100 tablets in Al/Al or PVC/Al blister and box
- Not all pack sizes may be marketed in your country
🏢 Marketing Authorisation Holder:
Opella Healthcare Commercial Kft.
1045 Budapest, Tó u. 1–5, Hungary
This leaflet was last approved in: October 2021