Drotapil

Patient Information Leaflet User Instructions

Drotapil, 40 mg, tablets

Drotaverine hydrochloride

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

This medicine should always be taken exactly as described in this patient information leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after a few days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

• 1. What is Drotapil and what is it used for.
• 2. Important information before taking Drotapil
• 3. How to take Drotapil
• 4. Possible side effects.
• 5. How to store Drotapil
• 6. Contents of the pack and other information.

1. What is Drotapil and what is it used for

Drotapil is a spasmolytic medicine used to treat:

• smooth muscle spasms associated with biliary tract diseases: gallstones, bile duct stones, cholecystitis;
• smooth muscle spasms associated with urological diseases: kidney stones, ureteral stones, pyelonephritis, cystitis, and painful urination.

Drotapil may be used as an adjunctive treatment for:

• gastrointestinal spasms: gastric and duodenal ulcers, gastritis, gastric spasms, enteritis, irritable bowel syndrome with spastic constipation or intestinal bloating;
• Certain types of headaches (tension-type);
• gynecological disorders: dysmenorrhea.

In the event of no improvement and in the event of worsening symptoms, the patient should consult a doctor.

2. Important information before taking Drotapil

When not to take Drotapil:

• if the patient is allergic to the active substance (drotaverine) or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe liver, kidney, or heart failure.

Warnings and precautions

Before starting treatment with Drotapil, the patient should discuss it with their doctor or pharmacist.
Caution should be exercised when using drotaverine in patients with hypotension.

Drotapil and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Concomitant use of drotaverine with levodopa (a medicine used in Parkinson's disease) may weaken the effect of levodopa, which may cause increased muscle stiffness and tremors.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Pregnancy

Studies in animals and humans have not shown any harmful effects on the mother or fetus.
However, the use of this medicine during pregnancy requires special caution.

Breastfeeding

The use of this medicine is not recommended during breastfeeding, due to the lack of relevant study results.

Driving and using machines

Drotapil, when taken in usual doses, is unlikely to affect the ability to drive or operate machinery.
In the event of dizziness after taking this medicine, the patient should avoid hazardous situations, not drive, and not operate machinery.

Drotapil contains lactose

In the event of lactose intolerance, it should be noted that Drotapil contains lactose monohydrate (20 mg per tablet) as an excipient, which may cause gastrointestinal discomfort.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Drotapil

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist.
In case of doubt, the patient should consult their doctor or pharmacist.
Recommended dose
Adults: the daily dose is 120 to 240 mg, i.e., 3-6 tablets per day (in 2-3 divided doses).
Use in children and adolescents
No clinical studies have been conducted on the use of Drotapil in children.
If the use of this medicine is necessary:

• children aged 6 to 12 years: the daily dose should not exceed 80 mg, i.e., 2 tablets in 2 divided doses.
• adolescents over 12 years of age: the daily dose should not exceed 160 mg, i.e., 4 tablets (in 2-4 divided doses).
• no data are available for children under 6 years of age.

In case of doubt about the dose, the patient should consult their doctor or pharmacist.

Overdose of Drotapil

If the patient takes one tablet more than recommended, it is unlikely to cause any adverse effects.
In the event of taking a dose higher than recommended, the patient should immediately contact their doctor, as significant overdose of drotaverine may cause heart problems, which in some cases can be fatal.
If possible, the patient should take the medicine packaging with them to show it to the doctor.

Missed dose of Drotapil

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Drotapil can cause side effects, although not everybody gets them.
Some rare side effects may have serious consequences.
In the event of noticing any of the following side effects, the patient should stop taking Drotapil and immediately consult their doctor:

• angioedema, which is associated with sudden swelling of the deeper skin layers and may also affect the throat, eyelids, lips, and genital organs.

Rare (occurring in 1 to 10 per 10,000 patients):

allergic reactions (edema, urticaria, rash, pruritus),
headache, dizziness, insomnia, palpitations, hypotension,
nausea, constipation.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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
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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Drotapil

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Store in a temperature below 30°C.
Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines no longer required.
This will help protect the environment.

6. Contents of the pack and other information

What Drotapil contains

The active substance of Drotapil is drotaverine hydrochloride.
Each tablet contains 40 mg of drotaverine hydrochloride.
The other ingredients are: lactose monohydrate, microcrystalline cellulose (102), povidone K30, corn starch, magnesium stearate, talc.

What Drotapil looks like and contents of the pack

Yellow, round, biconvex tablets with the imprint "40" on one side and no imprint on the other side.
20 tablets in a transparent PVC/Aluminum blister pack and a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Biofarm Sp. z o.o. ul.
Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
email: [email protected]
Manufacturer
Meditop Pharmaceutical Ltd.
Ady Endre u. 1.
2097 Pilisborosjenő
Hungary

Date of last revision of the leaflet: