Drotapil

Drotapil, 40 mg, tablets
Drotaverini hydrochloridum
Please read the following package leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after a few days, or if you feel worse, consult your doctor.

Table of contents

1. What Drotapil is and what it is 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 Drotapil is and what it is used for

Drotapil is an antispasmodic medicine used to treat:

• Spasms of smooth muscles associated with biliary tract diseases: gallstones, cholelithiasis, cholecystitis;
• Spasms of smooth muscles associated with urological diseases: kidney stones, ureteric stones, pyelitis, cystitis, and painful urinary urgency.

Drotapil may also be used as supportive treatment in:

• Gastrointestinal tract spasms: peptic ulcer of the stomach and duodenum, gastritis, gastric spasms, enteritis, irritable bowel syndrome with spastic constipation or intestinal bloating;
• Certain headaches (tension-type);
• Gynecological conditions: dysmenorrhea (painful menstruation).

If there is no improvement in symptoms, or if symptoms worsen, medical advice should be sought from a doctor.

2. Important information before using Drotapil

When not to take Drotapil:

• if the patient is allergic to the active substance (drotaverine) or to 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, consult a doctor or pharmacist.
Caution is advised when using drotaverine in patients with arterial hypotension.

Drotapil and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Concomitant use of drotaverine with levodopa (a medicine used in Parkinson's disease) reduces the effectiveness of levodopa, which may lead to increased skeletal muscle rigidity and tremors.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

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

Breastfeeding
Use of this medicine during breastfeeding is not recommended due to lack of adequate study results.

Driving and operating machinery
Drotapil, when used at usual doses, is unlikely to affect the ability to drive or operate machinery. However, if dizziness occurs after taking this medicine, the patient should avoid hazardous situations, refrain from driving and operating machinery.

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

3. How to use Drotapil

This medicine should always be taken exactly as described in the patient leaflet or as directed by a
physician or pharmacist. If in doubt, consult a 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
Clinical studies on the use of Drotapil in children have not been conducted.
If 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 available for children under 6 years of age.

In case of doubt regarding dosage, consult a physician or pharmacist.
Taking more Drotapil than recommended
If a patient takes one extra tablet, it is unlikely to cause any adverse effects.
In case of overdose, seek immediate medical advice, as significant overdosage of drotaverine may cause heart problems, which in some cases may lead to death. If possible, bring the medicine packaging along to show the doctor.
Missed dose of Drotapil
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 or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some rare adverse reactions may have serious consequences. If you notice any of the adverse reactions listed below, discontinue use of Drotapil immediately and contact your doctor without delay:

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

Rare (occurring in 1 to 10 out of 10,000 patients):
allergic reactions (swelling, urticaria, rash, itching),
headache, dizziness, insomnia, palpitations, hypotension,
nausea, constipation.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: +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 marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Drotapil

Keep the medicine 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 stated month.
Store below 30°C. Keep in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the packaging and other information

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

What Drotapil looks like and contents of the pack
Yellow, round, biconvex tablets, embossed with the marking "40" on one side and unmarked on the other side.
20 tablets in a transparent PVC/Aluminium blister pack and a cardboard box.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
Wałbrzyska 13
60-198 Poznań
Poland
Tel.: +48 61 66 51 500
Fax: +48 61 66 51 505
E-mail: [email protected]

Manufacturer
Meditop Pharmaceutical Ltd.
Ady Endre u. 1.
2097 Pilisborosjenő
Hungary