Drotapil Forte

Patient Information Leaflet User Information

Drotapil Forte, 80 mg, tablets

Drotaverine hydrochloride

Read 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 your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after a few days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

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

Drotapil Forte is a spasmolytic medicine used to treat:

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

Drotapil Forte may be used as an adjunctive treatment for:

• gastrointestinal spasm: 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 absence of improvement and in the event of worsening symptoms, consult your doctor.

2. Important information before taking Drotapil Forte

When not to take Drotapil Forte:

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

Warnings and precautions

Before taking Drotapil Forte, discuss it with your doctor or pharmacist.
Caution should be exercised when taking drotaverine in patients with arterial hypotension.

Drotapil Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or 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 you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your 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 Forte, when taken in the usual doses, is unlikely to affect the ability to drive or operate machinery.
In the event of dizziness after taking this medicine, avoid hazardous situations, do not drive, and do not operate machinery.

Drotapil Forte contains lactose

In case of lactose intolerance, consider that Drotapil Forte contains lactose monohydrate (40 mg in each tablet) as an excipient, which may cause gastrointestinal discomfort.
If you have previously been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.

3. How to take Drotapil Forte

This medicine should always be taken exactly as described in the patient information leaflet or as directed by your doctor or pharmacist.
In case of doubt, consult your doctor or pharmacist.
Recommended dose
Adults: the daily dose is 120 to 240 mg (in 2-3 divided doses). If necessary, a 40 mg Drotapil tablet should be taken to achieve the appropriate single dose.
Use in children and adolescents
Clinical trials have not been conducted on the use of drotaverine in children.
In case of necessity, children over 12 years of age should not take more than 160 mg, i.e., 2 tablets (in 1-2 divided doses).
In case of doubt about the dose, consult your doctor or pharmacist.

Overdose of Drotapil Forte

If you take one tablet more than recommended, it is unlikely to cause any adverse effects.
In the event of an overdose, contact your doctor immediately, as significant overdosing of drotaverine may cause heart problems, which in some cases can be fatal. If possible, take the medicine packaging with you to show the doctor.

Missed dose of Drotapil Forte

Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare side effects may have serious consequences. If you notice any of the following side effects, stop taking Drotapil Forte and contact your doctor immediately:

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

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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 this medicine.

5. How to store Drotapil Forte

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 specified month.
Store at a temperature below 30°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Drotapil Forte contains

The active substance of the medicine is drotaverine hydrochloride. Each tablet contains 80 mg of drotaverine hydrochloride.
The other ingredients of the medicine are: lactose monohydrate, microcrystalline cellulose (102), povidone (K30), corn starch, magnesium stearate, talc.

What Drotapil Forte looks like and contents of the pack

Yellow, round, biconvex tablets with the engraving "80" on one side and a dividing line on the other side. The tablet can be divided into equal doses.
10 or 20 tablets in a transparent PVC/Aluminum blister pack and a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Biofarm Sp. z o.o. ul.
Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: biofarm@biofarm.pl
Manufacturer
Meditop Pharmaceutical Ltd.
Ady Endre u. 1.
2097 Pilisborosjenő
Hungary

Date of last revision of the leaflet: