Drotapil forte
PolandTable of Contents
Drotapil Forte, 80 mg, tablets
Drotaverini hydrochloridum
Please read this leaflet carefully before using the 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 a doctor or pharmacist.
- Keep this leaflet for future reference.
- If advice or further information is needed, please consult a pharmacist.
- If any adverse reactions occur, 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 the patient feels worse, consult a doctor.
Table of contents
- What Drotapil Forte is and what it is used for
- Important information before taking Drotapil Forte
- How to take Drotapil Forte
- Possible side effects
- How to store Drotapil Forte
- Contents of the pack and other information
1. What Drotapil Forte is and what it is used for
Drotapil Forte is a spasmolytic medicine used to treat:
- Spasms of smooth muscles associated with biliary tract diseases: gallbladder stones, biliary stones, cholecystitis;
- Spasms of smooth muscles associated with urological disorders: kidney stones, ureteral stones, pyelitis, cystitis, and painful urinary urgency.
Drotapil Forte may also be used as supportive treatment in:
- Gastrointestinal smooth muscle spasms: peptic ulcer disease of the stomach and duodenum, gastritis, gastric spasms, enteritis, irritable bowel syndrome with spastic constipation or intestinal distension;
- Certain types of headache (tension-type);
- Gynecological conditions: dysmenorrhea (painful menstruation).
If there is no improvement or if symptoms worsen, medical advice should be sought.
2. Important information before using Drotapil Forte
When not to take Drotapil Forte:
- 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 Forte, consult a doctor or pharmacist.
Caution should be exercised when using drotaverine in patients with hypotension.
Drotapil Forte and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Concomitant use of drotaverine with levodopa (a medicine used in Parkinson's disease) reduces the effect of levodopa, which may lead to increased muscle rigidity and tremors.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, 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 data.
Driving and operating machinery
Drotapil Forte, when administered at usual doses, is unlikely to affect the ability to drive or operate machinery. However, if dizziness occurs after taking this medicine, dangerous situations should be avoided and driving or operating machinery should be refrained from.
Drotapil Forte contains lactose
In case of lactose intolerance, it should be noted that Drotapil Forte contains lactose monohydrate as an excipient (40 mg in each tablet), 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 Forte
This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults: The daily dose is 120 to 240 mg (in 2–3 divided doses). If necessary, use Drotapil 40 mg tablets to achieve the appropriate single dose.
Use in children and adolescents
Clinical studies on the use of drotaverine in children have not been conducted.
If use is necessary, children over 12 years of age should not receive more than 160 mg, i.e. 2 tablets (in 1–2 divided doses).
In case of any doubt regarding dosage, consult a doctor or pharmacist.
Taking more Drotapil Forte than recommended
If a patient takes one extra tablet, it is unlikely to cause any adverse effects.
In case of overdose, contact a doctor immediately, as significant overdose of drotaverine may cause heart problems, which in some cases may lead to death. If possible, take the medicine packaging along to show it to the doctor.
Missed dose of Drotapil Forte
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, stop taking Drotapil Forte and contact your doctor immediately:
- angioedema, which is associated with sudden swelling of deeper layers of the 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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warszawa
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 Drotapil Forte
Keep this medicine out of the 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. This will help protect the environment.
6. Contents of the pack and other information
What Drotapil Forte contains
The active substance is dropropizine hydrochloride. Each tablet contains 80 mg of dropropizine hydrochloride.
Other ingredients are: monohydrate lactose, 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 imprint "80" on one side and a score line on the other. The tablet can be divided into equal doses.
10 or 20 tablets in transparent PVC/Aluminium blisters, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Biofarm Sp. z o.o.
Wałbrzyska 13
60-198 Poznań
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