Patient Information Leaflet

Drotafemme, 40 mg, coated tablets
Drotaverini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.
Always use this medicine exactly as described in this patient leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any that are not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If there is no improvement or if your condition worsens after 7 days, consult your doctor.

Table of contents

What Drotafemme is and what it is used for
Important information before taking Drotafemme
How to take Drotafemme
Possible side effects
How to store Drotafemme
Contents of the pack and other information

1. What Drotafemme is and what it is used for

Drotafemme is a spasmolytic medicine that reduces pain (painful spasms) in the abdominal cavity and pelvic organs, including the gastrointestinal tract (stomach and intestines), biliary and urinary tracts, and in women, also the genital tract.
Drotafemme contains drotaverine hydrochloride as the active substance. This substance is used in smooth muscle spasms of both neural and muscular origin, which most commonly manifest as abdominal pain. The spasmolytic effect of drotaverine does not depend on the type of innervation or the location of the smooth muscles (gastrointestinal tract, urogenital system, circulatory system, or biliary tract).
The medicine is metabolized in the liver and is excreted mainly in the urine and to a lesser extent via the gastrointestinal tract.
Drotafemme is indicated:

in spastic conditions of smooth muscles associated with biliary tract diseases: biliary colic, cholecystitis, pericholecystitis, cholangitis, and inflammation of the Vater's papilla;
in spastic conditions of the urinary tract: renal colic, ureteric colic, pyelitis, cystitis, and painful urinary urgency;

and as adjunctive therapy:

in spastic conditions of the gastrointestinal tract: gastric and duodenal ulcer, gastritis, enteritis, colitis, spasms of the pylorus and cardiac sphincter, irritable bowel syndrome, spastic constipation, intestinal flatulence, and pancreatitis;
in gynecological disorders: dysmenorrhea (painful menstruation).

2. Important information before using Drotafemme

When not to use Drotafemme:

if the patient is allergic to drotaverine or any of the other ingredients of this medicine (listed in section 6),
if the patient has severe liver, kidney or circulatory insufficiency,
if the patient has second- or third-degree atrioventricular block,
in children under 6 years of age.

Warnings and precautions
Before starting treatment with Drotafemme, consult your doctor or pharmacist.
Exercise caution when using Drotafemme:

in patients with hypotension,
in children over 6 years of age (see section 3),
in pregnant women.

Do not use the medicine during childbirth.
Drotafemme and other medicines
Inform your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take.
Exercise caution when administering concomitantly with levodopa (a medicine used in Parkinson's disease), due to reduced antiparkinsonian effect and worsening of tremors and rigidity.
Children
This medicine should not be used in children under 6 years of age.
Drotafemme with food and drink
The medicine can be taken with food or independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Drotaverine crosses the placenta.
Do not use the medicine during childbirth.
Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
At therapeutic doses, oral administration of the medicine has no effect on the ability to drive or operate machinery.
If dizziness occurs, avoid potentially hazardous activities such as driving or operating machinery.
Drotafemme contains lactose, maltodextrin (a source of glucose), sunset yellow and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
Due to the presence of sunset yellow, the medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, meaning the medicine is considered "sodium-free".

3. How to take Drotafemme

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults
The daily dose is 120 to 240 mg, divided into 2 to 3 doses.

Use in children and adolescents
Clinical studies have not been conducted in children.
If use of Drotafemme in children is necessary:

the daily dose for children aged 6 to 12 years is 80 mg, divided into 2 doses,
for children over 12 years of age, the daily dose is 160 mg, divided into 2 to 4 doses.

Caution should be exercised when administering Drotafemme to children aged 6 years and older.

The medicine is taken orally.
Do not use the medicine for longer than 7 days without consulting a doctor.

Taking more Drotafemme than recommended
If you take more than the recommended dose, contact your doctor or pharmacist immediately.

Missing a dose of Drotafemme
If you miss a dose, take it as soon as possible, unless it is almost time for the next dose.
Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicinal products, this medicine can cause adverse effects, although not everyone will experience them.
Rarely (may affect up to 1 in 1,000 patients), the following may occur:
nausea, constipation, peripheral (vestibular) vertigo, insomnia, palpitations, decreased blood pressure, and allergic reactions (angioedema, urticaria, rash, itching).
Frequency unknown (cannot be estimated based on available data): central vertigo.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, please inform your doctor or pharmacist. Adverse effects 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 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Drotafemme

Keep this medicine out of sight and reach of children.
Do not store above 30°C.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Medicines should 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 Drotafemme contains

The active substance is drotaverine hydrochloride. Each tablet contains 40 mg of drotaverine hydrochloride.
Other ingredients are: tablet core: lactose monohydrate, maize starch, maltodextrin, sodium croscarmellose, magnesium stearate; tablet coating: hypromellose, titanium dioxide (E 171), talc, sodium saccharin (E 954), macrogol 4000, orange lake (E 110), yellow iron oxide (E 172).

What Drotafemme looks like and contents of the pack
Drotafemme is an orange-coloured, film-coated, round, biconvex tablet.
Blister packs made of PVC/PE/PVDC/Aluminium in a cardboard carton containing 20, 30, 40 or 60 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki
tel. +48 22 350 66 69

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna, Germany