Drotafemme

Package Leaflet: Information for the User

Drotafemme, 40 mg, Coated Tablets

Drotaverine Hydrochloride

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

This medicine should always be taken exactly as described in the package leaflet for the patient or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 7 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Drotafemme and what is it used for

Drotafemme is a spasmolytic medicine that reduces pain (painful spasms) in the abdominal and pelvic cavities, i.e., in the digestive tract (stomach and intestines), bile ducts, and urinary tract, as well as in the female reproductive system.
Drotafemme contains drotaverine hydrochloride as the active substance. This substance is used to treat smooth muscle spasms of both nervous and muscular origin, most often manifested by abdominal pain. The spasmolytic effect of drotaverine does not depend on the type of innervation or the location of the smooth muscles (digestive tract, urogenital system, circulatory system, and bile ducts).
The medicine is metabolized in the liver and excreted mainly in the urine and to a lesser extent through the digestive tract.
Drotafemme is used:

• in spastic conditions of the smooth muscles associated with bile duct diseases: bile duct stones, cholecystitis, pericholecystitis, cholangitis, and papillitis of Vater,
• in spastic conditions of the smooth muscles of the urinary tract: kidney stones, ureteral stones, pyelonephritis, cystitis, and painful urination

and as an adjunct:

• in spastic conditions of the smooth muscles of the digestive tract: gastric and duodenal ulcers, gastritis, enteritis, colitis, spastic conditions of the pylorus and cardia of the stomach, irritable bowel syndrome, spastic constipation, intestinal bloating, and pancreatitis,
• in gynecological disorders: in painful menstruation.

2. Important information before taking Drotafemme

When not to take 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 failure,
• if the patient has a second- or third-degree atrioventricular block,
• in children under 6 years of age.

Warnings and precautions

Before starting to take Drotafemme, the patient should discuss it with their doctor or pharmacist.
Care should be taken when taking Drotafemme:

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

Drotafemme should not be taken during labor.

Drotafemme and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
Care should be taken when administering Drotafemme with levodopa (a medicine used in Parkinson's disease) due to the reduced effect of levodopa and increased tremors and stiffness.

Children

Drotafemme should not be taken by children under 6 years of age.

Drotafemme with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Drotaverine passes through the placenta.
Drotafemme should not be taken during labor.
It is not recommended to take this medicine during breastfeeding.

Driving and using machines

At therapeutic doses, the medicine does not affect the ability to drive or operate machinery when taken orally.
In case of dizziness, the patient should avoid potentially hazardous activities such as driving or operating machinery.

Drotafemme contains lactose, maltodextrin (a source of glucose), orange yellow, and sodium.

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Due to the presence of orange yellow, the medicine may cause allergic reactions.
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is considered "sodium-free".

3. How to take Drotafemme

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If there are any doubts, the patient should consult their doctor or pharmacist.

Adults

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

Use in children and adolescents

No clinical trials have been conducted in children.
In case Drotafemme needs to be taken by children:

• the daily dose for children aged 6 to 12 years is 80 mg, in 2 divided doses,
• for children over 12 years of age, the daily dose is 160 mg, in 2 to 4 divided doses. Care should be taken when administering Drotafemme to children aged 6 and over.

The medicine is taken orally.
Without consulting a doctor, the medicine should not be taken for more than 7 days.

Taking a higher dose of Drotafemme than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Drotafemme

In case a dose of the medicine is missed, it should be taken as soon as possible, unless it is close to the time of the next dose.
A double dose should not be taken to make up for a missed dose.
If there are any further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Drotafemme can cause side effects, although not everybody gets them.
Rarely (may affect up to 1 in 1000 patients), the following may occur:
nausea, constipation, peripheral (vestibular) headache and dizziness, insomnia, palpitations, decreased blood pressure, and allergic reactions (angioedema, urticaria, rash, pruritus).
Frequency not known (cannot be estimated from the available data): central dizziness.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient 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
tel.: +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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Drotafemme

The medicine should be stored 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Drotafemme contains

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

What Drotafemme looks like and contents of the pack

Drotafemme is orange, round, biconvex coated tablets.
Blisters of PVC/PE/PVDC/Aluminum in a cardboard box, containing 20, 30, 40, or 60 coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: