Drotafemme Forte

Package Leaflet: Information for the User

Drotafemme Forte, 80 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 after 7 days or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet

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

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

Drotafemme Forte 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 the reproductive organs in women.

Drotafemme Forte contains drotaverine hydrochloride as the active substance. This substance is used for 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 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 Forte is used:

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

and as an adjunct:

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

2. Important information before taking Drotafemme Forte

When not to take Drotafemme Forte:

• 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 12 years of age.

Warnings and precautions

Before starting to take Drotafemme Forte, the patient should discuss it with their doctor or pharmacist.

Care should be taken when taking Drotafemme Forte:

• in patients with hypotension,
• in children over 12 years of age (see section 3),
• in pregnant women.

The medicine should not be taken during labor.

Drotafemme Forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

Care should be taken when co-administering with levodopa (a medicine used in Parkinson's disease) due to reduced antiparkinsonian effect and increased tremors and stiffness.

Children

The medicine should not be taken by children under 12 years of age.

Drotafemme Forte with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Drotaverine crosses the placental barrier.

The medicine should not be taken during labor.

It is not recommended to take this medicine during breastfeeding.

Driving and using machines

In therapeutic doses, the medicine does not affect the ability to drive vehicles or operate machinery.

In case of dizziness, the patient should avoid potentially hazardous activities, such as driving or operating machinery.

Drotafemme Forte contains lactose, maltodextrin (a source of glucose), quinoline 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 quinoline 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 Forte

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

In case of 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 of necessity to use Drotafemme Forte in children over 12 years of age:

The maximum daily dose for children is 160 mg, in 2 to 4 divided doses.

Care should be taken when taking Drotafemme Forte in children over 12 years of age.

The medicine is taken orally.

The tablet can be divided into equal doses.

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

Overdose of Drotafemme Forte

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

Missed dose of Drotafemme Forte

In case of missing a dose, the patient should take it 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.

In case of further doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Drotafemme Forte can cause side effects, although not everybody gets them.

Rarely (may affect up to 1 in 1,000 patients), the following may occur:

nausea, constipation, peripheral (vestibular) headache and dizziness, insomnia, palpitations, decreased blood pressure, and allergic reactions (angioedema, urticaria, rash, itching).

Frequency not known (cannot be estimated from the available data): central dizziness.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they 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 Forte

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 Forte contains

• The active substance is drotaverine hydrochloride. Each tablet contains 80 mg of drotaverine hydrochloride.
• The other ingredients are: tablet core:lactose monohydrate, corn starch, maltodextrin, sodium croscarmellose, magnesium stearate, tablet coating:hypromellose, titanium dioxide (E171), talc, sodium saccharin (E954), macrogol 4000, quinoline yellow lake (E104), iron oxide red (E172).

What Drotafemme Forte looks like and contents of the pack

Drotafemme Forte is a yellow, round, biconvex coated tablet with a dividing line on both sides.

PVC/PE/PVDC/Aluminum blisters in a cardboard box, containing 20 coated tablets.

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: