Package leaflet: Information for the user

Drotafemme Forte, 80 mg, coated tablets
Drotaverini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, as it contains important
information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please contact your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, you should contact your doctor.

Contents of the leaflet

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

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

Drotafemme Forte is an antispasmodic medicine that reduces pain (painful spasms) in the organs of the
abdominal cavity and pelvic region, including the gastrointestinal tract (stomach and intestines),
biliary and urinary tracts, and in women, also the genital tract.
Drotafemme Forte contains, as the active substance, drotaverine hydrochloride. 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, urinary and genital systems, 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 Forte is indicated:

in smooth muscle spasm associated with biliary tract diseases: biliary calculi, cholecystitis, pericholecystitis, cholangitis, papillitis of Vater's papilla,
in smooth muscle spasm of the urinary tract: renal colic, ureteric colic, pyelitis, cystitis, painful urinary urgency,

and as adjunctive treatment:

in smooth muscle spasm of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, gastritis, enteritis, colitis, spasms of the gastric inlet and outlet (cardia and pylorus), irritable bowel syndrome, spastic constipation, intestinal distension, and pancreatitis,
in gynaecological conditions: dysmenorrhoea (painful menstruation).

2. Information before using Drotafemme Forte

When not to use 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 insufficiency,
if the patient has second- or third-degree atrioventricular block,
in children under 12 years of age.

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

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

Do not use the medicine during labour.
Drotafemme Forte and other medicines
Tell 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.
Exercise caution when administering concomitantly with levodopa (a medicine used in Parkinson's disease), due to reduced anti-Parkinsonian effect and worsening of tremor and rigidity.
Children
This medicine should not be used in children under 12 years of age.
Drotafemme Forte with food and drink
The medicine can be taken with food or independently of meals.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Drotaverine crosses the placenta.
Do not use the medicine during labour.
Use of this medicine during breastfeeding is not recommended.
Driving and operating machinery
At therapeutic doses, the medicine taken orally does not affect the ability to drive or operate machinery.
If dizziness occurs, potentially hazardous activities such as driving or operating machinery should be avoided.
Drotafemme Forte contains lactose, maltodextrin (a source of glucose), quinoline yellow and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this 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, meaning the medicine is considered "sodium-free".

3. How to use Drotafemme 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.
Adults
The daily dose is 120 to 240 mg, in 2 to 3 divided doses.
Use in children and adolescents
Clinical studies have not been conducted in children.
If use of Drotafemme Forte is necessary in children above 12 years of age:
the maximum daily dose for children is 160 mg, in 2 to 4 divided doses.
Caution should be exercised when using Drotafemme Forte in children above 12 years of age.
The medicine is taken orally.
The tablet may be divided into equal doses.
Do not use the medicine for longer than 7 days without consulting a doctor.
Taking more than the recommended dose of Drotafemme Forte
If more than the recommended dose is taken, consult a doctor or pharmacist immediately.
Missed dose of Drotafemme Forte
If a dose is missed, take it as soon as possible, except when it is close to the time for the next dose.
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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 everybody will experience them.
Rarely (may affect up to 1 in 1,000 patients), the following may occur:
nausea, constipation, peripheral (vestibular) dizziness, insomnia, palpitations,
decreased blood pressure, and allergic reactions (angioedema, urticaria, rash, itching).
Frequency not known (cannot be estimated based on available data): central dizziness.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Drotafemme Forte

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 following 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. Such measures 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, maize 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, film-coated, round, biconvex tablet with a break line on both sides.
Blister packs made of PVC/PE/PVDC/Aluminium in a cardboard box containing 20, 40 or 50 film-coated tablets.

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