Drotafemme Forte

Product description

Drotafemme Forte, 80 mg , film-coated tablets

Drotaverini hydrochloridum


pdf Package leafle Drotafemme Forte 80mg


Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

In this leaflet:
1. What Drotafemme Forte is and what it is used for
2. What you need to know before you take 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 Drotafemme Forte is and what it is used for

The active substance of Drotafemme Forte is drotaverine hydrochloride which is used in spasms of the smooth muscles of nervous and muscular origin often manifested by abdominal pain. The spasmolytic (relaxant) effect of drotaverine is independent of the arrangement or distribution of nerves (innervation) or location of smooth muscles (gastrointestinal tract, genitourinary system, circulatory system and bile ducts).
Drotafemme Forte 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:
- spasms of the smooth muscles associated with disorders of the biliary ways:
stones in the biliary ways, inflammation of the gall bladder, inflammation around the gall bladder, inflammation of the bile ducts, ampulla of Vater inflammation;
- spasms of the smooth muscles in the urinary tract:
stones in the kidneys and the urinary tract, renal pelvis inflammation, inflammation of the bladder, painful urination

Drotafemme Forte is also used as a complementary medicine in:

- spasm of the smooth muscles of the gastrointestinal tract: gastric and duodenal ulcer, inflammation of the stomach lining, bowel inflammation, inflammation of the colon, cardiospasm and polyrospasm, irritable bowel syndrome, spastic constipation, flatulence and pancreatitis,
- gynecological disorders: painful menstruation.


2. What you need to know before you take Drotafemme Forte

Do not take Drotafemme Forte:
- if you are allergic to drotaverine or any of the other ingredients of this medicine (listed in section 6)
- if you have serious liver, kidney and heart problems
- if you have 2nd or 3rd degree atrioventricular block
- in children under 12 years of age

Special warnings and precautions
Drotafemme Forte contains lactose which can cause gastrointestinal problems in patients with lactose intolerance.

Drotafemme Forte should be used with caution in patients with low blood pressure (hypotension).

Take special care when using Drotafemme Forte in pregnant women and children.

Drotafemme Forte and other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Caution should be taken when taking drotaverine together with levodopa (a medicine used in Parkinson's disease) as drotaverine reduces the anti-Parkinson effect which results in enhancement of shaking and rigidity.

Children

Drotafemme Forte should not be used in children under 12 years of age.

Taking Drotafemme Forte with food and drink

Drotafemme Forte can be taken with or without food and drink.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Drotaverine passes through the placenta.

Drotafemme Forte should not be used during labor and delivery.

Driving and using machines

At therapeutic doses, Drotafemme Forte has no effect on the ability to drive and use machines.
If you feel dizzy, you should avoid performing potentially hazardous activities such as driving and using machines.

Drotafemme Forte contains lactose and quinoline yellow.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Drotafemme Forte.

Drotafemme Forte contains quinoline yellow which may cause allergic reactions.

3. How to take Drotafemme Forte

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

Daily dose: 120 to 240 mg in 2 to 3 divided doses.

Children and adolescents

There are no clinical studies on the use of Drotafemme Forte in children.

If you have to use Drotafemme Forte in children over 12 years of age: the maximum daily dose in children is 160 mg in 2 – 4 divided doses.

Drotafemme Forte should be taken orally (by mouth).

The tablet can be divided into two equal doses.

Do not take Drotafemme Forte for more than 7 days without consulting your doctor.

If you take more Drotafemme Forte than you should

There are no reports of overdose with drotaverine.

If take more Drotafemme Forte than you should, talk to your doctor or pharmacist immediately.

If you forget to take Drotafemme Forte

If you forget to take your tablet, take it as soon as you remember, unless it is almost time for your next dose.

Do not take a double dose to make up for a forgotten tablet.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1,000 people): nausea, constipation, headache and dizziness, sleeplessness (insomnia), palpitations, reduced blood pressure and allergic reactions (angioedema, hives, rash, itching).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Pharmacovigilance Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPLWMiPB)
Al. Jerozolimskie 181C
02-222 Warszawa
Telephone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
E-mail: ndl@urpl.gov.pl

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Drotafemme Forte

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Keep the container tightly closed to protect from light.

Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help to 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 drotaverine hydrochloride.

The other ingredients are:
tablet core: lactose monohydrate, corn starch, maltodextrin, croscarmellose sodium, 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 are yellow, round, biconvex, tablets with scoreline on both sides.

PVC/PE/PVDC/Aluminium blisters in a carton box containing 20 film-coated tablets.


Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

This leaflet was last revised in October 2015