Drotafemme

Product description

Drotafemme, 40 mg, film-coated tablets

 

Drotaverini hydrochloridum

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 pdf Package leaflet Drotafemme 40 mg

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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 is and what it is used for
2. What you need to know before you take 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 Drotafemme is and what it is used for

The active substance of Drotafemme 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 is metabolized in the liver and excreted mainly in the urine and to a lesser extent through the digestive tract.

Drotafemme 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 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

Do not take Drotafemme:
- 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 6 years of age

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

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

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

Drotafemme 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 should not be used in children under 6 years of age.

Taking Drotafemme with food and drink

Drotafemme 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 should not be used during labour and delivery.

Driving and using machines

At therapeutic doses, Drotafemme 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 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.

Drotafemme contains quinoline yellow which may cause allergic reactions.

3. How to take Drotafemme

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 in children.
If you have to use Drotafemme in children:

- the maximum daily dose in children between 6 and 12 year of age is 80 mg in 2 divided doses.

- the maximum daily dose in children over 12 year of age is 160 mg in 2 to 4 divided doses.

Drotafemme should be taken orally (by mouth).

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

If you take more Drotafemme than you should

There are no reports of overdose with drotaverine.

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

If you forget to take Drotafemme

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 Marketing Authorisation Holder or 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

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 contains

The active substance is drotaverine hydrochloride.
Each tablet contains 40 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 (E110), iron oxide red (E172).

What Drotafemme looks like and contents of the pack

Drotafemme are orange, round, biconvex, tablets.

PVC/PE/PVDC/Aluminium blisters in a carton box containing 20, 30, 40 or 60 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 December 2016