METAFEN SPASMOLYTIC

Package leaflet: Information for the patient

Metafen rozkurczowy, 40 mg, tablets
Drotaverini hydrochloridum
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 10 days, or if the patient feels worse, consult a physician.

Table of contents of the leaflet

1. What Metafen rozkurczowy is and what it is used for
2. What you need to know before taking Metafen rozkurczowy
3. How to take Metafen rozkurczowy
4. Possible side effects
5. How to store Metafen rozkurczowy
6. Contents of the pack and other information

1. What Metafen rozkurczowy is and what it is used for

The active substance in Metafen rozkurczowy, drotaverine, is a synthetic derivative of papaverine. The medicine exerts a spasmolytic (muscle relaxant) effect on smooth muscles. Its spasmolytic action results from a direct effect on smooth muscle tissue and is independent of the type of innervation. The effect of the drug is particularly evident in spastic conditions affecting the abdominal cavity, biliary tract, urinary system, gastrointestinal tract, and the circulatory system.

Indications

• Smooth muscle spasms associated with biliary tract diseases: gallstones and biliary duct stones, cholecystitis.
• Smooth muscle spasms of the urinary tract: nephrolithiasis, pyelitis, cystitis, painful urge to urinate.

As adjunctive therapy:

• In smooth muscle spastic conditions of the gastrointestinal tract: peptic ulcer of the stomach and duodenum, spasms of the gastric inlet and pylorus, irritable bowel syndrome, spastic constipation, and intestinal bloating.
• In dysmenorrhea (painful menstruation).

2. Important information before using Metafen rozkurczowy

When not to use Metafen rozkurczowy:

• 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 heart, liver or kidney failure;
• if the patient has second- or third-degree atrioventricular block;
• in children under 6 years of age.

Warnings and precautions
Before starting treatment with Metafen rozkurczowy, discuss this with your doctor or
pharmacist:

• if the patient has porphyria;
• if the patient has hypotension;
• in children (see section 3);
• in pregnant women.

Do not use the medicine during childbirth.
Metafen rozkurczowy 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.
Concomitant use of drotaverine with medicines containing levodopa (medicines used in Parkinson's disease) reduces their effectiveness and increases the severity of tremors and rigidity.
Metafen rozkurczowy with food and drink
The medicine can be taken with food or independently of meals.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Drotaverine crosses the placenta. The medicine may be used in pregnant women only if clearly necessary.
Do not use the medicine during childbirth.
Breastfeeding
It is unknown whether drotaverine passes into breast milk; therefore, use of the medicine is not recommended during breastfeeding.
Fertility
There is a lack of available data regarding the effect on fertility.
Driving and operating machinery
When used according to recommendations, the medicine does not affect psycho-physical performance, ability to drive or operate machinery.
If dizziness occurs, potentially hazardous activities such as driving or operating machinery should be avoided.

3. How to use Metafen rozkurczowy

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is taken orally.
Use in adults:
120 mg to 240 mg per day in 2–3 divided doses.
The maximum daily dose is 240 mg.
Use in children:
Clinical studies have not been conducted in children.
If it is necessary to use Metafen rozkurczowy in children:

• daily dose for children aged 6 to 12 years: 80 mg in 2 divided doses
• daily dose for children over 12 years of age: 160 mg in 2–4 divided doses.

Without consulting a doctor, the medicine may be used for a maximum of 10 days.
Taking more than the recommended dose of Metafen rozkurczowy
If more than the recommended dose is taken, consult a doctor or pharmacist immediately.
The doctor may recommend gastric lavage with water containing activated charcoal, as well as symptomatic treatment.
Missed dose of Metafen rozkurczowy
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding 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 gets them.
Adverse reactions occurring rarely (occur less frequently than in 1 out of 1,000 patients, but
more frequently than in 1 out of 10,000 patients):

• headaches and dizziness, insomnia,
• nausea, loss of appetite, constipation,
• at high doses – drowsiness, weakness,
• low blood pressure, palpitations,
• allergic reactions (angioedema, urticaria, rash, itching).

Frequency unknown (cannot be estimated based on available data):

• postpartum haemorrhage.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Metafen rozkurczowy

Keep this medicine out of sight and reach of children.
Store in a dry place, in the original packaging.
Store at a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Metafen rozkurczowy contains

• The active substance is drotaverine. Each tablet contains 40 mg of drotaverine hydrochloride.
• The other ingredients are: microcrystalline cellulose, crospovidone, magnesium stearate.

What Metafen rozkurczowy looks like and contents of the pack
10, 20 or 40 tablets in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Production Plant in Nowa Dęba
ul. Metalowca 2, 39-460 Nowa Dęba

Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Branch in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz