Metafen rozkurhovi

Package Leaflet: Information for the Patient

Metafen Spasmolytic, 40 mg, Tablets

Drotaverine Hydrochloride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist.

• Keep this Leaflet, so you can Read it Again if you Need to.
• If you Need Advice or More Information, Ask your Pharmacist.
• If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor or Pharmacist. See Section 4.
• If there is no Improvement after 10 Days or if you Feel Worse, Contact your Doctor.

Table of Contents of the Leaflet

• 1. What is Metafen Spasmolytic and what is it Used for
• 2. Important Information Before Taking Metafen Spasmolytic
• 3. How to Take Metafen Spasmolytic
• 4. Possible Side Effects
• 5. How to Store Metafen Spasmolytic
• 6. Contents of the Pack and other Information

1. What is Metafen Spasmolytic and what is it Used for

The Active Substance of the Medication, Drotaverine, is a Synthetic Derivative of Papaverine. The Medication has a Spasmolytic (Antispasmodic) Effect on Smooth Muscles. Its Spasmolytic Effect is Associated with a Direct Influence on Smooth Muscle and is Independent of the Type of Innervation. The Medication's Effect is Particularly Pronounced in Spasmodic Conditions of the Abdominal Cavity, Bile Ducts, Urinary System, Gastrointestinal Tract, and Circulatory System.

Indications for Use

• Spasmodic Conditions of Smooth Muscles Associated with Bile Duct Diseases: Gallstones and Bile Duct Stones, Cholecystitis.
• Spasmodic Conditions of the Urinary System: Kidney Stones, Pyelonephritis, Cystitis, Painful Urination.

Supportively:

• In Spasmodic Conditions of the Gastrointestinal Tract: Gastric and Duodenal Ulcer Disease, Spasms of the Gastric Pylorus and Duodenum, Irritable Bowel Syndrome, Spastic Constipation, and Intestinal Flatulence.
• In Painful Menstruation.

2. Important Information Before Taking Metafen Spasmolytic

When not to Take Metafen Spasmolytic:

• If you are Allergic to Drotaverine or any other Component of this Medication (listed in Section 6);
• If you have Severe Heart, Liver, or Kidney Failure;
• If you have an Atrioventricular Block of II-III Degree;
• In Children under 6 Years of Age.

Warnings and Precautions

Before Starting to Take Metafen Spasmolytic, Discuss it with your Doctor or Pharmacist:

• If you have Porphyria;
• If you have Hypotension;
• In Children (see Section 3);
• In Pregnant Women.

Do not Take the Medication during Labor.

Metafen Spasmolytic and other Medications

Tell your Doctor or Pharmacist about all Medications you are Currently Taking or have Recently Taken, as well as those you Plan to Take. Concurrent Use of Drotaverine with Medications Containing Levodopa (used in Parkinson's Disease) Reduces their Efficacy and Increases the Severity of Tremors and Rigidity.

Metafen Spasmolytic with Food and Drink

The Medication can be Taken with or without Food.

Pregnancy, Breastfeeding, and Fertility

If you are Pregnant, Breastfeeding, Think you may be Pregnant, or are Planning to have a Child, Consult your Doctor or Pharmacist before Taking this Medication. Pregnancy Drotaverine Passes through the Placenta. The Medication can be Used in Pregnant Women only if Absolutely Necessary. Do not Take the Medication during Labor. Breastfeeding It is not Known if Drotaverine Passes into Breast Milk, so it is not Recommended to Take the Medication during Breastfeeding. Fertility There is no Available Data on the Effect on Fertility.

Driving and Operating Machinery

The Medication, when Taken as Directed, does not Affect Psychophysical Abilities, the Ability to Drive Vehicles, or Operate Machinery. If you Experience Dizziness, Avoid Potentially Hazardous Activities, such as Driving or Operating Machinery.

3. How to Take Metafen Spasmolytic

This Medication Should Always be Taken Exactly as Described in this Patient Leaflet or as Advised by a Doctor or Pharmacist. If you have any Doubts, Consult your Doctor or Pharmacist. The Medication is Taken Orally.

Adult Dosage:

120 mg to 240 mg per Day in 2-3 Divided Doses. The Maximum Daily Dose is 240 mg.

Pediatric Dosage:

Clinical Trials have not been Conducted in Children. If Metafen Spasmolytic Needs to be Used in Children:

• Daily Dose for Children aged 6 to 12 Years: 80 mg, in 2 Divided Doses
• Daily Dose for Children over 12 Years: 160 mg, in 2-4 Divided Doses.

Without Consulting a Doctor, the Medication should not be Taken for more than 10 Days.

Taking a Higher Dose of Metafen Spasmolytic than Recommended

If you have Taken more than the Recommended Dose, Contact your Doctor or Pharmacist Immediately. The Doctor may Recommend Gastric Lavage with Activated Charcoal and Symptomatic Treatment.

Missing a Dose of Metafen Spasmolytic

Do not Take a Double Dose to Make up for a Missed Dose. If you have any Further Questions about Taking this Medication, Consult your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Metafen Spasmolytic can Cause Side Effects, although not Everybody gets them. Rare Side Effects(occurring in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):

• Headaches and Dizziness, Insomnia,
• Nausea, Loss of Appetite, Constipation,
• After High Doses - Drowsiness, Weakness,
• Decreased Blood Pressure, Palpitations,
• Allergic Reactions (Angioedema, Urticaria, Rash, Itching).

Frequency not Known(cannot be Estimated from Available Data):

• Postpartum Hemorrhage.

Reporting Side Effects

If you Experience any Side Effects, including those not Listed in this Leaflet, Tell your Doctor, Pharmacist, or Nurse. Side Effects can be Reported Directly to the Department of Pharmacovigilance of 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 Side Effects can also be Reported to the Marketing Authorization Holder. By Reporting Side Effects, you can Help Provide more Information on the Safety of this Medication.

5. How to Store Metafen Spasmolytic

Store the Medication 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 Medication after the Expiration Date Stated on the Carton and Blister Pack after: EXP. The Expiration Date refers to the Last Day of the Specified Month. Medications should not be Disposed of in Sewers or Household Waste Containers. Ask your Pharmacist how to Dispose of Medications that are no longer Needed. This will Help Protect the Environment.

6. Contents of the Pack and other Information

What Metafen Spasmolytic Contains

• The Active Substance of the Medication is Drotaverine. Each Tablet Contains 40 mg of Drotaverine Hydrochloride.
• Other Ingredients are: Microcrystalline Cellulose, Crospovidone, Magnesium Stearate.

What Metafen Spasmolytic Looks like and what the Pack Contains

10, 20, or 40 Tablets in a Cardboard Box. Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Polpharma S.A. Production Plant in Nowa Dęba ul. Metalowca 2, 39-460 Nowa Dęba Polpharma S.A. Medana Plant in Sieradz ul. Władysława Łokietka 10, 98-200 Sieradz

Date of the Last Update of the Leaflet: