Dihidroergotaminum Filofarm

Package Leaflet: Information for the Patient

Dihydroergotaminum Filofarm

2 mg/g, Oral Solution

Dihydroergotamine Mesylate

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Dihydroergotaminum Filofarm and what is it used for
• 2. Important information before using Dihydroergotaminum Filofarm
• 3. How to use Dihydroergotaminum Filofarm
• 4. Possible side effects
• 5. How to store Dihydroergotaminum Filofarm
• 6. Contents of the pack and other information

1. What is Dihydroergotaminum Filofarm and what is it used for

Dihydroergotamine acts by constricting blood vessels, mainly in the brain, reducing migraine symptoms.
Dihydroergotaminum Filofarm is used for migraine attacks.

2. Important information before using Dihydroergotaminum Filofarm

When not to use Dihydroergotaminum Filofarm

Warnings and precautions

Before starting to use Dihydroergotaminum Filofarm, the patient should discuss it with their doctor if they have:

• heart rhythm disorders,
• gastrointestinal disorders (nausea, vomiting).

During treatment with this medication, side effects may occur, such as for most ergot alkaloids: slowing (bradycardia) or acceleration (tachycardia) of heart rate, nausea, vomiting.
The medication is not intended for long-term therapy.
Prolonged use of dihydroergotamine may lead to fibrosis outside the abdominal cavity, including pleural, pericardial, and valvular fibrosis - see section 4.
Before starting treatment, the doctor will check if the heart is functioning properly. An echocardiogram (heart ultrasound) is recommended. During treatment, the doctor will pay particular attention to any signs potentially related to the occurrence of fibrotic reactions. If necessary, an echocardiogram will be performed. If a fibrotic reaction occurs, treatment will be discontinued.
Prolonged use of any pain medication may cause worsening of headache. If the patient experiences or suspects such a cause of headache, they should stop the medication and consult a doctor. In patients who experience frequent or daily headaches despite (or due to) regular use of pain medications, the diagnosis of medication-overuse headache should be considered.
Prolonged use of dihydroergotamine may lead to ergotism (severe vasoconstriction) - see section 4. If the patient experiences tingling in their fingers or toes, they should stop taking the medication and contact their doctor.
The patient should consult a doctor, even if the above warnings refer to past situations.

Children and adolescents

The medication should not be used in children and adolescents under 16 years of age.

Dihydroergotaminum Filofarm and other medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

• A minimum of 24 hours should be allowed between taking dihydroergotamine and other ergot alkaloids: ergotamine, methysergide (migraine medications), as well as sumatriptan (migraine medication).
• Dihydroergotamine should not be used during therapy with bromocriptine or cabergoline (lactation-inhibiting medications) due to the risk of hypertension and myocardial infarction.
• During dihydroergotamine therapy and medications that inhibit alpha-adrenergic receptors (tolazoline, prazosin - vasodilators) and beta-adrenergic receptors (atenolol, nadolol, oxprenolol, propranolol, timolol - medications used in hypertension and coronary heart disease), an increase in blood pressure and angina pectoris may occur.
• Concomitant administration of macrolide antibiotics (clarithromycin, roxithromycin, erythromycin) or antifungal medications from the azole group may disrupt dihydroergotamine metabolism and cause poisoning.
• Concomitant use of antiviral medications (delavirdine, indinavir, ritonavir, nelfinavir) with dihydroergotamine increases the risk of serious side effects.
• Antidepressant medications (fluoxetine, fluvoxamine, paroxetine, and sertraline) in combination with dihydroergotamine may cause the occurrence of serotonin syndrome, characterized by

coordination disorders, general weakness, decreased reflexes, and high body temperature.

• The medication should not be used concomitantly with dopamine and dobutamine (medications that increase heart muscle contractility), as this may cause peripheral hypoperfusion and hypoxia leading to gangrene of the hands and feet.
• The alcohol contained in the medication may alter the effects of other medications.

Using Dihydroergotaminum Filofarm with food, drink, and alcohol

See section 3.
Do not drink alcohol while using Dihydroergotaminum Filofarm.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medication.
In pregnant or breastfeeding women, Dihydroergotaminum Filofarm should not be used.

Driving and using machines

Dihydroergotaminum Filofarm contains ethanol, which may impair psychophysical abilities, so the patient should not drive vehicles, use tools, or operate machines. The alcohol contained in Dihydroergotaminum Filofarm may impair the ability to drive vehicles and operate machines.

Dihydroergotaminum Filofarm contains glycerol (E 422) (glycerin)

1 ml of the oral solution contains 80 mg of glycerol. The medication may cause headache, gastrointestinal disorders, and diarrhea.

Dihydroergotaminum Filofarm contains alcohol (ethanol)

This medication contains from 212.5 mg to 637.5 mg of alcohol (ethanol) in a single dose (i.e., a dose of 0.5 to 1.5 ml of the medication), which is equivalent to 42.5% v/v.
The amount of ethanol in 1.5 ml of the medication is equivalent to 13 ml of beer (5% v/v) or 6 ml of wine (12% v/v).
The amount of ethanol in 1 ml of the product is equivalent to 9 ml of beer (5% v/v) or 4 ml of wine (12% v/v).
The small amount of alcohol in this medicinal product will not have noticeable effects.

3. How to use Dihydroergotaminum Filofarm

This medication should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor.

Adults and adolescents over 16 years of age:

The recommended dose is usually 0.5 ml to 1.5 ml of the oral solution, 3 times a day (i.e., 3 mg to 9 mg of dihydroergotamine mesylate per day).

Use in children and adolescents

The medication should not be used in children and adolescents under 16 years of age.
Method of administration
Do not take on an empty stomach.
To measure the correct dose of the medication, the patient should use the pipette provided with the packaging. Holding the pipette vertically, the patient should fill it by pulling the plunger. The scale on the pipette indicates the correct dose of the medication.
After measuring the correct dose, the patient should remove the pipette from the bottle and close the bottle tightly with the cap. After each use, the patient should rinse the pipette with water to remove any remaining medication.
Patients with renal and/or hepatic impairment:
Dihydroergotaminum Filofarm should not be used in patients with hepatic and/or renal impairment.
If the patient feels that the effect of Dihydroergotaminum Filofarm is too strong or too weak, they should consult their doctor.

Using a higher dose of Dihydroergotaminum Filofarm than recommended

In case of taking a higher dose of the medication than recommended, the patient should immediately consult their doctor.
Symptoms of acute overdose:
Numbness, tingling, pain, cyanosis of the limbs with weakness or loss of pulse, breathing difficulties, decreased or increased blood pressure, disorientation, hallucinations, seizures, coma, nausea, vomiting, abdominal pain.
There is no specific antidote. Vasodilators, such as sodium nitroprusside or phentolamine, are used.

Missing a dose of Dihydroergotaminum Filofarm

The patient should not take a double dose to make up for a missed dose.

Stopping the use of Dihydroergotaminum Filofarm

In case of any further doubts about the use of this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Dihydroergotaminum Filofarm can cause side effects, although not everybody gets them.
Abdominal pain, nausea, vomiting, gastrointestinal disorders, diarrhea, constipation, dry mouth, and loss of appetite, paresthesia of the peripheral parts of the body (numbness and tingling in the upper and lower limbs), limb weakness, headache, disorientation, dizziness, drowsiness, and in extreme cases, after prolonged use of high doses, seizures, heart rhythm disorders, increased or decreased blood pressure, skin changes, such as: rash, edema, purpura, necrosis of the skin, acne (these complications rarely occur during short-term therapy).
Prolonged use of the medication may lead to fibrosis outside the abdominal cavity, including pleural, pericardial, and valvular fibrosis.
Prolonged use of dihydroergotamine may lead to ergotism (severe vasoconstriction), characterized by initial numbness and cooling of the hands and feet, and in the next stage, impaired circulation in the limbs, prolonged vasoconstriction of the limbs, and consequently, gangrene of the limbs.
Prolonged use of the medication may lead to liver and kidney damage.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Dihydroergotaminum Filofarm

The medication should be stored out of sight and reach of children.
Do not use this medication after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Shelf life after first opening the bottle: 3 months.
Store in a temperature below 25°C.
Medications should not be disposed of via wastewater or household waste containers. The patient should ask their 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 Dihydroergotaminum Filofarm contains

• The active substance of the medication is dihydroergotamine mesylate. 1 ml of the oral solution contains 2 mg of dihydroergotamine mesylate.
• The excipients are: acetic acid, thiourea, glycerin (glycerol E 422), ethanol 96%, methanesulfonic acid, purified water.

What Dihydroergotaminum Filofarm looks like and what the pack contains

Dihydroergotaminum Filofarm is an oral solution.
Packaging:
The cardboard box contains one orange glass bottle closed with a white, non-transparent cap, and a pipette for dosing the medication.
One bottle contains 15 g of the oral solution.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative FILOFARM
Pułaskiego 39
85-619 Bydgoszcz
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Pharmaceutical Cooperative Filofarm
Pułaskiego 39, 85-619 Bydgoszcz
Phone: (52) 342 67 88
Information for the blind and visually impaired:The content of the Dihydroergotaminum Filofarm leaflet is available in the Ulotka Audio system under the national free phone number 800 706

• 848.

Date of the last update of the leaflet: