Dihydroergotaminum filofarm

Package leaflet: information for the patient

Dihydroergotaminum Filofarm
2 mg/g, oral solution
Dihydroergotamini mesilas
Please read the following leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Dihydroergotamine exerts a constricting effect on blood vessels, primarily those in the brain, thereby reducing migraine symptoms.
Dihydroergotaminum Filofarm is used for the treatment of migraine attacks.

2. Important information before using Dihydroergotaminum Filofarm

When not to use Dihydroergotaminum Filofarm

• if the patient is allergic (hypersensitive) to dihydroergotamine mesylate, other ergot alkaloids, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has ischaemic heart disease (previous myocardial infarction, angina pectoris also known as angina, angina Prinzmetal also known as variant angina),
• if the patient has peripheral vascular diseases such as: Raynaud's disease (episodic arterial spasm in the hands, less frequently in the feet), obliterative vasculitis, thrombophlebitis,
• if the patient has uncontrolled hypertension,
• if the patient has liver or kidney disease,
• if the patient has sepsis (also known as sepsis: excessive body response to infection),
• if the patient has undergone surgical procedures on blood vessels,
• if the patient currently has or has previously experienced reactions in the form of fibrosis (scarring) or severe constriction of blood vessels. Dihydroergotaminum Filofarm must not be used in pregnant or breastfeeding women.

Warnings and precautions

Before starting treatment with Dihydroergotaminum Filofarm, consult your doctor if the patient has:

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

During treatment with this medicine, adverse effects may occur, typical for most ergot alkaloids: slowing (bradycardia) or acceleration (tachycardia) of heart function, nausea, vomiting.
The medicine is not intended for long-term therapy.
Prolonged use of dihydroergotamine may lead to retroperitoneal fibrosis involving fibrosis of the pleura, pericardium, pericarditis, and fibrosis of heart valves – see section 4.
Before starting treatment, the doctor will check whether heart function is normal. An echocardiographic examination (ultrasound of the heart) is recommended. During treatment, the doctor will pay particular attention to any signs potentially related to fibrotic reactions. If necessary, an echocardiographic examination will be performed. If fibrotic reactions occur, treatment will be discontinued.
Long-term use of any painkillers may exacerbate headache. If the patient experiences or is suspected of having such a cause of headache, the medicine should be discontinued and medical advice sought. In patients who experience frequent or daily headaches despite (or due to) regular use of headache medications, medication-overuse headache should be considered.
Prolonged use of dihydroergotamine may lead to ergotism (severe vasoconstriction) – see section 4. If tingling in fingers or toes occurs, stop taking the medicine and contact your doctor.
Consult your doctor, even if the above warnings refer to conditions experienced in the past.

Children and adolescents
This medicine must not be used in children and adolescents under 16 years of age.

Dihydroergotaminum Filofarm and other medicines
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to use.

• A minimum interval of 24 hours must be maintained between taking dihydroergotamine and other ergot alkaloids: ergotamine, methysergide (anti-migraine medicines), as well as sumatriptan (anti-migraine medicine).
• Dihydroergotamine must not be used during treatment with bromocriptine or cabergoline (lactation-inhibiting medicines) due to the risk of hypertension and myocardial infarction.
• During treatment with dihydroergotamine and medicines blocking alpha-adrenergic receptors (tolazoline, prazosin – vasodilating medicines) and beta-adrenergic receptors (atenolol, nadolol, oxprenolol, propranolol, timolol – medicines used in hypertension and ischaemic heart disease), increased blood pressure and angina may occur.
• Concurrent administration of macrolide antibiotics (clarithromycin, roxithromycin, erythromycin) or antifungal azole medicines may disrupt dihydroergotamine metabolism and lead to drug intoxication.
• Antiviral medicines (delavirdine, indinavir, ritonavir, nelfinavir) used simultaneously with dihydroergotamine increase the risk of serious adverse effects.
• Antidepressants (fluoxetine, fluvoxamine, paroxetine, and sertraline) in combination with dihydroergotamine may cause serotonin syndrome, manifested by:

impaired motor coordination, general weakness, diminished reflexes, and high body temperature.

• This medicine must not be used simultaneously with dopamine and dobutamine (medicines increasing myocardial contractility), as this may cause peripheral ischaemia and hypoxia leading to necrosis of hands and feet.
• Alcohol contained in the medicine may alter the effects of other medicines.

Use of 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, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Dihydroergotaminum Filofarm must not be used in women who are pregnant or breastfeeding.

Driving and operating machinery
Dihydroergotaminum Filofarm contains ethanol, which may impair psycho-physical performance; therefore, do not drive, use tools, or operate machinery. The alcohol contained in Dihydroergotaminum Filofarm may impair the ability to drive and operate machinery.

Dihydroergotaminum Filofarm contains glycerol (E 422) (glycerine)
1 ml of oral solution contains 80 mg glycerol. The medicine may cause headache, gastrointestinal disturbances, and diarrhoea.

Dihydroergotaminum Filofarm contains alcohol (ethanol)
This medicine contains between 212.5 mg and 637.5 mg of alcohol (ethanol) per dosage unit (i.e. a single dose of 0.5 to 1.5 ml of medicine), equivalent to 42.5% v/v.
The amount of ethanol in 1.5 ml of medicine corresponds to 13 ml of beer (5% v/v) or 6 ml of wine (12% v/v).
The amount of ethanol in 1 ml of product corresponds 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 cause noticeable effects.

3. How to use Dihydroergotaminum Filofarm

This medicine should always be used as directed by the physician. If in doubt, consult your
doctor.
Adults and adolescents aged above 16 years:
The usual recommended dose is 0.5 ml to 1.5 ml of oral solution three times daily (i.e. 3 mg to
9 mg of dihydroergotamine mesilate per day).
Use in children and adolescents
Dihydroergotaminum Filofarm must 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 medicine, use the syringe pipette supplied with the unit
package. Holding the pipette vertically, fill it by pulling back the plunger. The graduations on the
dosing pipette indicate the appropriate amount of medicine to be drawn.
After measuring the correct dose, remove the pipette from the bottle and close the bottle tightly
with the cap. After each use, the syringe pipette used for dosing should be rinsed with water to
remove any residual medicine.
Patients with renal and/or hepatic impairment:
Dihydroergotaminum Filofarm must not be used in patients with impaired liver and/or kidney
function.
If you feel the effect of Dihydroergotaminum Filofarm is too strong or too weak, consult your doctor.
Taking more than the recommended dose of Dihydroergotaminum Filofarm
If you have taken more than the recommended dose, seek medical advice immediately.
Symptoms of acute overdose:
Numbness, tingling, pain, cyanosis of the limbs with weakened or absent pulse, breathing
difficulties, decreased or increased blood pressure, disorientation, delirium, seizures, coma, nausea,
vomiting, abdominal pain.
There is no specific antidote. Vasodilating agents should be used, such as sodium nitroprusside,
phentolamine.
Missed dose of Dihydroergotaminum Filofarm
Do not take a double dose to make up for a missed dose.
Stopping Dihydroergotaminum Filofarm
If you have any further questions about 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 everyone will experience them.
Upper abdominal pain, nausea, vomiting, gastrointestinal discomfort, diarrhoea, constipation, dry mouth,
loss of appetite, peripheral paraesthesia (numbness and tingling in the upper and lower limbs), limb weakness,
headache, disorientation, dizziness, drowsiness, and in extreme cases after long-term use of high doses,
seizures, cardiac arrhythmias, increased or decreased blood pressure, skin reactions such as erythema,
oedema, petechiae, skin necrosis, acne (these complications rarely occur during short-term therapy).
With prolonged use of the medicine, retroperitoneal fibrosis may occur, involving fibrosis of the pleura,
pericardium, pericarditis, and fibrosis of heart valves.
Long-term use of dihydroergotamine may lead to ergotism (severe vasoconstriction), initially manifesting
as numbness and coldness of hands and feet, followed by impaired circulation in the limbs, prolonged vasoconstriction of the limbs, and ultimately limb necrosis.
Prolonged use of the medicine may lead to liver and kidney damage.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
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 181C
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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Dihydroergotaminum Filofarm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 3 months.
Store below 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Dihydroergotaminum Filofarm contains

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

What Dihydroergotaminum Filofarm looks like and contents of the pack
Dihydroergotaminum Filofarm is an oral solution.
Pack:
In a cardboard box there is one amber glass bottle closed with a white opaque screw cap and a syringe pipette for dosing the medication.
One bottle contains 15 g of oral solution.

Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz

For further information, please contact the representative of the Marketing Authorisation Holder:
Farmaceutyczna Spółdzielnia Pracy Filofarm
ul. Pułaskiego 39, 85-619 Bydgoszcz
Tel.: (52) 342 67 88

Information for blind and partially sighted people: The package leaflet for Dihydroergotaminum Filofarm is available in the Audio Leaflet system via the national free phone number 800 706 848.