Ergotaminum filofarm

Package leaflet: Information for the patient

Ergotaminum Filofarm
1 mg, coated tablets
Ergotamini tartras
Please read all of this leaflet carefully before using the 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. The medicine may harm another person, even if their symptoms are the same.
• If any side effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

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

Ergotaminum Filofarm contains ergotamine tartrate. Ergotamine strongly constricts blood vessels,
but may also cause vasodilation depending on vascular resistance. If vascular resistance is
low, ergotamine causes vasoconstriction and an increase in arterial blood pressure; if vascular resistance is
high, ergotamine produces the opposite reaction – vasodilation. Ergotamine exerts a constricting effect primarily on
cerebral blood vessels, reducing migraine symptoms and blood flow.
Ergotamine has a strong oxytocic effect (causes contraction of the uterine muscle).
Indications
Ergotaminum Filofarm is used for the prevention and treatment of vascular headaches,
including migraine and cluster headaches.

2. Important information before using the medicine Ergotaminum Filofarm

When not to use Ergotaminum Filofarm

• if the patient is allergic to ergotamine tartrate, other ergot alkaloids, or any of the other components of this medicine (listed in section 6),
• if uncontrolled or severe hypertension, peripheral vascular diseases (Raynaud's disease, thromboangiitis obliterans, phlebitis, advanced atherosclerosis) are present,
• after vascular surgery,
• following recent angioplasty or if angioplasty is being considered,
• in malnutrition,
• in severe pruritus,
• in renal or hepatic dysfunction,
• in sepsis,
• in glaucoma,
• during pregnancy,
• during breastfeeding,
• concurrently with macrolide antibiotics, reverse transcriptase inhibitors of human immunodeficiency virus, antifungal azoles, vasoconstrictive agents, sumatriptan, or other serotonin 5-HT receptor agonists.

Warnings and precautions

Before starting treatment with Ergotaminum Filofarm, consult your doctor.
Individual hypersensitivity reactions to ergotamine may occur during treatment.
The medicine may cause myocardial ischemia or myocardial infarction even when treating with small doses of ergotamine. If the patient experiences tingling in fingers or toes, administration of the medicine should be discontinued and medical advice sought immediately. Peripheral vascular disorders may occur even after a single dose of ergotamine. Use with caution in patients with cardiac arrhythmias.
Consult your doctor, even if the above warnings refer to conditions experienced in the past.
Ergotamine may react with synthetic materials used in surgical reconstruction.
Ergotaminum Filofarm is not intended for long-term therapy and should not be used for migraine prophylaxis.
Prolonged use of any analgesic may lead to medication-overuse headache.
If the patient has or is suspected of having this type of headache, the medicine should be discontinued and medical advice sought. In patients who experience frequent or daily headaches despite (or because of) regular use of headache medications, medication-overuse headache should be considered.

Children and adolescents
The efficacy and safety of the medicine in children and adolescents have not been established.

Ergotaminum Filofarm and other medicines
Inform your doctor about all medicines currently used, recently used, or planned for use.
Sumatriptan (an antimigraine medicine) should not be combined with ergotamine-containing medicines due to the potential for additive vasoconstrictive effects. Ergotamine should not be used within 6 hours after taking sumatriptan. Sumatriptan should not be used within 24 hours after administration of ergotamine. Ergotamine should not be used during treatment with dihydroergotamine, methysergide (antimigraine medicines), bromocriptine, or cabergoline (lactation inhibitors) due to the risk of hypertension and myocardial infarction.
During treatment with ergotamine and alpha-adrenergic receptor blockers (tolazoline, prazosin—vasodilating agents) and beta-adrenergic receptor blockers (atenolol, nadolol, oxprenolol, propranolol, timolol—used in hypertension and ischemic heart disease), peripheral vasoconstriction accompanied by pain and cyanosis may occur. Concurrent administration of macrolide antibiotics (clarithromycin, roxithromycin, erythromycin) may impair ergotamine metabolism by inhibiting cytochrome P-450, leading to increased alkaloid toxicity. Antiviral drugs (delavirdine, indinavir, ritonavir, nelfinavir) used concurrently with ergotamine increase the risk of serious adverse effects. Antidepressants (fluoxetine, fluvoxamine, paroxetine, sertraline) used in combination with ergotamine may cause motor coordination disturbances, general weakness, and diminished reflexes. Dopamine and dobutamine (drugs increasing myocardial contractility) used concomitantly with ergotamine may cause peripheral ischemia and hypoxia leading to gangrene of hands and feet; therefore, these drugs should not be used simultaneously with ergot alkaloids.

Taking Ergotaminum Filofarm with food and drink
See section 3 of the leaflet.
Alcohol should not be consumed during treatment with Ergotaminum Filofarm.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine. Ergotaminum Filofarm should not be used in pregnant women or during breastfeeding.

Driving and operating machinery
There is no data available on effects impairing the ability to drive or operate machinery.

Ergotaminum Filofarm contains sucrose and lactose
One tablet contains 55.25 mg of sucrose and 42.8 mg of lactose (equivalent to 45 mg of monohydrated lactose).
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.

Ergotaminum Filofarm contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Ergotaminum Filofarm contains methyl parahydroxybenzoate (E 218) (nipagin M)
One tablet contains 0.0002 mg of methyl parahydroxybenzoate. The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Ergotaminum Filofarm

This medicine should be used as directed by the physician. If in doubt, consult your
doctor.
The medicine should be taken before a meal; however, if gastrointestinal discomfort occurs, it may be taken during a meal.
The medicine is usually used as described below.
The recommended dose is 2 to 4 coated tablets per day (2 mg to 4 mg of ergotamine tartrate per
day).
Do not take a single dose greater than 2 coated tablets, daily doses exceeding 4 coated tablets, or weekly doses exceeding 8 coated tablets. The medicine is used on an as-needed basis; prolonged use applies only to cluster headaches and must be supervised by a
physician.
Patients with renal and (or) hepatic impairment
Use of Ergotaminum Filofarm is contraindicated in patients with renal or hepatic dysfunction.
Elderly patients
No adjustment in dosage or administration is necessary in elderly patients.
If you feel that the effect of Ergotaminum Filofarm is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of Ergotaminum Filofarm
If you take more than the recommended dose, seek medical advice immediately.
Symptoms of overdose:
Fatigue, disorientation, depression, drowsiness, hallucinations, severe dyspnea, hypotension or hypertension, rapid and weak pulse, numbness of the extremities, loss of consciousness, shock, and death.
Missed dose of Ergotaminum Filofarm
Do not take a double dose to make up for a missed dose.
Discontinuation of Ergotaminum 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 everybody will experience them:
central nervous system disorders such as: peripheral paresthesia (numbness and tingling in the upper and lower limbs), limb weakness, headache, disorientation, irritability, dizziness, drowsiness or insomnia, nausea, vomiting, epigastric pain, constipation, gingival hyperplasia, ischemia, irritation, bleeding and anal ulceration caused by vasoconstriction, skin reactions (complications rarely occurring during short-term therapy) such as: erythema, edema, petechiae, epidermal necrosis, acne, cardiac arrhythmias, myocardial, valvular, coronary and aortic fibrosis, increased or decreased arterial blood pressure.
Cases of myocardial hypoxia and myocardial infarction have been reported during treatment even with low doses of ergotamine (2 mg/week).
Ergotamine may cause muscle cramps preceded by paresthesia, muscle spasms, and lower limb pain.
Long-term use of ergotamine, especially at higher doses, may lead to ergotism, initially manifested by numbness and coldness of hands and feet, followed by impaired circulation in the limbs, prolonged vasoconstriction of the extremities, and ultimately limb necrosis.
Prolonged use of the medicine may lead to liver and kidney damage.
There is a potential risk of dependence and development of tolerance during treatment.

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 of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
tel: 22 49 21 301
fax: 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 to provide more information on the safe use of the medicine.

5. How to store the medicine Ergotaminum Filofarm

Keep this medicine out of the reach and sight 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 specified month.
Store below 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ergotaminum Filofarm contains

• The active substance is ergotamine tartrate. Each coated tablet contains 1 mg of ergotamine tartrate.
• Excipients: The core of the coated tablet contains: potato starch, sodium carboxymethyl starch, lactose, magnesium stearate, talc. The coating of the coated tablet contains: sucrose, potato syrup, methyl 4-hydroxybenzoate (E 218) (nipagin M), yellow beeswax, ethanol 96%, rapeseed oil.

What Ergotaminum Filofarm looks like and contents of the pack
Ergotaminum Filofarm is a coated tablet.
Packaging:
One cardboard box contains 1 clear glass bottle with 20 coated tablets.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz
For further information about this medicinal product, please contact 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 of Ergotaminum Filofarm is available in the Audio Leaflet system via the nationwide free telephone number 800 706 848.