Ergotaminum Filofarm

Leaflet attached to the packaging: patient information

Ergotaminum Filofarm

1 mg, effervescent tablets

Ergotamine tartrate

Read the leaflet carefully before taking the medicine, 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 medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ergotaminum Filofarm and what is it 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 packaging and other information

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

Ergotaminum Filofarm contains ergotamine tartrate. Ergotamine strongly constricts blood vessels, but can also dilate them depending on vascular resistance. If vascular resistance is low, ergotamine causes vasoconstriction and increased arterial pressure; if vascular resistance is high, ergotamine causes the opposite reaction - vasodilation. Ergotamine acts mainly on the blood vessels of the brain, reducing migraine symptoms and blood flow. Ergotamine has a strong oxytocic effect (causing uterine muscle contraction).

Indications

Ergotaminum Filofarm is used to prevent and treat vascular headaches, including migraines and cluster headaches.

2. Important information before taking Ergotaminum Filofarm

When not to take Ergotaminum Filofarm

• if the patient is allergic to ergotamine tartrate, other ergot alkaloids, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has uncontrolled or severe hypertension, peripheral vascular disease (Raynaud's disease, thromboembolic vasculitis, thrombophlebitis, advanced arteriosclerosis),
• after vascular surgery,
• after recent angioplasty or if angioplasty is being considered,
• in malnutrition,
• in severe itching,
• in case of kidney or liver dysfunction,
• in sepsis,
• in glaucoma,
• in pregnancy,
• during breastfeeding,
• in combination with macrolide antibiotics, HIV protease inhibitors, antifungal agents from the azole group, vasoconstrictor agents, sumatriptan, and other 5-HT serotonin receptor agonists

Warnings and precautions

Before starting treatment with Ergotaminum Filofarm, the patient should discuss it with their doctor. During treatment with the medicine, very individual hypersensitivity reactions to ergotamine may occur. The medicine may cause myocardial hypoxia or myocardial infarction during treatment, even with small doses of ergotamine. If the patient experiences tingling in the fingers or toes, they should stop taking the medicine and contact their doctor. Peripheral vascular disorders may occur even after a single dose of ergotamine. The medicine should be used with caution in patients with heart rhythm disorders. The patient should consult their doctor, even if the above warnings refer to past situations. 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 pain medication may lead to increased headache. If the patient experiences or suspects such a cause of headache, they should stop taking the medicine and consult their 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.

Children and adolescents

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

Ergotaminum Filofarm and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Sumatriptan (a migraine medicine) should not be combined with ergotamine-containing medicines due to the potential for additive vasoconstrictive effects. Ergotamine should not be taken within 6 hours of sumatriptan administration, and sumatriptan should not be taken within 24 hours of ergotamine administration. Ergotamine should not be used during treatment with dihydroergotamine, methysergide (migraine medicines), bromocriptine, or cabergoline (lactation inhibitors) due to the potential for hypertension and myocardial infarction. During treatment with ergotamine and alpha-adrenergic receptor blockers (e.g., tolazoline, prazosin) or beta-adrenergic receptor blockers (e.g., atenolol, nadolol, oxprenolol, propranolol, timolol), peripheral vasoconstriction may occur, accompanied by pain and cyanosis. Concomitant administration of macrolide antibiotics (e.g., clarithromycin, roxithromycin, erythromycin) may disrupt ergotamine metabolism by inhibiting cytochrome P-450, leading to increased toxicity of the alkaloid. Antiviral agents (e.g., delavirdine, indinavir, ritonavir, nelfinavir) used concomitantly with ergotamine increase the risk of serious side effects. Antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline) in combination with ergotamine may cause coordination disorders, general weakness, and decreased reflexes. Dopamine and dobutamine (medicines that increase cardiac contractility) used concomitantly with ergotamine may cause peripheral hypoperfusion and hypoxia, leading to gangrene of the hands and feet; therefore, these medicines should not be used concomitantly with ergot alkaloids.

Using Ergotaminum Filofarm with food and drink

See section 3 of the leaflet. The patient should not drink alcohol while taking Ergotaminum 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 their doctor or pharmacist before taking this medicine. Ergotaminum Filofarm should not be used in pregnant or breastfeeding women.

Driving and using machines

There are no data on the effects of Ergotaminum Filofarm on the ability to drive or operate machinery.

Ergotaminum Filofarm contains sucrose and lactose

One effervescent tablet contains 55.25 mg of sucrose and 42.8 mg of lactose (equivalent to 45 mg of anhydrous lactose). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Ergotaminum Filofarm contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Ergotaminum Filofarm contains methyl parahydroxybenzoate (E 218) (nipagin M)

One effervescent tablet contains 0.0002 mg of methyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late-type reactions).

3. How to take Ergotaminum Filofarm

This medicine should be taken as directed by the doctor. In case of doubts, the patient should consult their doctor. The medicine should be taken before a meal, and if gastrointestinal disorders occur, it should be taken during a meal. The medicine is usually taken as described below. The recommended dose is 2-4 effervescent tablets per day (2-4 mg of ergotamine tartrate per day). The patient should not take a single dose larger than 2 effervescent tablets or more than 4 effervescent tablets per day, and no more than 8 effervescent tablets per week. The medicine is used as needed, and long-term use is only for cluster headaches and must be monitored by a doctor. Patient with kidney or liver dysfunctionshould not take Ergotaminum Filofarm. Elderly patientsdo not need to change the way the medicine is taken or the dosage. If the patient feels that the effect of Ergotaminum Filofarm is too strong or too weak, they should consult their doctor.

Taking a higher dose of Ergotaminum Filofarm than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor. Overdose symptoms: fatigue, disorientation, depression, drowsiness, hallucinations, severe shortness of breath, decreased or increased blood pressure, rapid and weak pulse, numbness of limbs, loss of consciousness, shock, and death.

Missing a dose of Ergotaminum Filofarm

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

Stopping treatment with Ergotaminum Filofarm

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

4. Possible side effects

Like all medicines, Ergotaminum Filofarm can cause side effects, although not everybody gets them: central nervous system disorders such as paresthesia of peripheral parts of the body (numbness and tingling in the upper and lower limbs), limb weakness, headaches, disorientation, irritability, dizziness, drowsiness or insomnia, nausea, vomiting, abdominal pain, constipation, gingival hyperplasia, ischemia, irritation, bleeding, and rectal ulcers caused by vasoconstriction, skin changes (rarely occurring during short-term therapy) such as erythema, edema, purpura, skin necrosis, acne, heart rhythm disorders, myocardial fibrosis, valvular fibrosis, coronary artery fibrosis, and aortic fibrosis, increased or decreased blood pressure. There have been reports of myocardial hypoxia and myocardial infarction during treatment with even small doses of ergotamine (2 mg/week). Ergotamine may cause muscle tension disorders preceded by paresthesia, muscle cramps, and limb pain. Prolonged use of ergotamine, especially in higher doses, may lead to the development of ergotism, which initially manifests as numbness and cooling of the hands and feet, and in the next stage, as circulatory disorders in the limbs, prolonged vasoconstriction, and eventually gangrene of the limbs. Long-term use of the medicine may cause liver and kidney damage. During treatment with the medicine, there is a potential risk of dependence and tolerance development.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ergotaminum Filofarm

The medicine should be stored in a place inaccessible to children. The medicine should not be used after the expiration date stated on the packaging after EXP. The expiration date means the last day of the given month. The medicine should be stored at a temperature below 25°C. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Ergotaminum Filofarm contains

• The active substance of the medicine is ergotamine tartrate. One effervescent tablet contains 1 mg of ergotamine tartrate.
• The excipients are: the core of the effervescent tablet contains potato starch, sodium carboxymethyl starch, lactose, magnesium stearate, talc; the coating of the effervescent tablet contains sucrose, potato syrup, methyl parahydroxybenzoate (E 218) (nipagin M), yellow beeswax, 96% ethanol, rapeseed oil.

What Ergotaminum Filofarm looks like and what the packaging contains

Ergotaminum Filofarm is an effervescent tablet. Packaging:The carton contains 1 glass vial containing 20 effervescent tablets.

Marketing authorization holder and manufacturer

Farmaceutyczna Spółdzielnia Pracy FILOFARM, ul. Pułaskiego 39, 85-619 Bydgoszcz. For more information on this medicine, the patient should contact the representative of the marketing authorization holder. Farmaceutyczna Spółdzielnia Pracy Filofarm, ul. Pułaskiego 39, 85-619 Bydgoszcz, tel: (52) 342 67 88. Information for the blind and visually impaired: The content of the Ergotaminum Filofarm leaflet is available in the Ulotka Audio system under the nationwide free phone number 800 706 848.

Date of leaflet approval: