Coffecorn mite

Package leaflet: Information for the patient

Coffecorn mite
500 µg + 25 mg, coated tablets
Ergotamini tartras + Coffeinum
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What Coffecorn mite is and what it is used for
Coffecorn mite contains ergotamine tartrate and caffeine. 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 induces the opposite reaction—vasodilation. Ergotamine primarily constricts
cerebral blood vessels, reducing migraine symptoms and blood flow.
Ergotamine partially stimulates and partially inhibits alpha-adrenergic receptors of blood vessels.
Ergotamine exerts a strong oxytocic effect (causes contraction of uterine muscles).
The rationale for combining caffeine with ergotamine is that caffeine facilitates the absorption of this alkaloid.
Caffeine, when used in therapeutic doses, stimulates cerebral cortex and autonomic centers.
It improves concentration, shortens reaction time, enhances mental performance, alleviates
mental fatigue, and relieves drowsiness. Caffeine dilates extracranial and intracranial vessels.
It accelerates cardiac activity, increases the force of contractions and cardiac output.
Caffeine enhances the effect of analgesic drugs. Caffeine is used as an adjunctive treatment
in headache, as a tonic in mental fatigue, hypotension, and fainting.
Indications
Coffecorn mite is indicated for migraine attacks and vascular headaches when analgesics are ineffective.

2. Important information before taking Coffecorn mite

When not to use Coffecorn mite

• if you are allergic to ergotamine tartrate, other ergot alkaloids, caffeine, or any of the other ingredients of this medicine (listed in section 6),
• in case of uncontrolled hypertension,
• if you are taking drugs that inhibit the activity of the CYP3A isoenzyme of cytochrome P450 (e.g. azole antifungal agents, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin),
• if you are taking drugs that constrict blood vessels,
• if you currently have or have previously experienced fibrotic (scar-forming) reactions affecting the heart muscle, lungs, peritoneum, or retroperitoneal tissue,
• in peripheral vascular diseases such as Raynaud's disease, obliterative vasculitis, thrombophlebitis, advanced atherosclerosis, or after vascular surgery,
• in myocardial ischemia,
• after myocardial infarction,
• in peptic ulcer disease of the stomach or duodenum,
• in kidney or liver disease,
• in sepsis,
• in glaucoma,
• during pregnancy,
• during breastfeeding,
• in children under 12 years of age.

Warnings and precautions
Before starting treatment with Coffecorn mite, discuss it with your doctor.
Very individual hypersensitivity reactions to ergotamine may occur during treatment.
The medicine may cause myocardial ischemia or myocardial infarction even when small doses of ergotamine are used. Peripheral vascular disturbances may occur even after a single dose of ergotamine. Use with caution in patients with cardiac arrhythmias.
If tingling sensations occur in the fingers or toes, discontinue taking the medicine and contact your doctor.
In patients undergoing long-term ergotamine treatment, the doctor will check heart, lung, and kidney function before initiating therapy. During treatment, the doctor will pay special attention to any signs potentially related to fibrosis. If necessary, appropriate tests will be performed. If fibrosis occurs, treatment will be discontinued.
Ergotamine may react with synthetic materials used in surgical reconstruction.
Consult your doctor even if the above warnings refer to conditions that occurred in the past.
Coffecorn mite is not intended for long-term therapy and should not be used for migraine prophylaxis.
Prolonged use of any analgesic drugs may lead to worsening of headache.
If you have or suspect this type of headache, you should discontinue the medicine and consult your doctor. In patients who experience frequent or daily headaches despite (or due to) regular use of headache medications, medication-overuse headache should be considered.
Concomitant use of drugs that inhibit the activity of the CYP3A isoenzyme of cytochrome P450 may enhance the effects of ergotamine and caffeine and increase the risk of adverse events. Severe, even life-threatening cerebral and/or peripheral ischemia may occur.

Children and adolescents
Do not use in children under 12 years of age.

Coffecorn mite with other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Medicines containing ergotamine should not be taken together with sumatriptan (an antimigraine drug) due to the risk of additive vasoconstrictive effects.
Ergotamine should not be used during therapy with dihydroergotamine, bromocriptine, cabergoline (drugs that inhibit lactation), or methysergide (an antimigraine drug) due to the risk of hypertension and myocardial infarction.
During ergotamine therapy and treatment with drugs blocking alpha-adrenergic receptors (tolazoline, prazosin—vasodilators) and beta-adrenergic receptors (atenolol, nadolol, oxprenolol, propranolol, timolol—used in hypertension and ischemic heart disease), increased arterial pressure and angina may occur.
Concomitant administration of ergotamine- and caffeine-containing products with inhibitors of the CYP3A isoenzyme of cytochrome P450 (e.g. azole antifungal agents, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, grapefruit juice) may result in stronger and prolonged effects of ergotamine and caffeine.
Simultaneous use of macrolide antibiotics (clarithromycin, roxithromycin, erythromycin) may impair ergotamine metabolism by inhibiting cytochrome P450, leading to increased alkaloid toxicity.
Antiviral drugs (delavirdine, indinavir, ritonavir, nelfinavir) used concomitantly with ergotamine increase the risk of serious adverse reactions.
Antidepressants (fluoxetine, fluvoxamine, paroxetine, sertraline) in combination with ergotamine may cause motor coordination disturbances, general weakness, and diminished reflexes.
Dopamine and dobutamine (drugs increasing myocardial contractility) used simultaneously with ergotamine may cause peripheral ischemia and hypoxia leading to necrosis of hands and feet; therefore, these drugs should not be used together with ergot alkaloids.
Caffeine contained in the medicine enhances the effects of central nervous system stimulants and drugs that increase blood pressure.

Taking Coffecorn mite with food, drink, and alcohol
See section 3.
Do not drink grapefruit juice or alcohol while taking Coffecorn mite.

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 using this medicine.
Coffecorn mite should not be used in pregnant or breastfeeding women.
Long-term use of ergotamine poses a risk to the fetus and may cause abortion due to its oxytocic effect.
Both ergotamine and caffeine pass into breast milk and may cause various disturbances in breastfed infants.

Driving and operating machinery
There are no data in the literature regarding ergot alkaloids and their derivatives or caffeine affecting the ability to drive or operate machinery.

Coffecorn mite contains sucrose and lactose
One tablet contains 134.98 mg of sucrose and 59.1 mg of lactose (equivalent to 62.2 mg of monohydrated lactose). If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

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

Coffecorn mite contains methyl parahydroxybenzoate (E 218) (nipagin M)
One tablet contains 0.00035 mg of methyl parahydroxybenzoate. The medicine may cause allergic reactions (including delayed-type reactions).

3. How to use Coffecorn mite

This medicine should always be used as directed by a physician. In case of doubt, consult your doctor.
For maximum effectiveness, this medicine should be taken at the onset of the first symptoms of a migraine attack.

Method of administration
Adults and children over 12 years of age:
The recommended dose is 1 to 4 coated tablets at the onset of the first symptoms of a migraine attack.
Thereafter, if necessary, take 1 to 2 coated tablets every half hour to stop the migraine attack (maximum 8 coated tablets per day or 16 coated tablets per week). At least a 4-day interval must be maintained between consecutive maximum doses.

For other vascular headaches, take 1 to 2 coated tablets twice daily, not longer than four days.

The medicine should be taken before meals; however, in case of gastrointestinal discomfort, it may be taken during meals (see also "Use of Coffecorn mite with food, drink and alcohol" in section 2).

Patients with impaired renal and/or hepatic function
Use of Coffecorn mite is contraindicated in patients with impaired liver or kidney function.

If you feel that the effect of Coffecorn mite is too strong or too weak, consult your doctor.

Taking more Coffecorn mite than recommended
In case of overdose, seek immediate medical advice from a doctor or pharmacist.

Symptoms of overdose:
Fatigue, disorientation, depression, drowsiness, hallucinations, severe shortness of breath, decreased or increased arterial blood pressure, rapid and weak pulse, limb numbness, loss of consciousness, shock, and death.
If the patient is conscious, induce vomiting and seek medical help immediately.

Missed dose of Coffecorn mite
Do not take a double dose to make up for a missed dose.

Stopping Coffecorn mite
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Nervous system disorders
During treatment with ergotamine, central nervous system disorders may occur, such as: peripheral paresthesia, limb weakness, headaches, disorientation, dizziness, drowsiness.
The presence of caffeine may cause: insomnia, irritability, muscle tremors.
Cardiac and vascular disorders
During use of the product, cardiac rhythm disturbances, fibrosis of the myocardium, heart valves, coronary vessels and aorta, and increased or decreased blood pressure may occur.
Long-term use of ergotamine, especially at higher doses, may lead to ergotism, initially manifesting as numbness and coldness of hands and feet, followed by circulatory disturbances in the limbs, prolonged vasoconstriction of the extremities, and ultimately gangrene of the limbs.
Gastrointestinal disorders
Ergotamine and caffeine contained in the product may cause: nausea, gastrointestinal discomfort, epigastric pain, constipation, gingival hyperplasia. Ergotamine may cause ischemia, irritation, bleeding, and ulceration of the anus due to vasoconstriction of blood vessels.
Hepatic and biliary disorders
Prolonged use of the product may lead to liver damage.
Renal and urinary disorders
Prolonged use of the product may lead to kidney damage.
General disorders and administration site conditions
During treatment with ergotamine, skin changes may occur such as: erythema, edema, petechiae, epidermal necrosis, acne. These complications rarely occur during short-term therapy.
With long-term use of ergotamine, fibrotic (scar-like) reactions may occur affecting the myocardium, lungs, and peritoneal or retroperitoneal tissues.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist.
Adverse effects 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
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Coffecorn mite

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

6. Contents of the pack and other information

What the medicine Coffecorn mite contains

• The active substances are ergotamine tartrate and anhydrous caffeine. Each coated tablet contains 500 µg of ergotamine tartrate (Ergotamini tartras) and 25 mg of anhydrous caffeine (Coffeinum).
• Excipients: The core of the coated tablet contains methylcellulose, potato starch, sodium carboxymethyl starch, monohydrate lactose, magnesium stearate, talc. The coating of the tablet contains: sucrose, brilliant blue FCF (E 133), potato syrup. The glazing agent consists of: rapeseed oil, yellow beeswax, methyl parahydroxybenzoate (E 218) (methylparaben), ethanol 96%.

What Coffecorn mite looks like and contents of the pack
Coffecorn mite is a blue, biconvex coated tablet.
Packaging:
One cardboard box contains 1 clear glass bottle with 12 coated tablets.
Marketing Authorisation Holder and Manufacturer
Farmaceutyczna Spółdzielnia Pracy FILOFARM
ul. Pułaskiego 39
85-619 Bydgoszcz
For further information, 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 visually impaired persons: the package leaflet for Coffecorn mite is available in the Audio Leaflet system via the national free phone number 800 706 848.