Coffecorn mite

Package Leaflet: Information for the Patient

Coffecorn Mite

500 µg + 25 mg, Chewable Tablets

Ergotamine Tartrate + Caffeine

Read the Leaflet Carefully Before Taking 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 for a specific person. 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 Coffecorn Mite and what is it 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. Package contents and other information

1. What is Coffecorn Mite and what is it used for

Coffecorn Mite contains ergotamine tartrate and caffeine. 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 vasodilation. Ergotamine acts mainly on the blood vessels of the brain, reducing migraine symptoms and blood flow. Ergotamine partially stimulates and partially inhibits alpha-adrenergic receptors of blood vessels. Ergotamine has a strong oxytocic effect (causing uterine muscle contraction). The rationale for combining caffeine with ergotamine is that caffeine facilitates the absorption of this alkaloid. Caffeine, when used in therapeutic doses, stimulates the activity of the cerebral cortex and autonomic centers. It facilitates concentration, shortens reaction time, improves thinking performance, alleviates symptoms of mental fatigue, and removes drowsiness. Caffeine dilates extracranial and intracranial vessels. It accelerates heart rate, increases the strength of heart contractions, and increases cardiac output. Caffeine enhances the effect of painkillers. Caffeine is used as an auxiliary medication for headaches, tonic in states of mental fatigue, hypotension, and fainting.

Indications for Use

Coffecorn Mite is used for migraine attacks and headaches of vascular origin, when painkillers are ineffective.

2. Important Information Before Taking Coffecorn Mite

When Not to Take Coffecorn Mite

• if the patient is allergic to ergotamine tartrate, other ergot alkaloids, caffeine, or any of the other ingredients of this medication (listed in section 6),
• if uncontrolled hypertension occurs,
• if the patient is taking medications that inhibit the activity of the CYP3A isoenzyme of cytochrome P450 (e.g., azole antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin),
• if the patient is taking medications that constrict blood vessels,
• if the patient has currently or has had in the past fibrotic (scar) reactions of the heart muscle, lungs, peritoneum, or retroperitoneum,
• in peripheral vascular diseases such as Raynaud's disease, thromboangiitis obliterans, thrombophlebitis, advanced arteriosclerosis, and after surgical procedures on blood vessels,
• in myocardial hypoxia,
• after a heart attack,
• in peptic ulcer disease of the stomach and duodenum,
• in kidney and liver diseases,
• in sepsis,
• in glaucoma,
• during pregnancy,
• during breastfeeding
• in children under 12 years of age.

Warnings and Precautions

Before starting treatment with Coffecorn Mite, the patient should discuss it with their doctor. During treatment with the medication, very individual allergic reactions to ergotamine may occur. The medication may cause myocardial hypoxia or heart attack during treatment, even with small doses of ergotamine. Peripheral vascular disorders may occur even after a single dose of ergotamine. The medication should be used with caution in patients with heart rhythm disorders. If tingling occurs in the fingers or toes, the patient should stop taking the medication and contact their doctor. In patients taking ergotamine for a long time, the doctor will check if heart, lung, and kidney function is normal before starting treatment. During treatment, the doctor will pay particular attention to any signs potentially related to the occurrence of fibrosis. If necessary, appropriate tests will be performed. If fibrosis occurs, treatment will be discontinued. Ergotamine may react with synthetic materials used in reconstructive surgery. The patient should consult their doctor, even if the above warnings refer to past situations. Coffecorn Mite is not intended for long-term therapy and should not be used for migraine prophylaxis. Long-term use of any painkillers may cause increased headache. If the patient experiences or suspects such a cause of headache, they should stop taking the medication and consult their doctor. In patients who experience frequent or daily headaches despite (or due to) regular use of painkillers, the diagnosis of medication-overuse headache should be considered.

Children and Adolescents

The medication should not be used in children under 12 years of age.

Coffecorn Mite 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. Medications containing ergotamine should not be taken with sumatriptan (a migraine medication) due to the possibility of additive vasoconstrictive effects. Ergotamine should not be used during therapy with dihydroergotamine, bromocriptine, cabergoline (lactation inhibitors), methysergide (a migraine medication) due to the possibility of hypertension and heart attack. During treatment with ergotamine 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 use of a product containing ergotamine and caffeine with CYP3A isoenzyme inhibitors of cytochrome P450 (e.g., azole antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin) may enhance the effects of ergotamine and caffeine and cause increased adverse reactions. Concomitant administration of macrolide antibiotics (clarithromycin, roxithromycin, erythromycin) may disrupt ergotamine metabolism by inhibiting cytochrome P450 and cause increased toxicity of the alkaloid. Antiviral medications (delavirdine, indinavir, ritonavir, nelfinavir) used concomitantly with ergotamine increase the risk of serious adverse reactions. Antidepressant medications (fluoxetine, fluvoxamine, paroxetine, and sertraline) in combination with ergotamine may cause coordination disorders, general weakness, and decreased reflexes. Dopamine and dobutamine (medications that increase heart muscle contractility) used concomitantly with ergotamine may cause peripheral hypoxia and hypoperfusion leading to gangrene of the hands and feet, so these medications should not be used concomitantly with ergot alkaloids. The caffeine contained in the medication enhances the effect of medications that stimulate the central nervous system and increase blood pressure.

Using Coffecorn Mite with Food, Drink, and Alcohol

See section 3. The patient should not drink grapefruit juice or alcohol while taking Coffecorn Mite.

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 medication. 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 disorders in breastfed children.

Driving and Operating Machinery

There is no data in the literature on ergot alkaloids and their derivatives, as well as caffeine, regarding the effect on the ability to drive vehicles and operate machinery.

Coffecorn Mite Contains Sucrose and Lactose

One tablet contains 134.98 mg of sucrose and 59.1 mg of lactose (which is 62.2 mg of lactose monohydrate). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

Coffecorn Mite Contains Sodium

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

Coffecorn Mite Contains Methyl Parahydroxybenzoate (E 218) (Nipagin M)

One tablet contains 0.00035 mg of methyl parahydroxybenzoate. The medication may cause allergic reactions (possible late reactions).

3. How to Take Coffecorn Mite

This medication should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their doctor. To be maximally effective, the medication should be taken at the onset of the first symptoms of a migraine attack. The patient should take the medication before a meal, and if gastrointestinal disorders occur during treatment, they should take it during a meal (see also "Using Coffecorn Mite with Food, Drink, and Alcohol" in section 2).

Adults and Children Over 12 Years Old:

The recommended dose is 1 to 4 chewable tablets at the onset of the first symptoms of a migraine attack. Then, if necessary, to interrupt the migraine attack, the patient should take 1 to 2 chewable tablets every half hour (maximum 8 chewable tablets per day or 16 chewable tablets per week). The patient should maintain a minimum 4-day interval between consecutive maximum doses. For other headaches of vascular origin, the patient should take 1 to 2 chewable tablets twice a day, for no more than four days.

Taking a Higher Than Recommended Dose of Coffecorn Mite

In case of taking a higher dose than recommended, the patient should immediately consult their doctor or pharmacist. Symptoms of overdose: 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. If the patient is conscious, they should induce vomiting and consult their doctor.

Missing a Dose of Coffecorn Mite

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

Stopping Treatment with Coffecorn Mite

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

4. Possible Side Effects

Like all medications, Coffecorn Mite can cause side effects, although not everybody gets them. During treatment with ergotamine, disorders of the central nervous system may occur, such as paresthesia of peripheral parts of the body, limb weakness, headaches, disorientation, dizziness, and drowsiness. The presence of caffeine may cause: insomnia, irritability, muscle tremors. During treatment, disorders of heart rhythm, fibrosis of the heart muscle, valves, coronary vessels, and aorta, increased or decreased blood pressure may occur. Long-term use of ergotamine, especially in higher doses, may lead to the occurrence of ergotism, initially manifested by numbness and cooling of the hands and feet, and in the next stage, by circulation disorders in the limbs, prolonged vasoconstriction of the limbs, and ultimately, gangrene of the limbs. The medication may cause nausea, gastrointestinal disorders, abdominal pain, constipation, and gum hypertrophy. Ergotamine may cause hypoxia, irritation, bleeding, and ulceration of the anus, caused by vasoconstriction. During long-term treatment, liver damage may occur. During long-term treatment, kidney damage may occur. During treatment with ergotamine, skin changes such as erythema, edema, petechiae, skin necrosis, and acne may occur. These complications rarely occur during short-term therapy. During long-term treatment with ergotamine, fibrotic (scar) reactions of the heart muscle, lungs, peritoneum, and retroperitoneum may occur.

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 Post-Marketing Surveillance of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information on the safety of the medication can be collected.

5. How to Store Coffecorn Mite

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 specified month. Store in a temperature below 25°C. Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of unused medications. This will help protect the environment.

6. Package Contents and Other Information

What Coffecorn Mite Contains

• The active substances of the medication are ergotamine tartrate and anhydrous caffeine. One chewable tablet contains 500 µg of ergotamine tartrate and 25 mg of anhydrous caffeine.
• The excipients are: the core of the chewable tablet contains methylcellulose, potato starch, sodium carboxymethyl starch, lactose monohydrate, magnesium stearate, talc; the coating of the chewable tablet contains sucrose, brilliant blue FCF (E 133), potato syrup; the polishing mixture contains rapeseed oil, yellow beeswax, methyl parahydroxybenzoate (E 218) (nipagin M), 96% ethanol.

What Coffecorn Mite Looks Like and What the Package Contains

Coffecorn Mite is a blue, biconvex chewable tablet. The package is a cardboard box containing 1 glass vial with 12 chewable tablets.

Marketing Authorization Holder and Manufacturer

Farmaceutyczna Spółdzielnia Pracy FILOFARM, ul. Pułaskiego 39, 85-619 Bydgoszcz. For more detailed information, 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 Coffecorn Mite leaflet is available in the Ulotka Audio system under the nationwide free phone number 800 706 848.

Date of Last Update of the Leaflet: