Coffecorn forte

Package Leaflet: Information for the Patient

Coffecorn Forte

1 mg + 100 mg, coated tablets

Ergotamine tartrate + Caffeine

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 inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

Coffecorn Forte 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 the opposite reaction - 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 (causes uterine muscle contraction). The justification 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 vegetative centers. It improves concentration, shortens reaction time, improves thinking ability, alleviates symptoms of mental fatigue, and removes drowsiness. Caffeine dilates extracranial and intracranial vessels. It accelerates activity, increases the strength of heart contractions, and increases cardiac output. Caffeine enhances the effect of painkillers. Caffeine is used as an auxiliary medicine for headaches, tonic in states of mental fatigue, hypotension, and fainting.

Indications

Coffecorn Forte is used for migraine attacks and vascular headaches when painkillers are ineffective.

2. Important information before taking Coffecorn Forte

When not to take Coffecorn Forte

• if the patient is allergic to ergotamine tartrate, other ergot alkaloids, caffeine, or any of the other ingredients of this medicine (listed in section 6),
• if uncontrolled hypertension occurs,
• if the patient is taking medicines 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 medicines that constrict blood vessels,
• if the patient has currently or has had in the past fibrotic reactions (scarring) 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,
• in pregnancy,
• during breastfeeding.

Warnings and precautions

Before starting treatment with Coffecorn Forte, the patient should discuss it with their doctor.
During treatment with the medicine, very individual allergic reactions to ergotamine may occur.
The medicine 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 medicine 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 medicine and consult a doctor.
In the case of patients taking ergotamine for a long time before starting treatment, the doctor will check if the heart, lung, and kidney function is normal. During treatment, the doctor will pay special 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 plastics used in reconstructive surgery.
The patient should consult a doctor, even if the above warnings refer to past situations.
Coffecorn Forte is not intended for long-term therapy and should not be used for migraine prophylaxis.
Long-term use of any painkillers may lead to increased headache.
If the patient experiences or suspects such a cause of headache, they should stop taking the medicine and consult a doctor. In patients who experience frequent or daily headaches despite (or due to) regular use of painkillers, the diagnosis of headache dependent on continuous use of painkillers should be considered.
Concomitant use of medicines that inhibit the activity of the CYP3A isoenzyme of cytochrome P450 may enhance the effect of ergotamine and caffeine and cause an increase in adverse events. Serious, even life-threatening, cerebral and/or peripheral hypoperfusion is possible.

Children and adolescents

The medicine is not intended for use in children under 12 years of age.

Coffecorn Forte 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.
Medicines containing ergotamine should not be taken with sumatriptan (a migraine medicine) due to the possibility of summing up the spastic effect on blood vessels.
Ergotamine should not be used during therapy with dihydroergotamine, bromocriptine, cabergoline (lactation inhibitors), methysergide (a migraine medicine) due to the possibility of hypertension and heart attack.
During treatment with ergotamine and medicines that inhibit alpha-adrenergic receptors (tolazoline, prazosin - vasodilators) and beta-adrenergic receptors (atenolol, nadolol, oxprenolol, propranolol, timolol - medicines used in hypertension and coronary heart disease) an increase in blood pressure and angina pectoris may occur. When using a product containing ergotamine and caffeine with inhibitors of the CYP3A isoenzyme of cytochrome P450 (e.g., azole antifungals, HIV protease inhibitors, clarithromycin, telithromycin, verapamil, diltiazem, indinavir, ciprofloxacin, grapefruit juice) the effects of ergotamine and caffeine may be stronger and longer-lasting. Concomitant administration of macrolide antibiotics (clarithromycin, roxithromycin, erythromycin) may disrupt the metabolism of ergotamine by inhibiting cytochrome P450 and cause an increase in the toxicity of the alkaloid. Antiviral medicines (delavirdine, indinavir, ritonavir, nelfinavir) used concomitantly with ergotamine increase the risk of serious adverse events. Antidepressant medicines (fluoxetine, fluvoxamine, paroxetine, and sertraline) in combination with ergotamine may cause coordination disorders, general weakness, and decreased reflexes. Dopamine and dobutamine (medicines that increase heart muscle contractility) used concomitantly with ergotamine may cause peripheral hypoperfusion and hypoxia leading to gangrene of the hands and feet, so these medicines should not be used concomitantly with ergot alkaloids. The caffeine contained in the medicine enhances the effect of medicines that stimulate the central nervous system and increase blood pressure.

Using Coffecorn Forte with food, drink, and alcohol

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

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.
Coffecorn Forte should not be used in pregnant or breastfeeding women.
Chronic 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 using machines

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 and use machines.

Coffecorn Forte contains sucrose and lactose

One tablet contains 179.925 mg of sucrose and 33 mg of lactose (which is 34.70 mg of lactose monohydrate). If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

Coffecorn Forte contains sodium

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

Coffecorn Forte contains methyl parahydroxybenzoate (E 218) (nipagin M)

One tablet contains 0.00046 mg of methyl parahydroxybenzoate. The medicine may cause allergic reactions (possible late reactions).

3. How to take Coffecorn Forte

This medicine 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 medicine should be taken at the onset of the first symptoms of a migraine attack.
Usually, the medicine is used as described below.

Adults and children over 12 years of age:

The recommended dose is 1 to 2 coated 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 coated tablet every half hour (maximum 4 coated tablets per day or 8 coated tablets per week). The patient should maintain an interval of at least 4 days between consecutive maximum doses.
In the case of other vascular headaches, the patient should take 1 coated tablet twice a day, for no more than four days.
The medicine should be taken before a meal, and in case of gastrointestinal disorders, during a meal. (See also "Using Coffecorn Forte with food, drink, and alcohol" in section 2).
Patient with kidney and/or liver disorders
Using Coffecorn Forte in patients with liver or kidney function disorders is contraindicated.
If the patient feels that the effect of Coffecorn Forte is too strong or too weak, they should consult their doctor.

Overdose of Coffecorn Forte

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

Missed dose of Coffecorn Forte

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

Stopping treatment with Coffecorn Forte

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

4. Possible side effects

Like all medicines, Coffecorn Forte can cause side effects, although not everybody gets them.
Nervous system disorders
During treatment with ergotamine, disorders from the central nervous system may occur, such as: paresthesia of peripheral parts of the body, limb weakness, headaches, disorientation, dizziness, drowsiness.
The presence of caffeine may cause: insomnia, irritability, muscle tremors.
Heart and blood vessel disorders
During treatment with the medicine, heart rhythm disorders, 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, which initially manifests as numbness and cooling of the hands and feet, and in the next stage, impaired circulation in the limbs, prolonged vasoconstriction of the limbs, and ultimately, gangrene of the limbs.
Gastrointestinal disorders
The ergotamine and caffeine contained in the medicine may cause: nausea, gastrointestinal disorders, abdominal pain, constipation, gingival hyperplasia. Ergotamine may cause hypoperfusion, irritation, bleeding, and ulceration of the anus, caused by vasoconstriction.
Liver and bile duct disorders
During long-term use of the medicine, liver damage may occur.
Kidney and urinary tract disorders
During long-term use of the medicine, kidney damage may occur.
Musculoskeletal and connective tissue disorders
Ergotamine and caffeine may cause muscle tension disorders preceded by paresthesia, cramps, and pain in the lower limbs.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Coffecorn Forte

The medicine should be stored out of 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 given month.
Store in a temperature below 25°C.
Medicines should not be disposed of via wastewater or household waste. 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 pack and other information

What Coffecorn Forte contains

• The active substances of the medicine are: ergotamine tartrate and anhydrous caffeine. One coated tablet contains 1 mg of ergotamine tartrate and 100 mg of anhydrous caffeine.
• The excipients are: the core of the coated tablet contains: methylcellulose, potato starch, sodium carboxymethylcellulose, lactose monohydrate, magnesium stearate, talc; the coating of the coated tablet contains: sucrose, brilliant blue FCF (E 133), potato syrup; the composition of the polishing mixture: rapeseed oil, yellow beeswax, methyl parahydroxybenzoate (E218) (nipagin M), 96% ethanol.

What Coffecorn Forte looks like and contents of the pack

Coffecorn Forte is a coated tablet.
Packaging:
A cardboard box contains 1 colorless glass vial with 12 coated tablets.

Marketing authorization holder and manufacturer

Pharmaceutical Cooperative FILOFARM
Pułaskiego 39
85-619 Bydgoszcz
To obtain more detailed information, the patient should contact the representative of the marketing authorization holder:
Pharmaceutical Cooperative FILOFARM
Pułaskiego 39, 85-619 Bydgoszcz
Phone: (52) 342 67 88
Information for the blind and visually impaired: The content of the Coffecorn Forte leaflet is available in the Ulotka Audio system under the nationwide free phone number 800 706 848.

Date of last revision of the leaflet: