CAFERGOT 1 mg/100 mg TABLETS

Introduction

Package Leaflet: Information for the User

Cafergot 1 mg/100 mg Tablets

Ergotamine, tartrate/caffeine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Cafergot is and what it is used for
2. What you need to know before you take Cafergot
3. How to take Cafergot
4. Possible side effects
5. Storing Cafergot
6. Contents of the pack and other information

1. What Cafergot is and what it is used for

Ergotamine, the active substance of Cafergot, belongs to a group of medicines known as ergot alkaloids. This substance constricts the dilated blood vessels in the brain that are responsible for the painful sensation, thus cutting off migraine attacks. Caffeine accelerates and increases the absorption of ergotamine in the body.

Cafergot is indicated for the treatment of acute migraine attacks with or without "aura" (i.e., visual, sensory, or language problems that some people have shortly before the attack and that may also appear during and after the attack).

2. What you need to know before you take Cafergot

Do not take Cafergot

• - If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• - If you suffer from circulatory disorders, e.g., Raynaud's syndrome (a condition that affects blood supply to certain parts of the body, usually the fingers and toes), hyperthyroidism, vascular disease that reduces blood flow to the arms and legs (peripheral vascular disease), heart disease due to reduced blood flow to the heart (ischemic heart disease), uncontrolled high blood pressure, or generalized infection (sepsis or shock).
• - If you suffer from severe liver or kidney failure.
• - If you suffer from inflammatory disease of the temporal artery (the main artery in the head)
• - If you suffer from migraines accompanied by neurological symptoms such as balance disturbance, speech disturbance, vision disturbance, tingling sensation in fingers and toes, and around the mouth (hemiplegic or basilar migraine).
• - If you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Cafergot

• - Cafergot is only indicated for the treatment of acute migraine attacks and not as a preventive treatment.
• - Continuous use of Cafergot or use at doses higher than recommended should be avoided, as higher doses than recommended may cause vasospasm (contraction of the arteries that can lead to cerebral and cardiac disorders), and after prolonged treatment, changes in the pleura (membrane that covers the lungs), peritoneum (membrane that covers the intestinal loops), or, more rarely, heart valves, cardiac fibrosis, pulmonary fibrosis (a respiratory disease in which scars form in lung tissue), and pleural fibrosis (a condition in which the tissue covering the lungs becomes thick and rigid) and ergotism (a long-term poisoning effect of ergot) may appear, including severe symptoms of vasoconstriction, which may result in death.
• - Caution is recommended in patients with anemia.
• - Patients with rare hereditary disorders such as galactose intolerance or glucose-galactose malabsorption should not take this medicine.
• - If symptoms such as tingling in fingers and toes appear, treatment should be discontinued immediately and the doctor consulted.

• People with mild or moderate liver function impairment should be monitored (by their doctor).

Children and adolescents

Cafergot is not recommended for children and adolescents under 18 years of age.

Use in elderly patients

As this medicine contains ergotamine, caution is recommended in these patients, as they are more likely to have vascular disease that reduces blood flow to the arms and legs and, therefore, to experience adverse events related to reduced diameter of blood vessels in the arms and legs than younger adults. The risk of reduced blood flow in the heart's blood vessels is also higher in older people.

Taking Cafergot with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The administration of macrolide antibiotics (erythromycin, clarithromycin), tetracycline (an antibiotic used to treat bacterial infections), medications for the treatment of HIV infection (e.g., ritonavir, indinavir, nelfinavir, amprenavir, delavirdine, saquinavir, atazanavir, and efavirenz), or medications for the treatment of fungal infections (e.g., ketoconazole, itraconazole, voriconazole) with Cafergot may cause a lack of blood flow, as they increase ergotamine levels in the blood. Other medications that may cause interactions are: medications for the treatment of heart diseases and blood pressure, such as propranolol, other preparations containing ergot alkaloids, nicotine (e.g., excessive smoking), and medications for the treatment of migraine, such as sumatriptan.

• There is a higher risk of vasospasm (arterial contraction that can lead to cerebral and cardiac disorders) observed with triptans, such as almotriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan, and eletriptan. A higher risk of hypertension.
• Fluoroquinolones (broad-spectrum antibiotics), mexiletine (used to treat irregular heartbeats), fluvoxamine (a medication used in depression), and oral contraceptives may increase plasma caffeine exposure. Caffeine interactions with sympathomimetics (e.g., epinephrine) may lead to increased blood pressure.
• Moderate to weak CYP3A4 inhibitors, such as cimetidine, fluvoxamine, grapefruit juice, quinupristin/dalfopristin, and zileuton, may also increase ergotamine exposure, and caution is required for concomitant use.
• The concomitant use of ergotamine with serotonin reuptake inhibitors (e.g., amitriptyline), including selective agents (e.g., sertraline), may lead to serotonin syndrome (a potentially life-threatening pharmacological interaction) and should be used with caution.
• Drugs (e.g., nevirapine, rifampicin) that induce CYP3A4 may lead to a decrease in the pharmacological action of ergotamine.
• Quinupristin-dalfopristin (combination): ergotism with possible necrosis (cell damage) of the limbs.
• Stiripentol: ergotism with possible necrosis (cell damage) of the limbs.
• Dopaminergic ergot alkaloids (bromocriptine, cabergoline, pergolide, lisuride): risk of vasoconstriction and/or hypertensive crisis (a severe increase in blood pressure that can lead to a stroke).
• Alpha sympathomimetics (oral and/or nasal) (e.g., etilefrine, midodrine, nafazoline, oxymetazoline, phenylephrine, synephrine, tetrisoline, tuaminoheptane, timazoline): risk of vasoconstriction and/or hypertensive crisis.
• Taking it with reboxetine may cause high blood pressure.
• Enoxacin (fluoroquinolones): significant increase in caffeine concentrations in the body, which may lead to excitement and hallucinations.
• Fluoroquinolones (ciprofloxacin, norfloxacin): significant increase in caffeine concentrations in the body, which may lead to excitement and hallucinations.

Taking Cafergot with food, drinks, and alcohol

Cafergot can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Do not take Cafergot if you are pregnant or breastfeeding.

If you think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

In male rats that received the combination of ergotamine and caffeine orally, fertility was not altered.

Driving and using machines

Patients with a history of vertigo or other cerebral disorders should not drive or operate machines. Patients should not drive a vehicle or operate machinery if they experience visual disturbances.

This medicine may cause dizziness. You should be aware that some symptoms, such as drowsiness, dizziness, and weakness, caused by the migraine attack itself, may affect your ability to drive or use machines.

Important information about some of the ingredients of Cafergot

Athletes are informed that this medicine contains a component that may result in a positive doping test.

3. How to take Cafergot

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Cafergot. Do not stop treatment before consulting your doctor.

Oral use.

Cafergot should be administered when the first symptoms of a migraine attack appear.

The recommended dose is:

Adults

If it is the first time you take Cafergot, a dose of 2 tablets is recommended. If the pain has not subsided within the first half hour, another tablet can be taken. This can be repeated at half-hour intervals without exceeding the maximum daily dose.

Subsequent crises: depending on the doses that were necessary in previous crises, the initial dose can be increased to 3 tablets. If necessary, additional doses of one tablet can be administered at half-hour intervals until the maximum dose is reached.

Use in children and adolescents

Cafergot is not recommended for children and adolescents (under 18 years of age).

Maximum daily dose:

Adults: 6 mg of ergotamine tartrate = 6 tablets.

Maximum weekly dose

Adults: 10 mg of ergotamine tartrate = 10 tablets.

If you take more Cafergot than you should

In case of overdose or accidental ingestion, inform your doctor or pharmacist immediately or consult the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the package leaflet and the medicine packaging to the healthcare professional.

The symptoms caused by Cafergot overdose are: nausea, vomiting, drowsiness, confusion, tachycardia (increased heart rate), dizziness, numbness, tingling, and pain in fingers and toes. Reduced respiratory rate and coma may occur.

If you forget to take Cafergot

Do not take a double dose to make up for forgotten doses.

If you stop taking Cafergot

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, contact your doctor immediately:

• Severe allergic reactions such as rash or itching, swelling of the face, eyelids, lips, urticaria, difficulty breathing.

Other side effects:

Common: May affect up to 1 in 10 people

Dizziness, nausea, and vomiting not related to migraine, and abdominal pain.

Uncommon: May affect up to 1 in 100 people

Numbness and tingling of fingers and toes, blue discoloration of the skin, diarrhea, pain and weakness in arms and legs. Blue discoloration of the skin due to poor blood circulation.

Rare: May affect up to 1 in 1,000 people

Acceleration or slowing of heart rate, increased blood pressure, skin rash, swelling of the face, urticaria, muscle pain, lack of pulse, and difficulty breathing, headache, vertigo, muscle spasms, ergotism (long-term poisoning effect of ergot).

Very rare: May affect up to 1 in 10,000 people

Myocardial infarction (heart attack) or angina pectoris (chest pain), gangrene (death of body tissue due to lack of blood flow or bacterial infection).

Not known: Frequency cannot be estimated from the available data

Endocardial fibrosis (a form of heart disorder in which the heart walls are rigid and the heart is unable to stretch and fill with blood properly), pleural fibrosis (a condition in which the tissue covering the lungs becomes thick and rigid), retroperitoneal fibrosis (a rare condition in which the ducts that carry urine from the kidneys to the bladder are blocked by masses located in the back of the abdominal cavity), rectal ulcer, anal ulcer, drug-induced headache.

Reporting of side effects:

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Cafergot

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect from light.

Do not store above 25°C. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Pointof the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cafergot

The active substances are ergotamine (DOE) tartrate 1 mg and anhydrous caffeine 100 mg.

The other ingredients of the tablet are: tartaric acid, magnesium stearate, talc, cornstarch, microcrystalline cellulose, yellow iron oxide (E172).

Appearance and packaging of the product

Cafergot is presented in tablet form. Cafergot is available in aluminum/PVC/PVDC blister packs of 10 tablets. The score line is only for breaking and facilitating swallowing but not for dividing into equal parts.

Marketing authorization holder and manufacturer

Marketing authorization holder

Amdipharm Limited

Temple Chambers,

3 Burlington Road,

Dublin 4, Ireland

Manufacturer

CENEXI 52 rue Marcel et Jacques Gaucher (Fontenay Sous Bois) - 94120 - France

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local representative

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Revision date of this leaflet: July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/