Prospect: information for the user

Cafergot 1 mg/100 mg tablets

Ergotamine, tartrate/caffeine

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Cafergot and what is it used for

2.What you need to know before starting to take Cafergot

3.How to take Cafergot

4.Possible adverse effects

5.Storage of Cafergot

6.Contents of the package and additional information

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

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

Do not take Cafergot

• - If you are allergic to the active ingredient or any of the other components of this medication (including those listed in section 6).
• - If you have 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 arms and legs (obliterative vascular disease), cardiac disease due to reduced blood flow to the heart (ischemic cardiopathy), uncontrolled high blood pressure, generalized infection (sepsis or shock).
• - If you have severe liver or kidney failure.
• - If you have temporal arteritis (inflammation of the main artery of the head).
• - If you have migraines accompanied by neurological symptoms such as balance disturbances, speech disturbances, vision disturbances, tingling 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 for preventing their occurrence.
• - Avoid continuous use of Cafergot or use at doses higher than recommended, as higher doses may cause vasospasm (contraction of arteries that can lead to brain and heart disorders) and after prolonged treatment, pleural, peritoneal, or cardiac valve alterations, cardiac fibrosis, pulmonary fibrosis, and ergotism (long-term poisoning by ergot alkaloids), including severe cases of vasoconstriction symptoms, 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 medication.
• - If symptoms such as tingling in fingers and toes appear, discontinue treatment immediately and consult your doctor.

Patients with mild or moderate liver dysfunction should be monitored (by their doctor).

Children and adolescents

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

Use in the elderly

As this medication contains ergotamine, caution is recommended in this type of patient, as they are more susceptible to vascular disease that reduces blood flow to arms and legs and, therefore, to experiencing the adverse events of reduced blood flow to arms and legs that young adults experience. The risk of reduced blood flow to the heart is also higher in older people.

Cafergot use with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. The administration of macrolide antibiotics (erythromycin, clarithromycin), tetracycline (antibiotic used to treat bacterial infections), HIV treatment medications (e.g. ritonavir, indinavir, nelfinavir, amprenavir, delavirdine, saquinavir, atazanavir, and efavirenz), or antifungal medications (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 heart disease and high blood pressure such as propranolol, other preparations containing ergot alkaloids, nicotine (e.g. excessive smoking), and medications for migraine such as sumatriptan.

• There is a higher risk of vasospasm (contraction of arteries that can lead to brain and heart 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 (used to treat depression), and oral contraceptives may increase plasma exposure to caffeine. Caffeine interactions with sympathomimetics (e.g. epinephrine) may lead to increased blood pressure.
• Modest to weak CYP3A4 inhibitors, such as cimetidine, fluvoxamine, grapefruit juice, quinupristin/dalfopristin, and zileuton, may also increase exposure to ergotamine 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 (potentially fatal pharmacological interaction) and these should be used with caution.
• CYP3A4 inducers (e.g. nevirapine, rifampicin) may lead to a decrease in the pharmacological action of ergotamine.
• Quinupristin-dalfopristin (combined): ergotism with a possibility of necrosis (cell damage) of the extremities.
• Estriripentol: ergotism with a possibility of necrosis (cell damage) of the extremities.
• Dopaminergic ergot alkaloids (bromocriptine, cabergoline, pergolide, lisuride): risk of vasoconstriction and/or hypertension crisis.
• Alpha sympathomimetics (oral and/or nasal) (etilefrine, midodrine, naphazoline, oxymetazoline, phenylephrine, synephrine, tetrahydrozoline, timolol, tuaminoheptane): risk of vasoconstriction and/or hypertension crisis.
• Reboxetine may cause high blood pressure.
• Enoxacina (fluoroquinolones): a significant increase in caffeine concentrations in the body that may lead to excitement and hallucinations.
• Fluoroquinolones (ciprofloxacin, norfloxacin): a significant increase in caffeine concentrations in the body that may lead to excitement and hallucinations.

Cafergot use 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 may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Driving and operating machinery

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

This medication may cause dizziness. Be aware that some symptoms, such as drowsiness, dizziness, and weakness, caused by the migraine itself, may affect the ability to drive or use machinery.

Important information about some of the components of Cafergot

It is reported to athletes that this medication contains a component that may result in a positive analytical test for doping control.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with Cafergot. Do not discontinue treatment without consulting your doctor.

Oral administration.

Cafergot should be taken when the first symptoms of an attack appear.

Recommended dose:

Adults

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

Subsequent crises: depending on the doses needed in previous crises, the initial dose can be increased to 3 tablets. If necessary, additional doses of 1 tablet can be administered at half-hour intervals to reach the maximum dose.

Use in children and adolescents

Not recommended for use in children and adolescents (under 18 years old).

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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the package insert and the packaging of the medication 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 the fingers and toes. Respiratory frequency decrease and coma can occur.

If you forget to take Cafergot

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Cafergot

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Other side effects:

Frequent:: May affect up to 1 in 10 people

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

Occasional:: May affect up to 1 in 100 people

Numbness and tingling of the fingers of the hands and feet, 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, increase in blood pressure, skin rash, swelling in the face, urticaria, muscle pain, lack of pulse, and difficulty breathing, headache, dizziness, muscle spasms, ergotism (long-term poisoning effect).

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).

Unknown:: The frequency cannot be estimated from available data

Endocardial fibrosis (a type 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 tubes 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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in the original packaging to protect from light.

Do not store at a temperature above 25°C. Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at thelocal SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Cafergot

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

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

Appearance of the product and content of the packaging

Cafergot is presented in the form of tablets. Cafergot is available in aluminum/PVC/PVDC blister packs of 10 tablets. The groove serves only to break and facilitate swallowing but not to divide into equal parts.

Holder of the marketing authorization and responsible for manufacturing

Holder

Amdipharm Limited

Temple Chambers,

3 Burlington Road,

Dublin 4, Ireland

Responsible for manufacturing

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

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

Local Representative

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 – Barcelona

Review date of this leaflet: July 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/