CAFERGOT 1 мг/100 мг Таблетки

Содержание инструкции

1. CAFERGOT 1 mg + 100 mg tablets, 2 mg + 100 mg suppositories
   1. What CAFERGOT is and what it is used for
   2. What you need to know before taking CAFERGOT
   3. How to take CAFERGOT
2. CAFERGOT should be taken at the first sign of a migraine attack. Do not use CAFERGOT
   1. Possible side effects
   2. How to store CAFERGOT
   3. Contents of the pack and other information

CAFERGOT 1 mg + 100 mg tablets, 2 mg + 100 mg suppositories

Ergotamine tartrate - caffeine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 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. How to store CAFERGOT
• 6. Contents of the pack and other information

1. What CAFERGOT is and what it is used for

CAFERGOT contains the active ingredients ergotamine tartrate and caffeine and belongs to the group of
anti-migraine medications. It works by constricting the size of extracranial blood vessels. Caffeine, in addition to its analgesic effects, increases the intestinal absorption of ergotamine.
CAFERGOT is indicated for the following conditions: treatment of acute pulsating headache preceded or not by characteristic symptoms such as visual disturbances, neurological symptoms or
speech disorders (called migraine with or without aura). Migraine-type headache (e.g.
histamine headache). Headache caused by blood vessel disorders in the brain (vasomotor headache).
Tension headache: in case of emotional tension.

2. What you need to know before taking CAFERGOT

Do not take CAFERGOT

• if you are allergic to ergotamine tartrate, caffeine or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”);
• if you suffer from disorders affecting blood vessels, occlusive vascular diseases (obliterating angiopathies), or if you suffer from coronary circulatory disturbance;
• if you suffer from uncontrolled high blood pressure;
• if you have a severe systemic infection (septic state);
• if you are in a state of circulatory failure (shock);
• if you have severe kidney or liver problems;
• if you suffer from a disease that causes inflammation of the blood vessels, predominantly in the neck and head, called temporal arteritis;
• if you suffer from a specific type of migraine called basilar migraine or hemiplegic migraine;
• if you are taking a certain type of antibiotics called macrolides;
• if you are taking medicines to treat HIV infection (called HIV protease inhibitors, reverse transcriptase inhibitors, cobicistat);
• if you are taking medicines to treat hepatitis C virus infection (called HCV protease inhibitors);
• if you are taking certain types of medicines to treat fungal infections (called azole antifungals);
• if you are taking other medicines that cause constriction of blood vessels (including ergot alkaloids or medicines from the triptan family or 5-hydroxytryptamine receptor inhibitors (see “Other medicines and CAFERGOT”).

Warnings and precautions
Talk to your doctor or pharmacist before taking CAFERGOT.
CAFERGOT is only indicated for the acute treatment of migraine attacks and not for preventing them.
Strictly adhere to the dose prescribed by your doctor. You should avoid continuous and
daily use of CAFERGOT or its use beyond the recommended daily and weekly doses,
as this can lead to contraction or narrowing of the blood vessel lumen, known as
vasospasm (see “Possible side effects” and “If you take more CAFERGOT than you should”).
If chest pain, numbness or tingling in the fingers of the hands or
feet, vomiting and nausea not due to headache occur during treatment, stop treatment and contact
your doctor immediately.
In particular, inform your doctor:

• If you suffer from a condition called anemia (decrease in the number of red blood cells or hemoglobin in the blood).
• If you suffer from mild to moderate liver disorders or conditions that can cause problems with bile secretion and outflow.
• If you suffer from mild to moderate kidney disorders.
• If you are taking other medicines. See section "Other medicines and CAFERGOT".

CAFERGOT can cause a significant reduction in blood flow to the heart with myocardial ischemia or infarction.
Long-term use of ergotamine can lead to serious side effects such as the development of
fibrosis in some parts of the body (retroperitoneal space in the abdomen, heart, lung,
pleura, the membrane lining the outside of the lung, heart valves) and intense
vasoconstriction of the arteries producing symptoms of vascular ischemia of the limbs and
other tissues (ergotism), with a possible fatal outcome (see “Possible side effects”).
With frequent use of medicines containing ergotamine, physical and psychological dependence can occur, which increases its use. During prolonged and
uninterrupted treatment with CAFERGOT, headache caused by the medicine may occur (see
“Possible side effects”).
Following abuse of suppositories containing ergotamine, such as CAFERGOT, usually
with doses higher than recommended or with recommended doses administered
continuously for many years, rare cases of ulcers at the level of the rectum and anus have been reported
(see “Possible side effects”).
Consult your doctor if any of the above warnings apply to your current or past condition.

Children and adolescents
The safety and efficacy of CAFERGOT have not been established in pediatric patients.
CAFERGOT is not recommended in children and adolescents under the age of 18 years.

Elderly
Studies have not been conducted in elderly patients (aged 65 years or older).
CAFERGOT is not recommended in patients over 65 years of age.

Other medicines and CAFERGOT
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular:

• medicines used to treat HIV infection, such as amprenavir, saquinavir, indinavir, atazanavir, fosamprenavir, nelfinavir, ritonavir, tipranavir, lopinavir, darunavir, cobicistat, delavirdine efavirenz (see also “Do not take CAFERGOT”), nevirapine;
• medicines used to treat hepatitis C virus infection (boceprevir, telaprevir) (see also “Do not take CAFERGOT”);
• medicines used to treat fungal infections, such as ketoconazole, miconazole, itraconazole, posaconazole, voriconazole (see “Do not take CAFERGOT”), clotrimazole, fluconazole;
• antibiotic medicines of the tetracycline class or macrolides such as erythromycin, troleandomycin, clarithromycin, josamycin (see “Do not take CAFERGOT”);
• medicines used to treat bacterial infections e.g. fluoroquinolones (enoxacin, ciprofloxacin, norfloxacin), rifampicin, quinupristin/dalfopristin;
• medicines that have a vasoconstrictive action, used for migraine, called ergot alkaloids or medicines agonists of the serotonin receptor (such as sumatriptan, almotriptan, frovatriptan, naratriptan, rizatriptan, zolmitriptan and eletriptan);
• sympathomimetics (nasal and/or oral) (ethylphrine, midodrine, naphazoline, oxymetazoline, synephrine, tetryzoline, tuaminoheptane, thymazoline, ephedrine, phenylephrine, pseudoephedrine) many of which are used as decongestants;
• nicotine or substances containing nicotine;
• medicines for lowering blood pressure: beta-blockers such as propranolol, oxprenolol and diltiazem;
• medicines used to treat abnormal heart rhythm e.g. mexiletine;
• medicines used to treat excessive prolactin production in the body, for example cabergoline and bromocriptine;
• oral contraceptives;
• cimetidine, a medicine used to treat heartburn and stomach ulcers;
• grapefruit juice;
• medicines used for the maintenance treatment of asthma e.g. zileuton;
• medicines used to treat depression (e.g. amitriptyline, sertraline, fluvoxamine);
• medicines used to treat Parkinson's disease e.g. bromocriptine, cabergoline, pergolide, lisuride.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
CAFERGOT is contraindicated in pregnancy and during breastfeeding (see section “Do not
take CAFERGOT”).
CAFERGOT can pass into breast milk and can cause symptoms in the newborn, such as vomiting,
diarrhea, weak pulse and unstable blood pressure.
If you become pregnant during treatment with CAFERGOT, inform your doctor immediately.

Driving and operating machinery
CAFERGOT can cause dizziness, other nervous system disorders or visual disturbances. If such
symptoms affect you, do not drive or operate machinery until these effects have subsided.

3. How to take CAFERGOT

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

CAFERGOT should be taken at the first sign of a migraine attack. Do not use CAFERGOT

tablets/suppositories in the prevention of migraine attacks.
CAFERGOT tablets must be taken orally.
CAFERGOT suppositories must be taken rectally.

Adults
The recommended dose for the first migraine attack is 2 tablets or 1 suppository. If
after half an hour no improvement is observed, take 1 tablet or half a
suppository.
This dosage may be repeated every half hour, without exceeding the maximum daily dose
which is a total of 6 tablets or 3 suppositories in 24 hours.
If subsequent attacks occur, the initial dose may be increased to 3 tablets or
1 and a half suppositories in a single dose, depending on the total dose required in previous
attacks.
If the pain persists, take 1 tablet or half a suppository at intervals of half an hour
up to the maximum weekly dose of 10 tablets or 5 suppositories.
Keep a record of how many tablets/suppositories you use.
It is important that you:

• Do not use more than 3 suppositories or 6 tablets of CAFERGOT in 24 hours.
• Do not use CAFERGOT tablets/suppositories every day.
• Do not use CAFERGOT tablets/suppositories if you have already used a treatment cycle in the last 4 days.
• Do not use more than 5 suppositories or 10 tablets of CAFERGOT in a week.

Contact your doctor if you do not feel better or if you feel worse.

Use in children and adolescents
Do not administer CAFERGOT tablets/suppositories to children and adolescents under the age of
18 years.

Elderly
CAFERGOT is not recommended in patients over 65 years of age.

If you take more CAFERGOT than you should
If you accidentally use too many CAFERGOT tablets/suppositories, inform your doctor or go to
the nearest emergency room. Show all the remaining medicine or the empty package to the doctor.
The symptoms of an overdose include nausea, vomiting, drowsiness, confusion, convulsions,
dizziness, fast heartbeat (tachycardia), low blood pressure (hypotension),
cardiovascular insufficiency (shock), difficulty breathing, coma. Symptoms and
complications of intense peripheral vessel constriction with ischemia may occur: numbness, tingling and
pain in the fingers of the hands or feet, bluish discoloration of the skin and mucous membranes (cyanosis),
gangrene.
You will be given appropriate treatment.

If you forget to take CAFERGOT
If you forget to take a dose, take it as soon as possible, unless it is almost time
to take the next dose. Do not use a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With the use of CAFERGOT, the following side effects have been observed:

Common (may affect up to 1 in 10 people)

• nausea, vomiting (not related to migraine);
• abdominal pain;
• dizziness.

Uncommon (may affect up to 1 in 100 people)

• bluish discoloration of the skin and mucous membranes (cyanosis);
• constriction of peripheral blood vessels (see “Warnings and precautions”);
• pain or weakness in the arms, hands, legs and feet;
• tingling or numbness in the hands or feet;
• diarrhea.

Rare (may affect up to 1 in 1,000 people)

• allergic reactions that may include skin rash, facial swelling, appearance of a skin rash characterized by wheals with or without itching (urticaria) and difficulty breathing (dyspnea);
• a sensation of spinning and loss of balance (vertigo);
• slow (bradycardia) or fast (tachycardia) heartbeat;
• high blood pressure;
• muscle pain (myalgia);
• involuntary muscle contraction (muscle spasms);
• absence of pulses detected at the wrist;
• excessive vasoconstriction of the arteries (ergotism) with signs and symptoms of vascular ischemia of the extremities, spasm of the renal or cerebral arteries.

Very rare (may affect up to 1 in 10,000 people)

• angina or heart attack causing chest pain;
• necrosis of the extremities (gangrene).

Not known (frequency cannot be estimated from available data)

• headache caused by the medicine (see “Warnings and precautions”);
• fibrosis in some areas of the body (heart, lung, pleura, retroperitoneum) (see “Warnings and precautions”);
• rectal and anal ulcer (see “Warnings and precautions”);
• rebound headache (within 24-48 hours of ergotamine discontinuation, a headache occurs that intensifies with autonomic disturbances that can continue for 72 hours or more).

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly through the national reporting
system at
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store CAFERGOT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
CAFERGOT tablets: Store at a temperature below 25° C. Store in the original package to protect the medicine from light.
CAFERGOT suppositories: Do not store at a temperature above 25°C.
Do not use this medicine if you notice that the pack is damaged or tampered with.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What CAFERGOT contains

CAFERGOT 1 mg + 100 mg tablets

• The active ingredients are ergotamine tartrate and caffeine. One tablet contains 1 mg of ergotamine tartrate and 100 mg of caffeine.
• The other ingredients are: tartaric acid, magnesium stearate, yellow iron oxide pigment, talc, corn starch, microcrystalline cellulose.

CAFERGOT 2 mg + 100 mg suppositories

• The active ingredients are ergotamine tartrate and caffeine. One suppository contains 2 mg of ergotamine tartrate and 100 mg of caffeine.
• The other ingredients are: tartaric acid, lactose, semi-synthetic glycerides.

Description of the appearance of CAFERGOT and contents of the pack
CAFERGOT 1 mg + 100 mg tablets - 20 tablets
CAFERGOT 2 mg + 100 mg suppositories - 5 suppositories

Marketing authorisation holder
Amdipharm Ltd
3 Burlington road, Dublino 4 Temple Chambers - Ireland

Manufacturers

CAFERGOT 1 mg + 100 mg tablets
Cenexi SAS, 52 - rue Marcel et Jacques Gaucher - 94120 Fontenay-sous-Bois France
Mipharm S.p.A. - Via B. Quaranta, 12 - 20141 Milano (MI)
Novartis Farma S.p.A. - Officina di Torre Annunziata (NA)
Amdipharm UK Limited - Capital House, 85 King William Street - EC4N 7BL London - United Kingdom

CAFERGOT 2 mg + 100 mg suppositories
Cenexi SAS, 52 - rue Marcel et Jacques Gaucher - 94120 Fontenay-sous-Bois France
Mipharm S.p.A. - Via B. Quaranta, 12 - 20141 Milano (MI)
Novartis Pharma S.A.S. - Huningue (F)
Amdipharm UK Limited - Capital House, 85 King William Street - EC4N 7BL London - United Kingdom