Ergafein (Ergotamine) 150/60/0,25 Mg 20 Coated Tablets

ERGAFEIN dragee is taken by mouth.

Excipients:

lactose, calcium secondary phosphate, corn starch, gelatin, talc,

magnesium stearate, gum arabic, sugar (sucrose), titanium dioxide, green supra 78614, ewax

this Please read this INSTRUCTIONS carefully before you start using the drug, because it contains important information for you.

Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Operating Instructions:

1. What is ERGAFEIN and what is it used for?

2. Things to consider before using ERGAFEIN

3. How to use ERGAFEIN?

4. What are the possible side effects?

5. ERGAFEIN storage

headings are included.

2. What is the GOLDEIN and what is it used for?

• ERGAFEIN belongs to the group of drugs used against the headache called migraine. Contains active ingredients called paracetamol, ergotamine tartrate and caffeine.

• ERGAFEIN is in the form of green colored, round dragee. ERGAFEIN is available in blister packs and cardboard boxes containing 20 pieces of dragee.

• ERGAFEIN is used to prevent or cut headache called migraine (a kind of headache), migraine types or histamine cephalgia (a kind of headache).

3. How to use the GALLER?

Preventive treatment of seizures: In

migraine attacks, 1 or 2 dragees can usually prevent pain when the first sign of the pain seizure occurs. However, if necessary, this dose should be repeated after 30 or 60 minutes.

Treatment of migraine attacks: If the

crisis has started, 2 dragees should be taken. If necessary, up to 4-6 dragees can be taken every half hour.

Treatment of the following seizures:

During the first seizure, it is recommended to take the amount that interrupts the crisis at once. In case of other conditions, 3 times a day or 2 drops of dragee is taken.

ERGAFEIN should not be used daily chronic.

Paracetamol taken daily due to the risk of liver poisoning (hepatotoxicity) in people who take alcohol should not exceed 2 grams.

The route and method of

administration should preferably take ERGAFEIN after meals and with plenty of water.

Different age groups

Use in children Use in

elderly People in

elderly: No

special dosage adjustment is required in elderly patients. A normal adult dose is suitable for healthy, moving elderly people, but the frequency of dosing and dosing should be reduced in the weak, inactive elderly. However, ERGAFEIN should be used with the recommendation of a physician in the elderly because of the caffeine contained.

Renal / liver failure:

ERGAFEIN is not used in patients with renal or hepatic impairment.

If you have an impression that ERGAFEIN is too strong or weak, talk to your doctor or pharmacist.

If you use more ERGAFEIN than you should use

if you use ERGAFEIN, you may experience the following symptoms:

Nausea, vomiting, diarrhea, excessive thirst, feeling of cold, burning or itching, dizziness, deceleration or inability to pulse, numbness in hands and feet, tingling, pain and bruising, rapid pulse, elevation or fall in blood pressure, tachycardia (heart beat), respiration deterioration, faintness, coma, mind blurring, involuntary severe contractions in muscles, unconsciousness and shock.

Ergotism may develop in very sensitive individuals or in case of overdose and long-term drug use. In the hands and feet numbness, chills, burning, wilted or bruising and muscle pain may begin. Pulse cannot be taken in these regions. Increasingly, gangrene (tissue death) can develop in the fingers. Chest pain, increased or decreased heart rate, blood pressure drop or rise may occur.

If you have taken too much ERGAFEIN dragee by accident, or if you think a child has been taken, immediately contact the nearest hospital's emergency department. Take the medicine box and, if any, other medications.

Perturbation, loss of appetite, nausea and vomiting are common early symptoms of paracetamol, one of the active substances of ERGAFEIN. Liver damage is a dose-related complication of paracetamol overdose (diseases caused by overdose).

Talk to a doctor or pharmacist if you have used more than you should use from ERGAFEIN.

If you have forgotten to use ERGAFEIN,

take it when you remember and do not take double doses to compensate for the forgotten doses.

4. What are the possible side effects?

Like all medicines, ERGAFEIN may have side effects in people who are sensitive to the ingredients.

The most common side effect is nausea and vomiting. There may be complaints about the increase in blood pressure due to the ergotamine dose.

The use of caffeine up to 520 mg per day does not detect any undesirable effects in healthy individuals. However, the use of high doses of caffeine in people who are not sensitive or caffeine may cause

some undesirable effects. These include: tremors, insomnia, restlessness, irritability, anxiety, headache, tinnitus, rhythm disturbance in the heart, increased heart rate, excessive urination, digestive disorders and rapid breathing. People with these undesirable effects should stop the use of ERGAFEIN or other caffeine-containing drugs.

The cessation of the use of caffeine after regular use may cause some symptoms to last for 1 week. These include: headache, fatigue and decreased attention.

If you have any of the following, stop using ERGAFEIN and IMMEDIATELY tell your doctor and contact the emergency department of the hospital nearest you:

Skin rash, pruritus, eczema, allergic edema, swelling in the tongue and throat of the face (agioedema), generalized rashes (acute generalized exanthematous pustulosis) , hand, face and lace, redness, erythema multiforme, hypersensitivityBruising on

, numbness in hands and feet, tinglinghands and

toes Increasing

or slowing heart rate

Jamming, pressure, feeling of weight and restlessness. Chest pain spread to the neck, shoulders or arms

Difficulty in breathing

Blood pressure rise

Gangrene (tissue death)

Pulse retardation

Nausea and vomiting (not migraine)

These are all very serious side effects. If you have this situation, you have a serious allegory against ERGAFEIN. You may need urgent medical attention or hospitalization.

Side effects are classified as shown in the following categories:

Very common: It can be seen in at least one of 10 patients.

Common: Less than one in 10 patients, but more than one in 100 patients.

Uncommon: Less than one in 100 patients, but more than one in 1,000 patients.

Rare: Less than one in 1,000 patients.

Very rare: less than one in 10,000 patients.

Unknown: Unpredictable from available data.

Side effects associated with ERGAFEIN use:

Common side effects:

Drowsiness

Dizziness

Nausea and vomiting (not due to migraine)

Abdominal pain

Sleepiness (somnolans)

Headache

Symptoms of upper respiratory tract

Sensory disorders such as numbness, tingling and burning senses

Intestinal gas

Constipation

Indigestion

Uncommon side effects:

bruising of the arms and legs • loss of

Diarrhea

feelingPain and weakness in the arms and legs

Long-term use kidney damage that can lead to kidney failure

Hemorrhage in the digestive system

Infrequent side effects:

Excessive sensitivity reactions (skin rash, itching or rash; percent, swelling in the tongue or in another part of the body; wheezing or breathing difficultytogether with complaints such as breathing difficulty)

(Dizziness (vertigo),

slowing of heart beats or accelerating heart rate,

prolonged use of heart valves changes,

increased blood pressure,

hives (urticaria),

muscle pain

Absence of pulse,

shortness of breath and asthma

Stroke

Anemia (anemia), methemoglobinemia when blood is taken in large quantities (methomoglobinemia in the blood) Blood counts such as reduction in the number of blood platelets responsible), thrombocytopenic purpura [subcutaneous hemorrhage due to reduced platelet count], leukopenia (decrease in the number of white blood cells), neutropenia (decrease in the number of neutrophils present in the white blood cells) and pancytopenia changes

used for a long time; bruising on skin and tissues due to reduced blood cells

numbness, tingling, pain, bruising and absence of pulse in the arms and legs (ergotism)

Disorders of the lung membrane and lung, especially due to long-term overuse

Rapidly progressive inflamed skin rashes,

high fever, nausea , vomiting, muscle and joint pain, itching and the skin, mouth, lips, redness, and continued with the formation of bubbles followed by widespread hemorrhagic rash (Stevens-Johnson syndrome)

Hand, face and standing lace-like redness

Sudden and rapid progression skin and mucilage (Lyell's syndrome - toxic epidermal necrolysis)

Liver damage when taken in large amountsfailure

Heartdoes not lead to enough blood (myocardial ischemia) due to chest pain or heart attack,

tissue death (gangre n)

sudden arrival can decrease the number of blood cells (agranulocytosis)

Unknown: Center stimulation of the nervous system, dizziness, inflammation of the brain (encephalopathy), sleeplessness (insomnia), shaking (tremor)

false resultsof allergy testing

reduction ofof blood platelets under the influence of the immune system

heart palpitations

containing caffeine medications may cause undesirable effects such as anxiety, tremors, sweating, and rapid heartbeat. (See Chapter 4 - ı What are the possible side effects? G) Those who have the desired effects should stop using ERGAFEIN or other caffeine-containing drugs.

The cessation of the use of caffeine after regular use may cause some complaints to occur for a period of 1 week. These include: headache, fatigue and decreased attention.

Report of side effects Inrefer

the event of any side effects that occur in the instructions for use or not,to your doctor, pharmacist or nurse. Also you are experiencing side effects www.titck.gov.t is located in the sites "Drug Side Impact Statement" by clicking on the icon or OR 800 314 00 08 No. of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) if papers. Reporting side effects have occurred you will be helping to learn more about the safety of the drug you are using.