Avmigran 325 Mg 20 Tablets ingredient Ergotamine

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AVMİGRAN film tablet is applied orally.

Excipients

Tartaric acid, Aerosil, Gelatin, Magnesium stearate, Talc, PVP,

Lactose, Corn starch, Primojel, Hydroxypropyl methyl cellulose, Iron oxide Red (E172), Titanium dioxide, Diethyl Phthalate, Ewax.

Please read this INSTRUCTIONS carefully before using this medicine, as 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 Instructions for Use:

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

2. Things to consider before using AVMIGRAN

3. How to use AVMIGRAN?

4. What are the possible side effects?

5. AVMIGRAN Storage

Headers are included.

2. What is AVAMIGRAN and what is it used for?

• AVMIGRAN is a drug containing ergotamine tartrate, mecloxamine dihydrogen citrate, caffeine, paracetamol active substances in every film tablet.

• AVMIGRAN is a red-brown colored, round, biconvex film-coated tablet.

• AVMIGRANT is used to relieve the headaches and short migraine attacks associated with palpitations, dizziness and nausea (Cephalea vasomotorica-histamine headache, Horton syndrome).

3. How to use AVMIGRAN?

In migraine attacks, 1 or 2 tablets of AVMİGRAN film should be taken at the beginning of the pain episode.

If necessary, 1 tablet can be taken after half an hour.

The maximum daily dose is 4 film tablets. The maximum weekly dose is 10 film tablets.

When you feel the first signs of pain, you should take your medicine. The earlier the drug is taken, the lower the required dose and the more effective the treatment.

The route and method of

administration You should take AVMİGRAN after meals and with plenty of water.

Different age groups in

children Use in the

elderly Use in the

elderly:

Your doctor will determine your dose depending on your disease.

Special Use Cases

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

If you have an impression that the effect of AVMİGRAN is too strong or too weak, talk to your doctor or pharmacist.

If you use more AVMIGRAN use

than you should use, if you have used more than you should AVMIGRAN the following symptoms may be seen:

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 may develop in fingers. Chest pain, increased or decreased heart rate, blood pressure drop or rise may occur.

In addition, AVMİGRAN can cause liver damage and kidney damage when used more than it should be used due to paracetamol content.

If you have received too much from AVMİGRAN by accident, or if you think a child has been taken, immediately contact the emergency department of the nearest hospital. Take the medicine box and, if any, other medications.

In the overdose of paracetamol, one of the active substances of AVMİGRAN, pallor, loss of appetite, nausea and vomiting are common early symptoms. 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 AVMİGRAN.

forgot to use AVMIGRAN

If you If you forget to take AVMİGRAN and your next dose is not close to the time you remember, take your medicine.

Do not use double doses to compensate for forgotten doses.

The effects that may occur when treatment is discontinued with AVMİGRAN:

4. What are the possible side effects?

Like all medicines, AVMIGRAN may have side effects in people who are sensitive to the substances contained in its content.

The most common side effect is nausea and vomiting. Depending on the ergotamine dose, signs and symptoms of vasoconstriction may occur.

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 AVMİGRAN 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.

Stop using AVMIGRAN if you have any of the following and tell your doctor or contact the emergency department of your nearest hospital.

Skin rash, itching, eczema, allergic edema, swelling in the tongue and throat (angioedema), generalized rashes (acute generalized exanthematous pustulosis), hand face and induce a similar rash standing lace, hypersensitivity (erythema multiforme),

anaphylactic shock (severe allergic reactions which lead to low blood pressure and soldiers stenosis),

Stevens-Johnson syndrome (skin and mucous membrane of a disorder that seriously show adverse drug reaction or infection)

dizziness , numbness in the hands and feet, tingling Bruising on the hands and

toes Increasing

or slowing the heart rate

Jamming in the rib cage, feeling pressure and weight. Chest pain spreading to the neck, shoulders or arms

Difficulty in breathing Increasing

blood pressure

Gangrene (Tissue death)

Pulse retardation

Nausea and vomiting (not due to migraine)

These are very serious side effects. If you have this situation, you have serious allergies to AVMİGRAN. You may need emergency treatment or hospitalization.

Side effects are classified as shown in the following categories: They

can be seen in at least one of 10 patients.

Less than one in 10 patients, but more than one in 100 patients. Less than one in 100 patients, but more than one in 1,000 patients.

Less than one in 1,000 patients.

Less than one in 10,000 patients.

Unable to predict from available data.

Very common::

CommonUncommon:

Uncommon:

Rare:

Very sparse:

Unknown:

Common

headache

Dizziness

Drowsiness (somnolans)

Sensory disturbances, such as numbness, tingling or burning sensation

Symptoms of upper respiratory tract

nausea and vomiting (not migraine)

Upper abdominal region discomfort, pain and indigestion

Excessive amounts of gas in the stomach and intestines

Abdominal pain

Constipation

Drowsiness

Uncommon

Kidney damage that can lead to kidney failure in prolonged use In the

digestive tract bleeding

, bruising, narrowing (peripheral vasoconstriction)

Diarrhea,

pain and weakness in the arms and legs

loss of

Skin and mucosa blue (Cyanosis)

Uncommon ovarian reactions (skin rash, pruritus or rash; swelling in the face, tongue or other part of the body; wheezing, breathing or difficulty in breathing).

Dizziness (vertigo) ),

Decreasing heart beats or accelerating heart beats,

Changes in heart valves as a result of prolonged overuse,

Increased blood pressure,

Hives (urticaria),

Muscle pain

Absence of pulse

Shortness of breath and asthma

Stroke

Anemia when taken in large amounts, methemoglobinemia (methemoglobinemia in blood) in the case of prolonged use, prolonged use, thrombocytopenia due to hemolytic anemia (of blood platelets responsible for clotting

reduction in the number), thrombocytopenic purpura [subcutaneous hemorrhage due to decreased number of platelets], leukopenia (reduction in the number of white blood cells), neutropenia (white blood cells family) These side effects are not in the cause-effect relationship with paracetamol.

When 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 mucosal disease (toxic epidermal necrolysis) which can be fatal and deadly

Liver damage when taken in large amounts

Very rare Agranulocytosis (disease with decreased number of white cells in the blood)

Toxic epidermal necrolysis (Lyell syndrome) drug and various infections that can develop due to skin disease

Gangrene (Tissue death)

Stevens Johnson syndrome (skin or mucous membranes of the drug or a serious reaction against infection)

Myocardial ischemia (heart muscle not enough blood), myocardial infarction (heart attack)

Unknown Center nervous system stimulation, dizziness, drowsiness (somnolence) and inflammation of the brain (encephalopathy), insomnia, tension

positive Aleji (sensitivity) test (positive give allergy test) reduction of platelets by the action of the immune system

decreased platelets by the action of the immune system

flicker

heart palpitations

Caffeine-containing medications can cause undesirable effects such as anxiety, tremors, sweating, and rapid heartbeat. (See Section 4 - ı What are the possible side effects? Etkili) People with these adverse effects should stop the use of AVMİGRAN 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.

2. Before using should

AVMIGRAN, DO NOT USE AVMIGRAN in the following situations. AVMIGRAN

be used with food and drink

. Take AVMIGRAN with plenty of water after meals.

When taken with AVMİGRAN grapefruit juice, there is a risk of drug-related side effects.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

AVMİGRAN causes serious birth defects if applied during pregnancy.

You should not use AVMIGRAN if you are pregnant.

Use with other drugs

If you notice that you are pregnant during your treatment, consult your doctor immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

You should not breastfeed your baby while using AVMİGRAN.

AVMİGRAN passes into breast milk and can lead to ergotism symptoms such as vomiting, diarrhea, poor pulse and irregularity in blood pressure. Your doctor will ask you to discontinue AVMİGRAN or your baby.

Use of and machines may

toolsAVMİGRANcause symptoms such as drowsiness, dizziness, tremors and sweating. If you have such symptoms, you should not use a vehicle or machine until the effects have passed.

AVMIGRAN contains important information about some of the ingredients in

AVMIGRAN. If you have been told by your doctor that you are not sure of some sugars, contact your doctor before taking this medicinal product.

When Combination with other drugs

used inAvmigran's effect may change. Please tell your doctor if you are using the following medicines:

• Paracetamol:

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