Amigro 50 mg - 2 tablets

Each Amigro tablet contains a single dose of sumatriptan, which belongs to a group of medicines called triptans (also known as 5-HT1 receptor agonists).

Amigro is used after the initial diagnosis of migraine by a doctor for the acute treatment of the headache phases of migraine attacks with or without aura.

Migraine symptoms are thought to be caused by a temporary dilation of the blood vessels in the head. Amigro tablets are likely to reduce this vasodilatation. This helps reduce the headache and relieve the other symptoms of a migraine attack, such as nausea and vomiting and sensitivity to light and sound.

Amigro should only be used if migraine headaches have been diagnosed by a doctor.

Sumatriptan only works if a migraine attack has already started. It cannot prevent a migraine attack and should not be taken to prevent a migraine.
Amigro must not be used for general headaches.

Contraindications

Amigro must not be taken

• if you are allergic to sumatriptan or any of the other ingredients of this medicine listed in section 6.
• if you suffer from heart disease such as: B. narrowing of the arteries (ischemic heart disease) or chest pain (angina), or if you have already had a heart attack.
• if you have circulatory problems in your legs that cause cramping pain when walking (peripheral vascular disease).
• if you have had a stroke or minor stroke (also called a transient ischemic attack or TIA).
• if you have moderate or severe high blood pressure or if your blood pressure is too high despite drug therapy.
• if your liver function is severely restricted. If you have severe liver problems, Amigro is not suitable for you.
• if you are also taking other medicines to treat migraines, including those containing ergotamine or similar medicines such as methysergide maleate, triptans or 5-HT1 agonists (such as naratriptan or zolmitriptan).
• if you are also taking certain medicines to treat depression (monoamine oxidase inhibitors - MAO-s) or if you have taken them within the last 2 weeks.

Interactions

Taking Amigro with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines should not be taken with Amigro and others may cause side effects if taken with Amigro.

Be sure to tell your doctor or pharmacist if you are taking the following medicines:

• Ergotamine or similar substances such as methysergide, which are also used to treat migraines (see also section 2, “Amigro must not be used”). Amigro and these substances must not be used together. Do not take Amigro for at least 24 hours after using these substances and allow at least 6 hours after using Amigro before taking or using any medicines containing ergotamine or ergotamine-like substances again.
• other triptans/5-HT1 receptor agonists (such as Naratriptan, Rizatriptan, Zolmitriptan) which are also used to treat migraines (see also section 2, “Amigro must not be used”). Amigro and these substances must not be used together. Do not take Amigro for at least 24 hours after using these substances and allow at least 24 hours after using Amigro before taking or using the other medicines again.
• SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-norepinephrine reuptake inhibitors) to treat depression. Taking these medicines together with Amigro can cause serotonin syndrome (a collection of symptoms including restlessness, confusion, sweating, hallucinations, increased reflexes, muscle cramps, chills, palpitations and tremors). Taking Amigro and lithium at the same time can also pose a risk of serotonin syndrome. If you are affected, contact a doctor immediately.
• MAO s (monoamine oxidase inhibitors; e.g. moclobemide for depression or selegiline for Parkinson's disease). Do not use Amigro if you have taken these MAOIs within the last 2 weeks.
• Herbal preparations containing St. John's wort (Hypericum perforatum): If you take St. John's wort preparations and Amigro at the same time, the likelihood of side effects increases.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. There is limited information about the use of Amigro in pregnancy. Your doctor will decide with you about the use of Sumatriptan Hexal during your pregnancy.

Do not breast-feed for 12 hours after using Amigro and discard any milk expressed during this time as sumatriptan is excreted in breast milk.

Driving and using machines
Both the symptoms of migraine and taking your medicine can cause drowsiness. You must not drive a vehicle or use machines if this affects you.

Amigro contains lactose and sodium
If you know that you suffer from a sugar intolerance, please only take Amigro after consulting your doctor.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, meaning it is virtually “sodium free”.

Application

Only use Amigro if your migraine headache has already started.
Do not try to prevent an attack with Amigro.

Always take this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist tells you. Check with your doctor or pharmacist if you are unsure.

Unless otherwise prescribed by the doctor, the usual dose is:

Adults aged 18 to 65
The usual single dose for adults aged 18 to 65 is 1 Amigro 50 mg tablet. Some patients may require 100 mg sumatriptan (equivalent to 2 Amigro 50 mg tablets).
No improvement in effect is expected when taking doses higher than 100 mg of sumatriptan. Do not take more than 300 mg sumatriptan (equivalent to 6 Amigro50 mg tablets) within 24 hours.

Teens 12 to 18 years old
Amigro is not recommended for teens 12 to 18 years old.

Children under 12 years of age
Amigro should not be given to children under 12 years of age.
If a child has taken the medicine, contact a doctor or the nearest hospital immediately. Take the pack and any remaining tablets with you.

Elderly (over 65 years of age)
There is no experience with the use of Amigro in patients older than 65 years of age. Therefore, the use of Amigro in elderly patients is not recommended.

Patients with hepatic impairment
Low doses of 25 - 50 mg should be considered in patients with mild to moderate hepatic impairment. Please follow your doctor's advice.

Patients with renal impairment
Amigro should be used with caution in patients with renal impairment. Please follow your doctor's advice.

When should you use Amigro?
It is best to take Amigro as soon as you feel the start of a migraine attack, but it can also be used at any time during an attack.
Do not take Amigro to prevent a migraine attack.

If the symptoms get worse again or occur again:
If symptoms that have already subsided occur again, you can take another Amigro tablet at least two hours after taking the first tablet. Do not take more than 300 mg sumatriptan (equivalent to 6 Amigro 50 mg tablets) in 24 hours.

If the first tablet has no effect:
Do not take another Amigro tablet or any other sumatriptan-containing medicine for the same migraine attack. If Amigro has no effect after the first dose, a pain reliever containing paracetamol, acetylsalicylic acid or a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen should be taken.
→ Ask your doctor or pharmacist for advice if Amigro does not work.

Method of administration:
Oral use.

The tablets should be taken whole with sufficient water.

Side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some symptoms can also be caused by the migraine attack.

Allergic reaction: Get medical help immediately.

• Very rare: Allergy manifests itself as redness of the skin, rash, itchy redness of the skin (hives), wheezing, swelling of the eyelids, face or lips, circulatory collapse. If any of these symptoms occur shortly after taking Amigro,
• Do not take any more and see a doctor immediately.

Common side effects (may affect up to 1 in 10 people):

• Pain, heaviness, pressure or tightness in the chest and neck or other parts of the body, feeling warm or cold. These side effects can be very intense but usually pass quickly. If they persist or become severe (especially chest pain): Get urgent medical attention. In very few patients, these symptoms can indicate a heart attack.

Other common side effects include:

• Nausea and vomiting, this can also be caused by the migraine.
• Tiredness or sleepiness
• dizziness, feeling weak,
• temporary increase in blood pressure shortly after treatment, hot flashes
• breathlessness
• Muscle aches
• Unusual sensations including numbness and tingling

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

• Visual field loss and impaired vision

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

• Liver function disorders. If you have a blood test to check liver function, tell the doctor that you are using Amigro.
• Pain in the lower left side of the abdomen and bloody stools (ischemic colitis).
• Vision problems such as flickering, double vision, reduced vision, loss of vision and in some cases permanent damage (these can also be caused by the migraine attack)
• Eye trembling
• Palpitations, slow heartbeat, irregular heartbeat, chest pain (angina) or heart attack
• Drop in blood pressure and fainting
• Pale, bluish skin and/or pain in the fingers, toes, nose or jaw when cold or stressed (Raynaud's phenomenon)
• Seizures, muscle tremors, muscle spasms, persistent muscle tension
• Allergic reaction

Not known (frequency cannot be estimated from available data):

• Diarrhea
• feeling of fear
• Excessive sweating
• Joint pain, neck stiffness
• difficulties swallowing
• If you have recently had an injury or if you have an inflammation (such as rheumatism or inflammation of the colon), you may feel pain at the site of the injury or inflammation or the pain may get worse

Some symptoms can also be caused by the migraine attack.

composition

The active ingredient is sumatriptan.
1 tablet contains 50 mg sumatriptan (as sumatriptan succinate).

The other ingredients are:
lactose monohydrate, microcrystalline cellulose, ammonium methacrylate copolymer (type A), croscarmellose sodium, grapefruit flavor, magnesium stearate

Usually ships out within 3-4 business days