Rizatriptan 5mg. 3 tablets
Rizatriptan Actavis belongs to a class of drugs called selective 5-HT1B / 1D receptor agonists, serotonin.
Your doctor has prescribed rizatriptan Actavis to treat headache phase of a migraine attack you.
Treatment with rizatriptan Actavis reduces swelling of blood vessels surrounding the brain. This leads to swelling headache phase of migraine attacks.
2. BEFORE YOU TAKE rizatriptan Actavis
Do not take rizatriptan Actavis if:
you are allergic (hypersensitive) to rizatriptan benzoate or any of the other ingredients of rizatriptan Actavis (see. section 6 for list of ingredients);
have moderate or high blood pressure or slightly increased blood pressure, which is not controlled with drugs;
have or have ever had heart problems, including heart attack or chest pain (angina) or have had symptoms related to heart disease;
you have severe liver or severe kidney problems;
have had a stroke (cerebrovascular accident MSI) or mini-stroke (transient ischemic attack PEP);
have problems associated with blockage of the arteries (peripheral vascular disease);
monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (drugs against depression), or linezolid (an antibiotic), or if you have passed two weeks after discontinuation of MAO inhibitors;
currently taking drugs ergotamine type, such as ergotamine or dihydroergotamine for the treatment of migraine or methysergide to prevent a migraine attack;
taking any other drug in the same class, such as sumatriptan, naratriptan or zolmitriptan to treat migraine (see. "Taking other medicines" below).
If you are not sure if any of the above cited apply to you, talk to your doctor or pharmacist before taking rizatriptan Actavis.
Take special care with rizatriptan Actavis
Before taking rizatriptan Actavis, tell your doctor or pharmacist if:
have any of the following risk factors for heart disease: high blood pressure, diabetes, if you smoke or using nicotine replacement therapy, if someone in your family has a history of heart disease, if you are a man over 40 years of age or you are a postmenopausal woman;
you have kidney or liver problems;
have a special problem with heart rhythm (bundle branch block);
have or have had any allergies;
your headache is associated with dizziness, difficulty in walking, lack of coordination or weakness in the arms and legs;
use herbal products containing St. John's wort (may increase the risk of adverse effects);
have had an allergic reaction such as swelling of the face, lips, tongue and / or throat that may cause difficulty in breathing and / or swallowing (angioedema);
taking the so-called. selective inhibitors of serotonin reuptake inhibitors (SSRIs), for example, sertraline, escitalopram oxalate, and fluoxetine or serotonin reuptake inhibitors of serotonin-noradrenaline (SNRIs), for example, venlafaxine, and duloxetine for depression;
have had transient symptoms including pain and tightness in the chest.
If taking rizatriptan Actavis too often, it can cause you chronic headaches. In such cases you should contact your doctor as you may need to stop taking rizatriptan Actavis.
Please tell your doctor or pharmacist about your symptoms. Your doctor will decide if you have migraine. You should take rizatriptan Actavis only for a migraine attack. Rizatriptan Actavis should not be used for treatment of headaches, which may be caused by other more serious conditions.
Please tell your doctor if you are taking, have recently taken or intend to take any other medicines, including medicines obtained without a prescription. This includes herbal medicines and medicines that usually take for migraines. This is because rizatriptan Actavis may affect the way some medicines. Other drugs may also affect the operation of rizatriptan Actavis.
Taking other medicines
Do not take rizatriptan Actavis
if you already take 5HT 1B / 1D agonist (sometimes called "triptan"), for example sumatriptan, naratriptan or zolmitriptan;
if you are taking a monoamine oxidase inhibitor (MAOI) such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline or if they have not been two weeks of stopping the MAO inhibitor;
if you are taking drugs ergotamine type, such as ergotamine or dihydro-ergotamine to treat migraine;
if you are taking methysergide to prevent a migraine attack.
When the above drugs are taken with rizatriptan Actavis may increase the risk of side effects.
You should wait at least 6 hours after taking rizatriptan Actavis before taking ergotamine type medicines, such as ergotamine or dihydro-ergotamine or methysergide. You must wait at least 24 hours after taking ergotamine-type medicines before taking rizatriptan Actavis.
Ask your doctor for recommendations and risk acceptance of rizatriptan Actavis
if you are taking propranolol (see. Section 3: How to take rizatriptan Actavis);
if taking selective inhibitors of serotonin reuptake inhibitors, e. sertraline, escitalopram oxalate, and fluoxetine or selective inhibitors of the reuptake of serotonin, norepinephrine, such as venlafaxine and duloxetine for depression.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Taking rizatriptan Actavis with food and drink:
May need more time to rizatriptan Actavis to begin to act, if adopted after a meal. However, it is better to accept an empty stomach, you can still take it if you have eaten.
Pregnancy and lactation
It is not known whether rizatriptan Actavis is harmful to an unborn baby when taken by a pregnant woman.
Ask your doctor before taking this medicine if you are pregnant, planning to become pregnant or breast-feeding. Breastfeeding should be avoided for 24 hours after treatment.
Ask your doctor or pharmacist before taking any medicine.
Use in children
There is no experience with the use of rizatriptan Actavis in children under the age of 18 because rizatriptan Actavis should not be given to children.
Use in patients over 65 years
No complete clinical trials on the safety and effectiveness of rizatriptan Actavis in patients over 65 years.
Driving and using machines
You may feel sleepy or dizzy while taking rizatriptan Actavis. If this happens, do not drive or operate any tools or machines.
Important information about some of the ingredients of rizatriptan Actavis
Patients with phenylketonuria: Contains a source of phenylalanine. May be harmful for people with phenylketonuria (a genetic metabolic disorder). Each rizatriptan Actavis tablet, orodispersible 5 mg contains 4,4 mg aspartame (which contains phenylalanine). Each rizatriptan Actavis tablet, orodispersible 10 mg contains 8,8 mg aspartame (which contains phenylalanine).
3. HOW TO TAKE rizatriptan Actavis
Rizatriptan Actavis is used to treat migraine headaches. Take rizatriptan Actavis as quickly as possible after the onset of migraine headache. Do not use it to prevent the attack.
Always take rizatriptan Actavis exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
The usual dose is 10 mg (one rizatriptan Actavis tablet, orodispersible 10 mg).
If you are currently taking propranolol or have kidney or liver problems, you should use a dose of 5 mg rizatriptan Actavis. There must be at least 2 hours difference between doses of propranolol and rizatriptan Actavis, and may be a maximum of 2 doses of rizatriptan Actavis for a period of 24 hours.
Rizatriptan Actavis (rizatriptan benzoate) is available as a 5 mg and 10 mg tablets, orodispersible, that dissolve in the mouth.
Open the blister pack of rizatriptan Actavis with dry hands.
Orodispersible tablet in the mouth, should be placed on the tongue, where it dissolves and can be swallowed with saliva.
Tablets, orodispersible, can be used when you have liquids in hand, or to avoid the nausea and vomiting that may accompany the ingestion of tablets with liquids.
If migraines occur again in 24 hours
In some patients, migraine symptoms can reappear within 24 hours. If your migraine really reappears, you can take another dose of rizatriptan Actavis. You should always wait at least 2 hours between doses.
If after 2 hours you still have migraine
If you do not respond to the first dose of rizatriptan Actavis during an attack, you should not take a second dose of rizatriptan Actavis to treat the same attack. There is a chance, however, rizatriptan Actavis to work during the next attack.
Not take more than 2 doses rizatriptan Actavis for a period of 24 hours (for example, do not take more than two tablets, orodispersible, 10 mg or 5 mg per 24 hour period). You should always wait at least 2 hours between doses.
If your condition worsens, seek medical attention.
If you take more dose of rizatriptan Actavis
If you take more dose of rizatriptan Actavis, immediately contact your doctor or pharmacist. Take the medicine pack with you.
Symptoms of overdose may include dizziness, drowsiness, vomiting, fainting and slow heart rate.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, rizatriptan Actavis can cause side effects, although not everybody gets them.
In clinical trials, the most commonly reported side effects were dizziness, somnolence and fatigue.
Common (affects less than 1 in 10 patients):
tingling (paraesthesia), headache, decreased sensitivity of skin (hypoaesthesia), decreased sharpness of mind, tremors;
hurried or irregular heartbeat (palpitations), very fast heartbeat (tachycardia);
redness of the skin (transient flushing), hot flushes, sweating;
discomfort in the throat, difficulty in breathing (dyspnea);
feeling sick (nausea), dry mouth, vomiting, diarrhea;
a feeling of heaviness in parts of the body;
pain in the abdomen or chest.
Uncommon (affects less than 1 in 100 patients):
instability when walking (ataxia), dizziness (vertigo), blurred vision;
confusion, insomnia, nervousness;
high blood pressure (hypertension), thirst, indigestion (dyspepsia);
itching and convex rash (urticaria);
neck pain, feeling of tightness in parts of the body, stiffness, muscle weakness.
Rare (affects less than 1 in 1000 patients):
bad taste in the mouth;
fainting (syncope), a syndrome called "serotonin syndrome" that may cause side effects like coma, unstable blood pressure, very strong increase in body temperature, lack of muscle coordination, anxiety and hallucinations;
facial pain, wheezing;
allergic reaction such as swelling of the face, lips, tongue and / or throat that may cause difficulty in breathing and / or swallowing (angioedema); rash, severe peeling of the skin including accompanied by fever (toxic epidermal necrolysis);
heart attack, spasm of blood vessels of the heart, stroke. These symptoms usually occur in patients with risk factors for heart and vascular disease (high blood pressure, diabetes, smoking, nicotine replacement therapy, family history of heart disease or stroke, men over 40 years of age, postmenopausal women, particular problem with heartbeat [bundle branch block]).
(convulsions / seizures);
spasm of blood vessels in the extremities, including feeling cold and numbness in the hands or feet.
Tell your doctor immediately if you have symptoms of allergic reactions, serotonin syndrome, heart attack or stroke.
In addition, tell your doctor if you experience any symptoms that indicate an allergic reaction (such as rash or itching) after taking rizatriptan Actavis.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE rizatriptan Actavis
Keep out of the reach and sight of children.
Do not use rizatriptan Actavis after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What rizatriptan Actavis
The active substance of rizatriptan Actavis tablets, orodispersible is rizatriptan. Actavis one rizatriptan tablet, orodispersible 5 mg contains 5 mg of rizatriptan as 7,265 mg rizatriptan benzoate.
Actavis one rizatriptan tablet, orodispersible 10 mg contains 10 mg of rizatriptan as 14,53 mg rizatriptan benzoate.
The other ingredients of rizatriptan Actavis tablets, orodispersible are mannitol (E421), microcrystalline cellulose, calcium silicate, crospovidone type A (E1202), aspartame (E951), silicon dioxide, anhydrous; mint flavor and magnesium stearate (E470b).
Rizatriptan Actavis looks like and contents of the pack
Rizatriptan Actavis 5 mg tablets, orodispersible are white, round, with a diameter of 7 mm, flat tablets with bevelled edges, imprinted with "IZ 5" engraved on one side.
Actavis rizatriptan 10 mg tablets, orodispersible are white, round, with a diameter of 9 mm, flat tablets with bevelled edges, imprinted with "IZ 10" engraved on one side.
Blister packs of OPA / aluminum / PVC-aluminum foil which is pierced by pressure.