10 mg orodispersible tablet
What Rizatriptan Sandoz is and what it is used for
Rizatriptan Sandoz contains the active substance rizatriptan, which belongs to a group of medicines called selective serotonin 5 – HT 1B / 1D receptor agonists.
Rizatriptan Sandoz is used to treating the headache phase of adult migraine attacks.
Rizatriptan contained in Rizatriptan Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Rizatriptan Sandoz
Ta NOT Rizatriptan Sandoz
- if you are allergic to rizatriptan or any of the other ingredients of this medicine (listed in section 6)
- if you are currently taking monoamine oxidase inhibitors (MAOIs), such as moclobemide, phenelzine or tranylcypromine (for the treatment of depression), or linezolid (for the treatment of bacterial infections), or if it has been less than two weeks since you stopped using MAOIs ( see section “Other medicines and Rizatriptan Sandoz” )
- if you have severe liver or kidney function
- if you have previously had a stroke or TIA attacks, ie. symptoms similar to a stroke but lasting only one or two days
- if you have moderate or severe high blood pressure or mild high blood pressure that could NOT be controlled with medication
- if you have ever had coronary heart disease, heart attack, or a certain type of chest pain, so-called spasm angina
- if you have had problems with blood circulation in the legs ( peripheral vascular disease)
- if you are currently taking any other migraine medication, e.g. ergotamine, ergotamine-type medicinal product (dihydroergotamine, methysergide), or any other preparation in group 5 ‑ HT 1B / 1D – receptor agonists (eg sumatriptan, naratriptan or zolmitriptan) ( see section “ Other medicinal products and Rizatriptan Sandoz” ).
Warnings and cautions
Talk to your doctor before taking Rizatriptan Sandoz if any of the following apply to you:
- any of the following risk factors for heart disease:
- high blood pressure or diabetes
- you smoke or use nicotine substitutes
- heart disease in the family
- you are a man and over 40 years or you are a woman and have undergone menopause
- kidney or liver problems
- a certain heart problem (branch block)
- previous allergies _
- headache associated with dizziness, difficulty walking, coordination problems, or weakness in legs or arms
- a previous allergic reaction to these or similar tablets with symptoms such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing and/or swallowing ( angioedema )
- previous transient symptoms, such as chest pain and feeling of tightness in the chest.
If you take Rizatriptan Sandoz too often, you may get chronic headaches. If you experience this, contact your doctor as you may need to stop taking the tablets.
Tell your doctor or pharmacist about your symptoms. Your doctor will decide if it is a migraine. Rizatriptan Sandoz should only be taken for the treatment of migraine attacks. Rizatriptan Sandoz must not be taken for the treatment of other headaches that may be caused by other, more serious diseases.
If you are over 65 years old, your doctor will advise you on whether you can take the tablets.
Children and young people
The use of Rizatriptan Sandoz in children under 18 years of age is not recommended.
Other medicines and Rizatriptan Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do NOT take Rizatriptan Sandoz with:
MAOIs ( monoamine oxidase inhibitors ) such as moclobemide, phenelzine, linezolid, or tranylcypromine or within two weeks of stopping treatment with MAOIs.
Some other medicines for migraines, ie.
- other preparations in the same drug group as rizatriptan, e.g. sumatriptan, naratriptan or zolmitriptan.
- ergotamine-type preparations, e.g. ergotamine , dihydroergotamine or methysergide. Wait until at least 6 hours have elapsed after taking Rizatriptan Sandoz before taking these medicines. If you stop using ergotamine-type preparations, wait at least 24 hours before starting Rizatriptan Sandoz.
If you are also taking any of the following, ask your doctor for advice and information about the risks of Rizatriptan Sandoz:
- antidepressants, e.g. sertraline, escitalopram, fluoxetine, venlafaxine, or duloxetine
- propranolol (often for the treatment of high blood pressure ) – you can only take a lower dose of 5 mg rizatriptan
- the natural preparation of St. John’s wort ( Hypericum perforatum ). Concomitant intake of St. John’s wort and Rizatriptan Sandoz may increase the risk of side effects. It is recommended that Rizatriptan Sandoz and St. John’s wort not be taken at the same time.
Rizatriptan Sandoz with food
It is best to take the tablets on an empty stomach, but the preparation can be taken even after a meal. If Rizatriptan Sandoz is taken with food, it may take longer before the preparation starts to work.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
It is not known if rizatriptan is harmful to the fetus if taken by a pregnant woman. Avoid breastfeeding until 24 hours have elapsed after taking Rizatriptan Sandoz.
Driving and using machines
Migraine or treatment with Rizatriptan Sandoz may cause drowsiness in some patients. Dizziness has also been reported in some patients taking the drug. If you experience these effects, check if it is safe for you to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Rizatriptan Sandoz contains aspartame, sodium and sulfites
This medicine contains 5.6 mg of aspartame per orodispersible tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
This medicine contains less than 1 mmol (23 mg) sodium per orodispersible tablet, ie is essential ‘sodium-free’.
This medicine contains sulfites, which in rare cases can cause severe hypersensitivity reactions and convulsions in the trachea.
How to take Rizatriptan Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Rizatriptan Sandoz is not intended to prevent migraines. It only seems when the attack has already begun.
The recommended dose for adults over 18 is 10 mg at the first signs of a migraine attack. For some patients, however, the recommended dose is 5 mg. Your doctor will decide which dose is best for you. You must take the medicine according to your doctor’s instructions.
Most migraine attacks are treated with a dose (one tablet) of Rizatriptan Sandoz. However, if a tablet does not help, do NOT take another tablet to treat the same migraine attack without consulting your doctor.
Even if a migraine attack does not go away with Rizatriptan Sandoz, your next migraine attack will likely respond to treatment.
If you experience a NEW migraine attack within 24 hours of the first one, you can take another tablet of Rizatriptan Sandoz. But do not take more than two tablets within 24 hours. There should always be at least two hours between doses.
Method of administration
Take the orodispersible tablets as follows:
Tear off a tablet pocket along the dotted line.
Carefully pull off the foil and start at the side marked with an arrow.
The tablet should be placed on the tongue, where it dissolves and then swallowed with saliva. The tablets do not need to be taken with water.
If you take more Rizatriptan Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
The dose you take must be the one prescribed by your doctor. If you take more tablets than your doctor has prescribed, you should seek medical attention immediately as too many tablets can be harmful to your health. The effects of taking too many tablets include the symptoms mentioned in section 4, in particular the following: dizziness, drowsiness, fainting, or slow heart rate. You may also have high blood pressure and side effects that affect the heart and circulation.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In drug studies in adults, the most commonly reported side effects were dizziness, drowsiness, and fatigue.
Contact a doctor immediately if you experience symptoms of an allergic reaction, serotonergic syndrome, heart attack, or stroke:
- allergic reactions that can be very severe, e.g. swelling of the face, lips, tongue, and throat, which may cause difficulty breathing, swallowing, or speech ( angioedema )
- severe allergic reaction with rash, redness of the skin, blisters on the lips, eyes, or mouth, scaly skin, and fever
- chest pain, feeling of tightness in the chest or neck, or other symptoms that may indicate a heart attack
- weakness or complete paralysis of the arms, legs, or face, or speech difficulties, which may be a sign of a stroke
- so-called serotonin syndrome, which is characterized by unconsciousness, unstable blood pressure, extremely high body temperature, failing muscle coordination, arousal, and hallucinations.
Side effect ar
Common (may affect up to 1 in 10 people):
- dizziness, drowsiness, and a feeling of weakness/fatigue
- headache, and crawling ( paresthesia ), decreased sensitivity to the skin ( hypesthesia ), decreased mental acuity, insomnia
- fast or irregular heartbeat (palpitations)
- difficulty swallowing
- nausea, dry mouth, vomiting, diarrhea, digestive problems
- redness (short-lived in the face)
- the feeling of heaviness in parts of the body, pain in the neck, stiffness
- abdominal or chest pain.
Uncommon (may affect up to 1 in 100 people):
- failing muscle coordination, disorientation, nervousness, carousel feeling
- altered sense of taste (bad taste in the mouth)
- high blood pressure
- hot herds
- breathing difficulties
- rash, itchy and raised rash, swelling of the face, lips, tongue, and/or throat, which may cause shortness of breath and/or difficulty swallowing ( angioedema )
- the feeling of tightness in parts of the body, muscle weakness
- irregular heartbeat, ECG abnormalities (examination measuring the heart’s electrical activity)
- facial pain, muscle pain.
Rare (may affect up to 1 in 1,000 people):
- wheezing and hissing breathing
- allergic reaction (hypersensitivity), sudden life-threatening allergic reaction ( anaphylaxis )
- stroke. Most common in patients with risk factors for cardiovascular disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, heart disease or stroke in the family, men over 40 years, postmenopausal women, special heart rhythm disorders [branch block])
- slow heartbeat.
Has been reported (occurs in an unknown number of users)
- spasm of blood vessels in the arms and legs including feeling cold and numbness of the hands and feet
- a so-called serotonergic syndrome that can cause side effects such as coma, unstable blood pressure, extremely high body temperature, disturbance in the coordination of muscle movements, anxiety, and hallucinations
- severe skin rash with or without fever ( toxic epidermal necrolysis )
- ischemic colitis ( inflammation that causes abdominal pain and diarrhea)
- heart attack or spasm in the blood vessels of the heart. Most commonly found in patients with risk factors for cardiovascular disease (high blood pressure, diabetes, smoking, use of nicotine replacement therapy, heart disease or stroke in the family, men over 40 years, postmenopausal women, special heart rhythm disorders [branch block)).
How to store Rizatriptan Sandoz
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 blister and carton after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
No special temperature instructions.
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.
Contents of the pack and other information
- The active substance is rizatriptan. An orodispersible tablet contains 10 mg of rizatriptan (as benzoate).
- The other ingredients are calcium silicate, crospovidone type A, colloidal anhydrous silica, silicified microcrystalline cellulose, mannitol (E421), aspartame (E951), magnesium stearate, sweet orange aroma (contains gum arabic (E414), ascorbic acid, methyl butyric acid, E300) propylene glycol (E1520), sodium, sulfites).
What the medicine looks like and the contents of the pack
10 mg orodispersible tablets :
White to off-white, round, flat tablet, marked “RZT” on one side and “10” on the other.
The orodispersible tablets are packaged in aluminum/aluminum blisters and placed in a carton.
Pack sizes: 2, 3, 6, 12, 18 orodispersible tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, DK-2300 Copenhagen S, Denmark
Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia