Rizatriptan Flas Cinfa 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Rizatriptán flas cinfa 10 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What rizatriptán flas cinfa is and what it is used for.
2. What you need to know before taking rizatriptán flas cinfa.
3. How to take rizatriptán flas cinfa.
4. Possible side effects.
5. How to store rizatriptán flas cinfa.
6. Contents of the pack and other information.

1. What rizatriptan flas is and what it is used for

Rizatriptan flas cinfa belongs to a group of medicines called selective serotonin 5-HT1B/1D receptor agonists.

Rizatriptan flas cinfa is used to treat headache pain during migraine attacks in adults. Treatment with rizatriptan flas cinfa:

Reduces the swelling of blood vessels surrounding the brain. This swelling causes the headache pain associated with a migraine attack.

2. What you need to know before taking rizatriptan flas cinfa

Do not take rizatriptan flas cinfa

• if you are allergic to rizatriptan benzoate or any of the other ingredients of this medicine (listed in section 6).
• if you have moderately severe, severe, or uncontrolled mild high blood pressure.
• if you have or have ever had heart problems, including myocardial infarction or chest pain (angina), or have experienced signs related to heart disease.
• if you have severe liver or kidney problems.
• if you have had a stroke (CVA) or transient ischemic attack (TIA).
• if you have arterial obstruction problems (peripheral vascular disease).
• if you are taking monoamine oxidase inhibitors (MAOIs) such as moclobemide, phenelzine, tranylcypromine, or pargyline (medications for depression), or linezolid (an antibiotic), or if less than two weeks have passed since you stopped taking an MAOI.
• if you are currently taking an ergotamine-type medicine, such as ergotamine or dihydroergotamine to treat your migraine, or methysergide to prevent migraine attacks.
• if you are currently taking any other medicine of the same class, such as sumatriptan, naratriptan, or zolmitriptan to treat your migraine (see below Other medicines and rizatriptan flas cinfa).

If you are unsure whether any of the above apply to you, speak with your doctor or pharmacist before taking rizatriptan flas cinfa.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take rizatriptan flas cinfa.

Before taking rizatriptan flas, inform your doctor or pharmacist if:

• you have any of the following risk factors for heart disease: high blood pressure, diabetes, you are a smoker or using nicotine replacement products, your family has a history of heart disease, you are a man over 40 years old, or you are a postmenopausal woman.
• you have kidney or liver problems.
• you have a specific problem with your heart rhythm (left bundle branch block).
• you have or have had any allergies.
• your headache is associated with dizziness, difficulty walking, lack of coordination, or weakness in your arm or leg.
• you take herbal remedies containing St. John's wort.
• you have had allergic reactions such as swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (angioedema).
• you are taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.
• you have experienced transient symptoms including chest pain and tightness.

If you take rizatriptan flas too frequently, this may lead to chronic headache. In such cases, contact your doctor, as you may need to stop taking rizatriptan flas cinfa.

Inform your doctor or pharmacist about all your symptoms. Your doctor will determine whether you have migraine. You should only take rizatriptan flas cinfa for a migraine attack. Rizatriptan flas should not be used to treat other types of headaches that may be caused by more serious conditions.

Children and adolescents

The use of rizatriptan flas cinfa orodispersible tablets is not recommended in children and adolescents under 18 years of age.

Other medicines and rizatriptan flas cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes herbal remedies and any medicines you normally take for migraine. This is because rizatriptan flas cinfa may affect how some medicines work. Other medicines may also affect rizatriptan flas cinfa.

Do not take rizatriptan flas cinfa:

• if you are already taking a 5-HT1B/1D agonist (sometimes referred to as "triptans"), such as sumatriptan, naratriptan, or zolmitriptan.
• if you are taking a monoamine oxidase inhibitor (MAOI), such as moclobemide, phenelzine, tranylcypromine, linezolid, or pargyline, or if less than two weeks have passed since you stopped taking an MAOI.
• if you are taking ergotamine-type medicines, such as ergotamine or dihydroergotamine to treat your migraine.
• if you are taking methysergide to prevent migraine attacks.

The above-mentioned medicines, when taken with rizatriptan flas cinfa, may increase the risk of adverse effects.

After taking rizatriptan flas cinfa, you must wait at least 6 hours before taking ergotamine-type medicines such as ergotamine, dihydroergotamine, or methysergide.

After taking ergotamine-type medicines, you must wait at least 24 hours before taking rizatriptan flas cinfa.

Ask your doctor for instructions on how to take rizatriptan flas cinfa and information about the risks:

• if you are currently taking propranolol (see section 3 How to take rizatriptan flas cinfa).
• if you are currently taking selective serotonin reuptake inhibitors (SSRIs) such as sertraline, escitalopram oxalate, and fluoxetine, or serotonin-noradrenaline reuptake inhibitors (SNRIs) such as venlafaxine and duloxetine for depression.

Taking rizatriptan flas cinfa with food and drinks

Rizatriptan flas may take longer to work if taken after meals. Although it is better to take it on an empty stomach, you may still take it even if you have eaten.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Available data on the safety of rizatriptan during the first three months of pregnancy do not indicate an increased risk of birth defects. It is unknown whether rizatriptan flas is harmful to the fetus when taken by a pregnant woman after the first three months of pregnancy.

If you are breastfeeding, you may delay breastfeeding for 12 hours after treatment to avoid exposing the baby.

Use in patients over 65 years of age

There are no complete studies evaluating the safety and efficacy of rizatriptan flas in patients over 65 years of age.

Driving and using machines

This medicine, like migraine itself, may cause drowsiness. If you experience these effects, avoid driving or operating machinery, as it could be dangerous.

Rizatriptan flas cinfa contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Rizatriptan flas cinfa contains aspartame

This medicine contains 3.90 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take rizatriptan flas cinfa

Rizatriptan flas cinfa is used to treat migraine attacks. Take rizatriptan flas cinfa as soon as possible once your migraine headache starts. Do not use it to prevent an attack.

Follow exactly the instructions for use provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 10 mg.

If you are currently taking propranolol or have kidney or liver problems, you should use the 5 mg dose of rizatriptan. You must wait at least 2 hours between taking propranolol and rizatriptan, and take no more than 2 doses within a 24-hour period.

If migraine recurs within 24 hours

In some patients, migraine symptoms may recur within 24 hours. If your migraine returns, you may take an additional dose of rizatriptan flas cinfa. Always wait at least 2 hours between doses.

If you still have migraine after 2 hours

If you do not respond to the first dose of rizatriptan flas cinfa during an attack, you should not take a second dose of rizatriptan flas cinfa to treat the same attack. However, you are still likely to respond to rizatriptan flas cinfa during a subsequent attack.

Do not take more than 2 doses of rizatriptan flas cinfa within a 24-hour period (for example, do not take more than two 10 mg tablets within 24 hours). Always wait at least 2 hours between doses.

If your condition worsens, seek medical attention.

How to administer rizatriptan flas cinfa orodispersible tablets

Rizatriptan flas cinfa (rizatriptan benzoate) is available as orodispersible tablets of 10 mg that dissolve in the mouth.

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press on the blister (Figure 1).

1. Separate one blister

Each blister pack contains six blisters, separated by perforations. Separate one blister along the perforated lines (Figure 2).

1. Remove the foil

Carefully peel off the foil, starting at the corner marked “peel aluminum” (Figures 3 and 4).

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue, where it will dissolve and can be swallowed with saliva (Figure 5).

The orodispersible tablet can be used in situations where liquids are not available, or to avoid nausea and vomiting that may accompany swallowing tablets with liquid.

Rizatriptan is also available as tablets to be taken with liquid.

If you take more rizatriptan flas cinfa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the medication and amount ingested. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

Signs of overdose may include dizziness, drowsiness, vomiting, fainting, and slow heart rate.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

In studies in adults, the most frequently reported adverse effects were dizziness, somnolence and fatigue.

Frequent (may affect up to 1 in 10 people)

• tingling sensation (paraesthesia), headache, reduced skin sensitivity (hypoesthesia), decreased mental acuity, insomnia.
• fast or irregular heartbeat (palpitation).
• flushing (redness of the face lasting a short time).
• sore throat.
• malaise (nausea), dry mouth, vomiting, diarrhoea, indigestion (dyspepsia).
• heaviness in parts of the body, neck pain, numbness.
• abdominal or chest pain.

Uncommon (may affect up to 1 in 100 people)

• bad taste in the mouth.
• unsteadiness when walking (ataxia), dizziness (vertigo), blurred vision, tremor, fainting (syncope).
• confusion, nervousness.
• high blood pressure (hypertension); thirst, hot flushes, sweating.
• skin rash, itching and rash with bumps (urticaria); swelling of the face, lips, tongue or throat which may cause difficulty breathing or swallowing (angioedema), difficulty breathing (dyspnoea).
• sensation of stiffness in parts of the body, muscle weakness.
• changes in the rhythm or rate of heartbeat (arrhythmia); electrocardiogram abnormalities (a test that records the electrical activity of your heart), very fast heartbeat (tachycardia).
• facial pain; muscle pain.

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

• noises when breathing.
• allergic reaction (hypersensitivity); sudden and potentially life-threatening allergic reaction (anaphylaxis).
• stroke (this usually occurs in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block))).
• slow heartbeat (bradycardia).

Frequency not known (cannot be estimated from available data)

• heart attack (myocardial infarction), spasms of the blood vessels of the heart (these usually occur in patients with risk factors for heart or blood vessel disease (hypertension, diabetes, smoker, use of nicotine replacement therapy, family history of heart disease or stroke, men over 40 years, postmenopausal women, and a specific problem with the way the heart beats (left bundle branch block))).
• a syndrome called "serotonin syndrome" which may cause adverse effects such as coma, unstable blood pressure, extremely high fever, lack of muscle coordination, agitation and hallucinations.
• severe peeling of the skin with or without fever (toxic epidermal necrolysis).
• seizures (convulsions/spasms).
• constriction of blood vessels in the extremities, including cooling and numbness of hands and feet.
• constriction of blood vessels in the colon (large intestine), which may cause abdominal pain.

Contact your doctor immediately if you experience symptoms of an allergic reaction, serotonin syndrome, heart attack or stroke.

Also, inform your doctor if you experience any symptoms indicating an allergic reaction (such as rash or itching) after taking rizatriptan flas.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of rizatriptan flas cinfa

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of rizatriptán flas cinfa

• The active substance is rizatriptan. Each orodispersible tablet contains 10 mg of rizatriptan, equivalent to 14.52 mg of rizatriptan benzoate.
• The other components are: monohydrate lactose, microcrystalline cellulose (E-460a), calcium silicate, crospovidone, aspartame (E-951), peppermint flavour (contains natural flavour and peppermint extract, corn-derived maltodextrin, modified corn starch (E-1450)), anhydrous colloidal silica and magnesium stearate.

Appearance of the product and contents of the container

The 10 mg orodispersible tablets are white or almost white, flat-faced, round and with bevelled edges.

Rizatriptán flas cinfa 10 mg tablets are available in aluminum/aluminum peel-off blister packs containing 2 or 6 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Date of the most recent review of this package leaflet: May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicinal product by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77121/P_77121.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77121/P_77121.html