Cinie 50

Leaflet attached to the packaging: information for the user

Cinie 50, 50 mg, tablets

Cinie 100, 100 mg, tablets

Sumatriptan

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Cinie is and what it is used for

• 2. Important information before taking Cinie
• 3. How to take Cinie
• 4. Possible side effects
• 5. How to store Cinie
• 6. Contents of the pack and other information

1. What Cinie is and what it is used for

Cinie is a pain-relieving medicine belonging to the group of anti-migraine medicines. The active substance contained in Cinie is sumatriptan, a 5-HT receptor agonist.
It is believed that migraine is the result of blood vessel dilation. Cinie causes blood vessel constriction and, as a result, relieves migraine headache.
Cinie is used to treat acute migraine attacks with or without aura (warning symptoms, which usually include visual disturbances, such as flashes of light, lines, stars, or waves).

2. Important information before taking Cinie

When not to take Cinie:

• if the patient is allergicto sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• if the patient has had a heart attackin the past.
• if the patient has heart disease.
• if the patient has symptoms that may indicate heart disease, such as temporary chest pain or a feeling of pressure in the chest.
• if the patient has had a strokeor a transient ischemic attack (a milder form of stroke that lasts less than 24 hours) in the past.
• if the patient has circulation disorders in the legs that cause cramps and pain when walking (peripheral circulatory disorders).
• if the patient has significantly high blood pressureor if blood pressure is high despite treatment.
• if the patient has severe liver function disorders.
• if the patient is currently taking or has recently taken medicines containing ergotamineor medicines containing ergotamine derivatives (including methysergide) or other triptansor 5-HT receptor agonists(such as naratriptan, rizatriptan, or zolmitriptan).
• if the patient is currently taking or has recently taken antidepressant medicinesbelonging to the group of so-called monoamine oxidase inhibitors (MAOIs).

If the patient suspects that they have any of the above conditions or has any doubts, they should consult a doctor before taking Cinie.

Warnings and precautions

Before the doctor prescribes Cinie, they should determine whether the headache is caused by migraine and not another disease.
Before starting treatment with Cinie, the patient should discuss the following with their doctor or pharmacist:

• if the patient has liver or kidney disease.
• if the patient has been diagnosed with epilepsyor another disease that may lower the seizure threshold.
• if the patient has been found to be hypersensitive to sulfonamide antibacterial medicines.
• if the patient is being treated for high blood pressure, as sumatriptan may increase blood pressure in some cases.
• if the patient is taking antidepressant medicines, such as selective serotonin reuptake inhibitors (SSRIs, such as fluoxetine, paroxetine, fluvoxamine, or sertraline) or selective serotonin and norepinephrine reuptake inhibitors (SNRIs, such as venlafaxine) or the strong pain reliever buprenorphine. Taking these medicines with Cinie may lead to serotonin syndrome, a potentially life-threatening condition (see "Cinie and other medicines").
• if the patient experiences pain and/or a feeling of pressure in the chest or throat. These symptoms are usually short-lived. If they persist or worsen, the patient should contact their doctor immediately.
• if the patient experiences chronic headaches during the day. Taking Cinie too frequently may cause chronic headaches. In such cases, the patient should consult their doctor, as it may be necessary to stop taking Cinie.
• if the patient is at risk of heart disease (e.g., patients with diabetes, heavy smokers, or patients undergoing nicotine replacement therapy), especially in women after menopause and men over 40 years old, who have these risk factors, the doctor should examine the patient's heart function before starting treatment with Cinie. After taking Cinie, very rarely, serious heart symptoms have been reported, even if no heart disease symptoms were previously detected. In case of doubt, the patient should consult their doctor.

Cinie and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may affect the effectiveness of Cinie, and Cinie may affect the effectiveness of other medicines. The patient should consult their doctor when taking:

• other anti-migraine medicines:
• ergotamine, a medicine used to treat migraine, or medicines that work similarly, such as methysergide. The patient should not take Cinie at the same time as these medicines. After taking these medicines, the patient should wait at least 24 hours before taking Cinie. After taking Cinie, the patient should wait at least 6 hours before taking medicines containing ergotamine.
• other triptansor 5-HT receptor agonists, (such as naratriptan, rizatriptan, or zolmitriptan), medicines used to treat migraine. The patient should not take Cinie at the same time as these medicines. After taking these medicines, the patient should wait at least 24 hours before taking Cinie. After taking Cinie, the patient should wait at least 24 hours before taking any triptans or 5-HT receptor agonists.
• antidepressant or strong pain-relieving medicines:
• MAOIs (monoamine oxidase inhibitors). The patient should not take Cinie for 2 weeks after stopping treatment with MAOIs (see also the section "When not to take Cinie").
• selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SNRIs), and buprenorphine (strong pain reliever). Taking Cinie with these medicines may cause serotonin syndrome (a combination of symptoms that may include restlessness, agitation, confusion, excessive sweating, temperature above 38°C, hallucinations, coma, increased reflexes, muscle contractions, involuntary, rhythmic muscle contractions, including those controlling eye movements, shivering, rapid heart rate, and trembling). The patient should immediately inform their doctor if such symptoms occur.
• medicines used to treat bipolar affective disorder (manic-depressive disorder), such as lithium.

When taking sumatriptan and herbal medicines containing St. John's Wort (Hypericum perforatum), side effects may occur more frequently.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Information on the safety of sumatriptan in pregnant women is limited.
Available data do not indicate an increased risk of congenital anomalies. Cinie should not be taken during pregnancy, unless the doctor decides otherwise.
Breastfeeding
Sumatriptan, the active substance of Cinie, passes into breast milk. The patient should not breastfeed for 12 hours after taking Cinie. Milk expressed during this time should be discarded and not given to the baby.

Driving and using machines

Migraine or treatment with Cinie may cause drowsiness. In such cases, the patient should not drive or operate machinery.

Cinie contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking Cinie.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Cinie

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Cinie should not be taken prophylactically, as it is a medicine intended for the treatment of migraine attacks. Cinie should be taken as soon as possible after the onset of migraine pain. The medicine is equally effective when taken at a later stage of the migraine attack.
The recommended dose for adults is 50 mg. Some patients may require a dose of 100 mg. If Cinie does not cause rapid relief of symptoms, it is not beneficial to take another dose during the same attack. Sumatriptan can be taken during the next attack. If symptoms disappear after taking one dose and then recur, another tablet can be taken at the earliest 2 hours after the first tablet was taken.
The patient should not take more than 300 mg (six 50 mg tablets or three 100 mg tablets) in 24 hours.

Use in children and adolescents

Cinie is not recommended for use in children and adolescents.

Use in the elderly

Cinie is not recommended for use in patients over 65 years old.

Use in patients with liver function disorders

In patients with mild to moderate liver function disorders, a small dose of 25 mg to 50 mg should be considered.
Tablets should be swallowed whole and washed down with water.
Cinie 50: The dividing line on the tablet is not intended for breaking the tablet.

Taking a higher dose of Cinie than recommended

Symptoms of overdose are the same as the side effects listed in section 4. If the patient has taken too many tablets, they should contact their doctor or go to the hospital.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Cinie can cause side effects, although not everybody gets them.
In case of doubt, the patient should consult their doctor.
The following serious side effects have been reported, but their frequency is unknown

• Skin allergic reactions: skin rash in the form of red spots or hives (hives).
• Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face, or lips, and sudden wheezing, palpitations, or chest pressure).

If a severe allergic reaction occurs, the patient should stop taking Cinie and immediately consult their doctor.

The following side effects may occur with the following frequency:
Frequent(may affect up to 1 in 10 patients):

• Drowsiness, dizziness, tingling. Unusual sensations, including numbness, tingling, feeling hot or cold.
• Transient increase in blood pressure (occurring soon after treatment), flushing.
• Nausea or vomiting.
• Feeling of pressure. Usually, it is temporary, but it can be very severe and may affect any part of the body, including the chest and throat. Muscle pain.
• Shortness of breath.
• Pain, feeling hot or cold, pressure, tension, or anxiety. These symptoms may be very severe and may affect any part of the body, including the chest and throat.
• Feeling weak, tired.

Very rare(may affect up to 1 in 10,000 patients):

• Cinie may affect the results of blood tests that assess liver function.

Frequency not known(frequency cannot be estimated from the available data):

• Oculogyric crisis (involuntary eye movements), blindness (black spots in the field of vision), tremors, and dystonia (involuntary muscle contractions).
• Seizures - usually in patients with a history of epilepsy.
• Visual disturbances (flickering, double vision, reduced vision, loss of vision, including permanent damage), although they may be related to the migraine attack itself.
• Rapid heart rate, slow heart rate, palpitations, heart rhythm disorders, and severe coronary artery complications, chest pain, heart attack, transient ischemic changes in ECG.
• Decrease in blood pressure, disease characterized by pallor or cyanosis of the skin and (or) pain in the fingers of the hands and feet, nose, or cheeks in response to cold or stress (Raynaud's phenomenon).
• Colitis (inflammation of the colon), which is characterized by pain in the lower left part of the abdomen and bloody diarrhea. Diarrhea. Difficulty swallowing.
• Stiffness of the neck. Joint pain.
• Feeling anxious.
• Excessive sweating.
• In a patient who has recently had an injury or has an inflammatory condition (such as rheumatism or colitis), pain or worsening of pain at the site of injury or inflammation may occur.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products.
Al. Jerozolimskie 181 C, 02-222 Warsaw.
Phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Cinie

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry date". The expiry date refers to the last day of the month.
No special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cinie contains

The active substance of Cinie is sumatriptan.
Cinie 50: Each tablet contains 50 mg of sumatriptan (as succinate).
Cinie 100: Each tablet contains 100 mg of sumatriptan (as succinate).
The other ingredients are:
Cinie 50: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, iron oxide red (E172).
Cinie 100: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

What Cinie looks like and contents of the pack

Cinie 50, tablets: pink, oval, biconvex tablets with a dividing line on one side.
The dividing line on the tablet is not intended for breaking the tablet.
Cinie 100, tablets: white, oval, biconvex tablets.
Pack sizes:
Cinie 50: a box containing 2, 4, 6, or 12 tablets in OPA/Al/PVC/Al blisters.
Cinie 100: a box containing 2, 3, 4, 6, 12, or 18 tablets in OPA/Al/PVC/Al blisters.
Not all pack sizes may be marketed.

Marketing authorization holder

Zentiva k.s., U kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

Manufacturer

Saneca Pharmaceuticals a.s., Nitrianska 100, 920 27 Hlohovec, Slovak Republic

For more information on the medicine and its names in the Member States of the European Economic Area, please contact:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
phone: +48 22 375 92 00
Date of last revision of the leaflet:March 2021