Cinie 50

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Cinie 50 (Cinie), 50 mg, tablets

Sumatriptan
Cinie 50 and Cinie are different trade names for the same drug.

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

• The leaflet should be kept so that it can be read again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Cinie 50 and what is it used for
• 2. Important information before taking Cinie 50
• 3. How to take Cinie 50
• 4. Possible side effects
• 5. How to store Cinie 50
• 6. Contents of the packaging and other information

1. What is Cinie 50 and what is it used for

Cinie 50 is a pain-relieving medicine belonging to the group of anti-migraine medicines.
The active substance contained in Cinie 50 is sumatriptan, a 5-HT receptor agonist.
Migraine is thought to be the result of blood vessel dilation. Cinie 50 causes blood vessel constriction and, as a result, relieves migraine headache.
Cinie 50 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 50

When not to take Cinie 50:

• 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 elevated 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 triptans, or 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 50.

Warnings and precautions

Before the doctor prescribes Cinie 50, they should determine whether the headache is caused by migraine and not by another disease.
Before starting treatment with Cinie 50, 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 antibiotics.
• 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). Taking these medicines with Cinie 50 may lead to serotonin syndrome, a potentially life-threatening condition (see "Cinie 50 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 throughout the day. Taking Cinie 50 too frequently may cause chronic headaches. In such cases, the patient should consult their doctor, as it may be necessary to stop taking Cinie 50.
• 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 50. After taking Cinie 50, very rare cases of serious heart-related symptoms have been reported, even if no symptoms of heart disease were previously detected. In case of doubts, the patient should consult their doctor.

Cinie 50 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 50, and Cinie 50 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 50 at the same time as these medicines. After taking these medicines, the patient should wait at least 24 hours before taking Cinie 50. After taking Cinie 50, 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 50 at the same time as these medicines. After taking these medicines, the patient should wait at least 24 hours before taking Cinie 50. After taking Cinie 50, the patient should wait at least 24 hours before taking any triptans or 5-HT receptor agonists.

after taking these medicines, the patient should wait at least 24 hours before taking any triptans or 5-HT receptor agonists.

• antidepressant or strong pain-relieving medicines:
• MAO inhibitors (monoamine oxidase inhibitors). The patient should not take Cinie 50 for 2 weeks after stopping treatment with MAO inhibitors (see also the section "When not to take Cinie 50").
• selective serotonin reuptake inhibitors (SSRIs), selective serotonin and norepinephrine reuptake inhibitors (SNRIs), and buprenorphine (a strong pain-relieving medicine). Taking Cinie 50 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, accelerated heart rate, and trembling). The patient should immediately inform their doctor if such symptoms occur.
• medicines used to treat bipolar affective disorder (manic-depressive illness), 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 malformations. Cinie 50 should not be used during pregnancy unless the doctor decides otherwise.
Breastfeeding
Sumatriptan, the active substance of Cinie 50, passes into breast milk. The patient should not breastfeed for 12 hours after taking Cinie 50. Breast milk expressed during this time should be discarded and not given to the baby.

Driving and using machines

Migraine or treatment with Cinie 50 may cause drowsiness. In such cases, the patient should not drive or operate machines.

Cinie 50 contains lactose monohydrate and sodium

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

3. How to take Cinie 50

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the patient should consult their doctor or pharmacist.
Cinie 50 (50 mg) and Cinie 100 (100 mg) are available on the market.
Cinie 50 should not be used prophylactically, as it is a medicine intended for the treatment of migraine attacks. Cinie 50 should be taken as soon as possible after the onset of migraine pain.
The medicine is equally effective when administered in a later phase of the migraine attack.
The recommended dose for adults is 50 mg. Some patients may require a dose of 100 mg. If Cinie 50 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 the symptoms disappear after taking one dose and then recur, another tablet can be taken at least 2 hours after the first tablet.
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 50 should not be used in children and adolescents.

Use in elderly patients

Cinie 50 should not be used in patients over 65 years old.

Use in patients with liver function disorders

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

Taking a higher dose of Cinie 50 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 50 can cause side effects, although not everybody gets them.
In case of doubts, the patient should contact 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 (bumps).
• Anaphylaxis (severe allergic reactions, such as swelling of the eyelids, face, or lips, and sudden onset of wheezing, palpitations, or chest pressure).

If a serious allergic reaction occurs, the patient should stop taking Cinie 50 and immediately consult their doctor.

The following side effects may occur with the following frequency:
Common(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 shortly after treatment), flushing.
• Nausea or vomiting.
• Feeling of pressure. Usually, it is transient, 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 can be very severe and may affect any part of the body, including the chest and throat.

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

• Cinie 50 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.
• Accelerated heart rate, slowed heart rate, palpitations, heart rhythm disorders, and severe coronary artery complications, chest pain, heart attack, transient ischemic changes in the ECG.
• Decrease in blood pressure, a 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 of restlessness.
• 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 Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 (22) 49 21 301
fax: +48 (22) 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Cinie 50

The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are 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 packaging and other information

What Cinie 50 contains

The active substance of Cinie 50 is sumatriptan.
Each tablet contains 50 mg of sumatriptan (as sumatriptan succinate).
The other ingredients are:
lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, iron oxide red (E 172).

What Cinie 50 looks like and what the packaging contains

Pink, oval, biconvex tablets with a dividing line on one side.
The dividing line on the tablet is not intended for breaking the tablet.
Pack sizes:
A box containing 2, 4, 6, or 12 tablets in OPA/Al/PVC/Al blisters.
For more detailed information on the medicine, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

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

Manufacturer:

Saneca Pharmaceuticals, a.s., Nitrianska 100, 920 27 Hlohovec, Slovakia

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Lithuanian, export country authorization number: LT/1/06/0566/001
LT/1/06/0566/002
LT/1/06/0566/003
LT/1/06/0566/004
LT/1/06/0566/005

Parallel import authorization number: 12/24

Date of leaflet approval: 12.01.2024

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