Cinie 50

Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Cinie 50 (Cinie), 50 mg, tablets
Sumatriptanum
Cinie 50 and Cinie are different trade names for the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

1. What Cinie 50 is and what it is 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 pack and other information

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

Cinie 50 is an analgesic medicine belonging to the class of antimigraine agents.
The active substance in Cinie 50 is sumatriptan, a 5-HT receptor agonist.
Migraine is thought to result from the dilation of blood vessels. Cinie 50 causes
constriction of blood vessels and thereby relieves migraine headache.
Cinie 50 is used for the acute treatment of migraine attacks with or without aura (warning symptoms
which typically 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 allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• if the patient has previously had a myocardial infarction (heart attack).
• if the patient has heart disease.
• if the patient experiences symptoms that may indicate heart disease, such as transient chest pain or a feeling of pressure in the chest.
• if the patient has previously had a stroke or transient ischaemic attack (a milder form of stroke lasting less than 24 hours).
• if the patient has circulatory disorders in the legs causing painful cramps when walking (peripheral vascular disorders).
• if the patient has significantly elevated blood pressure or if blood pressure remains high despite treatment.
• if the patient has severe liver function disorders.
• if the patient is currently taking or has recently taken medications containing ergotamine or ergotamine derivatives (including methysergide), or other triptans, or 5-hydroxytryptamine receptor agonists 5-HT (such as naratriptan, rizatriptan, or zolmitriptan).
• if the patient is currently or has recently taken antidepressant medications belonging to the group of so-called monoamine oxidase inhibitors (MAO inhibitors).

If there is suspicion that the patient has any of the above conditions, or if there are any doubts, contact a doctor before using Cinie 50.

Warnings and precautions

Before prescribing Cinie 50, the doctor should confirm that the headache is caused by migraine and not by another condition.

Before starting treatment with Cinie 50, discuss the following with your doctor or pharmacist:

• if the patient has liver or kidney disorders.
• if the patient has been diagnosed with epilepsy or another condition that may lower the seizure threshold.
• if the patient has hypersensitivity to antibacterial drugs belonging to the sulfonamide group.
• if the patient is being treated for high blood pressure, as in rare cases sumatriptan may increase blood pressure.
• if the patient is taking antidepressant medications such as selective serotonin reuptake inhibitors (SSRIs, e.g. fluoxetine, paroxetine, fluvoxamine, or sertraline) or serotonin-noradrenaline reuptake inhibitors (SNRIs, e.g. venlafaxine) or the strong painkiller buprenorphine. Taking these drugs together with Cinie 50 may lead to serotonin syndrome, a potentially life-threatening condition (see "Cinie 50 with other medicines").
• if the patient experiences chest pain and/or a feeling of pressure in the chest or throat. These symptoms are usually short-lived. If they persist or worsen, contact a doctor immediately.
• if the patient develops chronic headaches during the day. Overuse of Cinie 50 may lead to chronic headaches. In such cases, contact a doctor, as discontinuation of Cinie 50 may be necessary.
• if the patient is at risk of heart disease (e.g. patients with diabetes, smokers, or those undergoing nicotine replacement therapy), especially postmenopausal women and men over 40 years of age with the above risk factors. Before starting Cinie 50, the doctor should assess heart function. Rarely, serious cardiac events have been reported after taking Cinie 50, even in patients without prior symptoms of heart disease. If in doubt, contact a doctor.

Cinie 50 with other medicines

Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.

Some medicines may affect the efficacy of Cinie 50, and Cinie 50 may affect the efficacy of other medicines. Contact your doctor if you are taking:

• other anti-migraine medicines:

• ergotamine, a medicine used to treat migraine, or similar-acting medicines such as methysergide. Do not take Cinie 50 simultaneously with these medicines. Wait at least 24 hours after taking these medicines before taking Cinie 50. After taking Cinie 50, wait at least 6 hours before taking any ergotamine-containing medicine.

• other triptans or 5-HT receptor agonists (such as naratriptan, rizatriptan, or zolmitriptan), medicines used to treat migraine. Do not take Cinie 50 simultaneously with these medicines. After taking these medicines, wait at least 24 hours before taking Cinie 50. After taking Cinie 50, wait at least 24 hours before taking any triptans or 5-HT receptor agonists.

• antidepressants or strong painkillers:

• MAO inhibitors (monoamine oxidase inhibitors). Do not take Cinie 50 for 2 weeks after stopping treatment with MAO inhibitors (see also section "When not to use Cinie 50").

• selective serotonin reuptake inhibitors (SSRIs), selective serotonin-noradrenaline reuptake inhibitors (SNRIs), and buprenorphine (a strong painkiller). Concomitant use of Cinie 50 with medicines from these groups may cause serotonin syndrome (a combination of symptoms that may include restlessness, agitation, confusion, excessive sweating, body temperature above 38°C, hallucinations, coma, hyperreflexia, muscle rigidity, involuntary rhythmic muscle contractions including those controlling eye movement, shivering, rapid heart rate, and tremor). Contact a doctor immediately if such symptoms occur.

• medicines used to treat bipolar disorder (manic-depressive illness), such as lithium.

Concomitant use of sumatriptan and herbal medicines containing St. John’s wort (Hypericum perforatum) may increase the risk of adverse effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy

Information on the safety of sumatriptan use in pregnant women is limited. Available data do not indicate an increased risk of congenital malformations. Use of Cinie 50 during pregnancy is not recommended unless otherwise decided by a doctor.

Breastfeeding

Sumatriptan, the active substance in Cinie 50, passes into breast milk. Breastfeeding should be avoided for 12 hours after taking Cinie 50. Milk expressed during this time should be discarded and not used to feed the infant.

Driving and operating machinery

Migraine or treatment with Cinie 50 may cause drowsiness. In such cases, do not drive or operate machinery.

Cinie 50 contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, contact a doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Cinie 50

Always take this medicine exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Available in the market are: Cinie 50 (50 mg) and Cinie 100 (100 mg).

Cinie 50 should not be used prophylactically, as it is 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 taken later during a migraine attack.

The recommended dose for adults is 50 mg. Some patients may require a dose of 100 mg. If Cinie 50 does not rapidly relieve symptoms, it is not advisable to take another dose during the same migraine attack. Sumatriptan may be used again during the next attack. If symptoms resolve after one dose but then recur, a second tablet may be taken no sooner than 2 hours after the first tablet.

Do not take more than 300 mg (six 50 mg tablets or three 100 mg tablets) within 24 hours.

Use in children and adolescents

Use of Cinie 50 is not recommended in children and adolescents.

Use in elderly patients

Use of Cinie 50 is not recommended in patients over 65 years of age.

Use in patients with liver function disorders

In patients with mild to moderate liver function disorders, consider using lower doses of 25 mg to 50 mg.

Tablets should be swallowed whole with water.

The tablet break line is not intended for splitting the tablet.

Taking more than the recommended dose of Cinie 50

Symptoms of overdose are the same as those listed in section 4. If too many tablets have been taken, contact a doctor or go to hospital.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If in doubt, you should consult your doctor.
The following serious adverse reactions have been reported, but their frequency is unknown:

• Skin allergic reactions: skin rash in the form of red spots or hives (wheals).
• Anaphylaxis (severe allergic reactions such as eyelid, facial or lip swelling, sudden wheezing, palpitations or chest tightness).

If a severe allergic reaction occurs, discontinue use of Cinie 50 immediately and seek medical attention.
The following adverse reactions may occur with the following frequency:
Common (may occur in up to 1 in 10 patients):

• Drowsiness, dizziness, tingling. Unusual sensations, including numbness, tingling, feeling of heat or cold.

• Transient increase in blood pressure (occurring shortly after treatment), flushing.

• Nausea or vomiting.

• Sensation of pressure. Usually transient, but may be severe and may affect any part of the body, including the chest and throat. Muscle pain.

• Shortness of breath.

• Pain, feeling of warmth or cold, pressure, tightness or anxiety. These symptoms may be severe
  and may affect any part of the body, including the chest and throat.

• Feeling of weakness, fatigue.

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

• Cinie 50 may affect blood test results assessing liver function.

Frequency unknown (frequency cannot be estimated from available data):

• Nystagmus (involuntary eye movements), scotoma (black spots in the visual field), tremor and dystonia (involuntary muscle contractions).
• Seizures – usually in patients with a history of epilepsy.
• Visual disturbances (flickering, double vision, reduced vision, vision loss, including permanent damage), although these may be related to the migraine attack itself.
• Increased heart rate, decreased heart rate, palpitations, cardiac arrhythmias, and severe complications involving the coronary arteries, chest pain, myocardial infarction, transient ischaemic changes on ECG.
• Decrease in blood pressure, a condition characterized by paleness or cyanosis of the skin and/or pain in fingers of hands and feet, nose or jaw in response to cold or stress (Raynaud's phenomenon).
• Colitis (inflammation of the colon) presenting with pain in the lower left abdomen and bloody diarrhoea. Diarrhoea. Difficulty swallowing.
• Neck stiffness. Joint pain.
• Feeling of restlessness.
• Excessive sweating.
• In patients who have recently suffered trauma or who have an inflammatory condition (e.g. rheumatism or inflammatory bowel disease), pain or worsening of pain at the site of injury or inflammation may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cinie 50

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

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

What Cinie 50 looks like and contents of the pack
Pink, oval, biconvex tablets with a division line on one side.
The division line on the tablet is not intended for breaking the tablet.

Pack sizes:
Carton containing 2, 4, 6 or 12 tablets in blisters OPA/Al/PVC/Al.

For more detailed information about the medicine, please contact the responsible entity or the parallel importer.

Marketing Authorisation 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, Poland

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

Marketing Authorisation numbers in Lithuania, the country of export:
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 licence number: 12/24