SUMATRIPTAN 27 mg Оральная Диспергируемая Пленка

Содержание инструкции

1. Sumatriptan Klaria 27 mg orally disintegrating film
   1. What is Sumatriptan Klaria and what it is used for
   2. What you need to know before you take
   3. How to take Sumatriptan Klaria
   4. Possible side effects
   5. How to store Sumatriptan Klaria
   6. Contents of the pack and other information

Sumatriptan Klaria 27 mg orally disintegrating film

Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Sumatriptan Klaria and what it is used for

Sumatriptan Klaria belongs to a group of medicines called triptans ( also known as 5-HT1 receptor agonists), used for the treatment of migraine headache.
The symptoms of migraine can be caused by the temporary widening of the blood vessels in the head.
It is believed that Sumatriptan Klaria reduces the widening of these blood vessels. This in turn helps to
eliminate the headache and relieve other symptoms related to migraine attacks, such as feeling unwell or sick (nausea or vomiting) and sensitivity to light and noise.
Sumatriptan Klaria only works when the migraine attack is already in progress. It does not prevent an attack from occurring.
You should not use sumatriptan to prevent a migraine attack.

2. What you need to know before you take

Do not take Sumatriptan Klaria

• if you are allergic to sumatriptan or any of the other ingredients of this medicine (listed in section 6).
• if you have heart problems, such as narrowing of the arteries (ischaemic heart disease) or chest pain (angina), or if you have had a heart attack.
• if you have problems with circulation in your legs that cause pain similar to cramps when walking (peripheral vascular disease).
• if you have had a stroke or a mini-stroke (also called a transient ischaemic attack or TIA)
• if you suffer from high blood pressure. The use of Sumatriptan Klaria may be allowed if the high blood pressure is mild and is being treated.
• if you suffer from severe liver disease.
• With other medicines for migraine containing ergotamine or similar medicines such as methysergide or any triptan/5-HT1 receptor agonist (medicines also used for the treatment of migraine)
• With MAOIs (monoamine oxidase inhibitors) antidepressants or if you have taken these medicines in the last 2 weeks.

In the presence of any of these conditions:
→ Consult your doctor and do not take Sumatriptan Klaria.

Warnings and precautions
Talk to your doctor or pharmacist before taking Sumatriptan Klaria.
o If you have other risk factors
o If you are a heavy smoker or if you are undergoing nicotine replacement therapy and especially
o If you are a man over 40 years of age, or
o If you are a postmenopausal woman.
In very rare cases, serious heart conditions have developed after taking sumatriptan, even in
the absence of any signs of heart disease. If any of the above points apply to you, you may have
an increased risk of developing heart disease, therefore:
→ Consult your doctor so that they can check your heart function before prescribing you Sumatriptan
Klaria.
If you have a history of seizures (convulsions)
Or if there are other conditions that could increase the likelihood of seizures, such as
head trauma or alcoholism.
If you suffer from liver or kidney disease
→ Consult your doctor to allow for adequate monitoring.
If you are allergic to antibiotics called sulfonamides
In this case, you may also be allergic to Sumatriptan Klaria. If you know you are allergic to an antibiotic
but are not sure if it is a sulfonamide:
→ Consult your doctor or pharmacist before using Sumatriptan Klaria.
If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors) or SNRIs
(serotonin and noradrenaline reuptake inhibitors)
→ Consult your doctor or pharmacist before using Sumatriptan Klaria. See also “Other medicines
and Sumatriptan Klaria” below.
If you use Sumatriptan Klaria frequently
Excessive use of Sumatriptan Klaria can worsen headaches.
→ Consult your doctor if this is the case. Your doctor may advise you to stop taking
Sumatriptan Klaria.
If you experience chest pain or a feeling of pressure in your chest after using Sumatriptan Klaria
These effects can be intense but usually pass quickly. If they do not pass quickly or worsen:
→ Contact your doctor immediately. Section 4 of this leaflet contains further information on
these possible side effects.

Other medicines and Sumatriptan Klaria
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Some medicines must not be taken with Sumatriptan Klaria and others may cause side
effects if taken with Sumatriptan Klaria. Tell your doctor if you are taking:

• ergotamine even for treating migraine or similar medicines such as methysergide (see section 2). Do not use Sumatriptan Klaria at the same time as these medicines. Stop taking these medicines at least 24 hours before using Sumatriptan Klaria. Do not take medicines containing ergotamine or ergotamine-like compounds again for at least 6 hours after using Sumatriptan Klaria.
• other triptan/5-HT1 receptor agonists (such as naratriptan, rizatriptan, zolmitriptan, almotriptan and eletriptan), also used to treat migraine (see section 2). Do not use Sumatriptan Klaria

at the same time as these medicines. Stop taking these medicines at least 24
hours before using Sumatriptan Klaria. Do not take another triptan/5-HT1 receptor agonist again for at least 24
hours after using Sumatriptan Klaria.

• SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and noradrenaline reuptake inhibitors) used to treat depression. Using Sumatriptan Klaria with these medicines can cause serotonin syndrome (a set of symptoms that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate and tremors).
• Immediately inform your doctor if you experience these symptoms.
• MAOIs (monoamine oxidase inhibitors) used to treat depression. Do not use Sumatriptan Klaria if you have taken them in the last 2 weeks.
• St John's Wort (Hypericum perforatum). Taking herbal remedies containing St John's Wort while using Sumatriptan Klaria can increase the likelihood of side effects.

Pregnancy, breastfeeding and fertility

• If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine. There is limited information on the safety of sumatriptan during pregnancy, although so far there is no evidence of an increased risk of birth defects. Your doctor will assess with you whether or not it is appropriate to use Sumatriptan Klaria during pregnancy.
• Do not breastfeed your baby for at least 12 hours after taking Sumatriptan Klaria. If you collect breast milk during this time, discard the milk and do not give it to your baby.

Driving and using machines
Both the symptoms of migraine and the medicine can make you feel sleepy. If this happens, do not drive and
do not use machines.
The use of sumatriptan can cause symptoms such as dizziness and weakness, which can alter reaction time.
Wait to see how you react to sumatriptan before driving vehicles or using machines.

Sumatriptan Klaria contains sorbitol
This medicine contains 9.6 mg of sorbitol in each orally disintegrating tablet of 27 mg.

Sumatriptan Klaria contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, that is to say essentially ‘sodium-free’.

3. How to take Sumatriptan Klaria

Only use Sumatriptan Klaria after your headache has started from a migraine.
Do not use Sumatriptan Klaria to try to prevent an attack.
Take this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

The recommended dose is:
Adults (18 to 65 years of age):
The usual dose for adults between 18 and 65 years of age is one orally disintegrating film of Sumatriptan Klaria
27 mg. Do not take more than two orally disintegrating films in 24 hours.
Adolescents (12 to 17 years of age):
The Sumatriptan Klaria orally disintegrating film is not recommended in adolescents due to the lack of
a lower dosage.
Children (under 12 years of age):
Sumatriptan Klaria is not recommended in children under 12 years of age.
Elderly (over 65 years of age):
Sumatriptan Klaria is not recommended in people over 65 years of age.

Method of administration

• 1. Open the sachet by tearing the perforated part and removing the top strip.
• 2. Separate the two halves of the sachet on the top side just enough to expose the orally disintegrating film.
• 3. Position the orally disintegrating film inside the cheek, at least 1.5 cm from the edge of the mouth. Make sure the film adheres.
• 4. Once in position, you can moisten the film with your tongue if it feels dry, but do not rub the film with your tongue after it has adhered.

The film will dissolve completely within 20 minutes. There will be nothing to remove from your mouth once
the film has dissolved.
Do not chew or swallow the film. The orally disintegrating film should not be taken with liquids. It can be
used in situations where liquids are not available. Orally disintegrating films may also be helpful
if you are feeling nauseous or unable to drink during a migraine attack, or if you do not want to swallow
conventional tablets.

When to use Sumatriptan Klaria
It is best to use Sumatriptan Klaria as soon as you feel the onset of a migraine, although it can be
used at any time during an attack.

If symptoms start to return
You can use a second Sumatriptan Klaria orally disintegrating film after 2 hours, but do not take more than two films
orally disintegrating films in 24 hours.

If the first orally disintegrating film has no effect

• Do not take a second orally disintegrating film or any other sumatriptan-based preparation for the same attack. If Sumatriptan Klaria does not provide any relief: → Seek advice from your doctor or pharmacist.

If you take more Sumatriptan Klaria than you should

• Do not take more than two Sumatriptan Klaria orally disintegrating films in 24 hours. Excessive use of Sumatriptan Klaria may cause symptoms. If you have taken more than two films in 24 hours: → Seek advice from your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms may be caused by the migraine itself.
Allergic reaction: seek medical advice immediately
The following side effects have been reported, but their exact frequency is unknown.

• Symptoms of allergy include skin rash, hives (itchy rash); wheezing; swelling of the eyelids, face or lips; complete collapse. If you experience any of these symptoms immediately after using Sumatriptan Klaria: →Do not use it again. Contact a doctor immediately.

Common(may affect up to 1 in 10 people):

• Heaviness, pressure, a feeling of tightness or pain in the chest, throat or other parts of the body or unusual sensations, including numbness, tingling and warmth or cold. These effects can be intense but usually pass quickly. If these effects persist or become severe (particularly chest pain): →Contact your doctor urgently. In a very limited number of people these symptoms may be caused by a heart attack.

Other common side effects include:

• Feeling sick (nausea) or being sick (vomiting).
• Tiredness or drowsiness.
• Dizziness, feeling of weakness or hot flushes.
• Temporary increase in blood pressure.
• Shortness of breath.
• Muscle aches.
• Headache.
• Skin irritation.

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

• Changes in liver function. If you are having a blood test to check your liver function, tell your doctor or nurse that you are taking Sumatriptan Klaria.

Some patients may experience the following side effects, but it is not known how frequently they occur

• Convulsions/seizures, tremors, muscle spasms, stiff neck.
• Visual disturbances such as flickering, blurred vision, double vision, loss of vision and in some cases also permanent defects (although these may be due to the migraine attack itself).
• Heart problems, where the heartbeat may speed up, slow down or become irregular, chest pain (angina) or heart attack.
• Paleness, bluish skin and/or pain in the fingers of the hands or feet, ears, nose or jaw in response to cold or stress (Raynaud's phenomenon).
• Feeling faint (possible drop in blood pressure).
• Pain in the lower left side of the abdomen and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Joint pain.
• Feeling anxious.
• Excessive sweating.
• If you have had a recent injury or if you have an inflammation (such as rheumatism or inflammation of the colon) you may experience pain or worsening of pain at the site of the injury or inflammation.
• Difficulty swallowing

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Sumatriptan Klaria

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after «EXP.». The expiry
date refers to the last day of that month.
Do not use this medicine if you notice visible signs of deterioration.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sumatriptan Klaria contains

• The active ingredient is sumatriptan. Each orodispersible film contains 27 mg of sumatriptan.
• The other ingredients are sorbitol, glycerol, sodium alginate, citric acid monohydrate and yellow iron oxide.

Description of the appearance of Sumatriptan Klaria and contents of the pack
Orodispersible film. The 27 mg orodispersible film is rectangular (25 x 20 mm) with a thickness of approximately 150
μm. The soft and flexible film is in colour from transparent to opaque, from yellow to orange-brown, with a
smooth and flat surface.
Sumatriptan Klaria 27 mg orodispersible film is available in packs of 2 and 6 sachets, each
containing one orodispersible film.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Klaria AB
Virdings allé 2
754 50 Uppsala
Sweden

Manufacturer
AdhexPharma SAS
42/44 Rue de Longvic
21300 Chenôve
France

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Germany Sumatriptan Klaria 27 mg Buccalfilm
Italy Sumatriptan Klaria 27 mg film orosolubile
Spain Sumatriptan Klaria 27 mg película bucal