Sumatriptan Klaría

PACKAGE LEAFLET

Package leaflet: Information for the user

Sumatriptan Klaria 27 mg orodispersible film

Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 taking 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 Sumatriptan Klaria is and what it is used for

Sumatriptan Klaria belongs to a group of medicines called triptans (also known as 5-HT₁ receptor agonists), which are used to treat migraine headache.
Migraine symptoms may be caused by the temporary dilation of blood vessels in the head.
Sumatriptan Klaria is thought to reduce this dilation of blood vessels, thereby helping to relieve headache and other symptoms associated with migraine attacks, such as discomfort or feeling unwell (nausea or vomiting) and sensitivity to light and sound.
Sumatriptan Klaria works only once a migraine attack has started. It does not prevent the onset of an attack.
You must not use sumatriptan to prevent a migraine attack.

2. What you need to know before taking it

Do not take Sumatriptan Klaria

• if you are allergic to sumatriptan or to any of the other ingredients of this medicine (listed in section 6).
• if you have heart problems, such as narrowed arteries (ischaemic heart disease) or chest pain (angina), or if you have already had a heart attack.
• if you have circulation problems in your legs causing cramp-like pain when walking (peripheral vascular disease).
• if you have had a stroke or a mini-stroke (also called 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 being treated.
• if you suffer from severe liver disease.
• together with other migraine medicines containing ergotamine or similar medicines such as methysergide, or any triptan/5-HT1 receptor agonists (medicines also used to treat migraine).
• together with antidepressants called MAOIs (monoamine oxidase inhibitors), or if you have taken these medicines within the last 2 weeks.

If any of these conditions apply to you:
→ Consult your doctor and do not take Sumatriptan Klaria.
Warnings and precautions
Talk to your doctor or pharmacist before taking Sumatriptan Klaria if:

• You have other risk factors
• You are a heavy smoker or are undergoing nicotine replacement therapy, especially
• If you are a man over 40 years of age, or
• 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 a higher risk of developing heart disease, therefore:
→ Consult your doctor so that your heart function can be checked before prescribing Sumatriptan Klaria.

If you have a history of seizures (epileptic fits)
or if other conditions exist that could increase the likelihood of seizures, such as head injury or alcoholism.

If you suffer from liver or kidney disease
→ Consult your doctor to allow for appropriate 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 unsure whether 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-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 may worsen headaches.
→ Consult your doctor if this applies to you. Your doctor may advise you to stop taking Sumatriptan Klaria.

If you experience chest pain or tightness 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 about 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 medicines.

Some medicines must not be taken with Sumatriptan Klaria, and others may cause side effects when taken together with it. Inform your doctor if you are taking:

• ergotamine, even if used to treat 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 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 for at least 24 hours after using Sumatriptan Klaria.

• SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin-noradrenaline reuptake inhibitors) used to treat depression. Taking Sumatriptan Klaria with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate, and tremors).
• Inform your doctor immediately if you experience these symptoms.
• MAOIs (monoamine oxidase inhibitors) used to treat depression. Do not use Sumatriptan Klaria if you have taken MAOIs within the last 2 weeks.
• St John's wort (Hypericum perforatum). Taking herbal remedies containing St John's wort during treatment with Sumatriptan Klaria may increase the likelihood of side effects.

Pregnancy, breastfeeding and fertility

• If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. There is only limited information available on the safety of sumatriptan in pregnant women, 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 express 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 this medicine can cause drowsiness. If you are affected, do not drive and do not operate machinery.
Taking sumatriptan may cause symptoms such as dizziness and weakness, which may affect reaction speed. Wait to see how you react to sumatriptan before driving or operating machinery.

Sumatriptan Klaria contains sorbitol
This medicine contains 9.6 mg of sorbitol in each 27 mg orodispersible film.

Sumatriptan Klaria contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Sumatriptan Klaria

Use Sumatriptan Klaria only after migraine headache has started.
Do not use Sumatriptan Klaria to try to prevent an attack.
Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Recommended dose:

Adults (aged 18 to 65 years):
The usual dose for adults aged between 18 and 65 is one 27 mg orodispersible film of Sumatriptan Klaria. Do not take more than two orodispersible films within 24 hours.

Adolescents (aged 12 to 17 years):
The orodispersible film of Sumatriptan Klaria is not recommended in adolescents due to the lack of a lower dosage formulation.

Children (under 12 years of age):
Sumatriptan Klaria is not recommended for children under 12 years of age.

Elderly (over 65 years of age):
Sumatriptan Klaria is not recommended for people over 65 years of age.

Method of administration

1. Open the sachet by tearing along the perforated part and removing the top strip.
2. Separate the two halves of the sachet at the top just enough to expose the orodispersible film.
3. Place the orodispersible film inside the cheek, at least 1.5 cm from the edge of the mouth. Make sure the film adheres properly.
4. Once in place, you may 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 the mouth once the film has dissolved.
Do not chew or swallow the film. The orodispersible film must not be taken with liquids. It can be used in situations where liquids are not available. Orodispersible films may also be useful if you experience nausea or are unable to drink during a migraine attack, or if you prefer not to swallow conventional tablets.

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

If symptoms recur
You may use a second orodispersible film of Sumatriptan Klaria after 2 hours, but do not take more than two orodispersible films within 24 hours.

If the first orodispersible film has no effect

• Do not take a second orodispersible film or any other sumatriptan-containing preparation for the same attack. If Sumatriptan Klaria provides no relief: → Consult your doctor or pharmacist.

If you take more Sumatriptan Klaria than you should

• Do not take more than two orodispersible films of Sumatriptan Klaria within 24 hours. Overuse of Sumatriptan Klaria may cause symptoms. If you have used more than two films within 24 hours: → Seek advice from your doctor.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

• Symptoms of allergy include rash, urticaria (itchy rash); wheezing; swelling of the eyelids, face or lips; complete collapse. If you experience any of these symptoms immediately after using Sumatriptan Klaria: → Stop using it. Contact a doctor immediately.

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

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

Other common side effects include:

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

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

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

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

• Seizures/epileptic fits, tremors, muscle spasms, neck stiffness.
• Visual disturbances such as tremor, reduced vision, double vision, loss of vision and in some cases even permanent defects (although these may be due to the migraine attack itself).
• Heart problems, in which the heartbeat may speed up, slow down or change rhythm, chest pain (angina) or heart attack.
• Pallor, bluish skin and/or pain in the fingers or toes, 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 part of the stomach and bloody diarrhoea (ischaemic colitis).
• Diarrhoea.
• Joint pain.
• Feeling anxious.
• Excessive sweating.
• If you have recently suffered an injury or have 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 experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not use this medicine if you notice any visible signs of deterioration.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sumatriptan Klaria contains

• The active substance is sumatriptan. Each orodispersible film contains 27 mg of sumatriptan.
• The other components are sorbitol, glycerol, sodium alginate, monohydrate citric acid 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, flexible film is transparent to opaque, yellow to orange-brown in colour, with a smooth, 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 European Economic Area Member States under the following names:
Germany Sumatriptan Klaria 27 mg Buccalfilm
Italy Sumatriptan Klaria 27 mg orodispersible film
Spain Sumatriptan Klaria 27 mg película bucal