SUMATRIPTAN KLARIA 27 mg BUCCAL FILM

2. What you need to know before you take Sumatriptan Klaria

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 a heart problem, such as narrowing of the arteries (ischemic heart disease) or chest pain (angina pectoris), or if you have already had a heart attack.
• If you have circulation problems in your legs that cause you pain similar to cramps when walking (peripheral vascular disease).
• If you have had a stroke or a mini-stroke (also called a transient ischemic attack or TIA)
• If you have high blood pressure. You may be able to use Sumatriptan Klaria if your high blood pressure is mild and you are being treated for it.
• If you have severe liver disease.
• With other medicines for migraine that contain ergotamine, or similar medicines such as methysergide or any triptan/5-HT1 receptor agonist (medicines that are also used to treat migraine).
• With antidepressants called MAOIs (monoamine oxidase inhibitors), or if you have taken these medicines in the last 2 weeks.

If any of these apply to you:

→ Tell your doctor before taking Sumatriptan Klaria.

Warnings and precautions

Talk to your doctor or pharmacist before taking Sumatriptan Klaria.

• If you have any additional risk factors
• If you smoke a lot, or are undergoing nicotine replacement therapy and especially
• If you are a man over 40 years old, or
• If you are a woman who has already had menopause.

In very rare cases, people have developed serious heart problems after using sumatriptan, even though they had no previous symptoms of heart disease. If you think you may be in one of these situations, it could mean that you have a higher risk of developing heart disease, so:

→ Tell your doctor so that they can monitor your heart function before prescribing Sumatriptan Klaria.

If you have a history of seizures

Or if you have other conditions that may make it more likely that you will have a seizure, for example, a head injury or if you have a history of alcoholism.

If you have liver or kidney disease

→ Tell your doctor so that they can monitor you more closely.

If you are allergic to antibiotics called sulfonamides

If this is the 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:

→ Tell your doctor or pharmacist before using Sumatriptan Klaria.

If you are taking antidepressants called SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors)

→ Tell your doctor or pharmacist before using Sumatriptan Klaria. Also, see the section "Other medicines and Sumatriptan Klaria" below.

If you use Sumatriptan Klaria frequently

Taking Sumatriptan Klaria too often can make your headaches worse.

→ Tell your doctor if this is the case. They may advise you to stop using Sumatriptan Klaria.

If you experience pain or pressure in your chest after using Sumatriptan Klaria

These effects can be intense, but they usually go away quickly. If they do not go away quickly or get worse:

→ Seek medical attention immediately. You can find more information about these possible side effects in section 4 of this leaflet.

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 if taken with Sumatriptan Klaria. You must tell your doctor if you are taking:

• Ergotamine, which is also 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 any medicine that contains ergotamine or ergotamine-like compounds for at least 6 hours after using Sumatriptan Klaria.
• Other triptans/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 and norepinephrine 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, shivering, rapid heartbeat, and tremors).
• Tell your doctor immediately if you experience any of these symptoms.
• MAOIs (monoamine oxidase inhibitors) used to treat depression. Do not use Sumatriptan Klaria if you have taken these medicines in the last 2 weeks.
• St. John's Wort (Hypericum perforatum). Taking herbal remedies that contain St. John's Wort while using Sumatriptan Klaria may increase the likelihood of side effects.

Pregnancy, breastfeeding, and fertility

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before taking this medicine. There is limited information on the safety of sumatriptan for pregnant women, although so far there is no evidence of an increased risk of birth defects. Your doctor will weigh the benefits and risks of using Sumatriptan Klaria while you are pregnant.
• Do not breastfeed your baby for 12 hours after using 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

Migraine symptoms or your medicine may make you feel drowsy. If this happens to you, do not drive or operate machinery.

Taking sumatriptan can cause symptoms such as dizziness and weakness, which can negatively affect your reaction time. Wait until you know how sumatriptan affects you before driving or operating machinery.

Sumatriptan Klaria contains sorbitol

This medicine contains 9.6 mg of sorbitol in each 27 mg buccal film.

Sumatriptan Klaria contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to take Sumatriptan Klaria

Use Sumatriptan Klaria only after your migraine has started.

Do not use Sumatriptan Klaria to try to prevent an episode.

Follow the instructions for taking this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist again.

The recommended dose is:

Adults (18 to 65 years old):

The usual dose for adults aged 18 to 65 years is one 27 mg Sumatriptan Klaria buccal film. Do not use more than two buccal films in 24 hours.

Adolescents (12 to 17 years old):

Sumatriptan Klaria buccal film is not recommended for adolescents due to the lack of a lower concentration.

Children (under 12 years old):

Sumatriptan Klaria is not recommended for children under 12 years old.

Older people (over 65 years old):

Sumatriptan Klaria is not recommended for people over 65 years old.

Method of administration

1. Open the sachet by tearing along the perforation and removing the top strip.
2. Separate the two halves of the sachet from the top enough to expose the buccal film.
3. Place the buccal film on the inside of your cheek, at least 1.5 cm from the edge of your mouth. Make sure the film adheres.
4. Once in place, you can moisten the film slightly with your tongue if it is dry, but do not rub it with your tongue after placing it.

The film will dissolve completely within 20 minutes. Once the film has dissolved, there will be nothing left in your mouth.

Do not chew or swallow the film. The buccal film does not need to be taken with liquid. It can be used in situations where liquids are not available. Buccal films can also be beneficial if you experience nausea or cannot drink during a migraine episode, or if you do not like swallowing conventional tablets.

When to use Sumatriptan Klaria

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

What to do if symptoms come back

You can use a second Sumatriptan Klaria buccal film after 2 hours, but do not use more than two buccal films in 24 hours.

If the first buccal film has no effect

• Do not use a second buccal film or any other sumatriptan preparation for the same episode. If Sumatriptan Klaria does not relieve your symptoms:

→ Consult your doctor or pharmacist, they will advise you.

If you take more Sumatriptan Klaria than you should

• Do not use more than two Sumatriptan Klaria buccal films in 24 hours. Taking too much Sumatriptan Klaria may harm you. If you have used more than two buccal films in 24 hours:

→ Contact your doctor, they will advise you.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any further 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 attention immediately

The following side effects have occurred, but their exact frequency is unknown.

• Allergy symptoms include skin rash, hives (itchy skin rash); wheezing; swelling of the eyelids, face, or lips; collapse. If you experience any of these symptoms soon after using Sumatriptan Klaria:→Stop using the medicine. 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, such as numbness, tingling, warmth, or cold. These effects can be intense, but they usually go away quickly. If these effects continue or get worse (especially chest pain):→Seek medical attention urgently. In a very small number of patients, these symptoms may be caused by a heart attack.

Other common side effects include:

• Feeling sick or vomiting.
• Feeling tired or sleepy.
• Feeling dizzy, weak, or flushed.
• Temporary increase in blood pressure.
• Difficulty breathing.
• Muscle pain.
• Headache.
• Skin irritation.

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

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

Some patients may have the following side effects with a frequency that is

not known

• Seizures/attacks, tremors, muscle spasms, stiffness in the neck.
• Visual disturbances such as flashes, reduced vision, double vision, loss of vision, and in some cases, even permanent defects (although these may be due to the migraine episode itself).
• Heart problems, in which the heart rate can speed up, slow down, or change, chest pain (angina pectoris), or heart attack.
• Pallor and bluish discoloration of the skin or pain in the fingers of the hands, feet, ears, nose, or jaw in response to cold or stress (Raynaud's phenomenon).
• Feeling of fainting (blood pressure may drop).
• Pain in the lower left side of the stomach and bloody diarrhea (ischemic colitis).
• Diarrhea.
• Pain in the joints.
• Feeling anxious.
• Excessive sweating.
• If you have had a recent injury or if you have inflammation (such as rheumatism or colon inflammation), 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 effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sumatriptan Klaria

Keep this medicine out of the sight and reach of children.

Store in the original packaging to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not use this medicine if you notice visible signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. Ask your 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

Composition of Sumatriptan Klaria

• The active substance is sumatriptan. Each buccal film contains 27 mg of sumatriptan.

• The other ingredients are sorbitol, glycerol, sodium alginate, citric acid monohydrate, and yellow iron oxide.

Appearance of the product and packaging

Buccal film. The 27 mg buccal film is rectangular (25 x 20 mm) and has an approximate thickness of 150 μm. The soft and flexible film is between transparent and opaque, between yellow and orange-brown, with a smooth and flat surface.

Sumatriptan Klaria 27 mg buccal film is available in packs of 2 and 6 sachets, each containing one buccal 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 medicine has been authorised in the Member States of the European Economic Area under the following names:

Germany Sumatriptan Klaria 27 mg Buccalfilm

Italy Sumatriptan Klaria

Spain Sumatriptán Klaria 27 mg buccal film

Date of last revision of this leaflet: 08/2024The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)