SUVEXX 85 MG/500 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Suvexx 85mg/500mg film-coated tablets

sumatriptan and naproxen sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Suvexx is and what it is used for

Suvexx contains two active substances, sumatriptan and naproxen sodium. Sumatriptan belongs to a group of medicines called triptans (also known as serotonin receptor agonists (5-HT1)) and naproxen sodium belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Suvexx is used to treat the headache phase of migraine attacks in adult patients, when treatment with one of the single components has been insufficient. This medicine can be used to treat migraine headache with or without aura (aura is a general warning, usually related to flashes of light, jagged images, stars, or waves).

Migraines are thought to be caused by the dilation of blood vessels in the head. Sumatriptan reduces the dilation of these blood vessels, thus relieving migraine, and naproxen decreases pain.

2. What you need to know before you take Suvexx

Do not takeSuvexx

• if you are allergic to sumatriptan, naproxen, or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic or have had previous allergic reactions (itching or skin rash) or symptoms of asthma (wheezing) to acetylsalicylic acid or other NSAIDs such as ibuprofen, diclofenac, or meloxicam,
• if you have or have had any heart disease such as severe heart failure, narrowing of the arteries (ischemic heart disease), or chest pain (angina) or myocardial infarction,
• if you have high blood pressure. If your doctor decides, you may be able to use this medicine if your high blood pressure is mild and being treated,
• if you have had a stroke or a mini-stroke (also called a transient ischemic attack or TIA), as you may be at increased risk of stroke,
• if you have circulation problems in your legs that cause cramp-like pains when walking (peripheral vascular disease),
• if you have or have had a stomach or duodenal ulcer,
• if you have or have had stomach or intestinal bleeding while taking NSAIDs,
• if you have severely reduced kidney function,
• if you have moderately or severely reduced liver function,
• if you use other migraine medicines, including those that contain ergotamine or similar medicines, such as methysergide or any triptan or 5HT1 agonist (such as naratriptan or zolmitriptan),
• if you use or have used in the last 2 weeks the so-called MAO inhibitors (e.g., moclobemide for depression or selegiline for Parkinson's disease),
• if you are in the third trimester of pregnancy.

Warnings and precautions

This medicine should only be used in cases of clear diagnosis of migraine. If the headache is different from your usual headaches, do not take it without consulting your doctor first.

Consult your doctor or pharmacist before starting to take this medicine if you have any of the following:

• if you have blood circulation disorders in hands and feet or brain.
• if you feel pain or pressure in the chest for a short period after using this medicine. These effects can be intense and radiate to the throat. In very rare cases, it may be due to effects on the heart. Therefore, if the symptoms do not disappear, contact your doctor.
• if you are at risk of heart disease; you are a heavy smoker or are on nicotine replacement therapy (patches or gum), and especially if you are:

• a woman who has passed menopause.
• a man over 40 years old.

In very rare cases, serious heart diseases have developed after using this medicine, despite not having signs of heart disease before. Contact your doctor if you have any doubts.

• if you have coronary artery disease.
• if you have unexplained stomach pain or anemia (low hemoglobin) or if you notice blood in your stool or your stool is black.
• if you have gastrointestinal disease, such as ulcerative colitis or Crohn's disease.
• if you have asthma or allergies or a history of facial swelling, lips, eyes, or tongue.
• if you have rhinitis or a history of nasal polyps.
• if you have a blood coagulation disorder or bleeding disorder.
• if you have epilepsy or any other disease that reduces your convulsive threshold.
• if you have hypersensitivity to certain antibiotics (sulfonamides).
• if you have reduced cardiac, renal, or hepatic function.
• if you are an elderly person.
• if you have an autoimmune disease, such as systemic lupus erythematosus (SLE).

There have been reports of serious skin reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), in association with naproxen. Stop taking Suvexx and consult your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.

Children and adolescents

Do not give this medicine to children under 18 years of age because the efficacy and safety of Suvexx in this age group have not been established.

Other medicines and Suvexx

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. It is important that you tell your doctor if you are taking any of the following medicines:

• other migraine medicines that contain ergotamine and triptans/5-HT1 receptor agonists. Do not take Suvexx at the same time as these medicines (see section "Do not take Suvexx"). Wait at least 24 hours between taking these medicines and this one.
• MAO inhibitors (such as moclobemide for depression or selegiline for Parkinson's disease). Do not take Suvexx if you have taken these MAO inhibitors in the last two weeks.
• SSRIs (selective serotonin reuptake inhibitors) or SNRIs (serotonin and norepinephrine reuptake inhibitors) used to treat depression. The use of Suvexx with these medicines may cause serotonin syndrome (a series of symptoms that can include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, shivering, increased heart rate, and tremors). Tell your doctor immediately if you have any of these symptoms.
• acetylsalicylic acid (aspirin) and other anti-inflammatory painkillers.
• medicines that prevent blood clotting and the formation of blood clots (such as warfarin, heparin, or clopidogrel), as their concomitant use increases the risk of bleeding. Their combined use should be avoided.
• methotrexate (for rheumatic and oncological diseases).
• digoxin (for heart diseases).
• lithium (for bipolar disorder). The concomitant use of this medicine with lithium may cause serotonin syndrome.
• certain immunosuppressive medicines (such as cyclosporine and tacrolimus).
• herbal medicines that contain St. John's Wort (Hypericum perforatum). Adverse effects may appear with greater probability.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Suvexx if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause problems in the kidney and heart of your fetus. It may affect your tendency to bleed and that of your baby, causing a possible delay in delivery or prolonging it more than expected.

Do not take Suvexx during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, this medicine may cause problems in the kidney of your fetus if taken for more than a few days, which can cause low levels of the fluid that surrounds the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Breast-feeding

Both sumatriptan and naproxen are excreted in breast milk. Therefore, this medicine should not be used during breast-feeding.

Do not breast-feed a baby for at least 12 hours after taking this medicine. If you express milk during this time, discard it and do not give it to your baby.

Fertility

This medicine may make it harder to become pregnant. You should tell your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant. It is not recommended to take this medicine if you are planning to have a baby.

Driving and using machines

Suvexx or migraine symptoms may cause drowsiness or dizziness. If you notice these effects, avoid driving or using machines.

Suvexx contains sodium

This medicine contains 60 mg of sodium (main component of cooking/table salt) in each tablet. This is equivalent to 3% of the maximum daily intake of sodium recommended for an adult.

3. How to take Suvexx

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Do not use this medicine to try to prevent an attack; it should only be used after the onset of migraine symptoms.

Adults

The recommended dose for adults is 1 tablet as soon as possible after the onset of a migraine.

If the symptoms decrease after the first dose but the headache comes back, you can take a second dose 2 hours after the first dose. Do not take more than two doses of this medicine in a 24-hour period.

If you do not have any relief after the first dose, do not take the second dose. Talk to your doctor or pharmacist first.

Patients with liver and kidney problems

If you have mild liver or kidney problems and need to take this medicine, you should only take one tablet in a 24-hour period.

Use in elderly patients (over 65 years)

This medicine is not recommended for patients over 65 years of age.

Use in children and adolescents

This medicine is not recommended for children and adolescents under 18 years of age.

Method of administration

Oral use. The tablets should be swallowed whole with water. Do not chew or crush the tablets, as this may affect the optimal absorption rate of the medicine. The tablets can be taken with or without food. Food does not have a significant effect on the effect of this medicine.

If you takemore Suvexx than you should

Do not take more than two doses of this medicine in a 24-hour period.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount ingested.

The symptoms of overdose are the same as those mentioned in section 4 "Possible side effects". If you have taken more medicine than you should, or if children have taken the medicine by accident, contact your doctor or hospital for advice on the risk and the measures to be taken.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Some of the reported adverse effects may be caused by the migraine itself.

Important Adverse Effects to Consider:

Stop taking this medicine and inform your doctor immediately if any of the following adverse effects occur. You may need urgent medical treatment.

Severe Stomach or Intestinal Problems, the signs include:

Uncommon (may affect up to 1 in 100 people):

• Stomach bleeding, which manifests with bloody vomiting or coffee grounds-like particles.
• Rectal bleeding, which manifests with black, tarry stools or bloody diarrhea.
• Formation of ulcers or perforations in the stomach or intestine. Symptoms include stomach discomfort, stomach pain, fever, feeling unwell.
• Worsening of ulcerative colitis or Crohn's disease, which manifests with pain, diarrhea, vomiting, and weight loss.

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

• Pancreatic problems. Symptoms are severe stomach pain that radiates to the back.

Frequency not known (frequency cannot be estimated from available data):

• Widespread skin rash, high body temperature, high liver enzyme levels, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
• A characteristic skin allergic reaction known as fixed drug eruption, which usually recurs in the same place or places upon re-exposure to the medicine and may appear as round or oval patches of redness and swelling of the skin, blisters (hives), itching.

Allergic Reactions, the signs include:

Rare (may affect up to 1 in 1,000 people):

• Severe allergic reaction with rapid onset that causes difficulty breathing or dizziness (anaphylactic reaction).
• Swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing (angioedema).

Liver Problems, the signs include:

Rare (may affect up to 1 in 1,000 people):

• Feeling tired, loss of appetite, feeling unwell (nausea, vomiting), pain or swelling in the upper right abdomen, dark urine, pale stools, and yellowing of the skin or whites of the eyes (toxic hepatitis).

Severe Skin Rashes, the signs include:

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

• Generally starts with symptoms similar to those of the flu (feeling unwell, fever, headache, cough, and joint pain) followed by a red or purple rash that develops rapidly, with painful blisters and skin peeling, and possibly blisters in the mouth, throat, eyes, and genital tract (Stevens-Johnson syndrome/toxic epidermal necrolysis).

Heart Attack, the signs include:

Frequency not known (cannot be estimated from available data):

• Chest pain that may radiate to the neck and shoulders and down the left arm.

Stroke, the signs include:

Frequency not known (cannot be estimated from available data):

• Muscle weakness and numbness. This may only be on one side of your body.
• Sudden change in sense of smell, taste, hearing, or vision, confusion.

Meningitis, the signs include:

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

• Fever, feeling unwell, stiffness in the neck, headache, sensitivity to bright lights, and confusion (very likely in people with autoimmune diseases such as systemic lupus erythematosus).

Other Possible Adverse Effects:

Very common (may affect more than 1 in 10 people):

• Upper abdominal pain.
• Feeling unwell (nausea), heartburn, constipation.

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

• Dizziness, tingling, drowsiness, sensory disturbances, headache, lightheadedness.
• Visual disturbances.
• Ringing in the ears, hearing disorders.
• Worsening of heart failure (edema, difficulty breathing), temporary increase in blood pressure (which appears shortly after treatment), flushing.
• Difficulty breathing.
• Nausea, vomiting, digestive disorders, diarrhea, inflammation of the mouth mucosa.
• Skin symptoms (e.g., itching, rash, red spots), bruising, increased sweating.
• Muscle pain.
• Feeling of pain, feeling of cold or heat, pressure, tightness, or heaviness, feeling of weakness, fatigue.

Uncommon (may affect up to 1 in 100 people):

• Increased potassium levels, fluid accumulation (edema).
• Mood changes, depression, reduced ability to concentrate, memory impairment, difficulty sleeping or changes in sleep patterns.
• Seizures/epileptic fits (seizures).
• Irregular heartbeats (palpitations).
• Increased liver enzyme and bilirubin levels (jaundice).
• Menstrual disorders.
• Thirst.

Rare (may affect up to 1 in 1,000 people):

• Hearing loss.
• Fluid accumulation in the lungs.
• Worsening of asthma.
• Hair loss.
• Skin more sensitive to the sun, blisters, and skin changes (pseudoporphyria).
• Muscle weakness, muscle pain.

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

• Blood problems, such as anemia, changes in white blood cell count, low platelet count, blood count abnormalities.
• Worsening of Parkinson's disease.
• Inflammation of blood vessels.
• Pneumonia.
• Swelling of the salivary glands.
• Mild changes in liver function tests.
• Skin disorder with red, itchy patches, usually on the palms of the hands, soles of the feet, and face (erythema multiforme), exacerbation of skin diseases (e.g., lichen planus, erythema nodosum, systemic lupus erythematosus (SLE)).
• Blood or protein in the urine, reduced kidney function, kidney inflammation (nephritis), other kidney disorders.

Frequency not known (cannot be estimated from available data):

• Anxiety.
• Involuntary movements (dystonia), tremor, nystagmus.
• Heart problems where heartbeats can accelerate, slow down, or change rhythm, chest pain (angina pectoris).
• Low blood pressure, Raynaud's phenomenon (a condition in which the fingers and toes turn white and numb).
• Difficulty swallowing.
• Excessive sweating.
• Stiffness of the neck, joint pain.
• Pain or worsening pain at the site of injury or inflammation, fever.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Suvexx

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

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

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Suvexx Composition

• The active ingredients are sumatriptan (as sumatriptan succinate) and sodium naproxen. Each tablet contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of sodium naproxen equivalent to 457 mg of naproxen.
• The other ingredients are calcium hydrogen phosphate, microcrystalline cellulose, sodium croscarmellose, sodium hydrogen carbonate, povidone, magnesium stearate, talc, and coating (hypromellose, titanium dioxide (E171), triacetin, aluminum lake indigo carmine (E132)).

Suvexx Appearance and Package Contents

Suvexx is a film-coated tablet (tablet) of medium blue color, capsule-shaped, with a length, width, and thickness of 19 mm x 10 mm x 7 mm, and with the inscription “85/500”on one side and smooth on the other.

Package sizes:

Child-resistant plastic bottle with screw cap: 9 tablets.

Each package contains a silica gel desiccant bottle and a PET coil.

Blister: 3 and 9 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Orion Pharma, S.L.

Avenida Alberto Alcocer 46B

28016 Madrid

Phone: +349 159 9 86 01

Date of the last revision of this leaflet: December 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/