Sumanet

Patient Information Leaflet: Information for the patient

Sumanet 85 mg/500 mg film-coated tablets

sumatriptan and sodium naproxen
Please read this leaflet carefully before taking this medicine because 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 other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Sumanet is and what it is used for

Sumanet contains two active substances, sumatriptan and sodium naproxen. Sumatriptan belongs to a group of medicines known as triptans (also called serotonin (5-HT1) receptor agonists), and sodium naproxen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Sumanet is used to treat the headache phase of migraine attacks in adult patients when treatment with a single component is insufficient. Sumanet can be used to treat migraine attacks with or without aura (aura is a sensation usually associated with flashes of light, jagged images, stars, or waves).
Migraine is thought to be due to the dilation of blood vessels in the head. Sumatriptan narrows these blood vessels, thereby relieving migraine, while naproxen reduces pain.

2. What you need to know before taking Sumanet

Do not take Sumanet if

• you are allergic to sumatriptan or naproxen, or to any of the other ingredients of this medicine (listed in section 6)
• you are allergic or have previously had allergic reactions (itching or skin rash) or asthma symptoms (wheezing) to acetylsalicylic acid or other NSAIDs such as ibuprofen, diclofenac, or meloxicam
• you have or have had heart problems such as severe heart failure, narrowed arteries (ischaemic heart disease), chest pain (angina pectoris), or a heart attack
• you have high blood pressure. If your doctor decides, you may use Sumanet if the hypertension is mild and being treated.
• you have had a stroke or a mini-stroke (also called transient ischaemic attack, TIA), because you may be at high risk of ischaemic attack
• you have circulation problems in the legs causing cramp-like pain when walking (peripheral vascular disease)
• you have or have had a gastric or duodenal ulcer
• you have experienced or previously had stomach or intestinal bleeding while taking NSAIDs
• you have severely reduced kidney function
• you have moderately or severely reduced liver function
• you are taking other migraine medications, including those containing ergotamine or similar medicines such as methysergide maleate or triptans/5HT1 agonists (such as naratriptan or zolmitriptan)
• you are taking, or have taken within the past 2 weeks, so-called MAO inhibitors (e.g., moclobemide for the treatment of depression or selegiline for the treatment of Parkinson's disease)
• you are in the last three months of pregnancy.

Warnings and precautions
Sumanet should only be used if the headache is definitely migraine. If the headache is different from
your usual one, do not take Sumanet without first contacting your doctor.
Talk to your doctor or pharmacist before taking Sumanet if any of the following apply to you:

• circulation disorders in the hands and feet or in the brain
• chest pain and a feeling of pressure for a short time after taking Sumanet. The pain may be very intense and may radiate to the throat. In very rare cases, this may be caused by effects on the heart. Therefore, if symptoms do not disappear, contact your doctor.
• you are at risk of developing heart disease; you are a heavy smoker or are using nicotine replacement therapy (patches or chewing gum), especially if you are a woman in menopause or a man over 40 years old. In very rare cases, serious heart problems have occurred after taking Sumanet, even in the absence of signs of heart disease. If in doubt, consult your doctor.
• coronary heart disease
• unexplained stomach pain or anaemia (low haemoglobin) or if you have noticed blood in your stools or if your stools are black
• a gastrointestinal disease such as ulcerative colitis or Crohn's disease
• asthma or allergies or history of swelling of the face, lips, eyes, or tongue
• rhinitis or history of nasal polyps
• blood clotting disorder or bleeding disorder
• epilepsy or any other condition that lowers the seizure threshold
• hypersensitivity to certain antibiotics (sulphonamides)
• reduced heart, kidney, or liver function
• you are elderly
• an autoimmune condition, such as systemic lupus erythematosus (SLE).

Children and adolescents
Do not give this medicine to children under 18 years of age, as the efficacy and safety of Sumanet in this age group have not been established.
Other medicines and Sumanet
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines purchased without a prescription and herbal medicines. In particular, inform your doctor or pharmacist if you are taking:

• other migraine medicines containing ergotamine and triptans/5-HT1 receptor agonists. These must not be taken at the same time as Sumanet (see section "Do not take Sumanet if"). Do not take these medicines and Sumanet within 24 hours of each other.
• MAO inhibitors (e.g., moclobemide for depression or selegiline for Parkinson's disease). Sumanet must not be taken within two weeks after stopping MAO inhibitors.
• SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors) used to treat depression. Taking Sumanet with these medicines may cause serotonin syndrome (a group of symptoms that may include restlessness, confusion, sweating, hallucinations, increased reflexes, muscle spasms, chills, increased heart rate, and tremors). Inform your doctor immediately

if you develop this type of syndrome.

• acetylsalicylic acid (aspirin) and other anti-inflammatory painkillers
• medicines that prevent blood clotting and clot formation (e.g., warfarin, heparin, or clopidogrel), because concomitant use increases the risk of bleeding. Combined use should be avoided.
• methotrexate (for rheumatic and tumour diseases)
• digoxin (for heart diseases)
• lithium (for bipolar disorder). Taking Sumanet with lithium may cause serotonin syndrome.
• certain immunosuppressive medicines (e.g., cyclosporine and tacrolimus)
• herbal products containing St John's wort (Hypericum perforatum). Side effects may occur more frequently.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Sumanet during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect the bleeding tendency of both the mother and the baby and may cause labour to start later or last longer than expected.
Do not take Sumanet during the first 6 months of pregnancy unless absolutely necessary and on the advice of your doctor. If treatment is needed during this period or while trying to conceive, you should use the lowest dose for the shortest possible time. If taken for more than a few days starting from week 20 of pregnancy, Sumanet may cause kidney problems in the unborn child, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment lasts for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Both sumatriptan and naproxen are excreted in breast milk; therefore, Sumanet must not be used during breastfeeding.
Do not breastfeed your baby for at least 12 hours after using Sumanet. If you produce breast milk during this time, discard it and do not give it to your baby.
Fertility
Sumanet may make it more difficult to become pregnant. You should inform your doctor if you are planning a pregnancy or if you have difficulty becoming pregnant. Taking Sumanet is not recommended if you are planning to have a baby.
Driving and using machines
Sumanet or the symptoms of migraine may cause drowsiness or dizziness. If you have a migraine, do not drive and do not use machines.
Sumanet contains sodium
This medicine contains 60 mg of sodium (a main component of table salt) in each tablet. This is equivalent to 3% of the maximum daily intake recommended in an adult's diet.

3. How to take Sumanet

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Do not use Sumanet to try to prevent an attack, but only
after the onset of migraine symptoms.
Adults
The recommended dose for adults is one tablet as soon as possible after the onset of migraine.
If the headache recurs or if you obtain only partial relief, a second dose may be taken two hours after the first. Do not take more than two doses of Sumanet within a 24-hour period.
If you do not experience any relief after the first dose, do not take a second dose. Speak to your
doctor first.
Patients with liver or kidney problems
If you have mild liver or kidney problems and need to take Sumanet, you should take only one tablet
within a 24-hour period.
Use in the elderly (over 65 years)
Sumanet is not recommended for elderly patients over 65 years of age.
Use in children and adolescents
Sumanet is not recommended for children and adolescents under 18 years of age.
Method of administration
For oral use. Tablets should be swallowed whole with water. Do not chew or crush the tablets, as this may impair the optimal absorption rate of the medicine. Tablets may be taken with or without food. Food does not have a significant effect on the action of Sumanet.
If you take more Sumanet than you should
Do not take more than two doses of Sumanet within a 24-hour period.
Symptoms of overdose are the same as those listed in section 4, "Possible side effects". If you or a child has taken more medicine than you should, or if a child has accidentally ingested the medicine, contact your doctor or hospital for advice on the risk and measures to take.
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 everybody gets them. Some of the reported side effects may be caused by the migraine attack itself.
Important side effects to be aware of:
Stop taking Sumanet and contact your doctor immediately if you experience any of the following side effects. You may require urgent medical treatment.
Severe stomach or intestinal problems, signs of which include:
Uncommon ( may affect up to 1 in 100 people ):

• bleeding from the stomach, appearing as vomiting blood or material resembling coffee grounds
• bleeding from the back passage (anus), appearing as black, sticky stools or bloody diarrhoea
• ulcers or perforations in the stomach or intestine. Signs include stomach pain, abdominal pain, fever, feeling unwell (nausea, vomiting)
• worsening of ulcerative colitis or Crohn's disease, manifesting as pain, diarrhoea, vomiting and weight loss.

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

• problems with the pancreas. Signs include severe stomach pain spreading to the back.

Allergic reactions, signs of which include:
Rare ( may affect up to 1 in 1,000 people ):

• severe, rapidly developing allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction)
• swelling of the face, tongue or throat, difficulty swallowing, hives and breathing difficulties (angioedema).

Liver problems, signs of which include:
Rare ( may affect up to 1 in 1,000 people ):

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

Severe skin rashes, signs of which include:
Very rare ( may affect up to 1 in 10,000 people ):

• initial flu-like symptoms (feeling unwell, fever, headache, cough, joint pain), followed by a rapidly developing red or purplish rash, 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, signs of which include:
Not known ( frequency cannot be estimated from available data ):

• chest pain that may spread to the neck, shoulders and left arm.

Stroke, signs of which include:
Not known ( frequency cannot be estimated from available data ):

• muscle weakness and numbness, which may occur on only one side of the body
• sudden changes in smell, taste, hearing or vision, confusion.

Meningitis, signs of which include:
Very rare ( may affect up to 1 in 10,000 people ):

• fever, feeling unwell (nausea and vomiting), stiff neck, headache, sensitivity to bright light and confusion (more likely in people with autoimmune disorders such as systemic lupus erythematosus).

Other possible side 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 disturbance
• worsening of heart failure (oedema, shortness of breath), temporary increase in blood pressure (occurring shortly after treatment), flushing
• breathing difficulties
• feeling unwell (nausea, vomiting), digestive disorders, diarrhoea, inflammation of the mouth mucosa
• skin symptoms (e.g. itching, rash, red spots), bruising, increased sweating
• muscle pain
• pain, sensation of heat or cold, pressure, tightness or heaviness, feeling of weakness, fatigue.

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

• increased potassium levels, fluid retention (oedema)
• mood changes, depression, reduced concentration, memory difficulties, difficulty sleeping or changes in dreaming
• seizures/epileptic fits (convulsions)
• irregular heartbeat (palpitations)
• increased liver enzymes and bilirubin (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
• increased skin sensitivity to sunlight, blistering and skin changes (pseudoporphyria)
• muscle weakness, muscle pain.

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

• blood disorders, such as anaemia, changes in white blood cell count, low platelet count, blood test abnormalities
• worsening of Parkinson's disease
• inflammation of blood vessels
• lung infection
• swelling of the salivary glands
• minor abnormalities in liver function tests
• skin disorders with itchy red 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.

Not known ( frequency cannot be estimated from available data ):

• anxiety
• involuntary movements (dystonia), tremor, nystagmus
• heart problems in which the heartbeat may speed up, slow down or change rhythm, chest pain (angina pectoris)
• low blood pressure, Raynaud's phenomenon (a condition in which fingers and toes become pale and numb)
• difficulty swallowing
• excessive sweating
• neck stiffness, joint pain
• pain or worsening of pain at the site of injury or inflammation, fever.

Reporting of side effects
If you experience any side effects, 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 Sumanet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sumanet contains

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

Description of the appearance of Sumanet and package contents
Sumanet is a medium blue, film-coated, capsule-shaped tablet (tablet), measuring 19 mm x 10 mm x 7 mm, with the inscription "85/500" in relief on one side and smooth on the other.
Packaging:
Plastic container with child-resistant screw cap: 9 tablets. Each container includes a silica gel desiccant and a PET coil.
Blister pack: 9 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Distributor: Orion Pharma S.r.l. - Milan

Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland