SUMANET 85 mg/500 mg Tabletki Powlekane

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1. Sumanet 85 mg/500 mg film-coated tablets
   1. What is Sumanet 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

Sumanet 85 mg/500 mg film-coated tablets

sumatriptan and sodium naproxen

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 Sumanet is and what it is used for
• 2. What you need to know before you take 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 is Sumanet and what it is used for

Sumanet contains two active substances, sumatriptan and sodium naproxen. Sumatriptan belongs to
a group of medicines called triptans (also called serotonin receptor agonists (5-HT1))
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 where
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 believed to be due to the dilation of blood vessels in the head. Sumatriptan constricts
these blood vessels, thus relieving the migraine, while naproxen alleviates the pain.

2. What you need to know before taking Sumanet

Do not take Sumanet if

• you are allergic to sumatriptan or naproxen or any of the other ingredients of this medicine (listed in section 6)
• you are allergic to or have had allergic reactions (itching or skin rash) or symptoms of asthma (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, narrowing of the arteries (ischemic heart disease), chest pain (angina pectoris) or heart attack
• you have high blood pressure. If your doctor decides, you can use Sumanet if the hypertension is mild and is being treated.
• you have had a stroke or a mini-stroke (also called a transient ischemic attack, TIA), because you may be at high risk of ischemic attack
• you have problems with blood circulation in your legs that cause cramp-like pain when walking (peripheral vascular disease)
• you have or have had a gastric or duodenal ulcer
• you suffer from or have suffered from bleeding in the stomach or intestine while taking NSAIDs
• you have severely impaired kidney function
• you have moderately or severely impaired liver function
• you are taking other medicines against migraine, 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 for 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, you should not take Sumanet without first contacting your doctor.
Talk to your doctor or pharmacist before taking Sumanet, if any of the following applies to you:

• disorders of blood circulation in the hands and feet or in the brain
• chest pain and a feeling of pressure for a short period 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 the symptoms do not disappear, contact your doctor.
• you are at risk of developing heart disease; you are a heavy smoker or are undergoing nicotine replacement therapy (patches or chewing gum), especially if you are a woman who is postmenopausal or a man over 40 years old. In very rare cases, serious heart problems have occurred following the taking of Sumanet, even if no signs of heart disease have been found. If in doubt, consult your doctor.
• coronary artery disease
• unexplained stomach pain or anemia (low hemoglobin) or if you have noticed blood in your stools or if your stools are black
• a gastrointestinal illness, such as ulcerative colitisor Crohn's disease
• asthma or allergies or a history of swelling of the face, lips, eyes or tongue
• rhinitis or a history of nasal polyps
• blood coagulation disorder or bleeding disorder
• epilepsy or any other condition that lowers the seizure threshold
• hypersensitivity to certain antibiotics (sulfonamides)
• reduced heart, kidney or liver function
• you are an elderly person
• an autoimmune condition, such as systemic lupus erythematosus (SLE).

Children and adolescents
Do not give this medicine to children under 18 years of age because 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 you have bought without a prescription and
herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

• other medicines for migraine containing ergotamine and triptans/5-HT1 receptor agonists. These should 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 should not be taken within two weeks of stopping the use of MAO inhibitors.
• SSRIs (Selective Serotonin Reuptake Inhibitors) or SNRIs (Serotonin and Noradrenaline Reuptake Inhibitors) used to treat depression. The use of Sumanet 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). Inform immediately

your doctor if you are affected by this type of syndrome.

• acetylsalicylic acid (aspirin) and other anti-inflammatory pain relievers
• medicines that prevent blood clotting and the formation of clots (e.g. warfarin, heparin or clopidogrel), because concomitant use increases the risk of bleeding. Combined use should be avoided.
• methotrexate (for rheumatic and tumor diseases)
• digoxin (for heart disease)
• lithium (for bipolar disorder). The use of Sumanet with lithium can cause serotonin syndrome.
• certain immunosuppressant 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, suspect you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Do not take Sumanet if you are in the last 3 months of pregnancy, as it may harm the unborn baby or
cause problems at the time of delivery. It can cause problems with the kidneys and heart of the unborn baby. It can affect
the tendency to bleed in the patient and the baby and make labour more delayed or
longer than expected.
Do not take Sumanet during the first 6 months of pregnancy unless absolutely necessary and on
your doctor's advice. If treatment is necessary during this period or while you are trying to
become pregnant, you should use the lowest dose for the shortest possible time. If taken for more than
a few days from the 20th week of pregnancy, Sumanet can cause kidney problems in the
unborn baby which can lead to low levels of amniotic fluid surrounding the baby
(oligohydramnios) or to the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If the
treatment lasts for more than a few days, your doctor may recommend further monitoring.

Breastfeeding
Both sumatriptan and naproxen are secreted in breast milk and therefore Sumanet should 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 period, 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 problems getting pregnant. Taking Sumanet is not recommended if
you are planning to have a baby.

Driving and using machines
Sumanet or the symptoms of migraine can cause drowsiness or dizziness. If you have a migraine, do not
drive or use machines.

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

3. How to take Sumanet

Take this medicine following exactly the instructions of 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 start of migraine symptoms.

Adults
The recommended dose for adults is one tablet as soon as possible after the migraine.
If the headache returns or if you only get some relief, you can take a second dose
two hours after the first. Do not take more than two doses of Sumanet within a 24-hour period.
If you do not get any relief after the first dose, do not take a second dose. Talk to your
doctor first.

Patients with liver and kidney problems
If you suffer from 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 the elderly 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
Oral use. The tablets must be swallowed whole with water. Do not chew or crush the tablets
to avoid compromising the optimal rate of absorption of the medicine. The tablets can be
taken with or without food. Food does not have a significant effect on the effect of Sumanet.

If you take more Sumanet than you should
Do not take more than two doses of Sumanet within a 24-hour period.
The symptoms of overdose are the same as those listed in paragraph 4 "Possible undesirable effects". In case
of taking a quantity of medicine higher than due or accidental ingestion by
children, contact your doctor or hospital for an opinion on the risk and advice on the measures to be taken.
If you have any doubts 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 everyone will experience them.
Some of the side effects reported may be caused by the migraine attack itself.

Important side effects to watch out for:
Stop taking Sumanet and immediately inform your doctor if any of the following
side effects occur. Urgent medical treatment may be needed.

Serious problems with the stomach or intestines,whose signs include:
Uncommon ( may affect up to 1 in 100 people):

• bleeding from the stomach, which manifests as vomiting blood or pieces that look like coffee grounds
• bleeding from the back passage (anus), which manifests with black, sticky stools or bloody diarrhoea
• ulcers or perforations in the stomach or intestines. Signs include stomach pain, abdominal pain, fever, feeling unwell
• worsening of ulcerative colitis or Crohn's disease, which manifests with 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 that radiates to the back.

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

• severe allergic reaction of rapid onset that causes difficulty breathing or dizziness (anaphylactic reaction)

Liver problems,whose signs 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 side of the abdomen, dark urine, pale stools and yellowing of the skin or whites of the eyes (toxic hepatitis).

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

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

Heart attack,whose signs include:
Not known ( frequency cannot be estimated based on available data):

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

Stroke,whose signs include:
Not known ( frequency cannot be estimated based on available data):

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

Meningitis, whose signs 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 diseases 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 impairment
• worsening of heart failure (edema, shortness of breath), temporary increase in blood pressure (occurring immediately after treatment), flushing
• difficulty breathing
• feeling unwell (nausea, vomiting), digestive disorders, diarrhoea, inflammation of the mouth lining
• skin symptoms (e.g. itching, rash, red spots), bruising, increased sweating
• muscle pain
• pain, feeling of heat or cold, pressure, tension or heaviness, feeling of weakness, fatigue.

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

• increased potassium levels, fluid retention (edema)
• mood changes, depression, reduced ability to concentrate, difficulty with memory, difficulty sleeping or changes in dreaming
• seizures/epileptic attacks (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
• 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 anaemia, changes in the number of white blood cells, low number of platelets, blood count abnormalities
• worsening of Parkinson's disease
• inflammation of blood vessels
• lung infection
• swelling of the salivary glands
• minor disturbances 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 based on available data):

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please 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 Sumanet

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging. The expiry
date refers to the last day of that month.
This medicine does not require any particular storage conditions
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 Sumanet contains

• 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 bicarbonate, povidone, magnesium stearate, talc and coating (hypromellose, titanium dioxide (E171), triacetin, indigo carmine aluminium lake (E132)).

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

Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Distributor for sales: 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