SYNFLEX 550 mg Tabletki Powlekane

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1. Synflex 550 mg coated tablets, 550 mg granules for oral suspension
   1. What is Synflex and what is it used for
   2. What you need to know before taking Synflex
   3. How to take Synflex
   4. Possible side effects
   5. How to store Synflex
   6. Contents of the pack and other information

Synflex 550 mg coated tablets, 550 mg granules for oral suspension

naproxen sodium

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Synflex and what is it used for

Synflex contains the active ingredient naproxen sodium.
Naproxen sodium belongs to a class of medicines called non-steroidal anti-inflammatory/antirheumatic drugs
which perform numerous activities, with an important function in pain control.
Synflex is used for the treatment of symptoms of:

• joint pain
• muscle pain
• pain due to surgical procedures
• pain due to dental procedures
• menstrual pain (dysmenorrhea)
• headache (migraine)

2. What you need to know before taking Synflex

Do not take Synflex

• if you are allergic to naproxen sodium or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a lesion of the mucous membrane of the stomach or duodenum (gastroduodenal ulcer and peptic ulcer in progress)
• if you suffer from inflammation of the colon (ulcerative colitis)
• if you have a history of bleeding or perforation of the stomach or intestine due to previous treatments with naproxen or a history of bleeding/lesion of the stomach mucosa (peptic ulcer) frequent (two or more distinct episodes)
• if you suffer from severe heart problems (severe heart failure)
• if you have a history of allergies such as asthma, itching (urticaria), allergic rhinitis (hay fever), severe and rapid general allergic reaction (anaphylactic or anaphylactoid reactions), presence of droplet-shaped nodules inside the nose (nasal polyps) associated with the use of aspirin (acetylsalicylic acid) and/or other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you are pregnant or breastfeeding
• if you suffer from kidney problems (renal insufficiency)
• if you are a child under the age of 2 years.

Warnings and precautions
Consult your doctor or pharmacist before taking Synflex:

• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you are elderly as you may be more likely to experience some of the undesirable effects caused by Synflex such as bleeding/perforation of the stomach and intestine
• if you have a history of lesion of the stomach wall with bleeding/perforation (gastrointestinal bleeding, ulceration or perforation)
• if you have or have been diagnosed with acute inflammation of the intestinal tract or if you have had stomach or intestinal disorders after using medicines for rheumatic diseases
• if you have a history of toxicity to the stomach or intestine
• if you are taking anti-inflammatory drugs (oral corticosteroids), medicines to thin the blood (anticoagulants such as warfarin), medicines against depression (selective serotonin reuptake inhibitors) or medicines like aspirin or analogues (see “Other medicines and Synflex”)
• if you suffer from a chronic inflammatory disease of the stomach and intestine (ulcerative colitis or Crohn's disease)
• if you have problems with heart, liver or kidney function
• if you suffer from high blood pressure and/or heart problems (heart failure)
• if you have a history of swelling of the legs, arms, face, mouth or tongue (angioedema) or difficulty breathing (bronchospasm, asthma and rhinitis) and the presence of droplet-shaped nodules inside the nose (nasal polyps)
• if you have a history of allergic manifestations or ongoing allergic manifestations
• if you have bleeding problems (haemostasis disorders)
• if you are planning a pregnancy
• if you have fertility problems or are undergoing fertility investigations.

Severe skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with Synflex.If you notice any of the symptoms related to these severe skin reactions, described in section 4, stop treatment with Synflex and consult your doctor immediately.
Synflex must be discontinued at the first appearance of skin rash, mucous membrane lesions or any other sign of an allergic reaction (hypersensitivity).
The use of high doses and prolonged treatments of Synflex may increase, modestly, the risk of heart attack (myocardial infarction) or injury to the brain vessels (stroke).
Do not exceed the recommended dose or duration of treatment.
If you have heart problems or a history of stroke or think you may be at risk for these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your therapy with your doctor or pharmacist.

Children and adolescents
Synflex is contraindicated in children under the age of 2 years.

Other medicines and Synflex
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
The effects of Synflex may be affected by or affect the following medicines:

• Diuretics, ACE inhibitors and angiotensin II receptor antagonists (for the treatment of high blood pressure) as they may have a reduced effect if taken together with Synflex and increase the risk of kidney damage in some dehydrated or elderly patients who already have impaired kidney function.
• Furosemide (to increase the amount of urine) as the concomitant administration with some non-steroidal anti-inflammatory drugs may reduce the effect of this medicine.
• Lithium (for the treatment of manic-depressive illnesses) as the amount of lithium in the blood may become too high.
• Propranolol and beta-blockers (for the treatment of high blood pressure) as Synflex may reduce the effect of these medicines.
• Probenecid (for the treatment of gout) as it increases the amount and persistence of Synflex in the body.
• Methotrexate (for the treatment of tumors and for diseases of the body's defense system) as it remains longer in the body with the possibility of increasing its toxicity.
• Anticoagulants (to thin the blood) as non-steroidal anti-inflammatory drugs (NSAIDs) may increase the effects of anticoagulants, such as warfarin or coumarin-type anticoagulants (see the section “What you need to know before taking Synflex”).
• Antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors - SSRIs (for depression) as they increase the risk of bleeding from the stomach and intestine (see the section “What you need to know before taking Synflex”).
• Corticosteroids (anti-inflammatory hormones) as they increase the risk of injury or bleeding from the stomach and intestine (see the section “What you need to know before taking Synflex”).
• Naproxen sodium may decrease the effectiveness of contraceptive devices (intrauterine devices).
• Aspirin/acetylsalicylic acid to prevent blood clot formation.

The concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) including Synflex with is not recommended:

• naproxen
• acetylsalicylic acid
• other NSAIDs
• quinolones (antibiotics).

Synflex may interfere with some tests of adrenal function. If you are to undergo tests for adrenal function, temporarily suspend the therapy with Synflex 48 hours before the examination.
Synflex may also interfere with some tests for urinary 5-hydroxyindoleacetic acid.

Synflex with alcohol
Do not drink alcohol during treatment with Synflex.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
The medicine is contraindicated during pregnancy and breastfeeding. It may cause problems with the kidneys and heart in the unborn child. In addition, it may expose both you and the baby to possible bleeding and delay or prolong labor more than expected.
Do not take Synflex if you are planning a pregnancy. From the 20th week of pregnancy onwards, naproxen sodium may cause kidney problems in the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
Stop Synflex if you have fertility problems or are undergoing fertility investigations.

Driving and operating machinery
Due to the possible occurrence of dizziness, drowsiness, vertigo or depression, Synflex may impair the ability to drive vehicles and use machinery. Avoid, in these cases, activities that require vigilance.

Synflex coated tablets contain

• E110 (sunset yellow). May cause allergic reactions;
• sodium. This medicine contains 50 mg of sodium (the main component of table salt) per tablet. This is equivalent to 2.5% of the recommended daily intake with the diet of an adult.

Synflex oral suspension granules contain

• sucrose.If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine;
• sodium.This medicine contains 181 mg of sodium (the main component of table salt) per sachet. This is equivalent to 9% of the recommended daily intake with the diet of an adult.

3. How to take Synflex

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

Adults
The recommended dose is:

• 550 mg every 12 hours as directed by your doctor.

Elderly

• If you are elderly, your doctor will carefully determine the dose you need to take.

If you suffer from liver problems (hepatic insufficiency)

• Your doctor will carefully determine the dose you need to take.

If you suffer from kidney problems (impaired renal function)

• Your doctor will carefully determine the dose you need to take.

If you suffer from severe kidney problems (renal insufficiency)

• Do not take Synflex.

Use in children and adolescents
Synflex is contraindicated in children under 2 years of age (see “What you need to know before taking
Synflex”).

If you take more Synflex than you should
If you accidentally take an excessive dose of Synflex, immediately inform your doctor or go to the
nearest hospital.
If you take more Synflex than you should, you may experience dizziness, drowsiness, abdominal discomfort, stomach pain, nausea or vomiting, transient alterations in liver and kidney function, a decrease in a
blood substance that causes easy bleeding (hypoprothrombinemia), increased acids in the blood,
difficulty breathing, disorientation. Bleeding of the stomach and intestines may occur.

If you forget to take Synflex
Do not take a double dose to make up for a missed dose.

If you stop taking Synflex
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Stop taking Synflex and contact your doctor immediately if you notice any of the following side effects:

Not known:frequency cannot be estimated from available data

• Widespread skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), enlarged lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
• a distinctive allergic skin reaction known as fixed drug eruption, which usually reappears in the same location or locations upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, a skin rash with blisters (urticaria), a sensation of itching.

The main side effects are:

• alteration of the number of certain types of blood cells (thrombocytopenia, granulocytopenia, leucopenia, eosinophilia, aplastic or hemolytic anemia)
• severe and rapid general allergic reactions (type I anaphylactic or anaphylactoid reactions)
• high potassium concentration in the blood (hyperkalemia)
• abnormal dreams
• depression
• insomnia
• dizziness
• disorientation
• convulsions
• headache
• drowsiness
• inflammation of the optic nerve (retro-bulbar optic neuritis)
• cognitive dysfunction
• difficulty concentrating
• inflammation of the membranes surrounding the brain (aseptic meningitis)
• visual disturbances (papillitis, papilloedema, impaired vision, corneal opacity)
• hearing disorders (hearing impairment, ringing in the ears, tinnitus, vertigo)
• irregular or strong heartbeat (palpitations)
• fast heartbeat (tachycardia)
• problems with heart function (heart failure, myocardial infarction)
• brain vessel injury (stroke)
• high blood pressure (hypertension)
• inflammation of blood vessels (vasculitis)
• swelling (edema)
• difficulty breathing (dyspnea, asthma and bronchospasm)
• inflammation of the lungs (eosinophilic pneumonia)
• fluid build-up in the lungs (pulmonary edema)
• swelling of the throat (laryngeal edema)
• injury, bleeding or perforation of the stomach and intestines (peptic ulcers, perforation or gastrointestinal bleeding)
• nausea
• vomiting
• diarrhea
• passing gas from the anus (flatulence)
• constipation
• difficulty digesting food (dyspepsia)
• pain in the abdomen and stomach (abdominal and epigastric pain), heartburn (pyrosis gastrica)
• blood in the stool (melena)
• vomiting blood (hematemesis)
• inflammation of the mouth (ulcerative stomatitis)
• worsening of a chronic inflammatory bowel disease (exacerbation of colitis and Crohn's disease)
• inflammation of the esophagus (esophagitis)
• inflammation of the pancreas (pancreatitis)
• inflammation of the stomach (gastritis)
• yellow skin (jaundice)
• inflammation of the liver (hepatitis)
• skin rashes
• itching
• urticaria
• bruising (ecchymosis)
• rapid swelling of legs, arms, face or tongue (angioedema)
• appearance of red and swollen nodules under the skin (erythema multiforme, erythema nodosum, lichen planus)
• red spots on the body (purpura)
• blistering reactions including a condition called Stevens-Johnson syndrome with severe skin lesions, mouth and other parts of the body with high fever, vomiting, diarrhea and joint pain
• death of the skin (toxic epidermal necrolysis)
• abnormal and exaggerated skin reaction to light (photosensitivity reactions)
• hair loss (alopecia)
• muscle pain (myalgia)
• muscle weakness
• blood in the urine (hematuria)
• reduced kidney function (interstitial nephritis, nephrotic syndrome, kidney failure, renal papillary necrosis)
• infertility in women
• excessive thirst
• fever
• chills
• malaise
• alteration of the laboratory test to evaluate liver function, increased creatinine in the blood (hypercreatinemia)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at 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 Synflex

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 pack after “Expires”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water 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

Synflex 550 mg coated tablets

• The active ingredient is sodium naproxen. One coated tablet contains 550 mg of sodium naproxen.
• The other ingredients are: microcrystalline cellulose, povidone, talc, magnesium stearate, purified water. The tablet coating consists of: hypromellose, macrogol 8000, titanium dioxide, E 110 (sunset yellow).

Synflex 550 mg granules for oral suspension

• The active ingredient is sodium naproxen. One sachet contains 550 mg of sodium naproxen.
• The other ingredients are: microcrystalline cellulose, sodium chloride, sodium carboxymethylcellulose, povidone, orange flavour, citric acid, fumaric acid, sodium saccharin, sucrose, corn starch.

Description of the appearance of Synflex and contents of the pack
Synflex 550 mg coated tablets are available in packs of 10 and 30 tablets in PVC/aluminium blisters.
Synflex 550 mg granules for oral suspension are available in packs of 30 sachets in paper/aluminium/polyethylene laminate.

Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milan.

Distributor for sales: ALMIRALL S.p.A. Via Messina, 38 – Torre C – 20154 – Milan.

MANUFACTURER
Synflex 550 mg coated tablets
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milan.
SYNFLEX 550 granules for oral suspension
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 – 24041 Brembate (BG).