NAPROSYN 500 mg Suppository

Зміст інструкції

1. Naprosyn 500 mg gastro-resistant tablets, 500 mg suppositories, 500 mg granules for oral suspension
   1. What is Naprosyn and what is it used for
   2. What you need to know before taking Naprosyn
   3. How to take Naprosyn
   4. Possible side effects
   5. How to store Naprosyn
   6. Package Contents and Other Information
2. Naprosyn 250 mg granules for oral suspension
   1. What is Naprosyn and what is it used for
   2. What you need to know before taking Naprosyn
   3. How to take Naprosyn
   4. Possible side effects
   5. How to store Naprosyn
   6. Contents of the pack and other information
3. Naprosyn 100 mg/g gel
   1. What is Naprosyn and what is it used for
   2. What you need to know before using Naprosyn
   3. How to use Naprosyn
   4. Possible side effects
   5. How to store Naprosyn
   6. Contents of the pack and other information

Naprosyn 500 mg gastro-resistant tablets, 500 mg suppositories, 500 mg granules for oral suspension

naproxen

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

1. What is Naprosyn and what is it used for

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

• an inflammatory disease of the joints (rheumatoid arthritis)
• a degenerative disease of the joints (osteoarthritis or degenerative arthritis)
• an inflammatory disease of the spine (ankylosing spondylitis)
• a disease due to the presence of uric acid crystals in the joints (gouty arthropathy)
• diseases that affect the joints, bones, tendons (lumbosciatica, myalgia, neuralgia, radicular syndromes, periarthritis, fibromyositis).

2. What you need to know before taking Naprosyn

Do not take Naprosyn

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a lesion of the wall 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 or a history of bleeding/lesion of the stomach wall (peptic ulcer) frequent (two or more distinct episodes)
• if you have serious heart problems (severe heart failure)
• if you have had allergic reactions such as asthma, itching (urticaria), allergic cold (rhinitis), severe and rapid general allergic reaction (anaphylactic or anaphylactoid reactions), presence of droplet-shaped nodules in

the nose (nasal polyps), associated with the use of aspirin (acetylsalicylic acid) and/or other non-steroidal anti-inflammatory drugs (NSAIDs)

• if you are a child under 2 years of age
• if you are pregnant or breastfeeding
• if you have serious kidney problems

Warnings and precautions
Talk to your doctor or pharmacist before taking Naprosyn.
In particular, tell your doctor:

• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you have a history of a lesion of the stomach wall with bleeding/perforation (gastrointestinal bleeding, ulceration or perforation)
• if you have or have ever had an acute inflammation of the gastrointestinal 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: report any unusual symptoms to your doctor, especially at the beginning of treatment
• 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 such as aspirin or analogues (see “Other medicines and Naprosyn”)
• if you suffer from a chronic inflammatory disease of the stomach and intestine (ulcerative colitis or Crohn's disease)
• if you have heart problems
• if you have liver problems
• if you have kidney problems
• if you suffer from high blood pressure and/or heart problems (heart failure), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease
• 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 severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions)
• if you have bleeding problems (hemostasis 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 Naprosyn .If you notice any of the symptoms related to these severe skin reactions, described in section 4, stop treatment with Naprosyn and consult your doctor immediately.
If you notice the appearance of skin rashes (skin rash), mucous membrane lesions or any other sign of an allergic reaction (hypersensitivity) while using Naprosyn, stop treatment immediately and consult your doctor.
Medicines like Naprosyn may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatments. 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 the therapy with your doctor or pharmacist.
In the elderly and patients with a history of ulcer, especially if complicated by bleeding or perforation (see Do not take Naprosyn), the risk of gastrointestinal bleeding, ulceration or perforation increases with increasing dose. These patients should start treatment with the lowest available dose.
If you use Naprosyn for prolonged treatments, you should undergo periodic eye checks.

Children and adolescents
The use of the medicine is not intended for children. The doctor may prescribe Naprosyn only in cases of absolute necessity and in children over 2 years of age.

Elderly
If you are elderly, you are more likely to experience some of the side effects caused by Naprosyn, such as bleeding/perforation of the stomach and intestines

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

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

The concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) including Naprosyn with:

• naproxen sodium
• acetylsalicylic acid
• quinolones (antibiotics) .

Naprosyn with alcohol
Avoid drinking alcohol while taking Naprosyn.
The results of some laboratory tests (such as the adrenal function test or some tests for urinary 5-hydroxyindoleacetic acid) may be altered by Naprosyn

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Naprosyn during pregnancy and breastfeeding. It may cause problems with the kidneys and heart of 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 Naprosyn if you are planning a pregnancy. From the 20th week of pregnancy onwards, naproxen can cause kidney problems in the fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing a blood vessel (ductus arteriosus) in the baby's heart to narrow.
Stop Naprosyn 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, Naprosyn may impair the ability to drive vehicles and operate machinery. Avoid, in these cases, activities that require vigilance.

Naprosyn 500 mg granules for oral suspension contains

• sucrose.If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this medicine;
• sodium. This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.

Naprosyn 500 mg gastro-resistant tablets contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Naprosyn

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

Adults

• Attack therapy The recommended dose is:
• 500-1000 mg per day, divided into two doses, every 12 hours (in the morning during breakfast and in the evening during dinner) or in a single dose (during lunchtime or in the evening). The recommended dose is 1000 mg (2 x 500 mg) once a day:
• if you have severe nocturnal pain and/or morning stiffness
• if you have unsuccessfully taken other high-dose rheumatism medications
• if you have an inflammatory joint disease (osteoarthritis), when pain is the main symptom.
• Maintenance therapy Depending on the attack dose, the severity of the disease and the intensity of the pain, the recommended dose is:
• 750-250 mg divided into multiple doses (during meals) or in a single dose (during lunchtime or in the evening).
• If you suffer from acute gout The recommended dose is:
• 500 mg as an initial dose
• 250 mg every 8 hours for the first 24 hours
• 250 mg twice a day for 6-7 days as a maintenance dose.

Elderly
If you are elderly, your doctor will carefully determine the dose you need to take, evaluating a possible reduction of the
doses indicated above.
The Naprosyn granules for oral suspension sachets, appropriately dissolved in water, allow for a
faster absorption of the active ingredient and exert a more prompt pain-relieving (analgesic) action;
moreover, they are more suitable if you have difficulty swallowing.
The use of Naprosyn gastro-resistant tablets should be avoided in acute painful conditions where a rapid
pain-relieving action is required.

Children and adolescents
The use of this medicine is not intended for children. The doctor may prescribe Naprosyn only in cases of
absolute necessity and in children over 2 years of age.

If you have liver problems (hepatic insufficiency) or kidney problems (renal insufficiency)
Your doctor will prescribe you the minimum effective dose and will subject you to periodic checks to evaluate
clinical and laboratory parameters.
Do not take Naprosyn if you suffer from severe renal insufficiency.

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

If you forget to take Naprosyn
Do not take a double dose to compensate for missing the dose.
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 will experience them.
Stop taking Naprosyn and contact your doctor immediately if you notice the appearance of 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 paragraph 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, skin rash with blisters (urticaria), sensation of itching.
• The most commonly observed adverse events are of a gastrointestinal nature. Lesion, bleeding or perforation of the stomach and intestine (peptic ulcers, perforation or gastrointestinal bleeding) can occur, sometimes fatal, particularly in the elderly (see Warnings and precautions). The following have been reported after administration of Naprosyn: nausea, vomiting, diarrhea, flatulence (passage of gas from the anus), constipation (stipsis), difficulty digesting food (dyspepsia), abdominal and stomach 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). Less frequently, inflammation of the stomach (gastritis) has been observed.
Other side effects that may occur with the use of Naprosyn are:

• alteration of the concentration of certain types of cells in the blood (thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, aplastic or hemolytic anemia)
• severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions)
• high potassium concentration in the blood (hyperkalemia)
• abnormal dreams
• depression
• insomnia
• dizziness
• disorientation
• convulsions
• headache (cephalalgia)
• 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 (congestive heart failure, heart failure, myocardial infarction)
• damage to blood vessels in the brain (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 buildup in the lungs (pulmonary edema)
• swelling of the throat (laryngeal edema)
• yellowing of the 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 lesions on the skin, 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)
• decreased kidney function, kidney damage (interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis)
• infertility in women
• mild swelling of the extremities (peripheral edema)
• excessive thirst
• fever and chills
• general feeling of being unwell
• alteration of the laboratory test to evaluate liver function
• increased creatinine in the blood (hypercreatininemia)

With the suppository formulation, the following have also been reported:

• pain, rectal irritation
• burning and inflammation of the rectum (proctitis)
• itching
• painful spasm of the anus (tenesmus)

Medicines like Naprosyn may be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke.

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

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after “Exp.”. 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. Package Contents and Other Information

What Naprosyn Contains
Naprosyn 500 mg gastro-resistant tablets

• The active ingredient is naproxen. Each gastro-resistant tablet contains 500 mg of naproxen.
• The other ingredients are :povidone, sodium croscarmellose, magnesium stearate, acrylic acid copolymer, talc, sodium hydroxide, triethyl citrate, simethicone.

Naprosyn 500 mg suppositories

• The active ingredient is naproxen. Each suppository contains 500 mg of naproxen.
• The other ingredients are: semi-synthetic glycerides.

Naprosyn 500 mg granules for oral suspension

• The active ingredient is naproxen. Each sachet contains 500 mg of naproxen.
• The other ingredients are :mannitol, povidone, acrylic resin (Eudragit), sodium saccharin, lemon flavour, citric acid, precipitated silica, sucrose.

Description of the Appearance of Naprosyn and Package Contents
Naprosyn 500 mg gastro-resistant tablets are available in packs of 30 tablets.
Naprosyn 500 mg suppositories are available in packs of 10 suppositories.
Naprosyn 500 mg granules for oral suspension are available in packs of 30 sachets.

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

Manufacturer
Naprosyn 500 mg suppositories
Zeta Farmaceutici S.p.A. – Via Galvani, 10 – 36066 Sandrigo (VI).

Naprosyn 500 mg granules for oral suspension
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 – 24041 Brembate (BG).

Naprosyn 500 mg gastro-resistant tablets
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milano.

Naprosyn 250 mg granules for oral suspension

naproxen

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist
has told you to do.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What is Naprosyn and what is it used for

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

• an inflammatory disease of the joints (rheumatoid arthritis)
• a degenerative disease of the joints (osteoarthritis or degenerative arthritis)
• an inflammatory disease of the spine (ankylosing spondylitis)
• a disease due to the presence of uric acid crystals in the joints (gouty arthropathy)
• diseases that affect the joints, bones, tendons (lumbosciatalgia, myalgia, neuralgia, radicular syndromes, periarthritis, fibromyositis).

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before taking Naprosyn

Do not take Naprosyn

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from a lesion of the stomach or duodenal wall (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 or a history of bleeding/lesion of the stomach wall (peptic ulcer) frequent (two or more distinct episodes)
• if you have severe heart problems (severe heart failure)
• if you have had allergic reactions 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 a child under the age of 2 years
• if you are pregnant or breastfeeding
• if you have severe kidney problems

Warnings and precautions
Talk to your doctor or pharmacist before taking Naprosyn.
In particular, tell your doctor:

• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you have a history of a lesion of the stomach wall with bleeding/perforation (gastrointestinal bleeding, ulceration or perforation)
• if you have or have ever had acute inflammation of the gastrointestinal 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: report any unusual symptoms to your doctor, especially at the beginning of treatment
• if you are taking anti-inflammatory drugs (oral corticosteroids), medicines to thin the blood (anticoagulants such as warfarin), medicines for depression (selective serotonin reuptake inhibitors) or medicines such as aspirin or analogues (see “Other medicines and Naprosyn”)
• if you suffer from a chronic inflammatory disease of the stomach and intestines (ulcerative colitis or Crohn's disease)
• if you have heart problems
• if you have liver problems
• if you have kidney problems
• if you suffer from high blood pressure and/or heart problems (heart failure), established ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease
• 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 severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions)
• if you have bleeding problems (hemostasis 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
Naprosyn .If you notice any of the symptoms relating to these severe skin reactions, described in section 4,
stop taking Naprosyn and consult your doctor immediately.
If you notice the appearance of skin rashes (skin rash), mucosal lesions or
any other sign of an allergic reaction (hypersensitivity) while using Naprosyn, stop treatment immediately and
consult your doctor.
Medicines like Naprosyn may be associated with a modest increase in the risk of heart attack
(myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatments. 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 therapy
with your doctor or pharmacist.
In the elderly and patients with a history of ulcer, especially if complicated by bleeding or perforation
(see section Do not take Naprosyn), the risk of gastrointestinal bleeding, ulceration or
perforation increases with increasing dose. These patients should start treatment with the lowest
available dose.
If you use Naprosyn for prolonged treatments, you should undergo periodic eye checks.

Children and adolescents
The use of the medicine is not intended for children. The doctor may prescribe Naprosyn only in cases of absolute
necessity and in children over the age of 2 years.

Elderly
If you are elderly, you are more likely to experience some of the side effects caused by Naprosyn such as
bleeding/perforation of the stomach and intestines

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

• Hydantoins (for the treatment of epilepsy), sulfonylureas (for the treatment of diabetes), sulfonamides (antibiotics), coumarin anticoagulants (to thin the blood), barbiturates (sedatives used to treat conditions such as epilepsy), other non-steroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid as they may increase the amount of Naprosyn in the blood and cause side effects.
• Diuretics, ACE inhibitors and angiotensin II antagonists (for the treatment of high blood pressure) as they may have a reduced effect if taken together with Naprosyn and increase the risk of kidney damage in some dehydrated or elderly patients who already have impaired kidney function.
• Furosemide (for the treatment of high blood pressure) as concomitant administration 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 Naprosyn may reduce the effect of these medicines.
• Probenecid (for the treatment of gout) as it increases the amount and persistence of Naprosyn 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 section “What you need to know before taking Naprosyn”).
• Antiplatelet agents (aspirin or similar medicines) and selective serotonin reuptake inhibitors -SSRIs (used for depression) as they increase the risk of bleeding in the stomach and intestines (see section “What you need to know before taking Naprosyn”).
• Corticosteroids (anti-inflammatory hormones) as they increase the risk of injury or bleeding in the stomach and intestines (see section “What you need to know before taking Naprosyn”).
• Naproxen may decrease the effectiveness of contraceptive devices (intrauterine devices).
• Aspirin/acetylsalicylic acid for preventing blood clot formation.

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

• naproxen sodium
• acetylsalicylic acid
• quinolones (antibiotics) .

Naprosyn with alcohol
Avoid drinking alcohol while taking Naprosyn.
The results of some laboratory tests (such as adrenal function test or some tests for urinary 5-hydroxyindoleacetic acid) may be altered by Naprosyn

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not use Naprosyn 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 Naprosyn if you are planning a pregnancy. From the 20th week of pregnancy onwards, naproxen
can 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 taking Naprosyn if you have fertility problems or are undergoing fertility investigations.

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

Naprosyn contains

• sucrose.If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this medicine;
• sodium.This medicine contains 18.24 mg of sodium (a major component of table salt) per sachet. This is equivalent to 0.91% of the recommended daily intake with the diet of an adult.

3. How to take Naprosyn

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

Adults

• Attack therapy The recommended dose is:
• 500-1000 mg per day, divided into two doses, every 12 hours (in the morning during breakfast and in the evening during dinner) or in a single dose (during lunchtime or in the evening). The recommended dose is 1000 mg (2 x 500 mg) once a day:
• if you have severe nocturnal pain and/or morning stiffness
• if you have unsuccessfully taken other high-dose rheumatism medications
• if you have an inflammatory joint disease (osteoarthritis), when pain is the main symptom.
• Maintenance therapy Depending on the attack dose, the severity of the disease and the intensity of the pain, the recommended dose is:
• 750-250 mg divided into two doses, every 12 hours (in the morning during breakfast and in the evening during dinner) or in a single dose (during lunchtime or in the evening).
• If you suffer from acute gout The recommended dose is:
• 500 mg as an initial dose
• 250 mg every 8 hours for the first 24 hours
• 250 mg twice a day for 6-7 days as a maintenance dose.

Elderly
If you are elderly, your doctor will carefully determine the dose you need to take, evaluating a possible reduction
of the doses indicated above.
Naprosyn granules for oral suspension, appropriately dissolved in water, allow a
faster absorption of the active ingredient and exert a more prompt pain-relieving (analgesic) action;
moreover, they are more suitable if you have difficulty swallowing.

Children and adolescents
The use of this medicine is not intended for children. The doctor may prescribe Naprosyn only in cases of
absolute necessity and in children over 2 years of age.

If you have liver problems (hepatic insufficiency) or kidney problems (renal insufficiency)
Your doctor will prescribe you the minimum effective dose and will subject you to periodic checks to evaluate the
clinical and laboratory parameters.
Do not take Naprosyn if you suffer from severe renal insufficiency.

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

If you forget to take Naprosyn
Do not take a double dose to make up for the missed dose.
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 everybody gets them.
Stop taking Naprosyn 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 place or places upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, skin rash with blisters (urticaria), sensation of itching.
• The most commonly observed adverse events are of a gastrointestinal nature. Lesion, bleeding or perforation of the stomach and intestine (peptic ulcers, perforation or gastrointestinal bleeding) can occur, sometimes fatal, especially in the elderly (see Warnings and precautions). The following have been reported after administration of Naprosyn: nausea, vomiting, diarrhoea, flatulence (passage of gas from the anus), constipation (stipsis), difficulty digesting food (dyspepsia), abdominal and stomach pain, heartburn (pyrosis gastrica), blood in the stools (melena), vomiting blood (haematemesis), 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). Less
frequently, inflammation of the stomach (gastritis) has been observed.
Other side effects that may occur with the use of Naprosyn are:

• alteration of the concentration of certain types of cells in the blood (thrombocytopenia, granulocytopenia, leucopenia, eosinophilia, aplastic or hemolytic anemia)
• severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions)
• high potassium concentration in the blood (hyperkalemia)
• abnormal dreams
• depression
• insomnia
• dizziness
• disorientation
• convulsions
• headache (cephalalgia)
• 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 (impaired hearing, ringing in the ears, tinnitus, vertigo)
• irregular or strong heartbeat (palpitations)
• fast heartbeat (tachycardia)
• problems with heart function (congestive heart failure, heart failure, myocardial infarction)
• damage to blood vessels in the brain (stroke)
• high blood pressure (hypertension)
• inflammation of blood vessels (vasculitis)
• swelling (edema)
• difficulty breathing (dyspnea, asthma and bronchospasm)
• inflammation of the lungs (eosinophilic pneumonia)
• increased fluid in the lungs (pulmonary edema)
• swelling of the throat (laryngeal edema)
• yellowing of the 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 lesions of the skin, 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)
• decreased kidney function, kidney damage (interstitial nephritis, nephrotic syndrome, kidney failure, renal papillary necrosis)
• infertility in women
• mild swelling of the extremities (peripheral edema)
• excessive thirst
• fever and chills
• feeling unwell
• alteration of the laboratory test to evaluate liver function
• increased creatinine in the blood (hypercreatininemia)

Medicines like Naprosyn may be associated with a modest increase in the risk of heart attack
(myocardial infarction) or stroke.

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 Naprosyn

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date that is stated on the pack after “Scad.”. 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

What Naprosyn contains

• The active ingredient is naproxen. Each sachet contains 250 mg of naproxen.
• The other ingredients are: sodium chloride, sodium dioctylsulfosuccinate, povidone, peppermint flavour, liquorice flavour, mannitol, sodium saccharin, sucrose.

Description of the appearance of Naprosyn and contents of the pack
Naprosyn 250 mg granules for oral suspension is available in packs of 30 sachets.

Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 - 20 148 Milano.

Manufacturer
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 – 24041 Brembate (BG).

Naprosyn 100 mg/g gel

naproxene

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after a short period of treatment.

Contents of this leaflet:

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

1. What is Naprosyn and what is it used for

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

• muscle pain (myalgia)
• back pain (lumbago)
• neck pain (torticollis)
• muscle inflammation (fibromyalgia)
• joint inflammation (bursitis, tendinitis, tenosynovitis, periarthritis)
• trauma (contusions, muscle tears, sprains, hematomas, edema and traumatic infiltrates)
• vein inflammation (phlebitis)

Naprosyn gel is also used as support for:

• orthopedic therapies
• rehabilitation therapies

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Naprosyn

Do not use Naprosyn

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to substances closely related chemically to naproxen
• if you are in the last 3 months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before using Naprosyn:

• if you are suffering from or have suffered from any allergies
• if you are allergic to medicines such as aspirin (acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs).

If you have wounds, avoid applying the gel.
Prolonged use of medicines like Naprosyn gel can cause allergies (sensitization phenomena). In
this case, stop treatment immediately.
To avoid any allergies, including those to light (photosensitization), do not expose yourself to
direct sunlight, including solariums, during treatment and for the two weeks following.
If the medicine is applied to a large area and for a prolonged period of time, the possibility of side
effects throughout the body cannot be excluded.

Other medicines and Naprosyn
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
Naprosyn gel can enhance the effect of other therapies with anti-inflammatory drugs taken, for example, orally or
intravenously, which are distributed throughout the body (systemic therapies).

Pregnancy, breastfeeding and fertility
Oral forms (e.g. tablets) of Naprosyn can cause adverse effects in the fetus. It is not known whether
the same risk applies to Naprosyn when used on the skin.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use Naprosyn if you are in the last 3 months of pregnancy. You should not use Naprosyn in the first 6 months
of pregnancy, unless it is clearly necessary and recommended by your doctor. If you need
treatment during this period, you should use the lowest dose for the shortest possible time.

Breastfeeding
The risk of harmful effects on the baby cannot be excluded.
Therefore, if you are breastfeeding, your doctor will carefully assess the need to use Naprosyn gel.

Driving and using machines
Naprosyn gel does not affect the ability to drive vehicles and use machines.

Naprosyn contains ethanol
This medicine contains 30 g of alcohol (ethanol) in 100 g of gel, which is equivalent to 300 mg/g (30% w/w).
It may cause a burning sensation on damaged skin.

3. How to use Naprosyn

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Naprosyn gel to the area where you have pain, 2 times a day, massaging lightly until fully absorbed.

If you use more Naprosyn than you should
There are no known cases of overdose. If you accidentally use an excessive dose of Naprosyn gel, immediately inform your doctor or go to the nearest hospital.

If you forget to use Naprosyn
Do not use a double dose to make up for a missed dose.
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 everybody gets them.
The side effects that may occur with the use of Naprosyn gel are:

• redness of the skin (erythema)
• skin inflammation (contact dermatitis)
• itching
• skin irritation
• feeling of heat or burning
• blistering rashes of varying severity
• possible abnormal and exaggerated skin reactions to light (photosensitivity).

Use, especially if prolonged, of products to be applied to the skin can give rise to sensitization phenomena (allergy to one or more components). In this case, discontinue treatment and contact your doctor
who will take appropriate therapy.

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

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular storage conditions.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. 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

What Naprosyn contains

• The active ingredient is naproxen. 1 gram of gel contains 100 milligrams of naproxen.
• The other ingredients are: carbomer, ethanol, triethanolamine, sodium metabisulfite, rose fragrance, purified water.

Description of the appearance of Naprosyn and contents of the pack
Naprosyn gel is available in packs of 1 tube containing 50 grams of gel.

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

Manufacturer
VAMFARMA S.r.l. – Via Kennedy, 5 – 26833 Comazzo (LO).
DOPPEL FARMACEUTICI S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC).