Patient Information Leaflet

Naprosyn 500 mg enteric-coated tablets, 500 mg suppositories, 500 mg granules for oral suspension

naproxen
Please read all of 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 they have the same symptoms as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Naprosyn is and what it is used for
What you need to know before taking Naprosyn
How to take Naprosyn
Possible side effects
How to store Naprosyn
Contents of the pack and other information

1. What Naprosyn is and what it is used for

Naprosyn contains the active substance naproxen.
Naproxen belongs to a class of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs),
which have various actions, with an important role in pain control.
Naprosyn is used to treat the symptoms of:

an inflammatory joint disease (rheumatoid arthritis)
a degenerative joint disease (osteoarthritis or degenerative arthritis)
an inflammatory disease of the spine (ankylosing spondylitis)
a disease caused by the presence of uric acid crystals in the joints (gouty arthropathy)
conditions affecting the joints, bones, and tendons (lumbosciatica, myalgia, neuralgia, radicular syndromes, periarthritis, fibromyalgia).

2. What you need to know before taking Naprosyn

Do not take Naprosyn

if you are allergic to naproxen or to any of the other ingredients of this medicine (listed in section 6)
if you have a lesion in the wall of the stomach or duodenum (active gastroduodenal ulcer or peptic ulcer)
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 frequent bleeding/lesion of the stomach wall (peptic ulcer) (two or more distinct episodes)
if you have severe heart problems (severe heart failure)
if you have experienced allergic reactions such as asthma, itching (urticaria), allergic rhinitis, severe and rapid generalized allergic reaction (anaphylactic or anaphylactoid reactions), presence of drop-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 it is for a child under 2 years of age
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, inform your doctor:

if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs)
if you have a history of stomach wall injury with bleeding/perforation (gastrointestinal hemorrhage, ulceration or perforation)
if you have or have ever had acute inflammation of the gastrointestinal tract or if you have experienced stomach or intestinal disturbances after using medications for rheumatic diseases
if you have a history of stomach or intestinal toxicity: report any unusual symptoms to your doctor, especially at the beginning of treatment
if you are taking anti-inflammatory medicines (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), antidepressants (selective serotonin reuptake inhibitors - SSRIs), or medicines such as aspirin or similar agents (see "Other medicines and Naprosyn")
if you suffer from 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 have 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 in the legs, arms, face, mouth or tongue (angioedema) or breathing difficulties (bronchospasm, asthma and rhinitis) and presence of drop-shaped nodules inside the nose (nasal polyps)
if you have severe and rapid generalized allergic reactions (anaphylactic or anaphylactoid reactions)
if you have bleeding disorders (coagulation disorders)
if you are planning a pregnancy
if you have fertility problems or are undergoing fertility investigations

Serious 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 serious skin reactions described in section 4,
stop treatment with Naprosyn and contact your doctor immediately.
If, while using Naprosyn, you notice the appearance of skin rashes, mucosal lesions, or any other sign of allergic reaction (hypersensitivity), stop treatment immediately and consult your doctor.
Medicines such as Naprosyn may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. 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, high cholesterol or are a smoker), discuss your treatment
with your doctor or pharmacist.
In elderly patients and in patients with a history of ulcers, 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 treatment, you should undergo periodic eye examinations.
Children and adolescents
This medicine is not intended for use in children. Your doctor may prescribe Naprosyn only in cases of
absolute necessity and in children over 2 years of age.
Elderly
If you are elderly, you have a higher likelihood of experiencing some of the adverse effects caused by Naprosyn,
such as bleeding/perforation of the stomach and intestine.
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 influenced by, or may influence, the following medicines:

Hydantoins (for treatment of epilepsy), sulfonylureas (for treatment of diabetes), sulfonamides (antibiotics), coumarin anticoagulants (to thin the blood), barbiturates (sedatives used in the treatment of 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 treatment of high blood pressure), as their effect may be reduced when taken together with Naprosyn and may increase the risk of kidney damage in some dehydrated patients or elderly patients who already have impaired kidney function.
Furosemide (for treatment of high blood pressure), as concomitant administration may reduce the effect of this medicine.
Lithium (for treatment of manic-depressive disorders), as the amount of lithium in the blood may become too high.
Propranolol and beta-blockers (for treatment of high blood pressure), as Naprosyn may reduce the effect of these medicines.
Probenecid (for treatment of gout), as it increases the amount and duration of Naprosyn in the body.
Methotrexate (for treatment of cancer and autoimmune diseases), as it remains longer in the body, potentially 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 stomach and intestinal bleeding (see section "What you need to know before taking Naprosyn").
Corticosteroids (anti-inflammatory hormones), as they increase the risk of stomach and intestinal injury or bleeding (see section "What you need to know before taking Naprosyn").
Naproxen may reduce the effectiveness of contraceptive devices (intrauterine devices).
Aspirin/acetylsalicylic acid used to prevent blood clots.

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

sodium naproxen
acetylsalicylic acid
quinolones (antibiotics).

Naprosyn and alcohol
Avoid consuming alcohol during treatment with Naprosyn.
Results of certain laboratory tests (such as adrenal function tests or certain urinary 5-
hydroxyindoleacetic acid tests) may be altered by Naprosyn.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not use Naprosyn during pregnancy and breastfeeding. It may cause kidney and heart problems in the unborn child.
In addition, it could expose both you and your baby to possible bleeding and delay or prolong labor beyond the expected duration.
Do not take Naprosyn if you are planning a pregnancy. From the 20th week of pregnancy onwards, naproxen
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.
Discontinue Naprosyn if you have fertility problems or are undergoing fertility investigations.
Driving and using machines
Due to possible dizziness, drowsiness, vertigo or depression, Naprosyn may impair your ability to drive vehicles and operate machinery. Avoid, in such cases, activities requiring alertness.
Naprosyn 500 mg granules for oral suspension contains

sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult 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 contain 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 exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
Adults

Initial treatment The recommended dose is:
500–1000 mg per day, divided into two doses every 12 hours (in the morning with breakfast and in the evening with dinner) or as a single daily dose (during lunch or evening meal). The recommended dose is 1000 mg (2 x 500 mg) once daily:
if you have severe night pain and/or morning stiffness
if you have previously taken other anti-rheumatic medicines at high doses without success
if you have an inflammatory joint disease (osteoarthritis), when pain is the main symptom.
Maintenance therapy Depending on the initial dose, severity of the disease and intensity of pain, the recommended dose is:
750–250 mg, divided into multiple doses (with meals) or as a single dose (during lunch or evening meal).
If you have acute gout The recommended dose is:
500 mg as initial dose
250 mg every 8 hours during the first 24 hours
250 mg twice daily for 6–7 days as maintenance dose.

Elderly
If you are elderly, your doctor will carefully determine the appropriate dose, possibly reducing the doses
indicated above.
Naprosyn oral suspension granules, properly dissolved in water, allow faster absorption of the active substance
and provide a more rapid analgesic (pain-relieving) effect; they are also more suitable if you have difficulty
swallowing.
The use of Naprosyn gastro-resistant tablets should be avoided in acute painful conditions requiring rapid
pain relief.
Children and adolescents
This medicine is not intended for use in children. Your doctor may prescribe Naprosyn only in cases of
absolute necessity and only in children over 2 years of age.
If you have liver (hepatic insufficiency) or kidney (renal insufficiency) problems
Your doctor will prescribe the lowest effective dose and will schedule periodic check-ups to monitor
clinical and laboratory parameters.
Do not take Naprosyn if you have 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 prescribed, you may experience dizziness, drowsiness, abdominal disturbances,
stomach pain, nausea or vomiting, transient alterations in liver and kidney function,
decreased levels of a blood substance causing increased bleeding tendency (hypoprothrombinemia),
accumulation of acid in the blood, breathing difficulties, disorientation. Gastrointestinal bleeding 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

Not known: frequency cannot be estimated from the available data

Widespread skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
A distinct allergic skin reaction known as fixed drug eruption, which usually recurs at the same site or sites upon re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, skin rash with blisters (urticaria), or itching.
The most commonly observed adverse events are gastrointestinal in nature. Ulceration, bleeding, or perforation of the stomach or intestine (peptic ulcers, gastrointestinal perforation or hemorrhage), sometimes fatal, may occur, particularly in the elderly (see Warnings and precautions). After administration of Naprosyn, the following have been reported: nausea, vomiting, diarrhea, flatulence (passing wind), constipation (stipsis), indigestion (dyspepsia), abdominal and stomach pain, heartburn (gastric pyrosis), blood in the stool (melena), vomiting blood (hematemesis), inflammation of the mouth (ulcerative stomatitis), worsening of 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 adverse effects that may occur with the use of Naprosyn include:

changes in the concentration of certain types of blood cells (thrombocytopenia, granulocytopenia, leukopenia, eosinophilia, aplastic or hemolytic anemia)
severe and rapid generalized allergic reactions (anaphylactic or anaphylactoid reactions)
elevated potassium levels in the blood (hyperkalemia)
abnormal dreams
depression
insomnia
dizziness
disorientation
seizures
headache (cephalalgia)
drowsiness
inflammation of the optic nerve (retrobulbar optic neuritis)
cognitive dysfunction
difficulty concentrating
inflammation of the membranes covering the brain (aseptic meningitis)
vision disturbances (papillitis, papilledema, visual impairment, corneal opacity)
hearing disturbances (hearing impairment, ear noise, tinnitus, vertigo)
irregular or forceful heartbeat (palpitations)
rapid heartbeat (tachycardia)
heart function problems (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)
breathing difficulties (dyspnea, asthma, bronchospasm)
inflammation of the lungs (eosinophilic pneumonia)
fluid accumulation in the lungs (pulmonary edema)
throat swelling (laryngeal edema)
yellowing of the skin (jaundice)
inflammation of the liver (hepatitis)
skin rashes
itching
urticaria
bruising (ecchymoses)
rapid swelling of legs, arms, face, or tongue (angioedema)
appearance of red, swollen nodules under the skin (erythema multiforme, erythema nodosum, lichen planus)
red spots on the body (purpura)
blistering skin reactions including a condition called Stevens-Johnson syndrome, with severe lesions of the skin, mouth, and other body parts, accompanied by high fever, vomiting, diarrhea, and joint pain
skin death (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, kidney damage (interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis)
female infertility
mild swelling of extremities (peripheral edema)
excessive thirst
fever and chills
malaise
abnormal liver function laboratory test
increased creatinine in the blood (hypercreatinemia)

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

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

Medicines such as Naprosyn may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse 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 stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Naprosyn contains
Naprosyn 500 mg gastro-resistant tablets

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

Naprosyn 500 mg suppositories

The active substance is naproxen. Each suppository contains 500 mg of naproxen.
The other components are: semi-synthetic glycerides.

Naprosyn 500 mg granules for oral suspension

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

Description of the appearance of Naprosyn and contents of the pack
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 Milan, Italy.

Manufacturer
Naprosyn 500 mg suppositories
Zeta Farmaceutici S.p.A. – Via Galvani, 10 – 36066 Sandrigo (VI), Italy.
Naprosyn 500 mg granules for oral suspension
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43 – 24041 Brembate (BG), Italy.
Naprosyn 500 mg gastro-resistant tablets
RECORDATI Industria Chimica e Farmaceutica S.p.A. - Via Matteo Civitali, 1 – 20148 Milan, Italy.

Patient Information Leaflet

Naprosyn 250 mg granules for oral suspension

naproxen
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

What Naprosyn is and what it is used for
What you need to know before taking Naprosyn
How to take Naprosyn
Possible side effects
How to store Naprosyn
Contents of the pack and other information

1. What Naprosyn is and what it is used for

Naprosyn contains the active ingredient naproxen.
Naproxen belongs to a class of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs (NSAIDs) which have several actions, including an important role in pain control.
Naprosyn is used to treat the symptoms of:

an inflammatory joint disease (rheumatoid arthritis)
a degenerative joint disease (osteoarthritis or degenerative arthritis)
an inflammatory disease of the spine (ankylosing spondylitis)
a disease caused by the presence of uric acid crystals in the joints (gouty arthritis)
conditions affecting the joints, bones, and 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 to any of the other ingredients of this medicine (listed in section 6)
if you have a lesion in the wall of the stomach or duodenum (active gastroduodenal ulcer or peptic ulcer)
if you have inflammation of the colon (ulcerative colitis)
if you have a history of bleeding or perforation of the stomach or intestine due to previous treatment, or a history of frequent bleeding/lesion of the stomach wall (peptic ulcer) (two or more distinct episodes)
if you have severe heart problems (severe heart failure)
if you have experienced allergic reactions such as asthma, itching (urticaria), allergic rhinitis, severe and rapid generalized allergic reaction (anaphylactic or anaphylactoid reactions), presence of drop-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 it is for a child under 2 years of age
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, inform your doctor:

if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs)
if you have a history of stomach wall injury with bleeding/perforation (gastrointestinal hemorrhage, ulceration, or perforation)
if you have or have ever had acute gastrointestinal inflammation or have experienced stomach or intestinal disturbances after using medications for rheumatic diseases
if you have a history of gastrointestinal toxicity: report any unusual symptoms to your doctor, especially at the beginning of treatment
if you are taking anti-inflammatory medicines (oral corticosteroids), blood-thinning medicines (anticoagulants such as warfarin), antidepressants (selective serotonin reuptake inhibitors), or medicines such as aspirin or similar agents (see "Other medicines and Naprosyn")
if you have 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 have high blood pressure and/or heart problems (heart failure), confirmed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease
if you have a history of swelling in the legs, arms, face, mouth, or tongue (angioedema), or breathing difficulties (bronchospasm, asthma, and rhinitis), and presence of drop-shaped nodules inside the nose (nasal polyps)
if you have severe and rapid generalized allergic reactions (anaphylactic or anaphylactoid reactions)
if you have bleeding disorders (coagulation disorders)
if you are planning a pregnancy
if you have fertility problems or are undergoing fertility investigations

Serious 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 serious skin reactions described in section 4,
discontinue treatment with Naprosyn and contact your doctor immediately.
If, while using Naprosyn, you notice the appearance of skin rashes, mucosal lesions, or any other sign of allergic reaction (hypersensitivity), stop treatment immediately and consult your doctor.
Medicines such as Naprosyn may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke. The risk is more likely with high doses and prolonged treatment. 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, high cholesterol, or are a smoker), discuss your treatment
with your doctor or pharmacist.
In elderly patients and those with a history of ulcers, 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 long-term treatment, you should have regular eye examinations.
Children and adolescents
This medicine is not intended for use in children. Your doctor may prescribe Naprosyn only in cases of absolute
necessity and only in children over 2 years of age.
Elderly
If you are elderly, you have a higher likelihood of experiencing some of the adverse effects caused by Naprosyn, such as
gastrointestinal bleeding/perforation.
Other medicines and Naprosyn
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
The effects of Naprosyn may be influenced by or may influence the following medicines:

Hydantoins (for treatment of epilepsy), sulfonylureas (for treatment of diabetes), sulfonamides (antibiotics), coumarin anticoagulants (to thin the blood), barbiturates (sedatives used for 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 treatment of high blood pressure), as their effect may be reduced when taken together with Naprosyn and may increase the risk of kidney damage in some dehydrated patients or elderly patients who already have impaired kidney function.
Furosemide (for treatment of high blood pressure), as concomitant administration may reduce the effect of this medicine.
Lithium (for treatment of manic-depressive illness), as the amount of lithium in the blood may become too high.
Propranolol and beta-blockers (for treatment of high blood pressure), as Naprosyn may reduce the effect of these medicines.
Probenecid (for treatment of gout), as it increases the amount and duration of Naprosyn in the body.
Methotrexate (for treatment of cancer and autoimmune diseases), as it remains longer in the body, potentially increasing its toxicity.
Anticoagulants (to thin the blood), as non-steroidal anti-inflammatory drugs (NSAIDs) may enhance 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 gastrointestinal bleeding (see section "What you need to know before taking Naprosyn").
Corticosteroids (anti-inflammatory hormones), as they increase the risk of gastrointestinal injury or bleeding (see section "What you need to know before taking Naprosyn").
Naproxen may reduce the effectiveness of contraceptive devices (intrauterine devices).
Aspirin/acetylsalicylic acid used to prevent blood clot formation.

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

sodium naproxen
acetylsalicylic acid
quinolones (antibiotics)

Naprosyn and alcohol
Avoid consuming alcohol during treatment with Naprosyn.
Results of certain laboratory tests (such as adrenal function tests or certain tests for urinary 5-
hydroxyindoleacetic acid) may be altered by Naprosyn.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Do not use Naprosyn during pregnancy and breastfeeding. It may cause kidney and heart problems in the unborn child.
Additionally, it could expose both you and your baby to possible bleeding and delay or prolong labor beyond the expected duration.
Do not take Naprosyn if you are planning a pregnancy. From week 20 of pregnancy onwards, naproxen
may cause kidney problems in the fetus, reducing levels of amniotic fluid surrounding the baby
(oligohydramnios), or causing narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
Discontinue Naprosyn if you have fertility problems or are undergoing fertility investigations.
Driving and using machines
Due to possible dizziness, drowsiness, vertigo, or depression, Naprosyn may impair your ability to drive or operate machinery. Avoid such activities when these symptoms occur.
Naprosyn contains

sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine;
sodium. This medicine contains 18.24 mg of sodium (main component of table salt) per sachet. This corresponds to 0.91% of the maximum daily dietary intake recommended for an adult.

3. How to take Naprosyn

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults

Initial treatment: The recommended dose is:
- 500–1000 mg per day, divided into two doses every 12 hours (in the morning with breakfast and in the evening with dinner), or as a single daily dose (at lunchtime or in the evening). The recommended dose is 1000 mg (2 x 500 mg) once daily:
  - if you have severe night pain and/or morning stiffness
  - if you have previously taken other anti-rheumatic medicines at high doses without success
  - if you have an inflammatory joint disease (osteoarthritis), when pain is the main symptom.
Maintenance therapy: Depending on the initial dose, disease severity and intensity of pain, the recommended dose is:
- 750–250 mg divided into two doses every 12 hours (in the morning with breakfast and in the evening with dinner) or as a single daily dose (at lunchtime or in the evening).
If you suffer from acute gout: The recommended dose is:
- 500 mg as initial dose
- 250 mg every 8 hours during the first 24 hours
- 250 mg twice daily for 6–7 days as maintenance dose.

Elderly
If you are elderly, your doctor will carefully determine the appropriate dose for you, possibly reducing the doses indicated above.

The Naprosyn oral suspension granules, when properly dissolved in water, allow faster absorption of the active substance and provide a more rapid analgesic (pain-relieving) effect; they are also more suitable if you have difficulty swallowing.

Children and adolescents
This medicine is not intended for use in children. Your doctor may prescribe Naprosyn only when absolutely necessary and only for children over 2 years of age.

If you have liver (hepatic insufficiency) or kidney (renal insufficiency) problems
Your doctor will prescribe the lowest effective dose and will schedule periodic check-ups to monitor clinical and laboratory parameters.

Do not take Naprosyn if you have severe renal failure.

If you take more Naprosyn than you should
If you take an excessive dose of Naprosyn, contact your doctor immediately or go to the nearest hospital.

If you take more Naprosyn than prescribed, you may experience dizziness, drowsiness, abdominal disturbances, stomach pain, nausea or vomiting, transient alterations in liver and kidney function, reduced levels of a blood substance leading to increased bleeding tendency (hypoprothrombinemia), accumulation of acids in the blood (acidosis), breathing difficulties, or disorientation. Bleeding from the stomach or intestines may also 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 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.
Stop taking Naprosyn and contact your doctor immediately if you notice any of the following side effects:

Not known: frequency cannot be estimated from the available data

Widespread skin rash, high body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.
A distinct allergic skin reaction known as fixed drug eruption, which usually reappears at the same site or sites upon re-exposure to the medicine and may appear as round or oval patches with redness and swelling of the skin, skin rash with blisters (urticaria), itching sensation.
The most commonly observed adverse events are gastrointestinal in nature. Ulceration, bleeding or perforation of the stomach or intestine (peptic ulcers, gastrointestinal perforation or bleeding), sometimes fatal, particularly in the elderly, may occur (see Warnings and precautions). After administration of Naprosyn, the following have been reported: nausea, vomiting, diarrhoea, flatulence (passing wind), constipation, indigestion (dyspepsia), abdominal and stomach pain, heartburn (gastric pyrosis), blood in the stools (melena), vomiting blood (haematemesis), inflammation of the mouth (ulcerative stomatitis), worsening of chronic inflammatory bowel disease (exacerbation of colitis and Crohn’s disease), inflammation of the oesophagus (oesophagitis), 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:

changes in the concentration of certain types of blood cells (thrombocytopenia, granulocytopenia, leucopenia, eosinophilia, aplastic or haemolytic anaemia)
severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions)
elevated potassium levels in the blood (hyperkalaemia)
abnormal dreams
depression
insomnia
dizziness
disorientation
seizures
headache (cephalalgia)
drowsiness
inflammation of the optic nerve (retrobulbar optic neuritis)
cognitive dysfunction
difficulty concentrating
inflammation of the membranes surrounding the brain (aseptic meningitis)
vision disturbances (papillitis, papilloedema, visual impairment, corneal opacity)
hearing disturbances (hearing impairment, ear noise, tinnitus, vertigo)
irregular or rapid heartbeat (palpitations)
increased heart rate (tachycardia)
heart function problems (congestive heart failure, cardiac failure, myocardial infarction)
damage to blood vessels in the brain (stroke)
high blood pressure (hypertension)
inflammation of blood vessels (vasculitis)
swelling (oedema)
breathing difficulties (dyspnoea, asthma and bronchospasm)
inflammation of the lungs (eosinophilic pneumonia)
fluid accumulation in the lungs (pulmonary oedema)
throat swelling (laryngeal oedema)
yellowing of the skin (jaundice)
inflammation of the liver (hepatitis)
skin rashes
itching
hives
bruising (ecchymoses)
rapid swelling of legs, arms, face or tongue (angioedema)
appearance of red, 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, mouth and other body part lesions accompanied by high fever, vomiting, diarrhoea and joint pain
skin death (toxic epidermal necrolysis)
abnormal and exaggerated skin reaction to light (photosensitivity reactions)
hair loss (alopecia)
muscle pain (myalgia)
muscle weakness
blood in the urine (haematuria)
reduced kidney function, kidney damage (interstitial nephritis, nephrotic syndrome, renal failure, renal papillary necrosis)
infertility in women
mild swelling of extremities (peripheral oedema)
excessive thirst
fever and chills
malaise
abnormal liver function laboratory test
increased creatinine in the blood (hypercreatinemia)

Medicines such as Naprosyn may be associated with a small increased 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, talk to your doctor or pharmacist. You can also report side effects directly via 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 requires no special storage conditions.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine 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 Naprosyn contains

The active substance is naproxen. Each sachet contains 250 mg of naproxen.
The other components are: sodium chloride, sodium dioctyl sulfosuccinate, povidone, mint flavour, liquorice flavour, mannitol, sodium saccharin, sucrose.

Description of the appearance of Naprosyn and package contents
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).

Patient information leaflet

Naprosyn 100 mg/g gel

naproxen
Read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any of the side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

What Naprosyn is and what it is used for
What you need to know before using Naprosyn
How to use Naprosyn
Possible side effects
How to store Naprosyn
Contents of the pack and other information

1. What Naprosyn is and what it is used for

Naprosyn contains the active substance naproxen.
Naproxen belongs to a class of medicines called non-steroidal anti-inflammatory/anti-rheumatic drugs which have various actions, including an important role in pain control.
Naprosyn gel is used for the local treatment of:

muscle pain (myalgia)
back pain (lumbago)
neck pain (torticollis)
muscle inflammation (fibromyositis)
joint inflammation (bursitis, tendinitis, tenosynovitis, periarthritis)
trauma (bruises, muscle strains, sprains, haematomas, oedema and traumatic infiltrations)
vein inflammation (phlebitis)

Naprosyn gel is also used as an adjunct to:

orthopaedic 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 to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to substances chemically closely related 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 or have previously suffered from any allergies
if you are allergic to medicines such as aspirin (acetylsalicylic acid) or to other non-steroidal anti-inflammatory drugs (NSAIDs).

If you have wounds, avoid applying the gel.
Prolonged use of medicines such as Naprosyn gel may cause allergic reactions (sensitization). In this case, stop treatment immediately.
To avoid possible allergic reactions, including sensitivity to light (photosensitization), do not expose yourself to direct sunlight, including sunbeds, during treatment and for two weeks afterwards.
If the medicine is applied over a large area and for a prolonged period, the occurrence of systemic side effects cannot be ruled out.

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

Pregnancy, breast-feeding and fertility
Oral forms (e.g. tablets) of Naprosyn may cause adverse effects on the fetus. It is not known whether the same risk applies when Naprosyn is used on the skin.
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breast-feeding, 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 during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If treatment is needed during this period, the lowest possible dose for the shortest possible time should be used.

Breast-feeding
The risk of harmful effects on the infant cannot be excluded.
Therefore, if you are breast-feeding, your doctor will carefully consider whether Naprosyn gel is necessary.

Driving and using machines
Naprosyn gel does not affect the ability to drive or operate machinery.

Naprosyn contains ethanol
This medicine contains 30 g of alcohol (ethanol) in 100 g of gel, 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 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 painful area twice daily, gently massaging until completely absorbed.

If you use more Naprosyn than you should
Cases of overdose are not known. If you accidentally use too much Naprosyn gel, inform your doctor immediately or go to the nearest hospital.

If you forget to use Naprosyn
Do not use a double dose to make up for the missed dose.

If you have any questions 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 will experience them.
Side effects that may occur with the use of Naprosyn gel are:

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

The use, especially if prolonged, of topical products may lead to sensitisation phenomena (allergy to one or more components). If this occurs, discontinue treatment and contact your doctor, who will provide appropriate therapy.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You may also report side effects directly via 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 requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
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 Naprosyn contains

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

Description of the appearance of Naprosyn and package contents
Naprosyn gel is available in a pack containing 1 tube of 50 grams of gel.
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – Via Matteo Civitali, 1 – 20148 Milan.
Manufacturer
VAMFARMA S.r.l. – Via Kennedy, 5 – 26833 Comazzo (LO).
DOPPEL FARMACEUTICI S.r.l. - Via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC).