NAPRIUS 500 mg Tablet

Зміст інструкції

1. Naprius 100 mg/gel
   1. What is Naprius gel and what it is used for
   2. What you need to know before using Naprius gel
   3. How to use Naprius gel
   4. Possible side effects
   5. How to store Naprius gel
   6. Contents of the pack and other information
2. Naprius
   1. What is Naprius and what is it used for
   2. What you need to know before taking Naprius
   3. How to take Naprius
   4. Possible side effects
   5. How to store Naprius
   6. Contents of the pack and other information

Naprius 100 mg/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.

Contents of this leaflet:

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

1. What is Naprius gel and what it is used for

Naprius gel contains the active ingredient naproxene, a non-steroidal anti-inflammatory drug
(NSAID).
Naprius gel is a topical medicine used in the treatment of: muscle pain,
bruises, sprains and muscle tears, dislocations, hematomas, swelling (edema) and infiltrates due
to trauma, inflammation of the muscles (fibromyalgia) and of all tissues adjacent to tendons and
joints (bursitis, tendinitis, tenosynovitis, periarthritis) and inflammation of the veins (phlebitis).
Naprius gel is also associated with orthopedic and rehabilitation therapies.

2. What you need to know before using Naprius gel

Do not use Napriusgel

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you are in the last 3 months of pregnancy;
• in children, unless otherwise advised by your doctor in cases of absolute necessity (see “Children and adolescents”);
• on wounds (see “Warnings and precautions” and “How to use Naprius gel”);
• if you suffer from or have suffered from allergies due to acetylsalicylic acid (aspirin) and/or other non-steroidal anti-inflammatory drugs (NSAIDs)

Warnings and precautions
Consult your doctor or pharmacist before using Naprius gel.

Stop using Naprius gel and consult your doctor if a rash appears
(skin rash), mucosal lesions or any other sign of excessive sensitivity.
During treatment with Naprius gel and for two weeks after, allergic reactions or sensitivity to light may occur.
Avoid exposure to direct sunlight, including solariums, during treatment and for two weeks after
(see “Possible side effects”).
The amount of active ingredient absorbed through the skin does not reach concentrations in the circulation
high enough to expose you to the risks of side effects and to make the warnings relating to
systemic administration of the medicine (by mouth or by injection) valid. However, it is
not recommended to use Naprius 10% gel in patients in whom acetylsalicylic acid (aspirin) and/or other
non-steroidal anti-inflammatory drugs (NSAIDs) cause allergic reactions. It is also not recommended
to use it in patients who suffer from or have suffered from allergies.
Consult your doctor before using Naprius gel if you are allergic to acetylsalicylic acid
(aspirin) or other NSAIDs (medicines of the same type as Naprius gel) and in any case if you suffer from or have
suffered from allergies.
Severe skin reactions, some of which have been fatal, such as exfoliative dermatitis (severe
skin inflammation), Stevens-Johnson syndrome and toxic epidermal necrolysis (or
Lyell's syndrome), have been very rarely reported in association with the use of non-steroidal anti-inflammatory drugs (NSAIDs) (see “Possible side effects”). Stop using
Naprius gel if a rash appears, mucosal lesions or any other sign of
excessive sensitivity.
Avoid using this medicine on wounds.

Children and adolescents
Do not use this medicine in children and adolescents.

Other medicines and Napriusgel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Tell your doctor if you are taking anti-inflammatory medicines for systemic use (by mouth or
by injection).

Pregnancy and breastfeeding
Oral forms (e.g. tablets) of Naprius can cause adverse effects in the fetus. It is
not known whether the same risk applies to Naprius gel when used on the skin.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Naprius gel if you are in the last 3 months of pregnancy. You should not use Naprius gel 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
time possible.
Do not use Naprius gel while breastfeeding unless your doctor prescribes it in cases of absolute necessity.

Driving and using machines
Naprius gel does not impair the ability to drive and use machines.

3. How to use Naprius gel

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 Naprius gel to the site of pain, twice a day, massaging gently until fully absorbed.
Do not apply the medicine to wounds.

If you forget to use Napriusgel
Do not apply a double dose to compensate for a missed application.
previous application.

If you stop using Napriusgel
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 following side effects have been reported:

• skin rashes with blisters (bullous reactions) including two serious skin diseases such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
• red and swollen skin (erythema), itching, irritation, a feeling of heat or burning and rash in the application area (contact dermatitis);
• sensitivity to light reactions (photosensitivity).

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
http://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 Naprius gel

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
There are no special storage precautions for this medicine.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Napriusgelcontains

• The active ingredient is naproxen. 100 g of gel contain 10 g of naproxen.
• The other ingredients are: carbopol, ethyl alcohol, triethanolamine, sodium metabisulfite, rose essence, deionized water.

Description of the appearance of Napriusgel and contents of the pack
Naprius gel is presented as a gel for topical use.
The pack contains an aluminum tube containing 30 g of gel with a concentration of
naproxen equal to 100 mg/g.

Marketing Authorisation Holder
S.F. GROUP S.r.l. – Via Tiburtina, 1143 – 00156 Rome

Manufacturer
Mitim S.r.l. - Via Cacciamali, 34-36-38 - 25125 Brescia

Naprius

500 mg tablets
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 their symptoms are the same as yours, as it could 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 Naprius is and what it is used for
• 2. What you need to know before you take Naprius
• 3. How to take Naprius
• 4. Possible side effects
• 5. How to store Naprius
• 6. Contents of the pack and other information

1. What is Naprius and what is it used for

Naprius contains the active ingredient naproxen which belongs to the category of non-steroidal anti-inflammatory/antirheumatic drugs, so-called NSAIDs. This medicine acts against pain, fever and inflammation (analgesic, antipyretic and anti-inflammatory) with prolonged action.
Naprius is used for the treatment of the following conditions:
inflammatory diseases that damage the joints (osteoarthritis and polyarthritis, rheumatoid arthritis, gouty arthropathy, ankylosing spondylitis);
pain caused by irritation of one or more nerves (neuralgia);
muscle pain (myalgia).

2. What you need to know before taking Naprius

Do not take Naprius

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you have or have had recurrent ulcers or bleeding in the stomach or intestine;
• if you suffer from inflammation of the colon (ulcerative colitis);
• if you suffer from serious heart problems;
• if you are allergic to acetylsalicylic acid (aspirin) and/or other NSAIDs (medicines of the same type as Naprius). The signs of an allergy are: asthma, itching (urticaria), inflammation of the nasal mucosa (rhinitis), severe general allergic reactions with rapid onset (anaphylactic or anaphylactoid reactions);
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Do not use Naprius in children and adolescents. The doctor may prescribe Naprius only in cases of
absolute necessity (see “Children and adolescents”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Naprius.
It is important to use the lowest effective dose for the shortest duration necessary to
control the symptoms.

Take special care and talk to your doctor before taking Naprius:
if you suffer from high blood pressure and/or have heart disease, as fluid retention (fluid retention) and swelling (edema) have been reported following treatment with NSAIDs.

• If you suffer from serious heart, kidney or liver problems. Medicines like Naprius may be associated with an increased risk of heart attack (myocardial infarction) or stroke. The risk increases when the dose taken is high and the medicine is used for a long time. Do not exceed the recommended dose prescribed. If you have heart problems, have had a stroke or if you think you may be at risk (for example, if you have high blood pressure, diabetes, high cholesterol or if you smoke), you should talk to your doctor or pharmacist before taking this medicine.

Tell your doctor before taking Naprius if you have had gastrointestinal disorders following
the use of other medicines for the treatment of rheumatism.
Gastrointestinal ulcers or bleeding, which can be fatal, can
occur at any time during treatment with NSAIDs, even without previous
disorders.
If you experience an ulcer or gastrointestinal bleeding, stop using this
medicine immediately and consult your doctor. The risk increases at higher doses, with previous gastrointestinal symptoms, in combination with medicines that thin the blood such as aspirin
(antiplatelet agents), medicines that help prevent blood clots in blood vessels
such as warfarin (anticoagulants), anti-inflammatory drugs (corticosteroids) taken orally and
medicines used against depression (selective serotonin reuptake inhibitors) and in
the elderly. See also “Other medicines and Naprius”.
If you suffer from gastrointestinal diseases such as Crohn's disease or ulcerative colitis, especially if you are
elderly, NSAIDs may worsen these conditions. If you experience unusual abdominal symptoms, contact
your doctor.
If you have allergic manifestations in progress or a history of allergies, Naprius may cause
narrowing of the bronchi with difficulty breathing (bronchospasm), asthma and other forms of
allergy.
Naprius may affect blood clotting and therefore may decrease blood clotting and prolong bleeding time.
Take caution if you are performing activities that require vigilance, as you may experience dizziness, drowsiness, vertigo or depression during treatment with
Naprius.
Serious skin reactions, some of which have been fatal, have been very rarely reported with the use
of NSAIDs. These reactions include: exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms (DRESS) and usually occur at the
beginning of treatment. Stop using Naprius immediately and consult your
doctor if you have symptoms such as: skin irritation (rash), mucosal lesions or any
other signs of hypersensitivity (see “Possible side effects”).
The use of Naprius together with other NSAIDs, including selective cyclo-oxygenase 2 (COX-2) inhibitors, must be avoided.
If you take this medicine for prolonged periods, have periodic eye checks.
Consult your doctor if any of the above warnings apply to you or have applied to you in
the past.
You should consult your doctor or pharmacist:

• if you develop gastrointestinal symptoms (such as stomach pain, heartburn or bleeding) after using Naprius;
• if you have fluid retention (such as swollen ankles and feet) after using Naprius;
• if you are using an intrauterine device, as this medicine may decrease the effectiveness of intrauterine devices (see “Other medicines and Naprius”).
• if you are planning a pregnancy, as the use of Naprius is not recommended (see “Pregnancy and breastfeeding”).
• the administration of NAPRIUS should be suspended in women who have fertility problems or who are undergoing fertility investigations.

Elderly
If you are elderly, you are more likely to experience some of the side effects caused by
Naprius, such as bleeding/perforation of the stomach and intestines, which can be
fatal.

Children and adolescents
The use of Naprius is not intended for pediatric age. The doctor may prescribe Naprius only in cases
of absolute necessity (see “Do not take Naprius”).

Other medicines and Naprius
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines.
In particular, talk to your doctor if you are taking:

• Other painkillers and anti-inflammatory drugs (NSAIDs(anti-inflammatory drugs of the same type as Naprius): do not take Naprius at the same time as its salt (sodium naproxene).
• Quinolone antibiotics(used to treat infections), as the concomitant use with Naprius is not recommended.
• Corticosteroids(used to treat inflammatory conditions): if you take corticosteroids together with Naprius, there may be an increased risk of ulcer or gastrointestinal bleeding (see “Warnings and precautions”).
• Anticoagulants(medicines that thin the blood) such as warfarin: medicines of the same type as Naprius (NSAIDs) may increase the effect of these medicines (see section “Warnings and precautions”).
• Antiplatelet agents(medicines that slow down blood clotting) and selective serotonin reuptake inhibitors(SSRIs) (medicines for depression): if you take these types of medicines at the same time as Naprius, the risk of gastrointestinal bleeding increases (see “Warnings and precautions”).
• Furosemide(used to increase urine production): the concomitant administration with some non-steroidal anti-inflammatory drugs such as Naprius may reduce the effect of this medicine.
• Lithium(used to treat manic-depressive illnesses): NSAIDs increase the levels of this medicine in the blood.
• Propranololand other beta-blockers(medicines used for high blood pressure): Naprius, like other non-steroidal anti-inflammatory drugs, may reduce the effect of these medicines.
• Probenecid(used to treat gout): because it may increase the risk of side effects of Naprius.
• Methotrexate(used in the treatment of rheumatoid arthritis, psoriasis and some cancers): because Naprius may increase the toxicity of this medicine.
• Antihydantoins(used to treat epilepsy), sulfonamides(used against bacterial infections), barbiturates(used as sedatives): if you receive Naprius and these medicines at the same time, you must be monitored for the risk of overdose.

In patients treated with other non-steroidal anti-inflammatory drugs and with coumarin anticoagulants,
cases of reduced or delayed blood clotting (increased prothrombin time and decreased platelet aggregation) have been observed.
Take caution if you are using an intrauterine device, as this medicine may decrease
the effectiveness of intrauterine devices.

Interactions with laboratory tests
Temporarily suspend therapy with Naprius 48 hours before performing tests for
adrenal gland function, as Naprius may interfere with some tests (tests for 17-ketogenic steroids for urinary 5-hydroxy-indoleacetic acid.
Talk to your doctor or pharmacist if you are taking aspirin (acetylsalicylic acid) to prevent
the formation of blood clots.

Naprius with alcohol
Avoid drinking alcohol during therapy with Naprius.

Pregnancy, breastfeeding and fertility
Pregnancy
Do not take Naprius if you are pregnant, as it may harm the fetus or cause problems
during childbirth. NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect
the tendency of the mother and baby to bleed and delay or prolong labor more than
expected. From the 20th week of pregnancy, NSAIDs can cause kidney problems in the
fetus, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or
causing the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. Where
treatment is necessary for more than a few days, the doctor may advise additional
monitoring.
Breastfeeding
Do not use this medicine during breastfeeding.
Fertility
If you have fertility problems or are undergoing fertility investigations, stop treatment with
Naprius.

Driving and using machines
Take caution if you are performing activities that require vigilance while
being treated with Naprius, as this medicine may cause dizziness, drowsiness, vertigo or depression.

Naprius tablets contains lactose
The medicine contains 4.68 g of lactose. When taken according to the recommended dosage, each
dose provides up to 156 mg of lactose. If your doctor has diagnosed you with an intolerance to some
sugars, contact him before taking this medicine.

Naprius oral suspension granules contains sucrose
The package contains 65 g of sucrose. When taken according to the recommended dosage,
each dose provides up to 3.250 g of sucrose. If your doctor has diagnosed you with an intolerance to
some sugars, contact him.

3. How to take Naprius

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

The recommended dose in adults is:
The initial dose of Naprius is 500-1000 mg (1-2 tablets or sachets) per day, divided into two doses, 12 hours apart.
Therefore, depending on the intensity of the symptoms, take a dose of 250 mg (half a tablet or half a sachet) or one of 500 mg (1 tablet or sachet) in the morning, with breakfast, and the other in the evening, with dinner.
The maximum dose of 1000 mg per day (2 tablets or sachets) is particularly indicated if you have severe nocturnal pain and/or morning stiffness, in acute attacks of rheumatoid arthritis, if you have already been treated unsuccessfully with other high-dose antirheumatic drugs and in osteoarthritis, when pain is the predominant symptom.
Subsequently, the dose can be reduced to 750-500 mg (1 and a half tablets or 1 and a half sachets - 1 tablet or sachet) or even less, always divided into two administrations 12 hours apart.
When the doses are different from each other (for example 500 + 250 mg), take the larger one in the morning or in the evening, depending on whether the pain prevails during the day or in the evening.
In acute gout attacks, it is recommended to start with a dose of 500 mg (1 tablet or sachet) followed by 250 mg (half a tablet or half a sachet) every 8 hours on the first day, then moving on to doses of 250 mg (half a tablet or half a sachet) twice a day for 6-7 days.
The Naprius granules for oral suspension sachets, appropriately dissolved in water, allow for faster absorption of the active ingredient and exert a more prompt pain-relieving action. Furthermore, the granules are more suitable for patients with difficulty swallowing and/or with digestive disorders.

If you take more Naprius than you should
If you have taken an excessive dose of Naprius, immediately inform your doctor or go to the nearest hospital.
The following symptoms of overdose may occur: state of torpor, heartburn (pyrosis), indigestion (dyspepsia), nausea or vomiting.
In case of ingestion of a large amount of this medicine, medical personnel will perform gastric emptying and implement the normal measures required in these cases. Prompt administration of an adequate amount of activated charcoal may significantly reduce the absorption of the medicine.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Naprius and contact your doctor immediately if you notice the appearance of 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), 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 recurs in the same
location or locations upon new exposure to the medicine and may appear as round or oval patches
with redness and skin swelling, skin rash with blisters (urticaria), a sensation of itching.
Side effects to the stomach and intestines such as lesions (ulcers), perforations or bleeding
(haemorrhages), sometimes fatal, may occur, especially in the elderly.
Nausea, vomiting, diarrhoea, gas in the intestines (flatulence), constipation, indigestion (dyspepsia),
abdominal pain, black stools (melena), vomiting blood (haematemesis), lesions of the mouth mucosa
(ulcerative stomatitis), worsening of colon inflammation (exacerbation of colitis) and Crohn's disease
have also been reported. Gastritis may occur less frequently.
Swelling (oedema), increased blood pressure (hypertension) and heart failure have been reported with
the use of NSAIDs (medicines of the same type as Naprius).
The use of NSAIDs may increase the risk of arterial thrombotic events (e.g. myocardial infarction or
stroke).
Very rarely, the formation of blisters (bullous reactions) may occur, even very severe ones such as
Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.
Among the gastrointestinal effects, the most common are: nausea, vomiting, abdominal pain, heartburn,
indigestion, constipation, diarrhoea, stomatitis. Gastrointestinal bleeding, peptic ulcer and colitis
may occur occasionally.
Headache, drowsiness, insomnia and difficulty concentrating; skin rashes, itching, bruises
(ecchymosis), urticaria, swelling of the skin and mucous membranes (angioedema) may occur.
Allergic reactions (hypersensitivity) to naproxen and naproxen sodium, eosinophilic pneumonia,
appearance of reddish blisters on the skin (erythema multiforme), sensitivity to light (photosensitivity),
narrowing of the bronchi with difficulty breathing (bronchospasm), swelling (oedema) of the larynx
may rarely occur.
Increased heart rate (tachycardia, difficulty breathing (dyspnoea) and swelling of the limbs (mild
peripheral oedema), heart failure.
Sporadically, a reduction in the number of platelets (thrombocytopenia), white blood cells
(granulocytopenia), aplastic or haemolytic anaemia may occur.
Disturbances of hearing and vision, ringing in the ears, dizziness, yellowish discoloration of skin and
mucous membranes (jaundice), severe liver inflammation (hepatitis), reduced kidney function, blood in
the urine (haematuria), lesions of the mouth (ulcerative stomatitis), inflammation of the meninges
(aseptic meningitis), inflammation of the blood vessels (vasculitis), feeling of thirst, alterations in
liver function tests may also occur.
Rarely, hair loss (alopecia), seizures, increased levels of potassium in the blood (hyperkalaemia) have
been reported.
Serious allergic reactions may occur, even with or without prior use of this class of medicines.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system at the
address: 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 Naprius

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Naprius contains
Naprius 500 mg tablets

• The active ingredient is naproxen. Each tablet contains 500 mg of naproxen.
• The other ingredients are: lactose, corn starch, polyvinylpyrrolidone, magnesium stearate. Naprius 500 mg granules for oral suspension
• The active ingredient is naproxen. Each sachet contains 500 mg of naproxen.
• The other ingredients are: mannitol, sodium chloride, ammonium glycyrrhizate, mint flavour, anise mint flavour, sodium dioctylsulfosuccinate, sucrose, polyvinylpyrrolidone.

Description of the appearance of Naprius and contents of the pack
Naprius is available as tablets or granules for oral suspension.
500 mg tablets - 30 tablets
500 mg granules for oral suspension - 20 sachets

Marketing Authorisation Holder
S.F. GROUP S.r.l. – Via Tiburtina, 1143 – 00156 Rome

Manufacturer
Naprius 500 mg tablets
L A.FA.RE. S.r.l. - Via Sacerdote Benedetto Cozzolino 77, 80056 Ercolano (NA)

Naprius 500 mg granules for oral suspension
MITIM S.r.l. - Via Cacciamali, 34-36-38 - 25125 Brescia