NAPREBEN 550 mg Hard Capsule

Зміст інструкції

1. NAPREBEN 550 mg hard capsules, 275 mg hard capsules
   1. What is NAPREBEN hard capsules and what is it used for
   2. What you need to know before taking NAPREBEN hard capsules
   3. How to take NAPREBEN hard capsules
   4. Possible side effects
   5. how to store NAPREBEN hard capsules
   6. Contents of the pack and other information
2. NAPREBEN 10% gel
   1. What is NAPREBEN gel and what it is used for
   2. What you need to know before using NAPREBEN gel
   3. How to use NAPREBEN gel
   4. Possible side effects
   5. How to store NAPREBEN gel
   6. Contents of the pack and other information

NAPREBEN 550 mg hard capsules, 275 mg hard capsules

Sodium naproxen betaine

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 may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet
1 What NAPREBEN hard capsules are and what they are used for
2 What you need to know before you take NAPREBEN hard capsules
3 How to take NAPREBEN hard capsules
4 Possible side effects
5 How to store NAPREBEN hard capsules
6 Contents of the pack and other information

1. What is NAPREBEN hard capsules and what is it used for

NAPREBEN hard capsules belongs to a group of medicines called “Non-Steroidal Anti-inflammatory Drugs” (NSAIDs). These medicines reduce pain and inflammation.
You can use NAPREBEN hard capsules for the treatment of various conditions such as:

• chronic joint disease (osteoarthritis)
• severe rheumatic disease affecting the musculoskeletal system (ankylosing spondylitis)
• inflammation of the joints causing pain and swelling (gout)
• various forms of non-articular rheumatism and affecting soft tissues (lumbosciatica, myalgia, neuralgia, radicular syndromes, periarthritis, fibromyositis)
• chronic and disabling rheumatic disease of the joints (rheumatoid arthritis)

2. What you need to know before taking NAPREBEN hard capsules

Do not take NAPREBEN hard capsules
if you are allergic to naproxen, or to any of the other ingredients of this medicine (listed in
section 6);
if you currently have an ulcer (lesion) in your stomach or intestine (gastroduodenal ulcer);
if aspirin (acetylsalicylic acid) or other NSAIDs cause allergic reactions in you (asthma, urticaria, rhinitis);
if you are pregnant or suspect you may be pregnant;
if you are breastfeeding;
if you have previously had bleeding or perforation of the stomach or intestine following
previous treatments or if you have experienced at least two different episodes of bleeding/ulcer in the
stomach or intestine;
if you have severe heart failure

Warnings and precautions
Talk to your doctor or pharmacist before taking NAPREBEN hard capsules. If you have or have had in the past
inflammatory diseases of the intestine or stomach, acute or chronic, or if you have experienced gastrointestinal
disorders following the use of other anti-inflammatory drugs, you can only take NAPREBEN hard capsules under strict
medical supervision.
The doctor will exercise particular caution in recommending the use of NAPREBEN hard capsules if you are currently
experiencing or have experienced allergic reactions, as breathing difficulties due to contraction of the
muscles of the airways (bronchospasm) or other allergic phenomena may occur.
If you have had episodes of ulcers, if you are elderly, if you regularly take a low dose of aspirin (acetylsalicylic acid)
or other drugs that may increase the risk of gastrointestinal events, your doctor may recommend starting with
the lowest possible dose and using protective medicines for the walls of the stomach and
intestine (misoprostol or proton pump inhibitors) at the same time.
If you suffer from problems with your stomach or intestines, and especially if you are elderly, you should report any
unusual symptoms in your stomach and intestines (especially gastrointestinal bleeding) to your doctor, particularly in the early
stages of treatment.
If you have heart problems, have a history of stroke, if you suffer from high blood pressure, diabetes or high cholesterol or
if you smoke, you should discuss your therapy with your doctor or pharmacist.
Medicines such as NAPREBEN hard capsules may be associated with a modest increase in the risk of
formation of blood clots inside the arteries (arterial thrombotic events) such as heart attack or stroke. Any
risk is more likely with high doses and prolonged treatments. Therefore, do not exceed the recommended doses and duration of
treatment.
If you should experience rashes or skin lesions or any other signs of allergic reactions to the drug
within the first month of treatment, you should stop treatment with NAPREBEN hard capsules and consult
your doctor.
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with

NaprebenIf you notice any of the symptoms relating to these severe skin reactions, described in section 4, stop the
treatment with Naprebenand consult your doctor immediately.

Use in the elderly
If you are elderly, you should discuss your therapy with your doctor, especially if you suffer from heart problems, kidney problems, liver problems and problems with your stomach or intestines.

Other medicines and NAPREBEN hard capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
In particular, be careful if you are taking NAPREBEN hard capsules together with:

• other NSAIDs
• medicines used to reduce the risk of blood clot formation, called thrombi (coumarin anticoagulants such as warfarin)
• medicines that prevent blood platelets from aggregating
• medicines for the treatment of type 2 diabetes (oral hypoglycemic agents)
• some medicines used to treat depression (selective serotonin reuptake inhibitors)
• some medicines used to treat epilepsy (hydantoins)
• some antibiotics (sulfonamides)
• other anti-inflammatory drugs (corticosteroids)
• a medicine used to increase urine production (probenecid)
• medicines for the treatment of high blood pressure (antihypertensives such as ACE inhibitors and angiotensin II antagonists), especially if you are elderly and/or have kidney problems
• diuretic medicines
• -

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• Aspirin/acetylsalicylic acid to prevent blood clot formation

You should avoid the concurrent use of NAPREBEN hard capsules with aspirin (acetylsalicylic acid) or certain
categories of anti-inflammatory drugs. Your doctor will give you information about this.

Pregnancy and breastfeeding
Do not use NAPREBEN hard capsulesif you are pregnant or suspect you may be pregnant, or if you are breastfeeding with
breast milk.
Your doctor will advise you to avoid treatment with NAPREBEN hard capsules if you are planning a
pregnancy, if you have fertility problems or are undergoing fertility tests.
Do not take Napreben 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
child to bleed and delay or prolong labor more than expected. From the 20th week of
pregnancy, NSAIDs can cause kidney problems in the fetus, thus 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.
Studies suggest an increased risk of abortion, heart defects, kidney problems and an
increased risk of a defect in the abdominal wall of the newborn (gastroschisis) due to use in the early stages of
pregnancy; this risk increases following an increase in dose and duration of therapy. At the end of
pregnancy, the risk involves bleeding and delay or prolongation of labor.
If you are pregnant, suspect or are planning a pregnancy or are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
It is advisable to be particularly careful when driving vehicles or using machines during
treatment with NAPREBEN hard capsules, especially if you are taking high doses of the medicine.

3. How to take NAPREBEN hard capsules

Take this medicine following the instructions of your doctor or pharmacist exactly. If you have doubts
consult your doctor or pharmacist.
The recommended initial dose is 550-1100 mg per day, divided into two doses, one in the morning with
breakfast and the second during dinner or during the midday or afternoon meal.
To achieve an improvement in your condition, therapy may be continued with doses of 275-550 mg
per day and prolonged, according to the doctor's judgment.

Use in the elderly
If you are elderly or at risk of developing liver and kidney problems, the dose of therapy must be established
carefully by the doctor, who may evaluate a reduction of the recommended dose and the duration of therapy to
minimize the risk of unwanted effects.
Take NAPREBEN hard capsules on a full stomach and with plenty of fluids.

If you take more NAPREBEN hard capsules than you should
Taking an excessive amount of NAPREBEN hard capsules may cause stomach pain, nausea,
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vomiting and diarrhea.
In case of accidental or voluntary ingestion of an excessive dose of NAPREBEN hard capsules, contact
your doctor immediately or go to the nearest hospital.
The doctor will implement the normal measures provided for in these cases.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The most common side effects that may occur following the use of NAPREBEN hard capsules are related to the
stomach and intestines. Ulcers, perforations or bleeding may occur, which could be fatal, especially if you are
elderly.
You may also experience: nausea, vomiting, diarrhea, gas in the intestines, constipation, difficulty digesting, abdominal
pain, black stools, vomiting blood, inflammation of the oral mucosa with the formation of
small ulcers, worsening of colitis, Crohn's disease (a chronic inflammatory bowel disease), heartburn and more
rarely gastritis. These symptoms are mild and disappear after a dose reduction and discontinuation of therapy.
Less frequently, you may experience headache, drowsiness, dizziness, lightheadedness.
At the skin level, you may experience itching, bruising, skin rashes, swelling, blister formation and very rarely
"Stevens-Johnson syndrome" characterized by skin rashes and blister formation and "toxic epidermal necrolysis", a
skin disease in which the skin peels off in layers.
Stop taking Napreben and contact your doctor immediately if you notice the appearance of any of the
following side effects:
Not known: frequency cannot be estimated based on available data

• Widespread 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 alsoparagraph 2.
• A distinctive allergic skin reaction known as fixed drug eruption, which usually reappears in the same location or in the same locations upon re-exposure to the medicine andmay appear as round or oval patches with redness and skin swelling,rash with blisters (urticaria), sensation of itchingYou may also experience tachycardia, difficulty breathing, swelling due to fluid accumulation (edema), increased blood pressure, heart failure.

Rarely, you may experience problems with the blood such as a reduction in the number of platelets, a reduction in
some types of white blood cells and red blood cells, jaundice (liver disease characterized by yellowing of the
eyes and skin), cases of severe hepatitis (liver infection), reduced kidney function, allergic reactions,
changes in hearing and vision, thirst.
Studies suggest that the use of some NSAIDs such as NAPREBEN hard capsules, at high doses and for prolonged
therapies, involves an increased risk of thrombus formation, blood clots in the arteries,
increased risk of developing a heart attack or stroke (arterial thrombotic events).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor,
pharmacist or nurse. You can also report side effects directly through the national reporting system
at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this
medicine.

5. how to store NAPREBEN hard capsules

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported 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 and household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.
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6. Contents of the pack and other information

What NAPREBEN hard capsules contain

• The active ingredient is sodium naproxen betaine. Each tablet contains 275 mg or 550 mg of sodium naproxen betaine.
• The other ingredients are:
• magnesium stearate, polyvinylpyrrolidone
• capsule constituents: gelatin, titanium dioxide (E171), yellow iron oxide (E172).

Description of the appearance of NAPREBEN hard capsules and contents of the pack
A pack of NAPREBEN hard capsules contains 3 blisters of 10 capsules of 275 mg or 550 mg.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
MERQURIO Pharma S.r.l
Corso Umberto I, 23
80138 Napoli
Manufacturer :
Fulton medicinali S.p.A.
Via Marconi 28/9
20020 Arese (MI)

NAPREBEN 10% gel

Naprossene betainate sodium

Read this leaflet carefully before using 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 experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

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

NAPREBEN gel belongs to a group of medicines called “Non-Steroidal Anti-Inflammatory Drugs” (NSAIDs). These medicines reduce pain and inflammation.
You can use NAPREBEN gel for the treatment of various conditions such as:

• muscle pain and inflammation
• back pain
• stiff neck
• pain and inflammation of the joints or tendons (such as bursitis, tendinitis, tenosynovitis, periarthritis)
• bruises, sprains or muscle tears
• hematomas
• swellings (edema)
• traumatic infiltrates
• in association with other medicines used in orthopedic or rehabilitation therapies.

2. What you need to know before using NAPREBEN gel

Do not use NAPREBEN gel
if you are allergic to naproxen or any of the other ingredients of this medicine
(listed in section 6);
if aspirin (acetylsalicylic acid) or other medicines belonging to the same group (NSAIDs) cause you
allergic reactions (such as asthma, urticaria, rhinitis);
if you are pregnant or suspect you may be pregnant;
if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using NAPREBEN gel.
Do not apply NAPREBEN gel to wounds.
Use of NAPREBEN gel for a prolonged period of time may cause allergic
skin reactions.
To avoid these allergic reactions or an increase in skin sensitivity to light
(photosensitization), you should avoid exposure to direct sunlight, including solariums,
during treatment with NAPREBEN gel or for two weeks afterwards.
If you experience an allergic reaction when using the medicine or are a subject prone to allergies, use
NAPREBEN gel with caution as it may cause difficulty breathing (bronchospasm),
asthma and other allergic phenomena.
Stop using NAPREBEN gel at the first sign of rash or skin lesions or of
any other sign of excessive sensitivity to the medicine.

Other medicines and NAPREBEN gel
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

Pregnancy, breastfeeding and fertility
Oral forms (e.g. tablets) of Napreben can cause adverse effects in the fetus. It is
not known whether the same risk applies to Napreben when used on the skin.
If you are pregnant, suspect you may be pregnant or are planning a pregnancy or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Do not use Napreben during pregnancy.

Do not use NAPREBEN gelif you are pregnant or suspect you may be pregnant, or if you are
breastfeeding.

Driving and operating machinery
NAPREBEN gel does not impair the ability to drive vehicles or operate machinery.

3. How to use NAPREBEN gel

Use this medicine following the instructions of your doctor or pharmacist exactly. If you
have any doubts, consult your doctor or pharmacist.
Apply NAPREBEN gel 3 times a day to the site of pain, massaging gently until
complete absorption of the gel.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone
experiences them.
As with many other NSAIDs applied to the skin, skin reactions may occur
such as erythema, itching, irritation, a feeling of heat or burning, contact dermatitis, allergic
reactions with blister formation, bruising, swelling due to fluid accumulation, rare syndromes
characterized by the appearance of blisters on the skin such as “Stevens-Johnson syndrome” and the
formation of areas of necrosis and shedding of the skin such as “toxic epidermal necrolysis”.
It is possible that your skin may become more sensitive to sunlight; in this case, discontinue
use of the medicine.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, contact
your doctor, pharmacist or nurse. You can also report side effects
directly through the national reporting system at:
http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on
the safety of this medicine.

5. How to store NAPREBEN gel

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the pack after Expiry. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in the 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 NAPREBEN gel contains

• The active ingredient is sodium naproxen betaine. 100 g of gel contains 10 g of sodium naproxen betaine.
• The other ingredients are: hydroxyethylcellulose, methyl parahydroxybenzoate, sodium dehydroacetate, distilled water.

Description of the appearance of NAPREBEN gel and contents of the pack
A pack of NAPREBEN gel contains a tube of 50 g of gel.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder :
MERQURIO Pharma S.r.l
Corso Umberto I, 23
80138 Napoli
Manufacturer:
New.FA.DEM. S.r.l.
Viale Ferrovia dello Stato 1, Zona A.S.I.
80014 Giugliano in Campania (NA)