LASER 750 mg Modified-Release Tablet

Зміст інструкції

1. LASER 750 mg modified-release tablets
   1. What LASER is and what it is used for
   2. What you need to know before taking LASER
   3. How to take LASER
   4. Possible side effects
   5. How to store LASER
   6. Contents of the pack and other information

LASER 750 mg modified-release tablets

Naproxene
Generic medicine

Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What LASER is and what it is used for

LASER contains the active ingredient naproxen, a substance that belongs to the group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
LASER is used for the treatment of:

• Diseases affecting the joints: hip osteoarthritis (coxarthrosis), osteoarthritis of the spine (spondyloarthrosis), knee osteoarthritis (gonarthrosis), cervical and dorsal osteoarthritis,
• an inflammatory disease of the joints including those of the hands and feet (rheumatoid arthritis)
• a disease due to the presence of uric acid crystals in the joints (gouty arthropathy)
• diseases affecting the nerves, bones, tendons, muscles and joints (lumbosciatalgia, myalgia, neuralgia, periarthritis, fibrositis, radicular syndromes). See your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking LASER

Do not take LASER

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
• if you suffer from a lesion of the wall of the stomach or duodenum (active gastroduodenal ulcer and 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 bleeding/lesion of the stomach wall (peptic ulcer) frequent (two or more distinct episodes)
• if you have serious heart problems (severe heart failure)
• if you have had allergic reactions such as asthma, itching (urticaria), allergic rhinitis (hay fever), severe and rapid general allergic reaction (anaphylactic or anaphylactoid reactions, associated with the use of aspirin

(acetylsalicylic acid) and/or other non-steroidal anti-inflammatory drugs (NSAIDs)

• if you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”)

LASER should not be used in children and adolescents under the age of 18 (see section
“Children and adolescents”).

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

• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs)
• if you have a history of lesion of the stomach wall with bleeding/perforation (gastrointestinal bleeding, ulceration or perforation)
• if you have or have ever had acute inflammation of the gastrointestinal tract or if you have had stomach or intestinal disorders after using medicines for rheumatic diseases
• if you have a history of toxicity to the stomach or intestine: report any unusual symptoms to your doctor, especially at the beginning of treatment if you are taking anti-inflammatory drugs (oral corticosteroids), medicines to thin the blood (anticoagulants such as warfarin), medicines for depression (selective serotonin reuptake inhibitors) or medicines such as aspirin or analogues (see “Other medicines and LASER”)
• if you suffer from a chronic inflammatory disease of the stomach and intestines (ulcerative colitis or Crohn's disease)
• if you have heart problems
• if you have liver problems
• if you have kidney problems
• if you suffer from high blood pressure and/or heart problems (heart failure), as fluid retention, hypertension and swelling (edema) and a modest increase in the risk of thrombosis (e.g. myocardial infarction or stroke) have been found in association with NSAID treatment;
• if you experience skin reactions, some of which may be fatal (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS))
• if you have or have had allergic reactions, as naproxen can cause breathing difficulties (bronchospasm) and other allergic phenomena.
• if you have blood clotting problems as naproxen inhibits platelet aggregation and may prolong bleeding time
• if you are planning a pregnancy
• if you are near term
• if you have fertility problems or are undergoing fertility investigations

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction
with eosinophilia and systemic symptoms (DRESS), have been reported in association with
LASER.
If you notice any symptoms relating to these severe skin reactions while using LASER, as described in
section 4, the appearance of skin rashes (skin eruption), mucous membrane lesions or any other sign of
allergic reaction (hypersensitivity), stop treatment with LASER and consult your doctor immediately.
Medicines like LASER may be associated with a modest increase in the risk of heart attack (myocardial
infarction) or stroke. Any risk is more likely with high doses and prolonged treatments. Do not exceed the dose
or duration of treatment recommended.
If you have heart problems (heart failure, established ischemic heart disease, peripheral arterial disease and/or
cerebrovascular disease) or a history of stroke or think you may be at risk for these conditions (for
example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss therapy
with your doctor or pharmacist.
In the elderly and patients with a history of ulcers, especially if complicated by bleeding or perforation (see
section Do not take LASER), 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
LASER for prolonged treatments, you should have periodic eye examinations. Elderly
If you are elderly, you are more likely to experience some of the side effects caused by LASER such as
bleeding/perforation of the stomach and intestines, which can be fatal.

Children and adolescents
The use of the medicine is not intended for children and adolescents under the age of 18. The doctor may
prescribe LASER only in cases of absolute necessity.

Other medicines and LASER
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other
medicines.
If you are taking any of the following medicines, tell your doctor, as these may interact with LASER:

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

The results of some laboratory tests (such as adrenal function tests or some tests for urinary 5-
hydroxyindoleacetic acid) may be altered by LASER, it is advisable to stop therapy with LASER
48 hours before performing the tests.
The concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs) including LASER is not recommended with:

• naproxen sodium
• acetylsalicylic acid
• quinolones (antibiotics). LASER with alcoholAvoid drinking alcohol during treatment with LASER. Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine. Do not take this medicine during pregnancy, if you are near term, if you plan to become pregnant or if you suspect you are pregnant as it may cause harm to your baby. NSAIDs can cause problems with the kidneys and heart of the fetus. They may affect the mother's and baby's tendency to bleed and delay or prolong labor more than expected. From the 20th week of pregnancy, NSAIDs can cause kidney problems in the fetus by reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing a narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you are a woman of childbearing potential, have fertility problems or are undergoing fertility investigations, you should inform your doctor as this medicine may interfere with fertility.

Driving and using machines
LASER may impair your ability to drive vehicles and use machines.
If you experience dizziness, drowsiness, dizziness or depression during treatment with naproxen, you should be careful
if you drive vehicles, operate machinery or perform an activity that requires vigilance.

LASER contains lactose
If your doctor has diagnosed you with intolerance to some sugars, contact him before taking this
medicine.

3. How to take LASER

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

Adults: The recommended dose is one LASER tablet once a day (during lunch or dinner).
Undesirable effects can be minimised with the use of the shortest possible duration of treatment needed to
control the symptoms.

Elderly
If you are elderly, your doctor will carefully determine the dose you need to take, considering a possible reduction of the
dose indicated above.

If you take more LASER than you should
If you take an excessive dose of Laser, immediately inform your doctor or go to the nearest hospital.
If you take more Laser than you should, drowsiness, heartburn (gastric pyrosis),
digestive disorders (dyspepsia), nausea or vomiting may occur.

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

If you stop taking Laser
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.
Medicines like LASER may be associated with a modest increase in the risk of heart attack
(“myocardial infarction”) or stroke.
In association with treatment with NSAIDs, edema, increased blood pressure and heart failure have been reported.
The most commonly observed side effects are of a gastrointestinal nature.
Lesion, bleeding or perforation of the stomach and intestine (peptic ulcers,
perforation or gastrointestinal bleeding) can occur, sometimes fatal, particularly in the elderly (see paragraph
“Warnings and precautions”).
Following administration of LASER, nausea, vomiting, diarrhea, flatulence (emission of gas
from the intestine), constipation, dyspepsia (digestive disorders), abdominal and epigastric pain, gastric pyrosis
(heartburn), melena (stools tending to black due to the presence of blood), hematemesis (emission of
blood with vomiting), ulcerative stomatitis (ulcers of the oral mucosa), worsening of colitis and Crohn's disease
(chronic inflammatory bowel diseases) have been reported (see paragraph “Warnings and precautions”).
Gastritis has been found less frequently.
Stop taking LASER and contact your doctor immediately if you notice the onset of any of the
following side effects:
Not known: frequency cannot be defined on the basis of 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 also paragraph 2).
• a distinctive skin allergic reaction known as fixed drug eruption, which usually recurs in the same location or in the same locations upon re-exposure to the medicine and may appear as round or oval patches with redness and skin swelling, rash with blisters (urticaria), sensation of itching Very rarely:
• reactions with blisters including a disease called Stevens-Johnson syndrome (SJS) with severe lesions to the skin, mouth and other parts of the body with high fever, vomiting, diarrhea and joint pain, death of the skin (toxic epidermal necrolysis (TEN))

Other side effects that may occur with the use of Laser are:

• alteration of the concentration of certain types of cells present in the blood (thrombocytopenia, granulocytopenia, aplastic or hemolytic anemia)
• hypersensitivity
• severe and rapid general allergic reactions (anaphylactic or anaphylactoid reactions)
• high potassium concentration in the blood (hyperkalemia)
• insomnia
• seizures
• headache
• drowsiness
• difficulty concentrating
• inflammation of the membranes surrounding the brain (aseptic meningitis)
• eye diseases
• hearing disorder (tinnitus, vertigo)
• fast heartbeat (tachycardia)
• problems with heart function (heart failure, myocardial infarction, decompensated heart failure)
• brain vessel injury (stroke)
• high blood pressure (hypertension)
• inflammation of blood vessels (vasculitis)
• swelling (edema)
• difficulty breathing (dyspnea, bronchospasm)
• lung inflammation (eosinophilic pneumonia)
• swelling of the throat (laryngeal edema)
• yellow skin (jaundice)
• severe liver inflammation (severe hepatitis)
• skin rashes
• itching
• urticaria
• bruises (ecchymosis)
• rapid swelling of legs, arms, face or tongue (angioedema)
• appearance of red and swollen nodules under the skin (erythema multiforme)
• abnormal and exaggerated skin reaction to light (photosensitivity reactions)
• hair loss (alopecia)
• blood in urine (hematuria)
• reduced kidney function
• mild swelling of the extremities (peripheral edema)
• feeling of thirst
• alteration of the laboratory test to evaluate liver function
• increased creatinine in the blood (hypercreatininemia)
• rectal bleeding, tenesmus (painful spasm of the anus and bladder with a continuous sensation of needing to defecate or urinate) and proctitis (inflammation of the rectum)
• bleeding from the gastrointestinal tract, peptic ulcer and colitis
• decreased platelet aggregation (blood cells that regulate blood clotting) and increased bleeding time Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://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 LASER

This medicine does not require any particular storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack.
The expiry date refers to the last day of that month
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What LASER contains

• The active ingredient is naproxen. Each modified-release tablet contains 750 mg of naproxen.
• The other ingredients are: Polyvinylpyrrolidone, Hydroxypropylmethylcellulose, Lactose, Magnesium stearate.

Description of the appearance of LASER and contents of the pack
Pack containing two blisters of 10 modified-release tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
EURO-PHARMA S.R.L. Via Garzigliana 8 -10127 Torino.
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l. Via Pascoli, 1 – Gorgonzola (MI).