Laser

Package leaflet: Information for the patient

LASER 750 mg modified-release tablets

Naproxen
Generic medicine
Please read 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult 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 taking 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 substance naproxen, a compound belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
LASER is used to treat:

• Joint diseases: hip osteoarthritis (coxarthrosis), osteoarthritis of the spinal joints (spondyloarthrosis), knee osteoarthritis (gonarthrosis), cervical and dorsal osteoarthritis,
• an inflammatory joint disease affecting joints of the hands and feet (rheumatoid arthritis),
• a disease caused by the presence of uric acid crystals in the joints (gouty arthropathy),
• diseases affecting nerves, bones, tendons, muscles, and joints (lumbosciatica, myalgia, neuralgia, periarthritis, fibromyositis, radicular syndromes).

Consult your doctor if you do not feel better or if you feel worse.

2. What you should know before taking LASER

Do not take LASER

• 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 of the stomach or duodenal wall (active gastroduodenal ulcer or peptic ulcer)
• if you suffer from inflammation of the colon (ulcerative colitis), or if you have a history of gastrointestinal bleeding or perforation of the stomach or intestine due to previous treatments, or a history of frequent bleeding/wall lesions of the stomach (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, or severe and rapid generalized allergic reactions (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 must not be used in children and adolescents under 18 years of age (see section “Children and adolescents”).

Warnings and precautions

Talk to your doctor or pharmacist before taking LASER.

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 currently have or have previously 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 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 LASER”)
• 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), as fluid retention, hypertension, and swelling (edema), along with a modest increase in the risk of thrombosis (e.g., myocardial infarction or stroke), have been observed during treatment with NSAIDs
• if you develop 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 may cause breathing difficulties (bronchospasm) and other allergic phenomena
• if you have coagulation disorders, since naproxen inhibits platelet aggregation and may prolong bleeding time
• if you are planning a pregnancy
• if you are near term (approaching childbirth)
• if you have fertility problems or are undergoing fertility investigations

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with LASER.

If, while using LASER, you notice any of the symptoms related to these serious skin reactions described in section 4, such as skin rash (rash), mucosal lesions, or any other sign of allergic reaction (hypersensitivity), stop treatment with LASER and contact your doctor immediately.

Medicines such as LASER may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

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, high cholesterol, or are a smoker), discuss your treatment with your doctor or pharmacist.

In elderly patients and in those with a history of ulcers, particularly 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 long-term treatment, periodic eye examinations are recommended.

Elderly

If you are elderly, you have a higher likelihood of experiencing some of the adverse effects caused by LASER, such as bleeding/perforation of the stomach and intestine, which may be fatal.

Children and adolescents

The use of this medicine is not indicated in children and adolescents under 18 years of age. Your doctor may prescribe LASER only if absolutely necessary.

Other medicines and LASER

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking any of the following medicines, inform your doctor, as they may interact with LASER:

• Hydantoin derivatives (for epilepsy treatment), sulfonamides (antibiotics for infections), barbiturates (sedatives), other non-steroidal anti-inflammatory drugs (NSAIDs), and acetylsalicylic acid, as they may increase the blood levels of LASER and cause side effects.
• ACE inhibitors and angiotensin II antagonists (for high blood pressure treatment), as their effect may be reduced when taken with LASER, and the risk of kidney damage may increase in some dehydrated patients or elderly patients with already compromised kidney function.
• Furosemide (for high blood pressure treatment), as concomitant administration may reduce the effect of this medicine.
• Lithium (for manic-depressive disorders), as blood levels of lithium may become too high.
• Propranolol and beta-blockers (for high blood pressure treatment), as LASER may reduce their effectiveness.
• Probenecid (for gout treatment), as it increases the amount and duration of LASER in the body.
• Methotrexate (for cancer treatment and autoimmune diseases), as it may remain in the body longer, 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 should 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 gastrointestinal bleeding (see section “What you should know before taking LASER”).
• Corticosteroids (for inflammatory conditions), as they increase the risk of gastrointestinal injury or bleeding (see section “What you should know before taking LASER”).
• Aspirin/acetylsalicylic acid, used to prevent blood clots.
• Quinolone antibiotics, used to treat bacterial infections.
• Other medicines containing sodium naproxen.
• Naproxen may reduce the effectiveness of contraceptive devices (intrauterine devices).

Results of certain laboratory tests (such as adrenal function tests or urinary 5-hydroxyindoleacetic acid tests) may be altered by LASER. It is recommended to discontinue LASER therapy 48 hours before undergoing these tests.

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

• sodium naproxen
• acetylsalicylic acid
• quinolones (antibiotics)

LASER and alcohol

Avoid consuming alcohol during treatment with LASER.

Pregnancy, breastfeeding and fertility

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist 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 harm your unborn child.

Do not take LASER if you are breastfeeding.

Do not take LASER if you are pregnant, as it may harm the fetus or cause complications during delivery. NSAIDs may cause kidney and heart problems in the fetus. They may affect the bleeding tendency in both mother and child and may delay or prolong labor beyond the expected time.

From the 20th week of pregnancy, NSAIDs may cause fetal kidney problems, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or may cause constriction of a blood vessel (ductus arteriosus) in the baby’s heart.

If you are a woman of childbearing age, have fertility problems, or are undergoing fertility investigations, inform your doctor, as this medicine may interfere with fertility.

Driving and using machines

LASER may impair your ability to drive or operate machinery.

If you experience dizziness, drowsiness, vertigo, or depression during treatment with naproxen, exercise caution when driving, operating machinery, or performing activities requiring alertness.

LASER contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.

3. How to take LASER

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Adults: The recommended dose is one LASER tablet once daily (during lunch or dinner).
Undesirable effects may be minimized by using the shortest duration of treatment necessary to control symptoms.
Elderly
If you are elderly, your doctor will carefully determine the dose you should take, possibly considering a reduction of the dose indicated above.
If you take more LASER than you should
If you take an excessive dose of Laser, contact your doctor immediately or go to the nearest hospital.
If you take more Laser than you should, the following may occur: drowsiness, stomach burning (gastric pyrosis), digestive disturbances (dyspepsia), nausea or vomiting.
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 using 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 such as LASER may be associated with a modest increase in the risk of heart attack ("myocardial infarction") or stroke.
Edema, increased blood pressure, and heart failure have been reported in association with treatment with NSAIDs.
The most commonly observed side effects are gastrointestinal in nature.
Ulceration, bleeding or perforation of the stomach or intestines (peptic ulcers, gastrointestinal perforation or bleeding), sometimes fatal, may occur, particularly in elderly patients (see section "Warnings and precautions").
After administration of LASER, the following have been reported: nausea, vomiting, diarrhoea, flatulence (passing gas from the intestine), constipation, dyspepsia (digestive disturbances), abdominal and epigastric pain, gastric pyrosis (heartburn), melaena (black stools due to presence of blood), haematemesis (vomiting blood), ulcerative stomatitis (ulcers of the oral mucosa), worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases) (see section "Warnings and precautions").
Gastritis has been reported 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 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 distinctive 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), itching sensation. Very rarely:
• blistering reactions including a condition called Stevens-Johnson syndrome (SJS) with severe skin, mouth and other body lesions, high fever, vomiting, diarrhoea and joint pain, skin death (toxic epidermal necrolysis (TEN))

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

• changes in the concentration of certain types of blood cells (thrombocytopenia, granulocytopenia, aplastic or haemolytic anaemia)
• hypersensitivity
• severe and rapid generalized allergic reactions (anaphylactic or anaphylactoid reactions)
• high potassium levels in the blood (hyperkalaemia)
• insomnia
• seizures
• headache (cephalalgia)
• drowsiness
• difficulty concentrating
• inflammation of the membranes surrounding the brain (aseptic meningitis)
• eye disorders
• hearing disturbances (tinnitus, vertigo)
• rapid heartbeat (tachycardia)
• heart function problems (heart failure, myocardial infarction, cardiac decompensation)
• damage to blood vessels in the brain (stroke)
• high blood pressure (hypertension)
• inflammation of blood vessels (vasculitis)
• swelling (oedema)
• breathing difficulties (dyspnoea, bronchospasm)
• lung inflammation (eosinophilic pneumonia)
• throat swelling (laryngeal oedema)
• yellowing of the skin (jaundice)
• severe liver inflammation (severe 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)
• abnormal and exaggerated skin reaction to light (photosensitivity reactions)
• hair loss (alopecia)
• blood in the urine (haematuria)
• reduced kidney function
• mild swelling of extremities (peripheral oedema)
• sensation of thirst
• changes in laboratory tests assessing liver function
• increased creatinine in the blood (hypercreatininaemia)
• rectal bleeding, tenesmus (painful spasm of the anus and bladder with a constant urge to defecate or urinate), and proctitis (inflammation of the rectum)
• gastrointestinal bleeding, peptic ulcer, and colitis
• decreased platelet aggregation (blood cells regulating blood coagulation) and prolonged bleeding time

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store LASER

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
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 LASER contains

• The active substance is naproxen. Each modified-release tablet contains 750 mg of naproxen.
• The other components are: Polyvinylpyrrolidone, hydroxypropylmethylcellulose, lactose, magnesium stearate.

Description of the appearance of LASER and the contents of the pack
Carton containing two blisters of 10 modified-release tablets each.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EURO-PHARMA S.R.L., Via Garzigliana 8 - 10127 Turin.
Manufacturer
Industria Farmaceutica NOVA ARGENTIA S.r.l., Via Pascoli, 1 – Gorgonzola (MI).