ARDBEG 80 mg Powder For Oral Solution

Зміст інструкції

1. ARDBEG 80 mg ADULTI powder for oral solution
   1. What ARDBEG is and what it is used for
   2. What you need to know before taking ARDBEG
   3. How to take ARDBEG
   4. Possible side effects
   5. How to store ARDBEG
   6. Contents of the pack and other information

ARDBEG 80 mg ADULTI powder for oral solution

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

1. What ARDBEG is and what it is used for

ARDBEG contains the active substance ketoprofen lysine salt.
Ketoprofen lysine salt belongs to a category of medicines called non-steroidal anti-inflammatory and
rheumatic drugs, used to relieve inflammatory conditions associated with pain, including:

• rheumatoid arthritis, ankylosing spondylitis, painful osteoarthritis, extra-articular rheumatism, post-traumatic inflammation,
• painful inflammatory conditions in dentistry, otolaryngology, urology and pneumology.

2. What you need to know before taking ARDBEG

Do not take ARDBEG

• if you are allergic to lysine ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the other components of this medicine (listed in section 6);
• if you have had an allergic reaction in the past after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. There is a possibility that if you are allergic to these substances you may also be allergic to lysine ketoprofen and could therefore experience breathing difficulties (bronchospasm, asthma attacks), rhinitis, urticaria or other allergic-type reactions. Serious allergic reactions with sudden onset (anaphylactic), rarely fatal, have been reported in these patients;
• if you have suffered from bronchial asthma;
• if you have severe heart problems (heart failure);
• if you suffer from or have suffered from bleeding, lesions (ulcers) or perforation of the stomach or intestines, even as a result of previous therapy with non-steroidal anti-inflammatory drugs;
• if you have ongoing bleeding or a predisposition to bleeding;
• if you suffer from chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
• if you suffer from blood disorders such as leukopenia and thrombocytopenia;
• if you suffer from haemostatic disorders;
• if you suffer from gastritis;
• if you have severe liver problems (severe hepatic insufficiency, hepatic cirrhosis, severe hepatitis);
• if you have severe kidney problems (severe renal insufficiency);
• if you suffer from hemorrhagic diathesis and other blood coagulation disorders;
• if you are in the last 3 months of pregnancy;
• if the person who is to take this medicine is of pediatric age (up to 14 years);
• if you are taking diuretics intensively, medicines that promote urine elimination.

Warnings and precautions
Consult your doctor or pharmacist before taking ARDBEG:

• If you suffer from asthma or asthma associated with a cold (chronic rhinitis), chronic sinusitis and/or nasal polyps. These conditions may expose you to a higher risk of developing allergic reactions to anti-inflammatory drugs and aspirin (acetylsalicylic acid) (see “Other medicines and ARDBEG”).
• If you suffer from severe kidney, heart or liver disorders, if you are undergoing therapy with diuretics or if you are elderly. In all these cases, the use of lysine ketoprofen may reduce blood flow to the kidneys and lead to renal failure. Only your doctor can decide reif you can use ARDBEG and, if so, will subject you to careful monitoring of renal function.
• If you have hypertension (high blood pressure).
• If you suffer from heart problems (congestive heart failure, confirmed ischemic heart disease), if you have problems with blood vessels (peripheral arterial disease), if you have cerebrovascular diseases or are affected by certain conditions that predispose you to developing cardiovascular diseases (e.g. hypertension, high levels of fats and cholesterol in the blood, diabetes mellitus, smoking). The use of ARDBEG should be evaluated by your doctor who will determine if the benefits outweigh the potential risks.
• If you have diabetes, kidney problems or are being treated with medicines that cause increased potassium levels. In this case, the doctor will need to monitor your potassium levels in the blood.
• If you have infections, as this medicine may mask symptoms such as fever.
• If you have vision problems.
• If you suffer from systemic lupus erythematosus (an autoimmune disease) or mixed connective tissue diseases.
• If you suffer from disorders of the formation and maturation of blood cells (hematopoietic alterations).
• If you are an elderly patient. Your age exposes you to a greater risk of having adverse effects from medicines, especially bleeding and perforations in the stomach or intestine, sometimes even with fatal outcome. The risk is increased with the use of high doses. Your doctor will advise you to start treatment with the lowest available dose, and to take drugs to protect the stomach walls.
• If you are taking other medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, antidepressants (selective serotonin reuptake inhibitors) or antiplatelet agents such as aspirin (see section “Other medicines and ARDBEG”).
• If you suffer from gastrointestinal diseases (ulcerative colitis, Crohn's disease). The use of NSAIDs may worsen your condition (see paragraph 4).
• If you have an infection - see paragraph «Infections» below.

Infections
ARDBEG can mask the symptoms of infections such as fever and pain. Therefore, it is possible that ARDBEG
may delay adequate treatment of the infection, which could increase the risk of
complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections
related to varicella. If you take this medicine while you have an infection and the symptoms of the infection
persist or worsen, consult your doctor immediately.

During the use of ARDBEG, keep in mind that:

• The use of this medicine at the lowest doses and for short periods of time reduces the occurrence of side effects (see below and paragraph 3).
• This medicine cannot be considered a simple painkiller and requires to be used under the strict control of the doctor.
• The concomitant use of ARDBEG with other anti-inflammatory drugs should be avoided, including selective cyclooxygenase-2 inhibitors (see “Other medicines and ARDBEG”).
• The use of anti-inflammatory drugs, especially at high doses for a long time, may increase the risk of developing heart attack or stroke.
• During treatment with all non-steroidal anti-inflammatory drugs (NSAIDs), at any time, with or without warning symptoms or a previous history of serious gastrointestinal events, gastrointestinal bleeding (hemorrhage), lesions (ulcerations) and perforations of the stomach and intestines have been reported, which can be fatal. The risk of such reactions appears to be higher with lysine ketoprofen than with other NSAIDs, especially at high doses (see also “Do not take ARDBEG”).
• If you are a patient with a history of ulcer, complicated by bleeding and perforation, especially if you are elderly, you should report any abdominal symptoms (especially gastrointestinal bleeding) particularly in the early stages of treatment.
• If you should experience gastrointestinal bleeding or ulceration, stop treatment immediately and consult your doctor or go to the nearest hospital.
• If you notice the onset of vision problems (such as blurred vision), stop treatment immediately and consult your doctor.
• During long-term treatments, tests should be performed to evaluate the number of blood cells (blood count) and tests to evaluate liver (especially if you are a patient with liver problems) and kidney function.
• As with other NSAIDs, in case of infections, it must be kept in mind that the anti-inflammatory, analgesic and antipyretic properties of lysine ketoprofen may mask the characteristic symptoms of infection progression, such as fever.
• The use of NSAIDs can rarely cause severe skin reactions, some of which are fatal, including severe widespread skin irritation and with skin shedding (exfoliative dermatitis), severe skin reaction with shedding and swelling of the skin, blisters on the skin, mouth, eyes, genitals (Stevens-Johnson syndrome), often accompanied by malaise, chills, myalgia and fever (toxic epidermal necrolysis) (see paragraph 4). The onset of reactions occurs in most cases within the first month of treatment. Immediately discontinue treatment with ARDBEG at the first appearance of a skin rash, mucous membrane lesions or any other sign of allergy (hypersensitivity).

Elderly
Elderly patients have a higher frequency of developing adverse reactions to NSAIDs, especially
bleeding and gastrointestinal perforations, which can be fatal (see paragraph 3).

Other medicines and ARDBEG
Inform your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
Some medicines can alter the effect of ARDBEG or the effect of these medicines can be
modified by ARDBEG. This type of interaction can reduce the effect of one or both medicines. In
alternative, it can increase the risk or severity of side effects.

Do not take ARDBEG with:

• Acetylsalicylic acid or other non-steroidal anti-inflammatory drugs: increased risk of gastrointestinal ulceration and bleeding.
• Anticoagulants (heparin and warfarin): NSAIDs can amplify the effects of anticoagulants such as warfarin and heparin.
• Antiplatelet agents such as ticlopidine, clopidogrel: increased risk of gastrointestinal bleeding (see “Warnings and precautions”). If co-administration is unavoidable, inform your doctor who will keep you under strict control.
• Lithium: risk of increased lithium levels in the blood, which can reach toxic values.
• Methotrexate at doses greater than 15mg/week: increased risk of blood toxicity caused by methotrexate. 12 hours must elapse between the suspension or start of treatment with lysine ketoprofen and the administration of methotrexate.
• Hydantoins and sulfonamides: the toxic effects of these substances may be increased.

Be particularly careful when using ARDBEG if you are taking the following medicines:

• Medicines that increase potassium levels in the blood such as potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs, heparin, cyclosporine, tacrolimus and trimethoprim;
• Tenofovir, (used in the treatment of some viral infections): concomitant use of tenofovir and NSAIDs may increase the risk of renal insufficiency;
• diuretics :NSAIDs can reduce the effect of diuretics and other medicines used to lower blood pressure (antihypertensives). In patients, especially those dehydrated who are taking diuretics, there may be a high risk of developing renal dysfunction. These patients must be adequately rehydrated before starting co-administration with NSAIDs and their renal function must be monitored when treatment begins (see “Warnings and precautions”);
• medicines that lower blood pressure (ACE inhibitors and angiotensin II antagonists): in patients with impaired renal function (e.g. dehydrated patients or elderly patients) the co-administration of a medicine used to lower blood pressure such as an ACE inhibitor or an angiotensin II antagonist and an NSAID may lead to a further worsening of renal function;
• Methotrexate (used in the treatment of neoplasms and autoimmune diseases) at doses less than 15mg/week;
• corticosteroids (used for allergies and inflammation): concomitant use may increase the risk of gastrointestinal ulceration or bleeding (see “Warnings and precautions”);
• Pentoxifylline (used to inhibit blood clot formation): these medicines increase the risk of bleeding if taken together with lysine ketoprofen. The doctor will subject you to more frequent clinical checks and monitoring of bleeding time;
• Zidovudine (medicine used to treat HIV): increased blood toxicity with possible severe anemia may occur. Blood tests should be performed after starting treatment with NSAIDs.
• sulfonylureas (used in the therapy of type 2 Diabetes): NSAIDs may increase their hypoglycemic effect (reduction in blood sugar concentration);
• Cardiac glycosides, used for the treatment of some heart diseases.

Inform your doctor if you are taking the following medicines. Only the doctor will be able to consider whether you can
take ARDBEG together with the following medicines:

• Antihypertensives (beta-blockers, angiotensin-converting enzyme inhibitors, diuretics). Co-administration with NSAIDs may reduce their effect.
• Mifepristone: the effectiveness of the contraceptive method may be reduced.
• Intrauterine devices (IUDs) the effectiveness of the device may be reduced with consequent pregnancy.
• Cyclosporine, tacrolimus (immunosuppressive drugs): used with lysine ketoprofen increase the risk of toxic effects on the kidneys, especially in the elderly.
• Thrombolytics (used to induce the breaking of thrombi): increase the risk of bleeding
• Antidepressants (Selective Serotonin Reuptake Inhibitors (SSRIs)): there is a risk of increased gastrointestinal bleeding
• Probenecid (used in the therapy of hyperuricemia and gout)
• Quinolone antibiotics: may increase the risk of developing seizures.
• Diphenylhydantoin (used for the treatment of epilepsy) and Sulfonamide antibiotics: the toxic effects of these substances may be increased
• Gemeprost, a medicine used in operations of the female genital apparatus.

ARDBEG and alcohol
Avoid drinking alcohol.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with breast milk,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

Do not takeARDBEG during the third trimester of pregnancy.
The use of ARDBEG is not recommended even during the first and second trimester of pregnancy,
because it may increase the risk of abortion and malformations. This medicine can only be used in
these cases if absolutely necessary and under strict medical supervision.
Breastfeeding
No data are available on the excretion of ketoprofen lysine salt into breast milk. Ketoprofen lysine
salt is not recommended in breastfeeding women.
Fertility
The use of NSAIDs may impair female fertility and is not recommended in women who
are trying to conceive. In women who have fertility problems or who are undergoing
fertility investigations, discontinuation of treatment with NSAIDs should be considered.

Driving and operating machinery
ARDBEG may cause dizziness, drowsiness, vertigo, convulsions or visual disturbances.
If any of these symptoms occur, do not drive or operate machinery and do not perform activities that
require particular attention.

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

3. How to take ARDBEG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you
have an infection, consult your doctor immediately if symptoms (such as fever and pain)
persist or worsen (see section 2).

Adults
One 80 mg sachet (full dose) three times a day during meals.
Pour the contents of one sachet into a half glass of water and mix.

Elderly
If you are elderly, your doctor will determine the appropriate dose for you.

Patients with kidney problems
If you have kidney problems, your doctor will determine the appropriate dose for you.
If you have severe kidney dysfunction, you should not take this medicine (see the section “Do
not take”).

Patients with liver problems
If you have liver problems, your doctor will determine the appropriate dose for you.
If you have severe hepatic dysfunction, you should not take this medicine (see the section “Do
not take”).

Use in children
ARDBEG should not be used in children under 14 years of age.

If you take more ARDBEG than you should
In case of accidental intake/ingestion of an excessive dose of ARDBEG, stop
administration of the medicine immediately and inform your doctor or go to the nearest
hospital, where you will be given the most effective therapeutic treatments based on the symptoms you exhibit.

If you forget to take ARDBEG
Do not take a double dose to make up for a missed dose.
Inform your doctor who will tell you how to continue therapy.
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 everybody gets them.
manifest.

The side effects that may occur with ARDBEG are:
Common (may affect up to 1 in 10 people)

• Nausea
• Digestive problems (dyspepsia)
• Abdominal pain
• Vomiting.

Uncommon (may affect up to 1 in 100 people)

• Headache, dizziness, vertigo
• Drowsiness
• Constipation, diarrhea, flatulence, inflammation of the stomach (gastritis)
• Skin irritation (rash) and itching, swelling due to fluid retention (edema)
• Fatigue
• Chills.

Rare (may affect up to 1 in 1,000 people)

• Decrease in red blood cells due to bleeding (hemorrhagic anemia)
• Alteration of the sensitivity of the limbs (paresthesia)
• Blurred vision
• Ringing in the ear (tinnitus)
• Asthma
• Inflammation of the mouth (stomatitis), ulcer (peptic ulcer), colitis, liver problems (hepatitis, increased values of some blood tests, such as transaminases, bilirubin due to liver disorders), jaundice
• Weight gain.

Very Rare (may affect up to 1 in 10,000 people)

• Movement disorders (dyskinesia)
• Syncope, low blood pressure
• Edema (swelling) of the larynx
• Presence of blood in the urine (hematuria)
• Swelling (edema) of the face
• Feeling of physical weakness.

Frequency not known (the frequency cannot be estimated from the available data)

• Inflammation of the membranes lining the brain (aseptic meningitis)
• Lymphatic vessel disease (lymphangitis)
• Reduction absence of some blood cells (thrombocytopenia, agranulocytosis, leukopenia, neutropenia)
• Bone marrow failure, increase of some blood cells (leukocytosis), insufficient production of blood cells (bone marrow failure), decrease of red blood cells (hemolytic anemia, aplastic anemia), thrombocytopenic purpura
• Allergic (anaphylactic) reactions, also severe, hypersensitivity
• Decrease in the amount of sodium in the blood (hyponatremia), increase in the amount of potassium in the blood (hyperpotassemia)
• Depression, hallucinations, confusion, mood alteration, excitability, insomnia, anxiety, behavioral disorders
• Convulsions
• Alterations of taste (dysgeusia)
• Tremors, movement disorders (hyperkinesia)
• Swelling of the area around the eye (periorbital edema)
• Heart problems (heart failure), alteration of the heartbeat (atrial fibrillation) palpitations, tachycardia, increased blood pressure, dilation of blood vessels, generalized redness due to alterations of blood vessels (vasculitis, including leucocytoclastic vasculitis)
• Constriction of the bronchi (bronchospasm), cold (rhinitis), difficulty breathing (dyspnea), laryngospasm, acute respiratory failure
• Problems with the stomach and intestines (gastralgia, worsening of colitis and Crohn's disease, gastrointestinal bleeding and perforation), gastric ulcer, duodenal ulcer, heartburn, swelling of the mouth and tongue, blood in the stool and vomit, inflammation of the pancreas (pancreatitis), stomach acidity, gastric pain, gastritis
• Excessive sensitivity to light (photosensitivity)
• Hair loss (alopecia)
• Skin diseases, also very serious (urticaria, blistering eruptions, Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis, erythema, exanthem, maculo-papular rash, purpura)
• Red and infected widespread lesions (acute generalized exanthematous pustulosis)
• Dermatitis, swelling of the skin, mucous membranes and submucosal tissues (angioedema)
• Kidney problems (acute renal failure, tubulointerstitial nephritis, nephritis, nephrotic syndrome, glomerular nephritis, retention of water/sodium with possible edema, acute tubular necrosis, renal papillary necrosis) reduction of urine (oliguria), abnormalities in renal function tests.

Please note that
Clinical studies and epidemiological data suggest that the use of products like ARDBEG (especially at high
doses and for long-term treatments) may be associated with a modest increase in the risk of
arterial thrombotic events (e.g., myocardial infarction or stroke).

Reporting of side effects
If 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 the address 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 ARDBEG

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 label after “Scad.” The expiry
date refers to the last day of that month and the product in intact packaging correctly
stored.
Store in the original packaging to protect the medicine from light. Do not store at
a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ARDBEG contains
The active ingredient is ketoprofen lysine salt.
One sachet contains ketoprofen lysine salt 80 mg (equivalent to 50 mg of ketoprofen).
The other ingredients are: Sorbitol, colloidal anhydrous silica, sodium chloride, sodium saccharin, mint flavour.

Description of the appearance of ARDBEG and contents of the pack
Lithographed cardboard box containing 30 sachets of powder for oral solution.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
LANOVA FARMACEUTICI S.R.L. – VIA CONCA D’ORO 212 – 00141 ROMA

Manufacturers
Mipharm S.p.A.
Via B. Quaranta, 12 – Milano
LA.FA.RE S.r.l.
Laboratorio Farmaceutico Reggiano
Via Sacerdote Benedetto Cozzolino, 77 – Ercolano (NA)