Ardbeg: detailed information

Package leaflet: Information for the patient

ARDBEG 80 mg ADULTS powder for oral solution

Ketoprofen lysine salt
“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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What ARDBEG is and what it is used for
What you need to know before taking ARDBEG
How to take ARDBEG
Possible side effects
How to store ARDBEG
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 group of medicines called non-steroidal anti-inflammatory and anti-rheumatic drugs, used to relieve inflammatory conditions associated with pain, such as:

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

2. What you need to know before taking ARDBEG

Do not take ARDBEG

if you are allergic to ketoprofen lysine salt, to other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced an allergic reaction 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 ketoprofen lysine salt, and respiratory difficulties (bronchospasm, asthma attacks), rhinitis, urticaria, or other allergic-type reactions may occur. Severe, sudden-onset allergic reactions (anaphylactic), rarely fatal, have been reported in such patients;
if you have suffered from bronchial asthma;
if you have severe heart problems (heart failure);
if you currently have or have previously had bleeding, lesions (ulcers), or perforation in the stomach or intestine, even as a result of previous treatment with non-steroidal anti-inflammatory drugs;
if you have active bleeding or are predisposed 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 coagulation disorders;
if you suffer from gastritis;
if you have severe liver problems (severe hepatic insufficiency, liver cirrhosis, severe hepatitis);
if you have severe kidney problems (severe renal insufficiency);
if you suffer from hemorrhagic diathesis or other blood coagulation disorders;
if you are in the last three months of pregnancy;
if the person taking this medicine is a child (under 14 years of age);
if you are taking diuretic medicines intensively.

Warnings and precautions
Talk to your doctor or pharmacist before taking ARDBEG:

If you suffer from asthma or asthma associated with colds (chronic rhinitis), chronic sinusitis, and/or nasal polyps. These conditions may increase your 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 being treated with diuretic medicines, or if you are elderly. In all these cases, the use of ketoprofen lysine salt may reduce blood flow to the kidneys and lead to renal failure. Only your doctor can decide whether you may use ARDBEG, and if so, will subject you to careful monitoring of kidney function.
If you are hypertensive (have high blood pressure).
If you suffer from heart problems (congestive heart failure, confirmed ischemic heart disease), if you have blood vessel disorders (peripheral arterial disease), cerebrovascular diseases, or if you have conditions that predispose you to cardiovascular diseases (e.g., hypertension, high blood lipid and cholesterol levels, diabetes mellitus, smoking). The use of ARDBEG should be evaluated by your doctor, who will determine whether the benefits outweigh the potential risks.
If you have diabetes, kidney problems, or are being treated with medicines that increase potassium levels. In this case, your doctor should monitor your blood potassium levels.
If you have infections, as this medicine may mask their symptoms, such as fever.
If you have vision problems.
If you suffer from systemic lupus erythematosus (an autoimmune disease) or mixed connective tissue disorders.
If you suffer from disorders affecting the formation and maturation of blood cells (hematopoietic alterations).
If you are an elderly patient. Your age increases your risk of experiencing adverse effects from anti-inflammatory drugs, especially gastrointestinal bleeding and perforation of the stomach or intestine, sometimes even fatal. The risk increases with higher doses. Your doctor will advise you to start treatment with the lowest available dose and may recommend taking gastric-protective medicines.
If you are taking other medicines that increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like 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 section 4).
If you have an infection – see the section «Infections» below.

Infections
ARDBEG may mask symptoms of infections such as fever and pain. Therefore, ARDBEG could delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms persist or worsen, contact your doctor immediately.

While using ARDBEG, keep in mind that:

Using this medicine at the lowest doses and for short periods reduces the occurrence of adverse effects (see below and section 3).
This drug should not be considered a simple painkiller and must be used under strict medical supervision.
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 prolonged periods, may increase the risk of developing heart attack or stroke.
During treatment with all non-steroidal anti-inflammatory drugs (NSAIDs), gastrointestinal bleeding (hemorrhage), lesions (ulceration), and perforation of the stomach and intestine, which may be fatal, have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events. The risk of such reactions appears to be higher with ketoprofen lysine salt compared to other NSAIDs, especially at high doses (see also "Do not take ARDBEG").
If you have a history of ulcers complicated by bleeding and perforation, particularly if you are elderly, report any abdominal symptoms (especially gastrointestinal bleeding) immediately, especially during the initial stages of treatment.
If you experience gastrointestinal bleeding or ulceration, stop treatment immediately and contact your doctor or go to the nearest hospital.
If you notice the onset of vision problems (such as blurred vision), stop treatment immediately and contact your doctor.
During long-term treatments, blood cell counts (hematological tests) and tests to assess liver (especially if you have liver problems) and kidney function should be performed.
As with other NSAIDs, in case of infections, it should be borne in mind that the anti-inflammatory, analgesic, and antipyretic properties of ketoprofen lysine salt may mask characteristic symptoms of infection progression, such as fever.
The use of NSAIDs may rarely cause serious skin reactions, some of which are fatal, including severe widespread skin irritation with desquamation (exfoliative dermatitis), severe skin reaction with desquamation 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 section 4). These reactions usually occur within the first month of treatment. Discontinue ARDBEG immediately at the first sign of skin rash, mucosal lesions, or any other sign of allergy (hypersensitivity).

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

Other medicines and ARDBEG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Some medicines may alter the effect of ARDBEG or the effect of these medicines may be altered by ARDBEG. This type of interaction may reduce the effect of one or both medicines. Alternatively, it may increase the risk or severity of adverse 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 may enhance 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 close monitoring.
Lithium: risk of increased lithium levels in the blood, which may reach toxic values.
Methotrexate at doses exceeding 15 mg/week: increased risk of blood toxicity caused by methotrexate. A 12-hour interval must be maintained between discontinuation or initiation of ketoprofen lysine salt treatment and methotrexate administration.
Hydantoins and sulfonamides: the toxic effects of these substances may be increased.

Exercise particular caution 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 certain viral infections): concomitant use of tenofovir and NSAIDs may increase the risk of renal failure;
Diuretics: NSAIDs may reduce the effect of diuretics and other medicines used to lower blood pressure (antihypertensives). In patients, especially dehydrated patients taking diuretics, there may be a high risk of developing kidney dysfunction. These patients should be adequately rehydrated before starting co-administration with NSAIDs, and their kidney function should be monitored when treatment begins (see "Warnings and precautions");
Medicines that lower blood pressure (ACE inhibitors and angiotensin II antagonists): in patients with impaired kidney function (e.g., dehydrated patients or elderly patients), co-administration of a blood pressure-lowering medicine such as an ACE inhibitor or an angiotensin II antagonist with an NSAID may lead to further worsening of kidney function;
Methotrexate (used in the treatment of neoplasms and autoimmune diseases) at doses below 15 mg/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 in vessels): these medicines increase the risk of bleeding when taken together with ketoprofen lysine salt. Your doctor will perform more frequent clinical checks and monitor bleeding time;
Zidovudine (a 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 treatment of type 2 diabetes): NSAIDs may enhance the hypoglycemic effect of sulfonylureas (reduction of blood sugar concentration);
Cardiac glycosides, used to treat certain heart conditions.

Inform your doctor if you are taking the following medicines. Only your doctor can determine whether you may take ARDBEG together with these medicines:

Antihypertensives (beta-blockers, angiotensin-converting enzyme inhibitors, diuretics). Administration together with NSAIDs may reduce their effect.
Mifepristone: contraceptive effectiveness may be reduced.
Intrauterine contraceptive devices (IUDs): device effectiveness may be reduced, leading to pregnancy.
Cyclosporine, tacrolimus (immunosuppressive drugs): when used with ketoprofen lysine salt, they increase the risk of kidney toxicity, especially in the elderly.
Thrombolytics (used to induce thrombus breakdown): increased risk of bleeding.
Antidepressants (Selective Serotonin Reuptake Inhibitors (SSRIs)): increased risk of gastrointestinal bleeding.
Probenecid (used in the treatment of hyperuricemia and gout).
Quinolone antibiotics: may increase the risk of developing seizures.
Phenytoin (used to treat epilepsy) and sulfonamide antibiotics: the toxic effects of these substances may be increased.
Gemeprost, a medicine used in gynecological procedures.

ARDBEG and alcohol
Avoid alcohol consumption.

Fertility, pregnancy, and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take ARDBEG during the third trimester of pregnancy.
The use of ARDBEG is not recommended during the first and second trimesters of pregnancy either, as it may increase the risk of miscarriage and malformations. This medicine may be used in these cases only if absolutely necessary and under strict medical supervision.

Breastfeeding
No data are available on the excretion of ketoprofen lysine salt in breast milk. Ketoprofen lysine salt is not recommended for breastfeeding women.

Fertility
The use of NSAIDs may impair female fertility and is not recommended for women attempting to conceive. In women experiencing fertility problems or undergoing fertility investigations, discontinuation of NSAID treatment should be considered.

Driving and using machines
ARDBEG may cause dizziness, drowsiness, vertigo, seizures, or visual disturbances.
If these symptoms occur, do not drive or operate machinery and avoid activities requiring special alertness.

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

3. How to take ARDBEG

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have
an infection, contact your doctor immediately if symptoms (for example, fever and pain)
persist or worsen (see section 2).
Adults
One 80 mg sachet (full dose) three times daily with meals.
Empty the contents of one sachet into half a glass of water and stir.
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.
Do not take this medicine if you have severe renal impairment (see section “Do not take”).
Patients with liver problems
If you have liver problems, your doctor will determine the appropriate dose for you.
Do not take this medicine if you have severe hepatic impairment (see section “Do not take”).
Use in children
ARDBEG must not be used in children under 14 years of age.
If you take more ARDBEG than you should
If you accidentally take or ingest an excessive dose of ARDBEG, stop taking the medicine immediately and contact your doctor or go to the nearest hospital. You will be given the most appropriate treatments based on the symptoms you experience.
If you forget to take ARDBEG
Do not take a double dose to make up for a forgotten dose.
Inform your doctor, who will advise you on how to continue the treatment.
If you have any doubts about how to use 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 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, diarrhoea, flatulence, inflammation of the stomach (gastritis)
Skin irritation (rash) and itching, swelling due to fluid accumulation (oedema)
Fatigue
Chills

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

Decrease in red blood cells due to bleeding (haemorrhagic anaemia)
Altered sensation in limbs (paraesthesia)
Blurred vision
Ringing in the ears (tinnitus)
Asthma
Inflammation of the mouth (stomatitis), ulcer (peptic ulcer), colitis, liver problems (hepatitis, increased levels of certain 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
Oedema (swelling) of the larynx
Presence of blood in urine (haematuria)
Swelling (oedema) of the face
Feeling of physical weakness

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

Inflammation of the membranes covering the brain (aseptic meningitis)
Lymphatic vessel disease (lymphangitis)
Reduction or absence of certain blood cells (thrombocytopenia, agranulocytosis, leucopenia, neutropenia)
Bone marrow failure, increase in certain blood cells (leucocytosis), insufficient production of blood cells (bone marrow failure), decrease in red blood cells (haemolytic anaemia, aplastic anaemia), thrombocytopenic purpura
Allergic (anaphylactic) reactions, even severe ones, hypersensitivity
Decreased sodium levels in blood (hyponatraemia), increased potassium levels in blood (hyperkalaemia)
Depression, hallucinations, confusion, mood changes, excitability, insomnia, anxiety, behavioural disturbances
Seizures
Taste disturbances (dysgeusia)
Tremors, movement disorders (hyperkinesia)
Swelling around the eye area (periorbital oedema)
Heart problems (heart failure), changes in heart rhythm (atrial fibrillation), palpitations, tachycardia, increased blood pressure, blood vessel dilation, generalized redness due to blood vessel disorders (vasculitis, including leukocytoclastic vasculitis)
Bronchial constriction (bronchospasm), cold symptoms (rhinitis), difficulty breathing (dyspnoea), laryngospasm, acute respiratory failure
Stomach and intestinal problems (gastralgia, worsening of colitis and Crohn's disease, gastrointestinal bleeding and perforation), gastric ulcer, duodenal ulcer, heartburn, swelling of mouth and tongue, blood in stool and vomit, inflammation of the pancreas (pancreatitis), stomach acidity, gastric pain, gastritis
Increased sensitivity to light (photosensitivity)
Hair loss (alopecia)
Skin disorders, even very severe ones (urticaria, bullous eruptions, Stevens-Johnson syndrome, Lyell's syndrome and toxic epidermal necrolysis, erythema, exanthema, maculopapular exanthema, purpura)
Widespread red and infected skin lesions (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, fluid/sodium retention with possible oedema, acute tubular necrosis, renal papillary necrosis), reduced urine output (oliguria), abnormalities in kidney function tests.

Please note that
Clinical studies and epidemiological data suggest that the use of products such as ARDBEG (especially at high doses and for long-term treatment) may be associated with a small increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: 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 ARDBEG

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp.". The expiry date refers to the last day of that month and applies to the product in its original, undamaged packaging stored correctly.
Store in the original packaging to protect the medicine from light. Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What ARDBEG contains
The active substance is ketoprofen lysine salt.
Each sachet contains ketoprofen lysine salt 80 mg (equivalent to 50 mg of ketoprofen).
The other components are: Sorbitol, anhydrous colloidal silica, sodium chloride, sodium saccharin, mint flavouring.

Description of the appearance of ARDBEG and the contents of the pack
Carton 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)