ALKET 200 mg Kapsułka O Przedłużonym Uwalnianiu

Treść ulotki

1. ALKET 200 mg prolonged-release hard capsules
   1. What is ALKET and what is it used for
   2. What you need to know before taking ALKET
   3. How to take ALKET
   4. Possible side effects
   5. How to store ALKET
   6. Contents of the pack and other information

ALKET 200 mg prolonged-release hard capsules

Ketoprofen
“Generic medicine”

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

1. What is ALKET and what is it used for

ALKET contains the active ingredient ketoprofen, which belongs to the category of non-steroidal anti-inflammatory, antirheumatic drugs.
ALKET is used for the treatment of rheumatoid arthritis, ankylosing spondylitis, acute gout, osteoarthritis with various locations, sciatica, radiculitis, myalgia, bursitis, tendinitis, tenosynovitis, synovitis, capsulitis, contusions, sprains, dislocations, muscle tears, phlebitis, superficial thrombophlebitis, lymphangitis, painful inflammatory conditions in dentistry, otolaryngology, urology and pneumology.

2. What you need to know before taking ALKET

Do not take ALKET

• if you are allergic to ketoprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions in the past such as bronchospasm (narrowing of the airways), asthma attacks, rhinitis, urticaria or other allergic-type reactions to ketoprofen, Acetylsalicylic Acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs). Severe, rarely fatal, anaphylactic reactions have been reported in these patients (see section “Possible side effects”);
• if you are taking diuretics (medicines that promote urine production) intensively;
• if you have severe kidney problems (severe renal insufficiency);
• if you have severe liver problems (liver cirrhosis, severe hepatitis);
• if you suffer from blood disorders, such as leukopenia (low white blood cell count) and thrombocytopenia (low platelet count);
• if you have a haemorrhage (blood loss);
• if you are predisposed to blood loss (haemorrhagic diathesis);
• if you are a subject with haemostatic disorders (blood coagulation disorders);
• if you have severe heart problems (severe heart failure);
• if you suffer from ulcers in the stomach or intestine (active peptic ulcer) or have suffered from bleeding, ulcers or perforation of the stomach and intestine;
• if you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if the person who is to take the medicine is a child.

Warnings and precautions
Consult your doctor or pharmacist before taking ALKET.
Pay particular attention with ALKET:

• if you suffer from or have suffered from allergies, if you are predisposed to problems with constriction of the airways, if you suffer from asthma associated with chronic colds, chronic sinusitis and nasal polyps;
• if you are taking other anti-inflammatory non-steroidal drugs (NSAIDs) (see section “Other medicines and ALKET);
• if you suffer from heart failure, cirrhosis, nephrosis, chronic renal insufficiency or take diuretic medicines (medicines that increase urine production), especially if you are elderly, your doctor will subject you to checks, as the administration of ketoprofen may worsen kidney function;
• if you suffer from high blood pressure and/or heart problems such as mild or moderate congestive heart failure because fluid retention and swelling due to fluid accumulation (edema) may occur;
• if you have an irregular heartbeat (atrial fibrillation);
• if you suffer from uncontrolled high blood pressure, heart and circulation problems (congestive heart failure, established ischemic heart disease, and peripheral arterial and/or cerebrovascular disease);
• if you suffer from diabetes, if you have high levels of fats in the blood (hyperlipidemia) or if you smoke. In these cases, the doctor will determine whether you can use this medicine;
• if you have suffered from problems with the stomach and intestines (ulcers, Crohn's disease, ulcerative colitis) or if you take medicines that may increase the risk of injury to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin or nicorandil) (see section “Other medicines and ALKET);
• if you have high levels of potassium, especially if you suffer from diabetes, kidney problems or are being treated with other medicines that cause increased potassium levels. In this case, the doctor will need to monitor these values
• if you suffer from an infection, because this medicine may mask its symptoms such as fever;
• if you suffer from liver problems or have suffered from liver problems, because ALKET may worsen your condition. In these cases, the doctor will need to subject you to frequent checks during treatment, especially for prolonged periods;
• if you suffer from an ulcer, especially if complicated by bleeding or perforation; the risk of gastrointestinal bleeding, ulceration or perforation is higher with high doses: start treatment with the lowest available dose; the doctor may prescribe medicines to protect the stomach, such as misoprostol or proton pump inhibitors.
• if you have an infection - see paragraph «Infections» below. This medicine can cause:
• serious heart and blood circulation problems (arterial thrombotic events, heart attack or stroke), especially at high doses and for prolonged treatments or if used to treat pain in the period before or after coronary artery bypass surgery;
• serious problems with the stomach and intestines that can be fatal (bleeding, ulcers, perforations), especially at high doses and if your body weight is low;
• serious, even very rare, skin and mucous membrane irritations, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which can manifest with lesions of the skin and mucous membranes. This can occur especially in the first month of treatment;
• visual disturbances (blurred vision). During therapy, especially if long-term, the doctor will need to monitor you.

If you experience any of these effects, stop treatment and consult your doctor immediately.
You can reduce the risk of experiencing side effects by taking ALKET at the minimum effective dose and for the shortest possible duration.
Avoid taking other non-steroidal anti-inflammatory drugs during treatment with ALKET.

Children and adolescents:
ALKET is contraindicated in childhood.

Elderly
If you are elderly, take this medicine with caution as you are more prone to bleeding and perforation of the stomach and intestines, which can be fatal, and to other side effects such as reduced kidney, heart and liver function (see section “Possible side effects”). The doctor will indicate the dose to be taken and whether it is necessary to take medicines that protect against ulcers (misoprostol or proton pump inhibitors). The doctor will need to monitor you during treatment with ketoprofen.

Other medicines and ALKET
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Infections
ALKET can mask the symptoms of infections such as fever and pain. It is therefore possible that ALKET 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 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.

Avoid taking the following medicines together with ALKET:

• other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Warnings and precautions”);
• medicines to make the blood more fluid (anticoagulants, e.g. heparin, warfarin, dabigatran, apixaban, rivaroxaban, edoxaban and antiplatelet agents such as ticlopidine and clopidogrel, or other salicylates) (see sections “Do not take ALKET” and “Warnings and precautions”);
• lithium, used to treat depression or similar disorders;
• methotrexate (medicine used to treat rheumatoid arthritis and cancer) used at high doses (15 mg per week).

Take ALKET with caution if you are taking any of 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 (low molecular weight or unfractionated), cyclosporine, tacrolimus and trimethoprim;
• diuretic medicines used to promote urine production, especially if you are an elderly patient particularly dehydrated (see sections “Do not take ALKET” and “Warnings and precautions”);
• medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II antagonists), especially if you are elderly and drink little water (are poorly hydrated);
• methotrexate at low doses (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for blood circulation problems;
• tenofovir, a medicine used to treat some viral infections;
• nicorandil, a medicine used to prevent or relieve chest pain due to heart problems;
• cardiac glycosides, substances used to treat some heart conditions.

The doctor will need to monitor you and may possibly reduce the dosage of ketoprofen if you are taking any of the following medicines:

• medicines used to treat high blood pressure such as beta-blockers, angiotensin-converting enzyme inhibitors;
• thrombolytics and anti-aggregating agents, used for blood coagulation problems;
• selective serotonin reuptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in operations of the female genital apparatus;
• intrauterine devices (IUDs) the effectiveness of the device may be reduced with consequent pregnancy;
• mifepristone (medicine used for termination of pregnancy), as the effectiveness of the method may, in theory, be reduced due to the anti-prostaglandin properties of non-steroidal anti-inflammatory drugs (NSAIDs);
• cyclosporine and tacrolimus (medicines used after a transplant or for the treatment of immune system disorders);
• quinolone antibiotics as patients taking NSAIDs and quinolones may have an increased risk of developing seizures. Pregnancy, breastfeeding and fertilityIf you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not take ALKET in the last 3 months of pregnancy as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and the baby's tendency to bleed and delay or prolong labour more than expected.

You should not take ALKET in the first 6 months of pregnancy unless absolutely necessary and under direct medical supervision. If treatment is necessary during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time.
From the 20th week of pregnancy, ALKET may cause kidney problems in the fetus, if taken for more than a few days, 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. If treatment is necessary for more than a few days, the doctor may advise additional monitoring.

Breastfeeding
ALKET is not recommended during breastfeeding.
Fertility
ALKET may cause fertility problems in women and is not recommended in women who intend to become pregnant.
You should inform your doctor if you plan to become pregnant, as this medicine may reduce fertility, and if you need to have fertility tests, as these may be altered.

Driving and using machines
As drowsiness, dizziness, vertigo, seizures or visual disturbances may occur during the taking of this medicine, do not drive vehicles or use machines if such symptoms occur.

ALKET contains sucrose
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take ALKET

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts
consult your doctor or pharmacist.
The use of this medicine is reserved for adult patients only.
The recommended dose in adults is 1 capsule of ALKET 200 mg once a day.
ALKET must be taken orally after a meal.
The doctor will indicate the appropriate dose according to your weight and the severity of your symptoms.
The maximum daily dose of ketoprofen is 200 mg.
The lowest effective dose for the shortest period necessary to relieve symptoms must be used. If you have
an infection, consult your doctor immediately if symptoms (e.g. fever and pain) persist or
worsen (see section 2).

Use in the elderly and people with kidney problems
If you are elderly or have kidney problems, your doctor will determine the dose.

Use in people with liver problems
If you suffer from mild or moderate liver problems, your doctor will monitor you carefully and advise
you on the minimum effective daily dose (see “Warnings and precautions” section).

Use in children
Do not give ALKET to children.

If you take more ALKET than you should
The disorders of an overdose with doses up to 2.5 g of ketoprofen are as follows: lethargy, drowsiness, sto-
mach pain, nausea and vomiting. If this occurs, consult your doctor who will establish an appropriate thera-
py for the symptoms.
In adults, the main signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhea
and abdominal pain. In cases of severe overdose, hypotension (low blood pressure), respiratory depression and gastrointestinal bleeding have been observed. If you experience any of these symptoms, you should
be immediately transferred to a specialist center to start symptomatic treatment.
In case of accidental ingestion of an excessive dose of this medicine, immediately inform
your doctor or go to the nearest hospital emergency room.

If you forget to take ALKET
If you forget to take a dose, take it as soon as you remember, unless it is almost time to take the
next dose. Do not take a double dose to make up for a missed dose.
If you have any questions 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.
The side effects that may occur with ALKET 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, giddiness, drowsiness
• Constipation, diarrhoea, flatulence, inflammation of the stomach (gastritis)
• Skin irritation (rash) and itching
• Swelling due to fluid retention (edema),
• Fatigue Rare(may affect up to 1 in 1,000 )
• Decrease in red blood cells due to bleeding (hemorrhagic anemia)
• Decrease in white blood cells (leukopenia)
• 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.

Frequency not known (the frequency of which cannot be estimated based on the available data)

• Blood problems (thrombocytopenia, agranulocytosis, bone marrow failure), decrease in red blood cells (hemolytic anemia)
• Depression, hallucinations, confusion, mood alteration, convulsions,
• Alterations of taste (dysgeusia)
• Inflammation of the membranes lining the brain not caused by bacteria (aseptic meningitis)
• Heart problems (heart failure), alteration of the heartbeat (atrial fibrillation, tachycardia, palpitations)
• Increased blood pressure, dilation of blood vessels, generalized flushing due to alterations of blood vessels (vasculitis, including leucocytoclastic vasculitis)
• Constriction of the bronchi (bronchospasm), common cold (rhinitis), difficulty breathing (dyspnea)
• Problems with the stomach and intestines (colitis and Crohn's disease, gastrointestinal bleeding and perforation)
• Blood in stools and vomit
• Inflammation of the pancreas (pancreatitis)
• Excessive sensitivity to light (photosensitivity)
• Generalized skin rash (cutaneous exanthem), erythema
• Hair loss (alopecia)
• Skin diseases, even very serious ones (urticaria, blistering rashes, Stevens-Johnson syndrome, and toxic epidermal necrolysis), widespread red and infected lesions (acute generalized exanthematous pustulosis), swelling of the skin, mucous membranes and submucosal tissues (angioedema)
• Kidney problems (acute renal failure, tubulo-interstitial nephritis, nephrotic syndrome, abnormalities in renal function tests)
• Allergic reactions (anaphylactic), even severe, with shock
• Decrease in the amount of sodium in the blood (hyponatremia), increase in the amount of potassium in the blood (hyperpotassemia)

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 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 ALKET

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 after Exp. The expiry date refers to the last day of that month. The expiry date indicated refers to the product in intact packaging correctly stored.
Do not dispose of any medicine in 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 ALKET contains

• The active ingredient is ketoprofen. One prolonged-release capsule contains 200 mg of ketoprofen
• The other ingredients are: sucrose and starch microgranules, povidone K 30, po- ly(methyl)methacrylates (Eudragit RS), talc. Capsule constituents: gelatin, titanium dioxide (E 171).

Description of the appearance of ALKET and contents of the pack
Hard prolonged-release capsules containing 200 mg of ketoprofen
Pack of 28 capsules.

Marketing Authorisation Holder
S.F. GROUP Srl – Via Tiburtina, 1143 – 01156 - Roma

Manufacturer
Aptalis Pharma S.r.l.
Via Marche, 9
20098 S. Giuliano Milanese (MI) Italy
FULTON MEDICINALI S.p.A.
Via Marconi, 28/9
Arese (MI)
LA.FA.RE. srl,
Via Sac. Benedetto Cozzolino 67
80056 Ercolano (NA)

This leaflet was last updated on