Alket

Package leaflet: Information for the patient

ALKET 200 mg prolonged-release hard capsules

Ketoprofen
“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 may 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:

1. What ALKET is and what it is 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

1. What ALKET is and what it is used for

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

2. What you should know before taking ALKET

Do not take ALKET

• if you are allergic to ketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• if in the past you have had allergic reactions such as bronchospasm (narrowing of the bronchial tubes), asthma attacks, rhinitis, urticaria or other allergic-type reactions to ketoprofen, acetylsalicylic acid (ASA) or other non-steroidal anti-inflammatory drugs (NSAIDs). Severe anaphylactic reactions, rarely fatal, have been reported in these patients (see section “Possible side effects”);
• if you are currently taking diuretic medicines that promote urine elimination (see sections “Warnings and precautions” and “Other medicines and ALKET”);
• 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 leucopenia (low white blood cells) or thrombocytopenia (low platelets);
• if you are experiencing bleeding (blood loss);
• if you are prone to bleeding (haemorrhagic diathesis);
• if you have coagulation disorders (blood clotting disorders);
• if you have severe heart problems (severe heart failure);
• if you suffer from stomach or intestinal ulcers (active peptic ulcer) or have previously experienced gastrointestinal bleeding, ulcers or perforation of the stomach or intestines;
• if you are in the third trimester of pregnancy (see section “Pregnancy and breastfeeding”);
• if the person taking the medicine is a child.

Warnings and precautions
Talk to your doctor or pharmacist before taking ALKET.
Exercise particular caution with ALKET:

• if you suffer from or have a history of allergies, if you are prone to bronchial constriction problems, or if you suffer from asthma associated with chronic colds, chronic sinusitis or nasal polyps;
• if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Other medicines and ALKET”);
• if you suffer from heart failure, cirrhosis, nephrosis, chronic renal insufficiency or are taking diuretic medicines (medicines that increase urine elimination), particularly if you are elderly; your doctor will monitor you, as ketoprofen administration may worsen kidney function;
• if you suffer from high blood pressure and/or heart problems such as mild or moderate congestive heart failure, as fluid retention and swelling due to fluid accumulation (oedema) may occur;
• if you have a heart rhythm disorder (atrial fibrillation);
• if you suffer from uncontrolled high blood pressure, heart problems or circulatory disorders (congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease);
• if you suffer from diabetes (diabetes mellitus), have high blood lipid levels (hyperlipidaemia) or smoke. In these cases, your doctor will determine whether you can use this medicine;
• if you have previously suffered from stomach or intestinal problems (ulcers, Crohn’s disease, ulcerative colitis) or if you are taking medicines that may increase the risk of damage to these organs (oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as aspirin or nicorandil) (see sections “Do not take ALKET” and “Other medicines and ALKET”);
• if you have high potassium levels, especially if you have diabetes, kidney problems or are being treated with other medicines that increase potassium levels. In this case, your doctor must monitor these values;
• if you suffer from an infectious disease, because this medicine may mask symptoms such as fever;
• if you suffer from liver problems or have previously had liver problems, because ALKET may worsen your condition. In such cases, your doctor should monitor you frequently during treatment, especially during prolonged therapy;
• if you suffer from ulcers, particularly if complicated by bleeding or perforation; the risk of gastrointestinal bleeding, ulceration or perforation is higher with higher doses: begin treatment with the lowest available dose; your doctor may prescribe medicines to protect the stomach, such as misoprostol or proton pump inhibitors;
• if you have an infection – see section «Infections» below;
• if you have ever developed fixed drug eruption (round or oval patches of redness and swelling of the skin that usually recur at the same site(s), blisters, urticaria and itching) with ketoprofen.

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

This medicine may cause:

• serious heart and circulatory problems (arterial thrombotic events, heart attack or stroke), especially at high doses, during prolonged treatment, or when used to treat pain before or after coronary artery bypass surgery;
• serious stomach and intestinal problems that may be fatal (bleeding, ulcers, perforations), particularly at high doses or if your body weight is low;
• severe, although very rare, skin and mucous membrane reactions, even fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, which may present as skin and mucous membrane lesions. These may occur especially within the first month of treatment;
• visual disturbances (blurred vision) (see section “Possible side effects”).

During treatment, especially if long-term, your doctor should monitor you.
If you experience any of these effects, stop treatment and consult your doctor immediately.
You can reduce the risk of side effects by taking ALKET at the lowest effective dose and for the shortest possible duration (see section “How to take ALKET”).
Avoid taking other non-steroidal anti-inflammatory drugs (NSAIDs) during treatment with ALKET.

Children and adolescents
ALKET is contraindicated in paediatric patients.

Elderly
If you are elderly, take this medicine with caution, as you are more prone to gastrointestinal bleeding and perforation, which may even be fatal, and to other side effects such as reduced kidney, heart and liver function (see section “Possible side effects”). Your doctor will advise you on the appropriate dose and whether you need to take medicines that protect against ulcers (misoprostol or proton pump inhibitors). Your doctor should monitor you during treatment with ketoprofen.

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

Avoid taking the following medicines together with ALKET:

• other non-steroidal anti-inflammatory drugs (NSAIDs) (see section “Warnings and precautions”);
• medicines that thin the blood (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 (a medicine used to treat rheumatoid arthritis and cancer) when 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 elimination, especially if you are an elderly, particularly dehydrated patient (see sections “Do not take ALKET” and “Warnings and precautions”);
• medicines for high blood pressure (ACE inhibitors and angiotensin II antagonists), especially if you are elderly and drink little water (are poorly hydrated);
• low-dose methotrexate (less than 15 mg per week);
• corticosteroids (medicines used for inflammation);
• pentoxifylline, a medicine used for circulatory problems;
• tenofovir, a medicine used to treat certain viral infections;
• nicorandil, a medicine used to prevent or relieve chest pain due to heart problems;
• cardiac glycosides, substances used to treat certain heart conditions.

Your doctor should monitor you and may need to reduce the dose 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 antiplatelet agents such as tirofiban, eptifibatide, abciximab and iloprost, used for blood clotting disorders;
• selective serotonin reuptake inhibitors (SSRIs) (see section “Warnings and precautions”);
• probenecid, a medicine used for gout;
• gemeprost, a medicine used in gynaecological procedures;
• intrauterine contraceptive devices (IUDs); their effectiveness may be reduced, leading to pregnancy;
• mifepristone (a medicine used for termination of pregnancy), as its efficacy may theoretically be reduced due to the antiprostaglandin properties of non-steroidal anti-inflammatory drugs (NSAIDs);
• cyclosporine and tacrolimus (medicines used after organ transplantation or to treat immune system disorders);
• quinolone antibiotics, as patients taking NSAIDs and quinolones may have an increased risk of developing seizures.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take ALKET during the last three months of pregnancy, as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It may affect your and your baby’s tendency to bleed and delay or prolong labour beyond the expected time.
You should not take ALKET during the first six months of pregnancy unless absolutely necessary and under direct medical supervision. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From week 20 of pregnancy, ALKET may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
ALKET is not recommended during breastfeeding.

Fertility
ALKET may cause fertility problems in women and is not recommended for women intending to become pregnant.
You should inform your doctor if you plan to start a pregnancy, as this medicine may reduce fertility, and if you are undergoing fertility tests, as these may be affected.

Driving and using machines
Since drowsiness, dizziness, vertigo, seizures or visual disturbances may occur while taking this medicine, do not drive or operate machinery if you experience any of these symptoms.

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

3. How to take ALKET

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
This medicine is intended for adult patients only.
The recommended dose in adults is 1 capsule of ALKET 200 mg once daily.
ALKET should be taken orally after a meal.
Your doctor will determine the appropriate dose based on your body weight and the severity of your symptoms.
The maximum daily dose of ketoprofen is 200 mg. Do not exceed the recommended dose.
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 (e.g. fever and pain) persist or worsen (see section 2).

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

Use in patients with liver problems
If you have mild or moderate liver impairment, your doctor will monitor you closely and recommend the lowest effective daily dose (see section 2 “Do not take ALKET” and “Warnings and precautions”).

Use in children
Safety and efficacy have not been established in children; therefore, ALKET is contraindicated in children.

If you take more ALKET than you should
Symptoms of overdose with doses up to 2.5 g of ketoprofen include lethargy, drowsiness, stomach pain, nausea, and vomiting. If this occurs, contact your doctor, who will initiate appropriate symptomatic treatment.
In adults, the main signs of overdose are headache, dizziness, drowsiness, nausea, vomiting, diarrhoea, 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 must be immediately transferred to a specialist centre to begin symptomatic treatment.
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital emergency department.

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 for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking ALKET
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences 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, vertigo, drowsiness
• Constipation, diarrhoea, flatulence, inflammation of the stomach (gastritis)
• Skin irritation (rash) and itching
• Swelling due to fluid retention (oedema)
• Fatigue

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

• Decrease in red blood cells due to bleeding (haemorrhagic anaemia)
• Decrease in white blood cells (leucopenia)
• 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 and bilirubin due to liver disorders)
• Jaundice
• Weight gain

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

• Blood disorders (thrombocytopenia, agranulocytosis, bone marrow failure), decrease in red blood cells (haemolytic anaemia)
• Depression, hallucinations, confusion, mood alterations, seizures
• Taste disturbances (dysgeusia)
• Inflammation of the membranes lining the brain not caused by bacteria (aseptic meningitis)
• Heart problems (heart failure), changes in heart rhythm (atrial fibrillation, tachycardia, palpitations)
• Increased blood pressure, dilation of blood vessels, generalized redness due to blood vessel disorders (vasculitis, including leukocytoclastic vasculitis)
• Bronchial constriction (bronchospasm), cold-like symptoms (rhinitis), breathing difficulties (dyspnoea)
• Stomach and intestinal problems (colitis and Crohn's disease, gastrointestinal bleeding and perforation)
• Blood in stools and vomit
• Inflammation of the pancreas (pancreatitis)
• Increased sensitivity to light (photosensitivity)
• Generalized skin rash (cutaneous exanthema), erythema
• Hair loss (alopecia)
• Skin disorders, including very severe ones (urticaria, bullous eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis), widespread infected red lesions (acute generalized exanthematous pustulosis), swelling of the skin, mucous membranes and submucosal tissues (angioedema)
• Symptoms of a distinct allergic skin reaction known as fixed drug eruption, which usually recurs at the same site(s) upon re-exposure to the drug and may appear as round or oval patches of redness and swelling of the skin, blister formation (urticaria), itching
• Kidney problems (acute renal failure, tubulointerstitial nephritis, nephrotic syndrome, abnormalities in kidney function tests)
• Allergic (anaphylactic) reactions, even severe ones, with shock
• Decreased sodium levels in the blood (hyponatraemia), increased potassium levels in the blood (hyperkalaemia)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via 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 packaging after Exp. The expiry date refers to the last day of that month. The stated expiry date applies to the product in its original packaging, provided it has been properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ALKET contains

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

Description of the appearance of ALKET and contents of the pack
Prolonged-release hard capsules containing 200 mg of ketoprofen.
Pack size: 28 capsules.

Marketing Authorization Holder
S.F. GROUP Srl – Via Tiburtina, 1143 – 01156 - Rome, Italy

Manufacturers
SPECIAL PRODUCT’S LINE S.p.A.
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy

FULTON MEDICINALI S.p.A.
Via Marconi, 28/9
Arese (MI), Italy

LA.FA.RE. S.r.l.
Via Sac. Benedetto Cozzolino 67
80056 Ercolano (NA), Italy

OSMOPHARM S.A.
Via alle fornaci
6930 Bedano – Switzerland