Ketoprofen lysinate Mylan Generics: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ketoprofene Sale di Lisina Mylan Generics 80 mg powder for oral solution

Ketoprofene Sale di Lisina
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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ketoprofene Sale di Lisina Mylan Generics is and what it is used for
What you need to know before taking Ketoprofene Sale di Lisina Mylan Generics
How to take Ketoprofene Sale di Lisina Mylan Generics
Possible side effects
How to store Ketoprofene Sale di Lisina Mylan Generics
Contents of the pack and other information

1. What Ketoprofene Lysine Salt Mylan Generics is and what it is used for

Ketoprofene Lysine Salt Mylan Generics contains the active substance ketoprofen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs ("NSAIDs").
Ketoprofene Lysine Salt Mylan Generics is indicated:

in adults , for the symptomatic treatment of pain in the presence of:
- inflammation affecting the joints (e.g. rheumatoid arthritis, ankylosing spondylitis, painful osteoarthritis, extra-articular rheumatism);
- inflammation due to trauma and painful inflammatory conditions affecting the mouth, teeth, ears, larynx, urinary tract and respiratory tract;

2. What you need to know before taking Ketoprofene Lysine Salt Mylan Generics

Do not take Ketoprofene Lysine Salt Mylan Generics

if you are allergic to ketoprofen, 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 suffered from asthma, breathing difficulties (bronchospasm), nasal congestion, nasal polyps, hives (skin rash), angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), or other allergic reactions after taking ketoprofen or other medicines with a similar mechanism of action (e.g. acetylsalicylic acid or other non-steroidal anti-inflammatory drugs -NSAIDs-). In such cases, a sudden, potentially fatal allergic reaction may occur.
if you currently have or have previously had a stomach or intestinal ulcer (e.g. active or recurrent peptic ulcer);
if you currently have or have previously had gastrointestinal bleeding or perforation;
if you have previously experienced stomach or intestinal bleeding or perforation following treatment with non-steroidal anti-inflammatory drugs (NSAIDs);
if you have a low white blood cell count (leucopenia) or low platelet count (thrombocytopenia);
if you have chronic digestive problems (including gastritis);
if you have an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis;
if you have previously experienced asthma (bronchial asthma);
if you have severe heart problems (heart failure);
if you have severe liver or kidney problems (hepatic insufficiency, liver cirrhosis, severe hepatitis, or renal insufficiency);
if you are prone to bleeding, have blood clotting disorders (hemostatic disorders), or are taking medicines that delay blood clotting (anticoagulants);
if you are taking high doses of medicines used to increase urine flow (diuretics);
if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
if the person taking the medicine is a child under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketoprofene Lysine Salt Mylan Generics.
Be especially careful with Ketoprofene Lysine Salt Mylan Generics if:

you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and Ketoprofene Lysine Salt Mylan Generics”);
you are elderly. In this case, adverse effects, especially gastrointestinal bleeding and perforation, are more likely and may be fatal. If this occurs, contact your doctor immediately.
you currently have or have previously had stomach and/or intestinal problems. In this case, your doctor may ask you to have regular check-ups and may recommend an additional medicine to protect your stomach (e.g. misoprostol or medicines that inhibit gastric acid production).
you experience burning, bleeding or stomach pain, stop treatment and inform your doctor.
you have a blood or blood cell formation disorder;
you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
you have diabetes, impaired kidney function, or are taking medicines that increase potassium levels. Your doctor may ask you to have regular check-ups;
you have an infectious disease, as this medicine may mask symptoms such as fever;
you have kidney, liver or heart problems, or fluid retention, or have previously experienced any of these conditions. In such cases, your doctor may ask you to have regular check-ups; you are taking diuretics or medicines used to reduce blood volume;
you have allergies or have previously experienced allergic reactions;
you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
you are taking medicines that may increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (selective serotonin reuptake inhibitors), or agents that prevent blood clot formation such as aspirin or anticoagulants like warfarin (see section “Other medicines and Ketoprofene Lysine Salt Mylan Generics”). In these cases, consult your doctor before taking Ketoprofene Lysine Salt Mylan Generics, as you may need to take an additional medicine to protect your stomach (e.g. misoprostol or acid-reducing medicines).
you are a woman with fertility problems. Since Ketoprofene Lysine Salt Mylan Generics may interfere with fertility, you should not take this medicine if you are planning a pregnancy or undergoing fertility investigations.
you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol levels, or are a smoker). Ketoprofene Lysine Salt Mylan Generics may be associated with a slight increase in the risk of heart attack and stroke. This risk is higher at high doses and with prolonged use. Do not exceed the recommended dose or duration of treatment.
you have asthma associated with chronic nasal congestion and/or nasal polyps;
you develop signs of a skin reaction, with or without lesions, after starting treatment. If this occurs, stop treatment and inform your doctor.
you experience visual disturbances (such as blurred vision). If this occurs, stop treatment and inform your doctor.
you have an infection – see section «Infections» below.
Infections
Ketoprofene Lysine Salt Mylan Generics may mask symptoms of infections such as fever and pain. Therefore, Ketoprofene Lysine Salt Mylan Generics may 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.
You can reduce the risk of experiencing adverse effects by taking Ketoprofene Lysine Salt Mylan Generics at the lowest effective dose and for the shortest possible duration.

Children and adolescents
Ketoprofene Lysine Salt Mylan Generics must not be administered to children or adolescents under 18 years of age.

Other medicines and Ketoprofene Lysine Salt Mylan Generics
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 Ketoprofene Lysine Salt Mylan Generics:

other non-steroidal anti-inflammatory drugs (NSAIDs) and high-dose salicylates (more than 3 g per day);
medicines used to prevent blood clots (anticoagulants such as heparin and warfarin, antiplatelet agents such as ticlopidine and clopidogrel);
lithium, used to treat depression or similar disorders;
high-dose methotrexate (more than 15 mg per week), used to treat rheumatoid arthritis and cancer. At least 12 hours must elapse between the administration of ketoprofen and methotrexate;
hydantoins, used for epilepsy;
sulfonamides, used for bacterial infections.

Combining Ketoprofene Lysine Salt Mylan Generics with any of the following medicines requires special precautions:

medicines that may increase blood potassium levels (e.g. potassium salts, potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, heparins, cyclosporine, tacrolimus, trimethoprim);
tenofovir, due to increased risk of renal failure;
low-dose methotrexate (less than 15 mg per week), used to treat rheumatoid arthritis and cancer;
corticosteroids, used for inflammation;
pentoxifylline, used to treat chronic venous ulcers;
zidovudine, used to treat AIDS;
sulfonylureas, used for diabetes;
cardioactive glycosides (e.g. digoxin), used to treat heart problems.

Your doctor should monitor you closely and may need to reduce the dose of Ketoprofene Lysine Salt Mylan Generics if you are taking any of the following medicines:

ACE inhibitors, diuretics and beta-blockers, used for high blood pressure and heart problems;
mifepristone, used for termination of pregnancy;
intrauterine contraceptive devices (e.g. coil);
cyclosporine and tacrolimus, used after organ transplantation or to treat immune system disorders;
thrombolytics, used for blood clotting disorders;
antiplatelet agents, used to prevent blood clot formation;
certain antidepressants, known as selective serotonin reuptake inhibitors (SSRIs);
probenecid, used for gout;
certain antibiotics such as quinolones and sulfonamides, used to treat bacterial infections;
phenytoin, used for epilepsy;
gemeprost, used for termination of pregnancy.

Ketoprofene Lysine Salt Mylan Generics and alcohol
Avoid consuming alcohol during treatment with this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Do not take Ketoprofene Lysine Salt Mylan Generics during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. 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 normal. You should not take Ketoprofene Lysine Salt Mylan Generics during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed 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, Ketoprofene Lysine Salt Mylan Generics may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding
Do not take Ketoprofene Lysine Salt Mylan Generics while breastfeeding.

Fertility
Ketoprofene Lysine Salt Mylan Generics may cause fertility problems in women and is therefore not recommended for women planning pregnancy. Inform your doctor if you have fertility problems and are planning a pregnancy, or if you are undergoing fertility testing.

Driving and using machines
Ketoprofene Lysine Salt Mylan Generics may cause dizziness, drowsiness or seizures. If this occurs, avoid driving or operating machinery.

Ketoprofene Lysine Salt Mylan Generics contains sorbitol
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This medicine contains 1690 mg of sorbitol per dose.

3. How to take Ketoprofen Lysine Salt Mylan Generics

Take this medicine exactly as directed 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 (such as fever and pain) persist or worsen (see section 2).
The recommended dose is 1 sachet of 80 mg three times daily, taken during meals.
The maximum daily dose must not exceed 320 mg.
Always use the lowest effective dose for the shortest possible duration.

Use in children
This medicine must not be used in individuals under 18 years of age.

Use in elderly
If you are elderly, your doctor will determine the appropriate dose.

Use in patients with liver problems
If you suffer from liver problems such as hepatic insufficiency, your doctor will determine the dose.

Use in patients with mild or moderate kidney problems
If you have mild or moderate kidney problems, a lower dose may be recommended. Additionally, your doctor will need to monitor you during treatment with this medicine.

Method of administration
Pour the contents of one sachet into half a glass of water and mix.

If you take more Ketoprofen Lysine Salt Mylan Generics than you should
If you (or someone else) have taken an excessive dose of Ketoprofen Lysine Salt Mylan Generics, or if you suspect that a child has taken an overdose, contact a doctor immediately.
Symptoms of overdose include: deep sleep (lethargy), drowsiness, nausea, vomiting, stomach or chest pain (epigastric pain), abdominal pain, headache (cephalalgia), dizziness, and diarrhea.
In case of accidental ingestion of an excessive dose, hypotension (low blood pressure), slowed breathing (respiratory depression), and gastrointestinal bleeding may occur.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so they know which medicine has been taken.

If you forget to take Ketoprofen Lysine Salt Mylan Generics
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 the forgotten dose.

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 most common side effects are gastrointestinal.
The side effects that may occur with Ketoprofene Lysine Salt Mylan Generics are:
Common (may affect up to 1 in 10 people)
Nausea, indigestion (dyspepsia), abdominal pain, vomiting.
Uncommon (may affect up to 1 in 100 people)
Headache (cephalalgia), dizziness, vertigo, drowsiness, abdominal discomfort, constipation, diarrhoea,
excessive intestinal gas (flatulence), inflammation of the stomach (gastritis), skin rash (rash), itching,
fluid retention (oedema), swelling of the extremities (peripheral oedema), fatigue, chills.
Rare (may affect up to 1 in 1,000 people)
Reduction in red blood cell count due to bleeding (haemorrhagic anaemia), tingling and numbness in hands and feet (paraesthesia), blurred vision, ringing in the ears (tinnitus), asthma,
inflammation of the colon (colitis), inflammation of the mouth (stomatitis), stomach or intestinal ulcer (peptic ulcer), inflammation of the liver (hepatitis), changes in certain blood tests used to assess liver function (elevated transaminases and bilirubin levels),
yellowing of the skin and whites of the eyes (jaundice), weight gain.
Very rare (may affect up to 1 in 10,000 people)
Difficulty controlling body movements (dyskinesia), loss of consciousness (syncope), low blood pressure (hypotension), swelling of the throat due to fluid accumulation (laryngeal oedema),
blood in the urine (haematuria), feeling of fatigue (asthenia), facial swelling (oedema).
Frequency not known (frequency cannot be estimated from the available data)
Non-infectious inflammation of the meninges (aseptic meningitis), inflammation of the lymphatic vessels (lymphangitis), reduced platelet count (thrombocytopenia), reduced number of granulocytes, a type of white blood cell (agranulocytosis), increased white blood cell count (leucocytosis), reduced white blood cell count (leucopenia), reduced neutrophil count, a type of white blood cell (neutropenia), skin rash due to reduced platelet count (thrombocytopenic purpura), reduced bone marrow activity (bone marrow failure), destruction of red blood cells (haemolytic anaemia), reduced production of red blood cells (aplastic anaemia), severe allergic reactions (anaphylactic reactions including shock), allergy (hypersensitivity), increased potassium levels (hyperkalaemia), decreased sodium levels (hyponatraemia), low mood (depression), hallucinations, confusion, mood changes, excitability, insomnia, seizures, altered taste (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), eye swelling (periorbital oedema), reduced heart function (heart failure), irregular heart rhythm (atrial fibrillation), awareness of heartbeat (palpitations), increased heart rate (tachycardia), high blood pressure (hypertension), vasodilation, inflammation of blood vessels (vasculitis, including leukocytoclastic vasculitis), bronchial constriction (bronchospasm), allergic rhinitis (rhinitis), difficulty breathing (dyspnoea), narrowing of the larynx (laryngospasm), acute respiratory failure, stomach pain (gastralgia), worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), bleeding and perforation of the stomach and intestine, injury to the stomach or intestine (gastric and duodenal ulcer, erosive gastritis), heartburn (gastric pyrosis), swelling of the mouth (mouth oedema) and tongue (tongue oedema), inflammation of the pancreas (pancreatitis), blood in the stool (melena), vomiting blood (haematemesis), excessive stomach acidity (hyperchlorhydria), stomach pain (gastric pain), inflammation of the stomach (erosive gastritis), a disease characterised by the formation of multiple haemorrhagic spots (purpura), light sensitivity (photosensitivity), hair loss (alopecia), urticaria, redness of the skin (erythema), skin rash (exanthema, maculopapular exanthema, bullous eruptions), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing and swallowing (angioedema), skin disorder (dermatitis), severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome), serious skin reaction (toxic epidermal necrolysis), severe widespread rash over the entire body (generalised acute exanthematous pustulosis), kidney problems (acute renal failure, tubulo-interstitial nephritis, nephritis or nephritic syndrome, nephrotic syndrome), glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in kidney function tests, swelling due to fluid and sodium retention (oedema), reduced urine output (oliguria).
Immediately inform your doctor if you notice any signs of gastrointestinal side effects (stomach pain, burning, bleeding), especially if you are elderly.
Immediately stop taking Ketoprofene Lysine Salt Mylan Generics and contact your doctor if you notice a skin rash, any sores inside the mouth or on the genitals, or any signs of an allergic reaction.
Medicines such as Ketoprofene Lysine Salt Mylan Generics may be associated with an increased risk of heart attack (myocardial infarction) and stroke.
Reporting of side effects
If you experience any side effects, 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketoprofen Lysine Salt Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
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 Ketoprofene Sale di Lisina Mylan Generics contains
The active substance is ketoprofen lysine salt. Each sachet contains 80 mg of ketoprofen lysine salt
(equivalent to 50 mg of ketoprofen).
The other components are: sorbitol (Neosorb P200C), sorbitol (Neosorb P650C), povidone, anhydrous colloidal silica, sodium chloride, sodium saccharin, peppermint flavour.

Description of the appearance of Ketoprofene Sale di Lisina Mylan Generics and package contents
Lithographed cardboard carton containing 30 single-dose sachets of 80 mg ketoprofen lysine salt.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani, 20 - 20124 Milano

Manufacturer
LA.FA.RE. S.r.l., Via Sacerdote Benedetto Cozzolino, 77, 80056 Ercolano (NA)