Ketoprofen lysinate Doc

Package leaflet: Information for the patient

KETOPROFEN LYSINE SALT DOC

80 mg ADULTS oral solution powder
Equivalent 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 reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What KETOPROFEN LYSINE SALT DOC is and what it is used for
2. What you need to know before taking KETOPROFEN LYSINE SALT DOC
3. How to take KETOPROFEN LYSINE SALT DOC
4. Possible side effects
5. How to store KETOPROFEN LYSINE SALT DOC
6. Contents of the pack and other information

1. What KETOPROFENE lysine salt DOC is and what it is used for

KETOPROFENE lysine salt DOC contains the active substance ketoprofen, which belongs to a group of
medicines called non-steroidal anti-inflammatory drugs ("NSAIDs").
KETOPROFENE lysine salt DOC is indicated, in adults, for the symptomatic treatment of pain associated with:

• inflammatory joint disorders (e.g. rheumatoid arthritis, ankylosing spondylitis, painful osteoarthritis, extra-articular rheumatism);
• inflammatory conditions 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 DOC

Do not take KETOPROFENE lysine salt DOC
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 inflammation,
nasal polyps, urticaria (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 similar
medicines (e.g. acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)). In this case,
a potentially fatal sudden 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 bleeding or perforation of the stomach or intestine;
• if you have previously experienced stomach or intestinal bleeding or perforation following administration of non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have suffered from chronic digestive problems;
• if you have inflammation of the stomach (gastritis);
• if you have an inflammatory bowel disease such as Crohn’s disease or ulcerative colitis;
• if you have severe heart problems (heart failure);
• if you have severe liver problems (hepatic insufficiency, liver cirrhosis or severe hepatitis);
• if you have severe kidney problems (renal insufficiency);
• if you are prone to bleeding or have blood clotting disorders;
• if you have low levels of white blood cells (leucopenia) or platelets (thrombocytopenia) in the blood;
• if you are taking certain medicines used to lower blood pressure (diuretics);
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”);
• if the person who is to take the medicine is under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking KETOPROFENE lysine salt DOC.

Take particular care with KETOPROFENE lysine salt DOC and inform your doctor 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 DOC”);
• you are elderly. In this case, adverse effects, especially gastrointestinal bleeding and perforation, are more likely. 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 decide to monitor you closely and prescribe an additional medicine to protect your stomach;
• you have a blood or blood cell formation disorder;
• you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• you have an infection, because this medicine may mask symptoms such as fever;
• you have kidney, liver or heart problems, fluid retention, or have previously suffered from any of these conditions. In these cases, your doctor should monitor you closely;
• you are taking diuretics or medicines used to reduce blood volume;
• you suffer from allergies or have previously had allergic reactions;
• you have previously suffered from a chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• you are taking medicines that may increase the risk of peptic ulcer or bleeding, for example oral corticosteroids, certain antidepressants (selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as aspirin or anticoagulants like warfarin) (see section “Other medicines and KETOPROFENE lysine salt DOC”). In these cases, consult your doctor before taking KETOPROFENE lysine salt DOC, as you may need to take an additional medicine to protect your stomach;
• you are a woman with fertility problems. Since KETOPROFENE lysine salt DOC 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 DOC may be associated with a slight increase in the risk of heart attack and stroke. This risk is more likely at high doses and with prolonged use. Do not exceed the recommended dose or duration of treatment;
• you suffer from asthma associated with chronic colds and/or nasal polyps;
• after starting treatment, you develop signs of a skin reaction, with or without lesions. If this occurs, stop treatment and contact your doctor;
• you experience visual disturbances (such as blurred vision). If this occurs, stop treatment and contact your doctor;
• you have an infection – see section «Infections» below. You can reduce the risk of experiencing adverse effects by taking KETOPROFENE lysine salt DOC at the lowest effective dose and for the shortest possible duration.

Infections
KETOPROFENE lysine salt DOC may mask symptoms of infections such as fever and pain. Therefore,
KETOPROFENE lysine salt DOC 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, contact your doctor immediately.

Children and adolescents
This medicine is not suitable for children or adolescents under 14 years of age.
KETOPROFENE lysine salt DOC should be administered with caution, under strict medical supervision and
only if necessary in adolescents aged 14 years and older, as it may cause bleeding and ulcers in the stomach
and intestine, which may be severe.

Other medicines and KETOPROFENE lysine salt DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Avoid taking the following medicines together with KETOPROFENE lysine salt DOC:

• other non-steroidal anti-inflammatory drugs (NSAIDs) and high-dose salicylates (over 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 (equal to or greater than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• hydantoins, used for epilepsy;
• sulfonamides, used for bacterial infections.

The combination of KETOPROFENE lysine salt DOC with any of the following medicines requires caution:

• medicines that may increase potassium levels in the blood (e.g. potassium salts, certain diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs, some heparins, cyclosporine, tacrolimus and trimethoprim);
• tenofovir, used to treat AIDS or hepatitis B;
• ACE inhibitors, diuretics, angiotensin II antagonists, used for high blood pressure and heart problems;
• 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;
• cardiac glycosides, used to treat certain heart problems.

Your doctor should monitor you and may need to reduce the dose of KETOPROFENE lysine salt DOC 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 medical termination of pregnancy;
• cyclosporine and tacrolimus, used after organ transplantation or to treat immune system disorders;
• thrombolytics, used for blood clotting disorders;
• antiplatelet agents, used to thin the blood;
• certain antidepressants, known as selective serotonin reuptake inhibitors (SSRIs);
• probenecid, used for gout;
• quinolone antibiotics, used to treat bacterial infections;
• phenytoin, used to treat epilepsy;
• sulfamides, used to treat bacterial infections;
• gemeprost, used before certain gynaecological procedures;
• if you are using intrauterine contraceptive devices.

KETOPROFENE lysine salt DOC and alcohol
Avoid consuming alcoholic beverages while taking 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 DOC 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 more than expected.
You should not take KETOPROFENE lysine salt DOC during the first six months of pregnancy unless
absolutely necessary and under medical advice. 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 the 20th week of pregnancy, KETOPROFENE lysine salt DOC 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
There is no available information on the excretion of ketoprofen in human breast milk. Therefore, avoid
taking KETOPROFENE lysine salt DOC during breastfeeding.

Fertility
KETOPROFENE lysine salt DOC may cause fertility problems in women and is therefore not recommended
for women who are planning a pregnancy. Inform your doctor if you have fertility problems and are planning a
pregnancy or undergoing fertility tests.

Driving and using machines
KETOPROFENE lysine salt DOC may cause dizziness, drowsiness or seizures. If this occurs, avoid driving
or operating machinery.

KETOPROFENE lysine salt DOC contains sorbitol and sodium

• This medicine contains 1.3 g of sorbitol per sachet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic condition in which patients cannot metabolize fructose, consult your doctor before taking this medicine.
• This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. it is essentially “sodium-free”.

3. How to take KETOPROFENE lysine salt DOC

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 sachet of 80 mg (full dose) three times a day, during meals.
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).
Use in children and adolescents
This medicine is not suitable for children or adolescents under 14 years of age.
Use in the elderly
If you are elderly, the dose will be determined by your doctor.
Use in patients with liver problems
If you suffer from liver problems such as hepatic insufficiency, the dose will be determined by your doctor.
Use in patients with mild or moderate kidney problems
If you have mild or moderate kidney problems, your doctor must monitor you during treatment with this medicine.
Do not use this medicine if you have severe liver or kidney problems (see section 2, "Do not take KETOPROFENE lysine salt DOC").
Method of administration
Pour the contents of one sachet into half a glass of water and mix.
If you take more KETOPROFENE lysine salt DOC than you should
If you (or someone else) have ingested an excessive dose of KETOPROFENE lysine salt DOC, contact a doctor immediately or go to the nearest hospital Emergency Department.
Symptoms of overdose include: lethargy, drowsiness, nausea, vomiting, stomach and abdominal pain, headache, dizziness, diarrhoea, low blood pressure, breathing difficulties, and gastrointestinal bleeding.
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 KETOPROFENE lysine salt DOC
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 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 KETOPROFENE lysine salt DOC 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, swelling due to fluid retention (oedema, peripheral oedema), fatigue, rash, itching, constipation, diarrhoea, excessive gas production in the gastrointestinal tract, inflammation of the stomach (gastritis), 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), inflammation of the mouth (stomatitis), stomach or intestinal ulcer (peptic ulcer), inflammation of the intestine (colitis), liver problems (hepatitis, jaundice, increased transaminases, elevated serum bilirubin levels), asthma, weight gain.

Very rare (may affect up to 1 in 10,000 people)
Swelling around the eyes, low blood pressure, swelling and narrowing of the larynx, presence of blood in the urine, facial swelling, movement disorders (dyskinesia), transient loss of consciousness (syncope), tiredness (asthenia).

Frequency not known (frequency cannot be estimated from the available data)
Changes in blood cell counts (thrombocytopenia, agranulocytosis), allergic reaction (hypersensitivity), sudden potentially fatal allergic reaction (including anaphylactic shock), seizures, taste disturbances, tremor, involuntary and uncoordinated movements (hyperkinesia), mood changes, excitability, insomnia, excessive sensitivity to light (photosensitivity), hair loss (alopecia), urticaria, skin irritation (erythema), skin rash (exanthema, maculopapular exanthema, acute generalised exanthematous pustulosis), skin disorder (dermatitis), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in breathing or swallowing (angioedema), rare skin condition with blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin reaction (toxic epidermal necrolysis, Lyell's syndrome), swelling of the tongue, worsening of colitis and Crohn's disease (chronic inflammatory bowel diseases), gastrointestinal bleeding and perforation, stomach or intestinal ulcer (gastric and duodenal ulcer), heartburn, excessive production of stomach acid (hyperchlorhydria), erosive gastritis, stomach pain (gastralgia, gastric pain), inflammation of the pancreas (pancreatitis), reduced cardiac function, rapid or irregular heartbeat (palpitations), increased heart rate (tachycardia), changes in heart rhythm (atrial fibrillation), high blood pressure, vasodilation, inflammation of blood vessels (vasculitis, including leucocytoclastic vasculitis), breathing difficulties (bronchospasm), shortness of breath (dyspnoea), inflammation of nasal passages, acute respiratory failure, kidney problems (acute renal failure, tubulo-interstitial nephritis, nephrotic syndrome, nephritis or nephritic syndrome, abnormalities in kidney function tests, glomerular nephritis, acute tubular necrosis, renal papillary necrosis), swelling due to fluid and sodium retention, reduced urine output, heart attack (myocardial infarction), stroke, anxiety, seeing things that are not there (hallucinations), behavioural changes, depression, confusion, unusual weakness, blood in the stool, blood in vomit, inflammation of the meninges (aseptic meningitis), inflammation of the lymphatic vessels (lymphangitis), increased white blood cells in the blood (leucocytosis), a disease characterised by the appearance of multiple haemorrhagic spots (purpura, thrombocytopenic purpura), reduced white blood cells in the blood (leucopenia, neutropenia), anaemia (aplastic, haemolytic), problems in blood cell production (bone marrow failure), increased potassium levels in the blood, decreased sodium levels in the blood.

Inform your doctor immediately if you notice any stomach and/or intestinal side effects (stomach pain, burning, bleeding), especially if you are an elderly patient.

Stop taking KETOPROFENE lysine salt DOC immediately and contact your doctor as soon as you notice a skin rash, any lesion inside the mouth or on the genitals, or any sign of an allergic reaction.

Medicines such as KETOPROFENE lysine salt DOC may be associated with an increased risk of heart attack (myocardial infarction) and stroke.

Reporting of side effects
If you experience any side effect, 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 DOC

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 store above 30°C.
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 lysine salt DOC contains
The active substance is ketoprofene lysine salt.
Each sachet contains 80 mg of ketoprofene lysine salt (equivalent to 50 mg of ketoprofen).
The other components are: sorbitol, anhydrous colloidal silica, sodium chloride, sodium saccharin, mint flavour.
Description of the appearance of KETOPROFENE lysine salt DOC and contents of the pack
Pack containing 30 sachets.
Marketing Authorization Holder
DOC Generici S.r.l. – Via Turati 40 – 20121 Milan – Italy.
Manufacturer
Mipharm S.p.A. – Via Quaranta 12 – Milan – Italy.