DOLKET 40 mg Roztwór Doustny

Treść ulotki

1. DOLKET 40 mg oral solution
   1. What is DOLKET and what is it used for
   2. What you need to know before taking DOLKET
   3. How to take DOLKET
   4. Possible side effects
   5. How to store DOLKET
   6. Contents of the pack and other information

DOLKET 40 mg oral solution

Ketoprofene Lysine Salt

Read this leaflet carefully before taking this medicine as it contains
important information for you.
Always take this medicine exactly as described in this leaflet, or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after short periods of treatment.

Contents of this leaflet:

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

1. What is DOLKET and what is it used for

DOLKET contains the active ingredient ketoprofen, which belongs to a group of medicines
called non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
DOLKET is indicated in adults for the treatment of pain of various origins and nature, and in
particular: headache, toothache, neuralgia, menstrual pains, muscle and osteoarticular pains.

2. What you need to know before taking DOLKET

Do not take DOLKET

• if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory medicines (NSAIDs) or to any of the other ingredients of this medicine (listed in section 6);
• if taking medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) has caused you problems in the past such as asthma (asthma attacks), difficulty breathing due to a temporary narrowing of the bronchi (bronchospasm) or the presence of nodules inside the nose (nasal polyps), cold (acute rhinitis), allergic reactions affecting the skin such as urticaria or swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema). In this case, a sudden allergic reaction may occur, which may be life-threatening;
• if you suffer from or have suffered from a problem with your stomach or intestines (active or recurrent peptic ulcer), or digestive disorders;
• if you suffer from or have suffered from bleeding or perforation of the stomach and intestines, even following the use of non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have serious heart problems (heart failure);
• if you have serious problems with your liver or kidneys (hepatic or renal failure);
• if you have a predisposition to bleeding (haemorrhagic diathesis) or a problem due to a defect in blood coagulation or are taking medicines to improve blood fluidity (anticoagulants);
• if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
• if the person who is to take the medicine is a child or adolescent under 18 years of age. It is also not recommended to administer it at the same time as other anti-inflammatory drugs and acetylsalicylic acid.

Warnings and precautions
Talk to your doctor or pharmacist before taking DOLKET.
Pay particular attention with DOLKET if:

• you are taking other non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and DOLKET”);
• you are elderly, as this increases the possibility of injury or bleeding in the stomach or intestines, which may be life-threatening;
• you suffer from or have suffered in the past from problems with your stomach and/or intestines (e.g. peptic ulcers, perforation or bleeding from the stomach and intestines). In this case, the doctor may decide to monitor you closely and treat you with an additional medicine to protect your stomach (for example misoprostol or medicines that block the production of acid in the stomach);
• you suffer from a disease called systemic lupus erythematosus or a mixed connective tissue disease (disorders of the immune system that affect connective tissue);
• you suffer from allergies or have had allergic problems in the past;
• you have problems with your kidneys, liver or heart and fluid retention, or have suffered from any of these conditions in the past. In these cases, the doctor will need to monitor you closely;
• you have hepatic porphyria (a rare blood disease characterized by an alteration in the activity of one of the liver enzymes), as the medicine may trigger an attack;
• you have suffered in the past 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, some antidepressants (selective serotonin reuptake inhibitors) or agents that prevent blood clot formation such as aspirin or anticoagulants such as warfarin (see section “Other medicines and DOLKET”). In these cases, talk to your doctor before taking DOLKET because you may need to take an additional medicine to protect your stomach (for example misoprostol or medicines that block the production of acid in the stomach);
• you are a woman with fertility problems and are planning a pregnancy, as this medicine may interfere with your fertility;
• you have heart problems such as heart failure, ischemic heart disease, peripheral arterial disease, previous stroke or think you may be at risk for these conditions (for example if you have high blood pressure, suffer from diabetes, have high cholesterol levels in your blood or are a smoker). DOLKET may be associated with a slight increase in the risk of heart attack and stroke. This risk is more likely at high doses and for prolonged periods. Do not exceed the recommended dose and duration of treatment;
• you suffer from asthma associated with chronic allergic rhinitis and/or nasal polyps;
• you have an infection - see section “Infections” below.

Infections
DOLKET can mask the symptoms of infections such as fever and pain. Therefore, it is possible that
DOLKET 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 chickenpox. If you take this medicine while you have an infection and the
symptoms of the infection persist or worsen, see your doctor immediately.
As with other anti-inflammatory drugs, ketoprofen can mask the symptoms or signs of an infection
(such as fever) and can cause small, transient increases in some liver tests and
also increases in transaminases. If significant increases occur, stop treatment and
consult your doctor.
Avoid exposure to the sun during treatment with this medicine because the skin may become
more sensitive.
Take this medicine at the lowest doses and for short periods of time to reduce the occurrence
of side effects.

Stop taking this medicine and see your doctor immediately if

• you develop skin rashes, lesions of the mucous membranes or any other signs of hypersensitivity;
• you develop a severe skin reaction that is potentially fatal (exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis);
• you experience eye problems (such as blurred vision);
• you have burning, bleeding or pain in your stomach.

Children and adolescents
DOLKET should not be given to children and adolescents under 18 years of
age.

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

Avoid taking this medicine if you are taking:

• other non-steroidal anti-inflammatory drugs (NSAIDs) and high doses of salicylates (more than 3 g per day);
• medicines used to slow down the blood clotting process (anticoagulants such as heparin and warfarin; antiplatelet agents such as ticlopidine and clopidogrel);
• lithium, used to treat depression or similar disorders;
• methotrexate at high doses (more than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• hydantoins, used for epilepsy;
• sulfonamides, used for bacterial infections.

If you are taking any of the following medicines, tell your doctor who will monitor you:

• corticosteroids, used for inflammation;
• ACE inhibitors, diuretics, angiotensin II antagonists, beta-blockers, used for high blood pressure or heart problems;
• methotrexate at low doses (less than 15 mg per week), used to treat rheumatoid arthritis and cancer;
• pentoxifylline, used to treat chronic venous ulcers;
• zidovudine and tenofovir, used to treat AIDS;
• sulfonylureas, used for diabetes;
• thrombolytics, used for blood clotting problems;
• probenecid, used for gout;
• some antidepressants, known as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants;
• cyclosporine and tacrolimus, used after a transplant or to treat disorders of the immune system;
• some antibiotics, used against infections caused by bacteria.

The doctor will need to monitor you and may decide to reduce the dose of
DOLKET.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take DOLKET during the last 3 months of pregnancy, as it may harm the fetus or
cause problems during childbirth.
It can cause problems with the kidneys and heart of the fetus. It may affect your and your baby's
tendency to bleed and delay or prolong labor more than expected.
You should not take DOLKET in the first 6 months of pregnancy unless absolutely necessary
and under the advice of a doctor. 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, DOLKET can 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 a 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
recommend additional monitoring.
Breastfeeding
Do not take DOLKET while breastfeeding with breast milk.
Fertility
DOLKET can cause fertility problems in women. Therefore, if you plan to become
pregnant, you should tell your doctor because this medicine may reduce fertility.
Stop treatment if you have fertility problems and intend to plan a pregnancy or
undergo fertility tests.

Driving and using machines
This medicine can cause dizziness, drowsiness or convulsions. If this happens to you, avoid
driving vehicles or using machinery.

DOLKET contains sorbitol, methyl parahydroxybenzoate and sodium
This medicine contains 3.15 g of sorbitolper dose, equivalent to 9.45 g per maximum recommended daily
dose. Sorbitol is a source of fructose. If your doctor has told you that you are
intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance, a rare
genetic disease in which patients cannot transform fructose, talk to your doctor before
you take this medicine.
This medicine contains methyl parahydroxybenzoatewhich can cause allergic reactions (including
delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodiumper dose, i.e. essentially sodium-free.

3. How to take DOLKET

Take this medicine following exactly as indicated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have an infection, consult your doctor immediately if symptoms (such as
fever and pain) persist or worsen (see section 2).

Use in adults
The recommended dose is one stick, once, or repeated 2-3 times a day, for more intense painful conditions.

Use in the elderly
If you are elderly, take the lowest possible daily dose (see section 2 “What you need to know
before taking DOLKET - Warnings and precautions”).

Use in people with liver problems
If you suffer from mild or moderate liver problems, take the lowest possible daily dose.
Do not take this medicine if you have severe liver problems (see section 2 “What you need to know
before taking DOLKET - Do not take DOLKET”).

Use in people with kidney problems
If you have mild or moderate kidney problems, consult your doctor who will need to monitor you
during treatment with this medicine.
Do not take this medicine if you have severe kidney problems (see section 2 “What you need to know
before taking DOLKET - Do not take DOLKET”).
Do not use for prolonged periods without your doctor's advice and do not exceed the recommended
doses.
Limit the duration of therapy to overcoming the painful episode.

Method of administration
Oral use.
Take this medicine on a full stomach.
Take this medicine using always the minimum effective dose and for the shortest possible time
necessary to control the symptoms in order to reduce the occurrence of undesirable effects.

If you take more DOLKET than you should
The most common symptoms of an overdose are the following: lethargy, drowsiness, nausea, vomiting and
stomach pain.
Other symptoms may include headache, dizziness, confusion, loss of consciousness,
low blood pressure, respiratory depression, bluish discoloration of the skin and mucous membranes (cyanosis),
renal failure, convulsions and coma.
In case of accidental intake/ingestion of an excessive dose of this medicine, immediately notify
your doctor or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the remaining medicine and its container to the hospital or doctor
so they know which medicine was taken.

If you forget to take DOLKET
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 forgotten dose.
If you have any doubts 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 most commonly observed side effects are of a gastrointestinal nature. Gastrointestinal
disorders (peptic ulcers, perforation or bleeding from the stomach or intestine which can be life-
threatening, particularly in elderly patients) may occur. Inform your doctor immediately if you
notice the onset of side effects in the stomach and/or intestine (stomach pain, burning, bleeding),
especially if you are an elderly patient.
Stop taking DOLKET immediately and consult your doctor as soon as you notice the onset of skin
rash, any lesion inside the mouth or on the genitals or any sign of an allergic reaction.
The side effects that may occur with DOLKET are:

Common(may affect up to 1 in 10 people)
Nausea, vomiting, indigestion (dyspepsia), abdominal pain/discomfort.

Uncommon(may affect up to 1 in 100 people)
Headache, dizziness, drowsiness, diarrhea, excessive production of gas in the gastrointestinal tract
(flatulence), constipation, inflammation of the stomach lining (gastritis), skin rash, itching,
swelling due to fluid retention (edema), fatigue.

Rare(may affect up to 1 in 1,000 people)
Reduction in the number of red blood cells following bleeding (hemorrhagic anemia), tingling
and numbness of hands and feet (paresthesia), blurred vision, ringing in the ear (tinnitus), asthma,
inflammations of the mouth (ulcerative stomatitis), problems in the stomach or intestine (peptic
ulcer), liver problems (hepatitis, increased levels of transaminases and bilirubin in the blood),
yellowing of the skin and whites of the eyes (jaundice), increased body weight.

Frequency not known(the frequency cannot be estimated from the available data)
Inflammation of the membranes lining the brain and spinal cord (aseptic meningitis),
inflammation of the lymphatic vessels (lymphangitis), reduction in the number of platelets
(thrombocytopenia), reduction in the number of white blood cells (agranulocytosis), increase in the
number of white blood cells (leukocytosis), reduction in the number of white blood cells (leukopenia),
reduction in the number of neutrophils, a type of white blood cell (neutropenia), formation of
numerous haemorrhagic spots on the skin due to a reduction in the number of platelets (purpura
thrombocytopenica), reduced activity of the bone marrow (myelodysplasia), destruction of
red blood cells (hemolytic anemia), reduced production of red blood cells (aplastic anemia), sudden
allergic reaction potentially life-threatening (including anaphylactic shock), depression, seeing and
hearing things that do not exist (hallucinations), mood alteration, hyper-excitability, insomnia,
transient loss of consciousness (syncope), convulsions, altered taste (dysgeusia), tremor,
involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), vertigo,
swelling around the eyes due to fluid retention (periorbital edema), heart problems
(heart failure), perception of one's heartbeat (palpitations), accelerated heartbeat (tachycardia),
high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of
blood vessels (vasculitis), swelling of the larynx, difficulty in breathing (bronchospasm), common
cold (rhinitis), shortness of breath (dyspnea), difficulty breathing due to constriction of the larynx
(laryngospasm), acute respiratory failure, skin rash (exanthema, maculo-papular rash), skin
inflammation (erythema, dermatitis), excessive sensitivity to light (photosensitivity), hair loss
(alopecia), urticaria, swelling of the face, lips, mouth, tongue or throat that can cause difficulty in
breathing and swallowing (angioedema), rare skin condition with blisters and bleeding of
lips, eyes, mouth, nose and genitals (Stevens Johnson syndrome), severe skin disease
(Lyell's syndrome, toxic epidermal necrolysis), worsening of colitis and Crohn's disease
(chronic inflammatory bowel diseases), bleeding and perforation of the stomach and intestine,
ulcer in the stomach or duodenum, heartburn, stomach pain, damage to
the stomach lining without perforation resulting in bleeding (erosive gastritis), swelling
of the mouth or tongue, inflammation of the pancreas, emission of blood with the stool (melena),
blood loss with vomiting (hematemesis), kidney problems such as blood in the urine (hematuria),
acute renal failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome,
glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in
renal function tests, fluid retention, decreased urine production (oliguria), difficulty urinating
(dysuria), chills, fatigue (asthenia), swelling of the extremities (peripheral edema), swelling of the face
(facial edema).

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 DOLKET

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.
Do not dispose of any medicine in the 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 DOLKET contains
The active ingredient is ketoprofen lysine salt.
Each stick contains 40 mg of ketoprofen lysine salt.
The other ingredients are: non-crystallizing liquid sorbitol, disodium hydrogen phosphate dihydrate,
sodium methylparaben, sodium saccharin, mint flavour, liquorice flavour, purified water.

Description of the appearance of DOLKET and contents of the pack
DOLKET is presented as a clear, colourless to yellowish solution.
Each pack contains 10 or 20 sticks in PET/AL/PE of 7 ml.

Marketing Authorisation Holder
Epifarma S.r.l. - Via San Rocco, 6 - 85033 Episcopia (PZ)

Manufacturer
Special Product’s Line S.p.A.
Via Fratta Rotonda Vado Largo,
03012 Anagni (FR) – Italy