SOLKET 80 mg Oral Solution Powder

Зміст інструкції

1. SOLKET 80 mg powder for oral solution
   1. What SOLKET is and what it is used for
   2. What you need to know before taking SOLKET
   3. How to take SOLKET
   4. Possible side effects
   5. How to store SOLKET
   6. Contents of the pack and other information

SOLKET 80 mg powder for oral solution

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

1. What SOLKET is and what it is used for

SOLKET contains the active ingredient ketoprofen, which belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (“NSAIDs”), used against pain and inflammation.
SOLKET is indicated:

• in adults, for the symptomatic treatment of pain in the presence of:
• inflammations affecting the joints (e.g. rheumatoid arthritis, ankylosing spondylitis, painful osteoarthritis, extra-articular rheumatism);
• inflammations due to trauma and painful inflammations affecting the mouth, teeth, ears, larynx, urinary tract and respiratory tract;
• in children, for the symptomatic treatment of short duration of pain, even in the presence of fever, caused by:
• inflammations affecting the joints and bones;
• ear inflammations (otitis);
• surgical operations.

2. What you need to know before taking SOLKET

Do not take SOLKET

• 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 medicines (NSAIDs) has caused you problems in the past such as asthma (asthma attacks), difficulty breathing due to temporary narrowing of the bronchi (bronchospasm) or the presence of nodules inside the nose (nasal polyps), colds (acute rhinitis), allergic reactions affecting the skin such as hives 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 suffer from an inflammatory bowel disease, such as Crohn's disease or ulcerative colitis;
• if you have suffered from a respiratory problem called previous bronchial asthma;
• if you have severe heart problems (heart failure);
• if you have severe liver or kidney problems (hepatic or renal insufficiency);
• 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 under 6 years of age.

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

• you are taking other non-steroidal anti-inflammatory medicines (NSAIDs), such as aspirin, even at low doses (see section “Other medicines and SOLKET”);
• 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 keep you under strict control and treat you with a further 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 (immune system disorders affecting connective tissue);
• you suffer from allergies or have had allergic problems in the past;
• you have problems with your kidneys, liver or heart and have fluid retention, or have suffered from any of these conditions in the past. In these cases, the doctor will need to keep you under strict control;
• 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 clotting such as aspirin or anticoagulants such as warfarin) (see section “Other medicines and SOLKET”). In these cases, talk to your doctor before taking SOLKET 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 levels of cholesterol in your blood or are a smoker). SOLKET 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
Solket can mask the symptoms of infections such as fever and pain. It is therefore possible that Solket may
delay adequate treatment of the infection, which could increase the risk of complications. This has been
observed in pneumonia caused by bacteria and bacterial 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 adverse
effects.

Stop taking this medicine and see your doctor immediately if:

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

Children
SOLKET should be administered with caution, under strict medical supervision and only if necessary in
children over 6 years of age, because it can cause bleeding and ulcers in the stomach and intestines, which
can also be severe.

Other medicines and SOLKET
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 medicines (NSAIDs) and high doses of 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;
• 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:

• ACE inhibitors, diuretics, angiotensin II antagonists, used for high blood pressure and heart problems;
• methotrexate at low doses (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.

The doctor will need to monitor you and may need to reduce the dose of SOLKET if you are
taking any of the following medicines:

• ACE inhibitors, diuretics and beta-blockers, used for high blood pressure and heart problems;
• cyclosporine and tacrolimus, used after a transplant or for the treatment of immune system disorders;
• thrombolytics, used for blood clotting problems;
• anti-aggregating agents, used to prevent blood clots;
• some antidepressants, known as selective serotonin reuptake inhibitors (SSRIs);
• probenecid, used for gout.

Pregnancy, breastfeeding and fertility
If 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.
Pregnancy
Do not take SOLKET in the last 3 months of pregnancy, as it may harm the fetus or cause
problems during childbirth. It may cause problems with the fetus's kidneys and heart. It may affect your and
the baby's tendency to bleed and delay or prolong labor more than expected. You should not
take Solket in the first 6 months of pregnancy unless absolutely necessary and under the advice of
your 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, Solket 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.
The use of SOLKET is also not recommended during the first and second trimesters of pregnancy, unless
strictly necessary.
Breastfeeding
Do not take SOLKET while breastfeeding.
Fertility
SOLKET may cause fertility problems in women. Therefore, if you are planning 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, do not drive
vehicles or use machines.

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

3. How to take SOLKET

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask 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 the symptoms (for example fever and pain) persist
or worsen (see paragraph 2).

Use in adults
The recommended dose is 1 sachet of 80 mg (full dose) 3 times a day, during meals.
Take this medicine using always the minimum effective dose and for the shortest possible period.

Use in children aged between 6 and 14 years
The recommended dose is half a sachet of 40 mg (half dose) 3 times a day, during meals.

Use in the elderly
If you are elderly, your doctor will determine the dose (see paragraph 2 “What you need to know before taking SOLKET -
Warnings and precautions”).

Use in people with liver problems
If you suffer from liver problems such as hepatic insufficiency, take the minimum daily dose possible.
Do not take this medicine if you have severe liver problems (see paragraph 2 “What you need to know before
taking SOLKET - Do not take SOLKET”).

Use in people with mild or moderate kidney problems
If you have mild or moderate kidney problems, your doctor will need to monitor you during treatment
with this medicine.
Do not take this medicine if you have severe kidney problems (see paragraph 2 “What you need to know before
taking SOLKET - Do not take SOLKET”).
Take this medicine for the shortest possible period of time necessary to control the symptoms in order
to reduce the occurrence of undesirable effects.

Method of administration
Open the sachet along the line indicated "half dose" to obtain a 40 mg dose. If you want to obtain the dose
of 80 mg, open the sachet along the line indicated "full dose".
Pour the contents of one sachet or half a sachet into half a glass of water and mix.

If you take more SOLKET than you should
If you (or someone else) have ingested an excessive dose of SOLKET, or if you think a child has ingested
an excessive dose, consult a doctor immediately.
The most common symptoms of an overdose are as follows: lethargy, drowsiness, nausea, vomiting and stomach pain.
Other symptoms may include headache, dizziness, confusion, loss of consciousness, low blood pressure,
respiratory depression and cyanosis.
In case of accidental ingestion/intake of an excessive dose of this medicine, notify
your doctor immediately or go to the Emergency Room of the nearest hospital.

Bring with you this leaflet, the remaining medicine and its container to the hospital or doctor so
that they know which medicine has been taken.

If you forget to take SOLKET
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 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 side effects that may occur with SOLKET are:

Common(may affect up to 1 in 10 people)
Stomach or intestinal disorders (peptic ulcers, perforation or bleeding from the stomach or
intestine which can be life-threatening), nausea, vomiting, digestive difficulties (dyspepsia),
abdominal pain/discomfort

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

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 with the stomach or intestine (peptic ulcer),
liver problems (hepatitis, increased transaminases, high serum bilirubin levels), increased body weight.

Frequency not known(the frequency cannot be estimated from the available data)
Alteration of the number of blood cells (thrombocytopenia, agranulocytosis, bone marrow aplasia),
alteration of the number of certain blood cells (leukocytosis, leukopenia), inflammation of the lymphatic vessels
(lymphangitis), disease characterized by the formation of numerous hemorrhagic spots (purpura,
thrombocytopenic purpura), sudden, potentially life-threatening allergic reaction (including anaphylactic shock),
convulsions, altered taste, altered mood, hyperexcitability, insomnia, anxiety, seeing things that
do not exist (hallucinations), excitability, altered behavior, chills, movement disorders
(transient and hyperkinesia dyskinesia), fatigue (asthenia), vertigo, tremor, swelling around the eyes due to
fluid retention (periorbital edema), heart problems, fast or irregular heartbeat
(palpitations), rapid heart rate (tachycardia), high blood pressure (hypertension),
vasodilation, low blood pressure (hypotension), inflammation of blood vessels (vasculitis),
redness of the skin, skin rash (exanthema, maculopapular rash), skin disease
(dermatitis and contact dermatitis), excessive sensitivity to light (photosensitivity), hair loss
(alopecia), hives, 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 reaction (toxic epidermal necrolysis), severe skin disease (Lyell's syndrome), difficulty breathing
(bronchospasm), cold (rhinitis), shortness of breath (dyspnea), swelling and narrowing of the larynx, acute respiratory failure, swelling of the larynx, difficulty breathing due to constriction of the larynx
(laryngospasm), worsening of intestinal inflammation (colitis and Crohn's disease), passing blood in the stool (melena), vomiting blood (hematemesis), kidney problems (acute renal failure, tubulo-interstitial nephritis, nephritic syndrome, abnormalities in renal function tests),
difficulty urinating, swelling of the face and mouth, blood in the urine (hematuria), decreased
urine output (oliguria), swelling of the extremities (peripheral edema), transient loss of consciousness
(syncope).
Immediately inform your doctor if you notice the appearance of side effects in the stomach and/or intestine
(stomach pain, burning, bleeding), especially if you are an elderly patient.
Stop taking SOLKET immediately and see your doctor as soon as you notice the appearance of
skin rash, any lesion inside the mouth or on the genitals or any sign of an allergic reaction.
Medicines like SOLKET may be associated with a slight increase in the risk of heart attack
(myocardial infarction) and stroke.

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 SOLKET

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 “Scad.”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in the drain or with 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 SOLKET contains
The active ingredient is ketoprofen lysine salt.
Each sachet contains 80 mg of ketoprofen lysine salt (equivalent to 50 mg of ketoprofen).
The other ingredients are: sorbitol (Neosorb P60), sorbitol (Neosorb P30/P60), povidone, colloidal anhydrous
silica, sodium chloride, sodium saccharin, ammonium glycyrrhizinate, mint flavour.

Description of the appearance of SOLKET and contents of the pack
Powder for oral solution.
Pack of 30 bipartite sachets.

Marketing Authorisation Holder
Aesculapius Farmaceutici S.r.l. - Via Cefalonia, 70 - 25124 Brescia

Manufacturer
Special Product’s Line S.p.A - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR)