PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

SOLKET 80 mg oral solution powder

Lysine 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, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What SOLKET is and what it is used for
What you need to know before taking SOLKET
How to take SOLKET
Possible side effects
How to store SOLKET
Contents of the pack and other information

1. What SOLKET is and what it is used for

SOLKET contains as its active substance ketoprofen lysine salt, which belongs to a group of medicines
used against pain and inflammation called "Non-Steroidal Anti-Inflammatory Drugs" (NSAIDs).
This medicine is used for
Adults:
symptomatic treatment of inflammatory conditions associated with pain, including:

rheumatoid arthritis (an autoimmune disease causing joint pain and stiffness),
ankylosing spondylitis (a chronic inflammatory disease mainly affecting the spine and joints),
painful osteoarthritis (a disease affecting the joints),
extra-articular rheumatism (rheumatic diseases affecting structures outside the joints),
post-traumatic inflammation (inflammatory condition following trauma),
painful conditions in dentistry, otorhinolaryngology, urology and pneumology.

Children and adolescents:
short-term symptomatic treatment of inflammatory conditions associated with pain, even accompanied by
pyrexia (fever), such as those affecting the osteoarticular system, postoperative pain and otitis.

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 drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”);
if you have a history of hypersensitivity reactions (allergy) such as bronchospasm, asthma attacks, acute rhinitis, urticaria, nasal polyps, angioedema (swelling of deep dermis and subcutaneous tissue, which may also affect mucous membranes), or other allergic-type reactions to ketoprofen or to substances with similar mechanism of action (e.g., acetylsalicylic acid or other NSAIDs). Severe anaphylactic reactions, rarely fatal, have been observed in these patients (see section 4 “Possible side effects”);
if you suffer from pre-existing bronchial asthma;
if you have severe heart failure (inability of the heart to pump adequate blood flow to meet the body's needs);
if you have a peptic ulcer (in the stomach) or gastrointestinal bleeding, or if you have previously suffered from recurrent gastrointestinal bleeding or peptic ulcer (two or more distinct, documented episodes of bleeding or ulceration);
if you have previously experienced gastrointestinal bleeding, ulceration, or perforation, or chronic dyspepsia;
if you have a history of gastrointestinal bleeding or perforation related to previous NSAID therapy;
if you have leukopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets in the blood);
if you suffer from Crohn’s disease or ulcerative colitis;
if you suffer from gastritis;
if you have severe liver failure (liver cirrhosis, severe hepatitis, reduced liver function) or kidney failure (reduced kidney function);
if you have hemorrhagic diathesis (predisposition to bleeding) or other coagulation disorders, or if you have hemostatic disorders;
if you are undergoing intensive diuretic therapy;
if you are in the last three months of pregnancy or are breastfeeding (see section “Pregnancy, breastfeeding and fertility”);
Do not give this medicine to children under 6 years of age.

Warnings and precautions
Warnings
Side effects can be minimized by using the shortest possible duration of treatment necessary to control symptoms (see subsection “How to take Solket” and the subsections below on gastrointestinal and cardiovascular risks).
Concomitant use of Solket with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.
During treatment with all NSAIDs, including Solket, cases of gastrointestinal bleeding, ulceration, and perforation have been reported at any time, with or without warning symptoms or previous history of serious gastrointestinal events. These may be fatal.
Your doctor may recommend concomitant use of gastroprotective agents (e.g., misoprostol or proton pump inhibitors), especially if you are elderly, have a history of ulcers, or are taking low-dose acetylsalicylic acid or other medicines that may increase the risk of gastrointestinal events (see subsection “Other medicines and Solket”).
Report any unusual abdominal signs or symptoms (especially gastrointestinal bleeding), particularly in the early stages of treatment.
Exercise caution if you are taking medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids (medicines used to treat inflammatory conditions), selective serotonin reuptake inhibitors (SSRIs, e.g., medicines used to treat depression), anticoagulants (medicines that thin the blood, such as warfarin), or antiplatelet agents such as acetylsalicylic acid (see subsection “Other medicines and Solket”).
Elderly patients are at higher risk of developing adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which may be fatal (see section 3 “How to take Solket”). Elderly patients are more prone to reduced kidney, heart, and liver function.
Children:
Gastrointestinal bleeding, occasionally severe, and ulcers have been observed in some pediatric patients treated with lysine salt of ketoprofen (see section 4 “Possible side effects”). Therefore, the product should be administered under strict medical supervision, with dosage regimen evaluated on a case-by-case basis.
You should be closely monitored if you have or have previously had gastrointestinal disease, for the onset of digestive disturbances, especially gastrointestinal bleeding.
Immediately discontinue treatment with Solket at the first signs of gastrointestinal bleeding or ulceration.
Patients with active or past peptic ulcer:
Exercise caution if you have a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as these conditions may recur with NSAID use (see section 4 “Possible side effects”).
Ketoprofen, especially at high doses, may be associated with a higher risk of severe gastrointestinal toxicity compared to other NSAIDs.
Skin reactions:
Severe skin reactions, some of which are fatal, such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been very rarely reported in association with NSAID use (see section 4 “Possible side effects”). Patients appear to be at higher risk during the initial stages of therapy: the reaction typically occurs within the first month of treatment. Discontinue use of Solket at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Avoid exposure to sunlight during treatment with this medicine, as the skin may become more sensitive.
Consult your doctor or pharmacist before taking SOLKET:

If you have impaired kidney function, Solket should be administered with caution.
If you have heart failure (a condition in which the heart is weakened), liver function abnormalities such as cirrhosis (severe liver impairment), kidney function abnormalities such as nephrosis (degenerative kidney disease), or chronic kidney failure (impaired kidney function), if you are on diuretic therapy (medicines used to increase urine production), or if you may have low blood volume (hypovolemia), especially if you are elderly at the start of treatment, as kidney function must be closely monitored.
As with all NSAIDs, the medicine may increase certain laboratory test values, such as blood urea nitrogen and creatinine.
If you have liver disease or abnormal liver function tests, as liver enzyme (transaminase) levels should be periodically assessed, especially during long-term therapy.
As with other NSAIDs, the medicine may cause minor transient increases in some liver parameters and even significant increases in GPT/ALT and GOT/AST transaminases (liver enzymes) (see section 4 “Possible side effects”). If such parameters increase significantly, treatment should be discontinued. Rare cases of jaundice (yellowing of the skin and eyes) and hepatitis (liver disease) have been reported with ketoprofen use. Liver and kidney function tests and blood counts should be performed during long-term therapy.
If you suffer from uncontrolled hypertension (high blood pressure), congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate cardiac pumping function), established ischemic heart disease (heart condition due to reduced blood flow caused by narrowing of the coronary arteries), peripheral artery disease, and/or cerebrovascular disease (disease of blood vessels in the brain), as treatment with lysine salt of ketoprofen, like all NSAIDs, should only be initiated after careful evaluation.
If you have heart problems, history of stroke (cerebrovascular accident), or think you may be at risk for these conditions (e.g., if you have high blood pressure, diabetes, high cholesterol, or smoke).
If you have a history (even familial) of mild to moderate hypertension (high blood pressure) and/or congestive heart failure (fluid accumulation in the lungs, abdominal organs, and peripheral tissues due to inadequate cardiac pumping function), as adequate monitoring and appropriate instructions are required. Fluid retention and edema (swelling) have been observed during NSAID treatment.
Medicines such as Solket may be associated with a modest increased risk of heart attack (myocardial infarction) or stroke (cerebrovascular accident). Any risk is more likely with high doses and prolonged treatment.
An increased risk of atrial fibrillation (abnormal heart rhythm) has been reported with NSAID use.
Hyperkalemia may occur, especially if you have diabetes, kidney failure, and/or are on treatment with agents promoting hyperkalemia (see subsection “Other medicines and Solket”). In these circumstances, potassium levels should be monitored.
If you have an infection – see section «Infections» below.
If you have allergic manifestations or have previously suffered from allergies, as the medicine should be administered with caution.
Like all non-steroidal drugs, the use of ketoprofen in patients with bronchial asthma or allergic diathesis (predisposition to allergy) may trigger an asthma attack. If you have asthma associated with chronic rhinitis, chronic sinusitis, and/or nasal polyposis, you are at higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may cause asthma attacks or bronchospasm, shock, and other allergic phenomena, especially in subjects allergic to acetylsalicylic acid and/or NSAIDs (see subsection “Do not take Solket”).
Consult your doctor if you experience visual disturbances, such as blurred vision, as treatment must be discontinued.
If you have hematopoietic disorders (affecting blood cell formation and maturation), systemic lupus erythematosus (an immune system disease), or mixed connective tissue disorders, as Solket should be administered with caution.
Infections
Solket may mask symptoms of infections such as fever and pain. Therefore, Solket may delay appropriate treatment of the infection, potentially 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 infection symptoms persist or worsen, consult your doctor immediately.

Stop taking this medicine and contact your doctor immediately if:

you develop skin rashes, mucosal lesions, or any other sign of hypersensitivity;
you develop a severe, potentially life-threatening skin reaction (exfoliative dermatitis, Stevens-Johnson syndrome, or toxic epidermal necrolysis);
you experience eye problems (such as blurred vision);
you have burning, bleeding, or pain in the stomach.

Other medicines and SOLKET
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is not recommended that you take Solket in combination with:

other NSAIDs (including selective cyclooxygenase-2 inhibitors) and high-dose salicylates (over 3 g/day), as they may increase the risk of gastrointestinal ulcers and bleeding;
blood-thinning medicines (anticoagulants such as heparin and warfarin, and platelet aggregation inhibitors such as ticlopidine and clopidogrel). NSAIDs may enhance the effects of these medicines (see subsection “Warnings and precautions”), thereby increasing the risk of bleeding. If co-administration cannot be avoided, you must be closely monitored.
lithium (a medicine used to treat manic-depressive psychosis). NSAIDs may increase lithium blood levels to toxic values.
methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and some cancers), used at doses exceeding 15 mg/week: there may be an increased risk of methotrexate hematological toxicity. At least 12 hours should elapse between discontinuation or initiation of ketoprofen treatment and methotrexate administration.
hydantoins (such as phenytoin) and sulfonamides (such as certain antibiotics and other medicines): the toxic effects of these substances may be increased.

Caution is required if you take Solket in combination with:

Medicines that may promote hyperkalemia, such as potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated), cyclosporine, tacrolimus, and trimethoprim.
Tenofovir (a medicine used in the treatment of certain viral infections): may increase the risk of kidney failure.
Medicines used to treat high blood pressure, such as beta-blockers, diuretics, ACE inhibitors, and angiotensin II antagonists. You should be adequately hydrated before starting concomitant therapy, and renal function monitoring should be considered after starting concomitant therapy (see subsection “Warnings and Precautions”). NSAIDs may reduce the effect of diuretics.
methotrexate (a medicine indicated for the treatment of certain autoimmune diseases and some cancers), used at doses below 15 mg/week: increased hematological toxicity of methotrexate may occur. During the first weeks of combination use, weekly monitoring of complete blood count should be performed. If you are elderly or have impaired kidney function, monitoring should be more frequent.
corticosteroids (medicines used to treat inflammatory conditions): increased risk of gastrointestinal ulceration or bleeding may occur (see subsection “Warnings and Precautions”).
pentoxifylline (a medicine used to improve blood circulation in the limbs): increased risk of bleeding may occur. More frequent clinical monitoring may be necessary.
zidovudine (a medicine used for HIV treatment): increased blood toxicity with possible severe anemia may occur. Blood tests should be performed after starting treatment with NSAIDs.
sulfonylureas (diabetes medicines, such as gliclazide): NSAIDs may enhance the hypoglycemic effect of sulfonylureas.
Cardiac glycosides: NSAIDs may exacerbate heart failure, reduce glomerular filtration rate, and increase cardiac glycoside levels; however, a pharmacokinetic interaction between ketoprofen and cardiac glycosides has not been demonstrated.

Combinations with other medicines to consider:

Antihypertensive medicines (beta-blockers, ACE inhibitors, diuretics): NSAIDs may reduce the effect of antihypertensive medicines.
Mifepristone (a medicine used for medical termination of pregnancy): the effectiveness of the contraceptive method may theoretically decrease due to NSAID properties.
Intrauterine contraceptive devices: device effectiveness may be reduced, leading to pregnancy.
Cyclosporine, tacrolimus (medicines used after transplantation or for treating immune system disorders): risk of additional kidney toxicity, especially in the elderly.
Thrombolytics (medicines that help dissolve blood clots): increased risk of bleeding.
Antiplatelet agents (ticlopidine and clopidogrel) and selective serotonin reuptake inhibitors (SSRIs, such as certain antidepressants): increased risk of gastrointestinal bleeding.
Probenecid (a medicine used to treat gout): co-administration of probenecid may increase ketoprofen blood concentrations.
Quinolone antibiotics: possible increased risk of seizures.
Diphenylhydantoin and sulfamides: dosage reduction may be necessary.
Gemeprost (a medicine used in gynecological procedures): reduced effectiveness.
Avoid alcohol consumption.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use of ketoprofen during the first and second trimesters of pregnancy should be avoided.
Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonic/fetal development.
Epidemiological study results suggest an increased risk of miscarriage and cardiac malformations and gastroschisis (fetal abdominal wall defect) following use of a prostaglandin synthesis inhibitor in early pregnancy. The risk is considered to increase with dose and duration of therapy.
Do not take SOLKET during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It could affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Solket during the first 6 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 week 20 of pregnancy, Solket may cause kidney problems in the fetus if taken for more than a few days, thereby reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing constriction 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.
Use of the drug close to delivery may cause alterations in hemodynamics of the newborn’s pulmonary circulation with serious consequences for respiration.
Therefore, DO NOT use Solket during the third trimester of pregnancy (see subsection “Do not take Solket”).
Breastfeeding
There is no available information on the excretion of ketoprofen in human breast milk. Do not take SOLKET during breastfeeding.
Fertility
Use of NSAIDs, including Solket, may reduce female fertility and is not recommended in women attempting to conceive.
Administration of NSAIDs, including Solket, should be discontinued in women experiencing fertility problems or undergoing fertility investigations.
Driving and using machines
If drowsiness, dizziness, or seizures occur after taking ketoprofen, avoid driving, operating machinery, or performing activities requiring special alertness.
SOLKET contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.
SOLKET contains sorbitol
This medicine contains 1.7 g of sorbitol per dose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take SOLKET

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 (for example, fever and pain)
persist or worsen (see section 2).
Recommended doses are:
Adults: one 80 mg sachet (full dose) three times daily, taken with meals.
The maximum daily dose is 320 mg of ketoprofen lysine salt. Higher doses are not recommended
(see subsection “Warnings and precautions”).
Special populations
Use in children aged between 6 and 14 years: half a sachet (40 mg, half dose) three times daily, taken with meals.
Solket 80 mg oral solution powder is contraindicated in children under 6 years of age (see subsection “Do not take Solket”).
Use in the elderly: the dose must be carefully determined by the doctor, who should consider reducing the above doses (see subsection “Warnings and precautions”).
Use in patients with hepatic impairment:
treatment should be initiated at the lowest daily dose (see subsection “Warnings and precautions”).
Do not take this medicine if you have severe liver problems (see section 2 “What you need to know before taking SOLKET – Do not take SOLKET”).
Use in patients with mild or moderate renal impairment: it is recommended to reduce the initial dose and maintain therapy using the lowest effective dose. Individual dose adjustments may be considered only after good drug tolerability has been established. Monitor urine output and kidney function (see subsection “Warnings and precautions”).
Solket 80 mg powder for oral solution must not be used if you have severe renal dysfunction (see subsection “Do not take SOLKET”).
Method of administration
By opening the sachet along the line marked "half dose", a 40 mg dose is obtained.
By opening the sachet along the line marked “full dose”, an 80 mg dose is obtained.
Empty the contents of one sachet or half a sachet into half a glass of water and stir.
If you take more SOLKET than you should
In case of accidental ingestion/overdose of SOLKET, contact your doctor immediately or go to the nearest hospital.
Cases of overdose with doses up to 2.5 g of ketoprofen have been reported. In most cases, symptoms have been mild and limited to
lethargy, drowsiness, nausea, vomiting, epigastric pain (in the upper abdomen), abdominal pain, headache, dizziness, and diarrhoea.
In cases of severe overdose, hypotension, respiratory depression, and gastrointestinal bleeding have been observed.
The patient should be immediately transferred to a specialist centre to begin symptomatic treatment.
There are no specific antidotes in case of ketoprofen overdose. In case of suspected massive overdose, gastric lavage is recommended, along with symptomatic and supportive treatment.
In cases of renal failure, haemodialysis may be useful to remove the drug from the body.
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 for your next dose. Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of 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 commonly observed adverse events are gastrointestinal in nature.
The following adverse reactions have been observed with the use of ketoprofen in adults:

Common (may affect up to 1 in 10 people)

Dyspepsia (indigestion), nausea, abdominal pain, vomiting

Uncommon (may affect up to 1 in 100 people)

Headache, dizziness, drowsiness
Constipation, diarrhoea, flatulence (intestinal gas), gastritis, abdominal discomfort
Rash, pruritus (itching)
Oedema (fluid retention causing swelling), fatigue, peripheral oedema (swelling of extremities), chills

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

Haemorrhagic anaemia (anaemia due to blood loss)
Paraesthesia (abnormal skin sensation, tingling)
Blurred vision (see section “Warnings and precautions”)
Tinnitus (ringing in the ears)
Asthma
Stomatitis (mouth ulcer), peptic ulcer (gastric or duodenal ulcer), colitis
Hepatitis, increased transaminases (liver enzymes), increased blood bilirubin (elevated serum bilirubin levels due to liver disorders), jaundice
Weight gain

Very rare (may affect up to 1 in 10,000 people):

Dyskinesia (movement disorder), syncope (fainting)
Hypotension (low blood pressure)
Laryngeal oedema (swelling of the larynx)
Haematuria (blood in the urine)
Asthenia (physical weakness), facial oedema

Not known (frequency cannot be estimated from the available data):

Thrombocytopenia (reduced number of platelets in the blood), agranulocytosis (severe reduction in white blood cells), bone marrow failure (reduced production of blood cells), haemolytic anaemia (anaemia due to abnormal destruction of red blood cells), neutropenia (decrease in neutrophil white blood cells), aplastic anaemia (anaemia due to insufficient production of blood cells in the bone marrow), leukocytosis (increased number of white blood cells), thrombocytopenic purpura, leukopenia (reduced number of white blood cells)
Anaphylactic reactions (including shock), hypersensitivity
Depression, hallucinations, confusion, mood alterations, irritability, insomnia. In a paediatric patient who took a double dose compared to that recommended in the SmPC, anxiety and behavioural disorder were also observed
Seizures
Dysgeusia (altered taste)
Tremor, hyperkinesia
Heart failure (weakened heart), atrial fibrillation (irregular heart rhythm), palpitations, tachycardia (increased heart rate)
Hypertension (increased blood pressure), vasodilation (dilation of blood vessels), vasculitis (inflammation of blood or lymphatic vessels, including leukocytoclastic vasculitis)
Bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea (difficulty breathing), laryngospasm, acute respiratory failure (a single fatal case has been reported in an asthmatic patient sensitive to aspirin)
Gastralgia (stomach pain), exacerbation of colitis and Crohn’s disease, gastrointestinal haemorrhage, gastrointestinal perforation (sometimes fatal, particularly in the elderly), gastric pyrosis (heartburn), gastric ulcer, duodenal ulcer, oedema (swelling) of the mouth, pancreatitis, erosive gastritis, haematemesis (vomiting blood) or melena (passing digested blood in stools), hyperchlorhydria (excess hydrochloric acid in gastric juice), gastric pain (stomach pain), tongue oedema
Photosensitisation (reaction to sunlight or UV lamps), alopecia (hair loss), urticaria, angioedema, bullous eruptions including Stevens-Johnson syndrome, Lyell’s syndrome and toxic epidermal necrolysis (serious skin reactions), maculopapular rash, purpura, acute generalised exanthematous pustulosis (skin eruption with pustule formation), dermatitis
Acute kidney injury, tubulo-interstitial nephritis, nephritis or nephritic syndrome, nephrotic syndrome, glomerular nephritis, fluid/sodium retention with possible oedema, acute tubular necrosis (damage to renal tubular cells), renal papillary necrosis (damage to renal papillae), oliguria (reduced urine output), abnormal kidney function tests
Periorbital oedema (swelling around the eyes)
Aseptic meningitis (inflammation of the membranes covering the brain not caused by bacteria)
Lymphangitis (inflammation of the lymphatic vessels), hyperkalemia (increased potassium levels in the blood), hyponatremia (decreased sodium levels in the blood)

Medicines such as SOLKET may be associated (particularly at high doses and with long-term treatment) with an increased risk of arterial thrombotic events (formation of blood clots in blood vessels), such as heart attack (myocardial infarction) or stroke (cerebrovascular accident) (see section 2 “What you need to know before taking Solket”).

Following the instructions provided in this leaflet reduces the risk of side effects.
Inform your doctor immediately if you notice any gastrointestinal side effects (stomach pain, burning sensation, bleeding), especially if you are an elderly patient.
Stop taking SOLKET immediately and contact your doctor as soon as you notice a skin rash, any lesions inside the mouth or on the genitals, or any signs of an allergic reaction.

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 SOLKET

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. The indicated expiry date applies to the product if unopened and stored correctly.
This medicine does not require any special storage precautions.
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 SOLKET contains
The active substance is ketoprofen lysine salt.
Each dual-chamber sachet contains 80 mg of ketoprofen lysine salt, equivalent to 50 mg of ketoprofen.
The other components are: sorbitol (Neosorb P60), sorbitol (Neosorb P30/P60), povidone, anhydrous colloidal silica, sodium chloride, sodium saccharin, ammonium glycyrrhizinate, mint flavoring.
Description of the appearance of SOLKET and contents of the pack
Powder for oral solution.
Pack containing 30 dual-chamber sachets.
Marketing Authorization 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)