Kemic

Package leaflet: Information for the user

Kemic 25 mg oral solution in sachet

Dexketoprofen
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after 3–4 days.

Contents of this leaflet

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

1. What Kemic is and what it is used for

This medicine is an analgesic belonging to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as acute muscle pain, joint pain, painful menstruation (dysmenorrhoea), and toothache.
This medicine is intended for adults.

2. What you should know before taking Kemic

Do not take Kemic

• if you are allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
• if you suffer from asthma or have previously experienced asthma attacks, acute allergic rhinitis (short episodes of nasal mucosa inflammation), nasal polyps (polypoid masses in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or breathing difficulties) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• if you have previously experienced photoallergic or phototoxic reactions (a specific type of redness and/or irritation of skin exposed to sunlight) while taking ketoprofen (an NSAID) or fibrates (medicines used to lower blood lipid levels);
• if you have peptic ulcer/gastrointestinal bleeding or have previously experienced gastrointestinal bleeding, ulceration or perforation;
• if you have chronic digestive problems (e.g. indigestion, heartburn);
• if you have previously experienced stomach or intestinal bleeding or perforation due to the use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief;
• if you suffer from chronic inflammatory bowel diseases (Crohn’s disease or ulcerative colitis);
• if you have severe heart failure, moderate or severe renal insufficiency, or severe hepatic insufficiency;
• if you have bleeding disorders or coagulation disorders;
• if you are severely dehydrated (have lost a lot of fluids) due to vomiting, diarrhoea or insufficient fluid intake;
• if you are in the third trimester of pregnancy or if you are breastfeeding;

Warnings and precautions
Talk to your doctor or pharmacist before taking Kemic if:

• you suffer from allergies, or have had allergic problems in the past;
• you have kidney, liver or heart disease (hypertension and/or heart failure), fluid retention, or if you have previously suffered from any of these conditions;
• you are being treated with diuretics or are poorly hydrated, or if you have reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhoea, vomiting);
• you have heart disease, have had a stroke, or think you may be at risk for these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker); discuss treatment with your doctor or pharmacist; medicines like Kemic may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke). These risks are more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• you are elderly, as the risk of side effects is higher (see section 4); if any occur, consult your doctor immediately;
• you are a woman with fertility problems (this medicine may reduce female fertility, so you should not take it if you are planning a pregnancy or undergoing fertility investigations);
• you suffer from a blood and blood cell formation disorder;
• you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• you have previously suffered from chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• you suffer or have previously suffered from other stomach or intestinal disorders;
• you have an infection – see section “Infections” below;
• you are taking other medicines that increase the risk of peptic ulcer or bleeding, for example oral steroids, certain antidepressants (e.g. SSRIs, selective serotonin reuptake inhibitors), antiplatelet agents such as aspirin, or anticoagulants such as warfarin. In these cases, consult your doctor before taking this medicine: they may prescribe an additional medicine to protect your stomach (e.g. misoprostol or other drugs that reduce gastric acid production);
• you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a 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, especially in individuals allergic to acetylsalicylic acid or NSAIDs;

Kounis Syndrome
Signs of an allergic reaction to this medicine, including respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with dexketoprofen. Stop Kemic immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Infections
Dexketoprofen may mask symptoms of infections such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, potentially increasing 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, consult your doctor immediately.

Children and adolescents
The use of Kemic has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children and adolescents.

Other medicines and Kemic
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. Some medicines cannot be used together, while others require dosage adjustments when taken simultaneously.
Always inform your doctor, dentist or pharmacist if you are using or are being given any of the following medicines in addition to this product.

Not recommended combinations:

• Acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs;
• Warfarin, heparin or other medicines used to prevent blood clot formation;
• Lithium, used to treat mood disorders;
• Methotrexate (anti-cancer or immunosuppressive medicine), used at doses higher than 15 mg/week;
• Hydantoin and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Combinations requiring caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for hypertension and heart conditions;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used in the treatment of viral infections;
• Aminoglycoside antibiotics, used to treat bacterial infections;
• Sulfonylureas (e.g. chlorpropamide and glibenclamide) used for diabetes;
• Methotrexate, used at low doses, less than 15 mg/week.

Combinations requiring careful evaluation:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system disorders and as transplant therapy;
• Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines used to dissolve blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used to induce abortion (to terminate pregnancy);
• Selective serotonin reuptake inhibitor (SSRI) antidepressants;
• Antiplatelet agents used to reduce platelet aggregation and blood clot formation;
• Beta-blockers, used for high blood pressure and heart problems;
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines in combination with Kemic, consult your doctor or pharmacist.

Kemic with food, drinks and alcohol
It is recommended to take this medicine with meals to reduce the possibility of gastrointestinal disturbances (see section 3, “Method of administration”).
Do not drink alcohol while using this medicine. Some side effects, such as those affecting the gastrointestinal tract or central nervous system, may be more likely if alcohol is consumed together with Kemic.

Pregnancy, breastfeeding and fertility
Do not use this medicine if you are breastfeeding.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine, as Kemic may not be suitable for you.
The use of this medicine should be avoided in women who are planning a pregnancy or who are pregnant.
Do not take dexketoprofen 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 may also affect the tendency of both mother and baby to bleed and may delay or prolong labour more than expected.
You should not take Kemic 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 week 20 of pregnancy, Kemic may cause kidney problems in the fetus if taken for more than a few days, reducing amniotic fluid levels surrounding the baby (oligohydramnios) or causing 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.
The use of this medicine is not recommended while planning a pregnancy or during fertility investigations.
Regarding potential effects on female fertility, also refer to section 2, “Warnings and precautions”.

Driving and using machines
This medicine may slightly impair the ability to drive vehicles and use machinery due to possible side effects such as dizziness, drowsiness or visual disturbances. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

Kemic contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine. This medicine contains 2 g of sucrose per dose. This should be considered in patients with diabetes mellitus.

Kemic contains Methyl 4-hydroxybenzoate (E218)
This medicine may cause allergic reactions (including delayed reactions) as it contains methyl 4-hydroxybenzoate.

Kemic contains Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e. essentially ‘sodium-free’.

3. How to take Kemic

Take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure, 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).

Adults over 18 years of age
The recommended dose is generally 1 sachet (25 mg of dexketoprofen) every 8 hours, not exceeding 3 sachets per day (75 mg).

Consult your doctor if you do not feel better after 3–4 days, or if you feel worse. Your doctor will advise you on how many sachets per day you should take and for how long. The dose you need depends on the type, intensity, and duration of the pain.

If you are elderly or suffer from kidney or liver disease, treatment should begin with a total daily dose of no more than 2 sachets (50 mg of dexketoprofen).

In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg) if dexketoprofen has been well tolerated.

Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).

Method of administration
The oral solution can be taken directly from the sachet or, if preferred, the entire contents can be dissolved in a glass of water. Once the sachet is opened, take all of its contents.

Take the sachets with food, as this helps reduce the risk of gastrointestinal side effects (see also section 2 “Kemic with food, drink, and alcohol”). If the pain is severe and you wish to achieve faster relief, take the sachets on an empty stomach, i.e., at least 15 minutes before meals, as this helps the medicine act slightly more quickly.

If you take more Kemic than you should
If you have taken an excessive dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine pack or this leaflet with you.

If you forget to take Kemic
Do not take a double dose to make up for a forgotten dose. Take the next dose at the scheduled time (as described in section 3 “How to use Kemic”).

If you have further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Kemic can cause side effects, although not everyone experiences them.
The possible side effects are listed below, grouped according to how likely they are to occur. Since the list is
partly based on side effects reported for the dexketoprofen tablet formulation, and the oral solution is absorbed
more rapidly than tablets, the actual frequency of side effects (particularly gastrointestinal) may be higher with
Kemic oral solution in sachet form.

Common side effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain mainly in the upper quadrants, diarrhoea, digestive problems
(dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):
Dizziness, vertigo, somnolence, insomnia, nervousness, headache, palpitations, flushing, inflammation of the
gastric wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills,
general malaise.

Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer, haemorrhagic or perforated peptic ulcer (presenting with haematemesis, i.e. vomiting blood, or
black stools), fainting, hypertension, slowed breathing, fluid retention and peripheral oedema (e.g. swollen
ankles), laryngeal oedema, loss of appetite (anorexia), altered sensation, itchy rash, acne, increased sweating,
back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood
tests), hepatocellular damage (hepatitis), acute renal failure.

Very rare side effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (hypersensitivity reactions that may lead to collapse), open sores on the skin, mouth,
eyes, and genital area (Stevens-Johnson syndrome and Lyell’s syndrome), facial swelling or swelling of the lips
and throat (angioedema), breathlessness due to contraction of muscles surrounding the airways
(bronchospasm), shortness of breath, rapid heartbeat, hypotension, pancreatitis, blurred vision, ringing in the
ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Reduced number of white blood cells
(neutropenia), decreased platelet count in the blood (thrombocytopenia).

Not known: frequency cannot be estimated from the available data
Chest pain, which may be a sign of a potentially life-threatening allergic reaction called Kounis syndrome.

Drug-induced fixed eruption
An allergic skin reaction, known as drug-induced fixed eruption, which may appear as round or oval patches
with redness and swelling of the skin, blistering rash, and itching. Hyperpigmentation of the affected skin areas
may also occur and may persist after healing. Drug-induced fixed eruption usually recurs in the same location
(or locations) upon re-exposure to the medicine.

Inform your doctor immediately if you notice any stomach or intestinal side effects at the beginning of
treatment (e.g. stomach pain, acidity or bleeding), especially if you have previously experienced such side
effects from prolonged use of anti-inflammatory medicines, and particularly if you are elderly.

Stop using this medicine as soon as you notice a skin rash or any lesions inside the mouth or on the genitals, or
any signs of allergy.

During treatment with non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and swelling (especially
in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Kemic may be associated with a small increased risk of heart attack ("myocardial infarction")
or stroke.

In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed
connective tissue disease), anti-inflammatory medicines may, in rare cases, cause fever, headache, and neck
stiffness.

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, gastrointestinal
perforation, or bleeding, sometimes fatal—especially in the elderly—may occur. Nausea, vomiting, diarrhoea,
flatulence, constipation, dyspepsia, abdominal pain, melena, haematemesis, ulcerative stomatitis, and
worsening of colitis and Crohn’s disease have been reported following administration. Gastric wall inflammation
(gastritis) has been observed less frequently.

As with other NSAIDs, aseptic meningitis may occur, particularly in patients with systemic lupus erythematosus
or mixed connective tissue disease, along with haematological reactions (purpura, aplastic and haemolytic
anaemia, and more rarely agranulocytosis and bone marrow hypoplasia).

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 Kemic

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and sachets, after {Exp}.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 Kemic contains

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each oral solution sachet contains 25 mg of dexketoprofen as dexketoprofen trometamol.
• The other ingredients are sucrose, methyl parahydroxybenzoate (E218), macrogol 400, povidone K-90 (E1201), disodium phosphate, sodium dihydrogen phosphate dihydrate, lime flavour, mint flavour, sodium saccharin (E954), neohesperidin dihydrochalcone (E959), ammonium glycyrrhizinate, purified water (see section 2).

Description of the appearance of Kemic and contents of the pack
Clear to opalescent solution, slightly white-pink in colour, with lime and mint flavour, free from undissolved particles.
It is supplied in packs containing 10 or 20 sachets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Special Product’s Line S.p.A.
Via dei Castelli Romani 22
00071 – Pomezia (RM)
Italy

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

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