Dolket

Package leaflet: Information for the patient

DOLKET 40 mg oral solution

Lysine Ketoprofen
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, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if you notice worsening of symptoms 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 taking 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 DOLKET is and what it is used for

DOLKET contains the active substance ketoprofen, which belongs to a group of medicines known as non-steroidal anti-inflammatory drugs ("NSAIDs"), used to treat pain and inflammation.
DOLKET is indicated in adults for the treatment of pain of various origin and nature, and in particular: headache, toothache, neuralgia, menstrual pain, and musculoskeletal and osteoarticular pain.

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 drugs (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 previously caused you problems such as asthma (asthma attacks), breathing difficulties due to temporary narrowing of the bronchi (bronchospasm), or nasal polyps, acute rhinitis, allergic skin reactions such as urticaria, or swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema). In such cases, a sudden allergic reaction may occur, which could be life-threatening;
• if you currently suffer or have previously suffered from a stomach or intestinal problem (active or recurrent peptic ulcer), or digestive disorders;
• if you currently suffer or have previously suffered from bleeding or perforation of the stomach or intestines, even after taking non-steroidal anti-inflammatory drugs (NSAIDs);
• if you have severe heart problems (heart failure);
• if you have severe liver or kidney problems (hepatic or renal failure);
• if you have a tendency to bleed (hemorrhagic diathesis) or a condition due to a blood clotting disorder, or if you 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. Simultaneous administration with other anti-inflammatory medicines and acetylsalicylic acid is also not recommended.

Warnings and precautions
Talk to your doctor or pharmacist before taking DOLKET.
Be especially careful 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 risk of stomach or intestinal injury or bleeding, which may be life-threatening;
• you currently suffer or have previously suffered from stomach and/or intestinal problems (e.g. peptic ulcers, perforation, or bleeding from the stomach or intestines). In this case, your doctor may decide to monitor you closely and prescribe additional medication to protect your stomach (for example, misoprostol or medicines that block acid production in the stomach);
• you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• you have allergies or have previously experienced allergic reactions;
• you have kidney, liver, or heart problems, or fluid retention, or have previously suffered from any of these conditions. In such cases, your doctor should monitor you closely;
• you have hepatic porphyria (a rare blood disorder characterized by impaired activity of one of the liver enzymes), as the medicine could trigger an attack;
• you have previously suffered from 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 clot formation such as aspirin or anticoagulants like warfarin (see section “Other medicines and DOLKET”). In these cases, consult your doctor before taking DOLKET, as you may need to take additional medication to protect your stomach (for example, misoprostol or acid-reducing medicines);
• you are a woman with fertility problems and are planning 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, diabetes, high cholesterol levels, or are a smoker). DOLKET may be associated with a slight increase in the risk of heart attack and stroke. This risk is higher at high doses and with prolonged use. Do not exceed the recommended dose or duration of treatment;
• you suffer from asthma associated with chronic allergic rhinitis and/or nasal polyps;
• you have an infection – see the section “Infections” below.

Infections
DOLKET may mask symptoms of infections such as fever and pain. Therefore, DOLKET could 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, contact your doctor immediately.
As with other anti-inflammatory medicines, ketoprofen may mask symptoms or signs of infection (such as fever) and may cause minor transient increases in some liver function tests and also increases in transaminases. If significant increases occur, discontinue treatment and consult your doctor.
Avoid exposure to sunlight during treatment with this medicine, as your skin may become more sensitive.
Take this medicine at the lowest effective dose and for the shortest possible duration to reduce the likelihood of adverse effects.
Stop treatment with this medicine and contact your doctor immediately if:

• you develop skin rashes, mucosal lesions, or any other sign of hypersensitivity;
• you experience 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 stomach burning, bleeding, or pain.

Children and adolescents
DOLKET must not be administered to children and adolescents under 18 years of age.

Other medicines and DOLKET
Inform 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-dose salicylates (more than 3 g per day);
• medicines used to slow down blood clotting (anticoagulants such as heparin and warfarin; antiplatelet agents such as ticlopidine and clopidogrel);
• lithium, used to treat depression or similar disorders;
• high-dose methotrexate (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, inform your doctor, who will monitor you closely:

• corticosteroids, used for inflammation;
• ACE inhibitors, diuretics, angiotensin II antagonists, beta-blockers, used for high blood pressure or heart problems;
• low-dose methotrexate (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 disorders;
• probenecid, used for gout;
• certain antidepressants, known as selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants;
• cyclosporine and tacrolimus, used after organ transplantation or to treat immune system disorders;
• certain antibiotics, used for bacterial infections.

Your doctor should monitor you closely and may decide to reduce the dose of DOLKET.

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 DOLKET 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 or your baby’s tendency to bleed and may delay or prolong labor beyond the expected duration.
You should not take DOLKET 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, DOLKET 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
Do not take DOLKET while breastfeeding.

Fertility
DOLKET may cause fertility problems in women. Therefore, if you plan to become pregnant, inform your doctor, as this medicine may reduce fertility.
Stop treatment if you have fertility problems and are planning a pregnancy, or if you are undergoing fertility tests.

Driving and using machines
This medicine may cause dizziness, drowsiness, or seizures. If this occurs, avoid driving or operating machinery.

DOLKET contains sorbitol, methyl parahydroxybenzoate, and sodium
This medicine contains 3.15 g of sorbitol per dose, equivalent to 9.45 g for the maximum recommended daily dose. Sorbitol is a source of fructose. If your doctor has told you that you 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, speak with your doctor before taking this medicine.
This medicine contains methyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.

3. How to take DOLKET

Take this medicine exactly as stated in this leaflet or 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).

Use in adults
The recommended dose is one stick, once only, or repeated 2-3 times daily in cases of more intense pain.

Use in elderly patients
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 patients with liver problems
If you have mild or moderate liver impairment, 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 patients 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 medical advice and do not exceed the recommended doses.
Limit the duration of treatment to the resolution of the painful episode.

Method of administration
Oral use.
Take this medicine with food.
Always use the lowest effective dose for the shortest possible time necessary to control symptoms, in order to reduce the occurrence of adverse effects.

If you take more DOLKET than you should
The most common symptoms of overdose are: 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), kidney failure, seizures and coma.
In case of accidental ingestion of an excessive dose of this medicine, contact your doctor immediately or go to the nearest hospital Emergency Department.
Bring 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 DOLKET
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 most commonly observed side effects are gastrointestinal in nature. Stomach or intestinal problems may occur (peptic ulcers, perforation or bleeding from the stomach or intestine, which can be life-threatening, particularly in elderly patients). Inform your doctor immediately if you experience any side effects affecting the stomach and/or intestines (stomach pain, burning sensation, bleeding), especially if you are an elderly patient.
Stop taking DOLKET 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.

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, diarrhoea, excessive gas in the gastrointestinal tract (flatulence), constipation, inflammation of the stomach lining (gastritis), skin rash, itching, swelling due to fluid retention (oedema), fatigue.

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), asthma, inflammation of the mouth (ulcerative stomatitis), problems with 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), weight gain.

Frequency not known (frequency cannot be estimated from the available data)
Inflammation of the membranes covering the brain and spinal cord (aseptic meningitis), inflammation of the lymphatic vessels (lymphangitis), reduced platelet count (thrombocytopenia), reduced white blood cell count (agranulocytosis), increased white blood cell count (leucocytosis), reduced white blood cell count (leucopenia), reduced neutrophil count, a type of white blood cell (neutropenia), development of multiple bleeding spots on the skin due to reduced platelet count (thrombocytopenic purpura), reduced bone marrow activity (myelophthisis), destruction of red blood cells (haemolytic anaemia), reduced production of red blood cells (aplastic anaemia), sudden potentially fatal allergic reaction (including anaphylactic shock), depression, seeing and hearing things that are not real (hallucinations), mood changes, hyperexcitability, insomnia, transient loss of consciousness (syncope), seizures, altered taste (dysgeusia), tremor, involuntary and uncoordinated movements (hyperkinesia), movement disorders (dyskinesia), dizziness, swelling around the eyes due to fluid accumulation (periorbital oedema), heart problems (heart failure), awareness of your own heartbeat (palpitations), rapid heartbeat (tachycardia), high blood pressure (hypertension), low blood pressure (hypotension), vasodilation, inflammation of blood vessels (vasculitis), swelling of the larynx, breathing difficulties (bronchospasm), runny nose (rhinitis), shortness of breath (dyspnoea), breathing difficulties due to laryngeal spasm (laryngospasm), acute respiratory failure, skin rash (exanthema, maculopapular exanthema), skin inflammation (erythema, dermatitis), increased sensitivity to light (photosensitivity), hair loss (alopecia), hives, swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in breathing and swallowing (angioedema), rare skin condition with blisters and bleeding of the 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), gastrointestinal bleeding and perforation, gastric or duodenal ulcer, heartburn, stomach ache, damage to the stomach lining without perforation leading to bleeding (erosive gastritis), swelling of the mouth or tongue, inflammation of the pancreas, passage of blood in stools (melena), vomiting blood (haematemesis), kidney problems such as blood in urine (haematuria), acute kidney failure, tubulo-interstitial nephritis, nephritic syndrome, nephrotic syndrome, glomerular nephritis, acute tubular necrosis, renal papillary necrosis, abnormalities in kidney function tests, fluid retention, reduced urine output (oliguria), difficulty in urination (dysuria), chills, tiredness (asthenia), swelling of extremities (peripheral oedema), facial swelling (facial oedema).

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 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 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 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 DOLKET contains
The active substance is ketoprofen lysine salt.
Each stick contains 40 mg of ketoprofen lysine salt.
The other components are: non-crystallizable liquid sorbitol, disodium hydrogen phosphate dihydrate,
methyl parahydroxybenzoate sodium, sodium saccharin, mint flavour, liquorice flavour, purified water.
Description of the appearance of DOLKET and package contents
DOLKET is a clear, colourless to yellowish solution.
Each pack contains 10 or 20 PET/AL/PE sticks 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