Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Dexak (Keral)
25 mg, coated tablets

Dexketoprofen*
Dexak and Keral are different trade names for the same medicine.
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3–4 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

What Dexak is and what it is used for
Important information before taking Dexak
How to take Dexak
Possible side effects
How to store Dexak
Contents of the pack and other information

1. What Dexak is and what it is used for

Dexak is an analgesic medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for the symptomatic treatment of mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), or toothache.
If there is no improvement after 3–4 days, or if you feel worse, you should consult your doctor.

2. Important information before using Dexak

When not to use Dexak:

If the patient is allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
If the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
If the patient suffers from asthma or has previously experienced asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal lining), nasal polyps (nodules inside the nose caused by allergy), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue or associated respiratory disorders), or wheezing after taking acetylsalicylic acid or another NSAID;
If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly in the form of redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
If the patient currently has peptic ulcer disease of the stomach and/or duodenum, or gastrointestinal bleeding, or has previously experienced gastrointestinal bleeding, ulceration, or perforation;
If the patient currently suffers from chronic digestive problems (e.g. indigestion, heartburn);
If the patient has previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs used for pain relief;
If the patient has chronic inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If the patient has severe heart failure, moderate or severe renal failure, or severe hepatic failure;
If the patient has a tendency to excessive bleeding or coagulation disorders;
If the patient is severely dehydrated (excessive loss of body fluids) due to vomiting, diarrhoea, or inadequate fluid intake;
If the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions
Before starting to take Dexak, consult your doctor or pharmacist if:

The patient has any allergies or has previously experienced allergy-related problems;
The patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously;
In patients receiving diuretics or in patients who have reduced hydration and decreased blood volume due to excessive fluid loss (e.g. excessive urination, diarrhoea, or vomiting);
If the patient has heart problems, has had a stroke, or is suspected of being at risk for these conditions (e.g. in case of high blood pressure, diabetes, elevated cholesterol levels, or smoking). In such cases, consult a doctor before using Dexak. Taking medicines such as Dexak may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended;
If the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact a doctor immediately;
In women experiencing difficulty conceiving or undergoing fertility testing (Dexak may impair female fertility and is not recommended for women planning pregnancy or being treated for infertility);
If the patient has blood cell formation disorders or blood cell abnormalities;
If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
If the patient has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
If the patient currently has or has previously had other stomach or intestinal disorders;
If the patient has an infection - see below, section titled "Infections";
If the patient is taking other medicines that increase the risk of gastric or duodenal ulceration or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI group drugs, e.g. serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or anticoagulant drugs such as warfarin. In such cases, consult a doctor before taking Dexak. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs inhibiting gastric acid secretion);
If the patient has asthma and chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, Dexak may delay appropriate treatment of infection and consequently lead to an increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.

Children and adolescents
The use of this medicine has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established, and therefore Dexak should not be used in children and adolescents.

Dexak and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. Some medicines should not be used together with Dexak, and in other cases dosage adjustments may be necessary when Dexak is taken concomitantly.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexak:

Not recommended for concomitant use:
Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other anticoagulant drugs
Lithium used to treat certain mood disorders
Methotrexate (an anticancer or immunosuppressive drug) used in high doses of 15 mg per week
Hydantoin derivatives and phenytoin used to treat epilepsy
Sulfamethoxazole used to treat bacterial infections.
Concomitant use requiring caution:
ACE inhibitors, diuretics, and angiotensin II antagonists used to treat high blood pressure and heart diseases
Pentoxifylline and oxpentifylline used to treat ulcers in chronic venous insufficiency
Zidovudine used to treat viral infections
Aminoglycoside antibiotics used to treat bacterial infections
Sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide) used to treat diabetes
Methotrexate used in low doses, below 15 mg per week.
Concomitant use requiring special consideration:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
Cyclosporine and tacrolimus used to treat immune system disorders and in transplant patients
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve blood clots
Probenecid used to treat gout
Digoxin used to treat chronic heart failure
Mifepristone used as an abortion-inducing agent (terminating pregnancy)
Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants
Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
Beta-adrenergic blocking agents (beta-blockers) used to treat high blood pressure and heart diseases
Tenofovir, deferasirox, pemetrexed.

If you have any doubts regarding the use of Dexak, consult your doctor or pharmacist.

Taking Dexak with food and drink
Dexak tablets should be swallowed with sufficient water. Taking the tablets with food may reduce the risk of gastrointestinal adverse effects. However, in case of acute pain, it is recommended to take the medicine on an empty stomach, e.g. at least 30 minutes before a meal, to allow faster onset of action.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Do not take this medicine if the patient is in the last 3 months of pregnancy or during breastfeeding. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labour.
During the first 6 months of pregnancy, this medicine should not be used unless the doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible duration.
From the 20th week of pregnancy, Dexak, if taken for longer than a few days, may cause:
impaired kidney function in the unborn child – this may lead to reduced amniotic fluid surrounding the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing fertility testing.
Information on potential effects on fertility can be found in section 2, "Warnings and precautions".

Driving and operating machinery
Dexak may cause dizziness and fatigue and therefore may have a minor or moderate effect on the ability to drive vehicles or operate machinery. If such symptoms occur, do not drive or operate mechanical equipment until symptoms resolve. If in doubt, consult a doctor.

Dexak contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Dexak

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If symptoms of infection (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
Tablets may be divided into equal doses by breaking them along the division line.
The usual recommended daily dose is generally half a tablet (12.5 mg) every 4 to 6 hours, or one tablet (25 mg) every 8 hours, but not more than 3 tablets per day (75 mg).
If there is no improvement after 3 to 4 days, or if the patient feels worse, medical advice must be sought. The doctor will inform the patient how many tablets should be taken per day and for how long.
The dose of Dexak will depend on the type, severity, and duration of the patient's pain.
In elderly patients or in patients with kidney or liver disease, treatment should be initiated with a lower total daily dose corresponding to no more than 2 coated tablets (50 mg).
In elderly patients who tolerate the initial dose well, the dose may subsequently be increased to that recommended for the general population (75 mg).
In cases of acute pain requiring faster relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the medicine (see section 2, "Taking this medicine with food and drink").

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

Taking more Dexak than recommended
If an overdose is suspected, contact a doctor or pharmacist, or go immediately to the nearest hospital emergency department. Remember to bring the medicine packaging or patient leaflet with you.

If you miss a dose of Dexak
Do not take a double dose to make up for a missed dose. The next dose should be taken according to the prescribed dosing schedule (see section 3, "How to use Dexak").

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The possible adverse reactions listed below are categorized according to their likelihood of occurrence.
Common adverse reactions (may affect up to 1 in 10 people):
Nausea and (or) vomiting, abdominal pain, mainly in the upper quadrants, diarrhoea, indigestion (dyspepsia).
Uncommon adverse reactions (may affect up to 1 in 100 people):
Vertigo (of labyrinthine origin), drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the gastric mucosa (gastritis), constipation, dryness of the oral mucosa, bloating with flatulence, rash, fatigue, pain, feeling of fever and chills, malaise.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Peptic ulcer disease, gastrointestinal bleeding or perforation (which may present as vomiting blood or black stools), fainting, hypertension, reduced respiratory rate, fluid retention in the extremities and peripheral oedema (e.g. swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate gland disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.
Very rare adverse reactions (may affect up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock), skin ulceration of lips, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), breathlessness due to bronchial muscle spasm (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions and photosensitivity, itching, kidney damage, reduced white blood cell count (neutropia), reduced platelet count (thrombocytopenia).
Patients should inform their doctor if they experience any gastrointestinal adverse reactions (e.g. stomach pain, heartburn or bleeding) at the beginning of treatment, especially if they have previously experienced similar adverse reactions due to long-term use of anti-inflammatory medicines, particularly in elderly patients.
If a skin rash or any mucosal lesion (e.g. inside the mouth) or any allergic symptoms occur, treatment with Dexak should be stopped immediately.
During administration of non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and oedema (particularly of the ankles and legs), increased blood pressure and heart failure may occur.
Use of medicines such as Dexak may be associated with a small increased risk of heart attack ("myocardial infarction") or cerebrovascular events (stroke).
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.
The most frequently observed adverse reactions involved gastrointestinal disturbances. Particularly in elderly patients, gastric or duodenal ulceration, perforation or bleeding may occur, in some cases with fatal outcome.
After administration of the medicine, the following have been reported: nausea, vomiting, diarrhoea, bloating, constipation, dyspepsia, lower abdominal pain, tarry stools, vomiting blood, ulcerative inflammation of the oral mucosa, exacerbation of colitis and Crohn's disease. Gastric mucositis has been observed less frequently.
As with other NSAIDs, haematological reactions may occur (purpura, aplastic and haemolytic anaemia, rarely agranulocytosis and bone marrow hypoplasia).
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Dexak

Keep this medicine out of 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 the stated month.
[Blister Aclar/Aluminium or blister Aluminum/Aluminium:]
No special storage temperature requirements. Store in the original packaging to protect from light.
[Blister PVC/Aluminium:]
Do not store above 30°C. Keep the blister in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Dexak contains

The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
Other ingredients are: Tablet core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), glycerol distearate. Coating: dry film coating (composed of hypromellose, titanium dioxide, polyethylene glycol 6000), propylene glycol.

What Dexak looks like and contents of the pack
Dexak tablets are white, round, coated tablets with a central dividing groove.
Dexak is available in packs containing 10, 20 or 30 coated tablets.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Ireland, the country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg
Manufacturer:
Laboratorios Menarini S.A.
Alfons XII 587
08918 Badalona (Barcelona)
Spain
A. Menarini Manufacturing Logistics and Services, srl
Via Campo di Pile s/n Loc. Campo di Pile, L’Aquila, Italy
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Ireland, the country of export: PA 865/2/2
Parallel Import Authorisation Number: 3/25
This medicinal product is authorised for sale in the European Economic Area under the following trade names:
Spain (RMS), Austria, Belgium, Finland, France, Italy, Luxembourg, Portugal: Ketesse
Cyprus, Greece: Nosatel
Czech Republic: Dexoket
Germany: Sympal
Estonia, Latvia, Lithuania: Dolmen
Hungary: Ketodex
Ireland, Malta, United Kingdom (Northern Ireland): Keral
Netherlands: Stadium
Poland: Dexak
Slovakia: Dexadol
Slovenia: Menadex