Dexak

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Dexak (Enantyum), 25 mg, coated tablets
Dexketoprofen
Dexak and Enantyum are different trade names for the same medicine.
Please read the entire leaflet carefully before using 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, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions 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.

Table of contents of the leaflet:

1. What Dexak is and what it is used for
2. Important information before taking Dexak
3. How to take Dexak
4. Possible side effects
5. How to store Dexak
6. 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 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, 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 has asthma or previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal lining), nasal polyps (growths inside the nose caused by allergy), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of respiratory symptoms), or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly as 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 has gastric and/or duodenal peptic ulcer disease or gastrointestinal bleeding, or if they previously experienced gastrointestinal bleeding, ulceration or perforation;
• If the patient has chronic digestive problems (e.g. indigestion, heartburn);
• If the patient previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs used for pain relief;
• If the patient has inflammatory bowel diseases with chronic inflammation (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 high tendency to bleed or coagulation disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhoea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions
Before starting treatment with Dexak, consult your doctor or pharmacist if:

• The patient has allergies or previously experienced allergy-related problems;
• The patient has kidney, liver or heart function disorders (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred in the past;
• In patients receiving diuretics or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea or vomiting);
• If the patient has heart problems, a history of stroke, or suspicion of being in a risk group for these conditions (e.g. high blood pressure, diabetes, high 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 fertility problems or undergoing infertility investigations (Dexak may impair female fertility and is not recommended for women planning pregnancy or undergoing infertility treatment);
• If the patient has blood or blood cell formation disorders;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn’s disease);
• If the patient currently has or 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 and/or duodenal ulcers or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI group drugs, e.g. serotonin reuptake inhibitors), anticoagulant drugs such as acetylsalicylic acid or anticoagulants 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 that inhibit gastric acid production);
• 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. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Dexak may mask symptoms of infection such as fever and pain. Therefore, Dexak may delay appropriate treatment of infection and consequently increase the 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. Safety and efficacy have not been established, and therefore Dexak should not be used in children and adolescents.

Dexak and other medicines
Always inform your doctor, dentist or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription, or if you plan to start taking any. Some medicines should not be used together with Dexak, and others may require dose adjustment when taken together with Dexak.

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
  • High-dose methotrexate (an anticancer or immunosuppressive drug) at 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
  • Low-dose methotrexate, 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 (used to dissolve blood clots)
  • Probenecid used to treat gout
  • Digoxin used to treat chronic heart failure
  • Mifepristone used as an abortion-inducing agent (terminates pregnancy)
  • Selective serotonin reuptake inhibitors (SSRIs), antidepressant drugs
  • Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
  • 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 side 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, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take this medicine if the patient is in the last three months of pregnancy or during breastfeeding. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleed in both mother and child and may delay or prolong labour.
This medicine should not be used during the first six months of pregnancy 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 week 20 of pregnancy, Dexak, if taken for longer than a few days, may cause:
Renal function disorders in the unborn child – this may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the baby’s heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing infertility diagnosis.
Information on potential effects on fertility is provided 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 or operate machinery. If such symptoms occur, do not drive or operate mechanical equipment until symptoms resolve. If in doubt, consult your 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 the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a 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, consult a doctor immediately (see section 2).
Tablets may be divided into equal doses by breaking them along the score line.
The usual recommended daily dose is 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, contact a doctor. The doctor will inform the patient how many tablets should be taken per day and for how long.
The dose of this medicine will depend on the type, severity, and duration of the patient's pain.
In elderly patients or those with kidney or liver disease, treatment should start 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).
For acute pain, when faster relief is needed, 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, inform a doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Remember to bring the medicine packaging or patient leaflet with you.

Missed 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 there are any further questions regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 (vestibular origin), drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the gastric mucosa (gastritis), constipation, dryness of the oral mucosa, bloating with gas passage, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare adverse reactions (may affect up to 1 in 1000 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 limbs 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, lip, eye and genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), breathlessness caused by contraction of respiratory muscles (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 (neutrop游戏副本

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.
Do not store above 30°C. Store blisters in the original 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 (as dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
• Other ingredients are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glycerol distearate, hypromellose, titanium dioxide (E 171), macrogol 6000, propylene glycol.

What Dexak looks like and contents of the pack
Dexak tablets are white, round, film-coated tablets with a break line.
Dexak is available in packs containing 10, 20 or 30 film-coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in Spain, the country of export:
Laboratorios Menarini, S.A.
Alfons XII, 587
E-08918 Badalona (Barcelona)
Spain
Manufacturer:
Laboratorios Menarini, S.A.
Alfons XII, 587
E-08918 Badalona (Barcelona)
Spain
A. Menarini Manufacturing Logistics and Services, s.r.l.
Via 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 Spain, the country of export: 681957.9
Parallel Import Authorisation Number: 518/15
This medicinal product is authorised for sale in the European Economic Area countries and in the United Kingdom (Northern Ireland) 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