DEXOKET 25 mg granules 10 sachets

Dexoket 25 mg granules for oral solution

dexketoprofenum

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as your doctor or pharmacist has told you.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- If you get any side effects, talk to your doctor or pharmacist. Do the same for any side effects not listed in this leaflet. See point 4.

- If you do not feel better within 3-4 days or if you feel overwhelmed, you must consult a doctor.

 

What you will find in the package leaflet:

1. What Dexoket is and what it is used for

2. What you need to know before you take Dexoket

3. How to take Dexoket

4. Possible side effects

5. How to store Dexoket

6. Package contents and other information

 

1. What Dexoket is and what it is used for

Dexoket is a painkiller that belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term treatment of mild to moderate pain, such as acute muscle or joint pain, dysmenorrhea and toothache.

If you do not feel better within 3-4 days or if you become overweight, you must consult a doctor.

 

2. What you need to know before you take Dexoket

Do not take Dexoket:

- If you are allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (listed in section 6);

- If you are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;

- If you have asthma or have had an asthma attack, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths of the nasal mucosa caused by, for example, allergies), hives (skin rash), angioedema (swelling of the face, eyes, lips or tongue) or difficulty breathing) or difficulty breathing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;

- If you suffer from photoallergic or phototoxic reactions (some form of redness and / or blistering of the skin after exposure to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fats);

- If you have a stomach or duodenal ulcer / bleeding in the stomach or intestines, or if you have a history of bleeding in the stomach or intestines, ulcers or perforations;

- If you have chronic indigestion (eg indigestion, heartburn);

- If you have had bleeding in the stomach or intestines or a puncture in relation to previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain;

- If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);

- If you have severe heart failure, moderate or severe kidney problems or severe liver problems;

- If you suffer from bleeding disorders or blood clotting disorders;

- If you are severely dehydrated (ie if you lose a lot of fluids) due to vomiting, diarrhea or insufficient fluid intake;

- If you are in the last three months of pregnancy or breast-feeding;

Warnings and precautions :

Ask your doctor or pharmacist for advice before taking Dexoket.

- If you suffer from or have ever suffered from allergies;

- If you have kidney, liver or heart problems (high blood pressure and / or heart failure), if you suffer from fluid retention or have had such problems in the past;

- If you are taking diuretics (diuretics) or if you are very slightly hydrated (hydrated) and have a reduced blood volume due to excessive fluid loss (eg excessive urination, diarrhea or vomiting);

- If you have heart disease, if you have had a stroke or if you think you may be at risk for such diseases (eg if you have high blood pressure, diabetes or high cholesterol or if you smoke ), you must consult your doctor or pharmacist. Medicines such as Dexoket may slightly increase the risk of heart attack or stroke. Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended doses and duration of treatment.

- If you are elderly: you may be more likely to get side effects (see section 4). If you get any side effects, talk to your doctor straight away.

- If you are a woman and have fertility problems (Dexoket may impair your fertility, so you should not take it if you want to become pregnant or are being tested for infertility);

- If you have a disorder of blood and blood cell production;

- If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect the connective tissue);

- If you have a history of chronic inflammation of the bowel (ulcerative colitis, Crohn's disease);

- If you have or have had another disease of the stomach or intestines;

- If you have varicella (chickenpox), as NSAIDs may, in exceptional cases, make the infection worse;

- If you are taking other medicines that increase the risk of stomach or duodenal ulcers or bleeding in the stomach or intestines, such as oral (taken by mouth) corticosteroids, some antidepressants (such as SSRIs, ie selective serotonin reuptake inhibitors), medicines to prevent blood clots. such as acetylsalicylic acid or anticoagulants such as warfarin. In this case, talk to your doctor before taking Dexoket: your doctor may ask you to take another medicine that will protect your stomach (eg misoprostol or medicines that suppress the production of stomach acids).

-If you have asthma combined with chronic rhinitis, chronic sinusitis and / or nasal polyposis, you are at higher risk of allergy to acetylsalicylic acid and / or non-steroidal anti-inflammatory drugs (NSAIDs) than the rest of the population. Administration of this medicinal product may cause asthma attacks or bronchoconstriction, especially in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

The use of Dexoket in children and adolescents has not been studied. Therefore, safety and efficacy have not been established and therefore the product should not be used in children and adolescents.

Other medicines and Dexoket

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines must not be taken at the same time as this medicine, and some other medicines may need to be adjusted when taken at the same time.

Always tell your doctor, dentist or pharmacist if you are taking any of the following medicines at the same time as Dexoket:

Combinations not recommended:

- Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs

- Warfarin, heparin or other medicines used to prevent blood clots

- Lithium, which is used to treat certain mood disorders

- Methotrexate (a medicine used to treat cancer or to suppress the immune response), used at high doses of 15 mg / week

- Hydantoins and phenytoin, used in epilepsy

- Sulfamethoxazole, used to treat bacterial infections

Combinations requiring caution:

- ACE inhibitors, diuretics and angiotensin II antagonists, used to treat high blood pressure and heart disease

- Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers

- Zidovudine, used to treat viral infections

- Aminoglycoside antibiotics used to treat bacterial infections

- Chlorpropamide and glibenclamide, for the treatment of diabetes

- Methotrexate used in low doses, less than 15 mg / week

Combinations to consider carefully:

- Quinolone antibiotics (eg ciprofloxacin, levofloxacin), used to treat bacterial infections

- Cyclosporine or tacrolimus, which are used in diseases of the immune system and in organ transplants

- Streptokinase and other thrombolytics or fibrinolytics, ie medicines used to dissolve blood clots

- Probenecid, to treat gout

- Digoxin, used to treat chronic heart failure

- Mifepristone, used as an abortive (to terminate a pregnancy)

- Antidepressants from the group of selective serotonin reuptake inhibitors (SSRIs)

- Antiplatelet agents used to reduce blood clotting and blood clots

- Beta-blockers used to treat high blood pressure and heart problems

If you have any further questions on the use of other medicines at the same time as Dexoket, ask your doctor or pharmacist.

Dexoket with food and drink

If you have acute pain, take the sachets on an empty stomach, ie at least 15 minutes before a meal, as this allows the medicine to work a little faster.

Pregnancy, breastfeeding and fertility

Do not take Dexoket during the last three months of pregnancy or if you are breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

See also section 2 "Warnings and precautions" for possible effects on female fertility.

Driving vehicles and operating machines

Dexoket may slightly affect your ability to drive and use machines due to possible side effects of treatment such as dizziness, drowsiness and visual disturbances. If such effects occur, do not drive or use machines until the symptoms have disappeared. Talk to your doctor.

Dexoket contains sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This product contains 2.4-2.44 g of sucrose per dose. This should be taken into consideration by patients with diabetes.

 

3. How to take Dexoket

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

Adults (from 18 years of age)

The dose of Dexoket you need to be treated depends on the type, severity and duration of your pain. Your doctor will tell you how many sachets you need to take each day and for how long.

Treatment without consulting a doctor:

The recommended dose is 1 sachet (25 mg) every 8 hours, and you should not take more than 3 sachets a day (75 mg).

If you do not feel better within 3-4 days or if you become overweight, consult a doctor. Do not take this medicine for more than 4 days without consulting your doctor.

If you are elderly or have kidney or liver problems, you must start treatment with a total daily dose not exceeding 2 sachets per day (50 mg).

In the elderly, this starting dose may be increased to the usual recommended dose (75 mg dexketoprofen) if Dexoket is well tolerated.

If your pain is severe and you need to relieve it faster, take the sachets on an empty stomach (at least 15 minutes before eating) as they will be more easily absorbed (see section 2 “Taking Dexoket with food and drink”).

Use in children and adolescents

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

Instructions for proper use

Dissolve the entire contents of one sachet in a glass of water; shake / stir well to aid dissolution.

The resulting solution should be drunk immediately after preparation.

If you take more Dexoket than you should:

If you take too much of this medicine, talk to your doctor or pharmacist immediately or contact your nearest hospital emergency department. Please do not forget to take the packaging of this product or the package leaflet with you.

If you forget to take Dexoket:

Do not take a double dose to make up for a forgotten sachet. Take the next regular dose at the right time (see section 3, 'How to take Dexoket').

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

 

4. Possible side effects

Like all medicines, Dexoket can cause side effects, although not everybody gets them.

Possible side effects are listed below, depending on the likelihood of their occurrence. Because this list is partly derived from the side effects of Dexoket tablets and Dexoket granules are absorbed faster than tablets, it is possible that the actual frequency of side effects with Dexoket granules (in the gastrointestinal tract) will be higher.

Common side effects: may affect up to 1 in 10 people

Nausea and / or vomiting, pain especially in the upper abdomen, diarrhea, indigestion (dyspepsia).

Uncommon side effects: may affect up to 1 in 100 people

Vertigo, dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, gastritis, constipation, dry mouth, bloating, skin rash, tiredness, pain, fever and tremor , general feeling of being unwell (malaise).

Rare side effects: may affect up to 1 in 1,000 people

Gastric or duodenal ulcer, perforation of the stomach or duodenum or bleeding which may present as vomiting of blood or black stools, fainting, high blood pressure, very slow breathing, water retention and peripheral edema (eg swollen ankles), swelling larynx, loss of appetite (anorexia), unusual perception, itchy rash, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, liver function test results different from normal (blood tests), liver cell damage (liver inflammation) , acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 patients

Anaphylactic reaction (severe hypersensitivity reaction that may lead to collapse), open sores on the skin, mouth, eyes and genitals (Stevens-Johnson syndrome and Lyell's syndrome), swelling of the face or swelling of the lips and throat (angioedema) , shortness of breath caused by narrowing of the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Decreased white blood cell count (neutropenia), less platelets in the blood (thrombocytopenia).

If you experience any stomach / intestinal side effects (eg stomach pain, heartburn or bleeding) at the start of treatment, if you have had such side effects in the past due to long-term treatment with anti-inflammatory medicines and especially if you are elderly, tell your doctor immediately.

Stop taking Dexoket if you notice a skin rash or any damage to your mouth or genitals or any signs of allergies.

Fluid retention and swelling (especially of the ankles and feet), increased blood pressure and heart failure have been reported during treatment with non-steroidal anti-inflammatory drugs.

Medicines such as Dexoket may slightly increase the risk of heart attack or stroke (stroke).

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs may rarely cause fever, headache and stiff neck.

The most commonly observed side effects concern the digestive tract. Gastric or duodenal ulcers, perforation or bleeding into the digestive tract may occur, sometimes resulting in death, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, melena (black tarry stools), vomiting of blood, ulcerative inflammation of the oral mucosa, worsening of inflammation of the intestines (colitis and Crohn's disease) have also been reported after administration. Inflammation of the gastric mucosa (gastritis) has been observed less frequently.

As with other non-steroidal anti-inflammatory drugs (NSAIDs), haematological reactions (purpura, aplastic and haemolytic anemia, and rarely agranulocytosis and bone marrow hypoplasia) may occur.

 

5. How to store Dexoket

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and sachet. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help to protect the environment.

 

6. Package contents and other information

What Dexoket contains

Each sachet contains 25 mg dexketoprofen (as dexketoprofen trometamol).

The other ingredients are ammonium glycyrrhizate, neohesperidine dihydrochalcone, quinoline yellow (E104), lemon flavor, sucrose and colloidal hydrated silica.

One sachet contains 2.40-2.44 g of sucrose with colloidal hydrated silica.

 

What Dexoket looks like and contents of the pack

Dexoket 25 mg is supplied in sachets containing lemon yellow granules.

Dexoket 25 mg is supplied in packs containing 2, 4, 10 sachets.

Not all pack sizes may be marketed.

 

Marketing Authorization Holder

Menarini International Operations Luxembourg S.A., Luxembourg, Lucembursko

Producer

Laboratorios Menarini, SA, Badalona, ​​Spain