Dexofen 25 mg. 20 sachet

What is Dexofen 25 mg and what it is used for

Dexofen 25 mg is an analgesic drug from the non-steroidal anti-inflammatory drugs (NSAIDs). Dexofen 25 mg is used to treat mild to moderate pain such as muscle pain, painful menstruation (dysmenorrhoea) and toothache.
If after 3 to 4 days you do not feel better or your condition gets worse, you should seek medical attention.

2. What you need to know before taking Dexofen 25 mg

Do not take Dexofen 25 mg:
- if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
- if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
- if you have asthma or if you have had asthma attacks, acute allergic rhinitis (shortness of nose), nasal polyps (nasal nodules), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue or respiratory failure) or chest chest infection after administration of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
- if you have had photosensitive or phototoxic reactions (a particular form of reddening of the skin and / or blistering when exposed to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce lipid levels in blood);
- if you have peptic ulcer / stomach or intestinal bleeding or have previously had gastrointestinal or intestinal bleeding, ulcer or perforation;
- if you have chronic digestive disorders (eg indigestion, heartburn);
- if you have had stomach or intestinal bleeding or perforation as a result of previous use of non-steroidal anti-inflammatory drugs (NSAIDs) in pain; if you have intestinal disease with chronic inflammation (Crohn's disease or ulcerative colitis);
- if you suffer from severe heart failure, moderate to severe kidney problems or serious liver problems;
- if you have bleeding or clotting disorders;
- if you are severely dehydrated (ie if you have lost many body fluids) due to vomiting, diarrhea or insufficient fluid intake;
- if you are pregnant in a third trimester or are breast-feeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking Dexofen 25 mg:
- if you have an allergy or have had an allergic event in the past;
- if you have kidney, liver or heart disorders (hypertension and / or heart failure), fluid retention, or if you have suffered from any of the above mentioned disorders in the past;
- if you are taking diuretics or are dehydrated and have a reduced blood volume due to excessive fluid loss (eg urination, diarrhea or vomiting);
- if you have heart problems, have a stroke, or think you may be at risk for these conditions (eg if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss your treatment with your doctor or pharmacist. Medicines such as Dexofen® 25 mg may be associated with a slightly increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely at high doses or prolonged treatment. Do not exceed the recommended dose and duration of treatment;
- if you are elderly because you may be more prone to side effects (see section 4). If any side effects occur, talk to your doctor immediately.
- if you are a woman with conception problems (Dexofen® 25 mg may impair your reproductive capacity, so you should not take it if you are trying to become pregnant or doing infertility testing);
- if you have a disorder of blood circulation or blood cell formation;
- if you suffer from systemic lupus erythematosus or mixed connective tissue disease
(disorders of the immune system that affect the connective tissue);
- if you have had chronic gastrointestinal inflammation (ulcerative colitis or COPD) in the past
Crohn);
- if you have or have suffered from other gastric or intestinal disorders in the past;
- if you have chickenpox, as NSAIDs may, in exceptional cases, aggravate the infection;
- if you take other medicines that increase the risk of ulcer or bleeding, oral corticosteroids, some antidepressants (those of the SSRI type, so-called serotonin reuptake inhibitors), anticoagulant drugs, e.g. aspirin or anticoagulants such as warfarin. In these cases, talk to your doctor before taking Dexofen® 25 mg. He / she may advise you to take additional gastric (eg misoprostol or medicines that suppress stomach acid secretion);
- if you suffer from asthma combined with chronic rhinitis, chronic sinusitis and / or nasal polyposis because you have an increased risk of allergy to acetylsalicylic acid and / or NSAIDs compared to the rest of the population
Children and adolescents
Dexofen 25 mg has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and should not be used in children and adolescents.

Other medicines and Dexofen 25 mg
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines should not be taken with others or dose changes are needed if they are taken at the same time.

Always tell your doctor, dentist or pharmacist if you are taking or using any of the following medicines at the same time as Dexfen 25 mg:

Combinations that are not recommended:
- acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs;
- warfarin, heparin or other anti-caking agents;
- lithium used to treat certain mood disorders;
- methotrexate (a medicine used to treat cancer or to suppress the immune system),
- used at high doses of 15 mg per week;
- hydantoin and phenytoin used in epilepsy;
- sulfamethoxazole used in bacterial infections.

Combinations requiring special precautions:
- ACE inhibitors, diuretics and angiotensin-II antagonists used in high blood pressure and heart problems;
- pentoxifylline and oxpentifylline, used to treat chronic venous ulcers; zidovudine, used to treat viral infections;
- aminoglycoside antibiotics used to treat bacterial infections; - sulphonylureas (for example, chlorpropamide and glibenclamide) used in diabetes;
- methotrexate at low doses of less than 15 mg per week.

Combinations to be applied with caution:
- quinolone antibiotics (eg ciprofloxacin, levofloxacin) used in bacterial infections;
- ciclosporin or tacrolimus, used in the treatment of immune system diseases and organ transplants;
- streptokinase and other thrombolytic or fibrinolytic drugs, i. e. medicines to break blood clots;
- probenecid used in gout;
- digoxin, used in the treatment of chronic heart failure;
- mifepristone used to induce an abortion (termination of pregnancy); - antidepressants from the selective serotonin reuptake inhibitor (SSRIs) group;
- antiplatelet medicines used to suppress platelet aggregation and blood clotting;
- beta-blockers used for high blood pressure and heart problems; tenofovir, deferasirox and pemetrexed.

If you have any doubts about taking other medicines with Dexofen® 25 mg, talk to your doctor or pharmacist.

Dexofen 25 mg with food and beverages
Take the tablets with plenty of water. Take the tablets with food as this may reduce the risk of gastric or intestinal side effects. However, if you have severe pain, take the tablets on an empty stomach, for example at least 30 minutes before a meal, as this will speed up the effect of the medicine a little.

Pregnancy, breastfeeding and fertility
Do not take Dexofen 25 mg during the third trimester of pregnancy or during breast-feeding.

If you are pregnant, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine because Dexofen 25 mg may not be suitable for you.
The use of Dexofen 25 mg is not recommended until you get drunk or during infertility studies.
For potential effects on female fertility, see also section 2 "Warnings and Precautions".

Driving and using machines
Dexofen 25 mg may slightly affect your ability to drive and use machines because of the potential for dizziness or drowsiness as an undesirable effect. If you notice any such effects, do not drive or use machines until the symptoms disappear. Ask your doctor for advice.

3. How to take dexfen 25 mg

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is usually 1 tablet (25 mg) every 8 hours but no more than 3 tablets a day (75 mg).

Consult your doctor if you do not feel better or worse after 3-4 days. Your doctor will tell you how many tablets you should take daily and for how long. The dose of Dexofen 25 mg depends on the type, strength and duration of pain.

If you are elderly or if you suffer from impaired renal or hepatic function, you should start treatment with a total daily dose of no more than 2 tablets (50 mg).
In the elderly, the starting dose may be increased to the total recommended daily dose (75 mg) if Dexofen 25 mg is well tolerated.

If the pain is intense and you need a quick relief, take the tablets on an empty stomach (at least 30 minutes before a meal) as this will make it easier
Use in children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).

If you take more Dexofen 25 mg than you should
If you take too much medicine, tell your doctor or pharmacist or go to the emergency room of the nearest hospital. Please be sure to take the medicine pack or this leaflet with you.

If you forget to take Dexofen 25 mg
Do not take a double dose to make up for the missed tablet. Take the next regular dose as directed (see section 3 "How to take dexfen 25 mg").

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Possible side effects are listed below according to their incidence.

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

Uncommon side effects: may affect up to 1 in 100 people
Vertigo, dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitation, redness, inflammation of the stomach lining (gastritis), constipation, dry mouth, abdominal gas, skin rash, fatigue, general weakness (fatigue).

Rare side effects: may affect up to 1 in 1,000 people
Peptic ulcer, perforation or bleeding of peptic ulcer, which may occur as vomiting of blood and black stools, fainting, high blood pressure, delayed breathing, fluid retention and peripheral edema (eg swollen ankles), laryngeal swelling, loss loss of appetite (anorexia), unusual sensation, rash with itching, acne, increased sweating, back pain, frequent urination, menstrual disorders, prostate problems, abnormal liver function tests (blood tests) um), acute renal failure.

Very rare side effects: may affect up to 1 in 10,000 people
Anaphylactic reaction (a hypersensitivity reaction that can lead to loss of consciousness), skin, mouth, eye and genital wounds (Stevens-Johnson syndrome and Lyle syndrome), swelling of the face or swelling of the lips and throat (angioedema), difficulty in breathing due to narrowing of the airways (bronchospasm), superficial breathing, rapid heartbeat, low blood pressure, pancreatic inflammation, blurred vision, tinnitus, sensitive skin, sensitivity to light, itching, river breaches. Reduced white blood cell counts (neutropenia), decreased platelet count (thrombocytopenia).

Tell your doctor immediately if you experience any stomach / intestinal side effects at the beginning of treatment (eg stomach pain, heartburn or bleeding) if you have previously suffered from any of the side effects due to prolonged use of anti-inflammatory medicines, especially if you are in the elderly.

Stop using Dexofen 25 mg as soon as you notice a skin rash, mouth or genital lesions, or any sign of allergy.

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

Medicines such as dexfen 25 mg are associated with a slightly increased risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke).

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

The most commonly observed side effects are gastrointestinal. Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, may occur, especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, colitis and Crohn's disease have been reported during administration. Less frequent inflammation of the stomach lining (gastritis).

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anemia, rarely agranulocytosis and medullar hypoplasia) may occur.
How to store Dexofen 25 mg

Keep out of the reach and sight of children.

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

Store below 30 ° C. Store the blisters in the carton to protect them from light.

Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Dexofen 25 mg contains
- The active substance is dexketoprofen (such as dexketoprofen trometamol). Each film-coated tablet contains 25 mg dexketoprofen.
- The other ingredients are: corn starch, microcrystalline cellulose, sodium starch glycolate, glycerol distearate, hypromellose, titanium dioxide (E171), propylene glycol, macrogol 6000.

 

 

 

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