DEXOFEN 25 mg x 20 sachets
Dexofen
DEXOFEN sachet 25 mg * 20
LEAFLET: PATIENT INFORMATION
Dexofen Sachet 25 mg granules for oral solution
Dexofen sachet 25 mg granules for oral solution
Dexketoprofen
Read the entire leaflet carefully as it contains important information for you. Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See item 4.
If after 3-4 days you do not feel better or your condition worsens, you should seek medical help.
What this leaflet contains:
1. What Dexofen Sachet is and what it is used for
2. What you need to know before you take Dexofen Sachet
3. How to take Dexofen Sachet
4. Possible side effects
5. How to store Dexofen Sachet
6. Contents of the package and additional information
1. What Dexofen Sachet is and what it is used for
Dexofen sachet is an analgesic drug from the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Dexofen Sachet is used for the short-term symptomatic treatment of mild to moderate acute pain such as acute muscle or joint pain, painful menstruation (dysmenorrhoea) and toothache.
2. What you need to know before you take Dexofen Sachet
Do not take Dexofen Sachet;
if you are allergic to dexketoprofen trometamol or any of the other ingredients of this medicine (listed in item 6);
if you are allergic to acetylsalicylic acid (aspirin) or to other non-steroidal anti-inflammatory drugs;
if you have asthma or if you have had asthma attacks, acute allergic rhinitis (short-term inflammation of the nose), nasal polyps (growths in the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue or shortness of breath), or wheezing after taking aspirin or other NSAIDs;
if you have suffered from photoallergic or phototoxic reactions (a particular form of skin reddening and/or blistering when exposed to sunlight) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels );
if you have peptic ulcer/stomach or intestinal bleeding or have previously had stomach or intestinal bleeding, ulcer or perforation;
if you have chronic digestive disorders (e.g. 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) for pain;
if you have a bowel disease with chronic inflammation (Crohn's disease or ulcerative colitis);
if you suffer from serious 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 a lot of body fluids) due to vomiting, diarrhea or insufficient fluid intake;
if you are pregnant in the third trimester or are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Dexofen Sachet:
if you have an allergy or have had allergic reactions in the past;
if you have kidney* liver or heart problems (hypertension and/or heart failure), as well as fluid retention, or if you have suffered from any of the listed problems in the past;
if you are taking diuretics or are dehydrated and have reduced blood volume due to excessive fluid loss (eg frequent urination, diarrhea or vomiting);
if you have heart problems, have had a stroke or think you may be at risk of developing 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® Sachet may be associated with a slightly increased risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke). Any risk is more likely with high doses or long-term treatment. Do not exceed the recommended dose and duration of treatment;
if you are elderly, as you may be more prone to side effects (see section 4). If any adverse reaction occurs, consult your doctor immediately;
if you are a woman who has problems conceiving (Dxofen® Sachet can impair your reproductive capacity. Therefore, it should not be taken if you are planning a pregnancy or undergoing infertility tests);
if you suffer from a disorder in blood formation or blood cell formation;
if you suffer from systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
if you have had chronic intestinal inflammation (ulcerative colitis or Crohn's disease) in the past;
if you have or have suffered in the past from other stomach or intestinal disorders;
if you have chicken pox, as NSAIDs can exceptionally make the infection worse;
if you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral corticosteroids, some antidepressants (those of the SSRI type, so-called serotonin reuptake inhibitors), anticoagulant medicines, e.g. aspirin or anticoagulants such as warfarin. In these cases, consult your doctor before taking Dexofen Sachet. He/she may advise you to take additional medicine to protect the stomach (eg misoprostol or medicines that suppress the secretion of stomach acid).
Children and adolescents
Dexofen Sachet has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and it should not be used in children and adolescents.
Other medicines and Dexofen Sachet
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Some medicines should not be taken with others or a change in dose is required if they are used at the same time.
Always inform your doctor, dentist or pharmacist if you take or use any of the following medicines at the same time as Dexofen Sachet:
Combinations not recommended:
acetyl salicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs;
warfarin, heparin, or other anticoagulants
lithium, used to treat certain mood disorders
methotrexate (a medicine used against cancer or to suppress the immune system) in high doses of 15 mg/week;
hydantoin and phenytoin, used in epilepsy; sulfamethoxazole, used for bacterial infections.
Combinations that require special precautions:
ACE inhibitors, diuretics, beta-blockers and angiotensin-H antagonists used for 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;
chlorpropamide and glibenclamide, used in diabetes;
methotrexate used in low doses, less than 15 mg/week.
Combinations to be used with caution:
quinolone antibiotics (eg ciprofloxacin, levofloxacin) used for bacterial infections;
cyclosporine or tacrolimus, used to treat diseases of the immune system and in organ transplants;
streptokinase and other thrombolytic or fibrinolytic drugs, i.e. medicines to break up blood clots;
probenecid, used for gout;
digoxin used to treat chronic heart failure;
mifepristone, used to induce abortion (termination of pregnancy);
antidepressants from the group of selective serotonin reuptake inhibitors (SSRIs);
antiplatelet drugs used to suppress platelet aggregation and the formation of blood clots;
beta-blockers used for high blood pressure and heart problems.
If you have any doubts about taking other medicines with Dexofen Sachet, consult your doctor or pharmacist.
Dexofen sachet with food and drink
If the pain is acute, take the sachet on an empty stomach, i.e. at least 15 minutes before a meal, as this will speed up the effect of the medicine a little.
Pregnancy, lactation and fertility
Do not take Dexofen Sachet during the third trimester of pregnancy or while breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Regarding possible effects on female fertility, see also section 2 "Warnings and precautions".
Driving and using machines
Dexofen Sachet may slightly affect your ability to drive and operate machinery due to the possible induction of dizziness, drowsiness or visual disturbances such as
adverse drug reactions. If you notice the onset of such effects, do not drive or use machinery until the symptoms subside. Consult your doctor.
Dexofen sachet contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.
Contains 2.418 g of sucrose per dose. This should be taken into account in patients with diabetes mellitus.
3. How to take Dexofen Sachet
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Adults over 18 years old
The recommended dose is 1 sachet (25 mg) every 8 hours, but no more than 3 sachets daily (75 mg)-
Consult your doctor if after 3-4 days. you do not feel better or your condition has worsened. Your doctor will tell you how many sachets you should take per day and for how long. The dose of Dexofen® Sachet depends on the type, strength and duration of the pain. If you are elderly or if you suffer from kidney or liver problems, you should start treatment with a total daily dose of no more than 2 sachets (50 mg).
In elderly patients, the starting dose can then be increased to the total recommended daily dose (75 mg dexketoprofen) if Dexofen Sachet is well tolerated. If the pain is intense and you need quick relief, take the sachet on an empty stomach (at least 15 minutes before a meal) as it will be absorbed faster (see item 2 Dexofen1*1 sachet 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 the sachet in a glass of water; mix/shake well to facilitate dissolution. The resulting solution should be taken immediately after its preparation.
If you have taken more than the required dose of Dexofen Sachet
If you have taken a large amount of the medicine, tell your doctor or pharmacist immediately or go to the emergency department of the nearest hospital. Please remember to take the medicine package or this leaflet with you.
If you forget to take Dexofen Sachet
Do not take a double dose to make up for a missed tablet. Take the next regular dose as directed (according to item 3 'How to take Dexofen® Sachet').
If you have any other questions about the use of this medicinal product, please ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dexofen Sachet can cause side effects, although not everybody gets them.
Possible side effects are listed below according to frequency. The description is based in part on the side effects of the tablet form of Dexofen. Since Dexofen Sachet granules are absorbed faster than tablets,
it is possible that the current incidence of (gastrointestinal) side effects is higher with Dexofen Sachet.
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
dizziness (vertigo),
dizziness,
drowsiness,
sleep disorders,
nervousness,
headache,
heartbeat,
redness,
inflammation of the stomach lining (gastritis),
constipation
dry mouth,
flatulence,
skin rash
tiredness
pain
chills and shivers,
general weakness (fatigue).
Rare side effects: may affect up to 1 in 1,000 people
peptic ulcer,
perforation or bleeding of a peptic ulcer (which may manifest as vomiting blood and black stools),
feeling sick
high blood pressure,
slow breathing,
fluid retention and peripheral edema (eg swollen ankles),
swelling of the larynx,
loss of appetite (anorexia),
unusual feeling
itchy rash
acne,
increased sweating,
back pains,
frequent urination,
menstrual disorders,
prostate problems
abnormalities in liver function tests (blood tests),
liver cell damage (hepatitis),
acute renal failure.
Very rare side effects: may affect up to 1 in 10,000 people
an anaphylactic reaction (a hypersensitivity reaction that can also lead to loss of consciousness),
open sores on the skin, mouth, eyes and genital area (Stevens-Johnson syndrome and Lyle syndrome),
swelling of the face or lips and throat (angioedema),
difficulty breathing due to narrowing of the airways (bronchospasm),
surface breathing,
rapid heartbeat,
low blood pressure,
inflammation of the pancreas,
blurred vision
ringing in the ears (tinnitus),
sensitive skin, sensitivity to light, itching,
kidney problems.
reduced number of white blood cells (neutropenia),
reduced number of platelets in the blood (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 long-term use of anti-inflammatory drugs, and especially if you are elderly age.
Stop using Dexofen Sachet as soon as possible after you notice the appearance of a skin rash, lesions on the lining of the mouth or genitals, or any sign of allergy.
Fluid retention and edema (especially of the ankles and feet), increased blood pressure and heart failure have been reported during treatment with NSAIDs.
Medicines such as Dexofen Sachet are associated with a slightly increased risk of heart attack ("myocardial infarction") or cerebrovascular accident (stroke).
In patients with disorders of the immune system that affect the connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory drugs can rarely raise the temperature, cause headache and stiff neck.
The most frequently observed side effects are gastrointestinal in origin. Peptic ulcers, perforation, or gastrointestinal bleeding may occur, sometimes fatal, especially in the elderly.
Nausea, vomiting, diarrhea, flatulence, constipation, indigestion black stools, vomiting blood, ulcerative stomatitis, worsening of colitis
Crohn's have been reported following administration. Inflammation of the stomach lining (gastritis) has been observed less frequently.
Like other NSAIDs, hematological reactions (purpura, aplastic and hemolytic anemia and rarely - agranulocytosis and bone marrow hypoplasia) may occur.
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Phone: +359 2 8903417
website: www.bda.bg
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Dexofen Sachet
Keep out of the reach of children!
Do not use a Dexofen sachet after the expiry date which is stated on the carton and the sachet after EXP. The expiration date corresponds to the last day of the specified month.
This medicine does not require special storage conditions.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What a Dexofen sachet contains
- The active substance is: each sachet contains 25 mg of dexketoprofen (as dexketoprofen trometamol).
- The other ingredients are: ammonium glycyrrhizate, neohesperidin-dihydrochalcone, quinoline yellow (E104), lemon flavor and sucrose (see item 2 Dexofen® sachet contains sucrose).
What Dexofen Sachet looks like and what it contains
Dexofen sachet is produced in sachets containing lemon yellow colored granules. Dexofen sachet is supplied in packs containing 2, 4, 10, 20, 30, 40, 50, 100 and 500 sachets. Not all pack sizes may be available for sale.
License holder
Menarini International Operations Luxembourg SA, Luxembourg
An instigator
Laboratories Menarini SA, Spain
Leaflet last approved date July 2019.
