Package leaflet: Information for the patient

Dextin 25 mg coated tablets

Dexketoprofen *
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient. This medicine should always be used exactly as described in the 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 the patient experiences any adverse reactions, inform the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If there is no improvement or if the patient feels worse, contact the doctor.

Table of contents of the leaflet:

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

1. What Dextin is and what it is used for

Dextin is an analgesic medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs). Dextin
is used for the short-term treatment of mild to moderate pain, such as muscle pain, painful menstruation, or toothache.

2. Important information before using Dextin

When not to use Dextin:

If the patient is allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
If the patient is allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs (NSAIDs);
If the patient suffers from asthma or has previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (growths inside the nose caused by allergy), urticaria (rash), angioedema (swelling of the face, eyes, lips, tongue or throat, or a combination of breathing difficulties) 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 after exposure to sunlight) during treatment with ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
If the patient has gastric and/or duodenal ulcer disease or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration or perforation;
If the patient suffers from chronic digestive disorders (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 inflammatory bowel diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
If the patient has severe heart failure, moderate or severe renal dysfunction, or severe hepatic dysfunction;
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 treatment with Dextin, discuss this with your doctor or pharmacist.

If the patient has allergies or has previously experienced allergic problems;
If the patient has renal, hepatic or cardiac dysfunction (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred previously;
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 disease, has had a stroke, or is suspected of being at risk (e.g. due to high blood pressure, diabetes, elevated cholesterol levels or smoking). In such cases, consult your doctor or pharmacist before using Dextin. Use of medicines such as Dextin 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 reactions (see section 4). If adverse reactions occur, contact your doctor immediately;
In women experiencing difficulty becoming pregnant or undergoing fertility investigations (Dextin may impair female fertility and should not be used in women planning pregnancy or undergoing fertility 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 has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
If the patient has or has previously had other stomach or intestinal disorders;
If the patient has chickenpox, as in rare cases the use of non-steroidal anti-inflammatory drugs may worsen the course of infection;
If the patient is taking other medicines that increase the risk of gastric and/or duodenal ulcer disease or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI-class drugs, such as serotonin reuptake inhibitors), anticoagulant drugs such as acetylsalicylic acid or anticoagulants such as warfarin. In such cases, consult your doctor before taking the medicine, who may decide to prescribe an additional medicine to protect the stomach (e.g. misoprostol or drugs inhibiting gastric hydrochloric acid production);
In patients with asthma associated with 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.

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

Dextin and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription, and about any medicines you plan to take. Some medicines should not be used together with Dextin, and in other cases dosage adjustments may be necessary when Dextin is taken concomitantly. Always inform your doctor, dentist or pharmacist if you are taking any of the following medicines together with Dextin:

Not recommended for concomitant use:

Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory drugs;
Warfarin, heparin, or other anticoagulant drugs;
Lithium used in the treatment of certain mood disorders;
Methotrexate, an anticancer or immunosuppressive drug;
Hydantoin derivatives and phenytoin used in the treatment of epilepsy;
Sulfamethoxazole used in the treatment of bacterial infections.

Concomitant use requiring caution:

ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used in the treatment of high blood pressure and heart diseases;
Pentoxifylline and oxpentifylline used in the treatment of ulcers in chronic venous insufficiency;
Zidovudine used in the treatment of viral infections;
Aminoglycoside antibiotics used in the treatment of bacterial infections;
Chlorpropamide and glibenclamide used in the treatment of diabetes.

Concomitant use requiring special consideration:

Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used in the treatment of bacterial infections;
Cyclosporine and tacrolimus used in the treatment of immune system diseases and in transplant patients;
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve blood clots;
Probenecid, used in the treatment of gout;
Digoxin, used in the treatment of chronic heart failure;
Mifepristone, used for medical termination of pregnancy;
Selective serotonin reuptake inhibitor (SSRI) antidepressants;
Antiplatelet drugs used to reduce platelet aggregation and blood clot formation.

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

Dextin with food and drink
Take tablets with adequate fluid. Taking tablets with food may reduce the risk of gastrointestinal adverse effects.
For 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 effect on fertility
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Dextin should not be used during the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery or breastfeeding. Dextin may cause kidney and heart problems in the unborn child. Dextin may affect bleeding tendency in both you and your child and may cause delivery to occur later or last longer than expected. Dextin should not be taken during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, the lowest effective dose should be used for the shortest possible duration. If Dextin is taken for more than a few days after week 20 of pregnancy, it may cause kidney problems in the unborn child, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding
It is not known whether dexketoprofen passes into human milk.

Dextin
Use of DEXTIN is not recommended in women planning pregnancy or undergoing fertility investigations.

Driving and operating machinery
Dextin may have a minor influence on the ability to drive vehicles and operate machinery due to possible adverse effects such as dizziness or drowsiness. If such symptoms occur, do not drive or operate mechanical equipment until symptoms have resolved. If in doubt, consult your doctor.

3. How to take Dextin

This medicine should always be taken exactly as described in this patient information leaflet or as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Dextin is intended for short-term use only, and treatment should be limited to the period during which symptoms are present.
Adults
The required dose of Dextin depends on the type, severity, and duration of pain, and is half a tablet (12.5 mg) every 4–6 hours or one tablet (25 mg) every 8 hours. However, no more than 3 tablets per day (75 mg) should be taken.
In elderly patients or in patients with kidney or liver disease, it is recommended to start treatment with a lower total daily dose corresponding to no more than 2 tablets (50 mg).
If well tolerated, this initial dose may subsequently be increased in elderly patients to the dose recommended for the general population (75 mg).
In cases of acute pain, when faster action is required, 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: "Dextin with food and drink").
Use in children and adolescents
This medicine should not be used in children and adolescents (under 18 years of age).
Taking more Dextin than recommended
If an overdose is suspected, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Remember to bring the medicine’s packaging or patient information leaflet with you.
If you miss a dose of Dextin
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 take Dextin").
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The possible adverse reactions listed below are categorized according to the likelihood of their occurrence.
Common adverse reactions (may affect up to 1 in 10 people):
Nausea and (or) vomiting, abdominal pain, diarrhoea, indigestion (dyspepsia).
Uncommon adverse reactions (may affect up to 1 in 100 people):
Sensation of spinning, dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations,
flushing of the face, stomach disorders, constipation, dryness of the oral mucosa, bloating with gas release,
rash, fatigue, pain, feeling of fever and chills, malaise.
Rare adverse reactions (may affect up to 1 in 1,000 people):
Peptic ulcer disease, bleeding or perforation of the gastrointestinal ulcer, which may present as vomiting blood or black stools, fainting, high blood pressure, slowed breathing rate, fluid retention in limbs and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate gland disorders, abnormal liver function 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, ulceration of the mouth, eyes and genital areas (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to airway narrowing (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity reactions, photosensitivity, itching, kidney function disorders, reduced white blood cell count (neutropenia), reduced platelet count (thrombocytopenia).
Patients should immediately 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 damage inside the mouth or on genital organs, or any allergic symptoms occur, treatment with Dextin should be stopped immediately.
During administration of non-steroidal anti-inflammatory drugs, fluid retention and oedema (especially of ankles and legs), increased blood pressure and heart failure may occur.
Use of medicines such as Dextin may be associated with a small increased risk of heart attack ("myocardial infarction") or 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.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Dextin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the
blister pack after EXP. The expiry date refers to the last day of the stated month.
Store below 25°C. Keep the blister packs in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Dextin contains
The active substance is dexketoprofen. One coated tablet contains 36.90 mg of dexketoprofen with tromethamine, corresponding to 25 mg of dexketoprofen.
Other ingredients: corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), glycerol distearate, Coating (Opadry Y-1-7000): hypromellose, titanium dioxide (E 171), polyethylene glycol/PEG 400.
What Dextin looks like and contents of the pack
Dextin is a white, cylindrical, biconvex coated tablet with an imprint "DT2" on one side.
The tablets can be divided into equal doses.
Dextin is available in packs containing 10, 20 and 30 coated tablets in blisters (PVC/PVDC/Aluminium), packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
Poland
Tel. 81-4634882
Fax 81-4634886
e-mail: [email protected]
Manufacturer
SAG MANUFACTURING S.L.U.
Crta N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
Galenicum Health., S.L.U
Sant Gabriel 50
Esplugues de Llobregat,
08950 Barcelona
Spain
06 November 2024