Dextin

Leaflet attached to the packaging: patient information

Dextin 25 mg coated tablets

Dexketoprofen

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, they should tell their doctor or pharmacist. This also applies to any possible side effects not listed in this leaflet. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What Dextin is and what it is used for
• 2. Important information before taking Dextin
• 3. How to take Dextin
• 4. Possible side effects
• 5. How to store Dextin
• 6. Contents of the packaging and other information

1. What Dextin is and what it is used for

Dextin is a pain-relieving 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 taking Dextin

When not to take Dextin:

• 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 has had asthma attacks in the past, severe allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths in the nose caused by allergy), hives (rash), or angioedema (swelling of the face, eyes, lips, tongue, or respiratory disorders) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If the patient has had light sensitivity reactions: photoallergic or phototoxic reactions (especially redness and/or blisters after sun exposure) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels);
• If the patient has stomach or duodenal ulcers or bleeding from the stomach or intestines, or if they have had stomach or intestinal bleeding, ulcers, or perforation in the past;
• If the patient has chronic gastrointestinal disorders (e.g., indigestion, heartburn);
• If the patient has had stomach or intestinal bleeding or perforation due to previous use of NSAIDs used to treat pain;
• If the patient has intestinal diseases with chronic inflammation (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney impairment, or severe liver impairment;
• If the patient has a tendency to bleed excessively or has bleeding disorders;
• If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhea, or inadequate fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:

Before starting treatment with Dextin, the patient should discuss it with their doctor or pharmacist.

• If the patient has an allergy or has had allergy problems in the past;
• If the patient has kidney, liver, or heart problems (high blood pressure and/or heart failure), as well as fluid retention or if the patient has had any of these problems in the past;
• For patients taking diuretics or patients who are dehydrated and have reduced blood volume due to excessive fluid loss (e.g., frequent urination, diarrhea, or vomiting);
• If the patient has heart disease, has had a stroke, or is at risk (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking). In such cases, the patient should consult their doctor or pharmacist before taking Dextin. Taking such medicines as Dextin may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. The patient should not take higher doses or use the medicine for longer than recommended;
• If the patient is elderly: there is an increased risk of side effects (see section 4). If side effects occur, the patient should contact their doctor immediately;
• For women with fertility problems or undergoing fertility tests (Dextin may affect female fertility and should not be taken by women planning to become pregnant or undergoing fertility treatment);
• If the patient has blood disorders or blood cell disorders;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the past;
• If the patient has other stomach or intestinal diseases;
• If the patient has chickenpox, as non-steroidal anti-inflammatory drugs may rarely worsen the course of the infection;
• If the patient is taking other medicines that increase the risk of stomach ulcers or intestinal bleeding, such as oral steroids, certain antidepressants (SSRIs, e.g., selective serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or anticoagulant medications such as warfarin. In such cases, the patient should consult their doctor before taking the medicine, who may decide to administer an additional medicine to protect the stomach (e.g., misoprostol or acid-reducing medications).

• For patients with asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the rest of the population. Administration of this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Children and adolescents

Dextin has not been studied in children and adolescents. The safety and efficacy of this medicine have not been established, and therefore, it should not be taken by children and adolescents.

Dextin and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, including those available without a prescription, and about any medicines they plan to take. Some medicines should not be taken at the same time as Dextin, and for others, the dose may need to be changed when taking Dextin. The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines at the same time as Dextin:

• Acetylsalicylic acid (aspirin), corticosteroids, or other anti-inflammatory medicines;
• Warfarin, heparin, or other anticoagulant medicines;
• Lithium used to treat certain mood disorders;
• Methotrexate, an anticancer or immunosuppressive medicine;
• Hydantoin derivatives and phenytoin used to treat epilepsy;
• Sulfamethoxazole used to treat bacterial infections.

Concomitant use that requires caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart disease;
• Pentoxifylline and oxypentifylline used to treat ulcers in chronic venous insufficiency;
• Zidovudine used to treat viral infections;
• Aminoglycoside antibiotics used to treat bacterial infections;
• Chlorpropamide and glibenclamide used to treat diabetes.

Concomitant use that requires special consideration:

• Quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections;
• Cyclosporine and tacrolimus used to treat immune system diseases and in transplants;
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e., medicines used to dissolve clots;
• Probenecid used to treat gout;
• Digoxin used to treat chronic heart failure;
• Mifepristone used for pharmacological termination of pregnancy;
• Antidepressant medicines from the group of selective serotonin reuptake inhibitors (SSRIs);
• Antiplatelet medicines used to reduce platelet aggregation and blood clot formation.

In case of any doubts about taking Dextin, the patient should consult their doctor or pharmacist.

Dextin with food and drink

Tablets should be taken with a sufficient amount of water. Taking tablets with food can reduce the risk of side effects related to the stomach or intestines. In case of acute pain, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will allow the medicine to start working faster.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy: Dextin should not be taken during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery or breastfeeding. Dextin may cause kidney and heart problems in the unborn baby. Dextin may affect the patient's and their baby's tendency to bleed and may cause labor to be later or longer than expected. Dextin should not be taken during the first six months of pregnancy unless absolutely necessary and advised by a doctor. If treatment is needed during this period or while trying to conceive, the lowest dose should be used for the shortest possible time. If Dextin is taken for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, which may lead to low amniotic fluid levels or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, the doctor may recommend additional monitoring. Breastfeeding: It is not known whether dexketoprofen passes into human milk. Dextin: It is not recommended to take DEXTIN in women planning to become pregnant or during fertility diagnosis.

Driving and using machines

Dextin may have a minor effect on the ability to drive vehicles and operate machinery due to possible side effects such as dizziness or drowsiness. If such symptoms are observed, the patient should not drive vehicles or operate moving machinery until the symptoms have resolved. In case of doubts, the patient should consult their doctor.

3. How to take Dextin

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Dextin is intended for short-term use only, and treatment should be limited to the period of symptoms. 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 1 tablet (25 mg) every 8 hours. However, no more than 3 tablets per day (75 mg). For elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose not exceeding 2 tablets (50 mg). If the patient tolerates it well, the initial dose can be increased to the recommended dose for the general population (75 mg). In case of acute pain, when faster action is needed, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will cause faster absorption of the medicine (see section 2: "Dextin with food and drink").

Use in children and adolescents

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

Taking a higher dose of Dextin than recommended

In case of suspected overdose, the patient should immediately inform their doctor or pharmacist or go to the nearest hospital emergency department. The patient should remember to take the packaging or patient leaflet with them.

Missing a dose of Dextin

The patient should not take a double dose to make up for a missed dose. The next dose should be taken according to the dosing schedule (see section 3: "How to take Dextin"). In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Dextin can cause side effects, although not everybody gets them. Possible side effects are listed below and are grouped according to their frequency of occurrence.

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

Nausea and/or vomiting, stomach pain, diarrhea, indigestion (dyspepsia).

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

Dizziness, drowsiness, sleep disorders, nervousness, headaches, palpitations, facial flushing, stomach disorders, constipation, dry mouth, bloating with gas, rash, fatigue, pain, feeling of heat and chills, malaise.

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

Stomach ulcers, bleeding, or perforation of the digestive tract, which may manifest as bloody vomiting or black stools, fainting, high blood pressure, slowed breathing rate, fluid retention and peripheral edema (e.g., swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people):

Anaphylactic reactions (acute hypersensitivity reactions that can lead to anaphylactic shock), skin ulcers, mouth, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath caused by bronchospasm, shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), skin hypersensitivity reactions, skin hypersensitivity to light, itching, kidney disorders, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia). The patient should immediately inform their doctor if they notice any side effects related to the stomach or intestines (e.g., stomach pain, heartburn, or bleeding) at the beginning of treatment, especially if they have had similar side effects in the past due to long-term use of anti-inflammatory medicines, particularly in elderly patients. If a skin rash or any damage to the mucous membranes inside the mouth or on the genitals or any symptoms of allergy occur, the patient should stop taking Dextin immediately. When taking non-steroidal anti-inflammatory drugs, fluid retention and edema (especially of the ankles and feet) may occur, as well as increased blood pressure and heart failure. Taking medicines like Dextin may be associated with a small increased risk of heart attack or stroke. In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), taking anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Dextin

The medicine should be stored out of sight and reach of children. This medicine should not be taken after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. The medicine should be stored at a temperature below 25°C. The blisters should be stored in the outer packaging to protect them from light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Dextin contains

The active substance is dexketoprofen. One coated tablet contains 36.90 mg of dexketoprofen trometamol, which corresponds to 25 mg of dexketoprofen. The other ingredients are cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), glycerol distearate, coating (Opadry Y-1-7000): hypromellose, titanium dioxide (E 171), macrogol/PEG 400.

What Dextin looks like and contents of the packaging

Dextin is white, biconvex, coated tablets with a cylindrical shape and the inscription DT2 on one side. The tablets can be divided into equal doses. Dextin is available in packages containing 10, 20, and 30 coated tablets in blisters (PVC/PVDC/Aluminum) in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization 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

Date of last revision of the leaflet:

06 November 2024