METAFEN 25 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Metafen Dexketoprofen, 25 mg, coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Metafen Dexketoprofen and what is it used for
4. Important information before taking Metafen Dexketoprofen
   1. When not to take Metafen Dexketoprofen
   2. Warnings and precautions
   3. Children and adolescents
   4. Metafen Dexketoprofen and other medicines
   5. Metafen Dexketoprofen with food and drink
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Metafen Dexketoprofen contains sodium
5. How to take Metafen Dexketoprofen
   1. Use in children and adolescents
   2. Overdose of Metafen Dexketoprofen
   3. Missed dose of Metafen Dexketoprofen
6. Possible side effects
   1. Common side effects (may affect up to 1 in 10 people):
   2. Uncommon side effects (may affect up to 1 in 100 people):
   3. Rare side effects (may affect up to 1 in 1,000 people):
   4. Very rare side effects (may affect up to 1 in 10,000 people):
   5. Reporting side effects
7. How to store Metafen Dexketoprofen
8. Contents of the pack and other information
   1. What Metafen Dexketoprofen contains
   2. What Metafen Dexketoprofen looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

Leaflet attached to the packaging: patient information

Metafen Dexketoprofen, 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 this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 to 4 days, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Metafen Dexketoprofen and what is it used for

Metafen Dexketoprofen is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the symptomatic treatment of mild to moderate pain, such as muscle pain, painful menstruation, toothache.

2. Important information before taking Metafen Dexketoprofen

When not to take Metafen Dexketoprofen

• 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), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue, or respiratory distress syndrome) or wheezing after taking acetylsalicylic acid or another NSAID;
• If the patient has had hypersensitivity reactions to sunlight: photoallergic or phototoxic reactions (in particular, redness and/or blisters on the skin exposed to sunlight) 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 bleeding from the stomach or intestines, ulcers, or perforation in the past;
• If the patient has chronic gastrointestinal disorders (e.g., indigestion, heartburn);
• If the patient has had bleeding from the stomach or intestines, or perforations 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 Metafen Dexketoprofen, the patient should discuss it with their doctor or pharmacist.

• If the patient has an allergy or has had allergy-related problems;
• 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;
• If the patient is taking diuretics or has decreased hydration and decreased 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 of these conditions (e.g., due to high blood pressure, diabetes, high cholesterol, or smoking). In these cases, the patient should consult their doctor or pharmacist before taking Metafen Dexketoprofen. Taking such medicines as Metafen Dexketoprofen may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment.
• If the patient is elderly: there is an increased risk of side effects (see section 4). In this case, the patient should contact their doctor immediately;
• If the patient is a woman with fertility problems or undergoing fertility tests (Metafen Dexketoprofen may affect female fertility and should not be used in women planning pregnancy 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 disease (ulcerative colitis, Crohn's disease) in the past;
• If the patient has other stomach or intestinal diseases;
• If the patient has chickenpox, as the use of 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 (SSRI, e.g., selective serotonin reuptake inhibitors), anticoagulant medications such as acetylsalicylic acid, or anticoagulants such as warfarin. In these cases, the patient should consult their doctor before taking Metafen Dexketoprofen, who may decide to administer an additional protective medicine (e.g., misoprostol or stomach acid-reducing medications).
• If the patient has asthma and 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.

This may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid and/or NSAIDs.

Children and adolescents

Metafen Dexketoprofen has not been studied in children and adolescents. The safety and efficacy of the medicine have not been established, and therefore, it should not be used in children and adolescents.

Metafen Dexketoprofen 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 Metafen Dexketoprofen, and for others, the dose may need to be changed when taking Metafen Dexketoprofen.

• The patient should always inform their doctor, dentist, or pharmacist if they are taking any of the following medicines at the same time as Metafen Dexketoprofen:
• Concomitant use not recommended:
• acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs;
• warfarin, heparin, or other anticoagulant medications;
• lithium used to treat certain mood disorders;
• methotrexate used to treat rheumatoid arthritis and cancer;
• hydantoin derivatives and phenytoin used to treat epilepsy;
• sulfamethoxazole used to treat bacterial infections.

Concomitant use requiring 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;
• zydovudine used to treat viral infections;
• aminoglycoside antibiotics used to treat bacterial infections;
• chlorpropamide and glibenclamide used to treat diabetes.

Concomitant use requiring special consideration:

• quinolone antibiotics (e.g., ciprofloxacin, levofloxacin) used to treat bacterial infections;
• cyclosporine and tacrolimus used to treat immune system diseases and transplants;
• streptokinase and other thrombolytic or fibrinolytic agents (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;
• antidepressants from the SSRI group;
• antiplatelet agents used to reduce platelet aggregation and blood clot formation.

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

Metafen Dexketoprofen with food and drink

Metafen Dexketoprofen tablets should be swallowed with a sufficient amount of water. Taking the tablets with food reduces the risk of side effects related to the stomach or intestines. However, 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 for faster absorption of the medicine (see section 2 "Metafen Dexketoprofen with food and drink").

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Metafen Dexketoprofen should not be taken if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. Metafen Dexketoprofen may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the patient and child and cause delayed or prolonged labor. During the first 6 months of pregnancy, Metafen Dexketoprofen should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. Metafen Dexketoprofen taken for more than a few days, starting from the 20th week of pregnancy, may lead to kidney problems in the unborn child, which can result in low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If treatment is necessary for more than a few days, the doctor may recommend additional monitoring. Metafen Dexketoprofen should not be used during breastfeeding. In case of doubts, the patient should consult their doctor. Metafen Dexketoprofen is not recommended for use in women during fertility testing.

Driving and using machines

Metafen Dexketoprofen may have a minor effect on the ability to drive and use machines due to the possibility of side effects such as dizziness or drowsiness. If the patient experiences such symptoms, they should not drive or operate machines until the symptoms resolve. In case of doubts, the patient should consult their doctor.

Metafen Dexketoprofen contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Metafen Dexketoprofen

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist. Metafen Dexketoprofen tablets are intended for short-term use only, and treatment should be limited to the period of symptoms. Adults The dose of Metafen Dexketoprofen depends on the type, severity, stage, and duration of pain in the patient, usually 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). In elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose not exceeding 2 coated tablets (50 mg). If Metafen Dexketoprofen is well tolerated in elderly patients, this initial dose can be increased to the recommended dose for the general population (75 mg). In case of acute pain, when faster relief is needed, it is recommended to take the tablets on an empty stomach (at least 30 minutes before a meal), which will allow for faster absorption of the medicine (see section 2 "Metafen Dexketoprofen with food and drink").

Use in children and adolescents

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

Overdose of Metafen Dexketoprofen

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

Missed dose of Metafen Dexketoprofen

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 Metafen Dexketoprofen"). 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, Metafen Dexketoprofen can cause side effects, although not everybody gets them. Possible side effects are listed below and are grouped according to the frequency of their occurrence.

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

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

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

Dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, 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 edema, loss of appetite (anorexia), abnormal sensation, itching 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 allergic reactions that can lead to anaphylactic shock), skin ulcers, lip, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or lip and throat edema (angioedema), shortness of breath caused by bronchospasm, shortness of breath, rapid heart rate, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions, skin hypersensitivity to sunlight, itching, kidney disease, 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 drugs, particularly in elderly patients. The patient should immediately stop taking Metafen Dexketoprofen if they experience a skin rash or any mucosal lesions in the mouth or on the genitals, or any symptoms of allergy. When using non-steroidal anti-inflammatory drugs, fluid retention and edema (especially of the ankles and feet) and increased blood pressure and heart failure may occur. Taking medicines like Metafen Dexketoprofen 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), the administration of anti-inflammatory drugs may rarely cause fever, headache, and neck stiffness.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal 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 Metafen Dexketoprofen

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Store in a temperature below 25°C. Store the blisters in the outer packaging to protect 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 pack and other information

What Metafen Dexketoprofen contains

• The active substance of the medicine is dexketoprofen (in the form of dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
• The other ingredients are: cornstarch, microcrystalline cellulose, sodium carboxymethylcellulose (type A), glycerol distearate, hypromellose, titanium dioxide (E 171), macrogol/PEG 400.

What Metafen Dexketoprofen looks like and contents of the pack

Metafen Dexketoprofen is a white, biconvex, cylindrical tablet with DT2 embossed on one side. The tablets can be divided into equal doses. Metafen Dexketoprofen is packaged in single-dose blisters (PVC/PVDC/Aluminum), packaged in cardboard boxes containing 10x1, 20x1, 30x1 coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A. ul. Pelplińska 19, 83-200 Starogard Gdański tel. +48 22 364 61 01

Manufacturer

Galenicum Health, S.L. Avda. Cornellá 144, 7º-1ª Edificio LEKLA Esplugues de Llobregat 08950 Barcelona Spain SAG MANUFACTURING S.L.U Crta N-I, KM 36 28750 San Agustín del Guadalix, Madrid Spain Date of last revision of the leaflet:March 2023