Metafen dexketoprofen

Package leaflet: Information for the patient

Metafen Dexketoprofen, 25 mg, coated tablets
Dexketoprofenum
Please read the entire leaflet carefully before using this 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, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse after 3 to 4 days, you should consult your doctor.

Table of contents

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

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

2. Important information before taking Metafen Dexketoprofen

When not to take Metafen Dexketoprofen

• 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 has 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 (blister-like rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of respiratory disorders), 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 on skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient currently has peptic ulcer disease of the stomach and/or duodenum or gastrointestinal bleeding, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
• If the patient has chronic gastrointestinal disorders (e.g. indigestion, heartburn);
• If the patient has previously experienced gastrointestinal bleeding or perforation due to earlier use of NSAIDs used for pain relief;
• 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 function disorders, or severe liver function disorders;
• If the patient has an increased tendency to bleed 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 to take Metafen Dexketoprofen, discuss this with your doctor or
pharmacist.

• If the patient has allergies or has previously experienced allergy-related problems;
• If the patient has kidney, liver, or heart function disorders (hypertension and/or heart failure), fluid retention, or if any of these conditions have occurred previously;
• If the patient is taking diuretics or has reduced hydration and reduced 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 for these conditions (e.g. due to high blood pressure, diabetes, high cholesterol levels, or smoking). In such cases, consult your doctor or pharmacist before using Metafen Dexketoprofen. Taking medicines such as Metafen Dexketoprofen 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 effects (see section 4). In such cases, contact your doctor immediately;
• In women experiencing difficulty becoming pregnant or undergoing fertility investigations (Metafen Dexketoprofen may impair female fertility and should not be used in women planning pregnancy or undergoing fertility treatment);
• If the patient has disorders of blood or blood cell formation;
• 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 currently has or has previously had other stomach or intestinal diseases;
• 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 peptic ulcer disease of the stomach and/or duodenum or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI-class drugs, e.g. selective serotonin reuptake inhibitors), antithrombotic drugs such as acetylsalicylic acid, or anticoagulants such as warfarin. In such cases, consult your doctor before taking Metafen Dexketoprofen. The doctor may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs that inhibit gastric acid production);
• If the patient has asthma, 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

cause asthma attacks or bronchospasm, particularly in patients
with allergy to acetylsalicylic acid and/or NSAIDs.
Children and adolescents
The use of Metafen Dexketoprofen has not been studied in children and adolescents. Safety and efficacy have not been established, and therefore this medicine should not be used in children and adolescents.
Metafen Dexketoprofen and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. Some medicines should not be used together with Metafen Dexketoprofen, and in the case of others, dosage adjustments may be necessary when taken simultaneously with Metafen Dexketoprofen.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Metafen Dexketoprofen:
Not recommended for simultaneous use:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs;
• Warfarin, heparin, or other anticoagulant drugs;
• 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.

Simultaneous use requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists used to treat high blood pressure and heart disease;
• Pentoxifylline and oxpentifylline 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.

Simultaneous use requiring special consideration:

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

If you have any doubts regarding the use of Metafen Dexketoprofen,
consult your doctor or pharmacist.
Metafen Dexketoprofen with food and drink
Metafen Dexketoprofen tablets should be swallowed with sufficient water.
Taking the tablets with food may reduce the risk of gastrointestinal adverse effects. However, in the case of 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 effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Do not take Metafen Dexketoprofen if the patient is in the last three 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 tendency to bleeding in both the mother and the child and may delay or prolong labour.
During the first six months of pregnancy, do not use Metafen Dexketoprofen unless your doctor considers its use absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. Metafen Dexketoprofen taken for longer than a few days starting from week 20 of pregnancy may lead to impaired kidney function in the unborn child, which may result in low levels of amniotic fluid surrounding the child (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment for longer than a few days is necessary, your doctor may recommend additional monitoring.
Do not use Metafen Dexketoprofen during breastfeeding.
If in doubt, consult your doctor.
The use of Metafen Dexketoprofen is not recommended in women undergoing fertility investigations.
Driving and operating machinery
Metafen Dexketoprofen may have a minor influence on the ability to drive and operate machinery due to possible adverse effects such as dizziness or drowsiness. If such symptoms occur, do not drive or operate machinery until symptoms resolve. If in doubt, consult your doctor.
Metafen Dexketoprofen contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Metafen Dexketoprofen

This medicine should always be taken exactly as described in the patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Metafen Dexketoprofen tablets are intended for short-term use only, and treatment should be limited to the period during which symptoms are present.

Adults
The dose of Metafen Dexketoprofen depends on the type, severity, extent, and duration of pain in the patient. Usually, it 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.

For elderly patients or those with kidney or liver disease, it is recommended to start treatment with a lower total daily dose corresponding to no more than 2 coated tablets (50 mg).
If Metafen Dexketoprofen is well tolerated in elderly patients, this initial dose may subsequently be increased to the dose recommended for the general population (75 mg).

In cases 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 result in faster absorption of the medicine (see section 2, "Metafen Dexketoprofen with food and drink").

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

Taking more Metafen Dexketoprofen than recommended
If you suspect an overdose, contact your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Be sure to bring the medicine’s packaging or patient information leaflet with you.

If you forget to take Metafen Dexketoprofen
Do not take a double dose to make up for a missed dose. Take the next dose according to the prescribed dosing schedule (see section 3, "How to take Metafen Dexketoprofen").

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
The possible adverse effects are listed below, classified according to the likelihood of their occurrence.

Common adverse effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain, diarrhoea, indigestion (dyspepsia).

Uncommon adverse effects (may affect up to 1 in 100 people):
Vertigo, dizziness, somnolence, sleep disturbances, nervousness, headache, palpitations,
facial flushing, stomach disorders, constipation, dryness of the oral mucosa, flatulence,
rash, fatigue, pain, feeling of fever and chills, malaise.

Rare adverse effects (may affect up to 1 in 1,000 people):
Gastric ulcer, gastrointestinal bleeding or perforation (which may present as vomiting blood or black stools),
fainting, hypertension, reduced respiratory 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 renal failure.

Very rare adverse effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock),
skin, lip, eye and genital mucosa ulceration (Stevens-Johnson syndrome and Lyell's syndrome),
facial swelling or swelling of lips and throat (angioedema), shortness of breath due to respiratory muscle spasm
(bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision,
tinnitus, skin hypersensitivity reactions and photosensitivity, pruritus, kidney disorders, reduced white blood cell count (neutropenia), reduced platelet count (thrombocytopenia).

If the patient observes any adverse effects affecting the stomach or intestines (e.g. stomach pain, heartburn or bleeding) at the beginning of treatment, they should immediately inform their doctor, especially if the patient has previously experienced similar adverse effects due to long-term use of anti-inflammatory medicines, particularly in elderly patients.

Treatment with Metafen Dexketoprofen should be stopped immediately if a skin rash, any mucosal lesion inside the mouth or on the genital organs, or any allergic symptoms occur.

When using non-steroidal anti-inflammatory drugs (NSAIDs), fluid retention and oedema (especially in ankles and legs), increased blood pressure and heart failure may occur.

Use of medicines such as Metafen Dexketoprofen may be associated with a small increased risk of myocardial infarction ("heart attack") or cerebrovascular events (stroke).

In patients with systemic lupus erythematosus or mixed connective tissue disease (immunological disorders affecting connective tissue), administration of anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Metafen Dexketoprofen

Keep this medicine 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 stated month.
Store below 25°C. Keep blisters in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to safely dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Metafen Dexketoprofen contains

• The active substance is dexketoprofen (in the form of dexketoprofen trometamol). Each coated tablet contains 25 mg of dexketoprofen.
• Other ingredients are: maize starch, microcrystalline cellulose, sodium carboxymethyl starch (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 white, biconvex, cylindrical shaped coated tablets with "DT2" embossed on one side. The tablets can be divided into equal doses.
Metafen Dexketoprofen is packed in unit-dose blisters (PVC/PVDC/Aluminium), packed in cardboard boxes containing 10x1, 20x1, 30x1 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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