Dexketoprofen Pensavital: detailed information

Patient Information Leaflet

DEXPIDOL 25 mg film-coated tablets
Dexketoprofen
Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet

What DEXPIDOL is and what it is used for
What you need to know before taking DEXPIDOL
How to take DEXPIDOL
Possible side effects
How to store DEXPIDOL
Contents of the pack and other information

1. What DEXPIDOL is and what it is used for

DEXPIDOL is a pain-relieving medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), and toothache.

2. What you need to know before taking DEXPIDOL

Do not take DEXPIDOL:
if you are allergic to dexketoprofen or to any of the other ingredients of this
medicine (listed in section 6);
non-steroidal anti-inflammatory drugs (NSAIDs);
if you suffer from asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period
of inflammation of the nasal mucosa), nasal polyps (nasal growths caused by
allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or
tongue, or breathing difficulties) or wheezing after taking aspirin or other
non-steroidal anti-inflammatory drugs;
if you have previously experienced photoallergic or phototoxic reactions (a particular form of
redness and/or blistering of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
if you have or have previously had peptic ulcer, gastrointestinal bleeding or chronic digestive disorders (e.g. indigestion, heartburn);
if you have previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain relief;
if you have an intestinal disease with chronic inflammation (Crohn’s disease or ulcerative colitis);
if you have severe heart failure, moderate to severe kidney problems, or severe liver problems;
if you have a blood coagulation disorder or a blood clotting disorder;
if you are severely dehydrated (have lost significant body fluids) due to vomiting, diarrhoea or
insufficient fluid intake;
if you are in the third trimester of pregnancy or are breastfeeding.

Warnings and precautions:
Talk to your doctor or pharmacist before taking DEXPIDOL
if you suffer from allergies or have previously had allergic reactions;
if you have kidney, liver or heart problems (hypertension and/or heart failure), fluid retention, or have previously experienced any of these conditions;
if you are taking diuretics or are dehydrated and have reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea or vomiting);
if you have heart problems, have had a stroke, or think you may be at risk for these conditions (for example, if you have high blood pressure, diabetes or high cholesterol, or are a smoker); you should discuss treatment with your doctor or pharmacist; medicines like
DEXPIDOL may be associated with a slight increase in the risk of heart attack ("myocardial infarction") or stroke. The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
if you are elderly: you may be more likely to experience adverse effects (see section 4). If any of these occur, consult your doctor immediately;
if you are a woman with fertility problems (DEXPIDOL may impair fertility, therefore you should not take it if you are planning a pregnancy or undergoing fertility testing);
if you have a disorder affecting blood and blood cell formation;
if you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
if you have previously had a chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
if you have or have previously had other stomach or intestinal problems;
if you are taking other medicines that increase the risk of peptic ulcer or
gastrointestinal bleeding, such as oral steroids, certain antidepressants (SSRIs, i.e. selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as aspirin or anticoagulants like warfarin. In such cases, consult your doctor before taking DEXPIDOL: they may prescribe another medicine to protect your stomach (e.g. misoprostol or medicines that block gastric acid production);
if you suffer from asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyposis, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs compared to the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs.
With dexketoprofen, signs of an allergic reaction to this medicine have been reported, including breathing difficulties, swelling of the face and neck area (angioedema) and chest pain. Stop DEXPIDOL immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Children and adolescents
DEXPIDOL has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the product must not be used in children and adolescents.

Other medicines and DEXPIDOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription. There are some medicines that should not be taken together and others that may require dose adjustments if taken concurrently.
Always inform your doctor, dentist or pharmacist if you are using or taking any of the following medicines in addition to DEXPIDOL:

Combinations not recommended:
Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs
Warfarin, heparin or other medicines used to prevent blood clot formation
Lithium, used to treat certain mood disorders
Methotrexate, used for rheumatoid arthritis and cancer
Hydantoins and phenytoin, used for epilepsy
Sulfamethoxazole, used for bacterial infections

Combinations requiring precautions:
ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists, used for hypertension 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 for diabetes

Combinations to be considered with caution:
Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections
Cyclosporine or tacrolimus, used to treat immune system disorders and in organ transplantation
Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to dissolve blood clots
Probenecid, used in gout
Digoxin, used to treat chronic heart failure
Mifepristone, used as an abortifacient (to terminate a pregnancy)
Selective serotonin reuptake inhibitors (SSRIs)
Antiplatelet agents used to reduce platelet aggregation and blood clot formation
Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines with DEXPIDOL, consult your doctor or pharmacist.

DEXPIDOL with food and drink
Take the tablets with a sufficient amount of water. Take the tablets with food, as this helps reduce the risk of gastrointestinal side effects. However, if you have acute pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, as this helps the medicine act slightly faster.

Pregnancy, breastfeeding and fertility
Do not take DEXPIDOL during the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It could affect your tendency and that of your baby to bleed and may cause delayed or prolonged labour. You should not take DEXPIDOL during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to become pregnant, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, DEXPIDOL may cause kidney problems in the fetus, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning a pregnancy, consult your doctor or pharmacist before taking this medicine, as DEXPIDOL may not be suitable for you.
The use of DEXPIDOL should be avoided in women who are planning a pregnancy or who are pregnant. Treatment at any stage of pregnancy should only occur as directed by a doctor.
The use of DEXPIDOL is not recommended when trying to conceive or during fertility investigations.

Driving and using machines
DEXPIDOL may slightly affect your ability to drive and operate machinery, due to possible side effects such as dizziness or drowsiness. If you experience these effects, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

DEXPIDOL contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take DEXPIDOL

Take this medicine exactly as your doctor has told you. Check with your doctor if you are unsure.

The dose of DEXPIDOL you need depends on the type, severity, and duration of your pain. Your doctor will tell you how many tablets to take each day and for how long.

The recommended dose is generally 1 tablet (25 mg) every 8 hours, not exceeding 3 tablets per day (75 mg).

If you are elderly or have kidney or liver problems, you should start treatment with a total daily dose not exceeding 2 tablets (50 mg).
In elderly patients, this initial dose may subsequently be increased to the generally recommended dose (75 mg) if DEXPIDOL has been well tolerated.

If your pain is severe and you need faster relief, take the tablets on an empty stomach (at least 30 minutes before meals), as they will be more readily absorbed (see section 2 “DEXPIDOL with food and drink”).

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

If you take more DEXPIDOL than you should
If you take too much of this medicine, immediately inform your doctor or pharmacist or go to the nearest hospital emergency department. Remember to bring this medicine pack or the package leaflet with you.

If you forget to take DEXPIDOL
Do not take a double dose to make up for the missed tablet. Take the next dose as scheduled (according to section 3 “How to take DEXPIDOL”).

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause unwanted side effects, although not everyone experiences them.
The possible side effects are listed below, grouped according to their likelihood of occurrence.
Common side effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, stomach ache, diarrhoea, digestive problems (dyspepsia).
Uncommon side effects (may affect up to 1 in 100 people):
Dizziness, vertigo, drowsiness, disturbed sleep, nervousness, headache, palpitations, hot flushes, stomach problems, constipation, dry mouth, flatulence, skin rash, fatigue, pain, feeling of fever and chills, general malaise (malaise).
Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer, perforation or bleeding of the peptic ulcer (which may present as blood in vomit or black stools), fainting, hypertension, abnormally slow breathing, fluid retention and peripheral oedema (e.g. swollen ankles), laryngeal oedema, loss of appetite (anorexia), abnormal sensation, itchy skin rash, acne, increased sweating, back pain, frequent passage of urine, menstrual disorders, prostate problems, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.
Very rare (may affect up to 1 in 10,000 people):
Anaphylactic reaction (hypersensitivity reaction that may lead to collapse), open sores on the skin, mouth, eyes, and genital areas (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), shortness of breath due to narrowing of the airways (bronchospasm), difficulty breathing, rapid heartbeat, low blood pressure, inflammation of the pancreas, blurred vision, ringing in the ears (tinnitus), sensitive skin, light sensitivity, itching, kidney problems. Reduced number of white blood cells (neutropenia), reduced number of platelets in the blood (thrombocytopenia).
Not known: (frequency cannot be estimated from the available data)
Chest pain, which may be a sign of an allergic reaction called Kounis syndrome, potentially life-threatening.
Fixed drug eruption: An allergic skin reaction known as fixed drug eruption, which may appear as round or oval patches with redness and skin swelling, blistering rash, and itching. Hyperpigmentation of the skin in the affected areas may also occur and may persist after healing. Fixed drug eruption usually recurs in the same location (or locations) upon re-exposure to the medicine.
Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g. stomach pain, heartburn or bleeding), especially if you are elderly.
Stop using DEXPIDOL as soon as you notice the appearance of a skin rash, or any lesions inside the mouth or on the genital area, or any signs of allergy.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and swelling (especially in the ankles and legs), increased blood pressure, and heart failure have been reported.
Medicines such as DEXPIDOL may be associated with a modest increase in the risk of heart attack ("myocardial infarction") or stroke.
In patients with immune system disorders affecting connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store DEXPIDOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack.
The expiry date refers to the last day of that month.
Do not store above 30°C. Keep the blister packs in the outer packaging to protect them from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What DEXPIDOL contains
The active substance is dexketoprofen trometamol (36.90 mg), equivalent to dexketoprofen
25 mg.
The other components are maize starch, microcrystalline cellulose, sodium starch glycolate,
glycerol distearate, hypromellose, titanium dioxide and macrogol 400.

Description of the appearance of DEXPIDOL and contents of the pack
DEXPIDOL is available as white, biconvex, cylindrical, scored tablets, with "DT2" engraved on one side. The tablet can be divided into equal doses.
DEXPIDOL is supplied in packs containing 10 or 20 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
TOWA PHARMACEUTICAL S.p.A.
Via Enrico Tazzoli, 6
20154 Milan - Italy

Manufacturers:
SAG Manufacturing, S.L.U
Crta. N-I, Km 36,
San Agustín de Guadalix,
Madrid, 28750 - Spain

Galenicum Health, S.L.U.
Sant Gabriel, 50
Esplugues de Llobregat
Barcelona, 08950 – Spain

This medicinal product is authorized in the EEA Member States under the following
names:
Portugal: DEXPIDOL
Spain: DEXKETOPROFENO PENSAVITAL 25 mg comprimidos recubiertos con
película EFG
Italy: DEXPIDOL

Detailed and up-to-date information on this product is available by scanning the QR Code on the outer packaging using a smartphone. The same information can also be accessed at the following URL: https://www.pensapharma.it/dexpidol-25-mgcompresse/