Package Leaflet: Information for the User

DOLOVANZ FORTE 25 mg Film-Coated Tablets

dexketoprofen

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 4 days.

DOLOVANZ FORTE is a pain reliever belonging to the group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs). It is used for the short-term symptomatic treatment of mild to moderate acute pain, such as muscle pain or joint pain (for example, back pain, sprains, and acute trauma), menstrual pain (dysmenorrhea), or dental pain in adults.

Do not take DOLOVANZ FORTE

• If you are allergic to dexketoprofen trometamol or to any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to another nonsteroidal anti-inflammatory drug;
• If you have asthma or have had asthma attacks, acute allergic rhinitis (a short period of nasal mucosa inflammation), nasal polyps (fleshy formations in the nasal interior due to allergy), urticaria (skin eruption), angioedema (face, eye, lip, or tongue swelling, or difficulty breathing) or chest wheezing after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs;
• If you have had photoallergic or phototoxic reactions (a special form of skin redness or burns exposed to sunlight) during the taking of ketoprofen (a nonsteroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcer, stomach or intestinal bleeding, or if you have had in the past stomach or intestinal bleeding, ulceration, or perforation;
• If you have chronic digestive problems (for example, indigestion, stomach burning);
• If you have had in the past stomach or intestinal bleeding or perforation due to previous use of nonsteroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you have chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe renal insufficiency, or severe liver insufficiency;
• If you have bleeding disorders or blood clotting disorders;
• If you are severely dehydrated (have lost a lot of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or in the lactation period.

Warnings and precautions

Consult your doctor or pharmacist before starting to take DOLOVANZ FORTE:

• If you are allergic or have had allergy problems in the past;
• If you have kidney, liver, or heart diseases (hypertension and/or heart failure), or fluid retention or have had any of these diseases in the past;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (for example, excessive urination, diarrhea, or vomiting);
• If you have heart problems, a history of strokes, or think you may be at risk of these conditions (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker) consult this treatment with your doctor or pharmacist. Medicines like DOLOVANZ FORTE may be associated with a small increase in the risk of heart attacks ("myocardial infarction") or strokes ("cerebral infarction"). This risk is more likely to occur when high doses and prolonged treatments are used. Do not exceed the recommended dose or treatment duration;
• If you are an elderly patient, you may be more likely to experience adverse effects (see section 4).

If these occur, consult your doctor immediately;

• If you are a woman with fertility problems (see section 2, "Pregnancy, lactation, and fertility");
• If you have a disorder in blood production and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (diseases of the immune system that affect connective tissue);
• If you have chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If you have gastrointestinal or intestinal disorders;
• If you have an infection, see the "Infections" heading below;
• If you are taking other medicines that increase the risk of peptic ulcers or bleeding, for example, oral corticosteroids, some antidepressants (type ISRS, Selective Serotonin Reuptake Inhibitors), blood thinners like acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In these cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medicine to protect your stomach (for example, misoprostol or other medicines that block stomach acid production);
• If you have asthma, combined with rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of being allergic to acetylsalicylic acid and/or NSAIDs than the general population. The administration of this medicine may cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that this medicine may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to varicella. If you take this medicine while having an infection and the infection symptoms persist or worsen, consult a doctor without delay. Avoid using this medicine if you have varicella.

Children and adolescents

Dexketoprofen has not been studied in children or adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in children or adolescents.

Other medicines and DOLOVANZ FORTE

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. There are some medicines that should not be taken together and other medicines that may need a dose change if taken together.

Inform your doctor, dentist, or pharmacist if, in addition to dexketoprofen, you are taking any of the following medicines:

Non-recommended associations:

• Acetylsalicylic acid, corticosteroids, and other anti-inflammatory drugs;
• Warfarin, heparin, and other medicines used to prevent blood clotting;
• Lithium, used to treat some mood disorders;
• Metotrexate (cancer and immunosuppressant medicine), used at high doses of 15 mg/week;
• Hidantoins and phenytoin, used for epilepsy;
• Sulfamethoxazole, used for bacterial infections.

Medicines that require caution:

• ACE inhibitors, diuretics, and angiotensin II antagonists, used for high blood pressure and heart conditions;
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Aminoglycoside antibiotics, used for bacterial infections;
• Sulfonilureas (for example, chlorpropamide and glibenclamide), used for diabetes;
• Metotrexate, used at low doses, less than 15 mg/week.

Medicines to be taken into account:

• Quinolones (for example, ciprofloxacin, levofloxacin), used for bacterial infections;
• Ciclosporin or tacrolimus, used to treat immune system diseases and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines; that is, medicines used to break down blood clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (to interrupt pregnancy);
• Antidepressants of the type Selective Serotonin Reuptake Inhibitors (SSRIs);
• Antiplatelet agents used to reduce platelet aggregation and blood clotting;
• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Taking DOLOVANZ FORTE with food, drinks, and alcohol

Generally, it is recommended to take the medicine with meals to reduce the possibility of causing stomach problems (see also section 3, "Administration form").

The use of NSAIDs in combination with alcohol may worsen the adverse reactions caused by the active ingredient.

Pregnancy, lactation, and fertility

Do not take this medicine during the last three months of pregnancy or during lactation.

If you are pregnant or in the lactation period, consult your doctor or pharmacist before using this medicine.

Do not take dexketoprofen if you are in 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 your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take dexketoprofen during the first 6 months of pregnancy unless it is strictly necessary and as your doctor indicates. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, dexketoprofeno may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels 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 checks.

Women planning to become pregnant or who are pregnant should avoid using dexketoprofen. Treatment at any time during pregnancy should only take place under a doctor's instructions.

Do not recommend the use of dexketoprofen while trying to conceive or while studying a fertility problem.

Driving and using machines

Dexketoprofen may slightly affect your ability to drive and use machines, as it may cause drowsiness, dizziness, or blurred vision as adverse effects of treatment. If you notice these effects, do not use machines or drive until these symptoms disappear. Consult your doctor.

DOLOVANZ FORTE contains sodium.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; that is, it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist.

In case of doubt, ask your doctor or pharmacist.

The dose of dexketoprofen you need may vary, depending on the type, intensity, and duration of pain.

You should use the most effective dose for the shortest time necessary to alleviate symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults aged 18 years and older

Generally, the recommended dose is 1 tablet (25 mg of dexketoprofen) every 8 hours, without exceeding 3 tablets per day (75 mg).

Patients with advanced age or renal or hepatic insufficiency

If you are an elderly patient or suffer from severe renal problems or mild to moderate hepatic problems, it is recommended to start treatment with a maximum of 2 tablets per day (50 mg of dexketoprofen).

In elderly patients, this initial dose may be increased subsequently in accordance with the general recommended dose (75 mg of dexketoprofen) if dexketoprofen has been well tolerated.

You should not take dexketoprofen if you suffer from moderate or severe renal problems or severe hepatic problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

This medication should not be used in children and adolescents (under 18 years).

Administration form

Take the tablets with an adequate amount of water. Take the tablets with food, as this helps to reduce the risk of gastrointestinal disturbances. However, if your pain is intense and you need quick relief, take the tablets on an empty stomach (at least 30 minutes before eating) as they will be absorbed more easily (see section 2 “Taking DOLOVANZ with food, drinks, and alcohol”).

The tablet can be divided into equal doses.

Treatment duration

Treatment should not exceed 4 days. If pain persists after this period of time, worsens, or other symptoms appear, you should interrupt treatment and consult your doctor or pharmacist.

If you take more DOLOVANZ FORTE than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take DOLOVANZ FORTE

Do not take a double dose to compensate for the missed doses. Take the next dose when due (in accordance with section 3 “How to take DOLOVANZ FORTE”).

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The possible side effects are listed below in accordance with their frequency.

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

Nausea and/or vomiting, mainly upper abdominal pain, diarrhea, digestive disorders (dyspepsia).

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

Rotatory sensation (dizziness), dizziness, drowsiness, sleep disorders, nervousness, headache, palpitations, hot flashes, stomach wall inflammation (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish sensation, and chills, general discomfort.

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

Peptic ulcer, perforation of a peptic ulcer or bleeding (which may manifest with vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g., swelling of ankles), laryngeal edema, loss of appetite (anorexia), abnormal sensation, pruritic rash, acne, increased sweating, lower back pain, frequent urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute renal insufficiency.

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

Anaphylactic reaction (hypersensitivity reaction that can also lead to collapse), skin ulcers, mouth, eye, and genital area (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of the lips and throat (angioedema), respiratory difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis inflammation, blurred vision, tinnitus, sensitive skin, light sensitivity, itching, kidney problems. Decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

Inform your doctor immediately if you notice any gastrointestinal side effects at the start of treatment (e.g., stomach pain or burning, or bleeding), if you have previously experienced any of these side effects due to prolonged treatment with anti-inflammatory drugs, and especially if you are an elderly patient.

Stop taking DOLOVANZ FORTE immediately if you notice the appearance of a skin rash or any lesions inside the mouth or on the genitals, or any other sign of allergy.

During treatment with nonsteroidal anti-inflammatory drugs, cases of fluid retention and swelling (especially in ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines like DOLOVANZ FORTE may be associated with a small increase in the risk of suffering a heart attack ("myocardial infarction") or a stroke ("cerebrovascular accident").

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

The most commonly observed side effects are of a gastrointestinal nature. They may cause peptic ulcers, perforation, or gastrointestinal bleeding, sometimes fatal, especially in elderly patients.

After administration, nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, worsening of colitis, and Crohn's disease have been reported. Less frequently, gastric wall inflammation (gastritis) has been observed.

Like other NSAIDs, they may cause hematological reactions (purpura, aplastic and hemolytic anemia, and more rarely agranulocytosis and medullary hypoplasia).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Store in the original packaging to protect it from light.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofDOLOVANZ FORTE

The active ingredient is dexketoprofen trometamol. Each film-coated tablet contains 36.9 mg of dexketoprofen trometamol equivalent to 25 mg of dexketoprofen.

The other components are:

Core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch type A (from potato) and diestearoyl glycerol.

Coating: hypromellose, titanium dioxide (E-171) and macrogol.

Appearance of the product and content of the packaging

Film-coated, scored, white, biconvex, and cylindrical tablets marked with DT2 on one side (diameter size: 9.3 mm + 5%). The tablet can be divided into equal doses.

Presented in pre-cut, single-dose blisters of PVC-PVDC/AL. Boxes with 10 or 15 film-coated tablets.

Holder of the marketing authorization and responsible for manufacturing

Cinfa Laboratories, S.A

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) – Spain

Date of the last review of this leaflet:May 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/