Dolovan 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

DOLOVANZ FORTE 25 mg film-coated tablets

dexketoprofen

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Always follow exactly the instructions for use of this medicine as contained in this leaflet or as directed 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 4 days.

Contents of the leaflet

1. What DOLOVANZ FORTE is and what it is used for
2. What you need to know before taking DOLOVANZ FORTE
3. How to take DOLOVANZ FORTE
4. Possible adverse effects
5. How to store DOLOVANZ FORTE
6. Contents of the pack and other information

1. What DOLOVANZ FORTE is and what it is used for

DOLOVANZ FORTE is an analgesic belonging to the group of medicines 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 muscular or joint pain (for example, back pain, sprains and acute injuries), menstrual pain (dysmenorrhoea), or dental pain in adults.

2. What you need to know before taking DOLOVANZ FORTE

Allergic reactions to dexketoprofen have been reported, including breathing difficulties, swelling of the face and neck area (angioedema), and chest pain. Immediately stop treatment with DOLOVANZ and contact your doctor or nearest emergency service if you experience any of these symptoms.

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 any other non-steroidal anti-inflammatory drug (NSAID);
• If you have asthma or have previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (fleshy growths inside the nose due to allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips, or tongue, or difficulty breathing), or wheezing in the chest after taking acetylsalicylic acid or other NSAIDs;
• If you have previously experienced photoallergic or phototoxic reactions (a special type of redness or sunburn-like skin damage on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to reduce blood fat levels);
• If you have peptic ulcer, gastrointestinal bleeding, or have previously experienced stomach or intestinal bleeding, ulceration, or perforation;
• If you have chronic digestive problems (e.g., indigestion, heartburn);
• If you have previously experienced stomach or intestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief;
• If you have chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis);
• If you have severe heart failure, moderate to severe kidney failure, or severe liver failure;
• If you have bleeding disorders or blood coagulation disorders;
• If you are severely dehydrated (have lost a significant amount of body fluid) due to vomiting, diarrhea, or insufficient fluid intake;
• If you are in the third trimester of pregnancy or during breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before taking DOLOVANZ FORTE:

• If you are allergic or have previously had allergic problems;
• If you have kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or have previously had any of these conditions;
• If you are taking diuretics or have insufficient hydration and reduced blood volume due to excessive fluid loss (e.g., from excessive urination, diarrhea, or vomiting);
• If you have heart conditions, history of stroke, or think you may be at risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, or are a smoker). You should discuss this treatment with your doctor or pharmacist. Medicines like DOLOVANZ FORTE may be associated with a small increased risk of heart attacks (“myocardial infarction”) or strokes (“cerebrovascular accident”). This risk is more likely with high 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 (see section 2, “Pregnancy, breastfeeding, and fertility”);
• If you have a disorder affecting blood or blood cell production;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If you currently have or have previously had chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease);
• If you currently have or have previously had stomach or intestinal disorders;
• If you have an infection; see the section “Infections” below;
• If you are taking other medicines that increase the risk of peptic ulcer or bleeding, such as oral corticosteroids, certain antidepressants (SSRIs, selective serotonin reuptake inhibitors), or agents that prevent blood clotting such as acetylsalicylic acid (aspirin) or anticoagulants like warfarin. In such cases, consult your doctor before taking dexketoprofen: your doctor may prescribe an additional medicine to protect your stomach (e.g., misoprostol or other drugs that block gastric acid production);
• If you have asthma, especially combined with rhinitis or chronic sinusitis, and/or nasal polyps, as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the general population. Taking this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Infections

Dexketoprofen may mask signs of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately. Avoid using this medicine if you have chickenpox.

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 recently taken, or might need to take any other medicines. Some medicines should not be taken together, while others may require dose adjustments when used concomitantly.

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

Combinations not recommended:

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

Combinations requiring 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 to treat bacterial infections;
• Sulfonylureas (e.g., chlorpropamide and glyburide), used for diabetes;
• Methotrexate, when used at low doses, less than 15 mg/week.

Combinations to be aware of:

• Quinolones (e.g., ciprofloxacin, levofloxacin), used for bacterial infections;
• Cyclosporine or tacrolimus, used for immune system disorders and organ transplants;
• Streptokinase and other thrombolytic and fibrinolytic medicines, i.e., medicines used to dissolve clots;
• Probenecid, used for gout;
• Digoxin, used in the treatment of chronic heart failure;
• Mifepristone, used as an abortifacient (for pregnancy termination);
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) type;
• Antiplatelet agents used to reduce platelet aggregation and clot formation;
• Beta-blockers, used for high blood pressure and heart conditions;
• Tenofovir, deferasirox, pemetrexed.

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

Taking DOLOVANZ FORTE with food, drinks, and alcohol

In general, it is recommended to take the medicine with food to reduce the possibility of stomach-related side effects (see also section 3, “How to take”).

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

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take dexketoprofen during the last three months of pregnancy, as it may harm the fetus or cause delivery complications. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and may delay or prolong labor. You should not take dexketoprofen during the first six months of pregnancy unless strictly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest effective dose for the shortest possible time. From week 20 of pregnancy, dexketoprofen may cause kidney problems in your fetus if taken for more than a few days, 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 treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Women who are planning pregnancy or are already pregnant should avoid using dexketoprofen. Treatment at any stage of pregnancy should only occur under a doctor’s guidance.

The use of dexketoprofen is not recommended when trying to conceive or when being evaluated for infertility.

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. If you experience these effects, do not operate machinery or drive until symptoms resolve. Seek advice from your doctor.

DOLOVANZ FORTE contains sodium.

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

3. How to take DOLOVANZ FORTE

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist.

If in doubt, ask your doctor or pharmacist.

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

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Adults over 18 years of age

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

Elderly patients or patients with renal or hepatic impairment

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

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

You must not take dexketoprofen if you have moderate or severe renal problems or severe hepatic problems. Consult your doctor or pharmacist if you are unsure.

Use in children and adolescents

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

Method of administration

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

The tablet may be divided into equal doses.

Duration of treatment

Treatment must not exceed 4 days. If pain persists beyond this period, worsens, or new symptoms appear, you must stop treatment and consult your doctor or pharmacist.

If you take more DOLOVANZ FORTE than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take DOLOVANZ FORTE

Do not take a double dose to make up for a missed dose. Take the next dose as scheduled (according to section 3 “How to take DOLOVANZ FORTE”).

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.

The possible adverse effects are listed below according to their frequency.

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

Nausea and/or vomiting, mainly pain in the upper abdominal quadrant, diarrhoea, digestive disorders (dyspepsia).

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

Spinning sensation (vertigo), dizziness, drowsiness, sleep disturbances, nervousness, headache, palpitations, hot flushes, inflammation of the stomach wall (gastritis), constipation, dry mouth, flatulence, skin rash, fatigue, pain, feverish feeling and chills, general malaise.

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

Peptic ulcer, peptic ulcer perforation or bleeding (which may present as vomiting blood or black stools), fainting, high blood pressure, slow breathing, fluid retention and peripheral swelling (e.g. swollen ankles), laryngeal oedema, 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 kidney failure.

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

Anaphylactic reaction (hypersensitivity reaction which may also lead to collapse), skin, mouth, eye, and genital ulcers (Stevens-Johnson syndrome and Lyell syndrome), facial swelling or swelling of lips and throat (angioedema), breathing difficulty due to narrowing of the airways (bronchospasm), shortness of breath, tachycardia, low blood pressure, pancreatitis, blurred vision, ringing in the ears (tinnitus), sensitive skin, photosensitivity, itching, kidney problems. Decrease in white blood cell count (neutropenia), decrease in platelet count (thrombocytopenia).

Unknown (frequency cannot be estimated from available data):

Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Drug-induced fixed eruption: an allergic skin reaction known as drug-induced fixed eruption that may include round or oval red patches and skin swelling, blisters and itching. Skin darkening in affected areas may also occur, which can persist after healing. Drug-induced fixed eruption usually recurs in the same location or locations if the medicine is taken again.

Immediately inform your doctor if you notice any gastrointestinal adverse effects at the beginning of treatment (e.g. stomach pain or burning sensation or bleeding), especially if you have previously experienced any of these adverse effects due to long-term treatment with anti-inflammatory medicines, and particularly 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 signs of allergy.

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

Medicines such as DOLOVANZ FORTE may be associated with a small increased risk of having a heart attack (“myocardial infarction”) or stroke (“cerebrovascular accident”).

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.

The most commonly observed adverse effects are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation, or gastrointestinal bleeding, sometimes fatal, may occur, especially in elderly patients.

After administration, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, and worsening of colitis and Crohn's disease have been reported. Less frequently, inflammation of the stomach wall (gastritis) has been observed.

As with other NSAIDs, haematological reactions (purpura, aplastic and haemolytic anaemia, and more rarely agranulocytosis and bone marrow hypoplasia) may occur.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of DOLOVANZ FORTE

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Keep in the original packaging to protect from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of DOLOVANZ FORTE

The active substance 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 glyceryl distearate.

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

Appearance of the medicinal product and contents of the pack

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

Presented in single-dose cut blister packs made of PVC-PVDC/AL. Cartons containing 10 or 15 film-coated tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the most recent review of this leaflet: September 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/