Background pattern

Dolotren 46,5 mg comprimidos dispersables

About the medicine

How to use Dolotren 46,5 mg comprimidos dispersables

Introduction

Leaflet: information for the user

Dolotren 46.5 mg dispersible tablets

diclofenac

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

  • Keep this leaflet, as you may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
  • If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is Dolotren and what is it used for

The active ingredient in Dolotren 46.5 mg dispersible tablets is diclofenac (equivalent to 50 mg of diclofenac sodium).

Dolotren belongs to a group of medicines called non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

Dolotren is used as a short-term treatment for acute inflammatory and painful post-traumatic and postoperative conditions.

2. What you need to know before starting to take Dolotren

It is essential to use the smallest effective dose of Dolotren that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Do not take Dolotren

  • if you are allergic (hypersensitive) to diclofenac or any of the other components of this medication (including those listed in section 6).
  • if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other analgesics (pain medications) similar to Dolotren. Allergic reactions may include asthma (difficulty breathing), urticaria (skin rash with itching), acute rhinitis (inflammation of the nasal mucosa), or facial swelling. If you think you may be allergic, consult your doctor.
  • if you have had a stomach or duodenal hemorrhage in the past, or have experienced a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
  • if you currently have or have had more than one episode of stomach or duodenal ulcers or hemorrhage.
  • if you have active Crohn's disease or ulcerative colitis (diseases that cause diarrhea with or without blood and abdominal pain).
  • if you have severe kidney disease.
  • if you have severe liver disease.
  • if you have established cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral blood vessels, or have undergone surgery to remove an obstruction or perform a coronary bypass.
  • if you have peripheral arterial disease (problems with blood circulation).
  • if you are in the third trimester of pregnancy.
  • if you have bleeding disorders.

Make sure your doctor knows:

  • if you smoke.
  • if you have diabetes.
  • if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Warnings and precautions

Consult your doctor or pharmacist before starting Dolotren treatment.

  • if you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as severe or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcers and in the elderly. In these cases, your doctor may consider associating a stomach protector.

  • if you have any of the following conditions: asthma, mild heart disease, liver disease, kidney disease, high blood pressure (hypertension), bleeding disorders, or other blood disorders, including porphyria hepatica.
  • if you are taking other anti-inflammatory medications, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcers and/or gastrointestinal bleeding (see the section "Other medications and Dolotren").
  • if you are taking medications for high blood pressure or ciclosporin, as this increases the risk of kidney damage (see the section "Other medications and Dolotren").
  • Some people should not use Dolotren. Consult your doctor if you think you may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other components of Dolotren. (These are listed at the end of the prospectus). The signs of a hypersensitivity reaction are facial and lip swelling (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.

Inform your doctor

  • if you are taking medications that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants, or antiplatelet agents of the type acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
  • if you have Crohn's disease or ulcerative colitis, as Dolotren-type medications may worsen these conditions.
  • if you have high blood pressure, high cholesterol, high triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor will reevaluate whether you should continue treatment with Dolotren, especially if you have been taking it for more than 4 weeks.
  • if you have liver failure, kidney failure, or bleeding disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to monitor the function of your liver (transaminase levels), kidneys (creatinine levels), or blood (lymphocyte, erythrocyte, and platelet levels). Your doctor will then decide whether to interrupt or change your Dolotren dose.
  • if you have recently undergone or are about to undergo surgical intervention on the stomach or intestine before taking Dolotren, as Dolotren may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

Dolotren-type medications may be associated with an increased risk of heart attacks or strokes, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), and your doctor decides to treat you with this medication, do not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Additionally, this type of medication may cause fluid retention, especially in patients with heart disease and/or high blood pressure.

In general, it is very important to take the lowest effective dose of Dolotren for the shortest possible time to relieve pain and/or inflammation and reduce the risk of cardiovascular adverse effects.

If you experience chest pain, shortness of breath, weakness, or difficulty speaking while taking this medication, contact your doctor immediately.

Children and adolescents

This medication is not recommended for children and adolescents under 14 years old.

Use in elderly patients

Elderly patients may be more sensitive to the effects of this medication than the general adult population. Therefore, it is especially important for elderly patients to inform their doctor immediately about any adverse effects.

Other medications and Dolotren

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Certain medications may interact with Dolotren, in which case it may be necessary to change the dose or interrupt treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

-medications containing lithium or selective serotonin reuptake inhibitors (SSRIs) for treating depression,

  • medications containingmethotrexate (for treating cancer and rheumatoid arthritis),
  • medications containingciclosporin, tacrolimus (after transplants),
  • medications containingtrimetoprim (for preventing and treating urinary tract diseases),
  • medications for heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
  • medications used to treat diabetes, except for insulin,
  • medications for controlling high blood pressure (diuretics, beta-blockers, and ACE inhibitors),
  • medications forpreventing blood clots,
  • medications containing quinolone or ceftriaxone (for treating infections),
  • other medications in the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
  • corticosteroids(medications that reduce inflammation and the action of the immune system),
  • medications containing voriconazole (a medication used in the treatment of fungal infections),
  • medications containing phenytoin (a medication used to treat seizures),
  • medications containing misoprostol (for treating stomach ulcers),
  • medications containing cholestyramine and colestipol (for lowering cholesterol levels in the blood),
  • medications containing pentazocine (for relieving pain).

Taking Dolotren with food and alcohol

This medication should be taken preferably before meals or on an empty stomach, as food reduces absorption.

Consuming alcoholic beverages with Dolotren may increase its toxicity.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Due to the association of Dolotren-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary and as indicated by your doctor. 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, Dolotren may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

In the third trimester, the administration of Dolotren is contraindicated as it may harm your fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery.

Breastfeeding

Small amounts of Dolotren may appear in breast milk, so you should not take this medication while breastfeeding.

Fertility

For fertile women, it is essential to consider that Dolotren-type medications have been associated with a decrease in the ability to conceive.

Driving and operating machinery

The influence of diclofenac on the ability to drive and operate machinery is negligible or insignificant. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while taking Dolotren should avoid driving vehicles or operating machinery.

Dolotren 46.5 mg dispersible tablets contain sodium (from carboxymethylcellulose sodium from potato, sodium stearate fumarate, and sodium saccharin)

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

3. How to Take Dolotren

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults and children over 14 years old

In mild cases, 2 tablets of Dolotren per day are usually sufficient. Do not exceed a dose of 3 tablets (150 mg of diclofenac) per day. The total daily dose should be divided into 2 or 3 fractional doses.

Administration form

This medication should be taken preferably before meals or on an empty stomach (see section “Taking Dolotren with food and drinks”).

The tablets should be dissolved in a glass of water. Place one tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any remaining particles in the glass, add more water and repeat the process.

If you take more Dolotren 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 taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Dolotren

Do not take a double dose to compensate for the missed doses.

If you forget a dose, take it as soon as you can, except if it is almost time for the next one; then return to the usual administration schedule. If you forget several doses, consult your doctor.

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

4. Possible Adverse Effects

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

Some side effects can be serious.

Stop using Dolotren and immediately inform your doctor if you experience any of the following side effects:

  • Abdominal cramps and abdominal pain to palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea observed within 24 hours after the onset of abdominal pain (frequency unknown, cannot be determined from available data).
  • Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Frequent side effects (appear in at least 1 in 100 patients)

Nervous system disorders

  • Headache
  • Dizziness

Vestibular disorders

  • Dizziness

Gastrointestinal disorders

  • Nausea
  • Vomiting
  • Diarrhea
  • Acid reflux
  • Abdominal pain
  • Gas
  • Loss of appetite

Hepatobiliary disorders

  • Abnormal liver function test results (elevated serum transaminases)

Skin and subcutaneous tissue disorders

  • Rash

Rare side effects (appear in at least 1 in 10,000 patients):

Immune system disorders

  • Swelling of the face, eyes, or tongue, difficulty swallowing, shortness of breath, hives, and generalized itching, rash, fever, abdominal cramps, chest discomfort, difficulty breathing, dizziness, loss of consciousness (severe allergic reaction).

If these symptoms appear, consult your doctor immediately.

Nervous system disorders

  • Drowsiness

Respiratory, thoracic, and mediastinal disorders

  • Asthma

Gastrointestinal disorders

  • Stomach pain
  • Reflux
  • Bloody diarrhea
  • Ulcerative gastric or intestinal disease with or without bleeding or perforation (vomiting blood and appearance of blood in stool).If these symptoms appear, consult your doctor immediately.

Hepatobiliary disorders

  • Liver function abnormalities
  • Jaundice with or without yellowing of the skin and eyes.If these symptoms appear, consult your doctor immediately.

Skin and subcutaneous tissue disorders

  • Hives

General disorders and administration site conditions

  • Fluid retention, with swelling (edema)

Very rare side effects (appear in less than 1 in 10,000 patients):

Blood and lymphatic system disorders

  • Signs of anemia, such as fatigue, headache, shortness of breath, dizziness, paleness (anemia), frequent infections with fever, chills, sore throat, or mouth ulcers (leucopenia), excessive bleeding or bruising (thrombocytopenia).

If these symptoms appear, consult your doctor immediately.

Immune system disorders

  • Swelling of the face

Psychiatric disorders

  • Disorientation
  • Depression
  • Insomnia
  • Nightmares
  • Irritability
  • Psychotic reactions

Nervous system disorders

  • Prickling sensation
  • Memory disorders
  • Seizures
  • Anxiety
  • Tremors
  • Meningitis (inflammation of the membranes surrounding the brain) with symptoms such as fever, nausea, vomiting, headache, neck stiffness, or extreme sensitivity to bright light.If these symptoms appear, consult your doctor immediately.
  • Taste disorders
  • Cerebral infarction

Eye disorders

  • Blurred vision
  • Diplopia

Vestibular disorders

  • Tinnitus

Vascular disorders

  • Hypertension (high blood pressure)
  • Vasculitis (inflammation of the blood vessel walls)

Respiratory, thoracic, and mediastinal disorders

  • Dyspnea, wheezing (neumonitis).

If these symptoms appear, consult your doctor immediately.

Gastrointestinal disorders

  • Worsening of Crohn's disease and ulcerative colitis
  • Constipation
  • Tongue swelling (glossitis)
  • Mouth mucosa inflammation (stomatitis)
  • Swallowing difficulties (esophageal alteration)
  • Severe upper abdominal pain, nausea, vomiting, and loss of appetite (signs of pancreatitis).If these symptoms appear, consult your doctor immediately.

Skin and subcutaneous tissue disorders

  • Severe skin reactions with rash, redness, blisters on the lips, mouth, or eyes, skin peeling, accompanied by fatigue, nausea, loss of appetite, fever, chills, headache, cough, or body pain (Stevens-Johnson syndrome or toxic epidermal necrolysis).If these symptoms appear, consult your doctor immediately.
  • Generalized rash (eczema)
  • Redness (erythema and erythema multiforme)
  • Skin peeling (dermatitis exfoliativa)
  • Hair loss
  • Sun allergy (photosensitivity reaction)
  • Appearance of bruises (purpura)
  • Itching

Renal and urinary disorders

  • Renal function abnormalities that cause swelling in the feet or legs and sudden decrease in urine output (acute renal failure, interstitial nephritis, papillary necrosis)
  • Blood in urine (hematuria)
  • Protein in urine (nephrotic syndrome)

If these symptoms appear, consult your doctor immediately.

Isolated cases

Hepatobiliary disorders

  • Liver function abnormalities that cause yellowing of the skin and eyes, fever, upper abdominal pain, and bruising (hepatic insufficiency, fulminant hepatitis, hepatic necrosis)

If these symptoms appear, consult your doctor immediately.

Reporting of adverse reactions:

If you experience any type ofadverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 adverse reactions, you can contribute to providing more information on the safety of this medicine.

5. Dolotren Storage

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

Store the blister pack in the outer packaging to protect it from moisture.

Do not use Dolotren after the expiration date indicated on the box after CAD. The expiration date is the last day of the month indicated.

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

6. Content of the packaging and additional information

Composition of Dolotren

  • The active ingredient is diclofenac. Each tablet contains 46.5 mg of diclofenac (equivalent to 50 mg of diclofenac sodium).
  • The other components (excipients) are: microcrystalline cellulose, cornstarch, sodium carboxymethylstarch, crospovidone, orange flavor, polyethylene glycol 6000, sodium stearoylfumarate, sodium saccharin, anhydrous colloidal silica.

Appearance of the product and content of the packaging

Each package contains 40 dispersible tablets, white in color.

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma, S.A.

Maximo Agirre Kalea, 14

48940 Leioa (Bizkaia)

Spain

Or

Faes Farma, S.A.

Parque Científico y Tecnológico de Bizkaia

Ibaizabal Bidea, Edificio 901

48160 Derio (Bizkaia)

Spain

Last review date of this leaflet: February 2023

The detailed information of this medication is available on the website of the Spanish Agency of Medicaments and Health Products (AEMPS)http://www.aemps.gob.es/

About the medicine

How much does Dolotren 46,5 mg comprimidos dispersables cost in Spain in 2025?

The average price of Dolotren 46,5 mg comprimidos dispersables in July, 2025 is around 1.65 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.

Talk to a doctor online

Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.

5.07 reviews
Doctor

Anna Moret

Dermatology18 years of experience

Dr. Anna Moret is a board-certified dermatologist and dermatovenereologist. She specialises in adult and pediatric dermatology, venereology, aesthetic skin care, and general medicine. Her consultations are evidence-based and tailored to each patient’s dermatological needs.

Dr. Moret provides expert evaluation and treatment for: • Skin conditions such as eczema, acne, rosacea, dermatitis, and psoriasis • Hair and scalp issues including hair loss, dandruff, and seborrheic dermatitis • Pediatric skin problems — from newborns to adolescents • Sexually transmitted infections (STIs) and dermatovenereology • Aesthetic concerns: skin ageing, non-invasive cosmetic treatments • Skin allergies and hypersensitivity reactions • Mole checks, lesion evaluation, and skin cancer screening • Skincare advice and personalised cosmeceutical routines

Combining dermatology with general medical knowledge, Dr. Moret offers comprehensive care that addresses both skin health and underlying conditions. She also holds certification from the Canadian Board of Aesthetic Medicine, ensuring an internationally aligned approach to aesthetic dermatology.

CameraBook a video appointment
5.044 reviews
Doctor

Alina Tsurkan

Family medicine12 years of experience

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

Dr. Tsurkan supports patients with a wide range of health issues, including: • Respiratory infections: cold, flu, bronchitis, pneumonia, and lingering coughs • ENT conditions: sinusitis, tonsillitis, otitis (ear infections), sore throat, allergic rhinitis • Eye conditions: allergic or infectious conjunctivitis, red eyes, irritation • Digestive issues: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), constipation, bloating, nausea • Urinary and reproductive health: urinary tract infections (UTIs), cystitis, prevention of recurrent infections • Chronic diseases: hypertension, elevated cholesterol, weight management • Neurological complaints: headaches, migraines, sleep disturbances, fatigue, general weakness • Children’s health: fever, infections, digestive issues, follow-ups, vaccination guidance

She also provides: • IMT medical certificates for driving licence exchange in Portugal • Personalised preventive care and wellness consultations • Interpretation of test results and medical reports • Follow-up care and medication review • Support in managing multiple coexisting conditions • Remote prescription management and medical documentation

Dr. Tsurkan’s approach is evidence-based and holistic. She works closely with each patient to develop an individualised care plan that addresses both symptoms and root causes. Her goal is to empower patients to take control of their health and maintain well-being through lifestyle adjustments, routine check-ups, and early intervention.

CameraBook a video appointment
5.082 reviews
Doctor

Andrei Popov

General medicine6 years of experience

Dr. Andrei Popov is a licensed pain management specialist and general practitioner based in Spain. He provides expert online care for adults dealing with both chronic and acute pain, as well as a wide range of everyday health concerns.

He specialises in diagnosing and treating pain conditions that affect quality of life, including: • Chronic pain lasting more than 3 months • Migraines and recurring headaches • Neck, back, lower back, and joint pain • Post-traumatic pain following injury or surgery • Nerve-related pain, fibromyalgia, and neuralgia In addition to pain management, Dr. Popov helps patients with: • Respiratory infections (colds, bronchitis, pneumonia) • High blood pressure and metabolic conditions such as diabetes • Preventive care and routine health check-ups

Online consultations last up to 30 minutes and include a detailed symptom review, personalised treatment planning, and medical follow-up when needed.

Dr. Popov’s approach is rooted in evidence-based medicine, combined with individualised care tailored to each patient’s history, lifestyle, and clinical needs.

CameraBook a video appointment
5.017 reviews
Doctor

Yevgen Yakovenko

General surgery11 years of experience

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise: • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan. • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions. • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies. • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries. • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required. • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up. • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data. • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications: • 12+ years of clinical experience in university hospitals in Germany and Spain • International education: Ukraine – Germany – Spain • Member of the German Society of Surgeons (BDC) • Certified in radiological diagnostics and robotic surgery • Active participant in international medical conferences and research

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

CameraBook a video appointment
See all doctors

Stay informed and save on care

Get health tips, platform updates, and exclusive promos for subscribers.

Follow us on social media
FacebookInstagramTikTok