Dolotren 50 mg gastro-resistant tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dolotren 50 mg gastro-resistant tablets

diclofenac sodium

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• 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.

Leaflet contents

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

1. What Dolotren is and what it is used for

The active substance in Dolotren is diclofenac sodium. Diclofenac belongs to the group of medicines known as non-steroidal anti-inflammatory drugs.

This medicine is used for the symptomatic treatment of the following conditions:

• Chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis).
• Extra-articular rheumatism.
• Acute gout attacks.
• Menstrual pain.
• Post-traumatic inflammation.

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

It is important that you use the smallest dose of Dolotren that relieves or controls your pain, and you should not take this medicine for longer than necessary to control your symptoms.

Do not take Dolotren

• if you are allergic to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid or other similar painkillers (analgesic medicines). Reactions may include asthma (difficulty breathing), urticaria (skin allergic reaction with itching), acute rhinitis (inflammation of the nasal mucosa), or swelling of the face. If you think you may be allergic, consult your doctor.
• if you have previously experienced stomach or duodenal bleeding or a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug (NSAID).
• if you currently have or have had more than one episode of stomach or duodenal ulcer or bleeding.
• if you suffer from active Crohn's disease or active ulcerative colitis (conditions causing diarrhea with or without blood and abdominal pain).
• if you have severe kidney disease.
• if you have severe liver disease.
• if you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the blood vessels of the heart or brain, or have undergone surgery to remove an obstruction or coronary bypass.
• if you have blood clotting disorders or are receiving treatment for them.
• if you have or have had circulatory problems (peripheral arterial disease).
• if you are in the third trimester of pregnancy.

Before taking diclofenac, 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.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dolotren:

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

This risk is higher when high doses are used or treatment is prolonged, especially in patients with a history of peptic ulcer or in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

• if you are taking other anti-inflammatory medicines, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants (see section “Other medicines and Dolotren”).
• if you have any of the following conditions: asthma, mild heart disease, liver or kidney disease, hypertension, bleeding disorders, or other blood disorders including hepatic porphyria.
• if you are taking diuretic medicines (which increase urine volume).
• some people MUST NOT use Dolotren. Consult your doctor if you think you may be allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other components of Dolotren (listed at the end of the leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), difficulty breathing, chest pain, runny nose, skin rash, or any other allergic reaction.
• if you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking Dolotren or other painkillers.

Inform your doctor:

• if you are simultaneously taking medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• if you have Crohn's disease or ulcerative colitis, as medicines like Dolotren may worsen these conditions.
• if you have liver failure, kidney failure, or blood disorders, you will need frequent blood tests during treatment. These tests will monitor your liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This will allow your doctor to decide whether to stop or adjust your Dolotren dose.
• if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Dolotren, as Dolotren may sometimes impair intestinal wound healing after surgery.

Patients with cardiovascular problems

Medicines like Dolotren may be associated with a moderate increase in the risk of heart attacks (myocardial infarction) or strokes, especially when used at high doses or for prolonged periods. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

Also, these types of medicines may cause fluid retention, particularly in patients with heart disease and/or high blood pressure (hypertension).

Children and adolescents

Use of this medicine is not recommended in children and adolescents under 14 years of age.

Elderly patients

Elderly patients may be more sensitive to the effects of this medicine than other adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse reactions.

Other medicines and Dolotren

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interact with Dolotren, and in such cases it may be necessary to adjust the dose or discontinue treatment with one of them.

It is important that you inform your doctor if you are taking or have recently taken any of the following medicines:

• medicines containing lithium or serotonin reuptake inhibitors (used to treat certain types of depression),
• medicines containing methotrexate (used to treat rheumatoid arthritis and cancer),
• medicines containing cyclosporine (used after organ transplants),
• medicines containing digoxin (used to treat heart problems),
• calcium channel blockers such as verapamil or isradipine (used to treat heart problems),
• beta-blockers or ACE inhibitors (used to treat high blood pressure),
• medicines used to treat diabetes, except insulin,
• misoprostol (a medicine used to treat stomach ulcers),
• cholestyramine and colestipol (medicines used to lower blood cholesterol levels),
• pentazocine (an analgesic medicine used to relieve pain),
• medicines to increase urine output (diuretics),
• medicines to prevent blood clots,
• corticosteroids (medicines used to treat or relieve inflammation),
• certain antibiotics (quinolone antibacterials),
• other medicines in the same group as Dolotren (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• sulfinpyrazone (a medicine used to treat gout) or voriconazole (a medicine used to treat fungal infections),
• phenytoin (a medicine used to treat epileptic seizures).

Taking Dolotren with alcohol

You should not drink alcohol while taking this medicine, as it may increase the toxicity of Dolotren.

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 medicine.

Pregnancy

Do not take Dolotren 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 your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor more than expected. You should not take Dolotren during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible 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 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.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of diclofenac may pass into breast milk; therefore, you should not take Dolotren if you are breastfeeding.

Fertility

For women of childbearing age, it should be noted that medicines like Dolotren have been associated with a reduced ability to conceive.

Driving and using machines

If you experience symptoms such as drowsiness, dizziness, vertigo, vision disturbances, or other symptoms that impair your concentration, avoid tasks requiring special attention (such as driving vehicles or operating machinery) until you know how you tolerate the medicine.

Dolotren 50 mg gastro-resistant tablets contain sodium (from sodium carboxymethyl starch from potato and sodium diclofenac)

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

3. How to take Dolotren

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

The tablets must be swallowed whole with a glass of water or other liquid, without dividing or chewing them. It is recommended to take them before meals. Your doctor will tell you the dose you should take, depending on your condition.

The dose should be adjusted according to the patient's response. For each patient, it may be necessary to use other presentations containing the same active substance that better suit individual needs.

The recommended dose in mild cases or for long-term treatment is 75–100 mg of diclofenac per day (one tablet twice daily).

As a general rule, the maximum recommended daily dose is 100–150 mg (2 or 3 tablets). Do not exceed a daily dose of 150 mg (3 tablets).

For menstrual pain, the daily dose should be individually adjusted and ranges from 50 to 200 mg.

If you take more Dolotren than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Dolotren

Do not take a double dose to make up for missed doses.

If you forget a dose, take it as soon as you can, unless it is almost time for the next dose; then return to your regular dosing schedule. If you miss several doses, consult your doctor.

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 everyone will experience them. Some adverse effects may be serious.

Stop using Dolotren and inform your doctor immediately if you experience any of the following serious adverse effects; you may require urgent medical treatment:

• Stomach discomfort, heartburn, or upper abdominal pain.
• Vomiting blood, black stools, or blood in the urine.
• Severe skin allergic reaction, which may include widespread red or dark patches, skin swelling, blisters, and itching (generalized fixed bullous drug eruption).
• Skin problems such as rash or itching.
• Chest tightness, difficulty breathing.
• Yellowing of the skin or eyes.
• Persistent sore throat or high fever.
• Swelling of the face, feet, or legs.
• Severe headache.
• Chest pain when coughing.
• Mild abdominal cramps and abdominal tenderness beginning shortly after starting diclofenac treatment, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after onset of abdominal pain.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

The observed adverse effects are described below according to their frequency of occurrence:

Very common (affects at least 1 in 10 patients), common (affects between 1 and 10 in 100 patients), uncommon (affects between 1 and 10 in 1,000 patients), rare (affects between 1 and 10 in 10,000 patients), very rare (affects fewer than 1 in 10,000 patients), and frequency not known (cannot be estimated from available data).

Common adverse effects (occur in between 1 and 10 of every 100 patients) are:

Stomach pain, nausea, vomiting, diarrhoea, abdominal pain, indigestion (dyspepsia), flatulence (gas), loss of appetite, headache, dizziness, vertigo, skin rashes, increased serum transaminases.

Rare adverse effects (occur in between 1 and 10 of every 10,000 patients), very rare (occur in fewer than 1 in 10,000 patients), or those with unknown frequency (cannot be estimated from available data) are:

Gastrointestinal disorders

Rare adverse effects occurring with medicines such as Dolotren include: gastritis (inflammation of the gastric mucosa), peptic ulcers, gastrointestinal haemorrhage, perforations (in some cases fatal), especially in the elderly, haematemesis (blood in vomit), melena (blood in stools), haemorrhagic diarrhoea. Very rarely observed: colitis, worsening of ulcerative colitis and Crohn's disease, stomatitis (inflammation of the oral mucosa), glossitis (inflammation of the tongue), oesophageal disorders, constipation, oral ulcers, pancreatitis (inflammation of the pancreas), stenosis (intestinal narrowing).

Central nervous system disorders

Somnolence, disorientation, difficulty sleeping (insomnia), nightmares, irritability, seizures, depression, anxiety, tremor, psychotic reactions, aseptic meningitis.

Cardiovascular disorders

Medicines such as Dolotren may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Oedema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using medicines of the type of Dolotren.

Skin and subcutaneous tissue disorders

Urticaria, severe skin reactions, increased sensitivity of the skin to sunlight, haemorrhages. Medicines such as Dolotren may, very rarely, be associated with very severe skin reactions presenting with blistering, such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Frequency not known: skin allergic reaction, which may include round or oval-shaped red patches with skin swelling, blisters, and itching (drug eruption fixed). Skin darkening in affected areas may also occur, which could persist after healing. Fixed drug eruptions usually reappear in the same site(s) if the medicine is taken again.

Hepatic disorders

Medicines such as Dolotren may, rarely, be associated with hepatic disorders causing yellowing of the skin and eyes (signs of hepatitis/hepatic failure), sometimes accompanied by high fever or swelling and tenderness in the upper abdomen.

Discontinue treatment and inform your doctor immediately if any of the following reactions occur: yellowing of the skin or eyes.

Sensory organ disorders

Visual disturbances (blurred or double vision), hearing problems, tinnitus (ringing in the ears), taste disturbances.

Blood disorders

Symptoms of serious blood cell disorders.

Renal disorders

Very rarely, abnormalities in kidney function have been observed, causing swelling of the face, feet, or legs, sudden decrease in urine output, or bloody urine.

Hypersensitivity

Allergic reactions such as asthma, difficulty breathing, or fainting.

Other

Tingling in the extremities, persistent sore throat, and high fever.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 Dolotren

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Dolotren after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolotren 50 mg enteric-coated tablets

• The active substance is diclofenac sodium. Each tablet contains 50 mg of diclofenac sodium.
• The other components (excipients) are: microcrystalline cellulose, sodium carboxymethyl starch from potato (type A), magnesium stearate, copolymer of methacrylic acid and ethyl acrylate (1:1) 30% dispersion, talc, polyethylene glycol 6000 and quinoline yellow lake (E104).

Appearance of the product and contents of the pack

Each pack contains 20, 40 or 60 yellow coated tablets, distributed in PVC/Al blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

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

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

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