DOLOTREN 50 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Dolotren 50 mg Gastro-Resistant Tablets

diclofenac sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Dolotren 50 mg and what is it used for
2. What you need to know before you take Dolotren 50 mg
3. How to take Dolotren 50 mg
4. Possible side effects
5. Storage of Dolotren 50 mg
6. Contents of the pack and other information

1. What is Dolotren 50 mg and what is it used for

The active substance of Dolotren 50 mg is diclofenac sodium. Dolotren 50 mg belongs to a group of medicines called non-steroidal anti-inflammatory drugs.

Dolotren 50 mg is used for the symptomatic treatment of the following conditions:

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

Post-traumatic inflammation.

2. What you need to know before you take Dolotren 50 mg

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

Do not take Dolotren 50 mg

• If you are allergic to diclofenac or 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. Reactions can include asthma (difficulty breathing), hives (allergic reaction on the skin 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 had a stomach or duodenal bleeding or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medicine.
• If you currently have or have had more than one occasion a stomach or duodenal ulcer or bleeding.
• If you have active Crohn's disease or ulcerative colitis (diseases that produce 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 had surgery to remove a blockage or perform a coronary bypass.
• If you have blood coagulation disorders or are receiving treatment for them.
• If you have had problems with blood circulation (peripheral arterial disease).
• If you are in the third trimester of pregnancy.

Make sure your doctor knows before taking diclofenac:

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

Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Dolotren 50 mg:

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which can be manifested by intense or persistent abdominal pain and/or black stools or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protective medication.

• If you are taking other anti-inflammatory medicines, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants (see the section "Other medicines and Dolotren 50 mg").
• If you have any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure, bleeding disorders, or other blood disorders, including porphyria.
• If you are taking diuretic medicines (which increase urine volume).
• 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 ingredient of Dolotren (listed at the end of the leaflet). The signs of a hypersensitivity reaction are swelling of the face and mouth (angioedema), breathing problems, chest pain, runny nose, skin rash, or any other allergic reaction.
• If you have ever had a severe skin rash or peeling or blisters in the mouth after taking Dolotren or other painkillers.

Tell your doctor:

• If you are taking medicines that alter blood coagulation or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines of the Dolotren type may worsen these conditions.
• If you have liver or kidney failure, or blood disorders, you will need to have frequent blood tests during your treatment. This will allow your doctor to monitor the functioning of your liver (transaminase levels) or kidneys (creatinine levels) or blood (lymphocyte, erythrocyte, and platelet levels). With this, your doctor can decide to interrupt or change the dose of Dolotren.
• If you have recently undergone or are going to undergo stomach or intestinal surgery before taking Dolotren, as Dolotren may sometimes worsen the healing of wounds in the intestine after surgery.

Patients with Cardiovascular Problems

Medicines like Dolotren can be associated with a moderate increase in the risk of heart attacks (myocardial infarction) or strokes, especially when used in high doses and prolonged treatments. 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 of suffering from these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

Similarly, this type of medicine can cause fluid retention, especially in patients with heart disease and/or high blood pressure (hypertension).

Children and Adolescents

The use of Dolotren 50 mg is not recommended in children and adolescents under 14 years of age.

Elderly Patients

Elderly patients may be more sensitive to the effects of Dolotren 50 mg than the rest of adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse reactions that occur.

Other Medicines and Dolotren 50 mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines can interfere with Dolotren, in which case it may be necessary to change the dose or interrupt 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 (for treating some types of depression),
• medicines containing methotrexate (for treating rheumatoid arthritis and cancer),
• medicines containing cyclosporin (after transplants),
• medicines containing digoxin (for treating heart problems),
• calcium antagonist medicines such as verapamil or isradipine (for treating heart problems),
• beta-blocker or ACE inhibitor medicines (for treating high blood pressure),
• medicines used to treat diabetes, except insulin,
• Misoprostol (a medicine used to treat stomach ulcers),
• Colestyramine and Colestipol (medicines used to lower blood cholesterol levels),
• Pentazocine (a painkiller medicine used to relieve pain),
• medicines to increase urine volume (diuretics),
• medicines to prevent blood clots,
• corticosteroids (medicines to treat or alleviate inflammation),
• some medicines to treat infections (quinolone antibacterials),
• other medicines of 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

Do 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Because the administration of medicines like Dolotren has been associated with an increased risk of congenital anomalies/abortions, it is not recommended during the first and second trimester of pregnancy unless 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 the 20th week of pregnancy, Dolotren may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment during a period longer than a few days, your doctor may recommend additional checks.

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 more than expected.

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Small amounts of Dolotren 50 mg may appear in breast milk, so you should not take Dolotren 50 mg if you are breastfeeding.

Fertility

For female patients of childbearing age, it should be noted that medicines like Dolotren have been associated with a decrease in fertility.

Driving and Using Machines

If you notice symptoms of drowsiness, dizziness, nausea, vision disorders, or other symptoms that alter your ability to concentrate, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medicine.

Dolotren 50 mg contains sodium (from potato carboxymethyl starch and diclofenac sodium)

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

3. How to take Dolotren 50 mg

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The tablets should 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 indicate the dose you should take, according to your disease.

The dose must 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 adjust to individual needs.

The recommended dose in mild cases or in prolonged treatments is 75-100 mg of diclofenac per day (one tablet twice a day).

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

In menstrual pain, the daily dose, which should be individually adjusted, is 50-200 mg.

If you take more Dolotren 50 mg than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service immediately. Telephone: 91 562 04 20, indicating the medicine and the amount taken. It is recommended to carry the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Dolotren 50 mg

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

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

If you have any other doubts 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 all people suffer from them. Some adverse effects can be serious.

Stop using Dolotren 50 mg tablets and immediately inform your doctor if you experience any of the following serious adverse effects; you may need urgent medical treatment:

• Gastric discomfort, heartburn, or pain in the upper abdomen.
• Vomiting blood, black stools, or blood in the urine.
• Severe allergic skin reaction, which can include widespread large red or dark spots, skin swelling, blisters, and itching (generalized fixed drug eruption).
• Skin problems such as rash or itching.
• Wheezing in the chest, difficulty breathing.
• Yellowing of the skin or eyes.
• Persistent sore throat or high fever.
• Swelling of the face, feet, or legs.
• Sudden headache.
• Chest pain when coughing.
• Mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with Dolotren 50 mg tablets, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain.
• Chest pain, which can 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 (occurring in at least 1 in 10 patients), common (occurring in 1 to 10 in 100 patients), uncommon (occurring in 1 to 10 in 1,000 patients), rare (occurring in 1 to 10 in 10,000 patients), very rare (occurring in less than 1 patient in 10,000 patients), and of unknown frequency (cannot be estimated from available data).

Common adverse effects (occurring in 1 to 10 in 100 patients) are:

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

Rare (occurring in 1 to 10 in 10,000 patients) or very rare (occurring in less than 1 patient in 10,000 patients) or of unknown frequency (cannot be estimated from available data) adverse effects are:

Gastrointestinal disorders

Rare adverse effects that occur with medicines like Dolotren are: gastritis (inflammation of the gastric mucosa), peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly, hematemesis (blood in vomit), melena (blood in stools), hemorrhagic diarrhea. Very rarely, the following have also been observed: colitis, worsening of ulcerative colitis and Crohn's disease, stomatitis (inflammation of the oral mucosa), glossitis (inflammation of the tongue), esophageal disorders, constipation, oral thrush, pancreatitis (inflammation of the pancreas), stenosis (intestinal narrowing).

Central nervous system disorders

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

Cardiovascular disorders

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

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

Skin and subcutaneous tissue disorders

Urticaria, severe skin reactions, increased sensitivity of the skin to sunlight, bleeding. Medicines like Dolotren may be associated, in very rare cases, with very serious skin reactions that present with blister formation, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

With unknown frequency: allergic skin reaction, which can include round or oval patches of redness and skin swelling, blisters, and itching (fixed drug eruption). There may also be darkening of the skin in the affected areas, which could persist after healing. The fixed drug eruption usually reappears in the same or the same sites if the medicine is taken again.

Hepatic disorders

Medicines like Dolotren may be associated, in rare cases, with hepatic disorders that cause yellowing of the skin and eyes (signs of hepatitis/liver failure), sometimes with high fever or swelling and sensitivity of the upper abdomen.

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

Disorders of the senses

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

Blood disorders

Symptoms of serious alterations of blood cells.

Renal disorders

In very rare cases, renal function anomalies have been observed that cause swelling of the face, feet, or legs, sudden decrease in urine output, bloody urine.

Hypersensitivity

Allergic reactions such as asthma and difficulty breathing or fainting.

Others

Numbness in the limbs, 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 it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Dolotren 50 mg

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Dolotren 50 mg after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Dolotren 50 mg gastro-resistant tablets

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

Appearance of the Product and Packaging Content

Each package contains 20 or 40 coated yellow tablets, distributed in 2 or 4 PVC/Al blisters with 10 tablets each.

Not all package 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

Date of the Last Revision of this Prospectus: July 2025

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