DOLOTREN RETARD 100 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Dolotren Retard 100 mg Prolonged-Release Hard Capsules

diclofenac sodium

Read all of 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 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.

Contents of the Package Leaflet

1. What is Dolotren Retard 100 mg and what is it used for.
2. What you need to know before you take Dolotren Retard 100 mg.
3. How to take Dolotren Retard 100 mg.
4. Possible side effects.
5. Storage of Dolotren Retard 100 mg.
6. Contents of the pack and other information.

1. What is Dolotren Retard 100 mg and what is it used for

The active substance of Dolotren Retard 100 mg is diclofenac sodium.

Dolotren Retard 100 mg belongs to a group of medicines called non-steroidal anti-inflammatory drugs.

Dolotren Retard 100 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 Retard 100 mg

It is important that you use the smallest dose of Dolotren Retard 100 mg that relieves or controls your pain and you should not take this medicine for longer than necessary to control your symptoms.

Do not takeDolotren Retard 100 mg

• If you are allergic to diclofenac sodium 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, urticaria, acute rhinitis, or facial swelling. If you think you may be allergic, consult your doctor.
• If you have had a stomach or duodenal bleed or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• If you currently have or have had more than one occasion: a stomach or duodenal ulcer or bleeding.
• 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 suffer from active inflammatory bowel disease (ulcerative colitis, Crohn's disease).
• If you have severe kidney disease.
• If you have severe liver disease.
• If you have bleeding disorders.
• 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 Retard 100 mg:

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may 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 ulcers, 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 medications, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants (see the section "Other medicines and Dolotren Retard").
• 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 hepatic porphyria.
• If you are taking diuretic medications (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 non-steroidal anti-inflammatory drug, or any of the other ingredients of Dolotren. (These are listed at the end of the leaflet). The signs of a hypersensitivity reaction are swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.
• If you have ever had a severe skin rash or skin peeling, blisters, or ulcers in the mouth after taking Dolotren or other painkillers.

Tell your doctor:

• If you are taking medications that alter blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also discuss the use of other medications that could 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 medications like Dolotren can worsen these conditions.
• If you have recently undergone or are going to undergo stomach or intestinal surgery before taking Dolotren, as Dolotren can sometimes worsen wound healing in the intestine after surgery.

Cardiovascular precautions

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

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

Children and adolescents

The use of Dolotren Retard 100 mg is not recommended in children and adolescents.

Elderly patients

Elderly patients may be more sensitive to the effects of Dolotren Retard 100 mg than other adults. It is especially important that elderly patients inform their doctor immediately of any adverse reactions that occur.

Other medicines and Dolotren Retard 100 mg

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

Certain medicines may interfere with Dolotren, and it may be necessary to change the dose or stop 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 certain types of depression).

• Medicines containing methotrexate (for treating rheumatoid arthritis and cancer).
• Medicines containing cyclosporin (after transplants).
• Medicines containing digoxin (for treating heart problems).
• Beta-blockers or ACE inhibitors (for treating high blood pressure).
• Medicines used to treat diabetes, except insulin.
• Medicines to increase urine production (diuretics).
• Medicines to prevent blood clots.
• Corticosteroids (medicines to treat or alleviate inflammation).
• Some antibiotics (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).

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 can cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of the fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

In the third trimester of pregnancy, the administration of Dolotren Retard 100 mg is contraindicated as it may harm your fetus or cause problems during delivery. It can cause kidney and heart problems in your fetus. It can affect you and your baby's tendency to bleed and delay or prolong labor more than expected.

Breastfeeding

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

Small amounts of diclofenac sodium may appear in breast milk, so you should not take Dolotren Retard 100 mg if you are breastfeeding.

Fertility

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

Driving and using machines

At normal doses, Dolotren Retard 100 mg does not affect the ability to drive or use 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 Retard 100 mg contains sucrose and sodium (from diclofenac sodium)

This medicine contains sucrose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

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

3. How to take Dolotren Retard 100 mg

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

Your doctor will indicate the duration of treatment with Dolotren. Do not stop treatment before, even if you feel better.

The capsules should be swallowed whole with a glass of water or another liquid, without dividing or chewing them. It is recommended to take them during meals. Your doctor will indicate the dose you should take, according to your illness.

The dose must be adjusted according to the patient's response. To achieve the most suitable individual dose for each patient, it may be necessary to use other presentations containing the same active ingredient that better adjust to individual needs.

The recommended normal dose in mild cases or for prolonged treatments is 75 to 100 mg of diclofenac per day. The maximum recommended daily dose is 100-150 mg.

In menstrual pain, the daily dose, which should be individually adjusted, is 50-200 mg in one or two doses per day.

It should be taken into account that this presentation does not allow the administration of doses greater or lesser than 100 mg.

If you take moreDolotren Retard 100 mgthan 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 take the package and the leaflet of the medicine to the healthcare professional.

If you forget to takeDolotren Retard 100 mg

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 your regular dosing schedule.

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

If you forget several doses, consult your doctor.

If you have any other 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 all people suffer from them.

Some adverse effects can be serious.

Stop using Dolotren retard 100 mg and immediately inform your doctor if you experience any of the following serious adverse effects; you may need urgent medical treatment:

• Stomach upset, 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 patches, 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 retard 100 mg, 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 unknown frequency (cannot be estimated from the available data).

The 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.

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

Gastrointestinal disorders

The 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 (presence of 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).

-Mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with this medicine, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain (with unknown frequency, cannot be determined from the available data).

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

With an unknown frequency, chest pain may occur, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Disorders of the skin and subcutaneous tissue

Urticaria, severe skin reactions, hair loss, increased sensitivity of the skin to sunlight, bleeding into the skin. Medicines like Dolotren may be associated, in very rare cases, with very severe blistering reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

With an 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 recurs 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 central nervous system

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

Disorders of the sensory organs

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

Renal disorders

Rarely, renal function anomalies that cause swelling of the face, feet, or legs, sudden decrease in urine output, bloody urine.

Blood disorders

Symptoms of severe alterations of blood cells.

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 retard 100 mg

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Dolotren retard 100 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 disposed of through wastewater or household waste. Deposit the packaging and unused medicines 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. Package Contents and Additional Information

Composition of Dolotren retard 100 mg

• The active ingredient is sodium diclofenac. Each capsule contains 100 mg of sodium diclofenac.
• The other components (excipients) are: sucrose, cornstarch, shellac, acrylic and methacrylic acid ester polymers, colloidal silica, and talc.

The gelatin capsule is composed of: gelatin, patented blue V (E131), quinoline yellow (E104), and titanium dioxide (E171).

Appearance of the Product and Package Contents

Each package contains two blisters of 10 gelatin capsules each, with a green opaque cap and a transparent colorless body containing microgranules of prolonged release.

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/