Package Insert: Information for the Patient

Dolotren 50 mg Gastric-Resistant Tablets

Diclofenac Sodium

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

The active ingredient of Dolotren 50 mg is diclofenac sodium. Dolotren 50 mg belongs to the 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 gout attacks.
• M menstrual pains.

Post-traumatic inflammation.

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 50 mg

• If you are allergic to diclofenac or any of the other components of this medication (listed in section 6).
• If you are allergic or have had allergic reactions to acetylsalicylic acid or other analgesics (pain-relieving medications) similar to Dolotren. Allergic reactions may include asthma (difficulty breathing), urticaria (allergic skin reaction 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 or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• If you currently have or have had more than one episode of stomach or duodenal ulcer 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, or if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the coronary or cerebral blood vessels, or coronary artery bypass surgery.
• If you have bleeding disorders or are receiving treatment for them.
• If you have or have had peripheral arterial disease (circulation problems).
• If you are in the third trimester of pregnancy.

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 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 50 mg:

• 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 in patients with a history of peptic ulcer disease and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector.

• If you are taking other anti-inflammatory medications, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants (see the section "Other medications and Dolotren 50 mg").
• If you have any of the following conditions: asthma, mild heart disease, liver disease, kidney disease, hypertension, bleeding disorders, or other blood disorders, including porphyria hepatica.
• If you are taking diuretics (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 NSAID, or to any of the other components of Dolotren. (They are listed at the end of the leaflet). The signs of a hypersensitivity reaction are facial and oral 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 like acetylsalicylic acid. You should also mention the use of other medications that may increase the risk of these hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as Dolotren-type medications may worsen these conditions.
• If you have liver, kidney, or blood disorders, you will need to have frequent blood tests during your treatment. This will allow your doctor to control the functioning 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 stomach or intestinal surgery before taking Dolotren, as Dolotren may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

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

If you have cardiovascular problems, a history of strokes, or think you may be at risk of these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), consult this treatment with your doctor or pharmacist.

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

Children and adolescents

Dolotren 50 mg is not recommended for children and adolescents under 14 years old.

Older adults

Older adults may be more sensitive to the effects of Dolotren 50 mg than the rest of the adult population. Therefore, it is especially important for older adults to inform their doctor immediately of any adverse reactions they experience.

Other medications and Dolotren 50 mg

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

Certain medications may interact with Dolotren, in which case you may need 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 (for treating certain types of depression),
• Medications containing methotrexate (for treating rheumatoid arthritis and cancer),
• Medications containing ciclosporin (for after transplants),
• Medications containing digoxin (for treating heart problems),
• Calcium channel blockers such as verapamil or isradipine (for treating heart problems),
• Beta-blockers or ACE inhibitors (for treating high blood pressure),
• Medications used to treat diabetes, except for insulin,
• Misoprostol (a medication used to treat stomach ulcers),
• Colestiramina and Colestipol (medications used to lower cholesterol levels in the blood),
• Pentazocina (a pain-relieving medication),
• Diuretics (medications that increase urine volume),
• Medications to prevent blood clots,
• Corticosteroids (medications for treating or alleviating inflammation),
• Some antibiotics (quinolone antibiotics),
• Other NSAIDs, such as acetylsalicylic acid or ibuprofen,
• Sulfinpirazona (a medication used to treat gout) or Voriconazol (a medication used to treat fungal infections),
• Fenitoína (a medication used to treat seizures).

Taking Dolotren with alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you 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 Dolotren 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 renal 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 renal and cardiac problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong delivery.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

If you experience symptoms of drowsiness, dizziness, vertigo, visual disturbances, or other symptoms that impair concentration, do not perform tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Dolotren 50 mg contains sodium (from carboxymethylcellulose sodium from potato and diclofenac sodium)

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

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

The tablets should be taken whole with a glass of water or another 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 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 ingredient that better meet individual needs.

The recommended dose in mild cases or for prolonged treatments is 75-100 mg of diclofenac per day (one tablet 2 times a day).

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

In menstrual cramps, the daily dose, which should be adjusted individually, 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 Toxicological Information Service immediately. 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 50 mg

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 doubts about the use of this medication, ask your doctor or pharmacist.

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

Stop using Dolotren 50 mg tablets and IMMEDIATELY inform your doctor if you experience any of the following side effects:

The observed side effects are described below according to their frequency of presentation:

Very common (appears in at least 1 in 10 patients), common (occurs between 1 and 10 in 100 patients), uncommon (occurs between 1 and 10 in 1,000 patients), rare (occurs between 1 and 10 in 10,000 patients), very rare (occurs in fewer than 1 in 10,000 patients).

The common side effects (occur between 1 and 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.

The rare side effects (occur between 1 and 10 in 10,000 patients) or very rare side effects (occur in fewer than 1 in 10,000 patients) are:

Gastrointestinal disorders

The rare side effects that occur with medications like Dolotren are: gastritis (inflammation of the gastric mucosa), peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly, hematemesis (presence of blood in vomit), melena (blood in stools), hemorrhagic diarrhea. Very rarely, colitis, worsening of ulcerative colitis and Crohn's disease, stomatitis (inflammation of the oral mucosa), glossitis (inflammation of the tongue), esophageal disorders, constipation, oral ulcers, pancreatitis (inflammation of the pancreas), intestinal stenosis.

Central nervous system disorders

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

Cardiovascular disorders

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

Also, edema (fluid retention), high blood pressure, and heart failure have been observed in association with treatments with medications of the type of Dolotren.

Dermatological and subcutaneous tissue disorders

Urticaria, severe skin reactions, increased skin sensitivity to sunlight, hemorrhagic effusions. Medications like Dolotren may be associated, in very rare cases, with severe skin reactions that present with the formation of blisters, such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.

Liver disorders

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

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

Disorders of the sensory organs

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

Blood disorders

Symptoms of severe alterations in blood cells.

Renal disorders

In very rare cases, abnormalities in renal function 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.

Other

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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.

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

Composition of Dolotren 50 mg gastro-resistant tablets

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

Appearance of the product and content of the packaging

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

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Faes Farma, S.A.

Máximo Aguirre, 14

48940 Leioa (Bizkaia)

Spain

Last review date of this leaflet: February 2023

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