Package Insert: Information for the Patient

Dolotren retard 100 mg prolonged-release hard capsules

diclofenac sodium

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

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should 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 package insert

The active ingredient of Dolotren retard 100 mg is diclofenac sodium.

Dolotren retard 100 mg belongs to the 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 gout attacks.
• M menstrual cramps.
• Post-traumatic inflammation.

It is essential to use the smallest effective dose of Dolotren retard 100 mg that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

Do not takeDolotren retard 100 mg

• If you are allergicto diclofenac sodium or to 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 medications) similar to it. 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 previous stomach or duodenal hemorrhage or have experienced 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 a pre-existing 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 coronary artery bypass surgery.
• If you have an active inflammatory bowel disease (active ulcerative colitis or active Crohn's disease).
• If you have severe kidney disease.
• If you have severe liver disease.
• If you have blood clotting disorders.
• If you have peripheral artery disease.
• 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 to take Dolotren retard 100 mg:

• Ifyou 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 symptoms of warning.

This risk is higher when using high doses and prolonged treatments, especially 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 Dolotrén retard”).
• 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 (medications that increase urine production).
• 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 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 medications that may increase the risk of bleeding, 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 recently undergone or are about to undergo gastrointestinal surgery, as Dolotren may sometimes worsen intestinal wound healing after surgery.

Cardiovascular precautions

Medications like Dolotren may be associated with a moderate increase in the risk of suffering 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 cardiovascular 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) consult this treatment with your doctor or pharmacist.

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

Children and adolescents

Dolotren retard 100 mg is not recommended for children and adolescents.

Older adults

Older adults may be more sensitive to the effects of Dolotren retard 100 mg than the rest of adults. Therefore, it is especially important for older adults to inform their doctor immediately of any adverse reactions that occur.

Other medications and Dolotren retard 100 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 it may be necessary to change the dose or discontinue 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).
• Medications beta-blockers or inhibitors of the ECA (for treating high blood pressure).
• Medications used to treat diabetes, except insulin.
• Medications to increase urine production (diuretics).
• Medications to prevent blood clots.
• Corticosteroids (medications for treating or alleviating inflammation).
• Some medications for treating infections (quinolone antibiotics).
• Other medications in the same group as Dolotren (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen.
• Sulfinpirazona (a medication used for treating gout) or voriconazol (a medication used for treating fungal infections).
• Fenitoína (a medication used for treating epilepsy).

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 administering medications like Dolotren 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 when 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 a period longer than a few days, your doctor may recommend additional monitoring.

During 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 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

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

At normal doses, Dolotren retard 100 mg does not affect the ability to drive or operate 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 (drive vehicles or operate machinery) until you know how you tolerate the medication.

Dolotren retard 100 mg contains saccharose and sodium (from diclofenac sodium)

This medication contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

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

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

The dose should 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, which better meet individual needs.

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

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

It should be noted 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 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 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 one; then return to the usual administration schedule.

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

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.

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

Some side effects can be serious.

Stop using Dolotren retard 100 mg and inform your doctor IMMEDIATELY if you experience any of the following side effects:

The side effects observed are described below according to the 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), and unknown frequency (from available data).

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.

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.

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

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 Dolotren.

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

Dermatological and subcutaneous tissue disorders

Urticaria, severe skin reactions, hair loss, increased skin sensitivity to sunlight, bleeding under the skin. Medications like Dolotren may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis.

Heptatic 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 abdominal tenderness. Discontinue treatment and inform your doctor IMMEDIATELY if any of the following reactions occur: yellowing of the skin or eyes.

Central nervous system disorders

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

Disorders of the sensory organs

Visual disorders (blurred vision or double vision), hearing problems, ear ringing, taste alterations.

Renal disorders

In rare cases, renal function abnormalities that cause swelling of the face, feet, or legs, sudden decrease in urine output, bloody urine.

Blood disorders

Symptoms of severe alterations in blood cells.

Hypersensitivity

Allergic reactions such as asthma and difficulty breathing or fainting.

Others

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

Reporting 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 for the 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 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.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Dolotren retard 100 mg

• The active ingredient is diclofenac sodium. Each capsule contains 100 mg of diclofenac sodium.
• 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, patent blue V (E131), quinoline yellow (E104), and titanium dioxide (E171).

Appearance of the product and content of the packaging

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

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

Last review date of this leaflet: February 2023

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