Package Insert: Information for the Patient

Dolotren 75 mg Injectable Solution

Diclofenac Sodium

Read this entire package insert carefully before starting to use 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 you should not give it 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.

Dolotren contains diclofenac sodium, belonging to the group of medications known as nonsteroidal anti-inflammatory drugs, used to treat pain and inflammation.

This medication is used for the symptomatic treatment of intense acute pain associated with:

• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis
• Musculoskeletal soft tissue rheumatism
• Renal colic
• Acute gout attack
• Lower back pain
• Musculoskeletal pain
• Postoperative and post-traumatic pain.

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

Do not use Dolotren injectable

• 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 medications) similar to it. Allergic reactions may include asthma (difficulty breathing), urticaria (allergic reaction on the skin 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 suffered, on two or more occasions, a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• if you currently have or have had more than one stomach or duodenal ulcer.
• 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 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 a surgical procedure to remove an obstruction or perform a coronary bypass.
• if you have bleeding disorders or are receiving treatment for them.
• if you have or have had peripheral arterial 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 use Dolotren injectable:

• if you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments, 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, even at low doses, corticosteroids, anticoagulants, or antidepressants, as it increases the risk of stomach ulcers and/or gastrointestinal bleeding (see "Other medications and Dolotren injectable").
• if you have any of the following conditions: asthma, mild heart disease, liver disease, kidney disease, high blood pressure, bleeding disorders, or other blood disorders, including porphyria hepatica.
• if you are taking medications for high blood pressure or ciclosporin, as it increases the risk of kidney damage (see "Other medications and Dolotren injectable").
• 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 prospectus). The signs of a hypersensitivity reaction are facial and lip 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 of the type of acetylsalicylic acid. You must also inform them of 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 insufficiency, kidney insufficiency, 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) or kidneys (creatinine levels) or blood (lymphocyte, erythrocyte, and platelet levels). In this way, your doctor can decide to interrupt or change your Dolotren dose.
• Inform your doctor if you have recently undergone or are about to undergo a surgical procedure on the stomach or intestine before taking Dolotren, as Dolotren may sometimes worsen the healing of intestinal wounds after a surgical procedure.

Patients with cardiovascular problems

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

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

Children and adolescents

Dolotren injectable is not recommended for use in children and adolescents.

Other medications and Dolotren injectable

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, even those purchased without a prescription.

Certain medications may interact with Dolotren injectable; in these cases, it may be necessary 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 or tacrolimus (for after transplants),
• medications containing trimethoprim (for preventing and treating urinary tract diseases),
• medications for heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
• medications used to treat diabetes, except for insulin,
• medications for high blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medications for preventing blood clots,
• medications containing quinolone or ceftriaxone (for treating infections),
• corticosteroids (medications that reduce inflammation and the action of the immune system),
• other medications in the same group as Dolotren (nonsteroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• medications containing voriconazole (a medication used in the treatment of fungal infections),
• medications containing phenytoin (a medication used to treat seizures),
• medications containing misoprostol (for treating stomach ulcers),
• medications containing colestiramine and colestipol (for reducing cholesterol levels in the blood),
• medications containing pentazocine (for relieving pain).

As a general rule, Dolotren 75 mg injectable ampoules should not be mixed with other injectable solutions.

Use of Dolotren injectable and alcohol

The use of this medication with the consumption of alcoholic beverages may increase the toxicity of Dolotren.

Pregnancy, lactation, 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 the medication during the first and second trimesters of pregnancy, except when 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 kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional controls.

During the third trimester, the administration of Dolotren is contraindicated 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 that of your baby to bleed and delay or prolong delivery more than expected.

Lactation

Small amounts of diclofenac sodium may appear in breast milk, so you should not use Dolotren injectable during lactation.

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

The influence of diclofenac on the ability to drive and operate machinery is negligible or insignificant. However, patients who experience visual disturbances, dizziness, drowsiness, or other central nervous system disorders while taking Dolotren should avoid driving vehicles or operating machinery.

Dolotren injectable contains propylene glycol (E-1520), sodium metabisulfite (E-223), sodium (from sodium metabisulfite (E-223)), sodium hydroxide, and diclofenac sodium, and benzyl alcohol

This medication contains 624 mg of propylene glycol in each ampoule. It may produce symptoms similar to those of alcohol, which may reduce your ability to drive or operate machinery.

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sodium metabisulfite (E-223).

This medication contains less than 23 mg (1 mmol) of sodium per ampoule, which is essentially "sodium-free".

This medication contains 93.6 mg of benzyl alcohol in each ampoule. Benzyl alcohol may cause allergic reactions. It should not be administered to premature infants or newborns (up to 4 weeks old) unless recommended by your doctor. This medication should not be used for more than a week in children under 3 years old, as it may cause toxic and allergic reactions in children under this age.

Consult your doctor if you are pregnant or breastfeeding, as large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

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

Use in adults

The recommended dose is 1 ampoule (75 mg of diclofenac sodium) once a day. Exceptionally, in severe cases, two injections may be administered daily, separated by several hours.

Dolotren injectable should not be administered for more than two days. Once the acute crisis has stopped, treatment will continue with Dolotren in tablets or suppositories.

If a vial is combined with any of the other two pharmaceutical forms, the dosage will not exceed 150 mg/day.

Administration form

The medication will be injected intramuscularly via deep gluteal injection in the superior external quadrant.

To open the vial, follow these instructions:

4. Possible Adverse Effects

5. Conservation of Dolotren Injectable

6. Content of the packaging and additional information