Dolotren 75 mg solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dolotren 75 mg injectable solution

sodium diclofenac

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dolotren is and what it is used for

Dolotren contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

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

• rheumatoid arthritis
• ankylosing spondylitis
• osteoarthritis
• soft tissue rheumatism
• renal colic
• acute gout attack
• low back pain
• musculoskeletal pain
• postoperative and post-traumatic pain.

2. What you need to know before using Dolotren

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

Do not use Dolotren

• if you are allergic to diclofenac or to 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 (analgesics). Reactions may include asthma (difficulty breathing), urticaria (skin allergic 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 previously had a stomach or duodenal bleed, or have experienced, on two or more occasions, a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug (NSAID).
• if you currently have or have had recurrent stomach or duodenal ulcers or bleeding.
• if you have active Crohn’s disease or active ulcerative colitis (conditions causing 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), blockages in blood vessels of the heart or brain, or undergone surgery to remove an obstruction or coronary bypass.
• if you have blood clotting disorders or are receiving treatment for them.
• if you have or have had circulation problems (peripheral arterial disease).
• if you are in the third trimester of pregnancy.

Before taking diclofenac, 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.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Dolotren

• if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.

• if you are taking other anti-inflammatory medicines, including acetylsalicylic acid/aspirin, even at low doses, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of gastrointestinal ulcer and/or bleeding (see section “Other medicines and Dolotren”).
• if you suffer from any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure (hypertension), bleeding disorders, or other blood disorders including hepatic porphyria.
• if you are taking medicines for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Other medicines and Dolotren”).
• some people MUST NOT use Dolotren. Consult your doctor if you think you may be allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other ingredients of Dolotren (listed at the end of the leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), difficulty breathing, chest pain, runny nose, skin rash, or any other allergic reaction.
• if you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking Dolotren or other painkillers.

Inform your doctor:

• if you are simultaneously taking medicines that affect 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 medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• if you have Crohn’s disease or ulcerative colitis, as medicines like Dolotren may worsen these conditions.
• if you have liver failure, kidney failure, or blood disorders, you will need frequent blood tests during treatment. These will monitor your liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, red blood cell, and platelet levels). This allows your doctor to decide whether to stop or adjust your Dolotren dose.
• inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Dolotren, as Dolotren may sometimes impair wound healing in the intestine after surgery.

Patients with cardiovascular problems

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

If you have heart problems, a history of stroke, or think you may be at risk (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should discuss this treatment with your doctor or pharmacist.

Also, these types of medicines may cause fluid retention, especially in patients with heart disease and/or high blood pressure (hypertension).

Children and adolescents

The use of this medicine is not recommended in children and adolescents.

Other medicines and Dolotren

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even those obtained without a prescription.

Certain medicines may interact with Dolotren; in such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

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 (used to treat certain types of depression),
• medicines containing methotrexate (used to treat rheumatoid arthritis and cancer),
• medicines containing cyclosporine or tacrolimus (used after organ transplants),
• medicines containing trimethoprim (used to prevent and treat urinary tract infections),
• medicines used to treat heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin,
• medicines used to treat high blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines used to prevent blood clots,
• medicines containing quinolone or ceftriaxone (used to treat infections),
• corticosteroids (medicines that reduce inflammation and suppress the immune system),
• other medicines in the same group as Dolotren (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• medicines containing voriconazole (used to treat fungal infections),
• medicines containing phenytoin (used to treat epileptic seizures),
• medicines containing misoprostol (used to treat stomach ulcers),
• medicines containing colestyramine and colestipol (used to lower blood cholesterol levels),
• medicines containing pentazocine (used to relieve pain).

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

Use of Dolotren and alcohol

Using this medicine together with alcohol consumption 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take Dolotren during the last 3 months of pregnancy, 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 your baby's tendency to bleed and may delay or prolong labor more than expected. You should not take Dolotren during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible 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 levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding

Small amounts of sodium diclofenac may pass into breast milk; therefore, you should not use Dolotren during breastfeeding.

Fertility

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

Driving and using machines

The effect of diclofenac on the ability to drive and use machines is negligible or minor. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders while being treated with Dolotren should avoid driving or operating machinery.

Dolotren 75 mg solution for injection contains propylene glycol (E-1520), sodium metabisulfite (E-223), sodium (from sodium metabisulfite (E-223), sodium hydroxide, and sodium diclofenac), and benzyl alcohol

This medicine contains 624 mg of propylene glycol per ampoule. It may cause alcohol-like symptoms, which could impair your ability to drive or operate machinery.

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

This medicine contains less than 23 mg (1 mmol) of sodium per ampoule, i.e., essentially “sodium-free”.

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

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).

3. How to use Dolotren

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults

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

Dolotren must not be administered for longer than two days. Once the acute episode has resolved, treatment should continue with Dolotren tablets or suppositories.

If one ampoule is combined with either of the other pharmaceutical forms, the total daily dosage must not exceed 150 mg/day.

Method of administration

The medicine must be administered by intramuscular injection, given as a deep intragluteal injection into the upper outer quadrant.

To open the ampoule, follow these instructions:

Breakable ampoule. Place the thumb

Line of break below above the coloured

at the coloured point point and break the

ampoule by pressing

backward

Use in elderly patients

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

If you use more Dolotren than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number (91) 562 04 20, indicating the name of the medicine and the amount used. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to use Dolotren

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

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 everyone will experience them.

Some adverse effects may be serious.

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

• Severe allergic skin reaction, which may include widespread red or dark patches, skin swelling, blisters, and itching (generalized fixed bullous drug eruption).

Other adverse effects:

Frequent adverse effects (occur in at least 1 in every 100 patients)

Disorders of the nervous system

• headache
• dizziness

Disorders of the ear and labyrinth

• vertigo

Gastrointestinal disorders

• nausea
• vomiting
• diarrhoea
• heartburn
• abdominal pain
• gas (flatulence)
• loss of appetite

Hepatobiliary disorders

• changes in blood test results indicating liver function (increased serum transaminases)

Skin and subcutaneous tissue disorders

• skin rash

General disorders and administration site conditions

• reaction, hardening, and pain at the application site

Rare adverse effects (occur in at least 1 in every 10,000 patients):

Immune system disorders

• swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives, generalized itching, skin rash, fever, abdominal cramps, discomfort or tightness in the chest, difficulty breathing, dizziness, unconsciousness (severe allergic reaction). If these symptoms occur, consult your doctor immediately.

Nervous system disorders

• somnolence (sleepiness)

Respiratory, thoracic and mediastinal disorders

• asthma

Gastrointestinal disorders

• stomach pain
• reflux
• bloody diarrhoea
• gastric or intestinal ulcer with or without bleeding or perforation (vomiting blood and presence of blood in stools). If these symptoms occur, consult your doctor immediately.

Hepatobiliary disorders

• liver function impairment
• hepatitis with or without yellowing of the skin (jaundice). If these symptoms occur, consult your doctor immediately.

Skin and subcutaneous tissue disorders

• hives (urticaria)

General disorders and administration site conditions

• fluid retention with swelling (edema)
• development of a black crust on the skin

Very rare adverse effects (occur in fewer than 1 in every 10,000 patients):

Blood and lymphatic system disorders

• signs of low blood cell counts such as fatigue, headache, shortness of breath during exercise, dizziness, paleness (anaemia), frequent infections with fever, chills, sore throat or mouth ulcers (leucopenia), bleeding or bruising more easily than normal (thrombocytopenia). If these symptoms occur, consult your doctor immediately.

Immune system disorders

• facial swelling

Psychiatric disorders

• disorientation
• depression
• insomnia
• nightmares
• irritability
• psychotic reactions

Nervous system disorders

• tingling sensation (paraesthesia)
• memory disorders
• seizures
• anxiety
• tremor
• meningitis (inflammation of the membranes surrounding the brain), with symptoms such as fever, nausea, vomiting, headache, neck stiffness, or extreme sensitivity to bright light. If these symptoms occur, consult your doctor immediately.
• taste disturbances
• stroke

Eye disorders

• blurred vision
• double vision

Ear and labyrinth disorders

• tinnitus (ringing in the ears)

Cardiac disorders

• palpitations
• chest pain
• heart failure
• heart attack (myocardial infarction)

Vascular disorders

• hypertension (high blood pressure)
• vasculitis (inflammation of blood vessel walls)

Respiratory, thoracic and mediastinal disorders

• difficulty breathing, wheezing (pneumonitis).
  If these symptoms occur, consult your doctor immediately.

Gastrointestinal disorders

• worsening of Crohn's disease and ulcerative colitis
• constipation
• swelling of the tongue (glossitis)
• inflammation of the mucous membrane of the mouth (stomatitis)
• difficulty swallowing (oesophageal disorder)
• severe pain in the upper abdomen, nausea, vomiting, and loss of appetite (signs of pancreatitis). If these symptoms occur, consult your doctor immediately.

Skin and subcutaneous tissue disorders

• severe skin reactions with rash, redness, blisters on the lips, mouth or eyes, skin peeling, accompanied by fatigue, nausea, loss of appetite, fever, chills, headache, cough or body pain (Stevens-Johnson syndrome or toxic epidermal necrolysis). If these symptoms occur, consult your doctor immediately.
• widespread rash (eczema)
• redness (erythema and erythema multiforme)
• skin peeling (exfoliative dermatitis)
• hair loss (alopecia)
• sun allergy (photosensitivity reaction)
• appearance of bruises (purpura)
• itching

Renal and urinary disorders

• kidney function abnormalities causing swelling in feet or legs and sudden decrease in urine output (acute renal failure, interstitial nephritis, renal papillary necrosis)
• blood in urine (haematuria)
• foamy urine (nephrotic syndrome)
  If these symptoms occur, consult your doctor immediately.

Infections and infestations

• infection at the injection site

Adverse effects of unknown frequency (cannot be estimated from available data)

Cardiac disorders

• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome. If these symptoms occur, consult your doctor immediately.

Hepatobiliary disorders

• liver function abnormalities causing yellowing of the skin and eyes, fever, upper abdominal pain, and bruising (liver failure, fulminant hepatitis, hepatic necrosis)
  If these symptoms occur, consult your doctor immediately.

Gastrointestinal disorders

• mild abdominal cramps and abdominal tenderness beginning shortly after starting diclofenac treatment, followed by rectal bleeding or bloody diarrhoea, usually observed within 24 hours after onset of abdominal pain. If these symptoms occur, consult your doctor immediately.

Skin and subcutaneous tissue disorders

• skin allergic reaction, which may include round or oval-shaped red and swollen patches, blisters, and itching (fixed drug eruption). Darkening of the skin in affected areas may also occur, which could persist after healing. Fixed drug eruptions typically recur in the same spot or spots if the medicine is taken again.

Infections and infestations

• tissue damage at the injection site.

General disorders and administration site conditions

• injection site reactions, including pain, redness, swelling, formation of a hard lump, ulcers, or bruising at the injection site. These symptoms may progress to blackening and necrosis (tissue death) of the skin and underlying tissues surrounding the injection site, leaving a scar upon healing. This complication is also known as Nicolau syndrome. If these symptoms occur, consult your doctor immediately.

If you use diclofenac for a prolonged period, visit your doctor regularly for check-ups to ensure that no adverse effects are occurring.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolotren

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use Dolotren after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dolotren 75 mg injectable solution

• The active substance is sodium diclofenac. Each 3 ml ampoule contains 75 mg of sodium diclofenac.
• The other components (excipients) are: propylene glycol (E-1520), benzyl alcohol, mannitol (E-421), sodium metabisulfite (E-223), sodium hydroxide and water for injections.

Appearance of the product and contents of the pack

Each pack contains a holder with 6 clear 3 ml ampoules containing a clear, colourless or slightly yellowish aqueous solution free from foreign particles.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Laboratórios Basi Indústria Farmacêutica S.A.

Parque Industrial Manuel Lourenço Ferreira, Lotes 8,15 e 16

3450-232 Mortágua-Portugal

Date of the most recent revision of this leaflet: November 2025

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