Dolotren 100 mg suppositories

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Dolotren 100 mg suppositories

sodium diclofenac

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could 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

Diclofenac sodium, the active substance in this medicine, belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation.

It is used for the symptomatic treatment of mild to moderate pain associated with:

• rheumatoid arthritis
• ankylosing spondylitis
• osteoarthritis
• renal colic
• soft tissue rheumatism
• acute gout attack
• musculoskeletal pain
• post-traumatic inflammation
• menstrual 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 to other similar analgesics (painkillers). Reactions may include asthma (difficulty breathing), urticaria (skin rash with itching), acute rhinitis (inflammation of the nasal mucosa), or swelling of the face. If you think you may be allergic, consult your doctor.

• if you have previously experienced a stomach or duodenal bleed or have had two or more episodes of gastrointestinal perforation while taking a non-steroidal anti-inflammatory drug (NSAID).

• if you currently have or have had recurrent stomach or duodenal ulcer or bleeding.

• if you currently suffer from 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 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 circulatory problems (peripheral arterial disease).

• if you suffer from proctitis (inflammation of the rectum causing pain, bleeding, and occasionally mucus or pus) or rectal bleeding.

• 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 the elderly. In such cases, your doctor may consider prescribing a stomach-protective medicine.

• if you are taking other anti-inflammatory medicines, including acetylsalicylic acid/aspirin, 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 high 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 components of Dolotren (listed at the end of this 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 using Dolotren or other analgesics.

Tell your doctor

• if you are 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 liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This allows your doctor to decide whether to stop or adjust your Dolotren dose.
• 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 an increased risk of heart attacks (myocardial infarction) or strokes, 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 of these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), discuss this treatment with your doctor or pharmacist.

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

Use in children and adolescents

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

Elderly patients

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

Other medicines and Dolotren

Inform 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 stop treatment with one of the medicines.

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, 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 to control 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 (an antifungal medicine)
• medicines containing phenytoin (used to treat epileptic seizures)
• medicines containing misoprostol (used to treat stomach ulcers)
• medicines containing cholestyramine and colestipol (used to lower blood cholesterol levels)
• medicines containing pentazocine (used to relieve pain).

Use of Dolotren with alcohol

Using Dolotren 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 unborn baby. 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 unborn baby 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 is needed for longer than a few days, 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 operate machinery is negligible or none. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders while taking Dolotren should avoid driving or operating machinery.

Dolotren 100 mg suppositories contain sodium (from sodium diclofenac)

This medicine contains less than 23 mg of sodium (1 mmol) per suppository (from sodium diclofenac); this is essentially “sodium-free”.

3. How to use Dolotren

Follow exactly the administration instructions for Dolotren provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults

The recommended dose is 1 suppository daily, preferably at bedtime. If higher doses are required, 50 mg tablets will be administered.

In menstrual pain, the daily dose—individually adjusted—ranges from 50–200 mg (1 or 2 suppositories of Dolotren). An initial dose of 50–100 mg (1 suppository of Dolotren) should be administered, and if necessary, increased in subsequent menstrual cycles. Treatment should begin when the first symptom appears. Depending on its intensity, treatment will continue for several days.

Method of administration

Must be administered rectally.

If the suppository is too soft to insert, cool it in the refrigerator for a few minutes or under cold water before removing the wrapper. Do not divide the suppositories, as improper storage conditions may cause uneven distribution of the active substance. Never ingest the suppositories.

If you use more Dolotren than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, indicating the medication and amount taken. It is recommended to bring the medication packaging and leaflet to the healthcare professional.

If you forget to use Dolotren

If you forget to insert a suppository, do so as soon as possible, unless it is almost time for the next dose; then continue with your regular dosing schedule. If you miss several doses, consult your doctor.

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

If you have any further 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).

The adverse effects reported with the use of Dolotren are as follows:

Frequent adverse effects (may affect up to 1 in 10 patients)

Nervous system disorders

? headache
? dizziness

Ear and labyrinth disorders

? vertigo

Gastrointestinal disorders

? nausea
? vomiting
? diarrhoea
? heartburn
? abdominal pain
? flatulence
? loss of appetite

Hepatobiliary disorders

? changes in blood test results indicating liver function abnormalities (elevated serum transaminases)

Skin and subcutaneous tissue disorders

? skin rash

General disorders and administration site conditions

? irritation at the application site

Rare adverse effects (may affect up to 1 in 1,000 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

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 blood in stools). If these symptoms occur, consult your doctor immediately.
? rectal pain, bleeding, and occasionally mucus or pus.

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

General disorders and administration site conditions

? fluid retention, with swelling (edema)

Very rare adverse effects (may affect up to 1 in 10,000 patients)

Blood and lymphatic system disorders

? signs of low blood cells causing 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 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
? memory disorders
? seizures
? anxiety
? tremor
? meningitis (inflammation of the membranes covering 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 mouth mucosa (stomatitis)
? difficulty swallowing (oesophageal disorder)
? severe upper abdominal pain, 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 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.
? generalized rash (eczema)
? redness (erythema and erythema multiforme)
? skin peeling (exfoliative dermatitis)
? hair loss
? 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.

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

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, stop using this medicine and 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.

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.

Skin and subcutaneous tissue disorders

? allergic skin reaction, which may include round or oval-shaped red and swollen skin 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 usually reappear in the same location(s) if the medicine is taken again.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 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 containers and medicines at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of Dolotren 100 mg suppositories

• The active substance is sodium diclofenac. Each suppository contains 100 mg of sodium diclofenac.
• The other components (excipients) are: saturated fatty acid triglycerides.

Appearance of the medicinal product and contents of the pack

Each pack contains 12 white suppositories.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer responsible for manufacturing

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700 – 327 Amadora

Portugal

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

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/