DOLOTREN 100 mg SUPPOSITORIES

2. What you need to know before starting to use Dolotren 100 mg suppositories

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

Do not use Dolotren 100 mg suppositories

• 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 similar painkillers. Reactions may include asthma (difficulty breathing), hives (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 bleeding or have suffered from two or more occasions of perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
• If you currently have or have had more than one occasion of stomach or duodenal ulcers or bleeding.
• 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 heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the blood vessels of the heart or brain, or have had surgery to remove a blockage or perform a coronary bypass.
• If you have coagulation disorders or are receiving treatment for them.
• If you have had problems with blood circulation (peripheral arterial disease).
• If you have proctitis (inflammation of the rectum that causes pain, bleeding, and occasionally mucus or pus) or rectal bleeding (bleeding from the rectum).
• If you are in the third trimester of pregnancy.

Make sure your doctor knows before taking diclofenac:

• If you smoke
• If you have diabetes
• If you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Dolotren suppositories:

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.

• If you are taking other anti-inflammatory medications, including acetylsalicylic acid/aspirin, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcers and/or gastrointestinal bleeding (see the section "Other medications and Dolotren suppositories").
• If you have 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 medications for blood pressure or cyclosporine, as this increases the risk of kidney damage (see the section "Other medications and Dolotren suppositories").
• 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 non-steroidal anti-inflammatory drug, or to any of the other components of Dolotren (listed at the end of the leaflet). The signs of a hypersensitivity reaction are facial swelling and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.
• If you have ever had a severe skin rash or desquamation, blisters, or ulcers in the mouth after using Dolotren or other painkillers.

Tell 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 such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medications like Dolotren may worsen these conditions.
• If you have liver or kidney failure, or blood disorders, you will need to have frequent blood tests during treatment. This will allow your doctor to monitor the functioning of your liver (transaminase levels) or kidneys (creatinine levels) or blood (lymphocyte, erythrocyte, and platelet levels). Your doctor may decide to interrupt or change the dose of Dolotren.
• If you have recently undergone or are going 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 an increased risk of heart attacks (myocardial infarction)or strokes, especially when used in high doses and for prolonged periods. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of strokes, or think you may be at risk of suffering from these conditions (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment.

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

Other medications and Dolotren suppositories

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

Certain medications may interact with Dolotren 100 mg suppositories; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medications:

• medications containing lithium or serotonin reuptake inhibitors (for treating certain types of depression)
• medications containing methotrexate (for treating rheumatoid arthritis and cancer)
• medications containing cyclosporine, tacrolimus (after transplants)
• medications containing trimethoprim (for preventing and treating urinary tract diseases)
• medications for treating heart problems (digoxin, calcium channel blockers such as verapamil or isradipine)
• medications used to treat diabetes, except insulin
• medications for controlling 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 (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen
• medications containing voriconazole (a medication used to treat fungal infections)
• medications containing phenytoin (a medication used to treat epileptic seizures)
• medications containing misoprostol (for treating stomach ulcers)
• medications containing cholestyramine and colestipol (for reducing cholesterol levels in the blood)
• medications containing pentazocine (for relieving pain).

Using Dolotren 100 mg suppositories with alcohol

Using Dolotren with alcohol consumption may increase the toxicity of Dolotren.

Elderly patients

Elderly patients may be more sensitive to the effects of Dolotren 100 mg suppositories than other adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse reactions that occur.

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

Because the administration of medications like Dolotren has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters of pregnancy unless 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 the 20th week of pregnancy, Dolotren may cause kidney problems in the fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

In 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 the fetus. It may affect you and your baby's tendency to bleed and delay or prolong labor more than expected.

Breastfeeding

Small amounts of diclofenac sodium may appear in breast milk; therefore, you should not use Dolotren 100 mg suppositories during breastfeeding.

Fertility

For patients of childbearing age, it should be noted that medications like Dolotren have been associated with a decrease in fertility.

Driving and using machines

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

Dolotren suppositories contain sodium (from diclofenac sodium)

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

3. How to use Dolotren 100 mg suppositories

Follow the administration instructions of Dolotren 100 mg suppositories indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults

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

In menstrual pain, the daily dose, which should be adjusted individually, is 50-200 mg (1 or 2 Dolotren suppositories). An initial dose of 50-100 mg (1 Dolotren suppository) will be administered, and if necessary, it will be increased in subsequent menstrual cycles. Treatment should be started when the first symptom appears. Depending on the intensity, it will be continued for a few days.

Form of administration

It should be administered rectally.

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

Use in children and adolescents

The use of Dolotren 100 mg suppositories is not recommended in children and adolescents.

Elderly patients

Elderly patients may be more sensitive to the effects of Dolotren 100 mg suppositories than other adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse reactions that occur.

If you use more Dolotren 100 mg suppositories than you should

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

If you forget to use Dolotren 100 mg suppositories

If you forget to insert a suppository, do so 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.

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious.

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

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

The adverse effects that have been reported with the use of Dolotren 100 mg suppositories are the following:

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

? diarrhea

? acidity

? abdominal pain

? gas

? loss of appetite

Hepatobiliary Disorders

? alterations in blood test results for liver function (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, and itching, skin rash, fever, abdominal cramps, discomfort or oppression in the chest, difficulty breathing, dizziness, loss of consciousness (severe allergic reaction).

If these symptoms appear, consult your doctor immediately.

Nervous System Disorders

? sleepiness

Respiratory, Thoracic, and Mediastinal Disorders

? asthma

Gastrointestinal Disorders

? stomach pain

? reflux

? bloody diarrhea

? gastric or intestinal ulcer with or without bleeding or perforation (vomiting blood and appearance of blood in stools). If these symptoms appear, consult your doctor immediately.

? rectal pain, bleeding, and occasional mucus or pus.

Hepatobiliary Disorders

? alteration of liver function

? hepatitis with or without yellowing of the skin and eyes. If these symptoms appear, 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 lack of blood cells that produce fatigue, headache, shortness of breath when exercising, dizziness, paleness (anemia), frequent infections with fever, chills, sore throat or mouth ulcers (leukopenia), bleeding or more bruising than usual (thrombocytopenia).

If these symptoms appear, consult your doctor immediately.

Immune System Disorders

? swelling of the face

Psychiatric Disorders

? disorientation

? depression

? insomnia

? nightmares

? irritability

? psychotic reactions

Nervous System Disorders

? tingling sensation

? memory disorders

? convulsions

? anxiety

? tremors

? 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 appear, consult your doctor immediately.

? taste disorders

? cerebral infarction

Eye Disorders

? blurred vision

? double vision

Ear and Labyrinth Disorders

? tinnitus

Cardiac Disorders

? palpitations

? chest pain

? heart failure

? myocardial infarction (heart attack)

Vascular Disorders

? hypertension (high blood pressure)

? vasculitis (inflammation of blood vessel walls)

Respiratory, Thoracic, and Mediastinal Disorders

? difficulty breathing, wheezing (pneumonitis)

If these symptoms appear, consult your doctor immediately.

Gastrointestinal Disorders

? worsening of Crohn's disease and ulcerative colitis

? constipation

? tongue swelling (glossitis)

? inflammation of the mouth mucosa (stomatitis)

? difficulty swallowing (esophageal disorder)

? severe pain in the upper abdomen, nausea, vomiting, and loss of appetite (signs of pancreatitis).

If these symptoms appear, 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 appear, 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 disorders that cause swelling in feet or legs and sudden decrease in urine output (acute renal failure, interstitial nephritis, renal papillary necrosis)

? blood in urine (hematuria)

? foam in urine (nephrotic syndrome)

If these symptoms appear, consult your doctor immediately.

Frequency Not Known (cannot be estimated from available data)

Gastrointestinal Disorders

? mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with Dolotren 100 mg suppositories, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain. If these symptoms appear, stop using Dolotren 100 mg suppositories and consult your doctor immediately.

Hepatobiliary Disorders

? liver function disorders that cause yellowing of the skin and eyes, fever, with pain in the upper abdomen and bruising (liver failure, fulminant hepatitis, liver necrosis)

If these symptoms appear, consult your doctor immediately.

Cardiac Disorders

? chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

If these symptoms appear, inform your doctor immediately.

Skin and Subcutaneous Tissue Disorders

? Allergic skin reaction, which can include round or oval patches of redness and skin swelling, blisters, and itching (fixed medicamentous eruption). It can also cause darkening of the skin in the affected areas, which may persist after healing. The fixed medicamentous eruption usually reappears in the same or the same sites if the medicine is taken again.

Reporting Adverse Effects

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

5. Storage of Dolotren 100 mg Suppositories

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use Dolotren 100 mg suppositories after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Dolotren 100 mg Suppositories

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

Product Appearance and Package Contents

Each package contains 12 white suppositories.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700 – 327 Amadora

Portugal

Date of the Last Revision of this Leaflet: July 2025

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