Leaflet: information for the user

Dolotren 100 mg suppositories

diclofenac sodium

Read this leaflet carefully before you start taking 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 must 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 leaflet. See section 4

The sodium diclofenac, active ingredient of this medication, belongs to the group of non-steroidal anti-inflammatory drugs, 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
• Musculoskeletal rheumatism
• Acute gout attack
• Musculoskeletal pain
• Post-traumatic inflammation

Menstrual cramps

It is essential to use the smallest effective dose of Dolotren that relieves or controls pain and not to use this medication 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 analgesics (pain medications) similar to diclofenac. 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 stomach or duodenal ulcer bleeding in the past or have experienced two or more instances of gastrointestinal perforation while taking a nonsteroidal anti-inflammatory drug.
• if you currently have or have had more than one instance of stomach or duodenal ulcer or bleeding.
• if you have active Crohn's disease or ulcerative colitis (diseases that cause 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 coronary artery bypass surgery.
• if you have bleeding disorders or are receiving treatment for them.
• if you have peripheral arterial disease (circulation problems).
• if you have proctitis (rectal inflammation causing pain, bleeding, and occasionally mucus or pus) or rectal bleeding.
• if you are in the third trimester of pregnancy.

Make sure your doctor knows before taking diclofenac that:

• you smoke
• you have diabetes
• 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 suppositories:

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

This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease and 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, as it 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 disease, kidney disease, high blood pressure (hypertension), 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 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 NSAID, or to some of the other components of Dolotren. (They are listed at the end of the prospectus). The signs of a hypersensitivity reaction are facial and oral swelling (angioedema), breathing difficulties, chest pain, rhinorrhea, 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 should also inform your doctor about 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 pathologies.
• if you have liver insufficiency, kidney insufficiency, or blood disorders, you will need to undergo 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). This will enable your doctor to decide whether to interrupt or change your Dolotren dose.
• if you have recently undergone or are about to undergo gastrointestinal surgery, 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 suffering heart attacks (myocardial infarction)or strokes, especially when used in high doses and prolonged treatment. 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 of these conditions (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 disease and/or high blood pressure (hypertension).

Other medications and Dolotren suppositories

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 100 mg suppositories; 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, tacrolimus (after transplants)
• medications containing trimetoprim (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 controlling high blood pressure (diuretics, beta-blockers, and ACE inhibitors)
• medications to prevent blood clots
• medications containing quinolone or ceftriaxone (for treating infections)
• corticosteroids (medications that reduce inflammation and immune system activity)
• 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 cholestyramine and colestipol (to lower cholesterol levels in the blood)
• medications containing pentazocine (to relieve pain).

Use of Dolotren 100 mg suppositories with alcohol

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

Older patients

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

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Due to the association of diclofenac administration 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 renal 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 more than a few days, your doctor may recommend additional monitoring.

During the third trimester, the administration of Dolotren is contraindicated as it may harm your fetus or cause problems during delivery. It may cause renal and cardiac 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 100 mg suppositories during lactation.

Fertility

For fertile women, it should be noted 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 suppositories contain sodium (from diclofenac sodium)

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

Follow exactly the administration instructions for Dolotren 100 mg suppositories as indicated by your doctor or pharmacist. In case of 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.

For menstrual cramps, 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, increased in subsequent menstrual cycles.The treatment should start when the first symptom appears. Depending on its intensity, it will be continued for a few days.

Administration form

It must be administered rectally.

If the suppository is too soft to be inserted, chill it in the refrigerator for a few minutes or with cold water before removing the packaging. 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.

Older patients

Older patients may be more sensitive to the effects of Dolotren 100 mg suppositories than the rest of adults. Therefore, it is especially important that older 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 Toxicological Information Service. 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 use Dolotren 100 mg suppositories

If you forget to put in a suppository, put it in as soon as you can, except if it is almost time for the next one, then go back to the usual administration schedule. If you forget several doses, consult your doctor.

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

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.

The side effects reported with the use of Dolotren 100 mg suppositories are as follows:

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

Nervous system disorders

?headache

?dizziness

Vestibular disorders

?vertigo

Gastrointestinal disorders

?nausea

?vomiting

?diarrhea

?heartburn

?abdominal pain

?gas

?loss of appetite

Hepatobiliary disorders

?abnormal liver function test results (elevated serum transaminases)

Skin and subcutaneous tissue disorders

?skin rash

General disorders and administration site conditions

?irritation at the application site

Rare side effects (may affect up to 1 in 1,000 patients)

Immune system disorders

?swelling of the face, eyes, or tongue, difficulty swallowing, shortness of breath, hives, and generalized itching, rash, fever, abdominal cramps, chest discomfort, shortness of breath, dizziness, loss of consciousness (severe allergic reaction).

If these symptoms appear, consult your doctor immediately.

Nervous system disorders

?sleep

Respiratory, thoracic, and mediastinal disorders

?asthma

Gastrointestinal disorders

?stomach pain

?reflux

?diarrhea with blood

?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 occasionally mucus or pus.

Hepatobiliary disorders

?liver function impairment

?hepatitis with or without jaundice.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 side effects (may affect up to 1 in 10,000 patients)

Blood and lymphatic system disorders

?signs of anemia, such as fatigue, headache, shortness of breath, dizziness, paleness (anemia), frequent infections with fever, chills, sore throat, or mouth ulcers (leucopenia), bleeding or bruising more easily than normal (thrombocytopenia).

If these symptoms appear, consult your doctor immediately.

Immune system disorders

?swelling of the face

Mental and behavioral disorders

?disorientation

?depression

?insomnia

?nightmares

?irritability

?psychotic reactions

Nervous system disorders

?tingling sensation

?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 appear, consult your doctor immediately.

?gastrointestinal disorders

?infarction

Eye disorders

?blurred vision

?double vision

Vestibular disorders

?tinnitus

Cardiac disorders

?palpitations

?chest pain

?heart failure

?myocardial infarction

Vascular disorders

?hypertension (high blood pressure)

?vasculitis (inflammation of the blood vessel walls)

Respiratory, thoracic, and mediastinal disorders

?difficulty breathing, wheezing (neumonitis)

If these symptoms appear, consult your doctor immediately.

Gastrointestinal disorders

?worsening of Crohn's disease and ulcerative colitis

?constipation

?swelling of the tongue (glossitis)

?inflammation of the mucous membranes of the mouth (stomatitis)

?difficulty swallowing (esophageal alteration)

?severe abdominal pain, 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 (dermatitis exfoliativa)

?hair loss

?solar allergy (photosensitivity reaction)

?bruising

?itching

Renal and urinary disorders

?kidney function abnormalities that cause swelling in the feet or legs and sudden decrease in urine output (acute renal failure, interstitial nephritis, papillary necrosis)

?blood in urine (hematuria)

?foam in urine (nephrotic syndrome)

If these symptoms appear, consult your doctor immediately.

Unknown frequency

Gastrointestinal disorders

?mild abdominal colic and abdominal pain to palpation that begins shortly after starting treatment with Dolotren 100 mg suppositories, followed by rectal bleeding or diarrhea with blood, 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 abnormalities that cause yellowing of the skin and eyes, fever, upper abdominal pain, and bruising (hepatic insufficiency, fulminant hepatitis, hepatic necrosis)

If these symptoms appear, consult your doctor immediately.

Cardiac disorders

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

If these symptoms appear, inform your doctor immediately.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction 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 adverse reactions, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the 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 disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dolotren 100 mg suppositories

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

Appearance of the product and content of the packaging

Each package contains 12 white suppositories.

Marketing Authorization Holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma Portugal, S.A.

Rua Elias Garcia, 28

2700–327 Amadora

Portugal

Last review date of this leaflet: February 2023

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