DICLOFENAC LLORENS 100 mg SUPPOSITORIES

Introduction

Package Leaflet: Information for the User

Diclofenaco Llorens 100 mg Suppositories EFG

Diclofenac Sodium

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Diclofenaco Llorens and what is it used for
2. What you need to know before taking Diclofenaco Llorens
3. How to take Diclofenaco Llorens
4. Possible side effects
5. Storage of Diclofenaco Llorens
6. Package Contents and Additional Information

1. What is Diclofenaco Llorens and what is it used for

Diclofenac sodium, the active ingredient of this medication, belongs to the group of medications called non-steroidal anti-inflammatory drugs, used to treat pain and inflammation.

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

• rheumatoid arthritis
• ankylosing spondylitis
• osteoarthritis
• renal colic
• acute gout attack
• menstrual pain
• musculoskeletal pain
• post-traumatic inflammation
• soft tissue rheumatism

2. What you need to know before taking Diclofenaco Llorens

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

Do not use Diclofenaco Llorens:

• if you are allergic (hypersensitive) 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 pain relievers. Reactions may include asthma (difficulty breathing), chest pain, 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 gastrointestinal perforation 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 had problems with blood circulation (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have coagulation disorders.
• if you have proctitis (inflammation of the rectum that causes pain, bleeding, and occasionally mucus or pus) or rectal bleeding.

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.

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 Diclofenaco Llorens 100 mg suppositories.

Be especially careful with Diclofenaco Llorens:

• 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 prior warning symptoms.

This risk is higher 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 have any of the following conditions: asthma, mild heart disease, liver or kidney disease, high blood pressure, bleeding disorders, or other blood disorders, including hepatic porphyria.

• if you are taking other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcers and/or gastrointestinal bleeding (see section "Other medications and Diclofenaco Llorens").

• if you are taking medications for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section "Other medications and Diclofenaco Llorens").

• if you have ever had a severe skin rash or peeling after taking diclofenac or other pain relievers.

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 discuss 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 diclofenac may worsen these conditions.

• if you have high blood pressure, high cholesterol, or high triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with this medication, especially if you have been taking it for more than 4 weeks.

• 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). With this information, your doctor can decide whether to interrupt or change the dose of this medication.

• if you have recently undergone or are about to undergo stomach or intestinal surgery before using Diclofenaco Llorens, as Diclofenaco Llorens may sometimes worsen the healing of intestinal wounds after surgery.

Patient with Cardiovascular Problems

Medications like Diclofenaco Llorens may be associated with an increased risk of heart attacks ("myocardial infarction") or strokes, especially when used in high doses and for prolonged treatments. 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 having them (for example, you have high blood pressure, diabetes, high cholesterol, or are a smoker), and your doctor decides to treat you with Diclofenaco Llorens, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks.

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

In general, it is very important to take the lowest effective dose of this medication for the shortest possible time that relieves your pain and/or inflammation to reduce the risk of cardiovascular side effects.

If you experience chest pain, shortness of breath, weakness, or difficulty speaking while taking this medication, contact your doctor immediately.

Children and Adolescents

The use of this medication is not recommended in children and adolescents under 14 years of age.

Elderly Patients

Elderly patients may be more sensitive to the effects of this medication than other adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any side effects that occur.

Other Medications and Diclofenaco Llorens

Tell your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Certain medications may interfere with this medication; 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 antagonists 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 diclofenac (non-steroidal 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 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 Diclofenaco Llorens with Food, Drinks, and Alcohol

Consuming alcoholic beverages along with the use of this medication may increase its toxicity.

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

Do not take Diclofenaco Llorens if you are in 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 that of your baby to bleed and delay or prolong delivery more than expected. Because the administration of medications like Diclofenaco Llorens has been associated with an increased risk of congenital anomalies/abortions, it is not recommended during the first and second trimester of pregnancy unless strictly necessary and as indicated by your doctor. In these cases, the dose and duration will be limited to the minimum possible. From the 20th week of pregnancy, Diclofenaco Llorens may cause kidney problems in your 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 a period longer than a few days, your doctor may recommend additional checks.

Breastfeeding

Small amounts of this medication may appear in breast milk; therefore, you should not use this medication if you are breastfeeding.

Fertility

For patients of childbearing age, it should be noted that medications like diclofenac 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 zero or insignificant. However, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while taking this medication should avoid driving vehicles or operating machinery.

3. How to Use Diclofenaco Llorens

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Remember to use your medication.

Use in Adults

The usual dose is 1 suppository once a day, at bedtime. If higher doses are necessary, 50 mg tablets will be administered.

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

Method 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.

If you use more Diclofenaco Llorens 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 ingested.

If you forget to use Diclofenaco Llorens

Do not use a double dose to make up for forgotten doses. 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 your regular administration schedule. If you forget several doses, consult your doctor.

4. Possible Adverse Effects

Like all medicines, Diclofenaco Llorens can cause adverse effects, although not all people suffer from them. The adverse effects that have been reported with the use of diclofenac are the following:

Some adverse effects can be serious.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

Cardiac Disorders(at high doses during prolonged treatments)

• palpitations
• sudden severe chest pain (symptoms of myocardial infarction or heart attack)
• shortness of breath, difficulty breathing when lying down, swelling of feet and legs (signs of heart failure)

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

Rare Adverse Effects(may affect up to 1 in 1,000 people):

Immune System Disorders

• swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives, and generalized itching, skin rash, fever, abdominal cramps, discomfort or tightness in the chest, difficulty breathing, dizziness, loss of consciousness (severe allergic reaction)

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

Nervous System Disorders

• drowsiness

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). Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.
• rectal pain, bleeding, and occasional mucus or pus

Hepatobiliary Disorders

• liver function disorder
• hepatitis with or without yellowing of the skin and eyes. Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

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 people):

Blood and Lymphatic System Disorders

• signs of lack of blood cells that cause fatigue, headache, shortness of breath when exercising, dizziness, paleness (anemia), frequent infections with fever, chills, sore throat or mouth ulcers (leukopenia), bleeding or bruising more than usual (thrombocytopenia)

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

Immune System Disorders

• swelling of the face

Psychiatric Disorders

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

Nervous System Disorders

• tingling sensation
• memory disorders
• seizures
• anxiety
• tremors
• meningitis (inflammation of the membranes surrounding the brain) with symptoms such as fever, nausea, vomiting, headache, stiff neck or extreme sensitivity to bright light. Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.
• taste disorders
• stroke

Eye Disorders

• blurred vision
• double vision

Ear and Labyrinth Disorders

• ringing in the ears

Vascular Disorders

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

Respiratory, Thoracic, and Mediastinal Disorders

• difficulty breathing, wheezing (pneumonitis)

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

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 abdominal pain, nausea, vomiting, and loss of appetite (signs of pancreatitis). Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

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). Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.
• 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)

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

Adverse Effects with Unknown Frequency(frequency cannot be estimated from available data):

Gastrointestinal Disorders

• Mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with Diclofenaco Llorens, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain.

Cardiac Disorders

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

Skin and Subcutaneous Tissue Disorders

• Severe allergic skin reaction, which may include large, generalized red or dark spots, skin swelling, blisters, and itching (generalized bullous fixed drug eruption).
• Drug-induced skin reaction, which may include round or oval patches of redness and skin swelling, blisters, and itching (fixed drug eruption). It can also cause skin darkening in the affected areas, which may persist after healing. Fixed drug eruption usually recurs in the same or different areas if the medication is taken again.

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

Isolated Cases

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)

Stop using Diclofenaco Llorens and consult your doctor immediately if you notice these symptoms.

Reporting Adverse Effects:

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects that do not appear in this prospectus. 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 Diclofenaco Llorens

Keep this medicine out of sight and reach of children.

Protect from heat.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Diclofenaco Llorens

The active ingredient is diclofenac sodium. Each suppository contains 100 mg of diclofenac sodium.

The other ingredients are lactose monohydrate and semi-synthetic solid glycerides.

Appearance of the Product and Package Contents

Diclofenaco Llorens is presented in the form of white, torpedo-shaped suppositories.

Each box contains 12 suppositories.

Clinical packages contain 100 suppositories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Manufacturer

Laboratorios Llorens, S.L.

C/ Llacuna, 19-21

08005 Barcelona

Spain

Date of the Last Revision of this Prospectus:July 2025

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