Diclofenac Llorens 100 mg suppositories EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diclofenaco Llorens 100 mg suppositories EFG

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, 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Diclofenac sodium, the active substance in this medicine, 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 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 using Diclofenac Llorens

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

Do not use Diclofenac Llorens:

• if you are allergic (hypersensitive) to diclofenac or to any of the other components 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), chest pain, 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 experienced stomach or duodenal bleeding 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 more than once a 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), or blockages in the blood vessels of the heart or brain, or undergone surgery to remove an obstruction or coronary bypass.
• if you have or have had circulatory problems (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have blood clotting disorders.
• if you suffer from proctitis (inflammation of the rectum causing pain, bleeding, and occasionally mucus or pus) or rectal bleeding.

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

Consult your doctor or pharmacist before starting to use Diclofenac Llorens 100 mg suppositories.

Take special care with Diclofenac Llorens:

• 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 occur without prior warning symptoms.

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

• 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 other anti-inflammatory medicines, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of gastrointestinal ulcer and/or bleeding (see section “Other medicines and Diclofenac Llorens”).

• if you are taking medicines for high blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Other medicines and Diclofenac Llorens”).

• if you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking diclofenac 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 diclofenac may worsen these conditions.

• if you have high blood pressure, elevated cholesterol or triglyceride levels, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with this medicine, especially if treatment lasts longer than 4 weeks.

• if you have liver impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. These tests 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 dose.

• if you have recently undergone or are about to undergo stomach or intestinal surgery before using Diclofenac Llorens, as Diclofenac Llorens may sometimes impair wound healing in the intestine after surgery.

Patients with cardiovascular problems

Medicines like Diclofenac Llorens 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 (e.g., high blood pressure, diabetes, high cholesterol or triglycerides, or are a smoker) and your doctor decides to treat you with Diclofenac Llorens, you should not take more than 100 mg per day if treatment lasts longer than 4 weeks.

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

In general, it is very important to take the lowest effective dose of this medicine for the shortest possible time needed to relieve your pain and/or inflammation, in order to reduce the risk of cardiovascular adverse effects.

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

Children and adolescents

Use of this medicine 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 medicine than other adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse effects they experience.

Other medicines and Diclofenac Llorens

Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including those obtained without a prescription.

Certain medicines may interact with this medicine; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of them.

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 quinolones or ceftriaxone (used to treat infections)
• corticosteroids (medicines that reduce inflammation and suppress the immune system)
• other medicines in the same group as diclofenac (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 Diclofenac Llorens with food, drinks, and alcohol

Consuming alcoholic beverages while using this medicine may increase its toxicity.

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 Diclofenac 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 your baby's tendency to bleed and may delay or prolong labor more than expected. Because administration of medicines like Diclofenac Llorens has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary and as directed by your doctor. In such cases, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, Diclofenac Llorens 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). If you require treatment for longer than a few days, your doctor may recommend additional monitoring.

Breastfeeding

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

Fertility

For women of childbearing age, it should be noted that medicines like diclofenac 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 none. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders while taking this medicine should avoid driving vehicles or operating machinery.

3. How to use Diclofenac Llorens

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

Remember to use your medicine.

Use in adults

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

For 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) should be given and, if necessary, increased in subsequent menstrual cycles. Treatment should begin when the first symptom appears. Depending on the severity, treatment will continue for a few days.

Method of administration

This medicine 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 swallow the suppositories.

If you use more Diclofenac Llorens than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91.562.04.20, stating the medicine and the amount ingested.

If you forget to use Diclofenac Llorens

Do not use a double dose to make up for missed doses. If you forget to insert a suppository, insert it as soon as possible, unless it is almost time for the next dose; then return to your regular dosing schedule. If you miss several doses, consult your doctor.

4. Possible adverse effects

Like all medicines, Diclofenaco Llorens may produce adverse effects, although not everyone experiences them. The adverse effects reported with the use of diclofenac are listed below:

Some adverse effects may be serious.

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 can also report them directly through 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 Diclofenac Llorens

Keep this medicine out of sight and reach of children.

Protect from heat.

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

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

6. Contents of the pack and other information

Composition of Diclofenac Llorens

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

The other components are monohydrate lactose and solid semisynthetic glycerides.

Appearance of the product and contents of the pack

Diclofenac Llorens is presented as white, torpedo-shaped suppositories.

Each box contains 12 suppositories.

Clinical packs 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 most recent review of this summary: July 2025

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