Package Leaflet: Information for the User

Diclofenaco Llorens 100 mg Suppositories EFG

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do 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.

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

2. What you need to know before using Diclofenaco Llorens

3. How to use Diclofenaco Llorens

4. Possible side effects

5. Storage of Diclofenaco Llorens

6. Contents of the pack and additional information

Diclofenaco sodium, the active ingredient of this medication, belongs to a group of medications called nonsteroidal 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
• M menstrual cramps
• Musculoskeletal pain
• Post-traumatic inflammation
• Soft tissue rheumatism

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to control your symptoms.

Do not use Diclofenaco Llorens:

• if you are allergic (hypersensitive) to diclofenac or to 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-relieving medications) similar to diclofenac. Allergic reactions may include asthma (difficulty breathing), chest pain, urticaria (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 previous stomach or duodenal hemorrhage or have suffered two or more instances of a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• if you currently have or have had more than one instance of a stomach or duodenal ulcer.
• 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 cardiovascular disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the heart or brain blood vessels, or a surgery to remove an obstruction or perform a coronary bypass.
• if you have peripheral arterial disease (problems with blood circulation).
• if you are in the third trimester of pregnancy.
• if you have bleeding disorders.
• if you have proctitis (inflammation of the rectum that causes pain, bleeding, and occasionally mucus or pus) or rectal bleeding (bleeding through the rectum).

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.

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 Diclofenaco Llorens 100 mg suppositories.

Be especially careful with Diclofenaco Llorens:

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

This risk is higher when using high doses and prolonged treatment in patients with a history of peptic ulcer disease 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 disease, kidney disease, high blood pressure (hypertension), bleeding disorders, or other blood disorders, including porphyria hepatica.

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

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

Inform your doctor:

• if you are taking medications that alter 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 medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

• if you have Crohn's disease or ulcerative colitis, as medications like diclofenac can worsen these conditions.

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

• if you have liver, kidney, or blood disorders, you will need to have blood tests regularly during treatment. This will allow your doctor to monitor your liver function (transaminase levels), kidney function (creatinine levels), or blood counts (lymphocyte, erythrocyte, and platelet levels). Your doctor will then decide whether to interrupt or change your medication dosage.

• 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.

Patients with cardiovascular problems

Medications like Diclofenaco Llorens may be associated with an increased risk of heart attacks or strokes, especially when used in high doses and for prolonged periods. 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 (for example, you have high blood pressure, diabetes, high cholesterol, or triglycerides, or smoke) and your doctor decides to treat you with Diclofenaco Llorens, do 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.

It is generally very important to take the lowest effective dose of this medication for the shortest possible time to alleviate pain and/or inflammation to reduce the risk of cardiovascular adverse effects.

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

Children and adolescents

This medication is not recommended for children and adolescents under 14 years old.

Older adults

Older adults may be more sensitive to the effects of this medication than the rest of adults. Therefore, it is especially important for older adults to inform their doctor immediately of any adverse effects they experience.

Other medications and Diclofenaco Llorens

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

Certain medications may interact with this medication; in these cases, you may need 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 (SSRIs) for treating 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 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 for preventing 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 diclofenac (nonsteroidal 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 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 Diclofenaco Llorens with food, drinks, and alcohol

The consumption of alcoholic beverages with the use of this medication may increase its toxicity.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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. Due to the association of diclofenac-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer them during the first and second trimesters of pregnancy, except when strictly necessary and as indicated by your doctor. In these cases, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, Diclofenaco Llorens may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Breastfeeding

Small amounts of this medication may appear in breast milk, so you should not use this medication while breastfeeding.

Fertility

For fertile women, it is essential to consider that medications like diclofenac 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, vertigo, somnolence, or other central nervous system disorders while taking this medication should avoid driving vehicles or operating machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of 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 cramps, the daily dose, which should be adjusted individually, 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 begin when the first symptom appears. Depending on its intensity, it will be continued for a few days.

Administration form

It should 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.

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 Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to use Diclofenaco Llorens

Do not use a double dose to compensate for the missed doses. If you forget to apply a suppository, apply it as soon as possible, 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.

Like all medicines, Diclofenaco Llorens may cause side effects, although not everyone will experience them. The side effects reported with the use of diclofenac are as follows:

Some side effects can be serious.

Reporting of side effects:

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

Keep this medication out of the sight and reach of children.

Protect from heat.

Do not use this medication after the expiration date that appears on the packagingafter CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Diclofenaco Llorens

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

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

Appearance of the product and contents of the packaging

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

Each box contains 12 suppositories.

Clinical packs contain 100 suppositories.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Llorens, S.L.

Ciudad de Balaguer, 7-11

08022 Barcelona

Spain

Responsible for manufacturing

Laboratorios Llorens, S.L.

C/ Llacuna, 19-21

08005 Barcelona

Spain

Last review date of this leaflet:November 2022.

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