Diclofenac Pensa 50 mg gastro-resistant tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Diclofenaco Pensa 50 mg gastro-resistant tablets EFG

diclofenac sodium

Read the entire leaflet carefully before you start taking this medicine.

• 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Diclofenaco Pensa is and what it is used for
2. What you need to know before taking Diclofenaco Pensa
3. How to take Diclofenaco Pensa
4. Possible side effects
5. How to store Diclofenaco Pensa
6. Contents of the pack and other information

1. What Diclofenaco Pensa 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 to treat the following conditions:

• Chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis),
• Extra-articular rheumatism,
  • Acute gout attacks,
  • Menstrual pain,
  • Post-traumatic inflammation.

2. What you need to know before taking Diclofenac Pensa

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 take Diclofenac Pensa

Some people MUST NOT use [product]. Consult your doctor if:

• you are allergic (hypersensitive) to diclofenac or to any of the other components of this medicine (listed in section 6).
• you are allergic, have had allergic reactions, or may be allergic to diclofenac sodium, acetylsalicylic acid (aspirin), ibuprofen, or other similar painkillers (medicines used to treat pain). Reactions may include asthma (difficulty breathing), urticaria (skin rash with itching), acute rhinitis (inflammation of the nasal mucosa), or swelling of the face, chest pain. If you think you may be allergic, consult your doctor.
• you have previously experienced stomach or duodenal bleeding or have had, on two or more occasions, a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug.
• you currently have or have had on more than one occasion a stomach or duodenal ulcer or bleeding.
• you suffer from active Crohn's disease or active ulcerative colitis (conditions causing diarrhea with or without blood and abdominal pain).
• you have severe kidney disease.
• you have severe liver disease.
• you have established heart disease and/or cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), blockages in the blood vessels of the heart or brain, or surgery to remove an obstruction or coronary bypass.
• you have or have had circulatory problems (peripheral arterial disease).
• you are in the third trimester of pregnancy.
• you have blood clotting disorders.

Ensure that 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.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.

Take special care with Diclofenac Pensa

• 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 without prior warning symptoms.

This risk is higher when high doses are used and treatment is prolonged, especially in patients with a history of peptic ulcer or in elderly patients. 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 ulcer and/or gastrointestinal bleeding (see section “Use of other medicines”).

  • if you are taking medicines for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Use of other medicines”).

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 suffer from 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 more than 4 weeks.
• if you have liver insufficiency, kidney insufficiency, or blood disorders, you will need frequent blood tests during treatment. This will allow monitoring of liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This enables your doctor to decide whether to discontinue or adjust the dose of this medicine.
  • • if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Diclofenac Pensa, as Diclofenac Pensa may sometimes impair wound healing in the intestine after surgery.
  • • if you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking diclofenac or other painkillers.

Patients with cardiovascular problems

Medicines like diclofenac may be associated with an increased risk of heart attack ("myocardial infarction") or stroke, 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 (for example, you have high blood pressure, diabetes, high cholesterol or triglycerides, or you smoke) and your doctor decides to treat you with this medicine, you should not take more than 100 mg per day if treatment lasts longer than 4 weeks.

Also, these types of medicines may 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, 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.

Use of other medicines

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

Certain medicines may interfere 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 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 quinolone or ceftriaxone (used to treat infections),
• other medicines in the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen,
• corticosteroids (medicines that reduce inflammation and suppress immune system activity),
• medicines containing voriconazole (a medicine used to treat fungal infections),
• medicines containing phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (used to treat stomach ulcers),
• medicines containing colestyramine and colestipol (used to lower blood cholesterol levels),
• medicines containing pentazocine (used to relieve pain).

Taking Diclofenac Pensa with food and drinks

This medicine should preferably be taken before meals or on an empty stomach, as food delays the onset of its effect.

Consumption of alcoholic beverages together with this medicine may increase its toxicity.

Use in children and adolescents

This medicine is not recommended for use in children and adolescents under 14 years of age.

Use in 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.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Because administration of medicines like diclofenac has been associated with an increased risk of congenital abnormalities/miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. From week 20 of pregnancy, diclofenac 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) or constriction of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring. In such cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration of this medicine is contraindicated. It may cause kidney and heart problems in your fetus. It may affect your tendency and that of your baby to bleed and may delay or prolong labor beyond expectations.

For women of childbearing age, it should be noted that medicines like diclofenac have been associated with reduced fertility.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines

The effect of diclofenac on the ability to drive and use machines is negligible or minor. 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.

This medicine contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Diclofenac Pensa

Follow exactly the administration instructions for this medicine as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

Use in adults and children over 14 years of age

In milder cases, 2 tablets of this medicine per day are usually sufficient. Do not exceed a daily dose of 3 tablets (150 mg of diclofenac). The total daily dose should be divided into 2 or 3 divided doses.

For menstrual pain, the daily dose, which should be individually adjusted, is 50–200 mg (1 to 4 tablets). An initial dose of 50–100 mg (1 to 2 tablets) should be administered, and if necessary, increased in subsequent menstrual cycles. Treatment should begin at the onset of the first symptom and continued for several days, depending on symptom severity.

Method of administration

Take this medicine preferably before meals or on an empty stomach (see section "Taking Diclofenac Pensa with food and drinks").

The tablets must be swallowed whole with a glass of water or another liquid, without splitting or chewing them.

If you take more Diclofenac Pensa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91.562.04.20.

If you forget to take Diclofenac Pensa

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.

Some adverse effects can be serious.

The adverse effects reported with the use of this medicine are as follows:

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 not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: http://www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Diclofenac Pensa

Keep out of sight and reach of children.

No special storage conditions are required.

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

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE Point at your pharmacy (or any other medicine waste collection system). If in doubt, ask your pharmacist how to dispose of containers and unwanted medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diclofenac Pensa

The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac.

The other components are:
Core: sodium carboxymethyl starch (type A) (from potato), lactose monohydrate, povidone, microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E-470b), and corn starch.
Coating: hypromellose, macrogol, titanium dioxide (E-171), talc (E-553b), iron oxide red (E-172), iron oxide yellow (E-172), methacrylic acid L30D, triacetin.

Appearance of the product and contents of the pack

Diclofenac Pensa is available as orange-brown gastro-resistant tablets.

Each pack contains 40 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain

Manufacturer

Laboratorios Alter, S.A.
c/ Mateo Inurria, 30
28036 Madrid (Spain)

Date of the most recent review of this leaflet: July 2025

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