DICLOFENAC PENSA 50 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the Patient

Diclofenac Pensa 50 mg Gastro-Resistant Tablets EFG

diclofenac sodium

Read the entire package leaflet carefully before starting to take this medication.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Contents of the Package Leaflet:

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

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

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

This medication 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 the pain and do not take this medication for longer than necessary to control your symptoms.

Do not take Diclofenac Pensa

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

• if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medication (listed in section 6).
• if you are allergic, have had allergic reactions or may be allergic to diclofenac sodium, acetylsalicylic acid (aspirin), ibuprofen, or other similar pain relievers. Reactions may include asthma (difficulty breathing), hives (allergic reaction on the skin 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.
• if you have had a stomach or duodenal hemorrhage or have suffered, on two or more occasions, a perforation of the digestive tract while taking a non-steroidal anti-inflammatory medication.
• if you currently have or have had, on more than one occasion, a stomach or duodenal ulcer or hemorrhage.
• if you suffer from 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 undergone 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 blood coagulation disorders

Make sure 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

Side effects can be minimized by using the lowest effective dose for the shortest possible time.

Be careful with Diclofenac Pensa

• if you have had or developed an ulcer, hemorrhage, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, even without prior warning symptoms.

This risk is higher when high doses and prolonged treatments are used 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 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 medications, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcers and/or gastrointestinal bleeding (see section "Use of other medications").
  • if you are taking medications for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section "Use of other medications").

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 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 going to undergo stomach or intestinal surgery before taking Diclofenac Pensa, as Diclofenac Pensa may sometimes worsen the healing of intestinal wounds after surgery
  • - if you have ever had a severe skin rash or skin peeling, blisters, or sores in the mouth after taking diclofenac or other pain relievers.

Patients with cardiovascular problems

Medications like diclofenac 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 triglycerides, or are a smoker) and your doctor decides to treat you with this medication, 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 (hypertension).

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.

Use of other medications

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 important 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)
• other medications in the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen
• corticosteroids (medications that reduce inflammation and the action of the immune system)
• 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 blood cholesterol levels)
• medications containing pentazocine (for relieving pain)

Taking Diclofenac Pensa with food and drinks

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

Consuming alcoholic beverages with this medication may increase its toxicity.

Use in children and adolescents

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

Use in 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 inform their doctor immediately of any side effects that occur.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Because the administration of medications like diclofenac has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. From the 20th week of pregnancy, diclofenac may cause kidney problems in the fetus if taken for more than a few days, which can 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 you need treatment for more than a few days, your doctor may recommend additional checks. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of this medication is contraindicated. It may cause kidney and heart problems in the fetus. It may affect you and your baby's tendency to bleed and delay or prolong labor more than expected.

For women of childbearing age, it should be noted that medications like diclofenac have been associated with a decrease in fertility.

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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, drowsiness, or other central nervous system disorders while taking this medication should avoid driving vehicles or operating machinery.

This medication contains lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Diclofenac Pensa

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

Remember to take your medication.

Use in adults and children over 14 years

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

In 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) will be administered, and if necessary, it will be increased in subsequent menstrual cycles. Treatment should be started when the first symptoms appear. Depending on the intensity, it will be continued for a few days.

Method of administration

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

The tablets should be swallowed whole with a glass of water or other liquid, without dividing or chewing them.

If you take more Diclofenac Pensa than you should

In case of overdose or accidental ingestion, consult 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 forgotten doses.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Some adverse effects can be serious.

The adverse effects that have been reported with the use of this medicine are the following:

Reporting of Adverse Effects:

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

5. Storage of Diclofenaco Pensa

Keep out of sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy (or any other system for collecting medicinal waste). 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 Pensa

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

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

Appearance of the Product and Package Contents

Diclofenaco Pensa is presented in the form of orange-brown gastro-resistant tablets.

Each package 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 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/