DICLOFENAC ALTER 50 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

Diclofenaco Alter 50 mg Gastro-Resistant Tablets EFG

diclofenac sodium

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the Package Leaflet:

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

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

Diclofenac sodium, the active ingredient of this medicine, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), 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 attacks of gout,
  • Menstrual pain,
  • Post-traumatic inflammation.

2. What you need to know before you take Diclofenaco Alter

Tell your doctor if you have recently undergone or are going to undergo stomach or intestinal surgery before taking Diclofenaco Alter, as Diclofenaco Alter may worsen the healing of intestinal wounds after surgery.

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

Do not take Diclofenaco Alter

• if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other similar painkillers. Reactions may include asthma (difficulty breathing), chest pain, hives (allergic 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 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 drug.
• if you currently have or have had, on more than one occasion, a stomach or duodenal ulcer or hemorrhage.
• if you have active Crohn's disease or ulcerative colitis (diseases that cause 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:

• 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 Diclofenaco Alter

• 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 have 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 "Taking other medicines").
  • if you are taking medications for blood pressure or cyclosporine, as this increases the risk of kidney damage (see "Taking other medicines").

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 medicine, 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), and decide whether to interrupt or change the dose of this medicine.
• if you have ever had a severe skin rash or peeling of the skin, blisters, or sores in the mouth after taking Diclofenaco Alter or other painkillers.

Patients with cardiovascular problems

Medicines 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 duration of treatment.

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 medicine, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Additionally, this type of medicine 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 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 medicine, contact your doctor immediately.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Certain medicines may interfere with this medicine; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important to inform your doctor if you are taking or have recently taken any of the following medicines:

• medicines containing lithium or serotonin reuptake inhibitors (for treating certain types of depression),
• medicines containing methotrexate (for treating rheumatoid arthritis and cancer)
• medicines containing cyclosporine, tacrolimus (after transplants)
• medicines containing trimethoprim (to prevent and treat urinary tract diseases)
• medicines for heart problems (digoxin, calcium antagonists such as verapamil or isradipine)
• medicines used to treat diabetes, except insulin
• medicines to control blood pressure (diuretics, beta blockers, and ACE inhibitors)
• medicines to prevent blood clots
• medicines containing quinolone or ceftriaxone (to treat infections)
• other medicines of the same group as diclofenac (non-steroidal anti-inflammatory drugs), such as acetylsalicylic acid or ibuprofen
• corticosteroids (medicines that reduce inflammation and the action of the immune system)
• medicines containing voriconazole (a medicine used to treat fungal infections)
• medicines containing phenytoin (a medicine used to treat epileptic seizures)
• medicines containing misoprostol (to treat stomach ulcers)
• medicines containing cholestyramine and colestipol to reduce blood cholesterol levels)
• medicines containing pentazocine (to relieve pain)

Taking Diclofenaco Alter with food and drinks

This medicine should be taken preferably before meals or on an empty stomach (see "Taking Diclofenaco Alter with food and drinks").

The ingestion of alcoholic beverages with this medicine may increase its toxicity.

Use in children and adolescents

The use of this medicine 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 medicine than other adults. Therefore, it is especially important that elderly patients inform their doctor immediately of any side effects that occur.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Because the administration of medicines like diclofenac 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. In these cases, the dose and duration will be limited to the minimum possible.

Do not take Diclofenaco Alter 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. You should not take Diclofenaco Alter during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From the 20th week of pregnancy, Diclofenaco Alter 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 narrowing 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 the third trimester, the administration of this medicine is contraindicated.

Breastfeeding

Consult your doctor or pharmacist before taking any medicine.

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

Fertility

For women of childbearing age, it should be noted that medicines 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 negligible or minimal. 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 told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Diclofenaco Alter

Follow the instructions for administration of this medicine exactly 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

In milder cases, 2 tablets of this medicine 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 fractional doses.

In menstrual pain, the daily dose, which should be adjusted individually, 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 medicine preferably before meals or on an empty stomach (see "Taking Diclofenaco Alter 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 Diclofenaco Alter 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, indicating the medicine and the amount ingested.

If you forget to take Diclofenaco Alter

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.

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

Stop taking Diclofenaco Alter and go to a doctor immediately if you notice any of the following serious adverse effects; you may need urgent medical treatment:

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Severe skin allergic reaction, which can include large, generalized red or dark spots, skin swelling, blisters, and itching (generalized fixed drug eruption).

Stop taking Diclofenaco Alter and consult your doctor immediately if you notice:

Adverse effectswith unknown frequency, (cannot be determined from available data).

• Mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with Diclofenaco Alter, followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain.
• Allergic skin reaction, which can 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. The fixed drug eruption usually reappears in the same or same areas if the medicine is taken again.

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 Alter

Keep out of sight and reach of children.

It does not require special storage conditions. Store in the original package.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packages and medicines you no longer need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Diclofenaco Alter

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

The other components are: Core: sodium carboxymethyl starch (type A) (potato), lactose monohydrate, povidone 30, 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 Alter is presented in the form of gastro-resistant tablets, lenticular in shape and brown-orange in color.

Each package contains 40 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

(Spain)

Date of the last revision of this prospectus:August 2025

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