Diclofenac Alter 50 mg gastro-resistant tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Diclofenac Alter 50 mg gastro-resistant tablets EFG

sodium diclofenac

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; do 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 severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

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

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

Diclofenac sodium, the active substance in this medicine, belongs to a group of medicines known as 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 starting to take Diclofenac Alter

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before receiving/taking/using Diclofenac Alter, as Diclofenac Alter may sometimes impair wound healing in the intestine following surgery.

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

Do not take Diclofenac Alter

• 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 (aspirin) or other similar analgesics (painkillers). 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 gastrointestinal bleeding or perforation of the stomach or duodenum, 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 gastrointestinal bleeding.
• if you currently suffer from active Crohn's disease or active ulcerative colitis (conditions causing diarrhoea 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 blood vessels of the heart or brain, or undergone surgery to remove blockages 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.

Before taking diclofenac, ensure 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.

Take special care with Diclofenac Alter

• 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, 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), haemorrhagic 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 “Taking other medicines”).

  • if you are taking medicines for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Taking 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 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 failure, kidney failure, or blood disorders, you will need frequent blood tests during treatment. These tests 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 ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking Diclofenac Alter or other analgesics.

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 (e.g., 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 treatment lasts longer than 4 weeks.

Also, these medicines may cause fluid retention, particularly 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.

Taking other medicines

Inform your doctor or pharmacist if you are taking or have recently taken 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 one of the treatments.

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 used 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),
• 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 the immune system),
• medicines containing voriconazole (used to treat fungal infections),
• 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).

Taking Diclofenac Alter 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.

Consuming alcoholic beverages 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 younger adults. Therefore, it is especially important that elderly patients inform their doctor immediately of any adverse effects.

Pregnancy, breastfeeding, and fertility

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Because the use of medicines like diclofenac has been associated with an increased risk of congenital malformations or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Do not take Diclofenac Alter during the last three 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 labour more than expected. You should not take Diclofenac Alter during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Diclofenac Alter may cause kidney problems in your fetus if taken for more than a few days, which could 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 treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Administration of this medicine is contraindicated during the third trimester.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of diclofenac may pass into 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 reduced fertility.

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 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 him before taking this medicine.

3. How to take Diclofenac Alter

Follow exactly the instructions for administering this medicine as given 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

For milder conditions, a daily dose of 2 tablets of this medicine is 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 Alter with food and drink”).

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

If you take more Diclofenac Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Diclofenac 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 everyone will experience them.

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

Stop taking Diclofenaco Alter and seek medical attention immediately if you notice any of the following serious adverse effects; you may require urgent medical treatment:

• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.
• Severe skin allergic reaction, which may include widespread red or dark patches, skin swelling, blisters, and itching (generalized fixed bullous drug eruption).

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

Adverse effects with unknown frequency (cannot be estimated from the available data).

• Mild abdominal cramps and abdominal tenderness beginning shortly after starting treatment with Diclofenaco Alter, followed by rectal bleeding or diarrhoea with blood, usually observed within 24 hours after the onset of abdominal pain.
• Skin allergic reaction, which may include round or oval-shaped red, swollen skin patches, blisters, and itching (fixed drug eruption). Skin darkening in affected areas may also occur, which could persist after healing. Fixed drug eruptions typically reappear in the same location(s) if the medicine is taken again.

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 Alter

Keep out of sight and reach of children.

No special storage conditions are required. Store in the original container.

Do not use this medicine after the expiry date stated on the container 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 containers and medicines at a SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diclofenac Alter

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), monohydrate lactose, povidone 30, microcrystalline cellulose (E-460), anhydrous colloidal silica, magnesium stearate (E-470b) and maize starch.
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 contents of the pack

Diclofenac Alter is presented as gastro-resistant tablets, biconvex in shape and orange-brown in colour.

Each pack contains 40 tablets.

Marketing Authorisation Holder and Manufacturer

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

Date of the most recent revision of this leaflet: August 2025

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