Diclofenac Normon 50 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Diclofenac Normon 50 mg dispersible 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 you, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What Diclofenaco Normon 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 for the short-term treatment of acute inflammatory and painful conditions following trauma or surgery.

2. What you need to know before taking Diclofenac Normon

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

Inform your doctor if you have recently undergone or are scheduled to undergo stomach or intestinal surgery before taking Diclofenac Normon, as Diclofenac Normon may sometimes impair wound healing in the intestine after surgery.

Do not take Diclofenac Normon

• if you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of this medicine (listed in section 6).
• if you think you may be allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other components of Diclofenac Normon (listed at the end of this leaflet). Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), difficulty breathing, chest pain, runny nose, skin rash, or any other allergic reaction.
• if you have previously experienced stomach or duodenal bleeding, 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 bleeding
• if you suffer from active Crohn's disease or active ulcerative colitis (conditions causing 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 blood vessels of the heart or brain, or have undergone surgery to remove an obstruction or coronary bypass.
• if you have or have had circulation 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 Normon dispersible tablets if:

• 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, with prolonged treatment, in patients with a history of peptic ulcer, and 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 gastrointestinal ulcer and/or bleeding (see section “Use with other medicines”).
• if you are taking medicines for high blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Use with 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 inhibitors (SSRIs).

• if you have Crohn's disease or ulcerative colitis, as medicines like Diclofenac Normon may worsen these conditions.

• if you have high blood pressure, high 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 impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. These tests will 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 interrupt or adjust the dose of this medicine.

• if you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking Diclofenac Normon or other painkillers.

Patients with cardiovascular problems

Medicines like Diclofenac Normon 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 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 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 with other medicines

Inform your doctor or pharmacist if you are currently using or have recently used 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 to control blood pressure (diuretics, beta-blockers, and ACE inhibitors).
• medicines 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 (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 Normon with food and drinks

This medicine should preferably be taken before meals or on an empty stomach, as food reduces its absorption.

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

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Because the use of medicines like Diclofenac Normon has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary and as directed by your doctor. In such cases, the dose and duration will be limited to the minimum possible.

Administration of this medicine during the third trimester is contraindicated. 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 labor beyond expected duration.

From week 20 of pregnancy, Diclofenac Normon 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). If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

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

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.

Driving and using machines

The effect of diclofenac on the ability to drive and use machines is negligible or none. 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.

Diclofenac Normon contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially “sodium-free”.

3. How to take Diclofenac Normon

Follow exactly the instructions for use of this medicine as given by your doctor. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine.

Use in adults and children over 14 years of age

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

Method of administration

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

The tablets should be dissolved in a glass of water. Place one tablet into a glass of water and stir. Once dissolved, drink the liquid. If any residue remains in the glass, add more water and repeat the process.

If you take more Diclofenac Normon than you should:

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

If you forget to take Diclofenac Normon

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 experiences them. 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 Normon

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

Protect from heat and moisture.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Diclofenac Normon

The active substance is sodium diclofenac. Each tablet contains 50 mg of sodium diclofenac (equivalent to 46.5 mg of diclofenac).

The other components are: crospovidone, sodium saccharin, magnesium stearate (E-470b) and lemon flavouring.

Appearance of the medicine and contents of the pack

Diclofenac Normon is available as dispersible tablets for oral administration, in packs containing 20 or 40 dispersible tablets.

Marketing Authorisation Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

This leaflet was last reviewed in August 2025

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

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/64442/P_64442.html