DICLOFENAC NORMON 50 mg DISPERSIBLE TABLETS

Introduction

Package Leaflet: Information for the User

Diclofenaco Normon 50 mg Dispersible Tablets EFG

diclofenac sodium

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

• Keep this leaflet, 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. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Contents of the Package Leaflet

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

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

Diclofenac sodium, the active substance 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 as a short-term treatment for acute inflammatory and painful conditions after trauma or surgery.

2. What you need to know before taking Diclofenaco Normon

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

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

Do not take Diclofenaco Normon

• if you are allergic (hypersensitive) to diclofenac or any of the other ingredients of this medicine (listed in section 6).
• if you think you may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the other ingredients of Diclofenaco Normon (listed at the end of the leaflet). The signs of a hypersensitivity reaction are swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.
• if you have had a stomach or duodenal bleeding or have suffered, on two or more occasions, a perforation of the digestive tract while taking an NSAID.
• if you currently have or have had more than one occasion of stomach or duodenal ulcers or bleeding.
• 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 had surgery to remove a blockage or perform a coronary bypass.
• if you have 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 Diclofenaco Normon dispersible if:

• if you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, even without previous 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 protective 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 "Use of other medications").
• if you are taking medications for blood pressure or cyclosporine, as this increases the risk of kidney damage (see "Use of other medications").

Tell your doctor

• if you take 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 Diclofenaco Normon 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 your 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, your doctor can decide to interrupt or change the dose of this medication.

-if you have ever had a severe skin rash or skin peeling, blisters, or sores in the mouth after taking Diclofenaco Normon or other pain relievers.

Patients with cardiovascular problems

Medications like Diclofenaco Normon 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 medication, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks. Similarly, 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 obtained 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 of the same group as diclofenac (NSAIDs), such as acetylsalicylic acid or ibuprofen.
• corticosteroids (medications that reduce inflammation and the action of the immune system).
• medications containing voriconazole (a medication used to treat 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 Diclofenaco Normon with food and drinks

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

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.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Because the administration of medications like Diclofenaco Normon has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to take this medication during the first and second trimester of pregnancy unless it is strictly necessary and as indicated by your doctor. 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 your fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected.

From the 20th week of pregnancy, Diclofenaco Normon may cause kidney problems in your fetus if taken for more than a few days, which can lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

For women of childbearing age, it should be noted that medications like Diclofenaco Normon 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 negligible. 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.

Diclofenaco Normon contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Diclofenaco Normon

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

Remember to take your medication.

Use in adults and children over 14 years

In milder cases, 2 tablets 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.

Method of administration

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

The tablets should be dissolved in a glass of water. Put a tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any remains in the glass, add more water and repeat the process.

If you take more Diclofenaco Normon 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 Diclofenaco 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 all people suffer from them. 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 Normon

Keep this medicine out of sight and reach of children.

Protect from heat and humidity.

Do not use this medicine after the expiration date that appears on the packaging 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 packaging and medicines that you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Diclofenaco Normon

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

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

Appearance of the Product and Package Contents

Diclofenaco Normon is presented in the form of dispersible tablets for oral administration in packages containing 20 or 40 dispersible tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

This prospectus was revised in 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/

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