Package Insert: Information for the User

Diclofenaco Normon 50 mg Dispersible Tablets EFG

diclofenac sodium

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, 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 adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

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

2. What you need to know before starting to take Diclofenaco Normon

3. How to take Diclofenaco Normon

4. Possible adverse effects

5. Storage of Diclofenaco Normon

6. Contents of the package and additional information

Diclofenac sodium, the active ingredient of this medication, belongs to a group of medications called nonsteroidal anti-inflammatory drugs, used to treat pain and inflammation. This medication is used as a short-term treatment for acute inflammatory and painful post-traumatic and postoperative conditions.

It is essential to use the smallest effective dose that relieves or controls pain and not to take this medication for longer than necessary to manage your symptoms.

Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before taking Diclofenaco Normon, as Diclofenaco Normon may sometimes 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 components of this medication (listed in section 6).

- if you think you may be allergic to diclofenac sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other components of Diclofenaco Normon (listed at the end of the prospectus). The signs of a hypersensitivity reaction are facial and mouth swelling (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.

- if you have had a previous stomach or duodenal hemorrhage, or have suffered, on two or more occasions, a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.

- if you currently have or have had more than once a stomach or duodenal ulcer

- 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 a severe kidney disease.

- if you have a severe liver disease.

- if you have a established cardiovascular disease and/or a cerebrovascular disease, for example, if you have had a heart attack, stroke, mini-stroke (TIA), or blockages in the heart or brain blood vessels, or a surgery to remove some obstruction or make a 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 bleeding disorders

Make sure before taking diclofenac that your doctor knows:

- if you smoke,

- if you have diabetes,

- if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides.

The adverse effects can be minimized by using the lowest effective dose for the shortest possible period.

Be especially careful with Diclofenaco Normon dispersables if:

- if you have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as intense or persistent abdominal pain and/or black stools or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments in patients with a history of peptic ulcer and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

- if you suffer from any of the following conditions: asthma, mild heart disease, liver disease, kidney disease, high blood pressure (hypertension), bleeding disorders, or other blood disorders including porphyria hepatica.

- if you are taking other anti-inflammatory medications, corticosteroids, anticoagulants, or antidepressants, as it increases the risk of stomach ulcers and/or gastrointestinal bleeding (see "Use of other medications" section)

- if you are taking medications for high blood pressure or cyclosporine, as it increases the risk of kidney damage (see "Use of other medications" section).

Inform 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 inform your doctor about the use of other medications that may increase the risk of these hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitors.

- if you suffer from 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 will reevaluate periodically whether you should continue treatment with this medication, especially if you have been taking it for more than 4 weeks.

- if you have liver insufficiency, kidney insufficiency, or bleeding disorders, you will need to have frequent blood tests during your treatment. This will allow your doctor to control the functioning of your liver (transaminase levels), kidneys (creatinine levels), or blood (lymphocyte, erythrocyte, and platelet levels). Your doctor will then decide whether to interrupt or change the dose of this medication.

Patients with cardiovascular problems

Medications like Diclofenaco Normon may be associated with an increased risk of suffering heart attacks or strokes, especially when used in high doses and prolonged treatments. Do not exceed the recommended dose or treatment duration.

If you have cardiovascular problems, a history of strokes, 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 medication, do 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.

In general, it is very important to take the lowest effective dose of this medication for the shortest possible time to relieve 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 medication, contact your doctor immediately.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Certain medications may interact with this medication; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

- medications containing lithium or selective 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 heart problems (digoxin, calcium channel blockers such as verapamil or isradipine),

- medications used to treat diabetes, except for insulin,

- medications for high 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 (nonsteroidal 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 to treat fungal infections),

- medications containing phenytoin (a medication used to treat seizures),

- medications containing misoprostol (for treating stomach ulcers),

- medications containing cholestyramine and colestipol (to lower cholesterol levels in the blood),

- medications containing pentazocine (to relieve 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.

The consumption of alcoholic beverages with this medication may increase its toxicity.

Use in children and adolescents

This medication is not recommended for use in children and adolescents under 14 years old.

Use in elderly patients

Elderly patients may be more sensitive to the effects of this medication than the rest of adults. Therefore, it is especially important for elderly patients to inform their doctor immediately about any adverse effects.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Due to the association of diclofenac medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where 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 tendency and that of your baby to bleed and delay or prolong delivery more than expected.

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

For fertile women, it should be taken into account that diclofenac medications have been associated with a decrease in the ability to conceive.

Lactation

Consult your doctor or pharmacist before using any medication.

Small amounts of diclofenac may appear in breast milk, so you should not take this medication while breastfeeding.

Driving and operating machinery

The influence of diclofenac on the ability to drive and operate machinery is negligible 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.

Diclofenaco Normon contains sodium

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

Follow exactly the administration instructions for this medication 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 old

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

Administration form

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

Tablets should be dissolved in a glass of water. Place one tablet in a glass of water and stir. Once dissolved, drink the liquid. If there are any remaining particles 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 Toxicological Information Service, phone 91.562.04.20.

If you forgot to take Diclofenaco Normon

Do not take a double dose to compensate for the missed doses.

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects reported with the use of this medicine are as follows:

Reporting of side effects:

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

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

Protect from heat and humidity.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 aroma.

Appearance of the product and content of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid

This leaflet has been reviewed in February 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/