Product Information for the Patient

Diclofenaco Normon 50 mg Gastrorresistant Tablets EFG

diclofenac sodium

Read this entire product information carefully before starting to take the medication.

• Keep this product information, 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 any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this product information, inform your doctor or pharmacist.

1. What isDiclofenaco Normonand for what it is used

2. What you need to know before starting to takeDiclofenaco Normon

3. How to takeDiclofenaco Normon

4. Possible adverse effects

5. Storage ofDiclofenaco Normon

6. Contents of the package and additional information

Diclofenaco sódico, the active ingredient ofthis medication belongs to the group of medications known as nonsteroidal anti-inflammatory drugs, used to treat pain and inflammation.

This medication is used to treat the following conditions:

-Chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis),

-Extra-articular rheumatism,

• Acute gout attacks,
• M menstrual pains,
• Post-traumatic inflammation.

It is essential to use the smallest effective dose to alleviate or control pain and not to take this medication for longer than necessary to control 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. (They are listed at the end of the prospectus.) 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 hemorrhage in the past or have suffered, on two or more occasions, a perforation of the digestive system 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 coronary or cerebral 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 blood clotting 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

-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").

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

Inform your doctor

-if you are taking medications that alter blood clotting 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 bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

-if you suffer from Crohn's disease or ulcerative colitis, as medications like diclofenac can 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 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 blood disorders, you will need to undergo frequent blood tests during treatment. This will allow your doctor to control the functioning of your liver (transaminase levels) or 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 diclofenac can be associated with an increased risk of 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 heart 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 can 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 period to alleviate pain and/or inflammation and 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 can interact with this medication; in these cases, you may need 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 (SSRIs) for treating depression,
• medications containing methotrexate for treating rheumatoid arthritis and cancer,
• medications containing ciclosporin, 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 controlling 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 colestiramine and colestipol for lowering cholesterol levels in the blood,
• 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 it delays the onset of effect.

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 they experience.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medication.

Due to the association of diclofenac administration 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 when strictly necessary and as indicated by your doctor. In these cases, the dose and duration will be limited to the minimum possible.

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

In the third trimester, the administration of this medication is contraindicated. It may cause renal and cardiac problems in your fetus. It may affect your tendency and that of your baby to bleed and delay or prolong labor more than expected.

For fertile women, it is essential to consider that medications like diclofenac have been associated with a decrease in the ability to conceive.

Breastfeeding

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, somnolence, or other central nervous system disorders while taking this medication should avoid driving vehicles or operating machinery.

This medication contains lactose, sodium, and propylene glycol

Lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

Sodium

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

Propylene glycol

This medication contains 1.62 mg of propylene glycol per tablet.

Pediatric population

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

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 of this medication 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.

The daily dose for menstrual cramps, 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 begin when the first symptom appears. Depending on its intensity, it will be continued for a few days.

Administration form

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

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

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 out of sight and reach of children.

Do not store at a temperature above30°C.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy (or any other medication waste collection system). If in doubt, ask your pharmacist how to dispose of the packaging and medicines 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.

The other components are microcrystalline cellulose (E-460), lactose monohydrate, pregelatinized cornstarch, colloidal silica (E-551), povidone, magnesium stearate (E-470b), sodium carboxymethyl starch (type A) (from potato), talc (E-553b), titanium dioxide (E-171), macrogol 6000, propylene glycol, copolymer of methacrylic acid and ethyl acrylate (1:1), yellow iron oxide (E-172).

Appearance of the product and content of the packaging

This medicine is presented in the form of gastro-resistant tablets of light brown color, round and biconvex, in packaging of 40 tablets.

Holder of the marketing authorization and responsible for manufacturing

NORMON, S.A. Laboratories

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet: February 2023

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