DICLOFENAC CINFA 50 mg GASTRO-RESISTANT TABLETS

Introduction

Package Leaflet: Information for the User

diclofenaco cinfa 50 mg gastro-resistant tablets EFG

diclofenaco sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is diclofenaco cinfa and what is it used for
2. What you need to know before you take diclofenaco cinfa
3. How to take diclofenaco cinfa
4. Possible side effects
5. Storing diclofenaco cinfa
6. Pack contents and further information

1. What is diclofenaco cinfa and what is it used for

Diclofenaco sodium, the active ingredient in diclofenaco cinfa, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to treat pain and inflammation.

diclofenaco cinfa is used to treat the following conditions:

• Chronic inflammatory rheumatic diseases (rheumatoid arthritis, ankylosing spondylitis, osteoarthritis),
• Extra-articular rheumatism,
• Acute attacks of gout,
• Menstrual pain,

Post-traumatic inflammation.

2. What you need to know before you take diclofenaco cinfa

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

Do not takediclofenaco cinfa

• if you are allergic to diclofenaco sodium or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic or have had allergic reactions to acetylsalicylic acid (aspirin) or other analgesics (pain-relieving medicines) similar to diclofenaco. Reactions can include asthma (difficulty breathing), chest pain, hives (allergic skin reaction with itching), acute rhinitis (inflammation of the nasal mucosa) or swelling of the face, lips, tongue, throat and/or limbs (signs of angioedema). If you think you may be allergic, consult your doctor.
• 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 a non-steroidal anti-inflammatory drug.
• if you currently have or have had more than one occasion: a stomach or duodenal ulcer or bleeding.
• if you suffer from 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 or have had problems with blood circulation (peripheral arterial disease).
• if you are in the third trimester of pregnancy.
• if you have blood coagulation disorders.
• if you think you may be allergic to diclofenaco sodium, acetylsalicylic acid, ibuprofen, or any other NSAID, or any of the other ingredients of diclofenaco. (These are 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.

Make sure your doctor knows before taking diclofenaco:

• 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to take diclofenaco cinfa

• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe and persistent abdominal pain and/or black stools, or even without previous warning symptoms.

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

• 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 ulcers and/or gastrointestinal bleeding (see section "Other medicines and diclofenaco cinfa").
• If you are taking medicines for blood pressure or ciclosporin, as this increases the risk of kidney damage (see section "Other medicines and diclofenaco cinfa").
• If you have ever had a severe skin rash or peeling, blisters, or ulcers in the mouth after taking diclofenaco cinfa or other pain-relieving medicines.

Tell your doctor

• If you are taking medicines 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 medicines 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 medicines like diclofenaco can 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 diclofenaco, 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 whether to interrupt or change the dose of diclofenaco.
• Tell your doctor if you have recently undergone or are going to undergo stomach or intestinal surgery before using diclofenaco, as diclofenaco may sometimes worsen the healing of intestinal wounds after surgery.

Patients with cardiovascular problems

Medicines like diclofenaco 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 diclofenaco, you should not take more than 100 mg per day if the treatment lasts more than 4 weeks.

Also, this type of medicine can 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 diclofenaco for the shortest possible time that relieves your pain and/or inflammation to reduce the risk of cardiovascular side effects. If you notice chest pain, shortness of breath, weakness, or difficulty speaking while taking diclofenaco, contact your doctor immediately.

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, especially those who are frail or have low body weight, may be more sensitive to the effects of diclofenaco than other adults. Therefore, it is especially important that elderly patients inform their doctor immediately of any side effects that occur.

Other medicines and diclofenaco cinfa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Certain medicines may interfere with diclofenaco: 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 medicines:

• medicines containing lithium or serotonin reuptake inhibitors (for treating certain types of depression),
• medicines containing methotrexate (for treating rheumatoid arthritis and cancer),
• medicines containing ciclosporin, tacrolimus (after transplants),
• medicines containing trimethoprim (for preventing and treating urinary tract diseases),
• medicines for treating heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
• medicines used to treat diabetes, except insulin.
• medicines for controlling blood pressure (diuretics, beta-blockers, and ACE inhibitors),
• medicines for preventing blood clots,
• medicines containing quinolone or ceftriaxone (for treating infections),
• other medicines of the same group as diclofenaco (NSAIDs) such as acetylsalicylic acid or ibuprofen,
• corticosteroids (medicines that reduce inflammation and the action of the immune system),
• medicines containing voriconazole (a medicine used in the treatment of fungal infections),
• medicines containing phenytoin (a medicine used to treat epileptic seizures),
• medicines containing misoprostol (for treating stomach ulcers),
• medicines containing cholestyramine and colestipol for reducing cholesterol levels in the blood),
• medicines containing pentazocine (for relieving pain),
• the antibiotic rifampicin (used to treat bacterial infections).

Takingdiclofenaco cinfawith food, drinks, and alcohol

This medicine should be taken preferably before meals or on an empty stomach because it delays the onset of the effect.

Consuming alcoholic beverages with diclofenaco may increase its toxicity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take diclofenaco if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during delivery. It may cause kidney and heart problems in your baby. It may affect your tendency and that of your baby to bleed and delay or prolong delivery more than expected. Because the administration of medicines like diclofenaco has been associated with an increased risk of congenital anomalies/spontaneous abortions, it is not recommended during the first and second trimester of pregnancy unless strictly necessary and as indicated by your doctor. In these cases, the dose and duration will be limited to the minimum possible. From the 20th week of pregnancy, diclofenaco may cause kidney problems in your baby if taken for more than a few days, which can cause low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. 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 medicines like diclofenaco have been associated with a decrease in fertility.

Breastfeeding

Ask your doctor or pharmacist for advice before taking any medicine.

Small amounts of diclofenaco may appear in breast milk, so you should not take diclofenaco if you are breastfeeding.

Driving and using machines

The influence of diclofenaco on the ability to drive and use machines is negligible or minimal; however, patients who experience visual disturbances, dizziness, vertigo, somnolence, or other central nervous system disorders while taking diclofenaco should avoid driving vehicles or operating machinery.

diclofenaco cinfa contains lactose.

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

diclofenaco cinfa contains sodium.

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

3. How to take diclofenaco cinfa

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in adults and children over 14 years

The recommended dose for milder cases is 100 mg (one tablet twice a day). Do not exceed the dose of 150 mg (3 tablets) per day. The total daily dose should be divided into 2 or 3 divided doses.

In menstrual pain, the daily dose, 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 be started when the first symptoms appear. Depending on the intensity, it will be continued for a few days.

Method of administration

The tablets should be swallowed whole with a glass of water or other liquid, without dividing or chewing them. Take diclofenaco preferably before meals or on an empty stomach (see section "Taking diclofenaco cinfa with food, drinks, and alcohol").

If you take morediclofenaco cinfathan you should

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

If you forget to takediclofenaco cinfa

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.

Some adverse effects can be serious.

Stop using this medicine and consult your doctor immediately if you notice:

Mild abdominal colic and abdominal pain on palpation that begins shortly after starting treatment with diclofenac followed by rectal bleeding or bloody diarrhea, usually observed within 24 hours after the onset of abdominal pain (frequency not known, cannot be determined from available data).

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Severe skin allergic reaction, which can include large red or dark spots, skin swelling, blisters, and itching (generalized fixed drug eruption).

Other adverse effects that have been reported with the use of diclofenac are the following:

Frequent Adverse Effects (may affect up to 1 in 10 people):

Nervous System Disorders

• headache
• dizziness

Ear and Labyrinth Disorders

• vertigo

Gastrointestinal Disorders

• nausea
• vomiting
• diarrhea
• heartburn
• abdominal pain
• gas
• loss of appetite

Hepatobiliary Disorders

• abnormal liver function test results (elevated serum transaminases)

Skin and Subcutaneous Tissue Disorders

• skin rash

Infrequent Adverse Effects (may affect up to 1 in 100 people):

Cardiac Disorders(at high doses during prolonged treatments)

• palpitations
• sudden severe chest pain (symptoms of myocardial infarction or heart attack)
• shortness of breath, difficulty breathing when lying down, swelling of feet and legs (signs of heart failure)

If these symptoms appear, consult your doctor immediately

Rare Adverse Effects (may affect up to 1 in 1,000 people):

Immune System Disorders

• swelling of the face, eyes, or tongue, difficulty swallowing, wheezing, hives, and itching, skin rash, fever, abdominal cramps, discomfort or tightness in the chest, difficulty breathing, dizziness, loss of consciousness (severe allergic reaction)

If these symptoms appear, consult your doctor immediately

Nervous System Disorders

• drowsiness

If these symptoms appear, inform your doctor immediately

Respiratory, Thoracic, and Mediastinal Disorders

• asthma

Gastrointestinal Disorders

• stomach pain
• reflux
• bloody diarrhea
• gastric or intestinal ulcer with or without bleeding or perforation (vomiting blood and appearance of blood in stools)

If these symptoms appear, consult your doctor immediately

Hepatobiliary Disorders

• liver function disorders
• hepatitis with or without jaundice

If these symptoms appear, consult your doctor immediately

Skin and Subcutaneous Tissue Disorders

• hives

General Disorders and Administration Site Conditions

• fluid retention with swelling (edema)

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

Blood and Lymphatic System Disorders

• signs of lack of blood cells that produce fatigue, headache, shortness of breath when exercising, dizziness, paleness (anemia), frequent infections with fever, chills, sore throat or mouth ulcers (leukopenia), bleeding or bruising more than usual (thrombocytopenia)

If these symptoms appear, consult your doctor immediately

Immune System Disorders

• swelling of the face

Psychiatric Disorders

• disorientation
• depression
• insomnia
• nightmares
• irritability
• psychotic reactions

Nervous System Disorders

• tingling sensation
• memory disorders
• seizures
• anxiety
• tremors
• meningitis (inflammation of the membranes surrounding the brain) with symptoms such as fever, nausea, vomiting, headache, stiff neck or extreme sensitivity to bright light

If these symptoms appear, consult your doctor immediately

• taste disorders
• stroke

Eye Disorders

• blurred vision
• double vision

Ear and Labyrinth Disorders

• ringing in the ears

Vascular Disorders

• hypertension (high blood pressure)
• vasculitis (inflammation of blood vessel walls)

Respiratory, Thoracic, and Mediastinal Disorders

• difficulty breathing, wheezing (pneumonitis)

If these symptoms appear, consult your doctor immediately

Gastrointestinal Disorders

• worsening of Crohn's disease and ulcerative colitis
• constipation
• tongue swelling (glossitis)
• inflammation of the mouth mucosa (stomatitis)
• difficulty swallowing (esophageal disorder)
• severe pain in the upper abdomen, nausea, vomiting, and loss of appetite (signs of pancreatitis)

If these symptoms appear, consult your doctor immediately

Skin and Subcutaneous Tissue Disorders

• severe skin reactions with rash, redness, blisters on the lips, mouth, or eyes, skin peeling, accompanied by fatigue, nausea, loss of appetite, fever, chills, headache, cough, or body pain (Stevens-Johnson syndrome or toxic epidermal necrolysis)

If these symptoms appear, consult your doctor immediately

• generalized rash (eczema)
• redness (erythema and erythema multiforme)
• skin peeling (exfoliative dermatitis)
• hair loss
• sun allergy (photosensitivity reaction)
• appearance of bruises (purpura)
• itching

Renal and Urinary Disorders

• kidney function disorders that cause swelling in feet or legs and sudden decrease in urine output (acute renal failure, interstitial nephritis, renal papillary necrosis)
• blood in urine (hematuria)
• foam in urine (nephrotic syndrome)

If these symptoms appear, consult your doctor immediately

Isolated Cases

Hepatobiliary Disorders

• liver function disorders that cause yellowing of the skin and eyes, fever, with pain in the upper abdomen and bruising (liver failure, fulminant hepatitis, liver necrosis)

If these symptoms appear, consult your doctor immediately

Adverse Effects of Unknown Frequency (cannot be estimated from available data):

Skin and Subcutaneous Tissue Disorders

• allergic skin reaction, which can include round or oval patches of redness and skin swelling, blisters, and itching (fixed drug eruption). It can also cause darkening of the skin in the affected areas, which may persist after healing. The fixed drug eruption usually reappears in the same or same areas if the medicine is taken again

Reporting 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Diclofenac Cinfa

Keep this medicine out of sight and reach of children.

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.

Do not store at a temperature above 30°C.

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 ofDiclofenac Cinfa

• The active ingredient is diclofenac sodium. Each gastro-resistant tablet contains 50 mg of diclofenac sodium.
• The other components (excipients) are:

Core: lactose monohydrate, microcrystalline cellulose (E-460), corn starch, sodium croscarmellose, anhydrous colloidal silica, sodium lauryl sulfate, povidone (E-1201), talc (E-553b), magnesium stearate (E-470B).

Coating: hypromellose (E-464), ethyl acrylate and methacrylic acid copolymer (1:1) dispersion 30%, triethyl citrate (E-1505), talc (E-553b), titanium dioxide (E-171), yellow iron oxide (E-172), brown iron oxide (E-172).

Appearance of the Product and Package Contents

Cylindrical, biconvex tablets, light brown in color, coated and marked with the code "D50C".

They are presented in PVC-PVDC/Aluminum blisters. Each package contains 40 gastro-resistant tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Leaflet:August 2025

Detailed and updated 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 and updated information on this medicine by scanning the QR code included in the leaflet 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/62161/P_62161.html

QR code to: https://cima.aemps.es/cima/dochtml/p/62161/P_62161.html