Leaflet: information for the user

Diclofenac cinfa 50 mg gastro-resistant tablets EFG

Diclofenac sodium

Read this leaflet carefully before you start taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before starting to take diclofenac cinfa

3.How to take diclofenac cinfa

4.Possible side effects

5.Storage of diclofenac cinfa

6.Contents of the pack and additional information

Diclofenacsodium, the active ingredient of diclofenaco cinfa,belongs to the group of medications known as nonsteroidal anti-inflammatory drugs used to treat pain and inflammation.

diclofenaco cinfa is used to treat the following conditions:

Post-traumatic inflammation.

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 control your symptoms.

Do not takediclofenaco cinfa

• if you are allergic todiclofenaco sódicoor to any of the other components of this medication (listed in section 6).
• if you are allergic or have had allergic reactions toácido acetilsalicílico(aspirin) or other analgésicos (pain medications) similar to it. Allergic reactions may include asthma (difficulty breathing), chest pain, urticaria (skin reaction with itching), acute rhinitis (inflammation of the nasal mucosa), or swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema). If you think you may be allergic, consult your doctor.
• if you have had previous stomach or duodenal bleeding or have suffered, on two or more occasions, a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory medication.
• if you currently have or have had more than one occasion: stomach or duodenal ulcer or bleeding.
• 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 severe kidney disease.
• if you have severe liver disease.

• if you have established cardiovascular 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 a surgery to remove an obstruction or bypass the coronary artery.

• 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.
• if you think you may be allergic todiclofenaco sódico,ácido acetilsalicílico,ibuprofeno, or any otherAINE, or to any of the other components of diclofenaco. (They are listed at the end of the prospectus.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), breathing difficulties, chest pain, runny nose, skin rash, or any other allergic reaction.

Make sure before taking diclofenaco that your doctor knows:

• if you smoke.
• if you have diabetes.
• if you haveangina, 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.

Warnings and precautions

Consult your doctor or pharmacist before starting to takediclofenaco cinfa

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe 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 disease, and in elderly patients. 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 disordersincluding porphyria hepática.
• 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 section “Other medications and diclofenaco cinfa”).
• If you are taking medications for high blood pressure or ciclosporina, as it increases the risk of kidney damage (see section “Other medications and diclofenaco cinfa”).

Inform your doctor

• If you are taking anticoagulant medications, antiplatelet medications, or other medications that increase the risk of bleeding, such as anticoagulant oral medications, or antiplatelet medications likeácido acetilsalicílico. You must also inform your doctor about the use of other medications that may increase the risk of bleeding, such as corticosteroids and antidepressants.
• If you have Crohn's disease or ulcerative colitis, as diclofenaco may worsen these conditions.
• If you have high blood pressure, high cholesterol, high triglycerides, diabetes, or are a smoker (cardiovascular risk factors), your doctor will reevaluate whether you should continue taking diclofenaco, especially if you have been taking it for more than 4 weeks.
• If you have liver, kidney, or blood disorders, you will need to have regular blood tests during your treatment. This will allow your doctor to monitor your liver function (transaminase levels), kidney function (creatinine levels), or blood cell counts (lymphocyte, erythrocyte, and platelet levels). Your doctor will then decide to interrupt or change your diclofenaco dose.
• Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery, as diclofenaco may sometimes worsen intestinal wound healing after surgery.

Patients with cardiovascular problems

Medications likediclofenacomay be associated with an increased risk of heart attacks or strokes, especially when used in high doses and for prolonged periods. 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 are a smoker) and your doctor decides to treat you with diclofenaco, do not take more than 100 mg per day if the treatment lasts more than 4 weeks.

These types of medications may also 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 period to relieve 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 diclofenaco, contact your doctor immediately.

Children and adolescents

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

Use in elderly patients

Elderly patients, especially those who are more fragile or have a low body weight, may be more sensitive to the effects ofdiclofenacothan the general adult population. Therefore, it is especially important for elderly patients to inform their doctor immediately about any adverse effects they experience.

Other medications and diclofenaco cinfa

Inform your doctor or pharmacist if you are taking, have taken, or may need to take any other medication.

Certain medications may interact with diclofenaco: 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 taken any of the following medications:

• medications containing lithium or selective serotonin reuptake inhibitors (for treating certain types of depression),
• medications containing metotrexato (for treating rheumatoid arthritis and cancer),
• medications containing ciclosporina, tacrolimus (for after transplants),
• medications containing trimetroprim (for preventing and treating urinary tract diseases),
• medications for heart problems (digoxina, calcium channel blockers such as verapamilo or isradipino),
• 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 quinolona or ceftriaxona (for treating infections),
• other medications in the same group as diclofenaco (nonsteroidal anti-inflammatory medications) such asácido acetilsalicílicoor ibuprofeno,
• corticosteroids (medications that reduce inflammation and the action of the immune system),
• medications containing voriconazol (a medication used in the treatment of fungal infections),
• medications containing phenytoin (a medication used to treat epilepsy),
• medications containing misoprostol (for treating stomach ulcers),
• medications containing colestiramina and colestipol to lower cholesterol levels in the blood),
• medications containing pentazocina (for relieving pain),
• medications used to treat bacterial infections (rifampicina).

Taking diclofenaco cinfa with food, drinks, and alcohol

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

The consumption of alcoholic beverages with diclofenaco may increase its toxicity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Do not take diclofenaco if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. 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 delivery more than expected. Since the administration of medications like diclofenaco has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it 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 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 (oligohidramnios) or narrowing of a blood vessel (ductus arterioso) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

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

Breastfeeding

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machinery

The influence of diclofenaco 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 diclofenaco should avoid driving vehicles or operating machinery.

diclofenaco cinfa contains lactose.

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

diclofenaco cinfa 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 or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Use in adults and children over 14 years old

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

In menstrual cramps, 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 start when the first symptom appears. Depending on its intensity, it will be continued for a few days.

Administration form

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

If you take morediclofenac cinfathan 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, indicating the medication and the amount ingested.

If you forgot to takediclofenac cinfa

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

Like all medicines,this medicinecancauseside effects, although not everyone will experience them.

Some side effects may be serious.

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

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

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Other side effects that have been reported with the use of diclofenac are as follows:

Frequent side effects (may affect up to 1 in 10 people):

Nervous system disorders

• Headache
• Dizziness

Vestibular disorders

• Dizziness

Gastrointestinal disorders

• Nausea
• Vomiting
• Diarhea
• Acid reflux
• Abdominal pain
• Gas
• Loss of appetite

Hepatobiliary disorders

• Abnormal liver function test results (elevated serum transaminases)

Skin and subcutaneous tissue disorders

• Rash

Less frequent side effects (may affect up to 1 in 100 people):

Cardiac disorders(at high doses during prolonged treatment)

• Palpitations
• 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 occur, consult your doctor immediately

Rare side effects (may affect up to 1 in 10,000 people):

Immune system disorders

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

If these symptoms occur, consult your doctor immediately

Nervous system disorders

• Drowsiness

If these symptoms occur, report them to your doctor immediately

Respiratory, thoracic, and mediastinal disorders

• Asthma

Gastrointestinal disorders

• Stomach pain
• Reflex
• Bloody diarrhea
• Ulcerative stomach or intestinal disease with or without bleeding or perforation (vomiting blood and presence of blood in stool)

If these symptoms occur, consult your doctor immediately

Hepatobiliary disorders

• Liver function impairment
• Jaundice with or without yellowing of the skin and eyes

If these symptoms occur, consult your doctor immediately

Skin and subcutaneous tissue disorders

• Hives

General disorders and administration site conditions

• Fluid retention with swelling (edema)

Very rare side effects (may affect up to 1 in 10,000 people):

Blood and lymphatic system disorders

• Signs of anemia, such as fatigue, headache, shortness of breath when exercising, dizziness, paleness (anemia), frequent infections with fever, chills, sore throat, or mouth ulcers (leucopenia), bleeding or bruising more easily than normal (thrombocytopenia)

If these symptoms occur, consult your doctor immediately

Immune system disorders

• Swelling of the face

Psychiatric disorders

• Disorientation
• Depression
• Insomnia
• Nightmares
• Irritability
• Psychotic reactions

Nervous system disorders

• Prickling sensation
• Memory disorders
• Seizures
• Anxiety
• Tremors
• Meningitis (inflammation of the membranes surrounding the brain) with symptoms such as fever, nausea, vomiting, headache, neck stiffness, or extreme sensitivity to bright light

If these symptoms occur, consult your doctor immediately

• Disorders of taste
• Cerebral infarction

Eye disorders

• Blurred vision
• Diplopia

Vestibular disorders

• Tinnitus

Vascular disorders

• Hypertension (high blood pressure)
• Vasculitis (inflammation of blood vessel walls)

Respiratory, thoracic, and mediastinal disorders

• Shortness of breath, wheezing (neumonitis)

If these symptoms occur, consult your doctor immediately

Gastrointestinal disorders

• Worsening of Crohn's disease and ulcerative colitis
• Constipation
• Tongue swelling (glossitis)
• Mouth mucosa inflammation (stomatitis)
• Difficulty swallowing (esophageal alteration)
• Severe upper abdominal pain, nausea, vomiting, and loss of appetite (signs of pancreatitis)

If these symptoms occur, 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 occur, consult your doctor immediately

• Generalized rash (eczema)
• Redness (erythema and erythema multiforme)
• Skin peeling (dermatitis exfoliativa)
• Hair loss
• Sun allergy (photosensitivity reaction)
• Appearance of bruises (purpura)
• Itching

Renal and urinary disorders

• Abnormal kidney function that causes swelling in feet or legs and sudden decrease in urine output (acute kidney failure, interstitial nephritis, papillary necrosis)
• Blood in urine (hematuria)
• Protein in urine (nephrotic syndrome)

If these symptoms occur, consult your doctor immediately

Isolated cases

Hepatobiliary disorders

• Abnormal liver function that causes yellowing of the skin and eyes, fever, upper abdominal pain, and bruising (hepatic insufficiency, fulminant hepatitis, hepatic necrosis)

If these symptoms occur, consult your doctor immediately

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 leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https//www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not usethis medicationafter 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 disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofdiclofenaco 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), cornstarch, sodium croscarmellose, anhydrous colloidal silica, sodium lauryl sulfate, povidone (E-1201), talc (E-553b), magnesium stearate (E-470B).

Coating:hypromellose (E-464), copolymer of methacrylic acid and ethyl acrylate (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 contents of the packaging

Gastro-resistant tablets, cylindrical, biconvex, light brown in color, coated, and marked with the code “D50C”.

Presented in PVC-PVDC/Aluminum blisters. Each package contains 40 gastro-resistant tablets.

Marketing authorization holder and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:March 2023

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your 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