Diclofenac CINFA 50 mg enteric-coated tablets EFG: detailed information

Brand name Diclofenac CINFA 50 mg enteric-coated tablets EFG

Form tablets, enteric-coated

Active substance / Dosage

DICLOFENAC SODIUM · 50 mg

Prescription type Prescription Only Medicine

ATC code

M01A M01AB M01AB05

Registration number 62161

Manufacturer Laboratorios Cinfa S.A.

Diclofenac CINFA 50 mg enteric-coated tablets EFG tablets, enteric-coated

Table of Contents

Package leaflet: Information for the user
Introduction
1. What diclofenaco cinfa is 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 adverse effects
5. Storage of diclofenac cinfa
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

diclofenaco cinfa 50 mg gastro-resistant tablets EFG

diclofenac sodium

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

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

Leaflet contents

What diclofenaco cinfa is and what it is used for
What you need to know before taking diclofenaco cinfa
How to take diclofenaco cinfa
Possible adverse effects
How to store diclofenaco cinfa
Contents of the pack and other information

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

Diclofenac sodium, the active substance in diclofenaco cinfa, belongs to the group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs), which are 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 gout attacks,
Menstrual pain,
Post-traumatic inflammation.

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

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

Do not take diclofenac cinfa

if you are allergic to sodium diclofenac or to 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 to other similar painkillers (analgesic medicines). Reactions may include asthma (difficulty breathing), chest pain, hives (skin allergic 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 previously had a stomach or duodenal bleed or have experienced, on two or more occasions, a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug.
if you currently have or have had on more than one occasion: a stomach or duodenal ulcer or bleeding.
if you have active Crohn's disease or active ulcerative colitis (conditions causing 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), blockages in the blood vessels of the heart or brain, or a surgery to remove an obstruction or to perform 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.
if you think you may be allergic to sodium diclofenac, acetylsalicylic acid, ibuprofen, or any other NSAID, or to any of the other components of diclofenac. (Listed at the end of this leaflet.) Signs of a hypersensitivity reaction include swelling of the face and mouth (angioedema), difficulty breathing, chest pain, runny nose, skin rash, or any other allergic reaction.

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.

Adverse effects can be minimized by using the lowest effective dose for the shortest possible time.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take diclofenac cinfa

If you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is higher when high doses are used and with prolonged treatment, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider adding a stomach-protective medicine.

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 medicines, corticosteroids, anticoagulants, or antidepressants, as this increases the risk of ulcer and/or gastrointestinal bleeding (see section “Other medicines and diclofenac cinfa”).
If you are taking medicines for blood pressure or cyclosporine, as this increases the risk of kidney damage (see section “Other medicines and diclofenac cinfa”).
If you have ever had a severe skin rash, skin peeling, blisters, or mouth sores after taking diclofenac cinfa or other painkillers.

Tell your doctor

If you are simultaneously taking medicines that affect blood clotting or increase the risk of ulcers, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
If you have Crohn's disease or ulcerative colitis, as medicines like diclofenac may worsen these conditions.
If you have high blood pressure, elevated cholesterol or triglyceride levels, diabetes, or are a smoker (cardiovascular risk factors), your doctor should periodically reassess whether you should continue treatment with diclofenac, especially if treatment lasts longer than 4 weeks.
If you have liver impairment, kidney impairment, or blood disorders, you will need frequent blood tests during treatment. This will allow monitoring of liver function (transaminase levels), kidney function (creatinine levels), or blood parameters (lymphocyte, erythrocyte, and platelet levels). This will help your doctor decide whether to stop or adjust your diclofenac dose.
Inform your doctor if you have recently undergone or are about to undergo stomach or intestinal surgery before using diclofenac, as diclofenac may sometimes impair wound healing in the intestine after surgery.

Patients with cardiovascular problems

Medicines like diclofenac may be associated with an increased risk of heart attacks ("myocardial infarction") or strokes, especially when used at high doses and for prolonged periods. Do not exceed the recommended dose or duration of treatment. If you have heart problems, a history of stroke, or think you may be at risk (for example, you have high blood pressure, diabetes, high cholesterol or triglycerides, or you smoke) and your doctor decides to treat you with diclofenac, you should not take more than 100 mg per day if treatment lasts longer than 4 weeks.

Also, these types of medicines 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 diclofenac for the shortest possible time needed to relieve your 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 diclofenac, 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 diclofenac than other adults. Therefore, it is especially important that elderly patients immediately inform their doctor of any adverse effects they experience.

Other medicines and diclofenac cinfa

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Certain medicines may interfere with diclofenac: in such cases, it may be necessary to adjust the dose or discontinue 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 (used to treat certain types of depression),
medicines containing methotrexate (used to treat rheumatoid arthritis and cancer),
medicines containing cyclosporine, tacrolimus (used after organ transplants),
medicines containing trimethoprim (used to prevent and treat urinary tract infections),
medicines used to treat heart problems (digoxin, calcium antagonists such as verapamil or isradipine),
medicines used to treat diabetes, except insulin.
medicines to control blood pressure (diuretics, beta-blockers, and ACE inhibitors),
medicines used to prevent blood clots,
medicines containing quinolone or ceftriaxone (used to treat infections),
other medicines in the same group as diclofenac (non-steroidal anti-inflammatory drugs) such as acetylsalicylic acid or ibuprofen,
corticosteroids (medicines that reduce inflammation and suppress the immune system),
medicines containing voriconazole (an antifungal medicine),
medicines containing phenytoin (used to treat epileptic seizures),
medicines containing misoprostol (used to treat stomach ulcers),
medicines containing colestyramine and colestipol (used to lower blood cholesterol levels),
medicines containing pentazocine (used to relieve pain),
an antibiotic medicine used to treat bacterial infections (rifampicin).

Taking diclofenac cinfa with food, drinks, and alcohol

This medicine should preferably be taken before meals or on an empty stomach, as food delays the onset of effect.

Consuming alcoholic beverages together with diclofenac may increase its toxicity.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take diclofenac during 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 tendency and your baby's tendency to bleed and may delay or prolong labor more than expected. Because the use of medicines like diclofenac has been associated with an increased risk of congenital malformations/spontaneous abortions, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary and as directed by your doctor. In such cases, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, diclofenac may cause kidney problems in your fetus if taken for more than a few days, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

For women of childbearing age, it should be noted that medicines like diclofenac have been associated with a reduced ability to conceive.

Breastfeeding

Consult your doctor or pharmacist before using any medicine.

Small amounts of diclofenac may appear in breast milk; therefore, you should not take diclofenac if you are breastfeeding.

Driving and using machines

The effect of diclofenac on the ability to drive and use machines is negligible or minor. However, patients who experience visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders while taking diclofenac should avoid driving vehicles or operating machinery.

diclofenac cinfa contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

diclofenac 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 diclofenac cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Use in adults and children over 14 years of age

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

For menstrual pain, the daily dose, which should be individually adjusted, is 50–200 mg (1 to 4 tablets). An initial dose of 50–100 mg (1 to 2 tablets) should be administered, and if necessary, increased in subsequent menstrual cycles. Treatment should begin at the onset of the first symptoms and continued for a few days, depending on their severity.

Method of administration

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

If you take more diclofenac cinfa than you should

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

If you forget to take diclofenac cinfa

Do not take a double dose to make up for missed doses.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious.

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

Mild abdominal cramps and abdominal tenderness beginning shortly after starting treatment with diclofenac, followed by rectal bleeding or bloody diarrhoea usually observed 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 serious allergic reaction called Kounis syndrome.

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

Other adverse effects reported with the use of diclofenac are as follows:

Common adverse effects (may affect up to 1 in 10 people):

Nervous system disorders*
headache
dizziness
Ear and labyrinth disorders*
vertigo
Gastrointestinal disorders*
nausea
vomiting
diarrhoea
heartburn
abdominal pain
flatulence
loss of appetite
Hepatobiliary disorders*
abnormal liver function blood test results (increased serum transaminases)
Skin and subcutaneous tissue disorders*
skin rash

Uncommon adverse effects (may affect up to 1 in 100 people):

Cardiac disorders* (at high doses during prolonged treatment)
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)