Fenadol

Package leaflet: Information for the patient

FENADOL 100 mg prolonged-release tablets

Diclofenac sodium
Generic medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What FENADOL is and what it is used for
2. What you need to know before taking FENADOL
3. How to take FENADOL
4. Possible side effects
5. How to store FENADOL
6. Contents of the pack and other information

1. What FENADOL is and what it is used for

FENADOL contains the active substance sodium diclofenac, which belongs to the class of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
Sodium diclofenac is used to reduce pain and inflammation.
FENADOL is used to treat:

• joint diseases such as rheumatoid arthritis, ankylosing spondylitis, and osteoarthritis
• conditions causing pain and inflammation in the tissues surrounding the joints, such as tendons and ligaments (extra-articular rheumatism)
• pain due to non-rheumatic inflammation or trauma
• pain associated with menstruation

2. What you need to know before taking FENADOL

Do not take FENADOL

• if you are allergic to diclofenac or think you might be, to aspirin, ibuprofen, or any other NSAID, or to any component of FENADOL (listed in section 6). 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-type reaction.
• if you have a stomach or intestinal ulcer, bleeding, or perforation
• if you currently have bleeding or are prone to bleeding
• if you have previously experienced bleeding (haemorrhage) or perforation of the stomach or intestine after treatment with NSAIDs
• if you have had recurrent stomach or duodenal ulcer or bleeding (two or more distinct episodes of confirmed ulceration or bleeding)
• if you have liver problems
• if you have severe liver problems (hepatic failure)
• if you have severe kidney problems (renal failure)
• if you have established heart disease and/or cerebrovascular disease, e.g. if you have had a heart attack, stroke, mini-stroke (TIA), or blockage of blood vessels supplying the heart or brain, or surgery to remove or prevent such blockages
• if you have a blood cell production disorder
• if you are taking high doses of medicines that increase urine production (diuretics) (see "Other medicines and Fenadol")
• if you are in the third trimester of pregnancy (see section “Pregnancy, breastfeeding and fertility”)
• if you are breastfeeding (see section “Pregnancy, breastfeeding and fertility”)
• if the patient is under 14 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking FENADOL.
Inform your doctor if you have recently undergone or are about to undergo surgery on your stomach or intestinal tract before receiving/taking/using FENADOL, as FENADOL may sometimes impair wound healing in the intestine following surgery.
Before taking Fenadol, ensure your doctor is aware:

• if you smoke
• if you have diabetes
• if you have angina, blood clots, high blood pressure, high cholesterol, or high triglycerides
• if you have asthma
• if you have seasonal allergic rhinitis, nasal mucosa swelling (e.g. nasal polyps)
• if you have chronic obstructive pulmonary disease or chronic respiratory tract infections
• if you have liver problems (e.g. hepatic failure, hepatitis)
• if you have hepatic porphyria
• if you have ulcerative colitis or Crohn’s disease, as these conditions may worsen
• if you have kidney problems (e.g. renal failure)
• if you are taking medicines that increase urine production (diuretics) or other medicines that may affect kidney function
• if you have reduced body fluid volume (e.g. before or after major surgery)
• if you are undergoing or have undergone major surgery
• if you have blood clotting disorders (coagulation defects)
• if you have or have had high blood pressure, heart or brain problems (e.g. congestive heart failure, established heart disease, peripheral arterial disease, and/or stroke)
• if you have or have had stomach or intestinal problems (e.g. ulcer), or if you have experienced stomach or intestinal ulcers, bleeding, or perforation
• if you are taking medicines that may increase the risk of bleeding, ulcers, or perforation, such as acetylsalicylic acid (e.g. aspirin) or other NSAIDs, corticosteroids taken orally, by injection, or rectally (e.g. cortisone), anticoagulants (e.g. warfarin), or selective serotonin reuptake inhibitors (antidepressants) (see section “Other medicines and Fenadol”).

Inform your doctor if, during treatment with Fenadol, you develop:

• skin reactions, even severe ones, as very rare but potentially fatal skin reactions have been reported (see section 4 “Undesired effects”)
• fluid retention and swelling due to fluid accumulation (oedema)
• any signs of an allergic reaction
• signs and symptoms of liver problems or if liver function tests are abnormal (seen in blood tests)
• unusual stomach or intestinal symptoms, especially at the beginning of treatment with Fenadol, as they may indicate gastrointestinal bleeding or ulceration
• signs and symptoms typical of serious atherothrombotic events such as chest pain, shortness of breath, weakness, or difficulty speaking. In such cases, your doctor will assess whether to continue or stop treatment with Fenadol.

Also pay special attention to the following:

• At any time during treatment with NSAIDs, including diclofenac, gastrointestinal bleeding, ulceration, or perforation may occur, which can be fatal. Your doctor will prescribe the lowest effective dose of diclofenac to reduce the risk of gastrointestinal toxicity and may also prescribe protective medicines (e.g. misoprostol or proton pump inhibitors) to protect the gastrointestinal mucosa.
• If you are elderly, particularly if you are frail and underweight, your doctor will prescribe a low dose of Fenadol. Undesired effects can be reduced by using the lowest effective dose for the shortest possible time (see section 3 “How to take Fenadol”).
• Avoid using diclofenac during treatment with other NSAIDs taken orally, by injection, or rectally, including selective cyclooxygenase-2 inhibitors, as this increases the likelihood of undesired effects.
• Fenadol may mask the signs and symptoms of infection.
• Medicines like Fenadol may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Any risk is more likely with higher doses or prolonged treatment.
Your doctor will monitor you closely and periodically reassess the need for continued treatment with Fenadol.
Additionally, your doctor may arrange periodic tests to monitor your condition during treatment with Fenadol.
Children and adolescents
FENADOL must not be used in children and adolescents under 14 years of age.
Elderly patients
Elderly patients are more likely to experience adverse reactions, especially stomach or intestinal bleeding and perforation, which are generally more severe and may be fatal.
If you are elderly, particularly if you are frail and underweight, your doctor will prescribe a low dose of Fenadol.
As a precaution, your doctor may monitor your kidney function and prescribe medicines that protect the gastrointestinal mucosa, such as misoprostol or proton pump inhibitors.
Inform your doctor of any unusual stomach or intestinal symptoms, especially at the beginning of treatment with this medicine.
Other medicines and FENADOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The blood levels of the following medicines may increase when used together with Fenadol:

• lithium
• digoxin
• methotrexate
• phenytoin.

Your doctor will perform tests to monitor the blood levels of these medicines.
The effect of certain medicines used to lower blood pressure, such as:

• medicines that increase urine production (diuretics)
• beta-blockers
• angiotensin-converting enzyme inhibitors (ACE inhibitors)

may decrease when used together with Fenadol.
Your doctor will monitor you and carefully evaluate the co-administration of these medicines with Fenadol, especially if you are elderly.
Exercise particular caution and inform your doctor if you need to take Fenadol while already taking one or more of the following medicines.
Your doctor will monitor you and arrange tests as needed.

• blood pressure-lowering medicines or ACE inhibitors and angiotensin II antagonists, if you have kidney problems, or potassium-sparing diuretics (e.g. spironolactone)
• other anti-inflammatory medicines (non-steroidal anti-inflammatory drugs and corticosteroids)
• blood-thinning medicines (anticoagulants or antiplatelets)
• serotonin reuptake inhibitors (antidepressants)
• diabetes medicines
• ciclosporin and tacrolimus (immunosuppressants used to modify the body’s immune response)
• trimethoprim (an antibiotic)
• medicines from the quinolone class used to treat bacterial infections
• colestipol and cholestyramine, as they may delay or reduce diclofenac absorption. Your doctor will advise you when to take these medicines; generally, diclofenac should be taken 1 hour before or 4–6 hours after colestipol or cholestyramine.
• rifampicin (an antibiotic used to treat bacterial infections), as it may reduce diclofenac absorption.
• other medicines that may increase diclofenac blood levels, e.g. sulfinpyrazone (a medicine used to treat gout) and voriconazole (a medicine used to treat fungal infections).

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take FENADOL during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect the bleeding tendency in both mother and baby and delay or prolong labour beyond the expected time. You should not take FENADOL during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. If taken for more than a few days from week 20 of pregnancy onwards, FENADOL may cause kidney problems in the fetus, leading 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 is needed for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Fenadol must not be used during breastfeeding to avoid adverse effects on the newborn.
Fertility
As with other NSAIDs, Fenadol is not recommended for women who are trying to conceive, as this medicine may impair female fertility. Your doctor will assess whether treatment with Fenadol should be discontinued if you experience difficulty conceiving or require fertility investigations.
Driving and using machines
Fenadol may cause visual disturbances, dizziness, vertigo, drowsiness, or other disturbances that may affect your ability to drive or operate machinery. If you experience these symptoms, avoid driving or operating machinery.
FENADOL contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take FENADOL

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Fenadol prolonged-release tablets must be taken whole with a glass of liquid,
preferably during meals. The prolonged-release tablets must not be crushed, divided or
chewed.
Use in adults
The recommended dose is 1 tablet (100 mg) daily. Your doctor will tell you how much Fenadol to take and for
how long.
If symptoms are more severe at night or in the morning, take the Fenadol prolonged-release tablets
preferably in the evening.
Treatment of menstrual pain (primary dysmenorrhoea)
Your doctor will assess the dose according to your health condition.
The recommended initial dose is 50–100 mg daily, which may be gradually increased, if necessary,
up to a maximum of 150 mg daily. The daily dose should be divided into 2–3
doses.
Please note that if you need to take doses lower or higher than 100 mg, you will need to use other medicinal products containing diclofenac.
Start treatment at the onset of the first symptoms and continue for a few days, depending on how you feel.
Use in children and adolescents
Fenadol must not be used in children and adolescents under 14 years of age.
Use in the elderly
In elderly patients, a reduced dose of diclofenac may be necessary. Your doctor will tell you how much Fenadol you should take.
If you take more FENADOL than you should
If you accidentally take too much Fenadol, contact your doctor immediately or go to the nearest hospital.
If you take an excessive dose of Fenadol, you may experience vomiting, stomach or
intestinal bleeding, diarrhoea, dizziness, tinnitus (ringing or buzzing in the ears), or seizures. In more severe cases, serious kidney and liver damage may also occur.
Your doctor will treat acute poisoning caused by non-steroidal anti-inflammatory drugs, including diclofenac, according to the symptoms you present.
If you forget to take FENADOL
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects may be serious.
Stop taking the medicine and contact your doctor immediately if you experience:

• Mild cramps and abdominal tenderness occurring shortly after starting treatment with Fenadol, followed by rectal bleeding or bloody diarrhoea usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data).

Contact your doctor immediately if you experience the following reaction:
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

• Headache, dizziness
• Vertigo
• Nausea, vomiting
• Diarrhoea, passing gas (flatulence)
• Digestive problems (dyspepsia), abdominal pain
• Loss of appetite
• Abnormal results in blood tests (increase in certain liver enzymes: transaminases)
• Skin rash

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

• Awareness of your heartbeat (palpitations), chest pain
• Heart problems (heart failure), heart attack

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

• Allergic reactions, severe and rapidly occurring allergic reactions (anaphylaxis), including low blood pressure and collapse (shock)
• Drowsiness
• Asthma, difficulty breathing (dyspnoea)
• Inflammation of the stomach (gastritis), bleeding from the stomach or intestines, vomiting blood, stomach or intestinal ulcer with or without bleeding and perforation
• Blood in the stool
• Inflammation of the liver (hepatitis), yellowing of the skin, mucous membranes and eyes (jaundice), liver disorders
• Urticaria
• Oedema (swelling due to fluid accumulation). If you experience any of these side effects, contact your doctor immediately.

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

• Abnormal results in blood tests or low platelet count (thrombocytopenia) or reduced number of white blood cells (leucopenia) or reduced number of red blood cells (anaemia, including haemolytic and aplastic anaemia) or low granulocyte count (agranulocytosis)
• Abnormal results in urine tests or presence of blood in the urine (haematuria) or presence of protein in the urine (proteinuria)
• Allergic reaction with rapid swelling of the skin and mucous membranes (angioneurotic oedema), including facial oedema
• Disorientation, depression, insomnia, nightmares, irritability, severe mental disturbances (psychotic reactions)
• Memory impairment, seizures, anxiety, tremors
• Tingling (paraesthesia)
• Taste disturbances
• Inflammation of the membranes covering the brain (aseptic meningitis), stroke
• Vision disorders, blurred vision, double vision
• Ringing or buzzing in the ears, worsening of hearing
• High blood pressure, inflammation of blood vessels (vasculitis)
• Pneumonia
• Inflammation of the colon (colitis), including colitis with bleeding, worsening of ulcerative colitis or Crohn's disease
• Constipation
• Inflammation of the mucous membrane of the mouth (stomatitis), including stomatitis with ulcers, inflammation of the tongue (glossitis)
• Problems with the oesophagus, intestinal narrowing
• Inflammation of the pancreas (pancreatitis)
• A very severe and sudden form of hepatitis (fulminant hepatitis), liver necrosis, impaired liver function (liver failure)
• Skin reactions ranging from mild (bullous eruptions, eczema, erythema) to potentially fatal (multiform erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis)
• Appearance of red-brown spots on the skin (purpura), also as an allergic reaction
• Itching
• Hair loss
• Skin sensitivity to sunlight
• Kidney problems such as acute kidney failure, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Medicines such as Fenadol may be associated with a small increased risk of heart attack (myocardial infarction) or stroke (see above “Warnings and precautions”).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FENADOL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What FENADOL contains

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• The other components are: microcrystalline cellulose, lactose, starch, polyvinylpyrrolidone, magnesium stearate, hydroxypropylcellulose, cellulose acetate phthalate, triethyl citrate, titanium dioxide.

Description of the appearance of FENADOL and package contents
Carton pack containing 20 tablets, with 2 PVC/Al blisters of 10 tablets each.
Marketing Authorization Holder
PROGE FARM S.r.l. – Largo Donegani, 4/A – 28100 Novara – Italy
Manufacturer
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A. – Via Grignano 43
24041 Brembate (BG)