Patient Information Leaflet: Information for the User

Olfen UNO, 150 mg, modified-release tablets
Diclofenacum natricum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Olfen is and what it is used for
Important information before taking Olfen
How to take Olfen
Possible side effects
How to store Olfen
Contents of the pack and other information

1. What Olfen is and what it is used for

The medicine contains sodium diclofenac, an active substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which has anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of the drug involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain, and fever.
Olfen is used in the treatment of:

Rheumatoid arthritis,
Osteoarthritis,
Ankylosing spondylitis (Bechterew's disease),
Degenerative changes of the spine,
Extra-articular rheumatism (inflammation of muscles, ligaments, fasciae, bursae, tendons, and tendon sheaths),
Pain following injuries and surgical procedures,
Joint pain or painful menstruation.

2. Important information before using Olfen

When not to use Olfen

if the patient has a known allergy to the active substance or to any of the other ingredients of this medicine (listed in section 6)
if the patient has hypersensitivity to other non-steroidal anti-inflammatory drugs (NSAIDs)
if the patient has hypersensitivity to acetylsalicylic acid manifested by asthma attacks, chest pain, skin reactions, or allergic rhinitis
if the patient has disorders of the blood-forming system
if the patient has active gastric and/or intestinal ulceration
if the patient has bleeding or perforation of gastric and/or intestinal ulcers
if gastrointestinal bleeding or perforation occurred in the past due to use of painkillers (NSAIDs)
if the patient is in the third trimester of pregnancy
if the patient has severe liver, kidney, or heart failure
if the patient has heart disease (heart failure, ischemic heart disease) and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischemic attack (TIA), or arterial embolism in the heart or brain, or after revascularization or bypass surgery
if the patient has current or previous circulatory disorders (peripheral vascular disease).

If any of the above conditions apply to the patient, inform the doctor and do not
take Olfen until the doctor confirms that this medicine is suitable for the patient.
Children and adolescents
Olfen is not recommended for use in children and adolescents.
Warnings and precautions
Before starting treatment with Olfen, discuss this with your doctor, pharmacist, or nurse.
Inform your doctor:

if the patient is in the 1st or 2nd trimester of pregnancy
if the patient is breastfeeding
if any unusual gastrointestinal symptoms occur during treatment with Olfen (especially gastrointestinal bleeding), discontinue the medicine immediately and contact your doctor
if the patient has a history of gastrointestinal disorders, intestinal ulcers, or inflammatory bowel disease (ulcerative colitis, Crohn's disease)
if the patient has ever experienced severe skin rash, skin peeling, blistering, or oral ulcers after taking Olfen or other painkillers
if the first signs of skin rash, mucosal changes, or other symptoms of allergic reaction occur, discontinue the medicine and contact your doctor (diklofenac may, very rarely, especially at the beginning of treatment, cause life-threatening skin reactions such as exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, or toxic epidermal necrolysis with skin and mucosal lesions, high fever, and severe general condition)
if the patient has asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD), or chronic respiratory tract infections. This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching, or urticaria). The medicine should be used with particular caution (preferably under medical supervision)
if the patient has hepatic porphyria
if the patient has systemic lupus erythematosus (SLE) or mixed connective tissue diseases (collagenoses)
if the patient has hypertension and/or cardiac dysfunction
if the patient has renal dysfunction
if the patient has hepatic dysfunction
if the patient has recently undergone major surgery
if the patient is elderly.

Before taking diklofenac, inform your doctor

if the patient smokes
if the patient has diabetes
if the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

Do not use Olfen simultaneously with other systemic non-steroidal anti-inflammatory drugs,
including selective cyclooxygenase-2 (COX-2) inhibitors.
As with other non-steroidal anti-inflammatory drugs (NSAIDs), allergic reactions, including anaphylactic
and pseudoanaphylactic reactions, may rarely occur after administration of diklofenac, even if the
medicinal product has not been used previously.
Before taking Olfen, inform your doctor if the patient has recently undergone or is scheduled for
surgery of the stomach or gastrointestinal tract, as Olfen may sometimes impair intestinal wound
healing after surgery.
The medicine may mask symptoms of infection (e.g. headache, elevated body temperature) and complicate
accurate diagnosis. Inform your doctor about using this medicine during medical examinations.
Use of medicines such as Olfen may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke. This risk increases with long-term use of high doses. Do not use
higher doses or longer treatment duration than recommended.
If the patient has heart problems, has had a stroke, or suspects risk of these conditions
(e.g. high blood pressure, diabetes, high cholesterol, smoking), discuss the treatment approach with
your doctor or pharmacist.
The medicine may transiently inhibit platelet aggregation.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest
duration necessary.
Olfen and other medicines
Inform your doctor about all medicines currently or recently taken by the patient, as well as any
medicines the patient plans to take, including those available without a prescription.
Lithium: Diklofenac administered concomitantly with lithium-containing medicines may increase lithium plasma concentration. Monitoring of serum lithium levels is recommended.
Digoxin: Diklofenac administered concomitantly with digoxin-containing medicines may increase digoxin plasma concentration. Monitoring of serum digoxin levels is recommended.
Diuretics and antihypertensive medicines: As with other NSAIDs, concomitant use of diklofenac with diuretics or antihypertensive medicines, e.g. beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, may reduce their antihypertensive effect.
Therefore, use diklofenac with caution when administered together with diuretics or antihypertensive medicines. In patients, especially the elderly, monitor blood pressure regularly. Due to increased risk of nephrotoxic effects, patients should be adequately hydrated and renal function should be monitored periodically after starting treatment and during combination therapy, particularly after using diuretics and ACE inhibitors. During concomitant use of diklofenac and potassium-sparing diuretics, serum potassium levels may increase; therefore, serum potassium levels should be monitored regularly (see section 4.4).
Other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors, and corticosteroids: Concomitant administration of diklofenac with other NSAIDs or corticosteroids may increase the frequency of gastrointestinal adverse effects (see section 4.4).
Anticoagulants and antiplatelet agents: Exercise caution, as concomitant use may increase the risk of bleeding (see section 4.4). Although clinical studies do not indicate that diklofenac affects the action of anticoagulants, there are isolated reports of increased risk of hemorrhage with combined use of diklofenac and anticoagulants. Therefore, close monitoring of patients is recommended in such cases.
Selective serotonin reuptake inhibitors (SSRIs): Concomitant use of systemic NSAIDs, including diklofenac, and SSRIs may increase the risk of gastrointestinal bleeding (see section 4.4).
Antidiabetic medicines: Clinical studies have shown that diklofenac can be administered concomitantly with oral antidiabetic medicines without affecting their clinical efficacy.
However, isolated cases of both hypoglycemic and hyperglycemic effects have occurred, requiring adjustment of antidiabetic dosage during diklofenac treatment. Therefore, monitoring of blood glucose levels is necessary during combination therapy.
Methotrexate: Diklofenac may inhibit renal clearance of methotrexate, thereby increasing its blood concentration. Exercise caution when using NSAIDs within 24 hours before or after methotrexate treatment, as increased methotrexate blood levels and increased toxicity may occur.
Cyclosporine: Diklofenac and other NSAIDs may increase the nephrotoxicity of cyclosporine due to effects on renal prostaglandins. Therefore, diklofenac should be administered at lower doses than in patients not receiving cyclosporine.
Quinolone antibiotics: Isolated cases of seizures have been reported, possibly due to concomitant use of quinolones and NSAIDs.
Probenecid, sulfinpyrazone: May delay elimination of diklofenac.
Phenytoin: When phenytoin is used concomitantly with diklofenac, monitoring of serum phenytoin levels is recommended due to possible increased exposure to phenytoin.
Colestipol and cholestyramine: These agents may prolong or reduce absorption of diklofenac. Therefore, diklofenac should be taken at least one hour before or 4–6 hours after colestipol/cholestyramine.
Strong CYP2C9 inhibitors: Exercise caution when prescribing diklofenac with strong CYP2C9 inhibitors (e.g. sulfinpyrazone, voriconazole) due to possible significant increase in diklofenac concentration and exposure resulting from inhibition of diklofenac metabolism.
Angiotensin-converting enzyme (ACE) inhibitors: Concomitant administration of diklofenac with ACE inhibitors may reduce their efficacy and increase the risk of renal dysfunction.
Mifepristone: NSAIDs administered within 8–12 days after mifepristone may reduce its efficacy.
Acetylsalicylic acid: Concomitant administration of acetylsalicylic acid reduces blood levels and efficacy of diklofenac.
Cholestyramine resin: Since cholestyramine is an ion-exchange resin, consider possible inhibition of absorption of other orally administered medicines.
Olfen with food and drink
Swallow the tablet whole, without chewing, during a meal, with a large amount of liquid.
In patients with gastric irritation, it is recommended to take the medicine during meals.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Do not take Olfen if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause delivery complications. Olfen may cause kidney and heart dysfunction in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. Do not use Olfen during the first six months of pregnancy unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From the 20th week of pregnancy, Olfen may cause kidney dysfunction in the unborn child if used for more than a few days—this may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child's heart. If treatment longer than a few days is required, the doctor may recommend additional monitoring.
Breastfeeding
Diklofenac passes into breast milk in small amounts. Therefore, diklofenac should not be used during breastfeeding to avoid adverse effects in the infant.
Fertility
Diklofenac may cause difficulties in becoming pregnant. Consult your doctor for advice if planning pregnancy, becoming pregnant, or experiencing difficulty conceiving while using diklofenac.
Driving and operating machinery
Patients using Olfen who experience visual disturbances, balance disorders, drowsiness, dizziness, vertigo, fatigue, or other central nervous system effects should refrain from driving or operating machinery and inform their doctor or pharmacist.
Olfen contains mannitol and sodium
Mannitol
The medicine contains 36.40 mg of mannitol per tablet. The medicine may have a mild laxative effect.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Olfen

This medicine should always be used according to the instructions given by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Do not exceed the recommended doses or duration of treatment.
As a general rule, the doctor should individually adjust the dose for each patient and use the lowest effective dose for the shortest possible time.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
The dosage of diclofenac depends on the course and severity of the disease. The recommended daily dose of diclofenac is up to 150 mg.

Adults
1 modified-release tablet per day, equivalent to 150 mg of sodium diclofenac.

Use in children and adolescents
Due to the dose size, Olfen is not recommended for use in children and adolescents.

Method and duration of administration
The tablet should be swallowed whole, without chewing, during a meal, with plenty of fluid. In patients with gastric irritation, it is recommended to take the medicine during meals.
The duration of treatment is determined by the doctor. In rheumatoid arthritis, long-term treatment may be necessary.

Use in elderly patients
Olfen should be used with caution in elderly patients.

Use of a higher than recommended dose of Olfen
Overdose of Olfen does not produce characteristic symptoms.
Symptoms of overdose include disturbances of the central nervous system (dizziness, headache, loss of consciousness, tinnitus, convulsions) and gastrointestinal tract (nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea). In severe poisoning, acute kidney failure and liver damage may occur.
There is no specific antidote. In case of overdose, contact a doctor, pharmacist, or go to hospital immediately.

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

Stopping treatment with Olfen
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You must immediately stop taking Olfen and inform your doctor if any of the following occur:

Mild abdominal cramps and tenderness occurring shortly after starting treatment with Olfen, followed by rectal bleeding or bloody diarrhoea, usually appearing within 24 hours of the onset of abdominal pain (symptoms of ischemic colitis) (frequency unknown, cannot be estimated from available data).
Severe allergic skin reaction, which may manifest as extensive red and (or) dark spots, skin swelling, blisters, and itching (generalized fixed bullous eruption).

The adverse reactions listed below include those reported with Olfen as well as those observed during use of other formulations of diclofenac, administered either short- or long-term.

Common (may affect up to 1 in 10 people): headache, dizziness, vertigo, nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, bloating, loss of appetite, anorexia, increased aminotransferase activity, rash.

Uncommon (may affect up to 1 in 1000 people): hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including rapid drop in blood pressure and shock), somnolence, sensory disturbances, asthma (including breathlessness), gastric mucositis, gastrointestinal bleeding, abdominal cramps, vomiting blood, bloody diarrhoea, melena, peptic ulcer of the stomach and (or) duodenum (with or without bleeding or perforation), proctitis, hepatitis, jaundice, liver function disorders, urticaria, oedema.

Rare (may affect up to 1 in 10,000 people): thrombocytopenia (reduced number of platelets), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of white blood cells – neutrophil granulocytes), angioedema (including facial swelling, tongue swelling, laryngeal oedema with airway narrowing, breathlessness), disorientation, depression, insomnia, nightmares, irritability, psychotic disorders, memory disturbances, anxiety, fatigue, restlessness, excitement, agitation, anxiety states, paraesthesia, convulsions, anxiety, tremor, aseptic meningitis, taste disturbances, stroke, visual disturbances, blurred vision, diplopia, tinnitus, hearing disturbances, palpitations, chest pain, heart failure, myocardial infarction, hypertension, vasculitis, hypotension up to life-threatening shock, pneumonia, colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), constipation, stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorders, intestinal stricture, pancreatitis, exacerbation of haemorrhagic polyps, fulminant hepatitis, hepatic necrosis, liver failure, bullous rash, exanthema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, allergic purpura (Henoch-Schönlein purpura), pruritus, acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, necrosis of renal papillae.

Frequency not known (frequency cannot be estimated from available data): allergic skin reaction, which may present as round or oval redness and swelling of the skin, blisters and itching (fixed erythema). The skin in affected areas may also appear darker, which may persist after healing. Upon re-administration of the drug, fixed erythema usually reappears in the same locations.

Prolonged use of medicines such as Olfen at high doses (150 mg per day) may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

If any of the above-mentioned or other unlisted adverse reactions occur, inform your doctor immediately.

You must immediately stop taking Olfen and inform your doctor if any of the following adverse reactions occur:

Stomach discomfort, heartburn or upper abdominal pain
Vomiting blood, blood in stool, blood in urine
Skin changes such as rash or itching
Wheezing or shortness of breath
Yellowing of the skin or whites of the eyes
Persistent sore throat or high fever
Swelling of the face, feet or legs
Severe migraine
Chest pain associated with cough
Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome.

Reporting of adverse reactions
If you experience any adverse effects, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Olfen UNO

Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the outer carton or blister pack after “Expiry date (EXP)” or “EXP”. The expiry date refers to the last day of the stated month.
The batch number is indicated on the packaging after “Batch number (Lot)” or “Lot”.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures help protect the environment.

6. Contents of the packaging and other information

What Olfen contains

The active substance is sodium diclofenac. Each modified-release tablet contains 150 mg of sodium diclofenac.
Other components of the medicine are:
Release-controlling layer: hypromellose (Methocel K 4M), hypromellose (Methocel K 100M), mannitol, povidone (Plasdone K 29/32), microcrystalline cellulose (Avicel pH 102), talc, colloidal silicon dioxide, magnesium stearate.
Inactive layer: hypromellose (Methocel K 100M), hydrogenated castor oil (Cutina HR), yellow iron oxide E 172, ethylcellulose, colloidal silicon dioxide, magnesium stearate.
Rapid-release layer: hypromellose (Methocel K 4M), mannitol, sodium starch glycolate (Primojel), microcrystalline cellulose (Avicel pH 102), talc, colloidal silicon dioxide, magnesium stearate.

What Olfen looks like and contents of the pack
Modified-release tablets, 150 mg, round, cylindrical, biconvex.
Packaging
Aluminium/PVDC blisters in a cardboard box.
10, 30, or 60 modified-release tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm, Germany
Manufacturer:
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warszawa
tel. +48 22 345 93 00

Olfen uno