Olfen 50

Leaflet accompanying the packaging: patient information

Olfen 50, 50 mg, coated tablets

Diclofenac sodium

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Olfen 50 and what is it used for
• 2. Important information before taking Olfen 50
• 3. How to take Olfen 50
• 4. Possible side effects
• 5. How to store Olfen 50
• 6. Contents of the packaging and other information

1. What is Olfen 50 and what is it used for

Olfen 50 contains diclofenac sodium, belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-rheumatic, anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action of Olfen 50 involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of inflammation, pain, and fever.

In adults, Olfen 50 may be used to treat pain and inflammation in the following cases:

• acute inflammatory joint diseases (including acute gout);
• chronic inflammatory joint diseases, in particular rheumatoid arthritis (chronic arthritis);
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
• juvenile rheumatoid arthritis (Still's disease);
• disorders resulting from degenerative joint disease and spinal inflammation;
• rheumatic inflammatory diseases of soft tissues;
• pain caused by post-traumatic and post-operative inflammatory conditions and swelling, e.g., after dental or orthopedic procedures;
• painful and inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis;
• as an adjunctive treatment for severe, painful infections of the ear, nose, or throat, e.g., pharyngitis and tonsillitis, otitis. In accordance with general therapeutic principles, in the case of the above-mentioned diseases, causal treatment should be applied first. Fever, as the only symptom, is not an indication for use.

In case of doubts about the action or reasons for prescribing Olfen 50, consult a doctor.

Control tests during treatment with Olfen 50

In the case of diagnosed heart disease or significant risk factors for cardiovascular diseases, the doctor will periodically assess the patient's need for symptomatic treatment and their response to the medicine, especially if treatment lasts longer than 4 weeks.

During treatment, regular blood tests should be performed in case of any liver function disorders, kidney function disorders, and blood count abnormalities.

Both liver function (transaminase levels), kidney function (creatinine levels), and blood count (white and red blood cell count and platelet count) should be monitored. The doctor will take into account the results of blood tests when deciding to discontinue treatment with Olfen 50 or change the dose.

2. Important information before taking Olfen 50

Follow all instructions given by the doctor or pharmacist carefully, even if they differ from the general information contained in this leaflet.

When not to take Olfen 50:

• if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has ever had an allergic reaction after taking anti-inflammatory or analgesic drugs (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). In the above case, asthma, rhinitis, skin rash, facial swelling, lip, tongue, throat, and (or) limb edema (symptoms of angioedema), difficulty breathing, chest pain, or any other allergic reactions may occur. If the patient suspects an allergy, they should consult a doctor;
• if the patient has active or past stomach or duodenal ulcers, gastrointestinal bleeding, symptoms related to the presence of blood in the stool, black stools, or if the patient has experienced discomfort in the stomach area or heartburn after taking anti-inflammatory drugs;
• during the last three months of pregnancy (see section "Pregnancy, breastfeeding, and fertility");
• if the patient has liver failure;
• if the patient has kidney failure;
• if the patient has heart disease and (or) cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia (mini-stroke), or vascular occlusion of the heart or brain, or after a procedure to clear or bypass blocked vessels;
• if the patient has circulation disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Olfen 50 should not be taken by people who may experience an asthma attack, hives, or acute rhinitis after taking acetylsalicylic acid or other prostaglandin synthesis inhibitors.

If any of the above symptoms occur in the patient, they should inform their doctor and not take Olfen 50 until the doctor determines that the medicine is suitable for the patient.

Warnings and precautions

Before starting treatment with Olfen 50, discuss it with a doctor, pharmacist, or nurse.

Tell your doctor if:

• the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, elevated levels of fats in the blood (cholesterol, triglycerides), or if the patient is a smoker, and the doctor decides to prescribe Olfen 50, the dose should not be increased above 100 mg per day if treatment lasts longer than 4 weeks;
• the medicine is used in patients with a history of gastrointestinal ulcers or in the elderly. Diclofenac may cause gastrointestinal bleeding, ulcers, or perforation (with possible fatal outcome). Such action may be particularly dangerous when using high doses of diclofenac. If any unusual abdominal symptoms occur during treatment with Olfen 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and a doctor consulted;
• the patient is taking Olfen 50 simultaneously with other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" drugs, or certain antidepressants (see also "Olfen 50 and other medicines");
• the patient has asthma or allergic rhinitis (e.g., nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory infections, and is more likely to experience an allergic reaction to diclofenac (asthma exacerbation, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those who experience skin reactions, itching, or urticaria). The medicine should be administered with caution (preferably under medical supervision);
• the patient has a history of gastrointestinal disorders, e.g., stomach ulcers, bleeding, or black stools, or has experienced stomach discomfort or heartburn after taking NSAIDs in the past;
• the patient has inflammatory bowel disease (ulcerative colitis) or gastrointestinal disease (Crohn's disease); diclofenac may exacerbate the disease;
• the patient has kidney or liver disease; diclofenac may worsen the disease. The doctor's recommendations regarding liver function tests should be strictly followed;
• the patient has bleeding or blood disorders, including a rare liver disease called porphyria. Diclofenac may trigger a porphyria attack.

Before taking diclofenac, inform your doctor:

• if the patient smokes;
• if the patient has diabetes;
• if the patient has angina pectoris, thrombosis, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

Before taking Olfen 50, tell your doctor if the patient has recently undergone or is scheduled to undergo stomach or gastrointestinal surgery, as Olfen 50 may sometimes cause delayed wound healing after surgical procedures.

The occurrence of side effects can be reduced by using the medicine in the smallest effective dose and for no longer than necessary.

Take the smallest dose of Olfen 50 that relieves pain and (or) swelling and use it for the shortest time necessary to minimize the risk of side effects.

If, at any time during treatment with Olfen 50, the patient experiences symptoms indicating heart or blood vessel problems, such as chest pain, shortness of breath, weakness, or slurred speech, they should immediately contact a doctor or hospital emergency department.

In very rare cases (especially at the beginning of treatment), Olfen 50, like other anti-inflammatory drugs, may cause severe allergic skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and joint pain, and toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition). After the first signs of rash, mucous membrane lesions, or other symptoms of an allergic reaction, the medicine should be discontinued and a doctor consulted.

In rare cases, Olfen 50, like other anti-inflammatory drugs, may cause allergic reactions, including anaphylactic and pseudo-anaphylactic reactions, even if the medicine has not been used before.

Olfen 50 may mask the symptoms of infection (e.g., headache, high temperature), making it more difficult to diagnose and treat the infection. If the patient feels unwell and needs to see a doctor, they should inform the doctor about taking Olfen 50.

If any of the above warnings apply to the patient, they should inform their doctor before taking Olfen 50.

Other special warnings

Concomitant use of Olfen 50 with other systemically acting non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors, should be avoided.

Before taking the medicine, inform the doctor or pharmacist about the presence of the above-mentioned diseases.

Taking medicines like Olfen 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely after taking high doses and long-term treatment. Do not exceed the recommended dose or treatment duration.

The medicine may temporarily inhibit platelet aggregation.

Before taking Olfen 50, tell your doctor if the patient has recently undergone or is scheduled to undergo stomach or gastrointestinal surgery, as Olfen 50 may sometimes cause delayed wound healing after surgical procedures.

In case of heart problems, stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol levels, or smoking), discuss the treatment with a doctor or pharmacist.

Children and adolescents

Olfen 50 should not be taken by children and adolescents under 14 years of age.

Elderly patients (65 years of age and older)

Elderly patients may be more sensitive to the effects of Olfen 50.

Therefore, they should follow the instructions in the leaflet and the doctor's recommendations carefully and take the minimum dose of the medicine that ensures the disappearance of symptoms.

It is particularly important for patients to report any side effects to their doctor immediately.

Olfen 50 and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Inform your doctor especially about taking the following medicines:

• Lithium or selective serotonin reuptake inhibitors (medicines used to treat certain types of depression),
• Cardiac glycosides (e.g., digoxin) used to treat heart diseases,
• Diuretics (medicines that increase urine production),
• Angiotensin-converting enzyme inhibitors or beta-adrenergic blockers (a group of medicines used to treat high blood pressure and heart failure),
• Other anti-inflammatory drugs (such as acetylsalicylic acid or ibuprofen),
• Corticosteroids (medicines used to alleviate inflammatory conditions),
• Anticoagulant and antiplatelet drugs,
• Oral antidiabetic drugs (except insulin),
• Methotrexate (a medicine used to treat certain cancers or arthritis),
• Cyclosporine and tacrolimus (a medicine used in organ transplant patients),
• Trimethoprim (a medicine used to prevent and treat urinary tract infections),
• Quinolone antibacterials (medicines used against infections),
• Phenytoin (an antiepileptic drug),
• Cholestyramine and colestipol (a medicine that lowers cholesterol levels in the blood),
• Sulfinpyrazone (a medicine used to treat gout),
• Voriconazole (a medicine used to treat fungal infections),
• Mifepristone (a medicine used in gynecology),
• Diclofenac resin.

Taking Olfen 50 with food and drink

Swallow the tablets whole with water, preferably during a meal. Do not divide or chew the tablet.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult a doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Olfen 50 if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Olfen 50 may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in the patient and child and prolong or delay labor. During the first six months of pregnancy, Olfen 50 should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, taking Olfen 50 may lead to kidney problems in the unborn child, and if taken for more than a few days, it may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed if taking Olfen 50, as the medicine may harm the baby.

The doctor will discuss the potential risks of taking Olfen 50 during pregnancy and breastfeeding with the patient.

Fertility

Diclofenac may make it more difficult to conceive. Inform the doctor if the patient plans to conceive or has problems conceiving.

Driving and using machines

Do not drive or operate any machines if side effects occur while taking Olfen 50, such as vision disturbances, dizziness, vertigo, drowsiness, or other central nervous system disorders.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, which means the medicine is considered "sodium-free".

3. How to take Olfen 50

Always take this medicine exactly as the doctor has told you. If you are not sure, ask your doctor or pharmacist.

The doctor will tell you exactly how to take Olfen 50. Depending on the individual patient's response to treatment, the doctor may recommend a higher or lower dose of the medicine. The general recommendation is for the doctor to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible period. If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.

Dosage

Do not exceed the recommended dose. It is important to use the smallest effective dose for the shortest time necessary to control symptoms and not to take Olfen 50 for longer than necessary.

Adults

The recommended dose for adults is 1 to 3 tablets per day (50 to 150 mg of the active substance diclofenac sodium), unless the doctor recommends otherwise.

• The daily dose should be determined individually by the doctor for the patient. It usually ranges from 50 mg to 150 mg. Initially, 50 mg to 100 mg should be administered, and if necessary, the dose can be increased over several menstrual cycles to a maximum of 200 mg per day. Treatment should be started when the first symptoms appear and continued for several days, depending on their severity.

Children and adolescents

Olfen 50 in a dose of 50 mg in the form of coated tablets is not recommended for children and adolescents under 14 years of age.

Diagnosed cardiovascular disease or significant cardiovascular risk factors

Patients with diagnosed cardiovascular disease or significant risk factors for cardiovascular events should be treated with diclofenac only after careful consideration and with doses not exceeding 100 mg per day if treatment lasts longer than 4 weeks.

Kidney function disorders

Olfen 50 is contraindicated in patients with kidney failure.

No special studies have been conducted in patients with kidney function disorders, so no specific dosage recommendations can be made. Caution is recommended when administering Olfen 50 to patients with mild to moderate kidney function disorders.

Liver function disorders

Olfen 50 is contraindicated in patients with liver failure.

No special studies have been conducted in patients with liver function disorders, so no specific dosage recommendations can be made. Caution is recommended when administering Olfen 50 to patients with mild to moderate liver function disorders.

Method of administration

Swallow the tablets whole with water, preferably during a meal. Do not divide or chew the tablet.

How long to take Olfen 50

Strictly follow the doctor's recommendations. If you are taking Olfen 50 for a long time, regularly consult your doctor to ensure that no side effects have occurred. In case of doubts, consult a doctor or pharmacist.

Taking a higher dose of Olfen 50 than recommended

Overdose of Olfen 50 does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In the case of significant poisoning, acute kidney failure and liver damage may occur. If a higher dose of Olfen 50 than recommended is taken accidentally, inform a doctor or pharmacist or go to the hospital emergency department immediately. Medical attention may be necessary.

Missing a dose of Olfen 50

If a dose is missed, take one tablet as soon as possible. If it is almost time for the next dose, take the next tablet at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Olfen 50

In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Olfen 50 can cause side effects, although not everybody gets them.

Stop taking Olfen 50 and tell your doctor immediately if you experience:

• Mild, painful abdominal cramps and tenderness starting soon after taking Olfen 50, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of abdominal pain (frequency not known, cannot be estimated from available data),
• Chest pain - chest pain that may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• Discomfort in the stomach, heartburn, or pain in the upper abdomen,
• Bloody vomiting, blood in the stool, blood in the urine,
• Skin disorders such as rash or itching,
• Wheezing or shortness of breath,
• Yellowing of the skin or eyes,
• Persistent sore throat or high fever,
• Swelling of the face, feet, or legs,
• Severe migraine,
• Chest pain accompanied by coughing.

The following side effects have occurred during treatment with Olfen 50:

Some rare (may occur in less than 1 in 1000 patients) or very rare (may occur in less than 1 in 10,000 patients) side effects may be serious:

• Bruising or bleeding,
• High fever or persistent sore throat,
• Allergic reaction with facial swelling, lip, oral, tongue, or throat swelling, often associated with rash and itching, which can cause difficulty swallowing, low blood pressure (hypotension), fainting,
• Wheezing and feeling of tightness in the chest, shortness of breath (asthma symptoms),
• Sudden and severe headaches, nausea, dizziness, numbness, or difficulty speaking, paralysis (stroke symptoms),
• Stiffness of the neck (symptoms of meningitis),
• Seizures,
• High blood pressure (hypertension),
• Red or purple skin (possible symptoms of vasculitis), rash with blisters, blisters on the lips, eyes, and mouth, skin inflammation with exfoliation or peeling,
• Severe stomach pain, bloody or black stools, bloody vomiting, stomach or duodenal ulcers,
• Yellowing of the skin or eyes (symptoms of hepatitis),
• Blood in the urine, excess protein in the urine, significant reduction in urine output (symptoms of kidney function disorders),
• Decreased platelet count (thrombocytopenia),
• Decreased white blood cell count (leukopenia),
• Decreased neutrophil count (agranulocytosis).

If you experience any of the above symptoms, inform your doctor immediately.

Common side effects (may occur in less than 1 in 10 patients):

• Headache,
• Dizziness,
• Nausea,
• Vomiting,
• Diarrhea,
• Indigestion,
• Abdominal pain,
• Bloating,
• Loss of appetite,
• Liver function disorders (e.g., increased transaminase activity),
• Skin rash.

Uncommon side effects (may occur in less than 1 in 100 patients):

• Myocardial infarction,
• Heart failure,
• Chest pain (myocardial infarction symptoms),
• Palpitations.

Rare side effects (may occur in less than 1 in 1000 patients):

• Hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including sudden drop in blood pressure and shock),
• Asthma (including shortness of breath),
• Gastritis, gastrointestinal bleeding, bloody vomiting, bloody diarrhea, black stools,
• Stomach or duodenal ulcers (with or without bleeding and perforation),
• Hepatitis, jaundice, liver function disorders,
• Drowsiness,
• Urticaria,
• Edema.

Very rare side effects (may occur in less than 1 in 10,000 patients):

• Disorientation,
• Depression,
• Sleep disorders,
• Nightmares,
• Irritability,
• Psychotic disorders,
• Numbness or tingling of hands or feet,
• Memory disorders,
• Seizures,
• Anxiety,
• Tremors,
• Aseptic meningitis,
• Taste disorders,
• Visual or hearing disturbances, blurred vision, double vision, tinnitus,
• Pneumonitis,
• Oral ulcers,
• Constipation,
• Esophageal ulcers (upper part of the digestive tract leading food to the stomach),
• Hair loss,
• Redness, swelling, and blistering of the skin (due to increased sensitivity to sunlight),
• Anemia (anemia),
• Thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), anemia (including hemolytic and aplastic anemia), agranulocytosis (lack of granulocytes),
• Angioedema (including angioedema of the face),
• Cerebrovascular accident,
• Hypertension, vasculitis,
• Colitis (including bloody colitis and exacerbation of ulcerative colitis, Crohn's disease), glossitis, esophageal disorders, intestinal stricture, pancreatitis,
• Fulminant hepatitis, liver necrosis, liver failure,
• Bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, pruritus,
• Acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. Frequency not known (cannot be estimated from available data):
• Concomitant occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome).

Medicines like diclofenac may slightly increase the risk of heart attack (myocardial infarction) or stroke. The risk of this is more likely after taking high doses and long-term treatment. Do not exceed the recommended dose or treatment duration.

Inform your doctor if you experience any of the above side effects.

If you experience any side effects, including any not listed in this leaflet, consult your doctor, pharmacist, or nurse.

If Olfen 50 is taken for more than a few weeks, ensure regular medical check-ups to ensure that no unnoticed side effects have occurred.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Olfen 50

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.

The batch number is stated on the packaging after "Batch number" or "Lot".

Store below 25°C. Protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Olfen 50 contains

The active substance of the medicine is diclofenac sodium. Each tablet contains 50 mg of diclofenac sodium.

Excipients:

Tablet core: sodium carboxymethylcellulose (type A), microcrystalline cellulose, sodium stearyl fumarate, silicon dioxide, talc, hypromellose.

Coating (gastro-resistant): methacrylic acid and ethyl acrylate copolymer (1:1), dispersion 30%, talc, triethyl citrate.

Coating (colored): hypromellose, macrogol 6000, titanium dioxide (E 171), yellow iron oxide (E 172), quinoline yellow (E104), talc.

What Olfen 50 looks like and contents of the pack

Yellow, biconvex, coated tablets with beveled edges, with the inscription "mp" on one side and "O 50" on the other.

Aluminum/PVC/PVDC blister pack in a carton box.

Package of 20 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5,

2031 GA Haarlem,

Netherlands

Manufacturer/importer

Merckle GmbH,

Ludwig-Merckle-Strasse 3

89143 Blaubeuren, Germany

Teva Operations Poland Sp. z o.o.,

ul. Mogilska 80,

31-546 Kraków, Poland

For more information, contact the marketing authorization holder's representative:

Teva Pharmaceuticals Polska Sp. z o.o., tel. +48 22 345 93 00

Date of last revision of the leaflet: