OLFEN 75 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Olfen 75 SR, 75 mg, prolonged-release tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Olfen 75 SR and what is it used for
   1. Control tests during treatment with Olfen 75 SR
4. Important information before taking Olfen 75 SR
   1. When not to take Olfen 75 SR:
   2. Warnings and precautions
   3. Children and adolescents
   4. Elderly patients (65 years and older)
   5. Olfen 75 SR and other medicines
   6. Inform your doctor especially about taking the following medicines:
   7. Taking Olfen 75 SR with food and drink
   8. Pregnancy, breastfeeding, and fertility
   9. Pregnancy
   10. Breastfeeding
   11. Fertility
   12. Driving and using machines
   13. The medicine contains lactose and sodium.
   14. Lactose
   15. Sodium
5. How to take Olfen 75 SR
   1. Dosage
   2. Elderly patients (65 years and older)
   3. Diagnosed cardiovascular disease or significant cardiovascular risk factors
   4. Kidney function disorders
   5. Liver function disorders
   6. Method of administration
   7. How long to take Olfen 75 SR
   8. Taking a higher dose of Olfen 75 SR than recommended
   9. Missing a dose of Olfen 75 SR
   10. Stopping treatment with Olfen 75 SR
6. Possible side effects
   1. Stop taking Olfen 75 SR and inform your doctor immediately if you experience:
   2. Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) side effects can be serious:
   3. Common side effects (may affect up to 1 in 10 people):
   4. Uncommon side effects (may affect up to 1 in 100 people):
   5. Rare side effects (may affect up to 1 in 1,000 people):
   6. Very rare side effects (may affect up to 1 in 10,000 people):
   7. Reporting side effects
7. How to store Olfen 75 SR
8. Contents of the pack and other information
   1. What Olfen 75 SR contains
   2. What Olfen 75 SR looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer/Importer
   6. Date of last revision of the leaflet:

Leaflet accompanying the packaging: patient information

Olfen 75 SR, 75 mg, prolonged-release tablets

Diclofenac sodium

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Olfen 75 SR and what is it used for
• 2. Important information before taking Olfen 75 SR
• 3. How to take Olfen 75 SR
• 4. Possible side effects
• 5. How to store Olfen 75 SR
• 6. Contents of the pack and other information

1. What is Olfen 75 SR and what is it used for

Olfen 75 SR contains diclofenac sodium, which belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs) with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Olfen 75 SR involves the inhibition of prostaglandin biosynthesis, which plays a crucial role in the pathogenesis of inflammation, pain, and fever.

Olfen 75 SR can be used to treat pain and inflammation in the following cases:

• Acute inflammatory joint conditions;
• Chronic inflammatory joint conditions, particularly rheumatoid arthritis (chronic joint inflammation);
• Ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
• Disorders resulting from degenerative joint disease and spinal inflammation;
• Rheumatic inflammatory conditions of the soft tissues;
• Pain caused by post-traumatic and post-operative inflammatory conditions and swelling, e.g., after dental or orthopedic procedures;
• Painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis.

Control tests during treatment with Olfen 75 SR

In cases of diagnosed heart disease or significant risk factors for heart disease, 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 cases of 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 consider the results of blood tests when deciding to discontinue treatment with Olfen 75 SR or change the dose.

2. Important information before taking Olfen 75 SR

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

When not to take Olfen 75 SR:

• If you are allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6);
• If you have ever had an allergic reaction after taking anti-inflammatory or analgesic drugs (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). In such cases, you may experience asthma, rhinitis, skin rash, facial swelling, lip, tongue, or throat swelling (symptoms of angioedema), difficulty breathing, chest pain, or any other allergic reactions. If you suspect an allergy, consult your doctor for advice;
• If you have active or a history of stomach or duodenal ulcers, gastrointestinal bleeding, or signs of bleeding in the stool, black stools, or stomach discomfort after taking anti-inflammatory drugs;
• If you are in the last trimester of pregnancy (see "Pregnancy, breastfeeding, and fertility");
• If you have severe liver failure;
• If you have severe kidney failure;
• If you have heart disease or cerebrovascular disease, e.g., after a heart attack, stroke, transient ischemic attack (mini-stroke), or after vascular surgery, or angioplasty or bypass grafting of closed blood vessels;
• If you have circulation disorders (peripheral vascular disease). Like other non-steroidal anti-inflammatory drugs (NSAIDs), Olfen 75 SR should not be used in people who may experience an asthma attack, hives, or acute rhinitis after taking acetylsalicylic acid or other drugs that inhibit prostaglandin synthesis.

If any of the above symptoms occur, inform your doctor and do not take Olfen 75 SR until your doctor determines that the medicine is suitable for you.

Warnings and precautions

Before starting treatment with Olfen 75 SR, discuss the following with your doctor, pharmacist, or nurse:

• If you have diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, elevated lipid levels (cholesterol, triglycerides), or if you are a smoker, and your doctor decides to prescribe Olfen 75 SR, do not exceed a dose of 100 mg per day if treatment lasts longer than 4 weeks;
• If 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 effects can be particularly dangerous when using high doses of diclofenac. If you experience any unusual abdominal symptoms (especially gastrointestinal bleeding), stop taking the medicine and consult your doctor;
• If you are taking Olfen 75 SR with other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" drugs, or certain antidepressants (see also "Olfen 75 SR and other medicines");
• If you have asthma, allergic rhinitis, nasal polyps, chronic obstructive pulmonary disease, or chronic respiratory infections, you are more likely to experience an allergic reaction to diclofenac (exacerbation of asthma symptoms, angioedema, or urticaria). This warning also applies to patients allergic to other substances (e.g., those experiencing skin reactions, itching, or urticaria). The medicine should be administered with caution (preferably under medical supervision);
• If you have a history of gastrointestinal disorders, such as stomach ulcers, bleeding, or black stools, or if you have experienced stomach discomfort or heartburn after taking NSAIDs in the past;
• If you have inflammatory bowel disease (ulcerative colitis) or gastrointestinal disease (Crohn's disease), diclofenac may exacerbate the disease;
• If you have kidney or liver function disorders; diclofenac may worsen the disease. Follow your doctor's recommendations for monitoring liver function;
• If you have bleeding or blood disorders, including a rare liver disease called porphyria. Diclofenac may trigger a porphyria attack.

Before taking diclofenac, inform your doctor:

• If you smoke;
• If you have diabetes;
• If you have angina pectoris, thrombosis, high blood pressure, elevated cholesterol levels, or elevated triglyceride levels.

To minimize the risk of side effects, use the smallest effective dose for the shortest duration necessary to control symptoms.

Do not exceed the recommended dose or duration of treatment. If you experience any symptoms that may indicate cardiovascular or vascular disorders, such as chest pain, shortness of breath, weakness, or slurred speech, contact your doctor or hospital emergency department immediately.

Olfen 75 SR, like other anti-inflammatory drugs, may cause severe skin allergic 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 changes, high fever, and severe general condition). If you experience the first signs of a rash, mucous membrane changes, or other symptoms of an allergic reaction, stop taking the medicine and consult your doctor.

In rare cases, Olfen 75 SR, like other anti-inflammatory drugs, may cause allergic reactions, including anaphylactic and pseudo-anaphylactic reactions, even if the product has not been used before.

Olfen 75 SR may mask the symptoms of infection (e.g., headache, high temperature), making it more difficult to diagnose and treat the infection. If you feel unwell and need to see a doctor, inform them that you are taking Olfen 75 SR.

If any of the above warnings apply to you, inform your doctor before taking Olfen 75 SR.

Other special warnings

Do not take Olfen 75 SR with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.

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

Taking medicines like Olfen 75 SR may be associated with a slight increase in the 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 duration of treatment.

If you have heart problems, have had a stroke, or suspect that you are at risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol levels, or smoking), discuss your treatment with your doctor or pharmacist.

The medicine may temporarily inhibit platelet aggregation.

Before taking Olfen 75 SR, tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Olfen 75 SR may sometimes cause impaired wound healing in the intestines after surgery.

Children and adolescents

Olfen 75 SR should not be used in children and adolescents.

Elderly patients (65 years and older)

Elderly patients may be more sensitive to the effects of Olfen 75 SR. Therefore, they should follow the instructions in the leaflet and the doctor's recommendations carefully, especially when taking the minimum effective dose that provides symptom relief. It is particularly important for elderly patients to report any side effects to their doctor immediately.

Olfen 75 SR and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan 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 conditions,
• Diuretics (medicines that increase urine production),
• Angiotensin-converting enzyme inhibitors or beta-blockers (a group of medicines used to treat high blood pressure and heart failure),
• Other anti-inflammatory drugs (such as acetylsalicylic acid/aspirin or ibuprofen),
• Corticosteroids (medicines used to relieve inflammation),
• Anticoagulant and anti-platelet drugs,
• Oral hypoglycemic agents (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 to treat infections),
• Phenytoin (an antiepileptic medicine),
• 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 salts.

Taking Olfen 75 SR with food and drink

Swallow the tablets whole with water, preferably during a meal.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Do not take Olfen 75 SR if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Olfen 75 SR may cause kidney and heart problems in the unborn baby. It may also increase the risk of bleeding in the mother and baby and prolong labor.

During the first 6 months of pregnancy, do not take Olfen 75 SR unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. From the 20th week of pregnancy, Olfen 75 SR may cause kidney problems in the unborn baby if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed if you are taking Olfen 75 SR, as the medicine may harm the baby.

Your doctor will discuss the potential risks of taking Olfen 75 SR during pregnancy and breastfeeding.

Fertility

Diclofenac may make it more difficult to become pregnant. Inform your doctor if you plan to become pregnant or are having trouble conceiving.

Driving and using machines

Do not drive or operate any machinery if you experience side effects while taking Olfen 75 SR, such as vision disturbances, dizziness, drowsiness, or other central nervous system disorders.

The medicine contains lactose and sodium.

Lactose

If your doctor has confirmed that you have an intolerance to some sugars, consult your doctor before taking the medicine.

Sodium

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

3. How to take Olfen 75 SR

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

Your doctor will tell you exactly how to take Olfen 75 SR. Depending on your individual response to treatment, your doctor may recommend a higher or lower dose of the medicine. The general recommendation is to adjust the dose individually for each patient and use the smallest effective dose for the shortest possible duration. If you feel that the effect of the medicine is too strong or too weak, consult your doctor.

Dosage

Do not exceed the recommended dose. It is important to use the smallest effective dose for the shortest possible duration to control symptoms and not to take Olfen 75 SR for longer than necessary.

Adults

The recommended dose is 1 to 2 tablets per day (75 to 150 mg of diclofenac sodium), unless your doctor recommends otherwise. If you take more than one tablet per day, divide the dose throughout the day and take it with food.

Children and adolescents

Olfen 75 SR should not be used in children and adolescents under 18 years of age.

Elderly patients (65 years and older)

The medicine should be used with caution in elderly patients. For elderly patients and those with low body weight, the recommended dose is the smallest effective dose.

Diagnosed cardiovascular disease or significant cardiovascular risk factors

Patients with diagnosed cardiovascular disease or significant cardiovascular risk factors 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 75 SR is contraindicated in patients with severe 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 75 SR to patients with mild to moderate kidney function disorders.

Liver function disorders

Olfen 75 SR is contraindicated in patients with severe 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 75 SR 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 tablets. Do not exceed the recommended dose.

How long to take Olfen 75 SR

Follow your doctor's instructions carefully. If you are taking Olfen 75 SR for a long time, regularly consult your doctor to ensure that no side effects have occurred. If you have any doubts, consult your doctor or pharmacist.

Taking a higher dose of Olfen 75 SR than recommended

Overdose of Olfen 75 SR does not cause characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions. In cases of significant poisoning, acute kidney failure and liver damage may occur. If you have accidentally taken a higher dose of Olfen 75 SR than recommended, inform your doctor or pharmacist or go to the hospital emergency department immediately. Medical attention may be necessary.

Missing a dose of Olfen 75 SR

If you miss a dose, take one tablet as soon as you remember. If it is almost time for your 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 75 SR

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olfen 75 SR can cause side effects, although not everybody gets them.

Stop taking Olfen 75 SR and inform your doctor immediately if you experience:

• Mild, painful abdominal cramps and tenderness occurring shortly after starting treatment with Olfen 75 SR, followed by rectal bleeding or black, tarry stools (frequency not known - cannot be estimated from the 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 upper abdominal pain,
• Vomiting blood, blood in the stool, or blood in the urine,
• Skin disorders such as rash or itching,
• Shortness of breath or wheezing,
• Yellowing of the skin or eyes,
• Prolonged sore throat or high fever,
• Swelling of the face, feet, or ankles,
• Severe migraine,
• Chest pain accompanied by coughing.

Some rare (may affect up to 1 in 1,000 people) or very rare (may affect up to 1 in 10,000 people) side effects can be serious:

• Bruising or bleeding,
• High fever or persistent sore throat,
• Allergic reaction with facial swelling, lip, tongue, or throat swelling, often associated with rash and itching, which can cause difficulty swallowing, low blood pressure, fainting,
• Wheezing and a feeling of tightness in the chest, shortness of breath (asthma symptoms),
• Sudden and severe headache, nausea, dizziness, numbness, or difficulty speaking (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, bleeding, or black stools, stomach ulcers (with or without bleeding and perforation),
• Yellowing of the skin or eyes (symptoms of hepatitis),
• Blood in the urine, excess protein in the urine, significantly reduced 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 side effects, inform your doctor immediately.

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

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

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

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

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

• Hypersensitivity, anaphylactic and pseudo-anaphylactic reactions (including sudden drop in blood pressure and shock),
• Asthma (including shortness of breath),
• Gastritis, gastrointestinal bleeding, vomiting blood, 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 affect up to 1 in 10,000 people):

• Disorientation,
• Depression,
• Insomnia,
• Nightmares,
• Irritability,
• Psychotic disorders,
• Numbness or tingling of hands or feet,
• Memory disorders,
• Seizures,
• Anxiety,
• Tremors,
• Aseptic meningitis,
• Taste or hearing disorders: blurred vision, double vision, tinnitus,
• Pneumonitis,
• Oral ulcers,
• Constipation,
• Esophageal ulcers (upper part of the digestive tract leading 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),
• Stroke,
• Hypertension, vasculitis,
• Colitis (including bloody colitis and exacerbation of ulcerative colitis, Crohn's disease), glossitis, esophageal disorders, intestinal stricture,
• Fulminant hepatitis, liver failure, hepatic necrosis,
• Hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal failure, papillary necrosis.

Frequency not known (frequency cannot be estimated from the available data):

• Concurrent 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. Any risk is more likely after taking high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment.

Inform your doctor if you experience any side effects, including those not listed in this leaflet.

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

Reporting side effects

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

Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

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

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olfen 75 SR

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

Do not use this medicine after the expiry date stated on the packaging.

The expiry date refers to the last day of the month.

Do not store above 25°C.

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

6. Contents of the pack and other information

What Olfen 75 SR contains

• The active substance is diclofenac sodium. Each prolonged-release tablet contains 75 mg of diclofenac sodium.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, hypromellose, talc, magnesium stearate, titanium dioxide (E 171), iron oxide red (E 172), macrogol 6000.

What Olfen 75 SR looks like and contents of the pack

Pink, round, biconvex, film-coated tablets with "75" engraved on one side and "SR" on the other.

The tablets are packaged in aluminum/PVC/PVDC blisters.

The pack contains 10 or 30 prolonged-release tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer/Importer

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80

31-546 Kraków

Merckle GmbH,

Ludwig-Merckle-Strasse 3

89143 Blaubeuren, Germany

To obtain more detailed information, contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., tel. +48 22 345 93 0

Date of last revision of the leaflet: