OLFEN 100 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Olfen 100 SR, 100 mg, prolonged-release capsules
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Olfen 100 SR and what is it used for
   1. Control tests during treatment with Olfen 100 SR
4. Important information before taking Olfen 100 SR
   1. Warnings and precautions
   2. Children and adolescents
   3. Elderly patients (65 years and older)
   4. Olfen 100 SR and other medicines
   5. You should especially inform your doctor about taking the following medicines:
   6. Taking Olfen 100 SR with food and drink
   7. Pregnancy, breastfeeding, and fertility
   8. Pregnancy
   9. Breastfeeding
   10. Fertility
   11. Driving and operating machinery
   12. The medicine contains lactose and sodium
   13. Lactose
   14. Sodium
5. How to take Olfen 100 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 100 SR
   8. Taking a higher dose of Olfen 100 SR than recommended
   9. Missing a dose of Olfen 100 SR
   10. Stopping treatment with Olfen 100 SR
6. Possible side effects
   1. You should stop taking Olfen 100 SR immediately and inform your doctor 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 100 SR
8. Contents of the packaging and other information
   1. What Olfen 100 SR contains
   2. What Olfen 100 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 attached to the packaging: patient information

Olfen 100 SR, 100 mg, prolonged-release capsules

Diclofenac sodium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Olfen 100 SR and what is it used for
• 2. Important information before taking Olfen 100 SR
• 3. How to take Olfen 100 SR
• 4. Possible side effects
• 5. How to store Olfen 100 SR
• 6. Contents of the packaging and other information

1. What is Olfen 100 SR and what is it used for

Olfen 100 SR contains diclofenac sodium, which belongs to a group of so-called non-steroidal anti-inflammatory drugs (NSAIDs), which have anti-rheumatic, anti-inflammatory, analgesic, and antipyretic effects. The mechanism of action of Olfen 100 SR involves the inhibition of prostaglandin biosynthesis, which plays a fundamental role in the pathogenesis of the inflammatory process, pain, and fever.

Olfen 100 SR can be used to treat pain and inflammatory conditions, including:

• Acute inflammatory joint conditions;
• Chronic inflammatory joint conditions, in particular 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 100 SR

In the case 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 the event 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 the blood tests when deciding to discontinue treatment with Olfen 100 SR or change the dose of the medicine.

In case of doubts about the action or reasons for prescribing Olfen 100 SR, you should consult a doctor.

2. Important information before taking Olfen 100 SR

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

When not to take Olfen 100 SR:

If any of the above symptoms occur, you should inform your doctor and not take Olfen 100 SR until the doctor determines that the medicine is suitable for you.

Warnings and precautions

Before starting treatment with Olfen 100 SR, you should discuss it with your doctor, pharmacist, or nurse.

You should inform your doctor if:

If you experience any unusual symptoms in the abdominal area (especially gastrointestinal bleeding), you should stop taking the medicine immediately and consult a doctor;

Before taking diclofenac, you should inform your doctor

The occurrence of side effects can be reduced by using the medicine in the smallest effective dose and for no longer than necessary. You should use the smallest dose of Olfen 100 SR that provides relief from pain and/or swelling and use it for the shortest time necessary to minimize the risk of side effects.

If at any point during treatment with Olfen 100 SR you experience symptoms indicating cardiovascular or cerebrovascular disorders, such as chest pain, shortness of breath, weakness, or slurred speech, you should immediately contact your doctor or hospital emergency department.

In very rare cases (especially at the beginning of treatment), Olfen 100 SR, like other anti-inflammatory medicines, 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 lesions, high fever, and severe general condition). After the first signs of rash, mucous membrane lesions, or other symptoms of an allergic reaction, you should stop taking the medicine and consult a doctor.

In rare cases, Olfen 100 SR, like other anti-inflammatory medicines, may cause allergic reactions, including anaphylactic and pseudo-anaphylactic reactions, even if the medicine has not been used before.

Olfen 100 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, you should inform them that you are taking Olfen 100 SR.

If any of the above warnings apply to you, you should inform your doctor before taking Olfen 100 SR.

Other special warnings

Olfen 100 SR should not be used at the same time as other systemically acting non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.

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

Taking medicines like Olfen 100 SR may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk is more likely to occur after taking high doses and long-term treatment. You should not exceed the recommended dose or treatment duration.

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), you should discuss your treatment with your doctor or pharmacist.

The medicine may temporarily inhibit platelet aggregation.

Before taking Olfen 100 SR, you should tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Olfen 100 SR may sometimes cause impaired wound healing in the intestines after surgery.

Children and adolescents

Olfen 100 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 100 SR.

Therefore, they should follow the instructions in the leaflet and the doctor's recommendations carefully and take the minimum dose of the medicine that provides relief from symptoms. It is especially important for patients to report any side effects to their doctor immediately.

Olfen 100 SR and other medicines

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

You should especially inform your doctor 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 medicines (such as acetylsalicylic acid/aspirin or ibuprofen),
• Corticosteroids (medicines used to alleviate inflammatory conditions),
• Anticoagulant medicines and platelet inhibitors,
• Antidiabetic medicines, except for 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),
• Colestyramine 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 100 SR with food and drink

The capsule should be swallowed whole, with a glass of 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 child, you should consult your doctor or pharmacist before taking this medicine. The doctor will discuss with you the potential risks of taking Olfen 100 SR during pregnancy and breastfeeding.

Pregnancy

You should not take Olfen 100 SR if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery. Olfen 100 SR may cause kidney and heart disorders in the unborn child. It may also increase the risk of bleeding in the mother and child and prolong labor. During the first 6 months of pregnancy, Olfen 100 SR should not be used 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, Olfen 100 SR may cause kidney disorders in the unborn child 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 child's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

You should not breastfeed if you are taking Olfen 100 SR, as the medicine may harm the baby.

Fertility

Diclofenac may make it more difficult to conceive. You should inform your doctor if you are planning to conceive or are having difficulty conceiving.

Driving and operating machinery

You should not drive or operate any machinery if you experience side effects while taking Olfen 100 SR, such as vision disturbances, dizziness, drowsiness, or other central nervous system disorders.

The medicine contains lactose and sodium

Lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

Sodium

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

3. How to take Olfen 100 SR

This medicine should always be taken as directed by your doctor. If you are unsure, you should consult your doctor or pharmacist.

Your doctor will tell you exactly how to take Olfen 100 SR. Depending on your individual response to treatment, your 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, you should consult your doctor.

Dosage

You should not exceed the recommended dose. It is important to use the smallest effective dose for the shortest possible period to control symptoms and not to use Olfen 100 SR for longer than necessary.

Your doctor will tell you exactly how to take Olfen 100 SR. Depending on your individual response to treatment, your doctor may recommend a higher or lower dose of the medicine.

Adults

The recommended initial daily dose is 100-150 mg.

The recommended dose for adults is 1 capsule per day (100 mg of diclofenac sodium), unless the doctor recommends otherwise.

If necessary, treatment may be combined with a dose of 25 mg or 50 mg in the form of tablets or suppositories to a maximum dose of 150 mg of diclofenac sodium per day.

Elderly patients (65 years and older)

When taking Olfen 100 SR in elderly patients, special caution should be exercised, and the smallest effective dose should be used for the shortest possible period to alleviate symptoms. Regular monitoring for the possibility of gastrointestinal bleeding is recommended.

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 only with doses ≤100 mg per day if treatment lasts longer than 4 weeks.

Kidney function disorders

Olfen 100 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 100 SR to patients with mild to moderate kidney function disorders.

Liver function disorders

Olfen 100 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 100 SR to patients with mild to moderate liver function disorders.

Children and adolescents

Olfen 100 SR should not be used in children and adolescents under 18 years of age.

Method of administration

The capsules should be swallowed whole, with a glass of water, preferably during a meal. Do not chew.

How long to take Olfen 100 SR

You should strictly follow your doctor's recommendations. If you are taking Olfen 100 SR for a long time, you should regularly consult your doctor to ensure that no side effects have occurred.

In case of doubts, you should consult your doctor or pharmacist.

Taking a higher dose of Olfen 100 SR than recommended

Overdose of Olfen 100 SR does not cause characteristic symptoms, but may cause: vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or seizures. In the case of significant poisoning, acute kidney failure and liver damage may occur. If you have accidentally taken a higher dose of Olfen 100 SR than recommended, you should inform your doctor, pharmacist, or go to the hospital emergency department immediately. Medical attention may be necessary.

Missing a dose of Olfen 100 SR

If you miss a dose, you should take it as soon as you remember. If it is almost time for your next dose, you should skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

Stopping treatment with Olfen 100 SR

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

4. Possible side effects

Like all medicines, Olfen 100 SR can cause side effects, although not everybody gets them.

Some side effects can be serious.

You should stop taking Olfen 100 SR immediately and inform your doctor if you experience:

• Mild, painful abdominal cramps and tenderness starting soon after taking Olfen 100 SR, 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 stool, blood in urine,
• Skin disorders 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 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 swelling, tongue swelling, throat swelling, and/or limb swelling, often associated with rash and itching, which can cause difficulty swallowing, low blood pressure, 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, formation of blisters on the lips, eyes, and mouth, skin inflammation with exfoliation or peeling,
• Severe stomach pain, bleeding, or black stools, stomach ulcers, and/or duodenal ulcers (with or without bleeding and perforation),
• Yellowing of the skin or eyes (symptoms of hepatitis),
• Blood in urine, excess protein in 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, you should 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, bloody vomiting, bloody diarrhea, black stools,
• Stomach and/or duodenal ulcers (with or without bleeding and perforation),
• Hepatitis, jaundice, liver function disorders,
• Drowsiness,
• Hives,
• Swelling.

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

• Disorientation,
• Depression,
• Sleep disturbances,
• Nightmares,
• Irritability,
• Psychotic disorders,
• Numbness or tingling of hands or feet,
• Memory disorders,
• Seizures,
• Anxiety,
• Tremors,
• Aseptic meningitis,
• Taste disorders,
• Vision 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 facial swelling),
• Stroke,
• Hypertension, vasculitis,
• Colitis (including bloody colitis and exacerbation of ulcerative colitis, Crohn's disease), tongue inflammation, 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, pruritus,
• Acute kidney failure, hematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency not known (frequency 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 is more likely to occur after taking high doses and long-term treatment. You should not exceed the recommended dose or treatment duration.

You should inform your doctor if you experience any of the above side effects.

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

If Olfen 100 SR is used for more than a few weeks, you should have regular check-ups with your doctor to ensure that no unnoticed side effects have occurred.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should 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: +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.

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

5. How to store Olfen 100 SR

The medicine should be stored out of 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 the month stated.

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

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Olfen 100 SR contains

• The active substance of the medicine is diclofenac sodium. Each prolonged-release capsule contains 100 mg of diclofenac sodium.
• The other ingredients are: capsule contents:lactose monohydrate, microcrystalline cellulose PH 102, microcrystalline cellulose, and sodium croscarmellose, glycerol triacetate, titanium dioxide (E 171), triethyl citrate, colloidal silicon dioxide, ammonium methacrylate copolymer (type B). capsule shell:gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), erythrosine (E 127). ink used for capsule printing: shellac, iron oxide black (E 172), propylene glycol (E 1520), ammonium hydroxide.

What Olfen 100 SR looks like and contents of the pack

White-pink, two-part capsules filled with white granules and printed with black ink "100".

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

The pack contains 10 or 20 prolonged-release capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer/Importer

Merckle GmbH,

Ludwig-Merckle-Str. 3

89143 Blaubeuren

Germany

Teva Operations Poland Sp. z o.o.,

ul. Mogilska 80

31-546 Kraków

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

Teva Pharmaceuticals Polska Sp. z o.o.,

tel. +48 22 345 93 00

Date of last revision of the leaflet: