OLFEN 100 mg Capsules

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.
3. Olfen 100 SR (Diclofenac-ratiopharm), 100 mg, prolonged-release hard capsules
   1. You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
4. What is Olfen 100 SR and what is it used for
5. Important information before taking Olfen 100 SR
   1. When not to take Olfen 100 SR:
   2. Children and adolescents
   3. Warnings and precautions
   4. Olfen 100 SR and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. The medicine contains lactose and sodium.
6. How to take Olfen 100 SR
   1. Dosage
   2. When and for how long to take Olfen 100 SR
   3. How long to take Olfen 100 SR
   4. Taking a higher dose of Olfen 100 SR than recommended
   5. Missing a dose of Olfen 100 SR
   6. Stopping treatment with Olfen 100 SR
7. Possible side effects
   1. The patient should stop taking Olfen 100 SR and contact their doctor immediately if they notice:
   2. Some rare or very rare side effects may be serious:
   3. Reporting side effects
8. How to store Olfen 100 SR
9. Contents of the packaging and other information
   1. What Olfen 100 SR contains
   2. What Olfen 100 SR looks like and what the packaging contains
   3. Marketing authorization holder in Hungary, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Parallel import authorization number: 115/22 Date of leaflet approval: 01.03.2022

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Olfen 100 SR (Diclofenac-ratiopharm), 100 mg, prolonged-release hard capsules

Diclofenac sodium
Olfen 100 SR and Diclofenac-ratiopharm are different trade names for the same medicine.

You should read the contents of the leaflet before taking 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.
• If the patient experiences any side effects, including any side effects 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 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 belongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammatory conditions.
Olfen 100 SR relieves symptoms of inflammatory conditions, such as swelling and pain. It does not affect the causes of inflammatory conditions and fever.
Olfen 100 SR may be used to treat pain and inflammatory conditions, in the case of:

• 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 soft tissues;
• painful swelling or inflammation after injury.

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 follow all the 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 100 SR:

• during the last three months of pregnancy (see section "Pregnancy, breastfeeding, and fertility");

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

Children and adolescents

Olfen 100 SR should not be used in children and adolescents.

Warnings and precautions

Before starting treatment with Olfen 100 SR, the patient should discuss it with their doctor, pharmacist, or nurse.
The patient should inform their doctor if:

• they are taking Olfen 100 SR at the same time as other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines, or certain antidepressants (see also "Olfen 100 SR and other medicines"),
• they have asthma or allergies,
• they have had gastrointestinal disorders in the past, such as stomach ulcers, bleeding, or black stools, or have experienced stomach discomfort or heartburn after taking NSAIDs in the past,
• they have inflammatory bowel disease (ulcerative colitis) or gastrointestinal disease (Crohn's disease),
• they have or have had heart problems or high blood pressure (see "Other special warnings" below),
• they have kidney or liver problems,
• they have foot swelling,
• they have bleeding disorders or other blood diseases, including a rare liver disease called porphyria.

Before taking diclofenac, the patient should inform their doctor

Before taking Olfen 100 SR, the patient should tell their doctor if they have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Olfen 100 SR may sometimes cause weakening of the intestinal wound healing process after surgery.
The occurrence of side effects can be limited by using the medicine in the smallest effective dose and for no longer than necessary.
If any of the above warnings apply to the patient, they should inform their doctor before taking Olfen 100 SR.
Other special warnings
Olfen 100 SR should not be taken at the same time as other systemic nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
Taking medicines like Olfen 100 SR may be associated with a slight increase in the risk of heart attack or stroke. The risk is more likely to occur after taking high doses and long-term treatment. The recommended dose or treatment duration should not be exceeded.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol levels, or smoking), the patient should discuss their treatment with their doctor or pharmacist.
Olfen 100 SR may reduce the symptoms of infection (e.g., headache, high temperature), making it more difficult to diagnose and treat the infection effectively. If the patient feels unwell and needs to see a doctor, they should inform them about taking Olfen 100 SR.
In very rare cases, 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). Therefore, the patient should inform their doctor if they experience such reactions. In rare cases, Olfen 100 SR, like other anti-inflammatory medicines, may cause allergic reactions, including severe allergic reactions, even if the medicine has not been taken before.
Elderly patients
Elderly patients may be more sensitive to the effects of Olfen 100 SR.
Therefore, they should follow their doctor's instructions carefully and take the minimum effective dose for the shortest necessary period to relieve symptoms. It is particularly important for patients to report any side effects to their doctor immediately.

Olfen 100 SR and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
It is particularly important to inform the doctor about taking any of the following medicines:

• Lithium or selective serotonin reuptake inhibitors (medicines used to treat certain types of depression),
• Digitalis 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 relieve inflammation),
• Anticoagulant medicines (medicines that prevent blood clotting),
• Antidiabetic medicines, except insulin,
• Methotrexate (a medicine used to treat certain cancers or arthritis),
• Cyclosporin (a medicine used in organ transplant patients),
• Quinolone antibacterials (medicines used to treat infections),
• Phenytoin (an antiepileptic medicine),
• Cholestyramine and colestipol (a medicine used to treat high cholesterol),
• Sulfinpyrazone (a medicine used to treat gout),
• Voriconazole (a medicine used to treat fungal infections),
• Mifepristone (a medicine used in gynecology).
• Diclofenac resin

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Olfen 100 SR should not be taken during the first and second trimesters of pregnancy, unless it is necessary. When taking diclofenac in women planning to become pregnant or in the first and second trimesters of pregnancy, the smallest possible dose and the shortest possible treatment duration should be used.
Olfen 100 SR should not be taken during the last three months of pregnancy, as it may harm the baby or cause delayed or accelerated labor.
Breastfeeding
The patient should not breastfeed while taking Olfen 100 SR, as the medicine may have a harmful effect on the baby.
Fertility
Diclofenac may make it more difficult to become pregnant. The patient should inform their doctor if they plan to become pregnant or have difficulty becoming pregnant.

Driving and using machines

The patient should not drive or operate any tools or machines if they 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 the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release hard 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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The doctor will tell the patient exactly how to take Olfen 100 SR. Depending on the individual patient's response to treatment, the doctor may recommend a higher or lower dose of the medicine.

Dosage

The patient should not exceed the recommended dose. It is important to use the smallest effective dose for the shortest necessary period to control symptoms and not to take Olfen 100 SR for longer than necessary.
The doctor will tell the patient exactly how to take Olfen 100 SR. Depending on the individual patient's response to treatment, the doctor may recommend a higher or lower dose of the medicine.
Adults
The recommended initial daily dose is 100 mg to 150 mg.
The recommended dose for adults is 1 capsule per day (100 mg of diclofenac sodium), unless the doctor recommends otherwise.
If necessary, therapy may be combined with a dose of 25 mg or 50 mg in the form of tablets or suppositories to a maximum daily dose of 150 mg of diclofenac sodium.
Patients with renal and hepatic impairment
In patients with mild and moderate renal or hepatic impairment, there is no need to adjust the dose.
Elderly patients
When taking Olfen 100 SR in elderly patients, special caution should be exercised, and the smallest effective dose should be used for the shortest necessary period to relieve symptoms. The possibility of gastrointestinal bleeding should be regularly monitored.
Children and adolescents
Olfen 100 SR should not be used in children and adolescents.

When and for how long to take Olfen 100 SR

The capsules should be swallowed whole before meals, without chewing, and washed down with a glass of water.
The patient should not exceed the recommended dose.

How long to take Olfen 100 SR

The patient should strictly follow their doctor's instructions.

Taking a higher dose of Olfen 100 SR than recommended

If the patient accidentally takes a higher dose of Olfen 100 SR than recommended, they should inform their doctor or pharmacist or go to the hospital emergency department immediately. Medical attention may be necessary.

Missing a dose of Olfen 100 SR

If the patient misses a dose, they should take it as soon as they remember. If it is almost time for the next dose, they should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Olfen 100 SR

If the patient has any further doubts about taking this medicine, they should consult their 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.

The patient should stop taking Olfen 100 SR and contact their doctor immediately if they notice:

• 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 onset (frequency not known - cannot be estimated from available data).
• Chest pain - chest pain that may be a sign of a potentially serious allergic reaction called Kounis syndrome.

During treatment with Olfen 100 SR, the following side effects have occurred with the following frequencies:
Very common: 1 in 10 patients; common: 1 to 10 in 100 patients; uncommon: 1 to 10 in 1000 patients; rare: 1 to 10 in 10,000 patients; very rare: less than 1 in 10,000 patients; frequency not known (frequency cannot be estimated from available data).

Some rare or very rare side effects may be serious:

• Bruising or bleeding,
• High fever or persistent sore throat,
• Allergic reaction with facial swelling, lip, mouth, tongue, or throat swelling, often associated with rash and itching, which can cause difficulty swallowing, low blood pressure, and fainting,
• Wheezing and feeling of chest tightness, shortness of breath (asthma symptoms),
• Chest pain (heart attack symptoms),
• Sudden and severe headache, 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 peeling or shedding of the skin,
• Severe stomach pain, bloody or black stools, bloody vomiting, stomach ulcer disease, and/or duodenal ulcer,
• 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 disorders),
• Decreased platelet count (thrombocytopenia)
• Decreased white blood cell count (leukopenia)
• Decreased neutrophil count (agranulocytosis).

If the patient experiences any of the above symptoms, they should inform their doctor immediately.
Common:occurs in 1 to 10 in 100 patients

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

Rare:occurs in 1 to 10 in 10,000 patients

• Drowsiness
• Hives
• Swelling.

Very rare:occurs in less than 1 in 10,000 patients

• Disorientation
• Depression
• Sleep disturbances
• Nightmares
• Irritability
• Psychotic disorders
• Numbness or tingling of hands or feet
• Memory disorders
• Anxiety
• Tremors
• Taste disorders
• Visual or hearing disturbances
• Pneumonia
• Oral ulcers
• Constipation
• Esophageal ulcers (upper part of the digestive tract leading food to the stomach)
• Palpitations
• Hair loss
• Redness, swelling, and blistering of the skin (due to increased sun sensitivity).
• Anemia (anemia)

Medicines like diclofenac may slightly increase the risk of heart attack or stroke. The risk is more likely to occur after taking high doses and long-term treatment. The recommended dose or treatment duration should not be exceeded.
The patient should inform their doctor if they experience any of the above side effects.
If the patient experiences any side effects, including any side effects not listed in the leaflet, they should consult their doctor, pharmacist, or nurse.
If Olfen 100 SR is taken for more than a few weeks, the patient should have regular check-ups with their doctor to ensure that no unnoticed side effects have occurred.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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
By reporting side effects, more information can be collected 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 packaging. The expiry date refers to the last day of the month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 tablet contains 100 mg of diclofenac sodium.
• Excipients: lactose monohydrate, microcrystalline cellulose, microcrystalline cellulose, and sodium carmellose, glycerol trimyristate, titanium dioxide (E 171), triethyl citrate, colloidal silica, hydrated ammonio methacrylate copolymer (type B) Capsule shell: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172). Ink: shellac, iron oxide black (E 172), propylene glycol (E 1520), ammonium hydroxide, and/or potassium hydroxide.

What Olfen 100 SR looks like and what the packaging contains

Capsule No. 1, orange cap, colorless body, filled with white to light yellow pellets, with black printing "Diclo. ret." on both halves.
Blisters with PVDC//Aluminum foil in a cardboard box.
The packaging contains 10 or 20 prolonged-release hard capsules.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Hungary, the country of export:

Teva Gyógyszergyár Zrt., 4042 Debrecen, Pallagi út 13., Hungary

Manufacturer:

Merckle GmbH, 89079 Ulm, Graf-Arco-Strasse 3., Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Hungarian, export country marketing authorization number: OGYI-T-5411/12

Parallel import authorization number: 115/22 Date of leaflet approval: 01.03.2022

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