Olfen 100 Sr

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

Olfen 100 SR (Diclofenac-ratiopharm 100 mg Retard capsules)

100 mg, prolonged-release hard capsules

Diclofenac sodium
Olfen 100 SR and Diclofenac-ratiopharm 100 mg Retard capsules 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 as yours.
• 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 inflammation.
Olfen 100 SR relieves the symptoms of inflammatory conditions, such as swelling and pain. It does not affect the causes of inflammation and fever.
Olfen 100 SR may be used to treat pain and inflammation in the following cases:

• acute inflammatory joint diseases
• chronic inflammatory joint diseases, in particular rheumatoid arthritis (chronic joint inflammation);
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
• disorders that occur during degenerative joint disease and spinal inflammation;
• rheumatic inflammatory conditions of the 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:

• if the patient is allergic to diclofenac sodium or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has had stomach or duodenal ulcer, gastrointestinal bleeding, symptoms associated with the appearance of blood in the stool, black stools, or perforation of the stomach;
• if the patient has had bleeding or perforation of the intestines or stomach associated with the use of NSAIDs in the past;
• during the last three months of pregnancy (see section "Pregnancy and breastfeeding and fertility");
• if the patient has severe liver, kidney, or heart failure;
• if the patient has ever had an allergic reaction after taking an anti-inflammatory or analgesic medicine (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). In the above case, asthma, rhinitis, chest pain, skin rash, or facial swelling may occur. If the patient suspects an allergy, they should consult a doctor for advice;
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia, or occlusion of cardiac or cerebral blood vessels, or after a procedure to open or bypass blocked vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease).

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 to take Olfen 100 SR, you should discuss it with your doctor, pharmacist, or nurse.
You should inform your doctor if:

• the patient is 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")
• the patient has asthma or allergies
• the patient has had gastrointestinal disorders in the past, such as 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)
• the patient has or has had heart problems or high blood pressure (see "Other special warnings" below)
• the patient has kidney or liver problems
• the patient has foot swelling
• the patient has bleeding disorders or other blood diseases, including a rare liver disease called porphyria

Before taking diclofenac, you should inform your doctor

• if the patient smokes
• if the patient has diabetes
• if the patient has angina, blood clots, high blood pressure, high cholesterol, or high triglycerides

Before taking Olfen 100 SR, you should tell your doctor if the patient has recently undergone or is scheduled to undergo stomach or gastrointestinal surgery, as Olfen 100 SR may sometimes cause weakening of the intestinal 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 NSAIDs, including selective cyclooxygenase-2 inhibitors.
Taking medicines like Olfen 100 SR may be associated with a small increased risk of heart attack or stroke. Any risk is more likely after taking high doses and long-term treatment. You should not exceed the recommended dose or duration of treatment.
In case of heart problems, a history of stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, or smoking), you should discuss the treatment with your doctor or pharmacist.
Olfen 100 SR may reduce the symptoms of infection (e.g., headaches, high temperature), making it more difficult to diagnose and treat the infection effectively. In case of feeling unwell and needing to see a doctor, you should inform them about taking Olfen 100 SR.
In very rare cases, Olfen 100 SR, like other anti-inflammatory medicines, 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 changes, high fever, and severe general condition). Therefore, you should inform your doctor if such reactions occur. 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 people
Elderly patients may show greater sensitivity to the effects of Olfen 100 SR.
Therefore, they should follow their doctor's instructions particularly carefully and take the minimum effective dose of the medicine. 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 taking now or have taken recently, as well as any medicines you plan to take.
It is especially important to inform your doctor about taking any of 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 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),
• Cyclosporine (a medicine used in organ transplantation)
• 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 and breastfeeding and fertility

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

Pregnancy

You should not take Olfen 100 SR if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause complications during delivery. Olfen 100 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 cause delayed or prolonged labor. During the first 6 months of pregnancy, you should not take Olfen 100 SR unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest effective dose for the shortest possible time. From the 20th week of pregnancy, Olfen 100 SR may cause kidney problems in the unborn baby if taken for more than a few days - this may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, your 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 become pregnant. You should inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

You should not drive or operate any machines 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 monohydrate and sodium.

Lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact 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.

Dosage

You should not exceed the recommended dose. It is important to use the smallest effective dose for the shortest period necessary to control the symptoms and not to take 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 mg to 150 mg.
The recommended dose for adults is 1 capsule per day (100 mg of diclofenac sodium), unless your 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 dose of 150 mg of diclofenac sodium per day.
Patients with kidney and liver disorders
In patients with mild and moderate kidney or liver disorders, there is no need to adjust the dose.
Elderly patients
When taking Olfen 100 SR in elderly patients, you should exercise special caution and use the smallest effective dose for the shortest period necessary to relieve the symptoms. You should regularly monitor the possibility of gastrointestinal bleeding.
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. You should not exceed the recommended dose.

How long to take Olfen 100 SR

You should strictly follow your doctor's instructions.

Taking a higher dose of Olfen 100 SR than recommended

If you accidentally take a higher dose of Olfen 100 SR than recommended, you should inform your doctor or 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 take the next dose at the usual time. You should not take a double dose to make up for the missed dose.

Stopping 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 may be serious.

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

• Mild, painful abdominal cramps and tenderness starting soon after taking Olfen 100 SR, followed by rectal bleeding or black, tarry stools, usually within 24 hours of abdominal pain onset (frequency not known - cannot be estimated from the 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: more than 1 in 10 patients; common: 1 to 10 in 100 patients; uncommon: 1 to 10 in 1,000 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 the 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 (hypotension), and fainting
• Wheezing and feeling of chest tightness, shortness of breath (symptoms of asthma),
• Chest pain (symptoms of heart attack)
• Sudden and severe headaches, nausea, dizziness, numbness, or difficulty speaking, paralysis (symptoms of stroke)
• 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 and/or duodenal ulcer
• Yellowing of the skin or eyes (symptoms of hepatitis)
• Blood in the urine, excess protein in the urine, significant decrease in urine output (symptoms of kidney 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:occur 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:occur in 1 to 10 in 10,000 patients

• Drowsiness
• Hives
• Swelling

Very rare:occur 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 disorders
• 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 sensitivity to sunlight)
• Anemia (anemia)

Medicines like diclofenac may slightly increase the risk of heart attack or stroke. The risk of this is more likely after taking high doses and long-term treatment. You should not exceed the recommended dose or duration of treatment.
You should inform your doctor if you experience any of the above side effects.
If you experience any side effects, including any side effects not listed in this leaflet, you should consult your doctor or pharmacist or nurse.
If Olfen 100 SR is taken for more than a few weeks, you should ensure regular, monitoring visits to your doctor to make sure that no unnoticed side effects have occurred.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your 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, you can help 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.
The expiration date is the last day of the specified month.
Do not store above 25°C.

Translation of some abbreviations on the immediate packaging:

Ch.-B. und Verw. bis: see embossing - Batch number/expiry date: see embossing.
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 capsule contains 100 mg of diclofenac sodium.
• The other ingredients are: Capsule contents:lactose monohydrate, microcrystalline cellulose, microcrystalline cellulose and sodium carmellose, glycerol trimyristate, titanium dioxide, triethyl citrate, anhydrous colloidal silica, ammonio methacrylate copolymer (type B). Coating:gelatin, titanium dioxide, iron oxide red, iron oxide black, erythrosine. Ink used for capsule printing:shellac, iron oxide, propylene glycol, ammonium hydroxide.

What Olfen 100 SR looks like and what the packaging contains

White-pink, two-part capsules filled with white granules and printed with "100" in black.
PVC/PVDC/Aluminum blisters in a cardboard box.
The packaging contains 20 prolonged-release hard capsules.

Marketing authorization holder in Germany, the country of export:

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany

Manufacturer:

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren
Germany

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Germany, the country of export: 4369.00.03

Parallel import authorization number: 86/25

Date of leaflet approval: 05.03.2025

[Information about the trademark]