Olfen 100 sr

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Olfen 100 SR (Diclofenac-ratiopharm 100 mg Retardkapseln)
100 mg, prolonged-release capsules, hard
Diclofenacum natricum
Olfen 100 SR and Diclofenac-ratiopharm 100 mg Retardkapseln are different brand names of the
same medicine.
Please read the entire leaflet before using the medicine, as it contains important information
for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Olfen 100 SR is and what it is 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 pack and other information

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

Olfen 100 SR belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs),
which are used in the treatment of pain and inflammatory conditions.
Olfen 100 SR relieves symptoms of inflammatory conditions, such as swelling and pain. It does not affect
the underlying causes of inflammation or fever.
Olfen 100 SR may be used in the treatment of pain and inflammatory conditions in the following cases:

• acute joint inflammations
• chronic joint inflammations, particularly rheumatoid arthritis (chronic joint inflammation)
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic spinal disorders
• disorders arising from degenerative joint disease and spinal joint inflammations
• rheumatic inflammatory conditions of soft tissues
• painful swelling or inflammation following injury

If you have any doubts regarding the action or reasons for prescribing Olfen 100 SR, please consult your doctor.

2. Important information before using Olfen 100 SR

You must 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 use Olfen 100 SR:

• if the patient is allergic to sodium diclofenac or any of the other ingredients of this medicine (listed in section 6);
• if the patient has or has had peptic ulcer disease of the stomach and/or duodenum, gastrointestinal bleeding, symptoms related to blood in the stool, black stools, or gastric perforation;
• if the patient has previously experienced intestinal or gastric bleeding or perforation associated with the use of NSAIDs;
• during the last three months of pregnancy (see section "Pregnancy, breastfeeding and effects on fertility");
• if the patient has severe liver, kidney, or heart failure;
• if the patient has ever experienced an allergic reaction after taking an anti-inflammatory or pain-relieving medicine (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). In such cases, asthma, rhinitis, chest tightness, skin rash, or facial swelling may occur. If the patient suspects an allergy, medical advice should be sought;
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack, or arterial embolism in the heart or brain, or after a procedure to unblock or bypass obstructed blood vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease).

If any of the above conditions apply to the patient, the doctor should be informed and Olfen 100 SR must not be taken until the doctor confirms that this medicine is suitable for the patient.

Children and adolescents
Olfen 100 SR must not be used in children and adolescents.

Warnings and precautions
Before starting treatment with Olfen 100 SR, discuss this with your doctor, pharmacist, or nurse.

Inform your doctor if:

• the patient is taking Olfen 100 SR together with 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 previously experienced gastrointestinal disorders, such as gastric ulcers, bleeding, or black stools, or has had 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 ever had heart problems or high blood pressure (see "Other special warnings" below);
• the patient has kidney or liver problems;
• the patient has swelling of the feet;
• the patient has bleeding disorders or other blood diseases, including the rare liver disease called porphyria.

Before taking diclofenac, inform your doctor:

• if the patient smokes;
• if the patient has diabetes;
• if the patient has angina, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

Before using Olfen 100 SR, inform your doctor if the patient has recently undergone or is scheduled for surgery on the stomach or gastrointestinal tract, as Olfen 100 SR may sometimes impair wound healing in the intestines after surgery.

The risk of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary.

If any of the above warnings apply to the patient, the doctor should be informed before using Olfen 100 SR.

Other special warnings
Do not take Olfen 100 SR together with other systemic non-steroidal anti-inflammatory drugs, including selective COX-2 inhibitors.

The use of medicines such as Olfen 100 SR may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. The risk is greater with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.

If the patient has heart problems, has had a stroke, or is at risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking), discuss treatment options with your doctor or pharmacist.

Olfen 100 SR may reduce symptoms of infection (e.g. headache, high fever), making infections harder to diagnose and treat effectively. If the patient feels unwell and needs to see a doctor, inform them about taking Olfen 100 SR.

Very rarely, 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, or toxic epidermal necrolysis with skin and mucous membrane lesions, high fever, and severe general condition). Therefore, inform your doctor immediately if such reactions occur. Rarely, Olfen 100 SR, like other anti-inflammatory medicines, may cause allergic reactions, including severe allergic reactions, even if the medicine has not been used before.

Elderly patients
Elderly patients may be more sensitive to the effects of Olfen 100 SR. They should therefore follow medical advice particularly carefully and use the lowest effective dose needed to relieve symptoms. It is especially important that elderly patients report any adverse effects to their doctor immediately.

Olfen 100 SR and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.

It is particularly important to inform your doctor if the patient is 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 in the treatment of heart disease;
• Diuretics (medicines that increase urine output);
• Angiotensin-converting enzyme (ACE) inhibitors or beta-blockers (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 reduce inflammation);
• Anticoagulants (medicines that prevent blood clotting);
• Antidiabetic medicines, except insulin;
• Methotrexate (a medicine used in the treatment of certain cancers or rheumatoid arthritis);
• Cyclosporine (a medicine used in organ transplant recipients);
• Antibacterial quinolones (medicines used to treat infections);
• Phenytoin (an anticonvulsant medicine);
• Colestipol and cholestyramine (cholesterol-lowering medicines);
• Sulfinpyrazone (a medicine used in the treatment of gout);
• Voriconazole (a medicine used to treat fungal infections);
• Mifepristone (a medicine used in gynaecology);
• Diclofenac resinate.

Pregnancy, breastfeeding and effects on fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Do not take Olfen 100 SR if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Olfen 100 SR may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in both mother and child and delay or prolong labour. During the first 6 months of pregnancy, Olfen 100 SR should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From week 20 of pregnancy, Olfen 100 SR may cause kidney problems in the unborn child if taken for longer than a few days – this may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment lasting longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding
Do not breastfeed while taking Olfen 100 SR, as this medicine may harm the infant.

Fertility
Diclofenac may impair fertility. Inform your doctor if the patient is planning pregnancy or has difficulty becoming pregnant.

Driving and operating machinery
Do not drive or operate any machinery if adverse effects such as visual disturbances, dizziness, drowsiness, or other central nervous system disorders occur during treatment with Olfen 100 SR.

This medicine contains lactose monohydrate and sodium.

Lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

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

3. How to use Olfen 100 SR

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
Your doctor will tell you exactly how to use 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
Do not exceed the recommended dose. It is important to use the lowest effective dose for the
shortest duration necessary to control symptoms, and not to use Olfen 100 SR for longer than
necessary.
Your doctor will tell you exactly how to use 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 active substance sodium diclofenac),
unless otherwise directed by the doctor.
If necessary, therapy may be supplemented with 25 mg or 50 mg tablets or rectal capsules, up to a
maximum daily dose of 150 mg of active substance sodium diclofenac.
Patients with renal or hepatic impairment
Dose adjustment is not required in patients with mild to moderate renal or hepatic impairment.
Elderly patients
When using Olfen 100 SR in elderly patients, particular caution should be exercised and the lowest
effective dose should be used for the shortest duration necessary to relieve symptoms. The possibility
of gastrointestinal bleeding should be monitored regularly.
Children and adolescents
Do not use Olfen 100 SR in children and adolescents.
When and how long to use Olfen 100 SR
Capsules should be swallowed whole before food, without chewing, with a glass of water.
Do not exceed the recommended dose.
How long to use Olfen 100 SR
Follow your doctor's instructions strictly.
Use of a higher than recommended dose of Olfen 100 SR
If you have accidentally used more than the recommended dose of Olfen 100 SR, inform your
doctor or pharmacist immediately or go straight to the nearest hospital emergency department.
Medical assistance may be required.
Missed dose of Olfen 100 SR
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the
missed dose and take the next dose at the regular time. Do not take a double dose to make up for a
missed dose.
Stopping treatment with Olfen 100 SR
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious.
You must stop taking Olfen 100 SR immediately and inform your doctor if any of the following occur:

• Mild, painful abdominal cramps and tenderness beginning shortly after starting treatment with Olfen 100 SR, followed by rectal bleeding or bloody diarrhoea, usually within 24 hours of the onset of abdominal pain (frequency unknown – cannot be estimated from available data).
• Chest pain – chest pain which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

The following adverse reactions have been reported during treatment with Olfen 100 SR, 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 available data).
Some of the rare or very rare adverse reactions may be serious:

• Petechiae or bruising
• High fever or persistent sore throat
• Allergic reaction with swelling of the face, lips, mouth, tongue or throat, often associated with rash and itching, which may cause difficulty swallowing, hypotension (low blood pressure), fainting
• Wheezing and feeling of tightness in the chest, shortness of breath (symptoms of asthma)
• Chest pain (symptoms of heart attack)
• Sudden and severe headache, nausea, dizziness, numbness, difficulty or inability to speak, paralysis (symptoms of stroke)
• Stiff neck (symptoms of meningitis)
• Seizures
• High blood pressure (hypertension)
• Red or purple skin (possible symptoms of vasculitis), blistering rash, formation of blisters on lips, eyes and mouth, skin inflammation with peeling or erosion of the epidermis
• Severe stomach pain, bloody or black stools, vomiting blood, peptic ulcer of the stomach and/or duodenum
• Yellowing of the skin or eyes (symptoms of hepatitis)
• Blood in urine, excess protein in urine, significantly reduced urine output (symptoms of kidney dysfunction)
• Decreased platelet count (thrombocytopenia)
• Decreased white blood cell count (leukopenia)
• Decreased neutrophil count (agranulocytosis)

If any of the above symptoms occur, you should inform your doctor immediately.
Common: occur in 1 to 10 in 100 patients

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

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

• Somnolence
• Urticaria
• Oedema

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

• Disorientation
• Depression
• Difficulty falling asleep
• Nightmares
• Irritability
• Psychotic disorders
• Tingling or numbness in hands or feet
• Memory disturbances
• Restlessness
• Tremor
• Taste disturbances
• Visual or hearing disturbances
• Lung inflammation
• Oral ulcers
• Constipation
• Oesophageal 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)
• Anaemia

Medicines such as diclofenac may slightly increase the risk of heart attack or stroke. This risk is more likely with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment.
Inform your doctor if any of the above adverse reactions occur.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, consult your doctor, pharmacist or nurse.
If Olfen 100 SR is used for longer than a few weeks, regular medical check-ups should be arranged to ensure that no undetected adverse reactions have occurred.
Reporting of adverse reactions
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Olfen 100 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 indicated.
Do not store above 25°C.
Translation of some information on the immediate packaging:
Ch.-B. und verwendbar bis: siehe Prägung - Batch number and expiry date: see embossing
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Olfen 100 SR contains

• The active substance is sodium diclofenac. Each prolonged-release hard capsule contains 100 mg of sodium diclofenac.
• Other ingredients are:
  Capsule contents: monohydrate lactose, microcrystalline cellulose, microcrystalline cellulose and sodium carmellose, glycerol trimyristate, titanium dioxide (E 171), triethyl citrate, colloidal hydrated silica, ammonio methacrylate copolymer (type B).
  Capsule shell composition: gelatin, titanium dioxide (E 171), iron oxide red (E 172), iron oxide black (E 172), erythrosine.
  Printing ink composition: shellac, iron oxide black (E 172), propylene glycol, ammonium hydroxide.

What Olfen 100 SR looks like and contents of the pack
Hard gelatin capsule with a pink cap and a white, opaque body, printed with "100". The capsule contains pellets ranging in color from white to pale yellow.
PVC-Aluminum blisters in a cardboard box.
Pack contains 10 or 20 prolonged-release hard capsules.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization holder in Germany, country of export:
ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Manufacturer:
Merckle GmbH, Ludwig-Merckle-Str. 3, 89143 Blaubeuren, Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, country of export: 4369.00.03
Parallel import authorization number: 373/21