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
medicinal product.
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 questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any 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 to treat pain and inflammation.
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 inflammation
• Chronic joint inflammation, 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 inflammation
• 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, consult your doctor.

2. Important information before using Olfen 100 SR

You must follow all instructions provided 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 gastrointestinal bleeding or perforation associated with the use of NSAIDs;
• during the last three months of pregnancy (see section "Pregnancy, 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 pain-relieving medicine (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). In such cases, asthma, rhinitis, chest pain, 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 procedures 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 it 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, 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 inflammation (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 pectoris, thrombosis, hypertension, elevated cholesterol levels, or elevated triglyceride levels.

Before using Olfen 100 SR, tell 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, inform the doctor 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.

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 when high doses are used or treatment is prolonged. 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 these conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking), discuss the treatment approach with your doctor or pharmacist.

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

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 drugs, 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 the doctor's advice particularly carefully and use the lowest effective dose that controls symptoms. It is especially important that elderly patients report any adverse effects to their doctor immediately.

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

It is especially 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 inhibitors or beta-blockers (a group of medicines used to treat hypertension 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 arthritis);
• Cyclosporine (a medicine used in organ transplant recipients);
• Antibacterial quinolones (medicines used to treat infections);
• Phenytoin (an antiepileptic 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 resin.

Pregnancy, breastfeeding and 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 function disorders in the unborn child. It may also increase the risk of bleeding in both mother and child and may 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 function disorders 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 for 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 have harmful effects on the infant.

Fertility
Diclofenac may make it more difficult to become pregnant. Inform your doctor if the patient is planning a pregnancy or is having difficulty conceiving.

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

This medicine contains lactose monohydrate and sodium

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

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

3. How to use Olfen 100 SR

This medicine should always be used as directed by the doctor. 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 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.
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 the active substance sodium diclofenac),
unless otherwise directed by the doctor.
If necessary, therapy may be supplemented with a dose of 25 mg or 50 mg in the form of tablets or rectal capsules, up to a maximum daily dose of 150 mg of the active substance sodium diclofenac.
Patients with renal or hepatic impairment
Dose adjustment is not necessary in patients with mild to moderate renal or hepatic impairment.
Elderly patients
When using Olfen 100 SR in elderly patients, particular caution is required and the lowest effective dose should be used for the shortest duration necessary to relieve symptoms. 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
The capsules should be swallowed whole before a meal, not chewed, with a glass of water.
Do not exceed the recommended dose.
How long to use Olfen 100 SR
Follow your doctor's instructions carefully.
Taking more than the recommended dose of Olfen 100 SR
If you accidentally take more than the recommended dose of Olfen 100 SR, inform your doctor or pharmacist immediately, or go 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 Olfen 100 SR
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some side effects may be serious.
You must stop taking Olfen 100 SR immediately and inform your doctor if 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 side effects 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 uncommon or very rare side effects may be serious:

• Bruising or purpura,
• 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 in 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, inability or difficulty speaking, 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, gastric or duodenal ulcer,
• 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
• Flatulence
• 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 sleeping
• Nightmares
• Irritability
• Psychotic disorders
• Tingling or numbness of hands or feet
• Memory disturbances
• Restlessness
• Tremor
• Taste disturbances
• Visual or hearing disturbances
• Lung inflammation
• Oral mucosal ulcers
• Constipation
• Oesophageal ulcers (upper part of the gastrointestinal tract conducting 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 side effects occur. If you experience any side effects, including any possible side effects not listed in this leaflet, consult your doctor, pharmacist or nurse.
If Olfen 100 SR is used for longer than a few weeks, regular check-ups with your doctor are recommended to ensure that no unrecognised side effects have occurred.
Reporting of side effects
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also 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
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Olfen 100 SR

Keep this medicine 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 stated month.
Translation of some abbreviations appearing on the immediate packaging:
Ch.-B. und Verw. bis: siehe Prägung – Batch number/expiry date: see imprint.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olfen 100 SR contains

• The active substance is sodium diclofenac. Each tablet contains 100 mg of sodium diclofenac.
• Excipients: monohydrate lactose, microcrystalline cellulose, sodium carmellose, glyceryl trimyristate, titanium dioxide, triethyl citrate, anhydrous colloidal silicon dioxide, ammonio methacrylate copolymer (type B)
  Coating: gelatin, titanium dioxide, black iron oxide, red iron oxide, erythrosine.
  Printing ink: shellac, black iron oxide, propylene glycol, ammonium hydroxide.

What Olfen 100 SR looks like and contents of the pack
Two-part, gelatinous, white-pink capsules filled with white granules and marked with black ink
"100".
PVC/PE/PVDC-Aluminum blisters in a cardboard box.
The pack contains 10 or 20 prolonged-release hard capsules.
For more detailed information, please contact the marketing authorisation holder or
parallel importer.
Marketing authorisation 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:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
German marketing authorisation number, country of export: 4369.00.03
Parallel import authorisation number: 131/22