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, prolonged-release capsules, hard
Diclofenacum natricum
Olfen 100 SR and Diclofenac-ratiopharm are different brand names for 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 the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents:

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, such as:

• Acute joint inflammations
• Chronic joint inflammations, particularly rheumatoid arthritis (chronic joint inflammation)
• Ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine
• 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 stomach or duodenal ulcer, 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 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 pain, skin rash, or facial swelling may occur. If the patient suspects an allergy, medical advice should be sought;
• if the patient has heart disease and/or cerebrovascular disease, e.g. after a heart attack, stroke, transient ischaemic attack, arterial embolism in the heart or brain, or after a procedure to unblock or bypass blocked blood vessels;
• if the patient has or has had circulatory disorders (peripheral vascular disease).

If any of the above symptoms apply to the patient, the doctor should be informed and the patient
should not take Olfen 100 SR until the doctor confirms that this medicine is suitable.
Children and adolescents
Olfen 100 SR should 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 stomach 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 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 disorders, including a 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, blood clots, high blood pressure, high cholesterol levels, or high triglyceride levels.

Before using Olfen 100 SR, inform your doctor if the patient has recently undergone or is scheduled
for surgery of 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 cyclooxygenase-2 inhibitors.
The use of medicines such as Olfen 100 SR may be associated with a small increased risk of heart
attack 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 suspects a risk of such 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 the symptoms of infection (e.g. headache, high fever), making the infection
harder to diagnose and treat effectively. If the patient feels unwell and needs to see a doctor, inform
the doctor about the use of 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, or toxic epidermal necrolysis with skin and mucous membrane lesions, high
fever, and severe general condition). Therefore, 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 used before.
Elderly patients
Elderly patients may be more sensitive to the effects of Olfen 100 SR. They should follow their
doctor's advice particularly carefully and take the lowest effective dose that relieves 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 conditions;
• Diuretics (medicines that increase urine output);
• 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 inflammatory conditions);
• Anticoagulants (medicines that prevent blood clotting);
• Antidiabetic medicines, except insulin;
• Methotrexate (a medicine used in the treatment of certain cancers or joint inflammation);
• Cyclosporine (a medicine used in organ transplant recipients);
• Antibacterial quinolones (medicines used to treat infections);
• Phenytoin (an anticonvulsant medicine);
• Colestipol and cholestyramine (anti-atherosclerotic 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
Olfen 100 SR should not be used during the first and second trimesters of pregnancy unless
necessary. If diclofenac is used in women planning pregnancy or during the first and second
trimesters of pregnancy, the lowest possible dose and the shortest possible duration of treatment
should be used.
Olfen 100 SR must not be used during the last three months of pregnancy, as it may harm the baby or cause delayed or accelerated labour.
Breastfeeding
Breastfeeding should not be undertaken if the patient is taking Olfen 100 SR, as this medicine may have harmful effects on the infant.
Fertility
Diclofenac may impair fertility. Inform your doctor if the patient is planning a pregnancy or has difficulty becoming pregnant.
Driving and operating machinery
Do not drive or operate any tools or machinery if adverse effects such as visual disturbances, dizziness, drowsiness, or other central nervous system disorders occur while taking Olfen 100 SR.
This medicine contains lactose and sodium.
Lactose
If the patient has previously been 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 hard capsule, meaning the medicine is considered "sodium-free".

3. How to use Olfen 100 SR

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will tell you exactly how to take Olfen 100 SR. Depending on the individual patient's
response to treatment, your 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 take Olfen 100 SR. Depending on the individual patient's
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 the active substance sodium
diclofenac), unless otherwise advised by your 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 required 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
Olfen 100 SR must not be used in children and adolescents.
When and for how long to use Olfen 100 SR
The 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
Strictly follow your doctor's instructions.
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 necessary.
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 usual 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 effects

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

• Mild, painful cramps and abdominal 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 effects have been reported during treatment with Olfen 100 SR at the following frequencies:
Very common: 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 effects 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 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, difficulty or inability to speak, paralysis (symptoms of stroke),
• Neck stiffness (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, markedly 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
• Dyspepsia
• 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

• Drowsiness
• 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 mucosal 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 when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.
You should inform your doctor if any of the above adverse effects occur.
If you experience any adverse effects, including any possible adverse 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-up visits with your doctor are recommended to ensure that no undetected adverse effects have occurred.
Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the 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.
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 packaging 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, microcrystalline cellulose and sodium carmellose, glyceryl trimyristate, titanium dioxide (E 171), triethyl citrate, colloidal anhydrous silica, ammonio methacrylate copolymer (type B).
  Coating composition: gelatin, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).
  Printing ink: shellac, black iron oxide (E 172), propylene glycol (E 1520), ammonium hydroxide and/or potassium hydroxide.

What Olfen 100 SR looks like and contents of the pack
Size 1 capsule, orange cap, colourless body, filled with white to pale yellow pellets, printed in black with "Diclo. ret." on both halves.
Blister packs made of PVDC//Aluminium foil in a cardboard box.
The pack contains 10 or 20 hard prolonged-release capsules.
For further information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Hungarian marketing authorisation number in the country of export: OGYI-T-5411/12
Parallel import licence number: 115/22