Package leaflet: information for the patient

Olfen 75 SR, 75 mg, prolonged-release coated tablets
Diclofenacum natricum
Please read this leaflet carefully 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 adverse effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Olfen 75 SR is and what it is used for
Important information before taking Olfen 75 SR
How to take Olfen 75 SR
Possible side effects
How to store Olfen 75 SR
Contents of the pack and other information

1. What Olfen 75 SR is and what it is used for

Olfen 75 SR contains sodium diclofenac, which belongs to a group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Olfen 75 SR involves inhibition of prostaglandin biosynthesis, which plays a key role in the pathogenesis of inflammation, pain, and fever.
Olfen 75 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;
Pain caused by traumatic and postoperative inflammatory conditions and swelling, e.g., following dental or orthopedic procedures;
Painful and/or inflammatory conditions in gynecology, e.g., primary dysmenorrhea or adnexitis.

Monitoring tests during treatment with Olfen 75 SR
In patients with diagnosed heart disease or significant risk factors for heart disease, the treating physician will periodically assess the patient's need for symptomatic treatment and response to the drug, especially if treatment lasts longer than 4 weeks.
During treatment, regular blood tests should be performed if there are any signs of liver function abnormalities, kidney function disturbances, or blood abnormalities. Liver function (transaminase levels), kidney function (creatinine levels), and blood cell counts (white and red blood cells and platelets) should be monitored. The treating physician will consider the results of blood tests when deciding whether to discontinue treatment with Olfen 75 SR or adjust the dosage.

2. Important information before using Olfen 75 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 75 SR:

if the patient is allergic to sodium diclofenac or to any of the other ingredients of this medicine (listed in section 6);
if the patient has ever had an allergic reaction after taking anti-inflammatory or pain-relieving medicines (e.g. acetylsalicylic acid, diclofenac, or ibuprofen). In such cases, asthma, rhinitis, skin rash, swelling of the face, lips, tongue, throat and (or) limbs (symptoms of angioedema), breathing difficulties, chest pain or any other allergic-type reactions may occur. If the patient suspects an allergy, medical advice should be sought;
if the patient has active or a history of peptic ulcer disease of the stomach and (or) duodenum, gastrointestinal bleeding, signs of blood in the stool, black stools or gastric perforation; or if the patient previously experienced stomach discomfort or heartburn after taking anti-inflammatory medicines;
if the patient is in the last trimester of pregnancy (see section "Pregnancy, breastfeeding and fertility");
if the patient has severe liver failure;
if the patient has severe renal failure;
if the patient has heart disease and (or) cerebrovascular disease, e.g. following myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or following a procedure to unblock or bypass obstructed blood vessels;
if the patient has current or previous circulatory disorders (peripheral vascular disease).

Like other non-steroidal anti-inflammatory drugs (NSAIDs), Olfen 75 SR should not be used in patients in whom administration of acetylsalicylic acid or other prostaglandin synthesis inhibitors may trigger an asthma attack, urticaria or acute rhinitis.

If any of the above symptoms apply to the patient, the doctor should be informed and Olfen 75 SR should not be taken until the doctor confirms that this medicine is suitable for the patient.

Warnings and precautions

Before starting treatment with Olfen 75 SR, discuss this with your doctor, pharmacist or nurse:

if the patient has ever experienced severe skin rash, skin peeling, blistering or oral ulcers after taking Olfen 75 SR or other pain-relieving medicines;
if the patient has diagnosed cardiovascular disease (see above) or significant risk factors such as high blood pressure, abnormally elevated blood lipid levels (cholesterol, triglycerides), or if the patient is a smoker. If the doctor decides to prescribe Olfen 75 SR, the dose should not exceed 100 mg per day if treatment lasts longer than 4 weeks;
if the medicine is used in patients with a history of gastrointestinal ulcers or in elderly patients. Use of diclofenac may cause gastrointestinal bleeding, ulceration or perforation (which may be fatal). This risk may be particularly dangerous when high doses of diclofenac are used. If any unusual abdominal symptoms (especially gastrointestinal bleeding) occur during treatment with Olfen 75 SR, the medicine should be discontinued immediately and the patient should contact their doctor;
if the patient is taking Olfen 75 SR concurrently with other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines or certain antidepressants (see also "Olfen 75 SR and other medicines");
if the patient has asthma, allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease (COPD) or chronic respiratory tract infections, as they are more likely to experience an allergic reaction to diclofenac (worsening of asthma symptoms, Quincke's oedema or urticaria). This warning also applies to patients allergic to other substances (e.g. those experiencing skin reactions, itching or urticaria). The medicine should be administered with particular caution (preferably under medical supervision);
if the patient has previously experienced gastrointestinal disorders, such as gastric ulcers, bleeding or black stools, or if the patient previously experienced stomach discomfort or heartburn after taking NSAIDs;
if the patient has inflammatory bowel disease (e.g. ulcerative colitis) or Crohn's disease, as diclofenac may worsen the course of the disease;
if the patient has impaired kidney or liver function; diclofenac may exacerbate the condition. The patient must strictly follow the doctor's recommendations regarding regular liver function tests;
if the patient has bleeding disorders or other blood diseases, including the rare liver disease called porphyria. Diclofenac may trigger an attack of porphyria.

Before taking diclofenac, inform the doctor:

if the patient smokes;
if the patient has diabetes;
if the patient has angina pectoris, thrombosis, hypertension, elevated cholesterol or elevated triglyceride levels.

The risk of adverse effects can be reduced by using the lowest effective dose for the shortest duration necessary. The lowest effective dose of Olfen 75 SR that relieves pain and (or) swelling should be used, and treatment should be continued for as short a time as possible to minimize the risk of adverse effects.

If at any time during treatment with Olfen 75 SR the patient experiences symptoms suggesting cardiovascular problems, such as chest pain, shortness of breath, weakness or slurred speech, immediate contact with a doctor or emergency hospital department is required.

In very rare cases (especially at the beginning of treatment), Olfen 75 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 extensive skin and mucosal lesions, high fever and severe general condition). If the first signs of rash, mucosal lesions or other symptoms of allergic reaction occur, the medicine should be discontinued and the doctor contacted immediately.

Rarely, Olfen 75 SR, like other anti-inflammatory medicines, may cause allergic reactions, including anaphylactic and pseudo-anaphylactic reactions, even if the product has not been used previously.

Olfen 75 SR may reduce the symptoms of infection (e.g. headache, high temperature), making the infection more difficult to diagnose and treat effectively. If the patient feels unwell and needs to see a doctor, they should inform the doctor about taking Olfen 75 SR.

If any of the above warnings apply to the patient, the doctor should be informed before using Olfen 75 SR.

Other special warnings

Do not take Olfen 75 SR together with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors.

Before taking the medicine, inform the doctor or pharmacist if any of the above conditions are present.

Medicines such as Olfen 75 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, a history of stroke, or suspects they are at risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol or smoking), the treatment should be discussed with the doctor or pharmacist.

The medicine may transiently inhibit platelet aggregation.

Before taking Olfen 75 SR, inform the doctor if the patient has recently undergone or is scheduled for surgery of the stomach or gastrointestinal tract, as Olfen 75 SR may sometimes impair wound healing in the intestines after surgery.

Children and adolescents

Olfen 75 SR should not be used in children and adolescents.

Elderly patients (aged 65 years and over)

Elderly patients may be more sensitive to the effects of Olfen 75 SR. They should therefore follow the instructions in the leaflet and the doctor's advice particularly carefully and use the lowest effective dose that relieves symptoms. It is especially important that elderly patients report any adverse effects to their doctor immediately.

Olfen 75 SR and other medicines

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

Tell the doctor especially if 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 (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 and medicines that inhibit platelet function,
Antidiabetic medicines, except insulin,
Methotrexate (a medicine used in the treatment of certain cancers or arthritis),
Cyclosporine and tacrolimus (medicines used in organ transplant recipients),
Trimethoprim (a medicine used to prevent and treat urinary tract infections),
Antibacterial quinolones (medicines used to treat infections),
Phenytoin (an anticonvulsant),
Colestipol and cholestyramine (medicines that lower blood cholesterol),
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.

Taking Olfen 75 SR with food and drink

Tablets should be swallowed whole with water, preferably during a meal.

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 a doctor or pharmacist before using this medicine.

Pregnancy

Do not take Olfen 75 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 75 SR may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.

During the first six months of pregnancy, Olfen 75 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 75 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 is required for longer than a few days, the doctor may recommend additional monitoring.

Breastfeeding

Do not breastfeed while taking Olfen 75 SR, as this medicine may have harmful effects on the infant.

The doctor will discuss with the patient the potential risks of using Olfen 75 SR during pregnancy and breastfeeding.

Fertility

Diclofenac may make it more difficult to become pregnant. Inform the doctor if the patient is planning a 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 disturbances occur while taking Olfen 75 SR.

The medicine contains lactose and sodium.

Lactose

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

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per modified-release coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Olfen 75 SR

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Your doctor will tell you exactly how to use Olfen 75 SR. Depending on the individual patient's response
to treatment, the doctor may recommend a higher or lower dose. The general recommendation is that
the doctor individually adjusts the dose for each patient and uses the lowest effective dose for the
shortest possible duration. If you feel the medicine's effect is too strong or too weak, consult your doctor.
Dosage
Do not exceed the recommended dose. It is important to use the lowest effective dose for the shortest
period necessary to control symptoms and not to use Olfen 75 SR longer than necessary.
Adults
The recommended dose is 1 to 2 tablets per day (75 to 150 mg of the active substance sodium diclofenac),
unless otherwise directed by the physician. If the patient takes more than one tablet per day, the dose
should be divided throughout the day and taken with food.
Children and adolescents
Olfen 75 SR should not be used in children and adolescents under 18 years of age.
Elderly patients (aged 65 years and above)
Olfen 75 SR should be used with caution in elderly patients. In elderly patients and those with low body
weight, the lowest effective dose is recommended.
Established cardiovascular disease or significant cardiovascular risk factors
Patients with established cardiovascular disease or significant cardiovascular risk factors should only
be treated with diclofenac after careful consideration and only at doses ≤ 100 mg per day if treatment
lasts longer than 4 weeks.
Renal function impairment
Olfen 75 SR is contraindicated in patients with severe renal impairment.
No specific studies have been conducted in patients with renal function impairment; therefore, no
specific dosage recommendations can be made. Caution is advised when administering Olfen 75 SR
to patients with mild to moderate renal impairment.
Hepatic function impairment
Olfen 75 SR is contraindicated in patients with severe hepatic impairment.
No specific studies have been conducted in patients with hepatic function impairment; therefore, no
specific dosage recommendations can be made. Caution is advised when administering Olfen 75 SR
to patients with mild to moderate hepatic impairment.
Method of administration
Tablets should be swallowed whole with water, preferably during a meal. Do not divide or chew the
tablet. Do not exceed the recommended dose.
How long to use Olfen 75 SR
Strictly follow your doctor's instructions. If using Olfen 75 SR long-term, regular contact with your doctor
is necessary to ensure no adverse effects have occurred. In case of doubt, consult your doctor or
pharmacist.
Use of a higher than recommended dose of Olfen 75 SR
Overdose with Olfen 75 SR does not produce characteristic symptoms, but the following may occur:
vomiting, gastrointestinal bleeding, diarrhea, dizziness, tinnitus, or convulsions. In cases of severe
poisoning, acute renal failure and liver damage may occur. If a higher than recommended dose of
Olfen 75 SR has been accidentally taken, inform your doctor or pharmacist immediately or go to the
hospital emergency department without delay. Medical assistance may be necessary.
Missed dose of Olfen 75 SR
If a dose is missed, take one tablet as soon as you remember. If it is almost time for the next dose, take
the next tablet at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Olfen 75 SR
If you have any further doubts regarding 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 experiences them.
You must immediately stop taking Olfen 75 SR and inform your doctor if any of the following occur:

Mild, painful cramps and abdominal tenderness appearing shortly after starting treatment with Olfen 75 SR, followed by rectal bleeding or bloody diarrhoea, usually occurring within 24 hours of the onset of abdominal pain (frequency not known – cannot be estimated from available data),
Chest pain – chest pain which may be a symptom of a potentially serious allergic reaction called Kounis syndrome,
Stomach discomfort, heartburn or upper abdominal pain,
Vomiting blood, blood in stool, blood in urine,
Skin reactions such as rash or itching,
Severe allergic skin reaction which may present as extensive red and (or) dark spots, skin swelling, blisters and itching (generalized bullous fixed drug eruption),
Wheezing or shortness of breath,
Yellowing of the skin or whites of the eyes,
Persistent sore throat or high fever,
Swelling of the face, feet or legs,
Severe migraine,
Chest pain associated with cough.

Some rare (may occur in up to 1 in 1,000 patients) or very rare (may occur in up to 1 in 10,000 patients) adverse reactions 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),
Sudden and severe headache, nausea, dizziness, numbness, inability or difficulty speaking, 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) intestines,
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 number of blood platelets (thrombocytopenia),
Decreased number of white blood cells (leukopenia),
Decreased number of neutrophils (agranulocytosis).

If any of the above symptoms occur, you should inform your doctor immediately.
Common adverse reactions (may occur in up to 1 in 10 patients):

Headache,
Dizziness,
Nausea,
Vomiting,
Diarrhoea,
Dyspepsia,
Abdominal pain,
Flatulence,
Loss of appetite,
Liver function abnormalities (e.g. increased aminotransferase activity),
Skin rash.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

Myocardial infarction,
Heart failure,
Chest pain (symptoms of heart attack),
Palpitations.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

Hypersensitivity, anaphylactic and pseudoanaphylactic reactions (including sudden drop in blood pressure and shock),
Asthma (including dyspnoea),
Gastritis, gastrointestinal bleeding, vomiting blood, bloody diarrhoea, tarry stools,
Peptic ulcer of the stomach and (or) duodenum (with or without bleeding and perforation),
Hepatitis, jaundice, liver function disorders,
Drowsiness,
Urticaria,
Oedema.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

Disorientation,
Depression,
Difficulty sleeping,
Nightmares,
Irritability,
Psychotic disorders,
Tingling or numbness of hands or feet,
Memory disturbances,
Seizures,
Anxiety,
Tremor,
Aseptic meningitis,
Taste disturbances,
Visual or auditory disturbances: blurred vision, double vision, tinnitus,
Lung inflammation,
Oral mucosal ulcers,
Constipation,
Oesophageal ulcers (upper part of the digestive tract leading food to the stomach),
Hair loss,
Redness, swelling and blistering of the skin (due to increased sensitivity to sunlight),
Anaemia (anaemia),
Thrombocytopenia (reduced number of blood platelets), leukopenia (reduced number of white blood cells in peripheral blood), anaemia (including haemolytic and aplastic anaemia), agranulocytosis (deficiency of white blood cells – neutrophils),
Angioedema (including facial swelling),
Stroke,
Hypertension, vasculitis,
Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis, Crohn's disease), glossitis, disorders of the oesophagus, membranous stricture of the intestines, pancreatitis,
Fulminant hepatitis, liver necrosis, liver failure,
Bullous rash, eczema, erythema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, alopecia, photosensitivity reactions, purpura, Schönlein-Henoch disease, pruritus,
Acute kidney failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis.

Frequency not known (frequency cannot be estimated from available data):

Simultaneous occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome),
Ischaemic colitis,
Allergic skin reaction which may present as round or oval red patches and skin swelling, blisters and itching (erythema multiforme). The affected skin areas may also have a darker colour, which may persist after healing. Upon re-administration of the drug, erythema multiforme usually reappears in the same locations.

Medicines such as diclofenac may slightly increase the risk of heart attack (myocardial infarction) or stroke. This risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. Inform your doctor if any of the above symptoms occur.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, consult your doctor, pharmacist or nurse.
If Olfen 75 SR is used for longer than a few weeks, regular check-up visits with your doctor are recommended 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 of Adverse Drug Reactions at the 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Olfen 75 SR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine Olfen 75 SR contains

The active substance is sodium diclofenac. Each prolonged-release coated tablet contains 75 mg of sodium diclofenac.
The other ingredients are: lactose monohydrate, microcrystalline cellulose, hypromellose, talc, magnesium stearate, titanium dioxide (E 171), iron oxide red (E 172), macrogol 6000.

What the medicine Olfen 75 SR looks like and contents of the pack
Pink, round, biconvex coated tablets, embossed with the code "75" on one side and "SR" on the other.
The tablets are packed in aluminium/PVC/PVDC blisters.
Pack sizes: 10 or 30 prolonged-release coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer/Importer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Poland
Merckle GmbH
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany

For further information, please contact the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., tel. +48 22 345 93 00

Olfen 75 sr