Olfen 50: detailed information

Package leaflet: Information for the patient

Olfen 50, 50 mg, coated tablets
Diclofenacum natricum
Please read carefully 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 any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Olfen 50 is and what it is used for
Important information before taking Olfen 50
How to take Olfen 50
Possible side effects
How to store Olfen 50
Contents of the pack and other information

1. What Olfen 50 is and what it is used for

Olfen 50 contains sodium diclofenac, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), with anti-rheumatic, anti-inflammatory, analgesic, and antipyretic properties. The mechanism of action of Olfen 50 involves inhibition of prostaglandin biosynthesis, which play a key role in the pathogenesis of inflammation, pain, and fever.
In adults, Olfen 50 may be used in the treatment of pain and inflammatory conditions in the following cases:

Acute joint inflammations (including acute gouty arthritis);
Chronic joint inflammations, particularly rheumatoid arthritis (chronic arthritis);
Ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
Juvenile rheumatoid arthritis (Still's disease);
Disorders associated with degenerative joint disease and spinal joint inflammations;
Rheumatic inflammatory conditions of soft tissues;
Pain caused by inflammatory states and edema following trauma or surgery, e.g.: after dental or orthopedic procedures;
Painful and inflammatory conditions in gynecology, e.g.: primary dysmenorrhea or adnexitis;
As an adjunctive treatment in severe, painful ear, nose, or throat infections, e.g.: pharyngitis and tonsillitis. According to general therapeutic principles, in the above-mentioned diseases, causal treatment should be applied first. Fever alone is not an indication for use.

If you have any doubts regarding the action or reasons for prescribing Olfen 50, please consult your doctor.
Monitoring examinations during treatment with Olfen 50
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 medicine, especially if treatment lasts longer than 4 weeks.
Regular blood tests should be performed during treatment if there are any disturbances in liver function, kidney function, or blood parameters.
Liver function (transaminase levels), kidney function (creatinine levels), and blood cell counts (white blood cells, red blood cells, and platelets) should be monitored. The treating physician will consider blood test results when deciding whether to discontinue treatment with Olfen 50 or adjust the dosage.

2. Information before using Olfen 50

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 50:

if the patient is allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6);
if the patient has ever experienced 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, they should consult a doctor for advice;
if the patient has active or previously diagnosed peptic ulcer disease of the stomach and (or) duodenum, gastrointestinal bleeding, symptoms related to blood in the stool, black stools, or perforation of the stomach; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory drugs;
during the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility");
if the patient has hepatic insufficiency;
if the patient has renal insufficiency;
if the patient has been diagnosed with heart disease and (or) cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischemic attack (mini-stroke), or arterial thrombosis or embolism in the heart or brain, or after 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 50 should not be used in patients in whom administration of acetylsalicylic acid or other drugs inhibiting prostaglandin synthesis may trigger an asthma attack, urticaria, or acute rhinitis.
If any of the above symptoms occur in the patient, they should inform their doctor and must not take Olfen 50 until the doctor confirms that this medicine is suitable for them.
Warnings and precautions
Before starting treatment with Olfen 50, discuss it with your doctor, pharmacist, or nurse.
Inform your doctor if:

the patient has ever developed a severe skin rash, skin peeling, blistering, and (or) mouth ulcers after taking Olfen 50 or other painkillers;
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, and the doctor decides to prescribe Olfen 50, the dose must not exceed 100 mg per day if treatment lasts longer than 4 weeks;
the medicine is used in patients with a history of gastrointestinal ulcers or in elderly patients. Diclofenac use may cause gastrointestinal bleeding, ulceration, or perforation (which may be fatal). These effects may be particularly dangerous when high doses of diclofenac are used. If any unusual gastrointestinal symptoms occur during treatment with Olfen 50 (especially gastrointestinal bleeding), the medicine should be discontinued immediately and the patient should contact their doctor;
the patient is taking Olfen 50 together with other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines, or certain antidepressants (see also "Olfen 50 and other medicines");
the patient has asthma or allergic rhinitis, nasal mucosal swelling (e.g. due to nasal polyps), chronic obstructive pulmonary disease, or chronic respiratory tract infections, as they are at higher risk of allergic reactions to diclofenac (worsening of asthma symptoms, Quincke's edema, 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);
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 inflammation (Crohn's disease); diclofenac may worsen the course of the disease;
the patient has kidney or liver disease; diclofenac may exacerbate the condition. Strict adherence to the doctor's recommendations regarding regular liver function tests is essential;
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 your doctor:

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

Before using Olfen 50, tell your doctor if the patient has recently undergone or is scheduled for surgery on the stomach or gastrointestinal tract, as Olfen 50 may sometimes impair intestinal wound healing after surgery.
The risk of adverse effects can be minimized by using the lowest effective dose for the shortest possible duration.
Use the lowest dose of Olfen 50 that relieves pain and (or) swelling, and use it for as short a time as possible to minimize the risk of adverse effects.
If at any time during treatment with Olfen 50 the patient develops symptoms indicating cardiovascular problems, such as chest pain, shortness of breath, weakness, or slurred speech, they should contact a doctor or emergency department immediately.
In very rare cases (especially at the beginning of treatment), Olfen 50, 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). At the first signs of rash, mucosal changes, or other symptoms of an allergic reaction, the medicine should be discontinued and the patient should contact their doctor.
In rare cases, Olfen 50, like other anti-inflammatory medicines, may cause allergic reactions, including anaphylactic and pseudoanaphylactic reactions, even if the medicine has not been used before.
Olfen 50 may mask 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 them about taking Olfen 50.
If any of the above warnings apply to the patient, they should inform their doctor before using Olfen 50.
Other special warnings
Avoid concomitant use of Olfen 50 with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-2) inhibitors.
Before using the medicine, inform your doctor or pharmacist about any of the above-mentioned conditions.
Use of medicines such as Olfen 50 may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
The medicine may transiently inhibit platelet aggregation.
Before taking Olfen 50, tell your doctor if the patient has recently undergone or is scheduled for surgery on the stomach or gastrointestinal tract, as Olfen 50 may sometimes impair intestinal wound healing after surgery.
If the patient has heart problems, has had a stroke, or suspects they are at risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, or smoking), they should discuss treatment options with their doctor or pharmacist.
Children and adolescents
Olfen 50 must not be used in children and adolescents under 14 years of age.
Elderly patients (aged 65 years and over)
Elderly patients may be more sensitive to the effects of Olfen 50. They should therefore follow the instructions in this leaflet, adhere carefully to the doctor's recommendations, and take the lowest effective dose that relieves symptoms. It is particularly important that elderly patients report any adverse effects to their doctor immediately.
Olfen 50 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 they plan to take.
Inform your doctor especially if the patient is taking 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 or ibuprofen),
Corticosteroids (medicines used to reduce inflammation),
Anticoagulants and medicines that inhibit platelet function,
Antidiabetic medicines, except insulin,
Methotrexate (a medicine used to treat certain cancers or joint inflammation),
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 levels),
Sulfinpyrazone (a medicine used to treat gout),
Voriconazole (a medicine used to treat fungal infections),
Mifepristone (a medicine used in gynecology),
Diclofenac resin.

Taking Olfen 50 with food and drink
Tablets should be swallowed whole with water, preferably during a meal. Do not divide or chew the tablets.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Do not take Olfen 50 if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Olfen 50 may cause kidney and heart function disturbances in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. During the first 6 months of pregnancy, Olfen 50 should not be used unless the doctor considers its use 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 the 20th week of pregnancy, use of Olfen 50 may cause kidney function disturbances 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 50, as this medicine may have harmful effects on the infant.
Your doctor will discuss with you the potential risks of using Olfen 50 during pregnancy and breastfeeding.
Fertility
Diclofenac may make it more difficult to become pregnant. Inform your doctor if you are planning pregnancy or have difficulty conceiving.
Driving and operating machinery
Do not drive or operate machinery if adverse effects such as visual disturbances, dizziness, vertigo, drowsiness, or other central nervous system disturbances occur while taking Olfen 50.
This medicine contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Olfen 50

This medicine should always be used exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.
Your doctor will tell you exactly how to use Olfen 50. Depending on the individual patient's response to treatment, your doctor may recommend a higher or lower dose. The general recommendation is that the doctor adjusts the dose individually for each patient and uses the lowest effective dose for the shortest possible duration. If you feel the medicine 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 50 for longer than necessary.

Adults

The recommended dose for adults is 1 to 3 tablets per day (50 to 150 mg of the active substance, sodium diclofenac), unless otherwise directed by your doctor.

In primary dysmenorrhoea, the daily dose is determined individually by the doctor. It usually ranges from 50 mg to 150 mg. Initially, 50 mg to 100 mg should be administered, and if necessary, the dose may be increased over several menstrual cycles up to the maximum daily dose of 200 mg. Treatment should begin at the onset of the first symptoms and, depending on their severity, continued for several days.

Children and adolescents

Olfen 50 at a dose of 50 mg in the form of coated tablets is not recommended for use in children and adolescents under 14 years of age.

Established cardiovascular disease or significant cardiovascular risk factors

Patients with established cardiovascular disease or significant risk factors for cardiovascular events should only be treated with diclofenac after careful assessment and only at doses ≤ 100 mg per day if treatment lasts longer than 4 weeks.

Renal function disorders

Olfen 50 is contraindicated in patients with renal failure.
No specific studies have been conducted in patients with renal function disorders; therefore, no specific dosage recommendations can be made. Caution is advised when administering Olfen 50 to patients with mild to moderate renal impairment.

Hepatic function disorders

Olfen 50 is contraindicated in patients with hepatic failure.
No specific studies have been conducted in patients with hepatic function disorders; therefore, no specific dosage recommendations can be made. Caution is advised when administering Olfen 50 to patients with mild to moderate hepatic impairment.

Method of administration

Tablets should be swallowed whole with food, not chewed or divided, and taken with a glass of water.

How long to use Olfen 50

Follow your doctor's instructions strictly. If you are using Olfen 50 long-term, you should regularly consult your doctor to ensure that no adverse effects have occurred. If in doubt, consult your doctor or pharmacist.

Overdose of Olfen 50

Overdose of Olfen 50 does not produce characteristic symptoms, but the following may occur: vomiting, gastrointestinal bleeding, diarrhoea, dizziness, tinnitus, or convulsions. In cases of severe poisoning, acute renal failure and liver damage may occur. If an overdose of Olfen 50 has been taken accidentally, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Medical assistance may be necessary.

Missed dose of Olfen 50

If you miss a dose, take one tablet as soon as you remember. If it is almost time for your 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 50

If you have any further questions about using 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.
You should immediately stop taking Olfen 50 and inform your doctor if any of the following occur:

Mild, painful abdominal cramps and tenderness beginning shortly after starting Olfen 50, 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,
Stomach discomfort, heartburn or upper abdominal pain,
Vomiting blood, blood in stools, blood in urine,
Skin disorders 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 body temperature,
Swelling of the face, feet or legs,
Severe migraine,
Chest pain associated with coughing.

The following adverse effects have been reported during treatment with Olfen 50:
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 effects may be severe:

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 sensation of chest tightness, breathlessness (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 signs 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) intestine,
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 adverse effects (may occur in up to 1 in 10 patients):

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

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

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

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

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

Very rare adverse effects (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 hearing disturbances, blurred vision, double vision, tinnitus,
Pneumonitis,
Oral 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,
Thrombocytopenia (decreased platelet count), leukopenia (decreased white blood cell count), 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, oesophageal disorders, membranous intestinal stricture, pancreatitis,
Fulminant hepatitis, hepatic 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 unknown (frequency cannot be estimated from available data):

Concurrent occurrence of chest pain and allergic reactions (symptoms of Kounis syndrome),
Ischaemic colitis,
Allergic skin reaction, which may present as round or oval redness and swelling of the skin, blisters and itching (erythema multiforme fixed). The skin in affected areas may also appear darker, which may persist after healing. Upon re-administration of the drug, erythema multiforme fixed 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 long-term treatment. Do not exceed the recommended dose or duration of treatment.
You should inform your doctor if any of the above adverse effects occur.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor, pharmacist or nurse.
If Olfen 50 is used for longer than a few weeks, regular medical check-ups should be arranged 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.: 22 49-21-301, fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Olfen 50

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging following:
EXP. The expiry date refers to the last day of the stated month.
The batch number on the packaging can be found after "Nr serii (Lot)" or "Lot".
Store below 25°C. Protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information
What Olfen 50 contains

The active substance is diclofenac sodium. Each tablet contains 50 mg of diclofenac sodium.
Other components are:
Tablet core: sodium carboxymethylstarch (type A), microcrystalline cellulose, sodium stearyl fumarate, colloidal anhydrous silica, talc, hypromellose.
Enteric coating: polymethacrylic acid copolymer and ethyl acrylate (1:1), 30% dispersion, talc, triethyl citrate.
Coloured coating: hypromellose, macrogol 6000, titanium dioxide (E 171), iron oxide yellow (E 172), quinoline yellow (E 104), talc.

What Olfen 50 looks like and contents of the pack
Yellow, biconvex film-coated tablets with bevelled edges, embossed with "mp" on one side and "O 50" on the other.
Aluminium/PVC/PVDC blister packs in a cardboard box.
Pack size: 20 tablets.

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

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

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