Olfen 75

Leaflet accompanying the packaging: patient information

Olfen 75, (37.5 mg + 10 mg)/ml, solution for injection

Diclofenac sodium + Lidocaine hydrochloride monohydrate

You should read the leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Olfen 75 and what is it used for
• 2. Important information before using Olfen 75
• 3. How to use Olfen 75
• 4. Possible side effects
• 5. How to store Olfen 75
• 6. Contents of the packaging and other information

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

Olfen 75 belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs), which are used to treat pain and inflammation.
Olfen 75 is intended for intramuscular injection and is administered only by qualified medical personnel.
Olfen 75 relieves symptoms of inflammatory conditions, such as swelling and pain. It does not affect the causes of inflammation and fever.
Olfen 75 can be used to treat severe pain and inflammation in cases of:

• acute inflammatory joint diseases (including acute gout);
• chronic inflammatory joint diseases, in particular rheumatoid arthritis (chronic joint inflammation);
• ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
• disorders resulting from degenerative joint disease and spinal inflammation;
• rheumatic inflammatory conditions of the soft tissues;
• painful swelling or inflammation after injury;
• renal or hepatic colic. In case of doubts about the action or reasons for prescribing Olfen 75, you should consult a doctor.

2. Important information before using Olfen 75

You should 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:

• if you are allergic to diclofenac or lidocaine hydrochloride monohydrate or any of the other ingredients of this medicine (listed in section 6),

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• if you have active or have had in the past stomach or intestinal ulcers, bleeding, or perforation; if you have experienced discomfort in the stomach area or heartburn after taking anti-inflammatory medicines,
• if you have had in the past bleeding or perforation of the intestines or stomach related to the use of NSAIDs,
• during the last three months of pregnancy (see "Pregnancy, breastfeeding, and fertility"),
• if you have severe liver, kidney, or heart failure,
• if you have had blood disorders and coagulation of unknown etiology,
• if you have had active bleeding from cerebral or other vessels,
• if you have had an allergic reaction after taking an anti-inflammatory or analgesic medicine (e.g., acetylsalicylic acid, diclofenac, or ibuprofen). In the above case, asthma, chest pain, runny nose, rash, or facial swelling may occur. If you suspect an allergy, you should consult a doctor,
• if you have had heart disease and/or cerebrovascular disease, e.g., after a heart attack, stroke, transient cerebral ischemia (mini-stroke), or vascular occlusion of the heart or brain, or after a procedure to clear blocked vessels,
• if you have had circulatory disorders (peripheral vascular disease),
• children and adolescents under 18 years of age.

Due to the presence of lidocaine, the solution for injection is contraindicated in cases of:

• hypersensitivity to lidocaine or local anesthetics of the amide type,
• severe conduction disorders of the heart,
• bradycardia,
• cardiogenic or hypovolemic shock.

If any of the above symptoms occur in you, you should inform your doctor and not take Olfen 75 until your doctor decides that the medicine is suitable for you.

Warnings and precautions

You should discuss the use of Olfen 75 with your doctor, pharmacist, or nurse before starting treatment.
You should inform your doctor if:

• you are taking Olfen 75 at the same time as other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines, or certain antidepressants (see also "Olfen 75 and other medicines"). In the case of such patients, the use of diclofenac is associated with an increased risk of hypersensitivity reactions;
• you are in the first or second trimester of pregnancy;
• you are breastfeeding;
• you have hay fever, nasal polyps, or chronic obstructive pulmonary disease, which are a group at increased risk of allergic reactions. They may manifest as asthma attacks (so-called analgesic asthma), angioedema, or urticaria;
• you have had gastrointestinal disorders in the past, such as stomach ulcers, bleeding, or black stools, or you have experienced stomach discomfort or heartburn after taking NSAIDs in the past;
• you have inflammatory bowel disease (ulcerative colitis) or gastrointestinal disease (Crohn's disease);
• you have hypertension and/or heart failure (see "Other special warnings" below);
• you have kidney or liver problems;
• you have foot swelling;

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• you have bleeding disorders or other blood diseases, including a rare liver disease called porphyria, in patients who have recently undergone major surgery;
• you have myasthenia (rapid fatigue and muscle weakness).

Before taking diclofenac, you should inform your doctor:

• if you smoke;
• if you have diabetes;
• if you have angina pectoris, thrombosis, hypertension, elevated cholesterol, or elevated triglycerides.

Before using Olfen 75, you should tell your doctor if you have recently undergone or are scheduled to undergo stomach or gastrointestinal surgery, as Olfen 75 may sometimes cause impaired wound healing in the intestines after surgery.
You should strictly follow the recommendations for administering the intramuscular injection to avoid side effects at the injection site, which can lead to muscle weakness, muscle paralysis, decreased sensation, and necrosis at the injection site.
The occurrence of side effects can be limited by using the medicine in the smallest effective dose and for no longer than necessary.
If any of the above warnings apply to you, you should inform your doctor before using Olfen 75.
Other special warnings
Due to the presence of lidocaine, Olfen 75 should be used with particular caution in patients with myasthenia.
Olfen 75 should not be used at the same time as other systemically acting non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors.
The use of medicines such as Olfen 75 may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely after taking high doses and long-term treatment. You should not exceed the recommended dose or treatment duration.
In case of heart problems, stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, elevated cholesterol, or smoking), you should discuss the treatment with your doctor or pharmacist.
Olfen 75 may mask the symptoms of infection (e.g., headache, high temperature), making it more difficult to diagnose and treat the infection. If you feel unwell and need to see a doctor, you should inform them that you are taking Olfen 75.
In very rare cases, Olfen 75, like other anti-inflammatory medicines, may cause severe allergic skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome with widespread rash, high fever, and pain in the joints, as well as toxic epidermal necrolysis with skin and mucous membrane changes, high fever, and severe general condition). Therefore, you should inform your doctor if you experience such reactions. In rare cases, Olfen 75, like other anti-inflammatory medicines, may cause allergic reactions, including anaphylactic and pseudo-anaphylactic reactions, even if the product has not been used before.
Special precautions should be taken in patients with asthma, taking diclofenac parenterally due to the possibility of exacerbating asthma symptoms.
Olfen 75 should be administered only after careful consideration of the benefit-risk ratio in cases of:

• inborn errors of porphyrin metabolism (e.g., acute intermittent porphyria);

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• systemic lupus erythematosus (SLE) and mixed connective tissue disease (mixed connective tissue disease).

Elderly
No dose adjustment is required.
Due to the profile of possible side effects, elderly patients should be closely monitored.
Elderly patients may be more sensitive to the effects of Olfen 75. Therefore, they should follow their doctor's recommendations very carefully and take the minimum dose of the medicine that ensures the relief of symptoms. It is particularly important for patients to report side effects to their doctor immediately.

Children and adolescents

Olfen 75 should not be used in children and adolescents under 18 years of age.

Olfen 75 and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
It is particularly important to inform your doctor about 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 to treat heart diseases,
• Diuretics (medicines that increase the amount of urine excreted),
• Angiotensin-converting enzyme inhibitors or beta-adrenergic blockers (a group of medicines used to treat hypertension and heart failure),
• Other antihypertensive medicines,
• Other anti-inflammatory medicines (such as acetylsalicylic acid or ibuprofen),
• Corticosteroids (medicines used to relieve inflammation),
• Anticoagulant medicines (medicines that prevent blood clotting),
• Antidiabetic medicines, except insulin,
• Methotrexate (a medicine used to treat certain cancers or arthritis),
• Cyclosporin (a medicine used in organ transplant patients),
• Quinolone antibacterials (medicines used against infections),
• Phenytoin (an antiepileptic medicine),
• Colestyramine and colestipol (an anti-cholesterol medicine),
• Sulfinpyrazone (a medicine used to treat gout),
• Probenecid (a diuretic medicine),
• Sulfonylurea derivatives,
• Voriconazole (a medicine used to treat fungal infections),
• Mifepristone (a medicine used in gynecology).

Lidocaine used at the same time as anti-arrhythmic medicines, beta-adrenergic blockers, or calcium antagonists may exhibit additional inhibitory effects on atrioventricular conduction, conduction of the cardiac impulse, and contractile force.

Olfen 75 with food, drink, and alcohol

Taking non-steroidal anti-inflammatory medicines (NSAIDs), including Olfen 75, and alcohol at the same time may increase the risk of side effects associated with the administration of the medicine (in particular, those related to the gastrointestinal system or the central nervous system).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
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Pregnancy

You should not take Olfen 75 if you are in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. Olfen 75 may cause kidney and heart problems in the unborn child. It may also increase the risk of bleeding in you and your child and prolong labor. During the first six months of pregnancy, you should not use Olfen 75 unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time. From the 20th week of pregnancy, Olfen 75 may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a low level of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is required for a longer period, your doctor may recommend additional monitoring.

Breastfeeding

You should not breastfeed if you are taking Olfen 75, as the medicine may have a harmful effect on the baby.

Fertility

Diclofenac may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.

Driving and using machines

You should not drive vehicles or operate any machines if you experience side effects while taking Olfen 75, such as vision disturbances, dizziness, dizziness of the labyrinth type, or drowsiness or other central nervous system disorders.

The medicine contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per 2 ml of solution (in one ampoule), which means the medicine is considered "sodium-free".

The medicine contains propylene glycol

The medicine contains 480 mg of propylene glycol in each 2 ml ampoule.

3. How to use Olfen 75

This medicine should always be used as directed by your doctor, pharmacist, or nurse. If you are unsure, you should consult your doctor, pharmacist, or nurse.
Olfen 75 is administered only by qualified medical personnel.
Your doctor will decide when and how to use Olfen 75. The medicine should be administered intramuscularly. The injection is usually given in the buttock.
It is essential that your doctor uses the lowest effective dose to control pain for the shortest possible period.
Exceptionally, in severe cases (e.g., colic pain), the daily dose may be increased to two injections of 75 mg, at an interval of several hours (one injection in each buttock). One 75 mg ampoule can also be administered in combination with another form of Olfen (tablets, suppositories), without exceeding a total daily dose of 150 mg.

Dosage

Adults
Olfen 75 is particularly indicated when rapid control of symptoms is required or when treatment with oral or rectal products is not possible. Olfen 75 should be administered as a single intramuscular injection (75 mg of diclofenac sodium).
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Olfen 75 should not be used for more than 2 days. If further treatment is necessary, other forms of the medicine should be used, i.e., oral or rectal. You should not exceed the maximum daily dose of 150 mg of diclofenac sodium.
Children and adolescents
Olfen 75 should not be used in children and adolescents under 18 years of age.

Using a higher dose of Olfen 75 than recommended

If you suspect that you have used a higher dose of Olfen 75 than recommended, you should contact your doctor or nurse.

Missing a dose of Olfen 75

You should not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult your doctor, pharmacist, or nurse.

Stopping Olfen 75

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Olfen 75 can cause side effects, although not everybody gets them.
Some side effects may be serious.

You should stop taking Olfen 75 and inform your doctor immediately if you experience:

• Mild painful abdominal cramps and tenderness starting soon after the start of Olfen 75 treatment, followed by rectal bleeding or bloody diarrhea, usually within 24 hours of the onset of abdominal pain (frequency not known, cannot be estimated from available data);
• Chest pain - chest pain that may be a sign of a potentially serious allergic reaction called Kounis syndrome
• Injection site reactions, including pain, redness, swelling, hardening, ulceration, and discoloration. This can lead to skin and tissue necrosis at the injection site, resulting in scarring, known as Nicolau's syndrome.

During treatment with Olfen 75, the following side effects have occurred with the following frequency:
Very common: more than 1 in 10 patients; common: 1 to 10 in 100 patients; uncommon: 1 to 10 in 1000 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 rare, very rare, or unknown frequency side effects may be serious:

• Ecchymoses or purpura,
• High fever or persistent sore throat,
• Allergic reaction with facial swelling, lip, oral, tongue, or throat swelling, often associated with rash and itching, which can cause difficulty swallowing, intratracheal swelling with narrowing of the airways, shortness of breath, tachycardia (rapid heart rate), hypotension, fainting,
• Wheezing and feeling of tightness in the chest, shortness of breath (symptoms of asthma),
• Chest pain (symptoms of myocardial infarction), heart failure,

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• Sudden and severe headaches, nausea, dizziness, numbness, inability or difficulty speaking, paralysis (symptoms of stroke),
• Symptoms of aseptic meningitis, with neck stiffness, headache, nausea, vomiting, fever, and altered consciousness,
• Seizures,
• Hypertension,
• Red or purple skin (possible symptoms of vasculitis),
• Rash with blisters, formation of blisters on the lips, eyes, and mouth, skin inflammation with exfoliation or peeling of the skin,
• Severe stomach pain, bloody or black stools, bloody vomiting, stomach ulcers and/or intestinal ulcers, colitis (e.g., bloody colitis), exacerbation of ulcerative colitis or Crohn's disease, constipation, pancreatitis, ischemic colitis,
• Jaundice (symptoms of hepatitis),
• Blood in the urine, excess protein in the urine, significant decrease in urine output, swelling, and poor general condition (symptoms of kidney disorders),
• Blood disorders:
• Decreased platelet count (thrombocytopenia),
• Decreased white blood cell count (leukopenia),
• Decreased neutrophil count (agranulocytosis), pancytopenia, anemia, hemolytic anemia. The first symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and bruising.
• Rash, urticaria, erythema, hypersensitivity reactions to light, and blistering skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome).

If you experience any of the above symptoms, you should inform your doctor immediately.
Very common:occur in more than 1 in 10 patients

• gastrointestinal symptoms, such as nausea, vomiting, and diarrhea, as well as minor gastrointestinal bleeding, which may occasionally cause anemia,
• local reactions after injection, pain, hardening after injection.

Common:occur in 1 to 10 in 100 patients

• headache
• dizziness
• drowsiness
• restlessness
• irritability
• fatigue
• nausea
• abdominal pain
• abdominal cramps
• bloating
• loss of appetite
• stomach ulcers (sometimes with bleeding and perforation)
• increased liver enzyme activity
• skin rash, itching (hypersensitivity reactions)
• injection site reactions (pain or hardening)

Uncommon:occur in 1 to 10 in 1000 patients

• hives

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• gastritis, bloody vomiting, black stools or bloody diarrhea
• liver damage, particularly in cases of prolonged treatment, acute hepatitis with or without jaundice
• edema, particularly in patients with hypertension or kidney failure
• hair loss

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

• edema
• asthma (including shortness of breath)
• hepatitis, liver function disorders

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

• disorientation
• depression
• anxiety
• sleep disturbances
• nightmares
• psychotic disorders
• tingling or numbness of hands or feet
• memory disorders
• restlessness
• tremors
• taste disorders
• vision or hearing disorders (double vision, blurred vision, tinnitus, transient hearing loss)
• pneumonia and vasculitis
• mouth ulcers
• stomatitis, tongue inflammation
• constipation
• esophageal ulcers (upper part of the digestive tract leading food to the stomach)
• lower abdominal discomfort
• palpitations
• hair loss
• redness, swelling, and blistering of the skin (due to increased sensitivity to sunlight)
• anemia (anemia)
• abscess at the injection site (occurrence of severe inflammatory conditions associated with infection, e.g., occurrence of necrotizing fasciitis)

Frequency not known:

• tissue damage at the injection site

Intramuscular administration can often cause local side effects at the injection site (burning sensation) or tissue damage, such as sterile abscess or fat and skin necrosis (Nicolau's syndrome).
Medicines like diclofenac may slightly increase the risk of myocardial infarction or stroke. The risk of this is more likely after taking high doses and long-term treatment. You should not exceed the recommended dose or treatment duration.
Additional effect of lidocaine:
Rarely, hypersensitivity reactions have been reported in the form of urticaria, edema, bronchospasm, or respiratory failure syndrome.
Due to the presence of lidocaine, rapid administration of the medicine (unintentional intravenous injection, injection into well-vascularized tissue) or overdose may cause systemic reactions, such as dizziness, drowsiness, seizures, confusion, nausea, vomiting, bradycardia, arrhythmias, decreased blood pressure to the level observed in shock.
You should inform your doctor if you experience any of the above side effects.
If you experience any side effects, including those not listed in this leaflet, you should consult your doctor, pharmacist, or nurse.
If Olfen 75 is used for more than a few weeks, you should ensure regular, monitoring visits to your doctor to ensure that no unnoticed side effects have occurred.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olfen 75

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the month stated.
The batch number on the packaging is stated after "Batch number (Lot)" or "Lot".
Store in a temperature below 25°C. Ampoules should be stored in the carton to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Olfen 75 contains

The active substances of the medicine are diclofenac sodium and lidocaine hydrochloride monohydrate.
Each ampoule contains 75 mg of diclofenac sodium and 20 mg of lidocaine hydrochloride monohydrate.

• The other excipients are: N-acetylcysteine, disodium edetate, propylene glycol, macrogol 400, sodium hydroxide, water for injections.

What Olfen 75 looks like and contents of the pack

Clear to slightly yellowish solution in a 2 ml glass ampoule made of orange glass in a carton.
The packaging contains 5 ampoules of 2 ml each.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer

Merckle GmbH,
Ludwig-Merckle-Strasse 3
89143 Blaubeuren, Germany
To obtain more detailed information, you should contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o., phone: +48 22 345 93 00
Date of last revision of the leaflet:
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