Olfen 75

Package leaflet: Information for the patient

Olfen 75, (37.5 mg + 10 mg)/ml, solution for injection
Diclofenacum natricum + Lidocaini hydrochloridum monohydricum
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What Olfen 75 is and what it is 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 pack and other information

1. What Olfen 75 is and what it is 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 must be administered only by qualified medical personnel.
Olfen 75 relieves symptoms of inflammatory conditions, such as swelling and pain. It does not affect the underlying causes of inflammation or fever.
Olfen 75 may be used in the treatment of severe pain and inflammatory conditions in cases of:

• Acute joint inflammation (including acute gouty arthritis);
• Chronic joint inflammation, particularly rheumatoid arthritis (chronic arthritis);
• Ankylosing spondylitis (Bechterew's disease) and other inflammatory rheumatic diseases of the spine;
• Disorders arising from degenerative joint disease and spinal joint inflammation;
• Rheumatic inflammatory conditions of soft tissues;
• Painful swelling or inflammation following injury;
• Renal and hepatic colic.

If you have any doubts regarding the action or reasons for prescribing Olfen 75, please consult your doctor.

2. Information before using Olfen 75

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:

• if the patient is allergic to diclofenac or lidocaine hydrochloride monohydrate, or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has active or a history of gastric or intestinal ulcer, bleeding, or perforation; if the patient has previously experienced stomach discomfort or heartburn after taking anti-inflammatory drugs,
• if the patient has previously had gastrointestinal bleeding or perforation associated with the use of NSAIDs,
• during the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility"),
• if the patient has severe liver, kidney, or heart failure,
• if the patient has haematological or coagulation disorders of unknown origin,
• if the patient has active bleeding from cerebral or other blood vessels,
• 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, chest pain, nasal congestion, skin rash, or facial swelling may occur. If the patient suspects an allergy, medical advice should be sought,
• if the patient has been diagnosed with heart disease and/or cerebrovascular disease, e.g. after myocardial infarction, stroke, transient ischaemic attack (TIA), or arterial embolism in the heart or brain, or after a procedure to unblock or bypass obstructed vessels,
• if the patient has current or previous circulatory disorders (peripheral vascular disease),
• children and adolescents under 18 years of age.

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

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

If any of the above conditions apply to the patient, inform the doctor and do not take Olfen 75 until the doctor confirms it is suitable for the patient.

Warnings and precautions

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

Inform your doctor if:

• the patient is taking Olfen 75 together with other NSAIDs, including acetylsalicylic acid, corticosteroids, "blood-thinning" medicines, or certain antidepressants (see also "Olfen 75 with other medicines"). In such patients, the use of diclofenac is associated with an increased risk of hypersensitivity reactions;
• the patient is in the 1st or 2nd trimester of pregnancy;
• the patient is breastfeeding;
• the patient has hay fever, nasal polyps, or chronic obstructive respiratory disease, which constitute a group at increased risk of allergic reactions. These may manifest as asthma attacks (so-called drug-induced asthma), angioedema, or urticaria;
• the patient has a history of gastrointestinal disorders, such as gastric ulcers, bleeding, or black stools, or if the patient previously experienced stomach discomfort or heartburn after taking NSAIDs;
• the patient has inflammatory bowel disease (ulcerative colitis) or gastrointestinal tract disease (Crohn's disease);
• in cases of hypertension and/or heart dysfunction (see "Other special warnings" below);
• the patient has kidney or liver problems;
• the patient has swelling of the feet;
• the patient has bleeding disorders or other blood diseases, including the rare liver disease called porphyria, especially in patients who have recently undergone major surgery;
• if the patient has myasthenia (rapid muscle fatigue and weakness).

Before taking diclofenac, inform your doctor:

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

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

Strictly follow the instructions for intramuscular injection to avoid adverse reactions at the injection site, which may lead to muscle weakness, paralysis, reduced sensation, or necrosis at the injection site.

The occurrence 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 75.

Other special warnings

Due to the presence of lidocaine, Olfen 75 should be used with particular caution in patients with myasthenia.

Do not use Olfen 75 simultaneously with other systemic non-steroidal anti-inflammatory drugs, including selective cyclooxygenase-2 (COX-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. This risk is higher with high 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 suspected risk of such conditions (e.g. high blood pressure, diabetes, high cholesterol, or smoking), discuss the treatment approach with your doctor or pharmacist.

Olfen 75 may reduce the symptoms of infection (e.g. headache, high temperature), making the infection harder to diagnose and treat effectively. If the patient feels unwell and needs to see a doctor, inform them about the use of Olfen 75.

Very rarely, Olfen 75, 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.

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

Particular caution is required in patients with bronchial asthma receiving parenteral diclofenac, due to the possibility of worsening of disease symptoms.

Olfen 75 should be administered only after careful consideration of the benefit-risk ratio in the following cases:

• inherited porphyrin metabolism disorders (e.g. acute intermittent porphyria);
• systemic lupus erythematosus (SLE) and mixed connective tissue disease.

Elderly patients

Dose adjustment is not required.

Due to the profile of possible adverse effects, elderly patients should be closely monitored.

Elderly patients may be more sensitive to the effects of Olfen 75. Therefore, they should follow medical advice particularly carefully and use the lowest effective dose that relieves symptoms. It is especially important that patients report any adverse effects to their doctor immediately.

Children and adolescents

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

Olfen 75 with 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 particularly important to inform your doctor if the patient is taking any of the following medicines:

• Lithium or selective serotonin reuptake inhibitors (medicines used to treat certain types of depression),
• Cardiac glycosides (e.g. digoxin), used in the treatment of heart disease,
• Diuretics (medicines that increase urine output),
• Angiotensin-converting enzyme (ACE) inhibitors or beta-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 reduce inflammation),
• 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),
• Colestipol and cholestyramine (anti-atherosclerotic medicines),
• Sulfinpyrazone (a medicine used in the treatment of gout),
• Probenecid (a uricosuric agent),
• Sulfonylurea derivatives,
• Voriconazole (a medicine used to treat fungal infections),
• Mifepristone (a medicine used in gynaecology).

Lidocaine, when used concomitantly with antiarrhythmic drugs, beta-blockers, or calcium channel antagonists, may additionally inhibit atrioventricular conduction, ventricular conduction, and myocardial contractility.

Olfen 75 with food, drink, and alcohol

Concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs), including Olfen 75, and alcohol may increase the risk of adverse effects (particularly affecting the gastrointestinal or central nervous system).

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 75 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 may cause kidney and heart dysfunction 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 6 months of pregnancy, Olfen 75 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 may cause kidney dysfunction in the unborn child if used for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, the doctor may recommend additional monitoring.

Breastfeeding

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

Fertility

Diclofenac may impair fertility. Inform your doctor if the patient is planning pregnancy or has difficulty conceiving.

Driving and operating machinery

Do not drive or operate machinery if, during treatment with Olfen 75, adverse effects occur such as visual disturbances, vertigo, dizziness, somnolence, or other central nervous system disorders.

Sodium content

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

Propylene glycol content

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 exactly as recommended by your doctor, pharmacist, or nurse.
If in doubt, consult your doctor, pharmacist, or nurse.
Olfen 75 is administered exclusively by qualified medical personnel.
Your doctor will decide when and how to administer Olfen 75. The medicine should be given by intramuscular injection. The injection is usually administered into the buttock.
It is important that your doctor uses the lowest effective dose to control pain for the shortest possible duration.
Exceptionally, in severe cases (e.g., acute colicky pain), the daily dose may be increased to two injections of 75 mg, given several hours apart (one injection into each buttock). One ampoule of 75 mg may also be given in combination with another formulation of Olfen (tablets, suppositories), provided that the total daily dose does not exceed 150 mg of sodium diclofenac.
Dosage
Adults
Olfen 75 is indicated particularly when rapid symptom control is required or when treatment with oral or rectal formulations is not feasible. Olfen 75 should be administered as a single intramuscular injection (75 mg of sodium diclofenac).
Olfen 75 should not be used for longer than 2 days. If further treatment is necessary, other formulations of the medicine, such as oral or rectal, should be used. The maximum daily dose of 150 mg of sodium diclofenac must not be exceeded.
Children and adolescents
Olfen 75 must not be used in children and adolescents under 18 years of age.
Overdose of Olfen 75
If you suspect that more than the recommended dose of Olfen 75 has been administered, contact your doctor or nurse immediately.
Missed dose of Olfen 75
Do not administer a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.
Discontinuation of Olfen 75
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious.
You must stop taking Olfen 75 immediately and inform your doctor if the following occur:

• Mild painful abdominal cramps and tenderness beginning shortly after starting Olfen 75, 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 known as Kounis syndrome;
• Injection site reactions, including pain at the injection site, redness, swelling, hard lump, ulceration, and bruising. These may lead to blackening and necrosis (death) of the skin and surrounding tissues at the injection site, healing with scarring, presenting as a condition also known as Nicolau syndrome.

The following adverse reactions have occurred during treatment with Olfen 75 with the following frequency:
Very common: more than 1 in 10 patients; common: 1 to 10 in 100 patients; uncommon: 1 to 10 in 1,000 patients; rare: 1 to 10 in 10,000 patients; very rare: less than 1 in 10,000 patients; frequency not known (frequency cannot be estimated from available data).
Some adverse reactions occurring rarely, very rarely, or with unknown frequency may be severe:

• Petechiae (small red or purple spots) 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, laryngeal oedema with airway narrowing, shortness of breath, tachycardia (rapid heartbeat), hypotension, fainting;
• Wheezing and tightness in the chest, shortness of breath (asthma symptoms);
• Chest pain (symptoms of heart attack), heart failure;
• Sudden and severe headache, nausea, dizziness, numbness, difficulty or inability to speak, 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);
• Blistering rash, formation of blisters on lips, eyes, and mouth, skin inflammation with peeling or erosion of the epidermis;
• Severe stomach pain, bloody or black stools, vomiting blood, gastric or (and) intestinal ulceration, colitis (e.g. haemorrhagic colitis), exacerbation of ulcerative colitis or Crohn’s disease, constipation, pancreatitis, ischemic colitis;
• Yellowing of the skin or eyes (symptoms of hepatitis);
• Blood in urine, excess protein in urine, significantly reduced urine output, swelling, and general malaise (symptoms of kidney dysfunction);
• Blood disorders:
• Decreased platelet count (thrombocytopenia);
• Decreased white blood cell count (leukopenia);
• Decreased neutrophil count (agranulocytosis), pancytopenia, anaemia, haemolytic anaemia. Early symptoms may include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nosebleeds, and petechiae;
• Rash, skin eruptions, erythema, photosensitivity reactions, purpura (including allergic), and bullous skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome).

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

• Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, and minor gastrointestinal bleeding, occasionally leading to anaemia;
• Local reactions after injection: pain, induration (hardening) at the injection site.

Common: occurs in 1 to 10 in 100 patients

• Headache
• Dizziness
• Drowsiness
• Restlessness
• Irritability
• Fatigue
• Dyspepsia
• Abdominal pain
• Abdominal cramps
• Bloating
• Loss of appetite
• Gastric ulcers (sometimes with bleeding and perforation)
• Increased aminotransferase activity
• Skin rash, itching (hypersensitivity reactions)
• Injection site reactions (pain or induration)

Uncommon: occurs in 1 to 10 in 1,000 patients

• Urticaria (hives)

• Gastritis, vomiting blood, tarry stools or bloody diarrhoea

• Liver damage, particularly with long-term treatment, acute hepatitis with or without jaundice

• Oedema, especially in patients with hypertension or renal insufficiency

• Alopecia (hair loss)

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

• Oedema
• Asthma (including shortness of breath)
• Hepatitis, liver function abnormalities

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

• Disorientation
• Depression
• Anxiety
• Difficulty falling asleep
• Nightmares
• Psychotic disorders
• Tingling or numbness in hands or feet
• Memory disturbances
• Restlessness
• Tremor
• Taste disturbances
• Visual disturbances (double vision, blurred vision) or hearing disturbances (tinnitus, transient hearing loss)
• Pneumonitis and vasculitis
• Oral ulcers
• Stomatitis, glossitis (inflammation of mouth or tongue)
• Constipation
• Ulcers and lesions in the oesophagus (upper part of the digestive tract leading food to the stomach)
• Discomfort in the lower abdomen
• Palpitations
• Hair loss
• Redness, swelling, and blistering of the skin (due to increased sensitivity to sunlight)
• Anaemia
• Abscess at injection site (occurrence of worsening inflammatory conditions related to infection, e.g. necrotizing fasciitis)

Frequency not known:

• Tissue damage at the injection site

Intramuscular administration may frequently cause local adverse reactions at the injection site (burning sensation) or tissue damage, such as sterile abscess, necrosis of fatty tissue or skin (Nicolau syndrome).
Medicines such as diclofenac may slightly increase the risk of heart attack or stroke. This risk is more likely with higher doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
Additional effects of lidocaine:
Hypersensitivity reactions such as urticaria, oedema, bronchospasm, or respiratory failure syndrome have been reported rarely.
Due to the presence of lidocaine, rapid administration (unintentional intravenous injection, injection into well-perfused tissue) or overdose may cause systemic reactions such as dizziness, drowsiness, seizures, confusion, nausea, vomiting, bradycardia, cardiac arrhythmias, and hypotension reaching shock levels.
You should inform your doctor if any of the above adverse reactions occur.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, you should consult your doctor, pharmacist, or nurse.
If Olfen 75 is used for longer than a few weeks, regular medical check-ups should be arranged to ensure that no undetected adverse reactions have occurred.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Adverse reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Olfen 75

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard package following: EXP.
The expiry date refers to the last day of the stated month.
The batch number on the packaging is located after "Nr serii (Lot)" or "Lot".
Store below 25°C. Keep ampoules in the cardboard package to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the package and other information

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

• Other excipients: 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 yellow solution in a 2 ml amber glass ampoule.
The carton pack contains 5 ampoules of 2 ml.
Not all pack sizes may be marketed.

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

Manufacturer
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