Dexketoprofen sopharma

Patient Information Leaflet

Dexketoprofen Sopharma, 50 mg/2 ml
solution for injection/infusion
Dexketoprofenum
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, inform your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of contents

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

1. What Dexketoprofen Sopharma is and what it is used for

Dexketoprofen Sopharma is an analgesic medicine belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
It is used to treat acute moderate to severe pain in situations where oral administration of tablets is not recommended, such as postoperative pain, renal colic (severe kidney pain), or lower back pain.

2. Important information before using Dexketoprofen Sopharma

When not to use Dexketoprofen Sopharma:

• If the patient is allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6).
• If the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• If the patient has experienced asthma or asthma attacks, acute allergic rhinitis (a short-term inflammatory condition of the nasal mucosa), nasal polyps (nasal growths caused by allergy), urticaria (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or respiratory distress), or wheezing after taking acetylsalicylic acid or other NSAIDs;
• If the patient has experienced photoallergic or phototoxic reactions (a specific type of redness and/or blisters on sun-exposed skin) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
• If the patient currently has a peptic ulcer, gastrointestinal bleeding, or a history of gastrointestinal bleeding, ulceration, or perforation;
• If the patient has chronic gastrointestinal disorders (e.g. indigestion, heartburn);
• If the patient currently has or has previously experienced gastrointestinal bleeding or perforation due to prior use of non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief;
• If the patient has inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• If the patient has severe heart failure, moderate or severe kidney disease, or severe liver function impairment;
• If the patient has blood clotting disorders;
• If the patient is severely dehydrated (has lost a significant amount of body fluid) due to vomiting, diarrhoea, or insufficient fluid intake;
• If the patient is in the third trimester of pregnancy or is breastfeeding.

Warnings and precautions
Before starting treatment with Dexketoprofen Sopharma, discuss this with your doctor or pharmacist.

• If the patient has a history of chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If the patient currently has or has previously had other stomach or intestinal disorders;
• If the patient is taking other medicines that increase the risk of peptic ulcer disease or gastrointestinal bleeding, e.g. oral corticosteroids, certain antidepressants (e.g. SSRIs—selective serotonin reuptake inhibitors), anticoagulants such as aspirin, or antithrombotic agents such as warfarin. In such cases, consult your doctor before starting Dexketoprofen Sopharma: the doctor may recommend taking an additional medicine to protect the stomach (e.g. misoprostol or acid-reducing agents);
• If the patient has heart disease, has had a stroke, or suspects they are at risk of these conditions (e.g. due to high blood pressure, diabetes, high blood cholesterol, or smoking), they should discuss treatment with their doctor or pharmacist; taking medicines such as Dexketoprofen Sopharma may be associated with a small increased risk of heart attack or stroke. The risk is greater with higher doses and long-term treatment. Do not exceed the recommended dose or duration of treatment;
• In elderly patients, the likelihood of adverse effects is higher (see section 4). If any of these symptoms occur, contact a doctor immediately;
• If the patient has allergies or a history of allergic reactions;
• If the patient has kidney, liver, or heart disease (hypertension and/or heart failure), fluid retention, or a history of any of these conditions;
• If the patient is taking diuretics or is dehydrated and has reduced blood volume due to excessive fluid loss (e.g. from excessive urination, diarrhoea, or vomiting);
• If the patient has fertility problems (Dexketoprofen Sopharma may impair fertility; therefore, it should not be used when planning pregnancy or during fertility investigations);
• If the patient is in the first or second trimester of pregnancy;
• If the patient has disorders affecting blood or blood cell formation;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has chickenpox, as NSAIDs may in rare cases worsen infection symptoms;
• If the patient has asthma associated with chronic inflammation of the nasal mucosa, chronic sinusitis, and/or nasal polyposis, as such patients have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs. Using this medicine may trigger asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents
The use of Dexketoprofen Sopharma has not been studied in children and adolescents. Therefore, safety and efficacy have not been established, and the medicine should not be used in this age group.

Dexketoprofen Sopharma and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently taken, including those obtained without a prescription. Some medicines should not be taken together, while others may require dose adjustments when used concomitantly.

Inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with Dexketoprofen Sopharma:

Contraindicated combinations:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs;
• Warfarin, heparin, or other medicines used to prevent blood clot formation;
• Lithium, used in the treatment of certain mood disorders;
• Methotrexate (an anticancer and immunosuppressive agent) when used in high doses of 15 mg/week;
• Hydantoins and phenytoin, used in epilepsy;
• Sulfamethoxazole, used in bacterial infections.

Combinations requiring caution:

• ACE inhibitors, diuretics, beta-blockers, and angiotensin II antagonists, used in the treatment of high blood pressure and heart disease;
• Pentoxifylline, used in the treatment of chronic venous ulcers;
• Zidovudine, used in the treatment of viral infections;
• Aminoglycoside antibiotics, used in bacterial infections;
• Sulfonylurea derivatives (e.g. chlorpropamide and glibenclamide), used in diabetes treatment;
• Methotrexate, when used in low doses of less than 15 mg/week.

Combinations requiring careful consideration:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used in bacterial infections;
• Cyclosporine or tacrolimus, used in immune system disorders and after organ transplantation;
• Streptokinase and other thrombolytic or fibrinolytic agents (medicines used to dissolve blood clots);
• Probenecid, used in gout;
• Digoxin, used in chronic heart failure;
• Mifepristone, used for medical termination of pregnancy;
• Antidepressants of the selective serotonin reuptake inhibitor (SSRI) class;
• Antiplatelet agents used to reduce platelet aggregation and prevent blood clot formation;
• Beta-blockers, used in the treatment of high blood pressure and heart disease;
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about using other medicines together with Dexketoprofen Sopharma, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and effects on 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.

Do not use Dexketoprofen Sopharma during the last three months of pregnancy or during breastfeeding.

Women planning pregnancy or who are pregnant should avoid using Dexketoprofen Sopharma. Treatment at any stage of pregnancy should only be carried out under medical supervision and on a doctor's recommendation.

The use of Dexketoprofen Sopharma is not recommended when trying to conceive or during fertility investigations.

Further information on female fertility can be found in section 2, "Warnings and precautions".

Driving and operating machinery
Dexketoprofen Sopharma may slightly affect the ability to drive and operate machinery due to possible adverse effects such as dizziness or drowsiness. If such symptoms occur, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Dexketoprofen Sopharma contains ethanol and sodium
Each ampoule of Dexketoprofen Sopharma contains 12.35% v/v ethanol (alcohol), i.e. up to 200 mg per dose, equivalent to 5 ml of beer or 2.08 ml of wine per dose. This is harmful for individuals with alcohol-related disorders. This should be taken into account in pregnant and breastfeeding women, children, and individuals at high risk, such as patients with liver disease or epilepsy.

This medicine contains less than 1 mmol of sodium (23 mg) per ampoule, meaning it is essentially "sodium-free".

3. How to use Dexketoprofen Sopharma

This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a doctor or pharmacist.
The doctor will advise the patient on the dose of Dexketoprofen Sopharma to be taken, depending
on the type, severity, and duration of symptoms. The recommended dose is usually 1 vial (50 mg) of
Dexketoprofen Sopharma every 8–12 hours. If necessary, the injection may be repeated after 6 hours.
Under no circumstances should the total daily dose exceed 150 mg (3 vials) of Dexketoprofen
Sopharma.
Injections should be administered only during episodes of acute symptoms (i.e., no longer than two
days). Whenever possible, the patient should switch to oral pain treatment.
Elderly patients with impaired renal function, as well as patients with kidney or liver disease, should
not exceed a total daily dose of 50 mg of Dexketoprofen Sopharma (1 vial).
Method of administration
Dexketoprofen Sopharma may be administered intramuscularly or intravenously (detailed
information regarding intravenous administration is provided in the section “Information intended
exclusively for healthcare professionals:”).
When Dexketoprofen Sopharma is administered intramuscularly, the solution should be used
immediately after withdrawal from the coloured vial, by performing a slow, deep intramuscular
injection.
The solution should only be used if it is clear and colourless.
Use in children and adolescents
This medicine must not be used in children and adolescents (under 18 years of age).
Use of a higher than recommended dose of Dexketoprofen Sopharma
If a higher than recommended dose of the medicine is used, a doctor or pharmacist should be
informed immediately, or the nearest hospital should be contacted. Remember to bring the medicine
packaging or this leaflet with you.
Missed dose of Dexketoprofen Sopharma
Do not use a double dose to make up for a missed dose. Take the next scheduled dose at the
regularly scheduled time (according to the information provided in section 3 “How to use Dexketoprofen
Sopharma”).
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The possible adverse reactions are listed below and grouped according to their likelihood of occurrence.

Common: may affect up to 1 in 10 people
Nausea and/or vomiting, pain at injection site, reactions at injection site such as inflammation, bruising or bleeding.

Uncommon: may affect up to 1 in 100 people
Vomiting blood, low blood pressure, fever, blurred vision, dizziness, drowsiness, sleep disturbances, headache, anaemia, abdominal pain, constipation, digestive problems, diarrhoea, dry mouth, hot flushes with redness, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

Rare: may affect up to 1 in 1,000 people
Peptic ulcer, bleeding or perforation of peptic ulcer, high blood pressure, fainting, slow breathing, superficial thrombophlebitis (thrombotic inflammation of superficial veins), extra heartbeats (extrasystoles), rapid heartbeat, peripheral oedema, laryngeal oedema, abnormal sensation, fever and chills, ringing in the ears (tinnitus), itchy rash, jaundice, acne, back pain, kidney pain, frequent urination, menstrual disorders, prostate problems, muscle stiffness, joint stiffness, muscle cramps, abnormal liver function test results (blood tests), increased blood sugar (hyperglycaemia), decreased blood sugar (hypoglycaemia), increased blood triglycerides (hypertriglyceridaemia), loss of appetite (anorexia), presence of ketones in urine (ketonuria), presence of protein in urine (proteinuria), liver cell damage (hepatitis), acute kidney failure.

Very rare: may affect up to 1 in 10,000 people
Anaphylactic reaction (hypersensitivity reaction which may lead to shock), skin, oral cavity, eye and genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to contraction of muscles around the airways (bronchospasm), dyspnoea, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).

If any adverse reactions affecting the stomach or intestines occur during the initial period of treatment (e.g. abdominal pain, heartburn or bleeding), or if the patient has previously experienced any of these adverse reactions during long-term use of anti-inflammatory medicines, medical advice should be sought immediately. This particularly applies to elderly patients.

Treatment with Dexketoprofen Sopharma must be discontinued immediately if skin rash, any changes on mucosal surfaces (e.g. inside the mouth) or any symptoms of hypersensitivity occur.

Fluid retention and oedema (particularly in the legs and around the ankles), elevated blood pressure and heart failure have been reported during treatment with non-steroidal anti-inflammatory drugs.

Medicines such as Dexketoprofen Sopharma may cause a small increase in the risk of myocardial infarction or cerebrovascular accident (stroke).

In patients with systemic lupus erythematosus or mixed connective tissue disease (autoimmune connective tissue disorders), anti-inflammatory medicines may rarely cause fever, headache and neck stiffness.

The most frequently observed adverse reactions are gastrointestinal in nature. Peptic ulcers, gastrointestinal perforation or bleeding (sometimes fatal) may occur, particularly in elderly patients. After administration of the medicine, nausea, vomiting, diarrhoea, bloating, constipation, indigestion, abdominal pain, black tarry stools, vomiting blood, ulcerative stomatitis, exacerbation of colitis and Crohn's disease have been reported. Gastritis (inflammation of the gastric mucosa) has been observed less frequently.

As with other NSAIDs, haematological reactions may occur (thrombocytopenia, aplastic and haemolytic anaemia, rarely agranulocytosis and bone marrow hypoplasia).

If signs of infection occur or worsen during treatment with Dexketoprofen Sopharma, medical advice should be sought immediately.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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 Dexketoprofen Sopharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the ampoule after:
"EXP". The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store the ampoules in the outer packaging to protect from light.
Do not use this medicine if the solution is not clear and colourless, or if there are visible signs of deterioration (e.g. particulate matter). Dexketoprofen Sopharma solution for injection/infusion is intended for single use only and should be used immediately after opening.
Any unused portion of the product should be discarded.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use, as well as used needles and syringes. This will help protect the environment.

6. Contents of the packaging and other information

What Dexketoprofen Sopharma contains

• The active substance is dexketoprofen (in the form of dexketoprofen with trometamol).
• Each ml of solution contains 25 mg of dexketoprofen. Each 2 ml ampoule contains 50 mg of dexketoprofen.
• Other components of the medicine are ethanol 96%, sodium chloride, sodium hydroxide, and water for injections.

What Dexketoprofen Sopharma looks like and contents of the pack
Injection/infusion solution (for injection/infusion), a clear, colourless solution,
practically free from solid particles.
Each single dose is contained in a 2 ml ampoule made of amber glass (type 1), with a marked break point.
Each ampoule has a self-adhesive label.
PVC blisters may contain 1, 2, 5 or 10 ampoules.
Pack sizes contain: 1, 5, 6, 10, 20, 25, 50 or 100 ampoules.
The appropriate number of blisters and the package leaflet are enclosed in a cardboard carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw, Poland
Manufacturer
SOPHARMA AD
16, Iliensko Shosse str.
1220 Sofia, Bulgaria
This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Bulgaria: Декскетопрофен Софарма 50 mg/2 ml инжекционен/инфузионен разтвор
Estonia: Dexketoprofen Sopharma
Latvia: Dexketoprofen Sopharma 50 mg/2 ml šķīdums injekciju/infūziju pagatavošanai
Lithuania: Dexketoprofen Sopharma 50 mg/2 ml injekcinis ar infuzinis tirpalas
Poland: Dexketoprofen Sopharma
17.01.2024

Information intended exclusively for medical professionals:

Intravenous administration
Intravenous infusion: the contents of one ampoule (2 ml) of Dexketoprofen Sopharma should be
diluted in a volume of 30 or 100 ml of 0.9% sodium chloride solution, 5% glucose solution, or
Ringer's lactate solution. The diluted solution should be administered via slow intravenous infusion
over 10 to 30 minutes. The solution must always be protected from natural daylight.
Intravenous bolus: if necessary, the contents of one ampoule (2 ml) of Dexketoprofen Sopharma
may be administered as a slow intravenous bolus injection over no less than 15 seconds.
Due to its ethanol content, Dexketoprofen Sopharma is contraindicated for administration into the central nervous system (intrathecally or epidurally).
Instructions for handling the product:
When Dexketoprofen Sopharma is administered as an intravenous bolus, the solution should be
injected directly after withdrawal from the colored ampoule.
For intravenous infusion, the solution should be diluted under aseptic conditions and protected
from natural daylight.
The solution should only be used if it is clear and colourless.
Pharmaceutical compatibility
Dexketoprofen Sopharma solution for injection/infusion has been shown to be compatible when
mixed in small volumes (e.g. in a syringe) with injectable solutions of heparin, lidocaine, morphine,
and theophylline.
Dexketoprofen Sopharma solution for injection/infusion has been shown to be compatible with the
following materials: polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE).