Dexketoprofen Sopharma

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Dexketoprofen Sopharma, 50 mg/2 ml

injection/infusion solution
Dexketoprofen

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

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

Contents of the leaflet

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

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

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;
• If the patient has experienced asthma or asthma attacks, acute allergic rhinitis (short-term inflammation of the nasal mucosa), nasal polyps (growths in the nose caused by allergies), hives (skin rash), angioedema (swelling of the face, eyes, lips or tongue, or respiratory failure) or wheezing after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
• If the patient has experienced photoallergic or phototoxic reactions (a particular form of redness and/or blisters on sun-exposed skin) when taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower blood fat levels);
• If the patient has a stomach ulcer or gastrointestinal bleeding, or has had gastrointestinal bleeding, ulceration or perforation in the past;
• If the patient has chronic gastrointestinal disorders (e.g. indigestion, heartburn)
• If the patient has had gastrointestinal bleeding or perforation, or has had gastrointestinal bleeding or perforation in the past due to previous 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 disorders;
• If the patient has bleeding disorders;
• If the patient is severely dehydrated (has lost a large amount of water in the body) due to vomiting, diarrhea, or insufficient fluid intake;
• If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions

Before starting treatment with Dexketoprofen Sopharma, discuss it with your doctor or pharmacist.

• If the patient has had chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease);
• If the patient has had other gastrointestinal diseases in the past;
• If the patient is taking other medicines that increase the risk of stomach ulcers or bleeding, such as oral steroids, certain antidepressants (e.g. SSRIs, or selective serotonin reuptake inhibitors), anticoagulant medications, such as aspirin, or antiplatelet agents, such as warfarin. In such cases, before starting treatment with Dexketoprofen Sopharma, consult your doctor: they may recommend taking an additional medicine to protect the stomach (e.g. misoprostol or acid-reducing medications);
• If the patient has heart disease, has had a stroke, or suspects they are at risk of these conditions (e.g. if they have high blood pressure, diabetes, high cholesterol, or smoke), they should discuss treatment with their doctor or pharmacist; taking medications like Dexketoprofen Sopharma may be associated with a small increased risk of heart attack or stroke. The risk is higher with high doses and long-term treatment. Do not exceed the recommended dose or duration of treatment;
• In elderly patients, the likelihood of side effects is higher (see section 4). If any of these symptoms occur, seek medical attention immediately;
• If the patient has an allergy or has had an allergy in the past;
• If the patient has kidney, liver, or heart disease (hypertension and/or heart failure) or fluid retention in the body, or has had any of these diseases in the past;
• If the patient is taking diuretics or is dehydrated and has reduced blood volume due to excessive fluid loss (e.g. due to excessive urination, diarrhea, or vomiting);
• If the patient has fertility problems (Dexketoprofen Sopharma may affect fertility, so it should not be used in case of planned pregnancy or during fertility tests);
• If the patient is in the first or second trimester of pregnancy;
• If the patient has blood disorders;
• If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
• If the patient has chickenpox, as non-steroidal anti-inflammatory drugs (NSAIDs) may exacerbate symptoms of infection in rare cases;
• If the patient has asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyps, as the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher in such patients than in the rest of the population. Taking this medicine may cause asthma attacks or bronchospasm, especially in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

Dexketoprofen Sopharma has not been studied in children and adolescents. Therefore, its safety and efficacy have not been established, and it should not be used in this age group.

Dexketoprofen Sopharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you have bought without a prescription. Some medicines should not be taken together, and others may require a dose adjustment when taken together.
Tell your doctor, dentist, or pharmacist that you are taking any of the following medicines with Dexketoprofen Sopharma:
Contraindicated combinations:

• Acetylsalicylic acid, corticosteroids, or other anti-inflammatory medicines;
• Warfarin, heparin, or other anticoagulant medications;
• Lithium, used to treat certain mood disorders;
• Methotrexate (an anticancer and immunosuppressive medicine), used in high doses of 15 mg/week;
• Hydantoins and phenytoin, used in epilepsy;
• Sulfamethoxazole, used in bacterial infections.

Combinations requiring caution when used:

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

Combinations whose use should be carefully considered:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used in bacterial infections;
• Cyclosporine or tacrolimus, used to treat immune system diseases and after organ transplants;
• Streptokinase and other thrombolytic or fibrinolytic agents, or medications used to dissolve blood clots;
• Probenecid, used in gout;
• Digoxin, used to treat chronic heart failure;
• Mifepristone, used as a pharmacological abortion (to terminate pregnancy);
• Antidepressant medications from the selective serotonin reuptake inhibitor (SSRI) group;
• Antiplatelet agents used to reduce platelet aggregation and prevent blood clots;
• Beta-blockers, used to treat high blood pressure and heart disease;
• Tenofovir, deferiprone, pemetrexed.

In case of any doubts about using other medicines with Dexketoprofen Sopharma, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Do not use Dexketoprofen Sopharma during the last three months of pregnancy and during breastfeeding.
Women planning to become pregnant or who are pregnant should avoid using Dexketoprofen Sopharma. Treatment during any stage of pregnancy should only be carried out under the guidance of a doctor.
It is not recommended to use Dexketoprofen Sopharma when trying to conceive or during fertility tests.
More information on female fertility can be found in section 2, "Warnings and precautions".

Driving and using machines

Dexketoprofen Sopharma may slightly affect the ability to drive and use machines due to the possibility of dizziness or drowsiness as side effects of treatment. If such symptoms are observed, do not drive or operate machines until the symptoms have resolved. 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, which is equivalent to 5 ml of beer or 2.08 ml of wine per dose. This is harmful to individuals with alcohol dependence. This fact should be taken into account in pregnant or 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, which is essentially "sodium-free".

3. How to use Dexketoprofen Sopharma

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Your doctor will tell you what dose of Dexketoprofen Sopharma to use, depending on the type, severity, and duration of symptoms. The recommended dose is usually 1 ampoule (50 mg) of Dexketoprofen Sopharma every 8-12 hours. If necessary, the injection can be repeated after 6 hours. In no case should the total daily dose exceed 150 mg (3 ampoules) of Dexketoprofen Sopharma.
Injections should only be administered during the period of acute symptoms (i.e. no longer than two days). Whenever possible, the patient should switch to oral pain relief treatment.
Elderly patients with impaired renal function and patients with kidney or liver disease should not exceed the total daily dose of 50 mg of Dexketoprofen Sopharma (1 ampoule).

Method of administration

Dexketoprofen Sopharma can be administered intramuscularly or intravenously (detailed information on intravenous administration is provided in the section "Information intended for healthcare professionals only").
If Dexketoprofen Sopharma is administered intramuscularly, the solution should be used immediately after withdrawal from the colored ampoule, with slow injection deep into the muscle.
The solution can only be used if it is clear and colorless.

Use in children and adolescents

Do not use this medicine in children and adolescents (under 18 years of age).

Using a higher dose of Dexketoprofen Sopharma than recommended

In case of using a higher dose of the medicine than recommended, inform your doctor or pharmacist immediately or go to the nearest hospital. Remember to take the medicine packaging or this leaflet with you.

Missing a dose of Dexketoprofen Sopharma

Do not take a double dose to make up for a missed dose. Take the next regular dose at the scheduled time (as indicated in section 3 "How to use Dexketoprofen Sopharma").
In case of any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects are listed below and grouped by frequency of occurrence.

Common: may affect up to 1 in 10 people

Nausea and/or vomiting, pain at the injection site, reactions at the 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 disorders, headache, anemia, abdominal pain, constipation, digestive problems, diarrhea, dry mouth, hot flashes with redness, rash, skin inflammation, itching, increased sweating, fatigue, pain, feeling cold.

Rare: may affect up to 1 in 1,000 people

Stomach ulcers, gastrointestinal bleeding, or perforation, high blood pressure, fainting, slow breathing, superficial vein thrombophlebitis (vein inflammation caused by a blood clot), single extra heartbeats (extrasystole), rapid heart rate, peripheral edema, laryngeal edema, 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 test results (blood tests), elevated blood sugar levels (hyperglycemia), decreased blood sugar levels (hypoglycemia), elevated triglyceride levels (hypertriglyceridemia), loss of appetite (anorexia), presence of ketone bodies in the urine (ketonuria), presence of protein in the urine (proteinuria), liver cell damage (hepatitis), acute kidney failure.

Very rare: may affect up to 1 in 10,000 people

Anaphylactic reaction (allergic reaction that can also lead to shock), skin ulcers, mouth ulcers, eye ulcers, and genital ulcers (Stevens-Johnson syndrome and Lyell's syndrome), facial edema or lip and throat edema (angioedema), shortness of breath caused by muscle spasm in the airways (bronchospasm), dyspnea, pancreatitis, skin hypersensitivity reactions and photosensitivity, kidney damage, decreased white blood cell count (neutropenia), decreased platelet count (thrombocytopenia).
Inform your doctor immediately if you experience any side effects during the initial treatment period, such as stomach or gastrointestinal symptoms (e.g. abdominal pain, heartburn, or bleeding), or if you have experienced any of these side effects with long-term use of anti-inflammatory medications; this is especially important for elderly patients.
Stop using Dexketoprofen Sopharma immediately if you experience a skin rash, any changes on the mucous membranes (e.g. in the mouth), or any signs of an allergic reaction.
During treatment with non-steroidal anti-inflammatory drugs, fluid retention and edema (especially of the legs and ankles) have been reported, as well as increased blood pressure and heart failure.
Medicines like Dexketoprofen Sopharma may cause a small increase in the risk of heart attack or stroke.
In patients with systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue), non-steroidal anti-inflammatory drugs may rarely cause fever, headache, and stiffness in the back of the neck.
The most commonly observed side effects are gastrointestinal. Stomach ulcers, perforation, or gastrointestinal bleeding (sometimes fatal) may occur, especially in elderly patients. After administration of the medicine, nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, black stools, bloody vomiting, oral ulcers, and exacerbation of colitis and Crohn's disease have been reported. Less commonly, stomach inflammation (gastritis) has been observed.
As with other NSAIDs, hematological reactions (thrombocytopenia, aplastic anemia, and hemolytic anemia, rarely agranulocytosis and bone marrow hypoplasia) may occur.
If symptoms of infection worsen while using Dexketoprofen Sopharma, seek medical attention immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 month.
There are no special storage instructions 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 colorless, and there are signs of deterioration (e.g. solid particles). Dexketoprofen Sopharma injection/infusion solution is for single use only and should be used immediately after opening.
Any unused product should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required and how to dispose of used needles and syringes safely. This will help protect the environment.

6. Contents of the pack and other information

What Dexketoprofen Sopharma contains

• The active substance is dexketoprofen (in the form of dexketoprofen trometamol).
• Each ml of solution contains 25 mg of dexketoprofen. Each 2 ml ampoule contains 50 mg of dexketoprofen.
• The other ingredients 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), clear, colorless solution, practically free from particulate matter.
A single dose of the medicine is in a 2 ml ampoule made of orange glass (type 1), with a mark indicating the point of opening the ampoule. Each ampoule has a self-adhesive label.
Blisters of PVC may contain 1 (one), 2 (two), 5 (five), or 10 (ten) ampoules.
Packaging contains: 1, 5, 6, 10, 20, 25, 50, or 100 ampoules.
A suitable number of blisters and the package leaflet are placed in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Sopharma Warszawa Sp. z o.o.
Al. Jerozolimskie 136, 02-305 Warsaw

Manufacturer

SOPHARMA AD
16, Iliensko Shosse str.
1220 Sofia, Bulgaria

This medicinal product is authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet:

• 17.01.2024 ---------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Intravenous administration

Intravenous infusion: the contents of one ampoule (2 ml) of Dexketoprofen Sopharma should be diluted in a volume of up to 30 or up to 100 ml of 0.9% sodium chloride solution, 5% glucose solution, or Ringer's lactate solution. The diluted solution should be administered in a slow intravenous infusion lasting from 10 to 30 minutes. The solution should always be protected from natural daylight.
Intravenous bolus: if necessary, the contents of one ampoule (2 ml) of Dexketoprofen Sopharma can be administered in a slow intravenous bolus, lasting no less than 15 seconds.

Due to the ethanol content, Dexketoprofen Sopharma is contraindicated for administration into the central nervous system (intrathecally or epidurally).

Instructions for handling the product:

In the case of Dexketoprofen Sopharma being administered as an intravenous bolus, the solution should be injected immediately after withdrawal from the colored ampoule.
For intravenous infusion, the solution should be diluted under aseptic conditions and protected from natural daylight.
The solution can only be used if it is clear and colorless.

Pharmaceutical compatibility

Compatibility of Dexketoprofen Sopharma injection/infusion solution has been demonstrated after mixing in small volumes (e.g. in a syringe) with injection solutions of heparin, lidocaine, morphine, and theophylline.
Compatibility of Dexketoprofen Sopharma injection/infusion solution has been demonstrated with the following materials: polypropylene, high-density polyethylene (HDPE), and low-density polyethylene (LDPE).