Dicloflex 25 mg/ml. 3 ml. 10 ampules

1. What Dicloflex 25 mg/ml solution for injection is and what it is used for

DicloFLEX 25 mg/ml injection solution is a medicinal product with analgesic and anti-inflammatory action (non-steroidal anti-inflammatory drug - NSAID).

The solution is injected intramuscularly or, after dilution, administered intravenously in an infusion system.

DicloFLEX 25 mg/ml solution for injection, administered intramuscularly, is used for the symptomatic treatment of:

pain in rheumatic crises in the joints (arthritis), back pain, "frozen shoulder" syndrome, "tennis elbow" and other painful conditions in the bones and joints;

attacks of gout;

sharp pain in gallstones or kidney stones;

pain and swelling after surgery and trauma;

severe migraine attacks.

Intravenous infusions are used to treat or prevent pain after surgery and are administered in a hospital setting.

2. What you need to know before you use Dicloflex 25 mg/ml solution for injection

Do not use DicloFLEX 25 mg/ml solution for injection:

if you are allergic to the active ingredient diclofenac, to sodium metabisulphite or to any of the other ingredients of this medicine (listed in section 6);

if in the past you have reacted with asthma attacks, swelling of the nasal mucosa or skin reactions after taking acetylsalicylic acid or other HI anti-inflammatory products;

if you have a stomach or duodenal ulcer;

if you have had gastrointestinal bleeding in the past (with blood in the stools or black stools);

if you have severe liver or kidney disorders;

if you have established heart disease and/or cerebrovascular disease, for example if you have had a heart attack, stroke, microstroke (MI), or blockages in blood vessels of the heart or brain, or surgery to unblock blood vessels or bypass;

if you have or have had circulation problems (peripheral arterial disease); - if you have severe heart failure;

if you are in the last three months of pregnancy;

DicloFLEX 25 mg/ml solution for injection is not suitable for children and adolescents under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dicloflex 25 mg/ml solution for injection.

if you are taking other anti-inflammatory or pain-relieving medicines, including acetylsalicylic acid, corticosteroids, anticoagulants or some antidepressants (selective serotonin reuptake inhibitors).

if you suffer from asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (polyps), chronic obstructive pulmonary disease or chronic respiratory tract infections, reactions to NSAIDs (so-called intolerance to painkillers) resulting in worsening of asthma, swelling of the throat and face, or hives, are more common.

if you have or have ever had gastrointestinal problems such as a stomach ulcer, bleeding or black stools, stomach discomfort or heartburn after taking NSAIDs you should report any unusual signs in the abdominal cavity (especially bleeding) to your doctor and stop taking of DicloFLEX 25 mg/ml injection solution.

if you have inflammation of the large intestine (ulcerative colitis) or small intestine (Crohn's disease).

if you have or have had heart problems or high blood pressure.

if you have kidney or liver disease.

if you are dehydrated (from illness, diarrhoea, before or after surgery).

if you have swollen feet.

if you have an increased tendency to bleed or another blood disorder, including the rare liver disease called porphyria.

if you are pregnant in the first or second trimester of pregnancy, you should take DicloFLEX 25 mg/ml solution for injection only after consulting your doctor (see the section "Fertility, pregnancy and breast-feeding" below).

Tell your doctor immediately if you notice symptoms such as chest pain, shortness of breath, weakness, slurred speech, as they may be a sign of serious atherothrombotic events and may occur without warning signals.

With all nonsteroidal anti-inflammatory drugs (NSAIDs), including Dicloflex 25 mg/ml solution for injection, gastrointestinal bleeding, ulceration, or perforation may occur at any time during treatment with or without warning signs or a history of severe gastrointestinal events. If bleeding or ulceration occurs, the administration of Dicloflex 25 mg/ml solution for injection should be discontinued.

Very rarely, severe skin hypersensitivity reactions have been reported with NSAID therapy. At the first symptoms of skin rash or other hypersensitivity reactions, treatment with DicloFLEX 25 mg/ml solution for injection should be discontinued.

Dicloflex 25 mg/ml solution for injection can suppress the symptoms of infection (high fever).

Medicines such as diclofenac may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and long-term treatment. Do not exceed the recommended doses and prod

Elderly patients

If you are elderly and taking other major groups of drugs or are underweight, it is recommended that your doctor prescribe you the lowest effective dose.

Children

DicloFLEX 25 mg/ml solution for injection is not suitable for children and adolescents under the age of 18.

Other medicines and DicloFLEX 25 mg/ml solution for injection

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Lithium or selective serotonin reuptake inhibitors (medicines used to treat certain types of depression),

Digoxin (to treat heart disease).

Diuretics (medicines that increase the amount of urine produced and are often used to treat high blood pressure).

ACE inhibitors or beta-blockers (to treat high blood pressure and heart failure).

Other anti-inflammatory drugs such as acetylsalicylic acid, ibuprofen, etc. - Corticosteroids (anti-inflammatory drugs).

Medicines that suppress blood clotting and the formation of blood clots.

Medicines for the treatment of: diabetes (except insulin).

Methotrexate (to treat certain types of cancer or arthritis).

Cyclosporine (a medicine used in transplant patients).

Certain antibacterial drugs (quinolones) used to treat infections.

Medications to treat Tsodagra (sulfinpyrazone).

Medicines to treat fungal infections (voriconazole).

Medicines to treat epilepsy (phenytoin).

Colestipol and cholestyramine or medicines containing them (to lower blood cholesterol).

Medicines that can increase the level of potassium in your blood. These include potassium-sparing diuretics (increasing the amount of urine output), cyclosporine, tacrolimus (medicines that suppress the immune system) and trimethoprim (used to treat infections). Frequent monitoring of the level of potassium in your blood is necessary.

Pregnancy, lactation and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Women of childbearing age

There are no data to suggest recommendations in women of childbearing age.

Pregnancy

If pregnancy is detected during the administration of Dicloflex 25 mg/ml solution for injection, you must immediately inform your doctor. During the first and second trimesters of pregnancy, DicloFLEX 25 mg/ml injection solution should be administered only after consultation and on the recommendation of your doctor, as the dose should be as low as possible and the duration of administration as short as possible, as it is considered that the possible risk to the fetus increases with dose and duration of administration. From the 20th week of pregnancy, DicloFLEX 25 mg/ml solution for injection can cause kidney problems in your unborn baby if taken for more than a few days, which can lead to a reduced amount of amniotic fluid that surrounds the baby (oligohydramnios). or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment longer than a few days, your doctor may recommend additional follow-up. The product should not be used during the last trimester of pregnancy due to an increased risk of complications for the mother and the child at birth. It can cause kidney and heart problems in your unborn baby. It can affect your and your baby's tendency to bleed and can cause labor to start later or take longer than expected.

Breastfeeding

The active ingredient diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be taken during breastfeeding, in order to avoid unwanted effects on the infant.

Fertility

DicloFLEX 25 mg/ml solution for injection can make it difficult to get pregnant and therefore its use is not recommended in women trying to get pregnant. Discontinuation of diclofenac should be considered in women with difficulty conceiving and those undergoing infertility investigations.

Driving and using machines

There is no evidence of impaired concentration and reaction time when driving or operating machinery.

DicloFLEX 25 mg/ml solution for injection contains 120 mg of benzyl alcohol in one ampoule.

It should not be prescribed to premature and newborn children. Benzyl alcohol can cause toxic and allergic reactions in children under 3 years of age.

DicloFLEX 25 mg/ml solution for injection contains sodium metabisulfite (E223).

Rarely, it can cause severe hypersensitivity reactions and bronchospasm

DicloFLEX 25 mg/ml injection solution contains 10 vol. % ethanol (alcohol), i.e. up to 300 mg per dose (3 ml), corresponding to 6 ml of beer or 2.5 ml of wine per dose. Harmful for alcoholics. To be considered in pregnant and lactating women, children and high-risk groups such as patients with liver disease or epilepsy

Muscle injection

DicloFLEX 25 mg/ml solution for injection is administered deep into the gluteal muscle.

Intravenous infusion

The solution is diluted with saline or glucose solution and slowly infused into the vein.

Your doctor will determine the dosage and duration of treatment. It is important to take the lowest effective dose possible for the shortest period of time. Usually, in adults, DicloFLEX 25 mg/ml solution for injection is administered over a period of two days. If necessary, the treatment is continued with tablets or suppositories.

Consult your doctor or pharmacist if you think that the effect of Dicloflex 25 mg/m] solution for injection is too strong or too weak.

Use in children and adolescents

DicloFLEX 25 mg/ml injection solution is not suitable for use in children and adolescents. Elderly patients

DicloFLEX 25 mg/ml solution for injection should not be used for more than 2 days; if necessary, the treatment can be continued with tablets.

Patients with renal impairment

The use of diclofenac is contraindicated in patients with renal failure.

Patients with hepatic impairment

The use of diclofenac is contraindicated in patients with liver failure.

If you have used more than the required dose of DicloFLEX 25 mg/ml solution for injection

Overdose does not have a typical clinical picture. The following symptoms of overdose may occur: disorders of the central nervous system such as headache, tinnitus, drowsiness and unconsciousness, as well as convulsions, as well as abdominal pain, nausea and vomiting, diarrhea. Bleeding in the gastrointestinal tract is possible, as well as disturbances in the function of the liver and kidneys.

No specific antidote is known!

If you suspect an overdose with DicloFLEX 25 mg/ml solution for injection, inform your doctor. He/she will assess what measures are needed depending on the severity of the intoxication.

If you forget to use DicloFLEX 25 mg/ml solution for injection

Do not take a double dose to make up for a missed dose.

If you have any further questions related to the use of this product, please ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dicloflex 25 mg/ml solution for injection can cause side effects, although not everybody gets them.

The evaluation of side effects is based on their frequency:

Very common: seen in more than 1 in 10 treated patients.

Common: in less than 1 in 10 but more than 1 in 100 treated patients.

Uncommon: in less than 1 in 100 but more than 1 in 1,000 patients treated.

Rare: in less than 1 in 1,000 but more than 1 in 10,000 patients treated.

Very rare: affects less than 1 in 10,000 patients treated.

Not known: no estimate can be made from the available data.

Adverse drug reactions depend mainly on the dosage and are different for each patient. The adverse reactions listed below include those reported after both short-term and long-term treatment with diclofenac in various dosage forms.

Serious side effects are:

unusual bleeding or injury;

high fever or persistent sore throat;

allergic reactions with swelling of the face, lips, mouth, tongue or throat, often accompanied by a rash and itching, leading to difficulty swallowing, low blood pressure and fainting; wheezing or shortness of breath (asthma symptoms);

chest pain (heart attack symptoms);

sudden and severe headache, nausea, dizziness, numbness, difficulty or inability to speak, paralysis (stroke symptoms);

neck stiffness (symptoms of viral meningitis);

convulsions;

high blood pressure;

red or purple skin (a possible sign of inflammation of the blood vessels), skin rash with blisters on the lips, eyes and mouth, skin inflammation with blisters and peeling;

severe stomach pain with bloody or black stools; vomiting blood; yellowing of the skin or eyes (symptoms of hepatitis);

blood in the urine, excess protein in the urine, a severe decrease in the amount of urine (symptoms of kidney disorders).

Medicines such as diclofenac may be associated with a slightly increased risk of heart attack (myocardial infarction) or stroke.

Headache, dizziness, vertigo, nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, loss of appetite, change in liver function (some enzymes are increased), skin rash, injection site reactions such as pain, swelling and hardening.

Other uncommon side effects

Myocardial infarction, heart failure, palpitations (heart palpitations), chest pain.

Other rare side effects

Hypersensitivity, drowsiness, difficulty breathing (asthma), stomach pain, gastritis, bleeding from the gastrointestinal tract, vomiting blood, bloody diarrhea, stomach or intestinal ulcer, hepatitis, jaundice, liver disorders, urticaria, swelling of the hands and feet (edema ), necrosis at the application site.

5. How to store DicloFLEX 25 mg/ml solution for injection

At a temperature below 25°C, in a dry place protected from light.

To be stored in places inaccessible to children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container.

Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What DicloFLEX 25 mg/ml solution for injection contains

The active substance is: diclofenac sodium. Each 3 ml ampoule contains 75 mg diclofenac sodium.

Other ingredients (excipients) propylene glycol, benzyl alcohol, ethanol 96%, sodium metabisulfite (E223), sodium hydroxide, water for injections.

What DicloFLEX 25 mg/ml solution for injection looks like and contents of the pack

DicloFLEX 25 mg/ml solution for injection is a clear, colorless to pale yellow solution. Each carton contains 10 ampoules of 3 ml solution for injection in a 5 ml glass ampoule with a label placed together with a leaflet.