Metamizol Krka

Leaflet attached to the packaging: information for the user

Metamizol Krka, 500 mg/ml, solution for injection/infusion

Metamizolum natricum monohydricum

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What is Metamizol Krka and what is it used for

Metamizol Krka contains the active substance - metamizole sodium monohydrate. It is a pain reliever and antipyretic, which belongs to the group of pyrazolones.
Metamizol Krka is used to treat:

• severe pain after injuries or surgery,
• colic pain in the abdomen,
• cancer pain,
• other severe acute or chronic pain, when other treatment methods are not possible,
• high fever, when other medicines are ineffective.

The solution for injection/infusion is used only when the use of other pharmaceutical forms (tablets, oral solution, suppositories) is not indicated.

2. Important information before using Metamizol Krka

When not to use Metamizol Krka

• if the patient is allergic to metamizole or any of the other ingredients of this medicine (listed in section 6),
• if the patient is allergic to other pyrazolones (e.g. phenazone, propyphenazone) or pyrazolidines (e.g. phenylbutazone, oxyphenbutazone). This also applies to patients who have had a significant decrease in the number of certain white blood cells (agranulocytosis) after using these substances,
• if the patient has intolerance to painkillers (aspirin asthma syndrome or intolerance to painkillers manifested by urticaria and/or angioedema),
• if the patient has disorders of bone marrow function, e.g. after treatment with certain anticancer drugs,
• if the patient has blood disorders,
• if the patient has a hereditary disease associated with the risk of red blood cell breakdown (congenital glucose-6-phosphate dehydrogenase deficiency),
• if the patient has a congenital defect associated with disorders of red blood cell pigment synthesis (acute intermittent porphyria),
• if the patient has low blood pressure or circulatory disorders,
• if the patient is in the third trimester of pregnancy (last 3 months of pregnancy).

Warnings and precautions

Before starting to take Metamizol Krka, you should discuss it with your doctor, pharmacist, or nurse.
Metamizole may cause rare but life-threatening risks of:

• sudden circulatory collapse;
• agranulocytosis (severe disorder caused by a significant decrease in the number of granulocytes, which are specific white blood cells).

In case of the following symptoms, which may indicate the possibility of agranulocytosis, you should stop takingMetamizol Krka and immediately contact your doctor:

• unexpected deterioration of the patient's general condition (symptoms such as fever, chills, sore throat, difficulty swallowing),
• persistent or recurrent fever,
• painful changes in the mucous membranes, especially in the mouth, nose, and throat or genital and anal areas.

If the patient experiences symptoms of a decrease in the number of all blood cells (pancytopenia) (such as general malaise, infection, or persistent fever, bruising, bleeding, and pallor) or platelets (thrombocytopenia) (such as increased tendency to bleeding and the formation of petechiae on the skin and mucous membranes), you should stop takingMetamizol Krka and contact your doctor(see section 4).

Interaction with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take.
In particular, tell your doctor about taking the following medicines, which may interact with Metamizol Krka or whose action may be affected by Metamizol Krka:

• cyclosporine, an immunosuppressive drug. During concomitant use, the doctor will monitor cyclosporine levels in the blood.
• methotrexate, a drug used to treat cancer or rheumatic diseases. Concomitant use may increase the potential risk of methotrexate-induced blood cell damage, especially in elderly patients.
• acetylsalicylic acid, used in small doses to protect the heart. Concomitant use may reduce the effect of acetylsalicylic acid on platelets.
• bupropion, a drug used to treat depression or to help quit smoking. During concomitant use, the level of bupropion in the blood may decrease.
• efavirenz, a drug used to treat HIV infection (AIDS).
• methadone, a drug used to treat opioid addiction.
• valproate, a drug used to treat epilepsy or bipolar disorder.
• tacrolimus, a drug used to prevent organ rejection in patients after transplantation.
• sertraline, a drug used to treat depression.
• chlorpromazine, a drug used to treat mental disorders. Concomitant use may lead to excessive lowering of body temperature.

Using Metamizol Krka with alcohol

Do not drink alcohol while taking Metamizol Krka.

Pregnancy and breastfeeding

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 taking this medicine.
Pregnancy
Available data on the use of metamizole during the first 3 months of pregnancy are limited, but do not indicate harmful effects on the fetus.

3. How to use Metamizol Krka

The dose depends on the severity of the pain or fever and the individual sensitivity of the patient to Metamizol Krka.
Metamizol Krka will be injected into a vein or muscle (intravenous or intramuscular administration).

What to do if you have taken more Metamizol Krka than you should

Symptoms of overdose are:

• nausea,
• vomiting,
• abdominal pain,
• kidney function disorders, and even acute kidney failure (with symptoms of interstitial nephritis),
• dizziness,
• drowsiness,
• loss of consciousness,
• seizures,
• decreased blood pressure, up to circulatory failure (shock),
• heart rhythm disorders (tachycardia).

If you have taken more Metamizol Krka than you should, contact your doctor immediately.

4. Possible side effects

Like all medicines, Metamizol Krka can cause side effects, although not everybody gets them.
The following side effects can have serious consequences. You should stop takingMetamizol Krka if you experience any of the following side effects.

Other possible side effects

Uncommon side effects (may affect up to 1 in 100 people)

• Purple to dark red skin rash, sometimes with blisters (purpura),
• Decreased blood pressure, probably caused by the direct action of the medicine and not accompanied by other symptoms of hypersensitivity.

Rare side effects (may affect up to 1 in 1,000 people)

• Allergic reactions(anaphylactoid or anaphylactic reactions). Symptoms of mild reactions include:
• burning eyes,
• cough, runny nose, sneezing,
• chest tightness,
• redness of the skin, especially on the face and head,
• hives and facial swelling,
• less often: nausea and stomach cramps.

Very rare side effects (may affect up to 1 in 10,000 people)

• Severe decrease in the number of granulocytes - specific white blood cells (agranulocytosis), including cases with a fatal outcome, or a decrease in the number of platelets (thrombocytopenia).

Frequency not known (frequency cannot be estimated from the available data)

• Sudden circulatory failure due to a severe allergic reaction (anaphylactic shock),
• Myocardial infarction in the course of an allergic reaction(Kounis syndrome),
• Anemia with concomitant bone marrow dysfunction(aplastic anemia), a decrease in the number of white and red blood cells and platelets (pancytopenia), including cases with a fatal outcome.

5. How to store Metamizol Krka

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Store in the original packaging to protect from light.
After first opening and/or dilution, the medicine should be used immediately.
Medicines should not be disposed of via wastewater or household waste.

6. Contents of the packaging and other information

What Metamizol Krka contains

• The active substance is metamizole sodium monohydrate. 1 ml of the solution for injection/infusion contains 500 mg of metamizole sodium monohydrate.

What Metamizol Krka looks like and contents of the pack

The solution for injection/infusion is a clear, colorless to light yellow solution.
Metamizol Krka is available in packs of 5 ampoules (packed in blisters) of 2 ml or 5 ml solution for injection/infusion.

Marketing Authorisation Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Date of last revision of the leaflet: 13.04.2022