Metamizole sodium ABC

Package leaflet: information for the patient

Metamizole Sodium ABC 500 mg/ml oral drops, solution

Metamizole Sodium
Generic Medicine
Metamizole Sodium ABC may cause an abnormally low white blood cell count (agranulocytosis),
which can lead to serious and potentially fatal infections (see section 4).
You must stop taking the medicine and contact your doctor immediately if any of the following symptoms occur: fever, chills, sore throat, painful ulcers in the nose, mouth and throat, or in the genital or anal area.
If you have previously experienced agranulocytosis with the use of metamizole or similar medicines, you must never take these medicines again (see section 2).
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful to them.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Metamizole Sodium ABC is and what it is used for
2. What you need to know before taking Metamizole Sodium ABC
3. How to take Metamizole Sodium ABC
4. Possible side effects
5. How to store Metamizole Sodium ABC
6. Contents of the pack and other information

1. What Metamizolo Sodico ABC is and what it is used for

Metamizolo Sodico ABC contains metamizole, which belongs to a class of medicines called
"Analgesics and antipyretics, pyrazolones".
Metamizolo Sodico ABC is indicated for the treatment of:

• severe or resistant pain;
• severe or resistant fever.

2. What you need to know before taking Metamizole Sodium ABC

Do not take Metamizole Sodium ABC

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other medicines of the same class as Metamizole Sodium ABC: pyrazolones (e.g. phenazone, propyphenazone) or to medicines belonging to the pyrazolidine class (e.g. phenylbutazone, oxyphenbutazone);
• if you previously experienced severe skin reactions when using this medicine or other pyrazolones (see also section 4);
• if you previously had a significant reduction in a type of white blood cells called granulocytes, caused by metamizole or other medicines called pyrazolones or pyrazolidines;
• if you have bone marrow problems or a disease affecting the production or function of blood cells;
• if after taking non-opioid painkillers (e.g. salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen) you developed bronchospasm (a contraction of the bronchi that may cause breathing difficulties) or other allergic reactions (e.g. urticaria, rhinitis, angioedema, i.e. swelling of the throat, face and limbs);
• if you suffer from a condition called "acute intermittent hepatic porphyria", because Metamizole Sodium ABC may trigger an attack of this disease;
• if you were born with a condition called favism, caused by deficiency of a substance normally present in the body called "glucose-6-phosphate dehydrogenase", because Metamizole Sodium ABC may cause destruction of red blood cells (risk of haemolysis);
• if you are in the last three months of pregnancy;
• if you have fertility problems or have undergone fertility investigations.

It is recommended not to use Metamizole Sodium ABC during the first three months of pregnancy. Consult your doctor before using Metamizole Sodium ABC during the following three months (second trimester of pregnancy).
Warnings and precautions
Talk to your doctor or pharmacist before taking Metamizole Sodium ABC.
Unusually low white blood cell count (agranulocytosis)
Metamizole Sodium ABC may cause agranulocytosis, a very low level of a type of white blood cells called granulocytes, which are important for fighting infections (see section 4).
You must stop taking metamizole and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful ulcers on mucous membranes (moist linings of body cavities), especially in the mouth, nose, throat, genital or anal areas. Your doctor will perform a laboratory test to check your blood cell levels.
If you are taking metamizole for fever, some symptoms of newly developed agranulocytosis may go unnoticed. Similarly, symptoms may also be masked if you are undergoing antibiotic therapy.
Agranulocytosis may develop at any time during treatment with Metamizole Sodium ABC and even shortly after stopping metamizole.
You may develop agranulocytosis even if you previously used metamizole without problems.
Reduction in blood cell count
Metamizole Sodium ABC may cause a serious blood cell disorder called "pancytopenia".
Stop treatment immediately and contact your doctor immediately if you experience any of the following symptoms:

• general malaise,
• infections,
• persistent fever,
• red-purple spots on the skin (bruising, ecchymoses),
• bleeding,
• pallor.

Metamizole Sodium ABC may cause a serious disorder of certain blood cells called "thrombocytopenia".
Stop treatment and consult your doctor immediately if you experience bleeding (haemorrhage), with or without small red-purple spots on the skin (petechiae).
Allergic reactions (anaphylactic/anaphylactoid) and anaphylactic shock
Stop treatment with Metamizole Sodium ABC immediately and consult your doctor if you experience any of the following symptoms:

• swelling of the throat (larynx), face and limbs (angioedema),
• skin problems with redness and possible itching (urticaria, skin rash),
• breathing difficulties (dyspnoea),
• pallor,
• increased blood flow in certain areas of the body (generalized hyperemia),
• general malaise,
• drop in blood pressure (hypotension),
• shock.

These reactions mainly occur in sensitive patients; therefore, Metamizole Sodium ABC should be used with caution if you suffer from:

• drug-induced asthma (analgesic-induced asthma) or analgesic intolerance with urticaria and angioedema (facial, limb, throat swelling) (see "Do not take Metamizole Sodium ABC"),
• frequent allergic reactions (atopic patient),
• bronchial asthma, especially if you have nasal polyps and frequent colds (polypous rhinosinusitis),
• frequent (chronic) urticaria,
• alcohol intolerance, i.e. if you react to small amounts of alcoholic beverages with symptoms such as sneezing, tearing or facial flushing,
• allergy (intolerance) to dyes (e.g. tartrazine) or preservatives (e.g. benzoates).

If you suffer from any of these conditions, discuss them with your doctor before taking Metamizole Sodium ABC.
In particular, if you have previously experienced an allergic (hypersensitivity) reaction to metamizole, you must not take metamizole or other pyrazolone medicines again.
Severe skin reactions
Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizole treatment. Stop using metamizole and contact your doctor immediately if you experience any symptoms related to these severe skin reactions described in section 4.
If you have previously developed severe skin reactions, you must not restart treatment with Metamizole Sodium ABC at any time (see section 4).
Liver problems
Liver inflammation with symptoms developing within a few days or months after starting treatment has been reported in patients taking metamizole.
Stop using Metamizole Sodium ABC and contact a doctor if you experience symptoms of liver problems such as malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), itching, skin rash or upper abdominal pain. Your doctor will check liver function.
You must not take Metamizole Sodium ABC if you previously took a medicine containing metamizole and experienced liver problems.
Isolated hypotensive reactions
Administration of Metamizole Sodium ABC may cause isolated cases of blood pressure-lowering reactions (see "Possible side effects"). These reactions are dose-dependent and more likely with intravenous administration.
Furthermore, the risk of severe blood pressure-lowering reactions is increased if:

• intravenous administration is not performed slowly;
• you already have low blood pressure, dehydration, or instability or disturbance of the circulatory system (incipient circulatory failure);
• you have high fever.

If you suffer from blood vessel disorders affecting the heart (severe coronary insufficiency) or narrowing of vessels supplying the brain (stenosis) and are taking Metamizole Sodium ABC, your doctor may periodically perform certain tests (haemodynamic monitoring) to prevent a drop in blood pressure, which would be harmful in these cases.
Avoid using Metamizole Sodium ABC for minor disorders and use the medicine only for the time necessary to control pain and fever; the use of painkillers (analgesics) at high doses or for prolonged periods should be evaluated by a doctor.
Children and adolescents
For children under 5 years of age, administration under medical supervision is recommended.
Other medicines and Metamizole Sodium ABC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The effects of Metamizole Sodium ABC may be influenced by, or may influence, the following medicines:

• bupropion, a medicine used to treat depression or as an aid to stop smoking, because Metamizole Sodium ABC may reduce the blood concentration of this medicine;
• efavirenz, a medicine used to treat HIV/AIDS;
• methadone, a medicine used to treat opioid dependence;
• valproate, a medicine used to treat epilepsy or bipolar disorder;
• tacrolimus, a medicine used to prevent organ rejection in transplant patients;
• sertraline, a medicine used to treat depression;
• cyclosporine (antibiotic), because Metamizole Sodium ABC may reduce cyclosporine blood levels;
• methotrexate (used for cancer and autoimmune diseases), because Metamizole Sodium ABC may increase methotrexate toxicity, especially in elderly patients. Avoid combining Metamizole Sodium ABC with methotrexate;
• acetylsalicylic acid (used for inflammation or blood thinning), because Metamizole Sodium ABC may reduce the blood-thinning effect of acetylsalicylic acid. This combination should be used with caution if you are taking low-dose acetylsalicylic acid for heart protection.

Interference with laboratory tests using the Trinder method or a Trinder-like method has been reported in patients treated with Metamizole Sodium ABC, for example tests measuring creatinine, triglycerides, HDL cholesterol and uric acid levels in blood.
Metamizole Sodium ABC and alcohol
Avoid alcohol consumption during treatment with Metamizole Sodium ABC, as negative effects of the combination cannot be ruled out.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Available data on the use of metamizole during the first three months of pregnancy are limited but do not indicate harmful effects on the embryo. In selected cases, when no other treatment options are available, single doses of metamizole during the first and second trimesters may be acceptable after consulting your doctor and carefully weighing the benefits and risks of metamizole. However, in general, the use of metamizole is not recommended during the first and second trimesters.
You must not use Metamizole Sodium ABC during the last three months of pregnancy due to an increased risk of possible complications for mother and baby (bleeding, premature closure of an important fetal vessel, the so-called ductus arteriosus, which normally closes only after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in considerable amounts, and the risk to breastfed infants cannot be excluded. In particular, repeated use of metamizole during breastfeeding should be avoided. After a single dose of metamizole, mothers are advised to collect and discard breast milk for 48 hours following administration.
Fertility
Discontinue administration of Metamizole Sodium ABC if you have fertility problems or have undergone fertility investigations.
Driving and using machines
In patients taking Metamizole Sodium ABC, concentration and reaction abilities may be impaired, thus posing a risk in situations where these abilities are particularly important (e.g. driving vehicles or operating machinery), especially if alcohol has also been consumed.
Metamizole Sodium ABC contains ethanol
This medicine contains 6 mg of alcohol (ethanol) per 20-drop dose (equivalent to 500 mg of metamizole). This amount corresponds to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not produce significant effects.
Metamizole Sodium ABC contains sodium
This medicine contains 38 mg of sodium (main component of table salt) per 20-drop dose (equivalent to 500 mg of metamizole). This equals 1.9% of the maximum daily dietary intake recommended for an adult.

3. How to take Metamizolo Sodico ABC

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Take the drops diluted in a small amount of liquid.
500 mg/ml oral drops, solution (1 ml = 20 drops; 1 drop = 25 mg)
The dose depends on the intensity of pain or fever and on individual sensitivity to
Metamizolo Sodico ABC. The lowest effective dose required to control pain and
fever should always be used. Your doctor will tell you how to take Metamizolo Sodico ABC.
The following table shows the recommended single doses and maximum daily doses according to weight or
age:

Single doses may be administered up to four times daily, depending on the maximum daily dose.
A noticeable effect is expected 30 to 60 minutes after oral administration.
Use in children and adolescents
For pain treatment, children and adolescents up to 14 years of age may take a single dose of 8 to 16 mg of Metamizolo Sodico ABC per kilogram of body weight (see the following table). In case of fever, a dose of 10 mg of Metamizolo Sodico ABC per kilogram of body weight is generally sufficient for children, according to the scheme reported in the following table:

Elderly and patients in poor general health / with reduced renal function
Dosage reduction is required in elderly individuals, debilitated patients, and patients with reduced renal function, as delayed excretion of metabolites derived from metamizole metabolism may occur.

Patients with impaired renal or hepatic function
High repeated doses should be avoided in patients with impaired renal or hepatic function due to reduced elimination rate. For short-term use only, no dosage reduction is required. There is no experience regarding long-term use.

Instructions for use:
Take the drops diluted in a small amount of liquid.
To open the bottle, press down on the cap while simultaneously unscrewing it in a counterclockwise direction.

Close the bottle after use (the bottle is properly closed if, when unscrewing the cap without pressing, a clicking sound is heard).

If you take more Metamizole Sodium ABC than you should
Taking an excessive amount of Metamizole Sodium ABC (overdose) may lead to:

• nausea,
• vomiting,
• abdominal pain;
• kidney problems (acute renal failure). Less commonly, the following may occur:
• central nervous system symptoms:
  • dizziness,
  • drowsiness,
  • coma,
  • seizures
• drop in blood pressure, sometimes progressing to shock
• increased heart rate (tachycardia).

After administration of very high doses, red discoloration of the urine may occur.
In case of accidental ingestion/overdose of Metamizole Sodium ABC, contact your doctor immediately or go to the nearest hospital.

If you forget to take Metamizole Sodium ABC
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of 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.
Stop using Metamizole Sodium ABC and contact a doctor immediately if you experience any of the following
symptoms:
feeling unwell (nausea or vomiting), fever, feeling tired, loss of appetite, dark-coloured urine, pale-coloured
faeces, yellowing of the skin or the whites of the eyes, itching, skin rash or pain in the upper part of the stomach.
These symptoms may be signs of liver damage.
See also section 2. Warnings and precautions.

Uncommon side effects (may affect from 1 to 10 people in 1,000)

• allergic reactions (anaphylactic/anaphylactoid), with skin and mucous membrane disorders (such as itching, burning, redness, urticaria, swelling), breathing difficulties and, less frequently, stomach and intestinal disorders; in more severe cases, generalized urticaria, swelling of the throat (larynx), face and limbs (severe angioedema), severe bronchial constriction with breathing difficulties (bronchospasm), changes in heart rhythm, drop in blood pressure (sometimes preceded by a rise in blood pressure) and allergic shock (anaphylactic shock). These reactions may occur immediately after administration of Metamizole Sodium ABC or even several hours later; however, they usually occur within the first hour after administration. The risk of anaphylactic shock, however, appears to be higher with Metamizole Sodium ABC administered by injection. If you suffer from asthma caused by painkillers (analgesics), intolerance reactions usually manifest as asthma attacks.
• lowering of blood pressure, which may be occasional or transient, or rarely may present as an acute drop in blood pressure.

Rare side effects (may affect from 1 to 10 people in 10,000)

• skin disorders known as fixed drug eruptions,
• redness (skin rash).

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• Severe skin reactions. Discontinue treatment with metamizole and contact your doctor immediately if you experience any of the following serious side effects:
  • non-elevated reddish patches on the trunk, target-shaped or circular, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis),
  • widespread skin rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome),
• liver inflammation, yellowing of the skin and the whites of the eyes, increased liver enzymes in the blood,
• acute allergic heart disease (Kounis syndrome),
• anaemia (aplastic anaemia),
• changes in the number of certain blood cells (agranulocytosis, pancytopenia, which may be fatal, leucopenia and thrombocytopenia). See "Warnings and precautions". Typical symptoms of "agranulocytosis" (characterized by a decrease in the number of certain blood cells called granulocytes) are:
  • inflammatory lesions of the mucous membranes (e.g. mouth and throat, anorectal, genital),
  • sore throat,
  • fever (including persistent or recurring fever). Typical symptoms of "thrombocytopenia" include:
  • increased tendency to bleed,
  • red spots on the skin or mucous membranes (petechiae). These reactions may occur even if you have previously used Metamizole Sodium ABC without complications.
• worsening of kidney function (acute renal failure), which in some cases may be accompanied by:
  • reduced urine output (oliguria),
  • absence of urine output (anuria),
  • presence of protein in the urine (proteinuria),
  • a serious kidney disease called "acute interstitial nephritis".
• red discolouration of the urine, which disappears at the end of treatment.
• gastrointestinal bleeding.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Metamizolo Sodico ABC

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month and applies to the product in its original, unopened
packaging stored correctly.
Do not store above 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Metamizolo Sodico ABC contains
The active substance is sodium metamizole.
Each ml of solution (equivalent to 20 drops) contains 500 mg of sodium metamizole.
The other components are: dibasic sodium phosphate dodecahydrate, monobasic sodium phosphate dihydrate, raspberry flavour, sodium saccharin, purified water.

Description of the appearance of Metamizolo Sodico ABC and package contents
The medicine comes in a package containing 1 bottle of 20 ml.

Marketing Authorization Holder
ABC Farmaceutici S.p.A. – Corso Vittorio Emanuele II, 72 – 10121 Turin

Manufacturer
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10015 San Bernardo d’Ivrea (Turin)