Analgin Drops 500 mg/ml (20 ml)

How to take Analgin oral drops:

Always use Analgin oral drops exactly as described in this leaflet. If you are not sure, talk to your doctor or pharmacist. The prescribed single dose can be administered 2-3 times a day.

Body weight / age Single dose (drops):

• Adults and children over 15 years:
  20-40 drops in Children 46-53 kg (13-14 years)
  15-35 drops in Children 31-45 kg (10-12 years)
  10 -30 drops in Children 24-30 kg (7-9 years)
  8-20 drops in Children 16-23 kg (4-6 years)
  5-15 drops in Children 9-15 kg (0-3 years)
  3-10 Drops in Newborns 5-8 kg (3-11 months)
  2-4 Analgin oral drops should not be used in newborns up to the first 3 months after birth or at a body weight below 5 kg, unless absolutely necessary. If necessary, the single dose should not exceed 1 drop, and the daily dose should not exceed 1 drop twice a day.

Patients over 65 years of age:

If you are over 65 years of age and have liver or kidney problems, start treatment with a lower dose (10-20 drops 2-3 times a day). If necessary, consult a doctor.

Patients with impaired renal or hepatic function

If you have kidney or liver disease, start treatment with a low dose (1/2 of that recommended for adults). If you need longer treatment, consult a doctor.

Duration of treatment

Apply Analgin oral drops no more than 3 to 5 days. If after 3 days there is no relief or you continue to maintain a high temperature, consult your doctor.

ANALGIN drops 500 mg/ml 20 ml SOPHARMA

Package leaflet: patient information

ANALGIN® 500 mg/ml oral drops/solution ANALGIN® 500 mg/ml oral drops, solution

Metamizole sodium

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may have to read it again.
• If you need further information or advice, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 3 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

1. What Analgin oral drops are and what it is used
for 2. What you need to know before you use Analgin oral drops
3. How to take Analgin oral drops
4. Possible side effects
5. How to store Analgin oral drops
6. Contents of the pack and other information

1. What Analgin oral drops are and what it is used for

Analgin oral drops contains the active substance metamizole, which has a pronounced analgesic and temperature-lowering effect. Analgin oral drops are used for:

• lowering high temperature;
• Moderate to severe pain of various origins: headache, toothache, neuralgia, neuritis, muscle pain, trauma, burns, postoperative pain, phantom pain, menstrual pain, pain in oncological diseases, renal and biliary colic.

2. What you need to know before you use Analgin oral drops

Do not use Analgin oral drops

• • if you are allergic (hypersensitive) to the active substance metamizole, other pyrazolones e.g. phenazone, propyfenazone or pyrazolone derivatives e.g. phenylbutazone, oxyfenbutazone (this also includes reactions such as agranulocytosis) or any of the other ingredients of this medicine (listed in section 6);
• if you have a known intolerance to pain fighting products (analgesic asthma or urticaria-angioedema type analgesic). In these cases, you react to pain protection products (analgesics) such as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin or naproxen with bronchospasm (constriction of the bronchi, which makes breathing difficult) or other hypersensitivity reactions;
• if you have impaired bone marrow function (e.g. after treatment with cytostatins, cancer products) or diseases of the haematopoietic system (impaired blood formation);
• if you have congenital glucose-6-phosphatedehydrogenase deficiency (a rare metabolic disease) because of the risk of haemolysis (destruction of red blood cells);
• if you have acute liver porphyria (a rare metabolic disease), as there is a risk of a seizure of porphyria;
• if you are in the last three months of pregnancy.

Warnings and precautions

Analgin contains the pyrazolone derivative metamizole and is associated with a rare but life-threatening risk of shock (circulatory collapse) or agranulocytosis (a severe disease associated with a significantly reduced number of some white blood cells).

If you react to Analgin with hypersensitivity (anaphylactoid reactions), you are at increased risk of a similar reaction to other analgesics.

If you have an allergic or other (immune) reaction (e.g. agranulocytosis) to Analgin, you are at increased risk of a similar reaction to other pyrazolones or pyrazolone derivatives (chemically related substances).

If signs of agranulocytosis or thrombocytopenia occur, the use of Analgin should be stopped immediately and a blood count test (including differential blood counts) should be performed.

If signs of pancytopenia (severe decrease in blood count) occur, the use of metamizole should be stopped immediately and blood cell counts monitored until they return to normal.

Patients with analgesic intolerance (see section “Do not take Analgin”) are at increased risk of severe hypersensitivity reactions to Analgin.

The risk of possible severe hypersensitivity reactions to Analgin is significantly increased if you have the following diseases/intolerances:

• intolerance to analgesics and antirheumatic products manifested as e.g. itching and swelling (urticaria, angioedema);
• attacks of shortness of breath due to narrowing of the small airways (bronchial asthma), especially if you suffer from inflammation of the nose and nasal sinuses (rhinosinusitis) and nasal polyps;
• chronic urticaria;
• hypersensitivity to colourants (e.g. tartrazine) or preservatives (benzoates);
• Alcohol intolerance – if you react even to small amounts of alcohol with symptoms such as sneezing, watery eyes and severe redness of the face. Such alcohol intolerance can be a sign of undiagnosed analgesic asthma syndrome.

Serious skin reactions

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with methamisole treatment. Stop using metamizole and seek medical advice immediately if you notice any of the symptoms associated with these serious skin reactions described in section 4.
If you have ever developed severe skin reactions, you should never restart treatment with Analgin oral drops (see section 4).

Analgin may cause a decrease in blood pressure (see section 4).
The risk of such reactions is increased:

• • if you have low blood pressure (hypotension) or fluid loss, impaired blood circulation or incipient circulatory collapse (e.g. such as myocardial infarction or severe injuries);
• if you have a high fever.

Therefore, the use should be carefully weighed and you should be closely monitored. Prophylactic measures (e.g. circulatory stabilisation) may be necessary to reduce the risk of lowering blood pressure.

In patients who must avoid lowering blood pressure, such as patients with severe coronary heart disease or narrowing of cerebral vessels leading to impaired blood circulation, this product may only be used with careful monitoring of cardiovascular function.

If you have kidney or liver disorders Analgin should only be used after careful benefit/risk assessment and after appropriate precautions (see section 3).

Liver problems

Inflammation of the liver has been reported in patients taking metamizole and symptoms develop within a few days to several months of starting treatment.

Stop using Analgin and contact a doctor if you have symptoms of liver problems such as nausea or vomiting, fever, feeling tired, loss of appetite, darkening of urine, light stools, yellowing of the skin or whites of the eyes, itching, rash or pain in the upper abdomen. Your doctor will check your liver function.

You should not take Analgin if you have previously taken a medicine containing metamizole and have had liver problems.

Children

For children up to 10 years, this medicine is given only at the discretion of the doctor.

Elderly

The excretion of metamizole from the body may be delayed in the elderly.

Other medicines and Analgin oral drops

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

Simultaneous intake of Analgin and chlorpromazine (a medicine for the treatment of mental illness) can lead to a sharp decrease in body temperature (severe hypothermia).

Concomitant use of metamizole and methotrexate (a medicine to treat cancer and rheumatism) may increase the haematological toxicity of methotrexate. Therefore, this combination should be avoided.

The group of pyrazolons, to which Analgin also belongs, is known for its interactions with certain drugs:

• which suppress blood clotting (oral anticoagulants);
• lowering elevated blood pressure and used in certain heart diseases (captopril);
• for the treatment of psychiatric disorders (lithium);
• for drainage (triamterene).

It is not known to what extent this also applies to Analgin.

Analgin may decrease plasma concentrations of ciclosporin (a product that inhibits immune reactions in organ transplants) and ciclosporin levels should be monitored when co-administered with the product.

Metamizole (a substance to reduce pain and fever) may reduce the effect of acetylsalicylic acid on platelet aggregation (clumping of blood cells and blood clot) when taken at the same time. Therefore, this combination should be used with caution in patients taking low-dose aspirin for cardioprotection (prevention).

Metamizole should be used with caution with the following medicines, as it may reduce their effect:

• bupropion, a medicine used to treat depression or as an aid in stopping smoking;
• efavirenz, a medicine used to treat HIV/AIDS;
• methadone, a medicine used to treat dependence on prohibited substances (so-called opioids);
• valproate, a medicine used to treat epilepsy or bipolar disorder;
• tacrolimus, a medicine used to prevent organ rejection in transplanted patients;

sertraline, a medicine used to treat depression.

Analgin oral drops with food and drink

Concomitant administration with alcohol should be avoided, as negative interaction cannot be excluded.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice 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 for the embryo. In certain cases, where there are no other treatment options, it is possible to accept the administration of single doses of metamizole in the first and second trimesters after consultation with a doctor or pharmacist, and after careful consideration of the benefits and risks of using metamizole. In general, however, the use of metamizole in the first and second trimesters is not recommended.

During the last three months of pregnancy, you should not take Analgin oral drops because of the increased risk of complications for the mother and child (bleeding, premature closure of an important blood vessel, the so-called Bottali ductus in the unborn, which closes naturally only after birth).

Metamizole
breakdown products pass into breast milk in significant quantities and a risk to the infant cannot be excluded. Therefore, repeated use of metamizole during breast-feeding should be avoided. In the case of a single administration of metamizole, mothers are advised to collect and dispose of breast milk for 48 hours after dosing.

Driving and using machines

With the administration of the recommended dose, there are no known disturbances in concentration and reaction time. As a precautionary measure, when taking high doses, driving, operating machinery or other dangerous activities, especially after administration of alcohol, should be avoided.

Analgin oral drops contains in 1 ml (20 drops) 1.5567 mmol sodium.

To be taken into account in patients on a controlled sodium diet.

3. How to take Analgin oral drops

The dose depends on the intensity of pain or fever and individual sensitivity to analgin. The lowest dose needed to manage pain and fever should be selected. Your doctor will tell you how to take Analgin.

The following table shows the recommended single doses and maximum daily doses depending on weight or age:

Single doses can be taken up to four times a day depending on the maximum daily dose.
A pronounced effect can be expected 30 to 60 minutes after oral administration.

Use in children and adolescents

For the treatment of pain in children over 10 years of age and adolescents up to 14 years of age, you can take 8 to 16 mg of Analgin per kilogram of body weight as a separate dose (see table above).
In case of fever, a dose of 10 mg of Analgin per kilogram of body weight is usually sufficient for children:

For children under 10 years, Analgin for children 500 mg/ml oral drops, a solution on prescription, is recommended.

Elderly and patients with poor general health/renal impairment

The dose should be reduced in elderly patients, in debilitated patients and in patients with reduced renal function, as the excretion of metamizole degradation products may be delayed.

Impaired renal and hepatic functions

Since the rate of excretion is reduced in patients with impaired renal or hepatic function, repeated high doses should be avoided. No dose reduction is required only with short-term use. There is no experience available from long-term use.

Route of administration and duration of treatment

Oral drops should be taken with a small amount of liquid.

Apply Analgin oral drops no more than 3 to 5 days. If after 3 days there is no relief or you continue to maintain a high fever, consult your doctor.

If you take more Analgin oral drops than you should

Nausea, dizziness, abdominal pain, dizziness, fatigue to loss of consciousness, a sharp decrease in blood pressure and disturbances in the heart rhythm may be observed. If signs such as cold sweat, dizziness, lifting, discoloration and shortness of breath occur, seek medical attention immediately.

After taking very high doses, excretion of the harmless metabolic product rubazonic acid may result in red discoloration of the urine.

If you forget to take Analgin oral drops

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

4. Possible side effects

Like all medicines, Analgin oral calculi can cause side effects, although not everybody gets them.

Stop using Analgin and contact a doctor immediately if you experience any of the following symptoms:

Nausea or vomiting, fever, feeling tired, loss of appetite, darkening of urine, light stools, yellowing of the skin or whites of the eyes, itching, rash or pain in the upper abdomen. These symptoms may be signs of liver damage. See also section 2 “Warnings and precautions”.

The following side effects may have serious consequences. Do not take Analgin again and consult a doctor immediately.

Stop using metamizole and seek medical advice immediately if you notice any of the following serious side effects:

• Reddish, flat, target-like or round patches on the torso, often with centrally located blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

If signs of agranulocytosis or thrombocytopenia are observed (see below), administration of the product should be discontinued immediately. You should not wait until the results of laboratory tests are discontinued.

Analgin should be discontinued if characteristic signs of agranulocytosis occur:

• sudden deterioration of the general condition;
• the high temperature does not drop or reappears;
• painful changes in the mucous membranes, especially the mouth, nose and throat.

Side effects are classified by frequency as follows: Common (may affect up to 1 in 10 patients)Uncommon (may affect up to 1 in 100 patients)Rare (may affect up to 1 in 1000,1 patients)Very rare (may affect less than 10 in 000,<> patients)Not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Rare: Lowering of white blood cells (leukopenia).
Very rare: Significant decrease in some white blood cells (agranulocytosis) or decrease in platelets (thrombocytopenia), including fatal cases.
Not known: Aplastic anaemia, pancytopenia, including fatal cases.

These reactions are mainly immunologically determined. They can also occur if metamizole is administered without complications in the anamnesis. It has been shown that the risk of agranulocytosis may be increased in individual cases when metamizole is used for more than 1 week.

This reaction is not dose-dependent and can occur at any time during treatment. Typical signs of agranulocytosis include fever, chills, sore throat, difficulty swallowing, as well as inflammatory changes of the lip, nasal, pharyngeal, genital and mucous membranes.
In patients taking antibiotics, these signs may be poorly expressed. Typical signs of thrombocytopenia are increased bleeding and punctual hemorrhages on the skin and mucous membranes. In general, but not always, normal values of hemoglobin, erythrocytes and platelets are observed.
To overcome the condition, it is important to immediately stop taking it. Metamizole should be discontinued immediately and laboratory test results should not be waited if the general condition worsens unexpectedly, fever is not controlled or relapsed, or painful mucosal changes occur, especially in the mouth, nose or pharynx area.
In case of pancytopenia, treatment should be discontinued immediately and the complete blood count should be traced until normalization of the values.

Immune system disorders

Rare: Skin rash (maculopapular exanthema), hypersensitivity reactions (anaphylactic or anaphylactoid reactions) may develop even if repeated without complications.
Very rare: Attacks of analgesic asthma (shortness of breath due to narrowing of the small airways). In patients with analgesic asthma (see section 2 “Do not take Analgin”), hypersensitivity reactions usually occur in the form of asthma attacks.
Not known. Anaphylactic shock.
Such reactions may develop immediately after administration or a few hours later. They mainly develop in the first hours after administration. Milder reactions are manifested by typical signs such as itching and redness of the eyes, cough, runny nose, sneezing, chest tightness, redness of the skin (especially of the face and head), urticaria and swelling of the face, as well as, less commonly, nausea and abdominal pain. Specific warning signs are itching and a feeling of warmth on and under the tongue, especially on the palms and soles.
Milder reactions may progress into more severe forms with severe urticaria, severe angioedema (also in the larynx area), severe bronchospasm (spastic narrowing of the small airways), rapid heart rate (sometimes too slow a pulse), arrhythmias, a drop in blood pressure (sometimes it first begins as hypertension), loss of consciousness, and circulatory shock.

Cardiac disorders

Not known: Kunis syndrome (acute allergic coronary syndrome).

Vascular disorders

Uncommon: Lowering of blood pressure (hypotonic reactions) caused directly by the medicine and which is not accompanied by other signs of hypersensitivity reactions. Such a reaction can lead to severe hypotension. The risk of a critical drop in blood pressure may increase at a very high temperature.
Typical symptoms of low blood pressure are rapid heart rate, paleness, trembling, dizziness, nausea and loss of consciousness.
Very rare: Sudden circulatory shock.

Skin and subcutaneous tissue disorders

Uncommon: Violet to dark red, partly bubbly skin rash (typical medicinal rash).
Rare: Rash (e.g. maculopapular exanthema).
Not known: Serious skin reactions.

If skin reactions occur, Analgin should be stopped immediately.

Hepatobiliary

Not known: Inflammation of the liver, yellowing of the skin and the white part of the eyes, increase in the level of liver enzymes in the blood.

Kidney and urinary tract disorders

Very rare: Acute deterioration of renal function with insufficient or absent urine output, urinary blood protein excretion or acute renal failure, inflammation of the kidneys (interstitial nephritis).

Extensive disorders and effects at the site of application

Red urine colouration has been reported which may have been induced by the presence in low concentrations of the harmless metabolite rubazonic acid.

Reporting of adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Analgin oral drops

Keep out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

The solution can be used for up to 6 months after first opening the bottle.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Analgin oral drops contains

• The active substance is metamizole sodium 500 mg in 1 ml solution.
• The other ingredients are: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sucralose, liquid essence “Raspberry”, purified water.

What Analgin oral drops look like and contents of the pack

Transparent, colourless to pale yellow solution.

20 ml of solution in a brown glass bottle with a dripping device, with a plastic screw cap, in a cardboard box, together with a leaflet.

Marketing Authorisation Holder

SOPHARMA AD, Bulgaria

Manufacturer

SOPHARMA AD, Bulgaria