Analgin 500 mg (20 tablets)

It is administered orally.

• Adults: 250 – 500 mg Analgin 2-3 times a day.

Maximum single dose – 1 g.
Maximum daily dose – 3 g.

• Children over 15 years of age – half a tablet 2-3 times a day.

Metamizole should not be used for more than 3-5 days or in higher doses without consulting your doctor.

ANALGIN tablets 500 mg * 20 SOPHARMA

Package leaflet: information to the user
Analgin 500 mg tablets Analgin ® 500 mg tablets
metamizole sodium (metamizole sodium)

Read all of this leaflet carefully, it is harmful to start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your 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 is and what it is used for.
2. What you need to know before you use Analgin.
3. How to use Analgin.
4. Possible side effects.
5. How to store Analgin.
6. Contents of the pack and other information.

1. What Analgin is and what it is used for

Analgin tablets contain the active substance metamizole sodium, which belongs to painkillers (analgesics). In addition to analgesic, it also has a temperature-lowering effect.
Analgin is used for:

• Moderate to severe pain of various origins: headache, toothache, neuralgia, neuritis, myalgia (muscle pain), trauma, burns, postoperative pains, phantom pains (sensation of pain at the site of an absent limb), menstrual pain, pain in oncological diseases, renal and biliary colic.
• to lower high temperature.

2. What you need to know before you use Analgin

Do not use Analgin in the following cases

• If you are allergic (hypersensitive) to the active substance metamizole, to other medicines in the pyrazolone group or to any of the other ingredients of this medicine (listed in section 6);
• If you suffer from acute liver porphyria (an inherited disease with impaired red blood cell formation) or congenital glucose-6-phosphatedehydrogenase insufficiency (an inherited disease with a deficiency of this enzyme);
• If you have severe liver and/or kidney disease;
• If you have impaired bone marrow function (after cytostatic treatment) or blood diseases such as: aplastic anaemia (decrease in the number of blood cells, leading to weakness, bruising or increased likelihood of infection), agranulocytosis (a strong decrease in the number of white blood cells, which increases the likelihood of infections), leukopenia (decrease in the total number of white blood cells);
• If you are in the last three months of pregnancy.

Warnings and precautions

• If you are allergic to pain medications or antirheumatic drugs, other medications or foods;
• With allergic bronchial asthma (shortness of breath);
• If you are aware that you have a disease that occurs with a decrease in the number of white blood cells (leukocytes);
• If you have kidney or liver disorders;
• If you have low blood pressure.

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.

Other medicines and Analgin

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

• Co-administration of metamizole and chlorpromazine (a medicine for the treatment of mental illness) can lead to a sharp decrease in body temperature.
• Co-administration of metamizole and coumarin anticoagulants, such as acenocoumarol and warfarin (medicines that reduce blood clotting), should be avoided.
• Metamizole reduces the action of ciclosporin (a medicine used after organ transplantation and to treat tumour diseases).
• Chloramphenicol and other myelotoxic products (medicines that damage blood-bleeds) increase the risk of adverse effects by the blood-forming system when given together with metamizole.
• Do not simultaneously administer Analgin with sleeping pills, medicines to treat depression, contraceptives, analgesics, allopurinol (for the treatment of gout).
• Metamizole may interact with captopril (for the treatment of heart disease and high blood pressure), lithium (for the treatment of mental illness), methotrexate (for the treatment of rheumatic and tumour diseases), as well as alter the effects of antihypertensive (blood pressure-lowering) products and diuretics (drains).
• 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.

Taking Analgin with food and drink

During treatment with Analgin, it is not recommended to use alcohol due to the possibility of increasing the side effects of the drug.

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 or pharmacist 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 consulting 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 because of an 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

When taking high doses of Analgin, it is not recommended to drive motor vehicles or work with machines requiring active attention, as it is likely to adversely affect attention and disrupt reactions to unexpected situations.

Analgin contains wheat starch

The wheat starch in this medicine contains only very small amounts of gluten and is unlikely to cause problems if you have celiac disease (gluten intolerance). One tablet contains no more than 3.4 micrograms of gluten.
If you have an allergy to wheat (a condition other than celiac disease), you should not take this medicine.

Analgin contains sodium

This medicinal product contains 32.7 mg sodium per tablet, equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

3. How to use Analgin

Always use Analgin exactly as described in this leaflet. Check with your doctor or pharmacist if you are not sure.
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. Tablets are taken by mouth.

Adults and adolescents over 15 years of age Adults and adolescents 15 years of age
or older (weighing more than 53 kg) can take up to 1000 mg of metamizole as a single dose (2 tablets), which can be taken up to 4 times a day at intervals of 6 – 8 hours. The maximum daily dose is 4,000 mg (corresponding to 8 tablets).

Children from 10 to 14 years of age (weighing from 32 kg to 53 kg)
The following table shows the recommended single doses and maximum daily doses depending on weight or age:

Children under 10 years of age Analgin tablets 500 mg is not recommended for children under 10 years due to the inability to dosage in this age
group. Other dosage forms/quantities of the active substance are available which may be appropriately dosed in younger children.

A pronounced effect can be expected 30 to 60 minutes after oral administration.

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

Patients with impaired renal or hepatic function
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.

Duration of treatment

Apply Analgin no more than 3 to 5 days. If within 3 days there is no relief of symptoms, normalization of temperature, consult the attending physician.

If you take more Analgin than you should

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

If you forget to take Analgin

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

4. Possible side effects

Like all medicines, Analgin 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 white part 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.

Adverse reactions are classified by frequency as follows: very common (≥1/10), common (1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Uncommon (occurring in less than 1 in 100 users)
Skin rashes, lowering blood pressure, heart rhythm disturbances (rapid or irregular heartbeat).

Rare (occurs in less than 1 in 1,000 users)
Leukopenia (a decrease in the number of white blood cells, which increases the likelihood of infection); maculopapular rash (formation of skin plaques and nodules); hypersensitivity reactions (anaphylactic or anaphylactoid reactions) – itching, burning, redness of the skin, urticaria, edema (generalized or local), difficulty breathing and, rarely, gastrointestinal complaints, angioedema (including laryngeal), heart rhythm disturbances, lowering blood pressure; kidney damage such as the appearance of protein in the urine, decreased or increased amount of urine, inflammation of the kidneys.

Very rare (occurring in less than 1 in 10,000 users)
Agranulocytosis (a strong decrease in the number of white blood cells, which increases the likelihood of infections). Characteristic signs of agranulocytosis include inflammatory changes of the skin and mucous membranes of the mouth, throat, genitals, sore throat and fever. In case of sudden deterioration of the general condition, if the high temperature does not drop or reappears, if painful changes of the mucous membranes and skin occur, discontinue the administration of Analgin and see a doctor.
Very rarely, thrombocytopenia (a decrease in the number of platelets, which increases the risk of bleeding or bruising) may also be observed; haemolytic anaemia (decrease in the number of red blood cells, which may lead to paleness or yellowing of the skin, weakness or shortness of breath); aplastic anaemia (a strong decrease in the number of blood cells, leading to weakness, bruising or an increased likelihood of infections); asthma attack (in patients with analgesic asthma); Stevens-Johnson or Lyell syndrome (a severe reaction accompanied by blistering of the skin, mouth, eyes and genitals); circulatory shock.

Not known: nausea, vomiting, abdominal pain and discomfort, in rare cases ulcerations or bleeding from the mucous membrane of the gastrointestinal tract; inflammation of the liver, yellowing of the skin and the white part of the eyes, an increase in the level of liver enzymes in the blood.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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

Store in the original package in order to protect from light at a temperature below 25°C. Keep out of the reach of children.
Do not use the product after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unnecessary medicines. These measures will help to protect the environment.

6. Contents of the pack and other information

What Analgin contains

• The active substance is metamizole sodium 500 mg per tablet.
• The other ingredients are: cellulose, microcrystalline (type 101), magnesium stearate, povidone, wheat starch, talc.

What Analgin looks like and contents of the pack

Round, flat tablets with a score line on one side, diameter 13 mm, white to off-white, odorless. The dividing line is to divide the tablet into two equal halves. 10 tablets in PVC blister / aluminum foil; 1, 2, 6 or 50 blisters in a cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria