Analgin Chin 250 mg (10 tablets)

Analgin Chin tablets are taken orally whole, with a glass of water.

The usual dose is:

Children under 10 years of age: This formulation is not suitable for use in children under 10 years of age.

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 longer treatment is needed, consult a doctor.

Duration of treatment:

Apply Analgin Chin 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 CHIN tablets 250 mg * 10 SOPHARMA

Package leaflet: information for the user

Analgin Chin 250 mg film-coated tablets Analgin Chin® 250 mg film-coated tablets

metamizole sodium (métamizolesodium)

Read all of this leaflet carefully before you 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 Chin is and what it is used
for 2. What you need to know before you take Analgin Chin
3. How to take Analgin Chin
4. Possible side effects
5. How to store Analgin Chin
6. Contents of the pack and other information

1. What Analgin Chin is and what it is used for

Analgin Chin contains the active substance metamizole sodium, which belongs to painkillers (analgesics). At the same time, it also exhibits a temperature-lowering effect. Analgin Chin is used for:

• lowering high temperature;
• Influencing mild to moderate pain of various origins: headache, toothache, neuralgia, neuritis, myalgia, trauma, burns, postoperative pain, pain in oncological diseases, renal and biliary colic.

2. What you need to know before you take Analgin Chin

Do not take Analgin Chin

• 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 have acute liver porphyria (an inherited disease with impaired red blood cell formation) or congenital glucose-6-phosphatedehydrogenase deficiency (an inherited disease with a deficiency of this enzyme);
• If you have severe liver and/or kidney disease;
• If you have blood diseases such as aplastic anaemia (a decrease in the number of blood cells, leading to weakness, bruising or an increased likelihood of infection), agranulocytosis (a strong decrease in the number of white blood cells, which increases the likelihood of infections) and leukonium (a decrease in the total number of white blood cells);
• If you are in the last three months of pregnancy.

Warnings and precautions

Take special care with the use of Analgin Chin:

• If you are allergic to painkillers 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 Chin 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 Chin if you have previously taken a medicine containing metamizole and have had liver problems.

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 Chin (see section 4).

Other medicines and Analgin Chin

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

• Co-administration of metamizole and chlorpromazine (a medicine for the treatment of mental illness) may lead to a sharp decrease in body temperature.
• Co-administration of metamizole and coumarin angicoagulants, 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 for the treatment of tumor 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 Chin with sleeping pills, a drug for the treatment of depression, contraceptives, analgesics, allopurinol (for the treatment of gout).
• Metamizole can be combined with drugs that eliminate spasms of the smooth muscle of internal organs.
• 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 Chin with food, drink and alcohol

During treatment with Analgin Chin, the use of alcohol is not recommended 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 Chin 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).

Lactation

Metamizole degradation 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 Chin, it is not recommended to drive motor vehicles or operate machines requiring active attention, as it is likely to adversely affect attention and disrupt reactions to unexpected situations.

Analgin Chin contains quinine hydrochloride

At doses many times those recommended in this leaflet, it may cause heart rhythm disturbances, visual and auditory disorders, hypersensitivity reactions, blood disorders.

This medicine contains less than 1 mmoí sodium (23 mg) per tablet, that is, it can be said to be practically sodium free.

3. How to take Analgin Chin

Always use Analgin Chin 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 Chin.

The lowest dose needed to manage pain and fever should be selected. Your doctor will tell you how to take Analgin Chin.
Tablets are taken by mouth whole, with a glass of water.
The following table shows the recommended single doses and maximum daily doses depending on weight or age:

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

Analgin Chin 250 mg tablets is not recommended for children under the age of 10 years due to the fixed amount of 250 mg of metamizole contained in one tablet. Other dosage forms/quantities of the active substance are available which may be appropriately dosed in younger children.

Elderly and patents with deteriorating 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.

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 Chin 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 Chin 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.

If you forget to take Analgin Chin

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

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

4. Possible side effects

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

Stop using Analgin Hnh 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”. Serious skin reactions
Stop using metamizole and seek medical help 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).

Possible manifestations of hypersensitivity – itching, skin rash, hives (hives), edema (generalized or local), erythema. Very rarely – asthma attack, anaphylactic shock (severe life-threatening allergic condition). A feeling of discomfort, nausea, stomach and abdominal pain may appear. Rarely – vomiting, diarrhea; in isolated cases – ulcerations or bleeding from the mucous membrane of the gastrointestinal tract, headache, dizziness, lowering blood pressure, rapid heart rate, kidney damage such as the appearance of protein in the urine, decreased or increased amount of urine, inflammation of the kidneys. Very rarely, changes in the blood count may occur: agranulocytosis (a decrease in a certain type of white blood cell in the peripheral blood), leukopenia (decrease in the number of leukocytes), thrombocytopenia (decrease in the number of platelets).
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, stop taking Analgin Chin and see a doctor.
Not known, 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 were observed; serious skin reactions.

Reporting of adverse reactions

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 Chin

Keep out of the reach of children.
This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.

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 Chin contains

• The active substance is metamizole sodium 250 mg in one film-coated tablet.
• The other ingredients are: quinine hydrochloride; povidone; cellulose, microcrystalline; sodium starch glycolate; silica, colloidal, anhydrous; Talc; magnesium stearate. Film-coated Gopadrai green): gyulivinyl alcohol, macrogol, titanium dioxide (E 171), talc, quinoline yellow (E104), brilliant blue (E133).

What Analgin Chin looks like and contents of the pack

Analgin Chin 250 mg – round, biconvex, green film-coated tablets, with a diameter of 10 mm.
10 film-coated tablets in a blister of PVC / aluminum foil; 1 or 2 blisters in a cardboard box, together with a leaflet.

Marketing Authorisation Holder and Manufacturer

SOPHARMA AD, Bulgaria