Recommended dose for adults and children over 15 years:

The single dose can be 1 sachet (1000 mg). If the effect is not sufficient, the dose can be administered up to 3 times a day. The highest dose you can take is 3 g (3 sachets).

The product can be taken regardless of the meal time. Pour the contents of one sachet into a beaker of sufficient water (150 ml) and wait 2 minutes to obtain a homogeneous solution which is taken orally.

The duration of administration depends on the type and severity of the disease. With long-term use, your doctor will decide if a blood count is needed.

If this medicine is not prescribed by a doctor, its use as an analgesic should not exceed 5 days, and to lower the temperature – 3 days.

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.

The lowest possible dose should be used, which leads to lowering the temperature and controlling the pain.

ANALGIN MAX sachet 1000 mg * 20 SOPHARMA

Package leaflet: Patient information

Analgin Max 1000 mg effervescent powder Analgin Max 1000 mg effervescent powder

Metamizole sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for 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 3-5 days you do not feel better or your condition worsens, you should seek medical attention.

What is in this leaflet

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

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

Analgin Max contains metamizole. This drug has a pronounced painkiller and temperature-lowering effect and moderate anti-inflammatory effect.

Analgin Max is applied:- for short-term treatment of pie of different origin and intensity, when other means are ineffective or contraindicated:

• headache, toothache, painful menstruation, joint and muscle pain and inflammation, arthritis (inflammatory diseases of the joints), neuralgia (pain in nerve damage); posttraumatic and postoperative pain; pain in spasms of the renal and biliary tract;

– for short-term reduction of high body temperature that is not affected by other medicinal products or when they are contraindicated.

If after 3-5 days you do not feel better or your condition worsens, you should seek medical help

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

Do not use Analgin Max in the following cases:
– if you are allergic (hypersensitive) to metamizole or any of the other ingredients of this medicine (listed in section 6);

– if you are allergic (hypersensitive) to other medicines in the pyrazolone group;

– if you are allergic to aspirin or other anti-inflammatory medicinal products;

– rhinitis (inflammation of the mucous membrane of the nose and nasal cavity), hives (hives), asthma;

– in diseases of the hematopoietic system;

– in diseases of the bone marrow:

– if you suffer from porphyria (a rare hereditary disease associated with disorders in the formation of hemoglobin);

– genetic deficiency of glucose-b-phosphate dehydrogenase;

– if you are in the last three months of pregnancy

Warnings and precautions

Talk to your doctor or pharmacist before taking Analgin Max.

Take special care with Analgin Max

– if you have gastrointestinal diseases (ulcer, bleeding, perforation);

– if you have kidney failure;

– if you have hypertension (high blood pressure);

– if you have fluid retention and edema;

– if you have liver failure;

– if you have infectious diseases;

– with simultaneous use with chlorpromazine.

With prolonged use, control blood counts and differential leukocyte counts.

When taking metamizole, urine may turn red.

Children and adolescents

The dosage form (effervescent powder) of Analgin Max is not suitable for use in children under 15 years of age as it cannot be dosed properly.

Other medicines and Analgin Max

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

– Plasma Ciclosporin levels are decreased by concomitant use with Analgin Max;

– Analgin Max may reduce the effects of blood pressure lowering drugs (ACE inhibitors);

– Analgin Max may increase plasma lithium concentrations and cause increased toxicity;

– With simultaneous administration with coumarin anticoagulants, prolongation of bleeding time may be observed;

– Tricyclic antidepressants, oral contradeptives, and allopurinol, enhance the effects of Metamizole due to a slowdown in its metabolism;

– There is a risk of suppression of bone marrow function when taken simultaneously with chloramphenicol and other myelotoxic products.

Analgin Max with food, drink and alcohol

Alcohol consumption while taking this medicine should be avoided.

Pregnancy, breast-feeding and fertility

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.
In the last three months of pregnancy, you should not take 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

Analgin Max may change your ability to drive or use machines.

Important information about some of the ingredients of Analgin Max

This medicine contains in one sachet (one dose):

– 1068 mg sugar, which should be taken into account in patients with diabetes mellitus.

– 5.8 mmol (135 mg) sodium. This should be considered in patients on a controlled sodium diet.

If you have been told by your doctor that you have an intolerance to some sugars, ask your doctor for advice before taking this product.

3. How to take Analgin Max

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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

Recommended dosage for adults and children over 15 years.

Adults and adolescents over the age of 15 years or older (weighing more than 53 kg) can take 1 suppository/sachet as a single dose up to four times a day. The maximum daily dose for adults and adolescents over 15 years of age is 4 suppositories/sachets of effervescent powder (corresponding to 4,000 mg).

Use in children and adolescents

Analgin Max is not recommended for adolescents under 15 years and children, as they require dosage forms containing less active substance.

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.
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.

Route and duration of administration

The product can be taken regardless of the meal time. Pour the contents of one sachet into a glass with a sufficient amount of water (150 ml) and wait 2 minutes until a homogeneous solution is obtained, which is taken orally.

The duration of administration depends on the type and severity of the disease. With long-term administration, your doctor will decide whether monitoring of blood counts is necessary.

In the event that this drug is not appointed by a doctor, its application as an anesthetic agent should not exceed 5 days, and for lowering the temperature – 3 days.

If you take more Analgin Max than you should

In case of an overdose, immediately contact a doctor for help.

If you forget to take Analgin Max

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The frequency given below is that with which adverse reactions have been reported. Uncommon (occurs in less than 1 in every 100 patients)

• itching, skin rash (violet to dark red rash, sometimes accompanied by blistering);
• decrease in blood pressure, the manifestations of which are rapid pulse, pallor, sweating, trembling, dizziness, nausea, loss of consciousness. The risk of a significant drop in blood pressure increases at a very high temperature.

Rare (occurs in less than 1 in every 1000,<> patients)

• skin rashes, severe allergic reactions that may manifest with swelling of the face, tongue or throat, shortness of breath and wheezing in the chest, a drop in blood pressure;
• decrease in the number of white blood cells which increases the likelihood of infection, punctual hemorrhages on the skin and mucous membranes, decrease in the number of red blood cells, which may lead to pallor, weakness or shortness of breath;
• seizures after taking high doses.

Very rare (occurs in less than 1 patient in every 10,000 patients)

• a significant decrease in the number of white blood cells and an associated decrease in your resistance to infection;
• a significant decrease in the number of blood platelets (platelets), keto increases the risk of bleeding or bruising;
• severe skin damage and reactions, e.g. blistering on the skin of the hands, feet and feet, less often on the lips, face and genitals;
• asthma attack (shortness of breath and wheezing in the chest);
• disorders of kidney function, the appearance of protein in the urine, a decrease in the amount of urine excreted;
• bilirubin in the blood.

Not known (cannot be estimated from the available data)

• nausea, vomiting, decreased appetite;
• dizziness;
• rapid heartbeat, bruising of the skin of the fingers, nose, around the lips, mucous membranes;
• jaundice.

When taken in high doses, Analgin Max can cause flaccidity, dizziness and headaches, which can adversely affect attention and disrupt reactions to unexpected situations.

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

Reporting suspected 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 Max

Store below 25° C. Keep out of the reach of children.

Do not use this medicine after the expiry date which is stated on the sachet. 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 Max contains

• The active substance in 1 sachet is metamizole sodium (1000 mg).
• The other ingredients (excipients) are: sucrose (compressible), anhydrous citric acid, anhydrous sodium carbonate, anhydrous magnesium citrate, sodium cyclamate (E952), saccharin sodium (E954), colloidal anhydrous silica, lemon flavour (mixture of aromatic substances and maltodextrin)

What Analgin Max looks like and contents of the pack

White or off-white effervescent powder with the smell of lemon.

Powder for oral solution 3,0 g in a paper/aluminium/polyethylene sachet.

One pack contains 6, 10 or 20 pieces of sachets

Marketing Authorisation Holder and Manufacturer

Adipharm EAD,Bulgaria

Made for:

Sopharma AD, Bulgaria