Analgin Oral Drops 500mg/ml 20ml

DESCRIPTION:

ANALGIN ORAL DROPS 500mg/ml 20ml

1. What ANALGIN ORAL DROPS is and what it is used for

A medicinal product belonging to the group of pyrazolones that is used in case of pain and fever.

ANALGIN ORAL DROPS is used for:

-various conditions accompanied by a high temperature that is not affected by any other treatment

-severe acute or chronic pain (e.g., headache, toothache, neuralgia, neuritis, myalgia, migraine and migraine symptoms, menstrual pain, concomitant pain therapy for oncological diseases)

-colic (elastic abdominal pain), e.g. renal or biliary colic, acute and severe pain after injury or surgery if other agents are contraindicated or are ineffective (eg trauma, burns, postoperative pain)

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

2. What you need to know before you take ANALGIN ORAL DROPS

Do not take ANALGIN ORAL DROPS:

-if you are allergic (hypersensitive) to the active substance metamizole, other pyrazolones (eg phenazone, propipenazone) or pyrazolidines (eg phenylbutazone, oxyphenbutazone) (this also includes substances such as agranulocytosis of these ingredients) or any of the other ingredients (listed in section 6)

-if you have some intolerance to analgesic products (analgesic asthma or analgesic intolerance type urticaria - angioedema). In these cases, you respond to analgesic drugs such as salicylates, paracetamol, diclofenac

-ibuprofen, indomethacin or naproxen with bronchospasm (contraction of the bronchi resulting in breathing difficulties) or other hypersensitivity reactions (eg urticaria, rhinitis, angioedema)

-if you have disrupted bone marrow function (eg after treatment with cytostatics - products used in cancers) or haematopoietic system disorders (impaired hematopoiesis)

-if you have congenital glucose-6-phosphate dehydrogenase deficiency (a rare metabolic disorder) because of the risk of haemolysis (red blood cell destruction)

-if you have acute intermittent hepatic porphyria (a rare metabolic disorder) because there is a risk of porphyria

-during the last trimester of pregnancy or while breastfeeding

-in newborns and infants less than 3 months of age or weighing less than 5 kg as no data are available on the use of metamizole

Warnings and precautions:

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

If you react to ANALGIN ORAL DROPS with hypersensitivity (anaphylactoid reactions), you are at an increased risk for similar reactions to other analgesics.

If you have an allergic or other (immune) protective response (eg agranulocytosis) to ANALGIN ORAL DROPS, you are at an increased risk of similar reactions to other pyrazolones and pyrazolidines (chemically related substances).

If signs of agranulocytosis or thrombocytopenia arise, the use of ANALGIN ORAL DROPS should be stopped immediately and a blood count (including differential blood count) should be performed.

If signs of pancytopenia occur, the use of metamizole should be discontinued immediately and the number of blood cells brought back to normal.

Patients with analgesic intolerance (see section "Do not take ANALGIN ORAL DROPS") are at an increased risk of severe hypersensitivity reactions to ANALGIN ORAL DROPS.

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

-intolerance to analgesics and anti-rheumatic products, such as itching and swelling (urticaria, angioedema)

-dyspnea due to the 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 coloring agents (eg tartrazine) or preservatives (benzoates)

-alcohol intolerance. If you react to even small amounts of alcohol with symptoms such as sneezing, tearing and severe redness of the face. Such alcohol intolerance may be evidence of an undiagnosed analgesic asthma syndrome.

-Severe skin reactions

-Cases of life-threatening skin reactions like Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) have been reported with metamizole. If symptoms of SJS or TEN develop (as a progressive rash, often with blisters or mucosal lesions), treatment with metamizole should be stopped and never resumed.

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

-if you have low blood pressure (hypotension) or fluid loss, impaired circulation or initial circulatory collapse (eg as in a myocardial infarction or severe injury)

-if you have a high body temperature

-Therefore, use should be carefully considered and monitored closely. Prophylactic measures (eg, circulatory stabilization) may be necessary to reduce the risk of drops in blood pressure.

-In patients whose blood pressure lowering should be avoided, such as patients with severe coronary heart disease or cerebral vasospasm leading to impaired irrigation, ANALGIN ORAL DROPS can only be used with careful monitoring of the cardiovascular function.

-If you have kidney or liver disorders, ANALGIN ORAL DROPS should be used only after careful consideration of the benefit-risk ratio and after appropriate precautions (see section 3).

-For children up to 10 years of age, the product may only be used at the discretion of a doctor.

-For the elderly, the release of metamizole from the body may be delayed.

Other medicines and ANALGIN ORAL DROPS

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

Concomitant administration of ANALGIN ORAL DROPS and chlorpromazine (a medicine used to treat psychiatric disorders) may lead to a decrease in body temperature (severe hypothermia).

Concomitant use of metamizole and methotrexate may increase the haematological toxicity of methotrexate. Therefore, this combination should be avoided.

The group of pyrazolones (to which ANALGIN ORAL DROPS also belongs) is known for its interactions with some drugs used for:

blood-clotting (oral anticoagulants). Metamizole may reduce the effect of low-dose acetylsalicylic acid on platelet aggregation with concomitant use. Therefore, this combination should be used with caution when co-administering low dose acetylsalicylic acid (eg for cardioprotection).

decreasing elevated blood pressure and used in some heart diseases (captopril)

the treatment of psychiatric disorders (lithium)

the treatment of cancer or rheumatism (methotrexate)

drainage (triathlete)

It is not known to what extent this also applies to ANALGIN ORAL DROPS.

ANALGIN ORAL DROPS may decrease the plasma concentrations of cyclosporin (a product that suppresses immune responses to organ transplants), therefore, ciclosporin levels should be monitored with concomitant administration of the product.

Metamizole may reduce blood levels of bupropion. Therefore, caution should be exercised in cases of concomitant use of metamizole and bupropion.

Effect on blood tests

Patients treated with metamizole have reported it to have an impact on laboratory test methods based on the Triderder Reaction or Triderder-Like Reactions (ie measurement of serum creatinine, triglycerides, HDL cholesterol and uric acid).

Taking ANALGIN ORAL DROPS with foods, drinks and alcohol

Co-administration with alcohol should generally be avoided as negative interactions cannot be ruled out.

Pregnancy and breast-feeding

Pregnancy

You should not take ANALGIN ORAL DROPS during the first 3 months of pregnancy, as there is no data on the use in pregnant women.

In the first 3 months, you can only take ANALGIN ORAL DROPS after consulting a doctor and only after they have carefully evaluated the benefit / risk ratio.

Do not take ANALGIN ORAL DROPS in the last 3 months of pregnancy.

The product suppresses the natural function of platelets (platelet aggregation), which can lead to increased bleeding, especially at birth. It is possible to prematurely close a blood vessel that is important for the unborn child (the so-called Strait of the Bottle, which naturally closes only after birth).

Breastfeeding

During the first 48 hours after taking ANALGIN ORAL DROPS you should not breast-feed as the products of degradation pass into breast milk.

Driving and operating machines

There are no known disturbances in concentration and reactivity when applying the recommended dose. As a precautionary measure, especially when using high doses, driving, operating machinery or other hazardous activities, especially after using alcohol, should be avoided.

ANALGIN ORAL DROPS contains sodium

20 drops (1 ml) of solution containing 1.5 mmol (34.3 mg) of sodium. This should be considered if you are on a sodium controlled diet.

3. How to take ANALGIN ORAL DROPS?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose depends on the severity of the pain or the degree of increase in temperature and the individual sensitivity to metamizole.

In general, the lowest dose should be selected to treat pain and high body temperatures.

Children and adolescents from 10 to 14 years of age receive from 8 to 16 mg / kg bodyweight in a single dose of metamizole. In case of a high temperature, a dose of 10 mg / kg bodyweight is generally sufficient.

Adults and adolescents over 15 years of age (over 53 kg) may take up to 1000 mg in a single dose. If the effect is unsatisfactory, the corresponding unit dose may be given up to 4 times a day but no more than 3 g per day should be taken (maximum daily dose).

The following dosing table contains the recommended unit doses and maximum daily doses.

age / bodyweight single dose maximum daily dose

10-12 years (31-45 kg) 10-30 drops (equivalent to 250-750 mg metamizole sodium monohydrate) to 90 drops (equivalent to 2250 mg metamizole sodium monohydrate)

13-14 years (46-53 kg) 15-35 drops (equivalent to 375-875 mg metamizole sodium monohydrate) to 105 drops (equivalent to 2625 mg metamizole sodium monohydrate)

Adults and adolescents over 15 years (over 53 kg) 20-40 drops (equivalent to 500-1000 mg metamizole sodium monohydrate)  up to 120 drops (equivalent to 3000 mg metamizole sodium monohydrate)

In the elderly, the dose should be reduced as the excretion of decomposing ANALGIN ORAL DROPS products may be delayed.

Decreased general condition and impaired creatinine clearance

The dose should be reduced in patients with impaired general condition and impaired creatinine clearance as the excretion of degraded ANALGIN ORAL DROPS products may be delayed.

Impaired renal and hepatic function

As the excretion rate is reduced with impaired renal and hepatic function, high doses should be avoided. In short-term use, no dose reduction is required. There is no data on prolonged use.

Method of administration

ANALGIN ORAL DROPS oral drops may be taken with a little fluid.

Notes on the use: The packaging is child-proof. To open it, press the cap down and simultaneously rotate in the direction of the arrow. Keep the hole down and gently tap the bottom of the bottle. The drops drop evenly and are easily counted. After use, close well. The bottle is closed in a child-proof position when you hear a click while rotating without pressing.

Duration of administration

It is advisable not to take this product for more than 3 to 5 days without consulting your doctor or dentist.

If you take more ANALGIN ORAL DROPS than you should

If excessive amounts of ANALGIN ORAL DROPS are taken, nausea, vomiting, abdominal pain, impaired kidney function, acute renal failure (such as interstitial nephritis) and, in rare cases, vertigo, drowsiness, unconsciousness, convulsions, low blood pressure, shock, and arrhythmia (tachycardia) can occur.

Please tell your doctor immediately if you take too much ANALGIN ORAL DROPS in order to be able to take the necessary measures.

Note:

After taking very high doses, the release of a harmless metabolic product (rubasic acid) may cause red urine staining.

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

4. Possible side effects

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

The evaluation of adverse reactions is based on the following frequency information:

Common 1 to 10 of 100 patients treated

Uncommon 1 to 10 per 1,000 patients treated

Rare 1 to 10 in 10,000 patients treated

Very rarely less than 1 in 10,000 treated patients

A frequency can not be estimated from the available data

Blood and lymphatic system disorders

Rare: Reduced white blood cell count (leucopenia)

Very rare: Significant decrease in some white blood cells (agranulocytosis) or platelet depletion (thrombocytopenia) including fatal cases.

Not known: Allelic anemia, pancytopenia including fatal cases.

These reactions are predominantly immunologically conditioned. These may also occur if metamizole is administered without any history of complications. It has been shown that the risk of agranulocytosis may increase in isolated cases when metamizole is used for more than 1 week.

These reactions are not dose-dependent and may occur at any time during treatment. Typical signs of agranulocytosis include fever, chills, sore throat, difficulty swallowing, and inflammatory changes in the oral, nasal, pharyngeal, genital and anal mucosa.

In patients taking antibiotics, these signs may be less pronounced. Typical signs of thrombocytopenia are increased bleeding and punctual bleeding of the skin and mucous membranes. Generally, but not always, normal values ​​are observed for hemoglobin, erythrocyte and thrombosis.

Immediate discontinuation of treatment is important to overcome the condition.

In the case of pancytopenia, treatment should be discontinued immediately and the full blood count should be monitored until the values ​​are normalized.

Immune system disorders

Rare: Skin rash (maculopapular exanthema), hypersensitivity reactions (anaphylactoid reactions) may develop even in re-administration without previously known complications.

Very rare: Attacks of analgesic asthma (shortness of breath due to the narrowing of small airways). In patients with analgesic asthma (see section 2. Do not take ANALGIN ORAL DROPS for Children), hypersensitivity reactions usually occur in the form of asthma attacks;

Not known: Anaphylactic shock

Such reactions can develop immediately after administration or a few hours later. They mainly develop in the first hours after administration. Lighter reactions have typical signs of itching and redness of the eyes, cough, runny nose, sneezing, tightness of the chest, redness of the skin (especially on the face and head), urticaria and swelling of the face, and, less commonly, nausea and abdominal pain. Specific warning signs are itching and a feelings of warmth in and under the tongue, especially in the palms and feet.

Lighter reactions may progress to heavier forms with severe urticaria, severe angioedema (also in the larynx area), severe bronchospasm (elastic narrowing of small airways), accelerated heart rhythm (sometimes a heartbeat that is too slow), arrhythmias, drop in blood pressure (sometimes first started as hypertension), loss of consciousness and circulatory shock.

Gastrointestinal disorders

Not known: cases of bleeding from the gastrointestinal tract have been reported

Cardiac disorders

Not known: Cunis syndrome

Vascular disorders

Uncommon: Decline in blood pressure (hypotonic reactions) caused by the drug directly and not accompanied by other signs of hypersensitivity reactions.

Such a reaction can rarely lead to severe hypotension. The risk of a critical drop in blood pressure may increase at a very high body temperature.

Typical symptoms of low blood pressure include rapid heartbeat, pallor, shaking, dizziness, nausea and loss of consciousness

Very rare: sudden circulatory shock

Skin and subcutaneous tissue disorders

Uncommon: Violet to dark red, partly bloody skin rash (typical drug rash)

Rare: Rash (eg maculopapular exanthema)

Very rare: Severe blistering and scaling (Stevens-Johnson syndrome or Lyell, toxic epidermal necrolysis)

If skin reactions occur, ANALGIN ORAL DROPS should be discontinued immediately.

Renal and urinary disorders

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

General disorders and administration site conditions

Urinary red staining, which may be caused by the presence of the harmless metabolites of rubasic acid.

The following side effects may have serious consequences. Discontinue the use of ANALGIN ORAL DROPS and consult a doctor immediately.

Some side effects (such as severe hypersensitivity reactions, Stevens-Johnson syndrome or Lyell syndrome, agranulocytosis) may be life-threatening. In such cases, ANALGIN ORAL DROPS should only be taken under medical supervision. Immediate discontinuation of the drug is of paramount importance for recovery.

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

ANALGIN ORAL DROPS should be discontinued if symptoms of agranulocytosis arise:

Sudden worsening of the general condition, high body temperature that does not go down or recurrent painful changes in the mucous membranes, especially of the mouth, nose and throat.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes all possible side effects not listed in this leaflet. You can also report side effects directly.

5. How to store ANALGIN ORAL DROPS?

Keep out of the reach and sight of children.

ANALGIN ORAL DROPS is good for use 6 months after initial opening of the vial.

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

Do not dispose of medicines in the sewage system or in household waste containers. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Package Contents and Additional Information

What ANALGIN ORAL DROPS contains

The active substance is metamizole sodium monohydrate. 1 ml (20 drops) of oral drops contains 500 mg of metamizole sodium monohydrate.

The other ingredients are: sodium dihydrogen phosphate dihydrate, dodecahydrate disodium phosphate, saccharin sodium, two-component bitter flavor, distilled water.

What ANALGIN ORAL DROPS looks like and contents of the pack

ANALGIN ORAL DROPS are a clear yellow solution.

Brown glass bottle (type III) containing 20 ml