Nolotil

Nolotil

Nolotil contains one active substance - metamizole sodium. This is a pyrazolone derivative with pronounced analgesic, antipyretic and antispasmodic effects. It effectively relieves acute pain of various origins and helps reduce fever when other antipyretics are ineffective.

Metamizole acts as an inhibitor of the synthesis of prostaglandins, that is, substances that are involved in the transmission of pain impulses and thermoregulation. That is why it is often used for inflammatory pain, as well as for fever.

Nolotil is available in several dosage forms. This allows the doctor to choose the optimal method of administering the drug depending on the patient’s condition, pain intensity and characteristics of the clinical situation.

The following forms are currently available:

• Capsules — contain 575 mg of metamizole. Intended for oral use in adults and adolescents over 15 years of age. This is a convenient form for home use for moderate pain.

• Solution for injection — each ampoule contains 500 mg/ml metamizole. Available in volumes of 2 ml and 5 ml. Used for intramuscular or intravenous administration for severe or intractable pain.

• Rectal suppositories — contain 500 mg of active substance. An alternative for patients for whom oral administration is difficult or injections are contraindicated.

The choice of form depends on the clinical situation: for example, for acute pain in a hospital setting, injections are preferable, while capsules or suppositories are suitable for treatment at home.

Nolotil is prescribed for pain of moderate to severe intensity, especially if conventional analgesics are ineffective. It is also used as an antipyretic when other drugs do not help.

Most often, doctors prescribe the drug in the following cases:

• Postoperative pain — the drug helps to quickly cope with pain after surgery.

• Traumatic pain - effective for bruises, fractures, burns and other injuries accompanied by severe pain.

• Colicky pain - especially in the area of ​​the kidneys or gastrointestinal tract. Metamizole has an antispasmodic effect, which makes it effective for renal or hepatic colic.

• Cancer pain - can be part of complex therapy for pain in patients with cancer.

• Fever - used as an antipyretic at high temperatures that are resistant to other drugs.

Important: Nolotil is not a first-line drug; it is used in the absence of effect from milder agents, as well as in acute situations requiring rapid pain relief.

The correct dosage of Nolotil is selected by the doctor individually, depending on the intensity of pain, the patient’s condition and the form of release. Although some forms are available for home use, it is important to follow the instructions and not exceed the recommended dosage.

Main forms of application:

Capsules

Suitable for adults and teenagers over 15 years old (weight over 53 kg).

• Usual dose: 1–2 capsules (575–1150 mg) per dose.

• Maximum daily dose: no more than 8 capsules (4600 mg), divided into 3-4 doses.

• Capsules are not prescribed to children and adolescents under 15 years of age.

Capsules should be taken with a sufficient amount of water. Preferably after meals to reduce possible stomach irritation.

Solution for injection

Used for severe pain or inability to take it orally.

• Adults: 2–5 ml intramuscularly or slowly intravenously. If necessary, repeat after 6–8 hours.

• Maximum dose: no more than 10 ml per day.

• For children: The dosage is calculated individually by the doctor, based on body weight and age.

It is important to administer the solution slowly, especially when used intravenously - this reduces the risk of a sharp drop in pressure.

Suppositories (rectal suppositories)

Can be used when oral administration or injection is difficult.

• Adults and teenagers over 15 years of age: 1 suppository (500 mg) up to 4 times a day.

• Maximum dose: 4 suppositories (2000 mg) per day.

• For children use is not recommended - there are other forms and dosages for them.

Recommendations for admission:

• Do not use Nolotil longer than 3 days without consulting a doctor.

• If there is no effect or adverse reactions occur, treatment should be immediately reconsidered.

• During therapy, it is important to avoid taking alcohol and other drugs without a doctor's prescription.

Despite the effectiveness Nolotil may be dangerous in some conditions. Before use, it is important to exclude contraindications - this will help avoid serious complications.

The drug should not be used for:

• Allergies to metamizole or other pyrazolones (eg, phenylbutazone, oxyphenbutazone).

• Intolerance to other NSAIDs, including aspirin (aspirin asthma, triad).

• Severe hematopoietic disorders (agranulocytosis, leukopenia, anemia).

• Glucose-6-phosphate dehydrogenase deficiency increases the risk of hemolysis.

• Acute hepatic porphyria.

• Severe arterial hypotension (blood pressure below 100 mm Hg).

• Pregnancy in the 1st and 3rd trimester and during breastfeeding.

• Children's age (depending on the form of release).

• Hypersensitivity to alcohol - even a small amount can cause side effects (sneezing, rash, facial flushing).

• Bronchial asthma, especially if it is provoked by analgesics.

Before starting therapy, it is important to discuss with your doctor even those conditions that seem unrelated to treatment - many contraindications become critical when taking Metamizole.

Metamizole is not such a “mild” analgesic. It has several features that are worth knowing about, especially if the drug is taken as a course or for chronic pain.

Here are situations in which caution is required:

• Agranulocytosis - a rare but dangerous complication. This is a sharp decrease in the number of granulocytes in the blood, which can lead to severe infections. If you experience fever, sore throat, or mouth ulcers, stop taking immediately and consult a doctor. Long-term treatment requires a blood test.

• Allergic reactions - from skin rash to anaphylaxis. Patients with allergic rhinitis, asthma, and hay fever should be especially careful.

• Pressure drop - Metamizole may cause hypotension in some patients. At risk are people with heart failure, dehydration, shock, or taking antihypertensive drugs.

• Impaired liver or kidney function - Dosage adjustment may be required.

• Old age - such patients have an increased risk of side effects and delayed elimination of the drug.

• Concomitant use with other drugs - combination with drugs that suppress bone marrow is especially dangerous.

Even if you take Nolotil occasionally, you should monitor your condition closely and report any unexpected symptoms to your doctor immediately.

Metamizole may significantly change the effects of other drugs. Some combinations are strictly contraindicated, others require medical supervision. Below is a list of the most important interactions.

It is not recommended to combine Nolotil with:

• with alcohol - enhances the sedative effect and can provoke severe adverse reactions.

• Methotrexate — its toxicity increases, especially in relation to bone marrow.

• Cyclosporine — its concentration in the blood decreases, which reduces the effectiveness of immunosuppression.

• Sulfonamides (for example, glibenclamide) - the risk of hypoglycemia increases.

• Chlorpromazine - may enhance the hypothermic effect.

• Captopril - the hypotensive effect is enhanced, Sudden pressure surges are possible.

• Triamterene - increased risk of kidney failure.

• Other NSAIDs and barbiturates - toxic effects increase and the analgesic effect of Nolotil decreases.

Before starting treatment, it is important to inform your doctor about all medications, including dietary supplements and herbal preparations. Some combinations can be dangerous even if used once.

Nolotil cannot be called a universal drug: it has serious restrictions for use in pregnant and lactating women. It is also important to consider the possible effect on reproductive function.

Pregnancy

• I and III trimester: strictly contraindicated. In the first trimester there is a risk of teratogenicity (impact on fetal development), and in the third trimester there is a risk of premature closure of the ductus arteriosus in the fetus and blood clotting disorders in the mother.

• II trimester: allowed in exceptional cases if the benefit to the mother outweighs the potential risk. Only by doctor's prescription.

Breastfeeding

Metamizole passes into breast milk, so during treatment it is recommended to stop breastfeeding for at least 48 hours after the last dose. This is necessary to eliminate the risk of unwanted effects in the baby (allergies, hematopoietic disorders, toxic effects).

Fertility

Currently, there is no reliable data on the effect of metamizole on fertility in men and women. However, when planning pregnancy or treating infertility, it is worth discussing taking the drug with your doctor.

During treatment Nolotil slYou should be especially attentive to your well-being if you drive a car or work with equipment.

The drug may cause:

• Dizziness

• Drowsiness

• Slow reactions

• Decreased concentration

This is especially true in the first hours after administration or if the dose is exceeded. If you feel slightly disoriented, tired or foggy, it is best to refrain from driving and work that requires concentration.

Like any medicine, Nolotil may have unwanted reactions from various organs and systems. They can occur even with proper dosage and short-term use.

Frequent (≥1/100 – <1/10):

• Drop in blood pressure (hypotension)

Uncommon (≥1/1000 – <1/100):

• Rash, itching, urticaria

• Dizziness

Rare (≥1/10,000 – <1/1000):

• Leukopenia (decreased white blood cell count)

• Agranulocytosis is a potentially fatal complication

• Anaphylactic reactions (up to shock)

Very rare (<1/10,000):

• Thrombocytopenia (low platelet count)

• Stevens-Johnson syndrome, toxic epidermal necrolysis (severe skin reactions)

• Acute renal failure, protein in the urine (proteinuria), decreased urine volume (oliguria, anuria)

Frequency unknown:

• Anemia, aplastic anemia, pancytopenia

• “Aspirin asthma” (bronchospasm in sensitive patients)

• Change in urine color (red due to metabolites)

It is important to understand: Some side effects do not develop immediately. If fever, sore throat, rash or general deterioration of your condition appears during your appointment, do not delay your visit to the doctor.

Taking too much Nolotil can have serious consequences. Particularly dangerous are attempts to “extinguish” pain with several techniques in a row - this can damage the kidneys, cause convulsions or even coma.

Main symptoms of overdose:

• Nausea, vomiting, abdominal pain

• Dizziness, lethargy, drowsiness

• Convulsions, breathing problems

• Sudden drop in pressure

• Acute renal failure

• Agranulocytosis or other hematopoietic disorders

• Loss of consciousness, coma

What to do in case of overdose?

1. Stop taking the drug immediately.

2. Seek medical help - taking activated charcoal or gastric lavage are effective in the first hours.

3. In severe cases, hemodialysis, forced diuresis, or intravenous fluids may be necessary.

4. Monitoring of kidney, blood and cardiovascular function is mandatory.

Metamizole sodium, the active ingredient of Nolotil, belongs to the non-narcotic analgesics from the pyrazolones group. It has three main effects:

• Analgesic - effectively reduces pain, including acute and chronic pain.

• Antipyretic - normalizes body temperature in case of fever that is resistant to other antipyretics.

• Antispasmodic - relieves pain caused by spasm of smooth muscles (for example, with renal or hepatic colic).

The mechanism of action is based on inhibition of the enzyme cyclooxygenase (COX), which leads to a decrease in the production of prostaglandins - substances that play a key role in inflammation, pain and fever.

Metamizole also affects thermoregulation centers in the hypothalamus and can partially block the conduction of pain impulses at the level of the spinal cord, which enhances its analgesic effect.

Pharmacokinetic properties Nolotil explain its rapid onset of action and duration of effect. Below are the key parameters:

Absorption

After oral administration, metamizole is quickly and almost completely absorbed from the gastrointestinal tract. After 30–60 minutes, a pronounced analgesic effect is observed.

When administered intramuscularly, the effect occurs even faster - after about 20-30 minutes.

Distribution

About 50–60% of the drug binds to blood plasma proteins. Active metabolites penetrate well into tissues and biological fluids.

Metabolism

Metamizole is metabolized in the liver, turning into active compounds that provide a therapeutic effect.

Removal

It is excreted by the kidneys mainly in the form of metabolites. A small part may be excreted in bile. The half-life ranges from 2.5 to 4 hours - thanks to this, Nolotil can be used several times a day without losing effectiveness.

If renal or liver function is impaired, excretion may slow down, requiring dosage adjustment.

Nolotil belongs to the pharmacological group of analgesics and antipyretics, in particular to other analgesics and antipyretics from the pyrazolones subgroup. 

The international name of the active substance is Metamizole sodium. It is used as an effective remedy for reducing pain and fever, especially in cases where other drugs are not effective enough or cause adverse reactions.

In addition to the active component (metamizole sodium), the drug contains excipients. They provide dimensional stability, correct release and ease of use.

The composition depends on the dosage form:

Capsules:

• Magnesium stearate - used as a lubricant, facilitating the production process.

• Gelatin - the basis of the capsule shell.

• Titanium dioxide (E171) — gives the shell opacity and whiteness.

Solution for injection:

• Water for injections — ensures the sterility and solubility of the drug.

Suppositories:

• Hard fat - a base for rectal administration, which melts at body temperature, promoting the rapid release of the active substance.

Before use, it is important to familiarize yourself with the full composition - especially if the patient is allergic to the auxiliary components.

Best before date Nolotil depends on the release form and manufacturer, but in most cases it is 3 years from the date of production. This information is always indicated on the original packaging.

It is prohibited to use the drug after the expiration date - its effectiveness is reduced, and safety may be in question. This is especially true for injection forms, where changes in the physicochemical properties of the solution are possible.

If you are not sure about the expiration date, it is better to consult a pharmacist or replace the package with a new one.

In order for Nolotil to retain its properties throughout its shelf life, it is important to observe the correct storage conditions:

• You eat a preparation at a temperature not exceeding 25°C, away from direct sunlight and heat sources.

• Protect from moisture - this especially applies to capsules and suppositories.

• Solution for injection requires storage in a place protected from light. Freezing is not allowed.

• Keep out of the reach of children - especially ampoules and capsules, which may be taken by mistake.

If the appearance of the drug has changed (turbidity of the solution, damage to the capsule or suppository), do not use it.

Nolotil is available in different packages depending on the form:

• Capsules — packed in blisters that are placed in a cardboard box. The number of capsules may vary depending on the manufacturer.

• Solution for injection — supplied in glass ampoules of 2 or 5 ml. Ampoules are packaged in plastic or cardboard containers.

• Suppositories — are produced in standard blisters, usually 5 pieces, packed in a box.

The packaging always indicates the release form, dosage, production date and expiration date. There must also be instructions for use in the language of the country where the drug is sold.

Before use, be sure to check that the packaging is not damaged and that the expiration date has not expired.

Improper disposal of medications can be dangerous - both to people and the environment. This also applies Nolotil, especially its injectable forms.

Here's what to do with an expired or unnecessary drug:

• Do not dispose of capsules, ampoules or suppositories in the household trash or sink - this may affect water and soil quality.

• Take any leftover medication to a pharmacy that participates in a drug recycling program. There they will be accepted for processing or disposal according to sanitary standards.

• If this is not possible, check with your medical facility or local pharmacist where to return the expired medicine.

Such measures help to avoid accidentally taking an expired drug and protect the environment from pharmaceutical pollution.

Preparation Nolotil officially registered and available in several countries, mainly in Southern Europe and Latin America. It is most actively used in Spain, where it is one of the popular analgesics. 

It is also available in:

• Portugal

• Argentina

• Mexico

• Chile

• Colombia

• Ecuador

• Peru

• Bolivia

However, availability may vary from country to country, as may the specifics of the destination or form of leave. Nolotil is banned or restricted in some countries due to potential side effects (eg, agranulocytosis), so it is worth checking local regulations before purchasing or importing overseas.

Boehringer Ingelheim (Germany)

In all countries where Nolotil registered, he is released by doctor's prescription. In particular:

• IN Spain is a strictly prescription drug (Rx).

• IN Portugal, Argentina, Mexico, Chile, Colombia, Ecuador, Peru and Bolivia - also available by prescription, but the order of administration and monitoring may vary depending on local legislation.

Self-administration, especially injectable form, not recommended - due to the risk of adverse reactions and the need for medical supervision.

To receive Nolotil was safe and effective, it is important to follow a few key rules:

• Tell your doctor about all medications you take, including dietary supplements and headache medications - many of them can interact with metamizole.

• Do not exceed the dosage and duration of use, even if the pain does not go away. This will not enhance the effect, but will increase the risk of complications.

• Monitor your health, especially in the first days - if fever, rash, sore throat or mouth ulcers appear, stop taking it immediately and consult a doctor. This may be a sign of agranulocytosis.

• Monitor your blood testif you are taking the drug as a course or against the background of other drugs that depress the bone marrow.

• Eliminate alcohol during treatment - this is important not only for the liver, but also for reducing the risk of hypotension and allergic reactions.

A responsible approach to treatment is the key to Nolotil will bring benefit and will not harm.

N02BB02 - Metamizole sodium

According to the international classification of diseases (ICD-10) Nolotil can be used for the following conditions:

• G25.5 — Other types of chorea

• J06 — Acute upper respiratory tract infections

• J11 — Flu, virus not identified

• K08.8.0* — Toothache

• M25.5 - Joint pain

• M35.3 — Polymyalgia rheumatica

• M54.3 — Sciatica

• M79.1 — Myalgia

• M79.2 — Neuralgia and neuritis, unspecified

• N23 — Renal colic

• N94.0 - Pain in the middle of the menstrual cycle

• R07.2 - Pain in the heart area

• R50 — Fever of unknown origin

• R51 - Headache

• R52, R52.0 - Pain, sharp pain

• Z100* — Surgical practice (indication of additional use in surgery)