Nolotil 575 mg hard capsules

Patient Information Leaflet

Introduction

Patient Information Leaflet

Nolotim 575 mg hard capsules

Magnesium metamizole

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Nolotil is and what it is used for
2. What you need to know before taking Nolotil
3. How to take Nolotil
4. Possible adverse effects
5. Storage of Nolotil
6. Contents of the pack and other information

1. What Nolotil is and what it is used for

Nolotil belongs to a group of medicines called "Other Analgesics and Antipyretics".

This medicine is used for the treatment of moderate to severe acute pain following surgery or trauma, colicky pain, or pain of tumoral origin. It is also used in cases of high fever unresponsive to other measures or other antipyretic medicines.

2. What you need to know before starting to take Nolotil

Do not take Nolotil:

• If you have previously experienced a significant decrease in a type of white blood cells called granulocytes, caused by metamizole or other similar medicines known as pyrazolones or pyrazolidines.
• If you have problems with your bone marrow or have a disorder affecting the production or function of your blood cells.
• If you have previously had allergic reactions or hematological reactions (decrease in white blood cells, red blood cells, or platelets in the blood) to medicines containing metamizole or other similar compounds, or if you are allergic to any of the other components of this medicine (listed in section 6).
• If you have previously experienced symptoms of asthma, rhinitis, or urticaria (reddish skin rashes or hives that may cause itching) during treatment with other analgesics such as acetylsalicylic acid, paracetamol, or non-steroidal anti-inflammatory drugs, since sensitivity to metamizole (the active substance in Nolotil) may also occur in these cases.
  • If you suffer from acute intermittent porphyria (a metabolic disorder of blood pigments that are part of hemoglobin).
  • If you have a genetic deficiency of glucose-6-phosphate dehydrogenase.
  • If you have previously experienced disturbances in bone marrow function (responsible for blood cell formation); for example, during or after receiving antitumor chemotherapy (antineoplastic) or if you have had diseases related to blood cell formation.
  • If you are in the last three months of pregnancy.
  • If you have previously experienced severe skin reactions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) after using Nolotil or another medicine containing metamizole.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Nolotil.

Lower than normal white blood cell count (agranulocytosis).

Nolotil can cause agranulocytosis, a very low level of a type of white blood cells called granulocytes, which are important for fighting infections (see section 4). You must stop taking metamizole and contact a doctor immediately if you experience the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful sores in mucous membranes (moist body surfaces), especially in the mouth, nose, and throat, or in the genital or anal area. Your doctor will perform laboratory tests to check your blood cell levels.

If you take metamizole for fever, some symptoms of agranulocytosis may go unnoticed. Similarly, symptoms may be masked if you are taking antibiotics.

Agranulocytosis can occur at any time during the use of Nolotil and even shortly after stopping metamizole.

You may develop agranulocytosis even if you have previously used metamizole without problems.

Take special care:

• If you experience general malaise, infection, persistent fever, sore throat, swelling in the mouth, nose, or throat, lesions in the mucosa of the mouth or genitals, bruising, bleeding, or paleness, you must stop treatment and consult your doctor immediately. These disorders may be due to a decrease in the number of white blood cells in the blood (agranulocytosis), platelets (thrombocytopenia), or failure in the production of all blood cells (aplastic anemia).
• If you experience dizziness, difficulty breathing, rhinitis, facial swelling, drop in blood pressure, or sudden appearance of reddish skin rashes, stop treatment and consult your doctor. These symptoms may be due to a severe allergic reaction called anaphylactic shock. This reaction is more likely if you suffer from asthma or allergic-type disorders (atopy).
• If you have bronchial asthma (especially in the presence of nasal mucosa inflammation and nasal polyps), chronic urticaria, or if you are intolerant to dyes and/or preservatives or to alcohol, as the risk of severe allergic reactions is higher.
• If you have low blood pressure, hypovolemia (reduced circulating volume of blood or any other body fluid), dehydration, or unstable circulation, as the risk of a sudden drop in blood pressure is higher.
• If you have reduced kidney or liver function, as you may eliminate the medicine with greater difficulty.
• If you are elderly, pay special attention to the appearance of any of the disorders described above, as they may occur more frequently.

Liver problems:

Liver inflammation has been reported in patients taking metamizole, with symptoms developing within a few days to several months after starting treatment.

Stop taking Nolotil and contact a doctor if you experience symptoms of liver problems, such as malaise (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), itching, rash, or upper abdominal pain. Your doctor will check your liver function.

You should not take Nolotil if you have previously taken any medicine containing metamizole and experienced liver problems.

Severe skin reactions:

Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported in association with metamizole treatment. Stop taking metamizole and seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you have ever experienced severe skin reactions, you must never restart treatment with Nolotil (see section 4).

Taking Nolotil with food, drinks, and alcohol

When taken with alcohol, the effects of both alcohol and the medicine may be enhanced.

Pregnancy, breastfeeding, 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 on the embryo. In selected cases when no other treatment options are available, single doses of metamizole during the first and second trimesters may be acceptable after consulting with your doctor or pharmacist and carefully evaluating the benefits and risks of using metamizole. However, in general, the use of metamizole during the first and second trimesters is not recommended.

During the last three months of pregnancy, you must not take Nolotil due to the increased risk of complications for both mother and baby (bleeding, premature closure of an important fetal blood vessel called the ductus arteriosus, which normally closes after birth).

Breastfeeding

Metamizole metabolites are excreted in breast milk in considerable amounts, and risk to the infant cannot be excluded. Therefore, repeated use of metamizole during breastfeeding should be avoided. If a single dose of metamizole is administered, mothers are advised to express and discard breast milk for 48 hours following administration.

Driving and using machines

Although adverse effects on concentration and reaction ability are not expected, at the higher end of the recommended doses, it should be considered that these abilities may be affected, and the use of machines, driving vehicles, or other hazardous activities should be avoided.

Taking Nolotil with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

If administered concomitantly with cyclosporine (a medicine used to prevent transplant rejection), it may reduce cyclosporine blood levels, and therefore these levels should be monitored regularly.

If administered together with chlorpromazine (a medicine used to treat psychosis), it may cause a drop in body temperature.

If administered together with methotrexate or other antitumor medicines (antineoplastics), it may enhance the blood toxicity of antineoplastics, especially in elderly patients.

If administered together with acetylsalicylic acid, it may reduce the antiplatelet effect of acetylsalicylic acid and therefore should be used with caution in patients taking it for cardioprotection.

If administered together with bupropion (a medicine used to treat depression and/or to help quit smoking), efavirenz (a medicine used to treat HIV/AIDS), methadone (a medicine used to treat dependence on illicit drugs known as opioids), valproate (a medicine used to treat epilepsy or bipolar disorder), tacrolimus (a medicine used to prevent organ rejection in transplant patients), or sertraline (a medicine used to treat depression), it may reduce blood levels of these medicines, so caution is advised.

Metamizole may alter the effects of antihypertensives (medicines that lower blood pressure) and diuretics (medicines that increase fluid elimination).

3. How to take Nolotil

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

This medicine is intended for short-term use. Your doctor will determine the duration of your treatment.

This medicine is taken orally. The capsules must be swallowed whole, without chewing, with a little liquid.

The dose is determined according to the intensity of pain or fever and to the individual's sensitivity to treatment with Nolotil. The lowest dose necessary to control pain and fever should always be used. Your doctor will tell you how to take Nolotil.

Adults and adolescents aged 15 years or older

Adults and adolescents aged 15 years or older (weighing more than 53 kg) may take 1 capsule (575 mg metamizole) as a single dose, which can be administered up to 6 times daily at intervals of 4 to 6 hours. The maximum daily dose is 3,450 mg (equivalent to 6 capsules).

The effect of the medicine usually appears between 30 and 60 minutes after oral administration.

Children and adolescents under 15 years of age

Nolotil must not be used in children under 15 years of age. For younger children, other presentations and doses of this medicine are available; consult your doctor or pharmacist.

Elderly patients and patients with poor general health or renal insufficiency

The dose should be reduced in elderly patients, in debilitated patients, and in those with impaired renal function, since elimination of metamizole metabolites may be delayed.

Patients with renal or hepatic insufficiency

Since elimination rate is reduced in cases of renal or hepatic insufficiency, repeated administration of high doses should be avoided. In short-term treatments, dose reduction may not be necessary. Experience with prolonged treatment is lacking.

If pain persists or worsens, consult a doctor to investigate the cause of symptoms.

If you take more Nolotil than you should

Symptoms such as nausea, vomiting, abdominal pain, impaired kidney function, and less commonly dizziness, drowsiness, coma, convulsions, low blood pressure, or even shock and increased heart rate (tachycardia) may occur.

After administration of very high doses of metamizole, red discoloration of urine may occur, which disappears upon discontinuation of treatment.

If you have taken more medicine than you should, consult your doctor or pharmacist, or contact the Toxicology Information Service at telephone 91 562 04 20.

Information for the physician: No specific antidote is known. After oral overdose, gastric lavage and induction of vomiting may be possible. Forced diuresis or dialysis may be considered, since metamizole is dialyzable.

In case of severe allergic reactions, other standard emergency measures should also be applied, such as placing the patient in the lateral position, maintaining airways free of obstruction, or administering oxygen. Pharmacological emergency measures include administration of adrenaline, fluid therapy, and glucocorticoids.

Careful monitoring of vital functions is advised, together with the necessary general supportive measures.

If you forget to take Nolotil

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Stop taking metamizole and seek immediate medical attention if you notice any of the following serious adverse effects:

• Non-elevated reddish patches, or circular or target-shaped rashes on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Stop taking metamizole and contact a doctor immediately if you experience any of the following symptoms:

Feeling unwell (nausea or vomiting), fever, feeling tired, loss of appetite, dark urine, pale stools, yellowing of the skin or the whites of the eyes, itching, rash, or pain in the upper stomach area. These symptoms may be signs of liver damage. See also section 2 Warnings and precautions.

Mild allergic reactions (e.g. skin and mucous membrane reactions such as itching, burning, redness, swelling) as well as difficulty breathing and gastrointestinal discomfort may progress to more severe forms, e.g. generalized urticaria, swelling of feet, hands, lips, throat, and airways (angioedema), severe bronchospasm (narrowing of the bronchial walls), heart rhythm disturbances, and decreased blood pressure (sometimes preceded by an increase in blood pressure).

Other adverse effects that may occur with the following frequencies are:

Frequent (may affect up to 1 in 10 people):

• hypotension (decrease in blood pressure).

Uncommon (may affect up to 1 in 100 people):

• skin rashes and skin reactions.

Rare (may affect up to 1 in 1,000 people):

• allergic reactions, usually occurring during or shortly after administration, but also hours later,
• skin rashes and hives (urticaria),
• decrease in the number of white blood cells in the blood (leucopenia),
• asthma.

Very rare (may affect up to 1 in 10,000 people):

• skin reactions with the appearance of vesicles or blisters (toxic epidermal necrolysis, Stevens-Johnson syndrome),
• kidney problems with reduced or suppressed urine output,
• increased excretion of proteins in the urine,
• inflammation of the kidney (interstitial nephritis),
• severe decrease in white blood cells (agranulocytosis), which may result in death due to severe infections,
• decrease in the number of platelets in the blood (thrombocytopenia); in this case, inflammatory lesions in mucous membranes, sore throat, and fever may occur,
• shock (drastic drop in blood pressure).

Frequency not known (cannot be estimated from available data):

• sepsis (a serious infection causing a systemic inflammatory response that may result in death),
• aplastic anemia (failure in the production of bone marrow and blood cells),
• pancytopenia (low levels of red blood cells, white blood cells, and platelets simultaneously),
• anaphylactic shock (severe allergic reaction that may be fatal),
• Kounis syndrome (a type of cardiac disorder),
• gastrointestinal bleeding,
• chromaturia (abnormal discoloration of urine),
• inflammation of the liver, yellowing of the skin and whites of the eyes, increased blood levels of liver enzymes,
• severe skin reactions.

Reporting of adverse effects:

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nolotil

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Nolotil

• The active substance is magnesium metamizole. Each capsule contains 575 mg of magnesium metamizole.
• The other components are magnesium stearate, indigo carmine (E 132), erythrosine (E 127), titanium dioxide (E 171), and gelatin.

Appearance of the product and contents of the pack

Hard gelatin capsules, oblong, with body and cap of opaque garnet color, packed in blisters.

Available in packs containing 10, 20 or 500 hard capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Manufacturer:

Boehringer Ingelheim España, S.A.

Prat de la Riba, 50

08174 Sant Cugat del Vallès (Barcelona)

Spain

Delpharm Reims, S.A.S.

10 Rue Colonel Charbonneaux

51100 Reims

France

Date of the most recent revision of this leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.