Re-algin

Leaflet attached to the packaging: patient information

Re-Algin, 500 mg, tablets

Metamizole sodium

Re-Algin may cause a severely low number of white blood cells (agranulocytosis), which can lead to severe and life-threatening infections (see section 4).

You should stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms: fever, chills, sore throat, painful mouth sores, or sores in the genital or anal area.

If the patient has ever had agranulocytosis while taking metamizole or similar medicines, they should never take this medicine again in the future (see section 2).

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet so that you can read it again if you need to.
• If you need advice or additional information, you should contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If you do not improve or feel worse, you should contact your doctor.

Table of contents of the leaflet

• 1. What is Re-Algin and what is it used for
• 2. Important information before taking Re-Algin
• 3. How to take Re-Algin
• 4. Possible side effects
• 5. How to store Re-Algin
• 6. Contents of the packaging and other information

1. What is Re-Algin and what is it used for

Indications
Pain of various origins with high intensity or fever, when other medicines are contraindicated or ineffective.
Re-Algin is indicated for use in adults and adolescents aged 15 years or older (with a body weight of over 53 kg).

2. Important information before taking Re-Algin

When not to take Re-Algin

• if the patient is allergic to metamizole sodium or other pyrazolone derivatives, or any of the other ingredients of this medicine (listed in section 6),
• asthma triggered or worsened by non-steroidal anti-inflammatory drugs,
• hypersensitivity reactions to any non-steroidal anti-inflammatory drug or analgesic, particularly those with a history of angioedema, urticaria, or nasal polyps,
• in acute hepatic porphyria,

• in congenital glucose-6-phosphate dehydrogenase deficiency,
• in severe liver or kidney failure,
• in hematological disorders (blood disorders), including aplastic anemia (reduced number of blood cells, leading to fainting, bruising, and increased risk of infection), agranulocytosis (severe, life-threatening reduction in the number of white blood cells - granulocytes, which increases the risk of severe infections), and leukopenia (reduced total number of white blood cells),
• if the patient is in the last three months of pregnancy,
• in children under 15 years of age,
• if the patient has a history of severe reduction in the number of white blood cells called granulocytes caused by metamizole or other similar medicines called pyrazolones or pyrazolidines,
• if the patient has disorders of bone marrow function or a disease that affects the production or function of blood cells.

Warnings and precautions

Before starting to take Re-Algin, you should discuss it with your doctor or pharmacist.

Agranulocytosis (severely low number of white blood cells)

Re-Algin may cause agranulocytosis, a severely low number of a certain type of white blood cell called granulocytes, which play an important role in fighting infections (see section 4). You should stop taking metamizole and contact your doctor immediately if you experience any of the following symptoms, as they may indicate possible agranulocytosis: chills, fever, sore throat, and painful mouth sores, especially in the mouth, nose, and throat or in the genital or anal area.

You should contact your doctor if you experience any of the following symptoms, as they may indicate possible agranulocytosis:
chills, fever, sore throat, and painful mouth sores, especially in the mouth, nose, and throat or in the genital or anal area.

Your doctor will order a laboratory test to check your blood cell count.

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

Agranulocytosis can develop at any time during Re-Algin treatment, and even for a short time after stopping the medicine.

Agranulocytosis can occur even if metamizole was previously taken without complications.

You should stop taking the medicine and contact your doctor immediately if you experience:

• symptoms of agranulocytosis, such as fever, sore throat, or painful mouth sores;
• symptoms of a severe allergic reaction, such as difficulty breathing, swelling of the tongue or throat causing swallowing difficulties, angioedema, rash, or hives, itching, heart rhythm disturbances, or decreased blood pressure.

You should be particularly cautious:

• if you are allergic to painkillers or anti-rheumatic medicines, other products, or foods,
• if you have asthma (shortness of breath, asthma attacks), especially if it is accompanied by nasal polyps and sinusitis, and other allergic diseases,
• if you have blood disorders characterized by a reduced number of white blood cells,
• if you have low blood pressure, are dehydrated, or have heart failure,
• if you have kidney or liver dysfunction,
• if you have stomach or duodenal ulcers.

Liver disorders
Patients taking metamizole have experienced cases of liver inflammation, with symptoms appearing within a few days to several months after starting treatment.
You should stop taking Re-Algin and contact your doctor if you experience liver disorders, such as: feeling unwell (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes, itching, rash, or pain in the upper abdomen. Your doctor will check your liver function.
Patient should not take Re-Algin if they have previously taken any medicinal products containing metamizole and had liver disorders.
Severe skin reactions
Metamizole treatment has been associated with severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS). If you experience any of these severe skin reactions, you should stop taking metamizole and seek medical attention immediately.
If you have ever experienced severe skin reactions, you should never take Re-Algin again in the future (see section 4).

Re-Algin and other medicines

You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.
Before taking Re-Algin, you should consult your doctor, especially if you are taking any of the following medicines:

• anticoagulant medicines (e.g., warfarin, acenocoumarol),
• oral anti-diabetic medicines,
• phenytoin (an anti-epileptic medicine),
• antibacterial medicines (sulfonamides) - metamizole enhances their effect,
• cyclosporine (a medicine given after transplantation and in the treatment of cancer) - metamizole reduces its effect,
• chlorpromazine (a medicine used to treat mental illnesses) or other phenothiazine derivatives - a significant drop in body temperature may occur,
• bupropion, a medicine used to treat depression or as an aid to smoking cessation,
• efavirenz, a medicine used to treat HIV infection (AIDS),
• methadone, a medicine used to treat opioid dependence,
• valproate, a medicine used to treat epilepsy or bipolar disorder,
• tacrolimus, a medicine used to prevent organ rejection in patients after transplantation,
• sertraline, a medicine used to treat depression.

Metamizole (a substance with analgesic and antipyretic effects) may reduce the effect of acetylsalicylic acid on platelet aggregation (clotting of blood cells and clot formation) if these medicines are taken together. Therefore, caution should be exercised when taking metamizole in patients receiving acetylsalicylic acid.
You should not take Re-Algin with:

• sedatives,
• antidepressants,
• oral contraceptives,
• analgesic and antipyretic medicines (non-steroidal anti-inflammatory drugs),
• allopurinol (a medicine used to treat gout),
• alcohol.

Re-Algin is contraindicated with medicines from the pyrazolone derivative group (aminophenazone, phenylbutazone, oxyphenbutazone).

Re-Algin and alcohol

You should not consume alcohol while taking Re-Algin. Alcohol may increase the adverse effects of the medicine.

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 any harmful effects on the fetus. In selected cases, if there are no other treatment options, after consulting a doctor or pharmacist, the patient may take single doses of metamizole in the first and second trimester, provided that the benefits and risks of taking the medicine are carefully considered.
As a rule, the administration of metamizole in the first and second trimester is not recommended.
You should not take Re-Algin in the last three months of pregnancy due to the increased risk of complications in the mother and child (bleeding, premature closure of the ductus arteriosus in the unborn child, which normally closes after birth).
Breastfeeding
Metamizole metabolites pass into breast milk in significant amounts, and the risk to the breastfed infant cannot be excluded. Therefore, you should avoid repeated use of metamizole during breastfeeding.
In the case of single administration of metamizole, mothers should be advised to express and discard breast milk for 48 hours after administration of the medicine.

Driving and using machines

Re-Algin at recommended doses does not have a significant effect on the ability to drive vehicles or operate machinery.
Driving, operating machinery, and performing other activities that require active attention are not recommended during treatment with high doses of metamizole, as it may adversely affect reaction time in unexpected situations.
The medicine contains wheat starch.
This medicine contains very small amounts of gluten (from wheat starch). It is therefore very unlikely to cause any problems in patients with celiac disease. One tablet contains no more than 3.4 micrograms of gluten. Patients with a wheat allergy (other than celiac disease) should not take this medicine.

Re-Algin contains sodium

The medicine contains 32.7 mg of sodium (a major component of common salt) per tablet. This corresponds to 1.64% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Re-Algin

This medicine should always be taken exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
Re-Algin should be taken orally with a sufficient amount of water, preferably after a meal.
The tablet can be divided into two halves.
The dose depends on the severity of the pain or fever and the individual's response to Re-Algin.
You should always choose the smallest dose necessary to control the pain and fever.
The recommended dose of the medicine is:

Administration in adults and adolescents aged 15 years or older:

Adults and adolescents aged 15 years or older (with a body weight of over 53 kg) can be given a maximum of 1000 mg of metamizole in a single dose (2 tablets) no more than 4 times a day at 6-8 hour intervals. The maximum daily dose is 4000 mg (corresponding to 8 tablets).
A noticeable effect can be expected within 30 to 60 minutes after oral administration.
Re-Algin should not be used in children under 15 years of age.

Duration of treatment

The medicine should not be taken for more than 3 to 5 days.
Elderly patients and patients in poor general health or with kidney failure
In elderly patients, weakened patients, and patients with impaired kidney function, the dose should be reduced due to the possibility of prolonged elimination of metamizole metabolites.
Patients with kidney or liver dysfunction
Due to reduced elimination in patients with kidney or liver dysfunction, repeated administration of high doses should be avoided. In the case of short-term use, dose reduction is not required. There is a lack of experience with long-term use.

Administration in children and adolescents

Re-Algin is contraindicated in children under 15 years of age (see section 4.3).

Overdose of Re-Algin

In case of overdose, you should contact your doctor immediately.
After an overdose, dizziness, abdominal pain, nausea, vomiting, impaired consciousness, decreased body temperature, sudden drop in blood pressure, and heart rhythm disturbances may occur. There is a risk of severe shock, acute kidney and liver failure, seizures, and coma.

Missed dose of Re-Algin

You should not take a double dose to make up for a missed dose.

Stopping Re-Algin treatment

If you have any doubts about taking the medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Re-Algin can cause side effects, although not everybody gets them.
You should stop taking Re-Algin and seek medical attention immediately if you experience any of the following symptoms:
Feeling unwell (nausea or vomiting), fever, fatigue, loss of appetite, dark urine, pale stools, yellowing of the skin or eyes, itching, rash, or pain in the upper abdomen. These may be symptoms of liver damage. See also section 2 "Warnings and precautions".
During treatment with the medicine, the following may occur:

• common (in 1 to 10 patients out of 100): skin rash.

Rare (in 1 to 10 patients out of 10,000):

• hypersensitivity reactions, such as anaphylactic reaction or anaphylactic shock (a life-threatening, severe allergic reaction); symptoms of hypersensitivity may include itching, hives, generalized or localized swelling, redness of the skin (erythema), angioedema, heart rhythm disturbances, or decreased blood pressure.

Very rare (less than 1 patient out of 10,000):

• blisters on the skin and inside the mouth, or peeling of the skin, which may indicate a severe skin reaction called Stevens-Johnson syndrome;
• a life-threatening condition called Lyell's syndrome (characterized by blisters and necrosis, leading to peeling of large areas of skin);
• asthma attack (breathlessness);
• agranulocytosis (a severe, life-threatening reduction in the number of white blood cells - granulocytes), characterized by: fever, chills, sore throat, and difficulty swallowing, as well as inflammation of the mucous membranes of the mouth, nose, throat, genital, and anal areas;
• thrombocytopenia (reduced platelet count);
• hemolytic anemia (reduced red blood cell count, which may cause pallor or yellowing of the skin, weakness, or shortness of breath);
• aplastic anemia (a significant reduction in the number of all types of blood cells, which may cause bleeding, bruising, or increased risk of infection);
• kidney dysfunction, proteinuria (protein in the urine), oliguria (reduced urine output), polyuria (increased urine output), interstitial nephritis.

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

• nausea, vomiting, abdominal pain, and after high doses of the medicine, bloody vomiting, blood in the stool (black stools);
• liver inflammation, yellowing of the skin and eyes, and increased liver enzyme activity in the blood;
• severe skin reactions.

You should stop taking metamizole and seek medical attention immediately if you experience any of the following severe side effects:

• red, flat patches on the torso, target-like, or round, often with blisters in the center, peeling of the skin, mouth sores, throat, nose, genitals, and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. (22) 49-21-301, fax (22) 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Re-Algin

The medicine should be stored out of sight and reach of children. Store in the original packaging, at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
If you have any questions or doubts, you should contact your doctor or pharmacist.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Re-Algin contains

• The active substance of the medicine is metamizole sodium.
• One tablet contains 500 mg of metamizole sodium.
• The other ingredients of the medicine are wheat starch, microcrystalline cellulose (type 101), povidone K25, talc, magnesium stearate.

What Re-Algin looks like and contents of the packaging

Re-Algin is a white or almost white, odorless, round, flat tablet with a diameter of 13 mm, with a dividing line on one side.
The tablet can be divided into equal doses.
Packaging:
6 tablets, 10 tablets, or 20 tablets in a blister pack with an Al/PVC foil, together with a leaflet in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sopharma Warszawa Sp. z o. o.
Al. Jerozolimskie 136, 02-305 Warsaw
tel.: 22 613 39 30

Manufacturer

SOPHARMA AD
16, Iliensko Shosse str.
1220 Sofia, Bulgaria
Date of leaflet approval:12-2024