Prospect: information for the user

Sulfadiazine Reig Jofre 500 mg tablets

Sulfadiazine

1.What is Sulfadiazine Reig Jofre and what is it used for

2.What you need to know before starting to take Sulfadiazine Reig Jofre

3.How to take Sulfadiazine Reig Jofre

4.Possible adverse effects

5.Storage of Sulfadiazine Reig Jofre

6.Contents of the package and additional information

Sulfadiazina belongs to a group of medications called sulfonamides, which act by preventing the growth and multiplication of bacteria and other organisms that cause infections.

It is used for the treatment of infections, such as pneumonia, urinary tract infections, meningitis, etc., caused by organisms sensitive to sulfadiazina.

Consult a doctor if symptoms worsen or do not improve.

Do not takeSulfadiazina Reig Jofre

• If you are allergic to sulfadiazine or any of the other components of this medication (listed in section 6).
• If you are allergic to other sulfamides (antibiotics).
• If you are allergic to sulfonilureas antidiabetic (medicines used to reduce blood sugar levels), such as chlorpropamide, glibenclamide, or glipizide.
• If you are allergic to thiazides (medicines used to increase urine elimination), such as hydrochlorothiazide.
• If you are allergic to carbonic anhydrase inhibitors, such as acetazolamide or dichlorphenamide, used for glaucoma (increased eye pressure), epilepsy, or to increase urine elimination.
• If you have a severe decrease in kidney or liver function.
• If you have glucose-6-phosphate dehydrogenase deficiency (an enzyme found in red blood cells), as you have the risk of suffering from premature destruction of red blood cells.
• If you have porphyria (hereditary metabolic disease).
• If you are in your third trimester of pregnancy.
• This medication should not be administered to children under 2 months.

Warning and precautions

Consult your doctor or pharmacist before starting to take Sulfadiazina Reig Jofre.

• If you have a kidney or liver function alteration because the medication could accumulate in your body. In these cases, the doctor may decide to reduce your dose.
• If you have a history of allergy or asthma.
• Sulfadiazine should be administered with caution in elderly patients.

If any skin alteration (pallor, rashes, dermatitis) appears, interrupt the treatment with sulfadiazine and consult your doctor, as it may be indicative of very serious side effects.

If the treatment is prolonged, the doctor may perform regular blood tests.

Since it can produce the presence of crystals in the urine and the formation of kidney stones, it is essential to maintain an adequate fluid intake during treatment to avoid these problems.

This medication may increase skin sensitivity to sunlight, so prolonged exposure to the sun should be avoided during treatment.

Other medications and Sulfadiazina Reig Jofre

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.

Certain medications(including plant or natural products)may affect the action of others; in these cases, it may be necessary to change the dose or interrupt the treatment with one of the medications.

It is essential to inform your doctor if you take any of the following medications:

• Local anesthetics (medicines that produce temporary loss of sensitivity in the area where they are applied), such as benzocaine, procaine, or tetracaine.
• Oral anticoagulants (used to "thin" the blood and prevent the formation of blood clots).
• Methotrexate (used in cancer treatment and rheumatic diseases).
• Phenytoin (used for epilepsy).
• Sulfonilureas antidiabetic (medicines used to reduce blood sugar levels), such as chlorpropamide, glibenclamide, or glipizide.
• Ciclosporin (used to prevent transplant rejection).

During treatment with sulfadiazine, it is essential to avoid the use of substances that produce toxic effects on the liver, bone marrow, and kidneys.

Pregnancy and lactation

If you are pregnant or breastfeeding, consultyour doctor or pharmacist before using this medication.

You should not take this medication during the third trimester of pregnancy.In the first and second trimesters,it should only be used when, in the opinion of your doctor, the benefits outweigh the possible risks.

Sulfadiazine passes into breast milk. Do not take this medication if you are breastfeeding a child under 2 months. In other cases, the doctor should assess the convenience of its administration during lactation.

Driving and operating machinery

Although it is rare for drowsiness, dizziness, or confusion to appear when taking this medication, if you notice any of these effects, you should not drive or operate hazardous machinery.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults :

In severe cases, 4 tablets are recommended for the first dose, followed by 2 tablets every 4 hours. The average dose is 6 to 10 tablets per day for 5 to 10 days.

Children :

One tablet is recommended for every 5 kg of weight, taken every 4 hours.

This medication is administered orally.

In the case of small children or individuals with difficulty swallowing, it is recommended to take the tablets crushed and dissolved in water or another beverage.

If you take more Sulfadiazina Reig Jofre than you should

If you have taken more Sulfadiazina Reig Jofre than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Sulfadiazine intoxication is very rare. In the event of occurrence, symptoms may include loss of appetite, cramps, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness, fever, and presence of blood and/or crystals in urine. Icterus (yellow discoloration of skin and mucous membranes) and alteration in blood cell count may also occur.

The recommended treatment is stomach lavage and administration of a large amount of liquids and sodium bicarbonate (12 g daily), while maintaining a urine output of at least 2 liters per day.

If you forget to take Sulfadiazina Reig Jofre

Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Sulfadiazina Reig Jofre

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

Like all medications,Sulfadiazina Reig Jofremay cause side effects, although not everyone will experience them.

If you notice any of the following symptoms, discontinue treatment and consult your doctor immediately: fever, severe headache, inflammation of the mouth mucosa, conjunctivitis, rhinitis, skin eruptions, purpura (red spots on the skin), pallor, yellow discoloration of the skin and mucous membranes, or weakness.

The most characteristic side effects are:

Frequent (in at least 1 in 100 patients):

Nausea and vomiting.

Infrequent (in at least 1 in 1,000 patients):

Depression, hallucinations, confusion, psychosis, drowsiness, agitation, insomnia, headache, dizziness, movement coordination disorders, balance disturbances, tinnitus in the ears.

Rare (in at least 1 in 10,000 patients):

Fever, serum disease (allergic reaction), skin eruptions, itching, erythema (inflammatory redness of the skin), exfoliative dermatitis (generalized skin peeling), photosensitivity reactions, yellow discoloration of the skin and mucous membranes, hepatic necrosis (liver tissue death), kidney stones, decreased urine production, presence of crystals, proteins, and/or blood in urine, increased urea levels in blood, peripheral neuropathy (damage to nerves connecting the brain and spinal cord with muscles, skin, and other tissues and organs, which may manifest with tingling, numbness, burning, or pain, among other symptoms), decreased red blood cell count (hemolytic anemia, aplastic anemia), decreased white blood cell count (leukopenia, agranulocytosis), decreased platelet count (thrombocytopenia), increased eosinophil count (eosinophilia),increased metahemoglobin in blood(metahemoglobinemia),characterized by the appearance of a bluish discoloration of the skin,and decreased prothrombin in blood (hypoprothrombinemia), which favors the occurrence of hemorrhages.

Very rare (less than 1 in 10,000 patients):

Stevens-Johnson syndrome (severe rash affecting the skin, eyes, and mucous membranes).

If you consider that any of the side effects you experience is severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not appearing in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

No requires special conservation conditions.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofSulfadiazina Reig Jofre

- The active ingredient is sulfadiazine. Each tablet contains 500 mg of sulfadiazina.

- The other components (excipients) are sodium glycolate starch, cellulose, talc, methylcellulose, mannitol (E-421) and magnesium stearate.

Appearance of the product and contents of the packaging

Box of 20 and 500 tablets.

Holder of the marketing authorization andresponsible for manufacturing:

LABORATORIO REIG JOFRE, S.A.

Gran Capitán, 10, 08970 Sant Joan Despí (Barcelona)

Date of the last review of this leaflet: 04/2021