SULFADIAZINE REIG JOFRE 500 mg TABLETS

Introduction

Package Leaflet: Information for the User

Sulfadiazine Reig Jofre 500 mg Tablets

Sulfadiazine

Contents of the Package Leaflet

1. What is Sulfadiazine Reig Jofre and what is it used for
2. What you need to know before you take Sulfadiazine Reig Jofre
3. How to take Sulfadiazine Reig Jofre
4. Possible side effects
5. Storage of Sulfadiazine Reig Jofre
6. Contents of the pack and further information

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

Sulfadiazine belongs to a group of medicines 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 sulfadiazine.

You should consult a doctor if it worsens or does not improve.

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

Do not takeSulfadiazine Reig Jofre

• If you are allergic to sulfadiazine or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other sulfonamides (antibiotics).
• If you are allergic to sulfonylureas (medicines used to reduce blood sugar levels), such as chlorpropamide, glibenclamide, or glipizide.
• If you are allergic to thiazides (medicines used to increase urine production), such as hydrochlorothiazide.
• If you are allergic to carbonic anhydrase inhibitors, such as acetazolamide or dichlorphenamide, used for glaucoma (increased pressure inside the eye), epilepsy, or to increase urine production.
• If you have severe kidney or liver function impairment.
• If you have glucose-6-phosphate dehydrogenase deficiency (an enzyme found in red blood cells), as you are at risk of suffering from anemia due to premature destruction of red blood cells.
• If you have porphyria (a hereditary disease of metabolism).
• If you are in your third trimester of pregnancy.
• It should not be administered to children under 2 months of age.

Warnings and precautions

Consult your doctor or pharmacist before taking Sulfadiazine Reig Jofre:

• If you have kidney or liver function impairment, as the medicine may accumulate in your body. In these cases, your doctor may decide to reduce the dose.
• If you have a history of allergy or asthma.
• Sulfadiazine should be administered with caution in elderly patients.
• There have been reports of skin reactions that can be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) with the use of sulfadiazine. Initially, they appear as red, circular spots, often with a central blister.
• Other additional signs that may appear are sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
• These life-threatening skin reactions often occur with flu-like symptoms. The rash can progress to the formation of generalized blisters or peeling of the skin.
• The period of highest risk of severe skin reactions is during the first few weeks of treatment.
• If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Sulfadiazine Reig Jofre, you should not use Sulfadiazine Reig Jofre again at any time.
• If you develop a rash or these skin symptoms, stop using Sulfadiazine Reig Jofre, go to a doctor immediately, and inform them that you are using this medicine.

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

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

As it may cause the presence of crystals in the urine and the formation of kidney stones, adequate fluid intake should be maintained during treatment to avoid these problems.

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

Other medicines and Sulfadiazine Reig Jofre

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

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

It is important to inform your doctor if you are taking any of the following medicines:

• 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 clots).
• Methotrexate (used in the treatment of cancer and rheumatic diseases).
• Phenytoin (used for epilepsy).
• Sulfonylureas (medicines used to reduce blood sugar levels), such as chlorpropamide, glibenclamide, or glipizide.
• Cyclosporin (used to prevent transplant rejection).

During treatment with sulfadiazine, the use of substances that produce toxic effects on the liver, bone marrow, and kidneys should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You should not take this medicine 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 medicine if you are breastfeeding a child under 2 months of age. In other cases, your doctor should assess the convenience of its administration during breastfeeding.

Driving and using machines

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

3. How to take Sulfadiazine Reig Jofre

Follow exactly the administration instructions of this medicine indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults:

In severe cases, 4 tablets are recommended in 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:

1 tablet per 5 kg of body weight is recommended, divided every 4 hours.

This medicine is administered orally.

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

If you take more Sulfadiazine Reig Jofrethan you should

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

Overdose with sulfadiazine is very rare. If it occurs, loss of appetite, colic, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness, fever, and the presence of blood and/or crystals in the urine may appear. Jaundice (yellowing of the skin and mucous membranes) and changes in blood cell count may also occur.

The recommended treatment is stomach lavage and administration of large amounts of fluids and sodium bicarbonate (12 g daily), aiming to maintain urine production of at least 2 liters per day.

If you forget to takeSulfadiazine Reig Jofre

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

If you stop takingSulfadiazine Reig Jofre

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

4. Possible side effects

Like all medicines, Sulfadiazine Reig Jofre can cause side effects, although not everybody gets them.

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

The most characteristic side effects are:

Frequent (at least 1 in 100 patients):

Nausea and vomiting.

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

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

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

Fever, serum sickness (allergic reaction), skin rash, itching, erythema (inflammatory redness of the skin), exfoliative dermatitis (generalized peeling of the skin), reactions to sunlight, yellowing of the skin and mucous membranes, liver necrosis (death of liver tissue), kidney stones, decreased urine production, presence of crystals, proteins, and/or blood in the urine, increased urea values in the blood, peripheral neuropathy (damage to the nerves that connect the brain and spinal cord to muscles, skin, and other tissues and organs, which can 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 eosinophils (a type of white blood cell), increased methemoglobin in the blood (methemoglobinemia), characterized by the appearance of a bluish discoloration of the skin, and decreased prothrombin in the blood (hypoprothrombinemia), which favors the appearance of bleeding.

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

There have been reports of skin reactions that can be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sulfadiazine Reig Jofre

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date is the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition ofSulfadiazine Reig Jofre

• The active substance is sulfadiazine. Each tablet contains 500 mg of sulfadiazine.
• The other ingredients (excipients) are sodium starch glycolate, cellulose, talc, methylcellulose, mannitol (E-421), and magnesium stearate.

Appearance of the product and pack contents

Box of 20 and 500 tablets.

Marketing authorization holder and manufacturer:

LABORATORIO REIG JOFRE, S.A.

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

Date of last revision of this leaflet: 05/2025