Sulfadiazine Reig Jofre 500 mg tablets

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Sulfadiazine Reig Jofre 500 mg Tablets

Sulfadiazine

Package leaflet

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

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

Sulfadiazine Reig Jofre is an antibacterial agent belonging to the group of sulfonamides. The active substance, sulfadiazine, acts by inhibiting the growth of certain bacteria.

It is used in the treatment of infections caused by bacteria sensitive to sulfadiazine, particularly in combination with other medications for the treatment of toxoplasmosis.

Sulfadiazine belongs to a group of medications called sulfonamides, which work 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 your condition worsens or does not improve.

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

Do not take Sulfadiazine Reig Jofre

• If you are allergic to sulfadiazine or to 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 antidiabetic sulfonylureas (medicines used to lower blood sugar levels), such as chlorpropamide, glyburide, 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 internal eye pressure), epilepsy, or to increase urine elimination.
• If you have severely impaired kidney or liver function.
• If you have glucose-6-phosphate dehydrogenase deficiency (an enzyme found in red blood cells), as you are at risk of developing anemia due to premature destruction of red blood cells.
• If you have porphyria (a hereditary metabolic disorder).
• If you are in your third trimester of pregnancy.
• It must not be administered to children under 2 months of age.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Sulfadiazine Reig Jofre:

• If you have impaired kidney or liver function, as the medicine could accumulate in your body. In such cases, your doctor may decide to reduce your dose.
• If you have a history of allergies or asthma.
• Sulfadiazine should be used with caution in elderly patients.
• Skin rashes that may be life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported with the use of sulfadiazine; these initially appear as red spots or circular lesions, often with a central blister.
• Other additional symptoms that may occur include sores in the mouth, throat, nose, genitals, and conjunctivitis (swollen and red eyes).
• These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or skin peeling.
• The highest risk period for the occurrence of severe skin reactions is during the first weeks of treatment.
• If you have previously experienced Stevens-Johnson syndrome or toxic epidermal necrolysis with Sulfadiazine Reig Jofre, you must never use Sulfadiazine Reig Jofre again.
• If you develop skin rashes or these symptoms, stop using Sulfadiazine Reig Jofre immediately, seek medical attention right away, and inform the doctor that you are taking this medicine.

If any skin changes occur (pallor, rashes, dermatitis), discontinue treatment with sulfadiazine and consult your doctor, as these may indicate very serious adverse effects.

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

Since this medicine may cause the presence of crystals in the urine and the formation of kidney stones, adequate fluid intake should be maintained during treatment to prevent these problems.

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

Other medicines and Sulfadiazine Reig Jofre

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might need to take any other medicines.

Certain medicines (including herbal or natural products) may affect the action of others; in such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.

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

• Local anesthetics (medicines that cause temporary loss of sensation in the area where they are applied), such as benzocaine, procaine, or tetracaine.
• Oral anticoagulants (used to "thin" the blood and prevent clot formation).
• Methotrexate (used in the treatment of cancer and rheumatic diseases).
• Phenytoin (used for epilepsy).
• Antidiabetic sulfonylureas (medicines used to lower blood sugar levels), such as chlorpropamide, glyburide, or glipizide.
• Cyclosporine (used to prevent transplant rejection).

During treatment with sulfadiazine, avoid using substances that may cause toxic effects on the liver, bone marrow, and kidneys.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

You should not take this medicine during the third trimester of pregnancy. During the first and second trimesters, it should only be used if, in your doctor's opinion, the benefits outweigh the potential risks.

Sulfadiazine passes into breast milk. Do not take this medicine if you are breastfeeding a child under 2 months of age. In all other cases, your doctor will assess whether administration during breastfeeding is appropriate.

Driving and use of machines

Although drowsiness, dizziness, or confusion are uncommon with this medicine, if you experience any of these effects, you should not drive or operate dangerous machinery.

3. How to take Sulfadiazina Reig Jofre

Follow exactly the instructions for use of this medicine as 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 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:

1 tablet per every 5 kg of body weight, administered every 4 hours.

This medicine is administered orally.

For young children or patients 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Sulfadiazine intoxication is very rare. If it occurs, symptoms may include loss of appetite, colic, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness, fever, and presence of blood and/or crystals in urine. Jaundice (yellowing of the skin and mucous membranes) and disturbances in blood cell counts may also occur.

The recommended treatment is gastric lavage and administration of large amounts of fluids and sodium bicarbonate (12 g daily), ensuring a daily urine output of at least 2 liters.

If you forget to take Sulfadiazina Reig Jofre

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

If you stop taking Sulfadiazina Reig Jofre

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

4. Possible adverse effects

Like all medicines, Sulfadiazina Reig Jofre may produce adverse effects, although not everyone will experience them.

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

The most characteristic adverse effects are:

Frequent (affects at least 1 in 100 patients):

Nausea and vomiting.

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

Depression, hallucinations, confusion, psychosis, drowsiness, agitation, insomnia, headache, dizziness, lack of coordination of movements, disturbances in balance, tinnitus (ringing in the ears).

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

Fever, serum sickness (allergic reaction), skin rashes, itching, erythema (inflammatory redness of the skin), exfoliative dermatitis (generalized skin peeling), photosensitivity reactions, yellowish discoloration of the skin and mucous membranes, hepatic necrosis (death of liver tissue), kidney stones, decreased urine production, presence of crystals, proteins and/or blood in urine, increased blood urea levels, peripheral neuropathy (nerve damage affecting nerves connecting the brain and spinal cord to muscles, skin, and other tissues and organs, which may present as tingling, numbness, burning, or pain, among other symptoms), decreased number of red blood cells (hemolytic anemia, aplastic anemia), decreased number of white blood cells (leukopenia, agranulocytosis), decreased number of platelets (thrombocytopenia), increased number of a type of white blood cells called eosinophils (eosinophilia), increased methemoglobin levels in blood (methemoglobinemia), characterized by bluish discoloration of the skin, and decreased blood prothrombin levels (hypoprothrombinemia), which may lead to bleeding.

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

Life-threatening skin rashes have been reported (Stevens-Johnson syndrome, toxic epidermal necrolysis) (see section 2).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse 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 stated on the packaging after "EXP". The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. 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 Sulfadiazine Reig Jofre

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

Appearance of the product and contents of the pack

Box containing 20 and 500 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIO REIG JOFRE, S.A.

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

Date of the most recent revision of this leaflet: 05/2025