SALIDUR 77.6 mg / 25 mg TABLETS

Introduction

Package Leaflet: Information for the User

Salidur 77.6 mg / 25 mg Tablets

furosemide xantinol/triamterene

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What Salidur is and what it is used for

Salidur is a medication belonging to the group of diuretics (medicines that promote urine elimination) and contains an association of two active principles (furosemide and triamterene).

It is indicated in:

• cases where edema occurs, i.e., swelling due to fluid retention, which usually occurs in the legs.
• treatment of high blood pressure (arterial hypertension).

2. What you need to know before taking Salidur

Do not take Salidur

• If you are allergic to furosemide (such as xantinol), triamterene, antibiotics of the sulfonamide group, or any of the other components of this medication (listed in section 6).
  • If you have liver problems that affect the nervous system (hepatic coma)
  • If you have severe kidney disease (severe renal insufficiency) or do not urinate
  • If you have blood disorders such as low sodium, potassium, and/or decreased blood volume with or without hypotension (decreased blood pressure)
  • If you have high potassium levels in the blood with or without hypotension
  • If you are breastfeeding a baby (see section "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Salidur.

• If you have hypotension, diabetes (high blood sugar), severe heart failure (severe heart disease), hyperuricemia (high uric acid), gout, kidney failure associated with severe liver problems, (nephrolithiasis or nephrocalcinosis in premature newborns) or some ear disorder, as your doctor will need to monitor you continuously while taking this medication.

Consult your doctor before taking Salidur, even if any of the above circumstances have occurred to you in the past.

• If you have prostate enlargement (prostate hypertrophy) or urination problems. In these cases, this medication should be used with caution, as it may cause urinary retention.
• If you have any liver or kidney disease, as your doctor will need to adjust the dose.
• If you are an elderly person, if you are being treated with medications that can cause decreased blood pressure, or if you have other medical conditions that have associated risk of decreased blood pressure.
• If you have a disease called systemic lupus erythematosus, it could be activated or worsened.

During treatment with this medication, periodic monitoring of your blood levels of sodium, potassium, and creatinine will generally be required, and especially if you suffer from severe fluid loss, due to vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), your doctor may require interruption of treatment.

If during treatment with furosemide, you are going to receive a radiological contrast test, consult your doctor because you may experience a worsening of kidney function.

Other medications and Salidur

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, and in particular if you are taking:

• Antibiotics of the aminoglycoside group (medications used to treat some infections) such as gentamicin, especially if you are using high doses of Salidur.

• Non-steroidal anti-inflammatory drugs (medications used to treat pain and inflammation) such as acetylsalicylic acid, flurbiprofen, indomethacin, naproxen, piroxicam.
• Cephalosporins (medications used to treat some infections) such as cefaloridine, cefalotin.
• Corticosteroids (medications that reduce inflammation and the action of the body's defenses) such as cortisone, hydrocortisone, carbenoxolone.
• Digitalis (medications used to treat some heart diseases) such as digoxin
• Angiotensin-converting enzyme inhibitors (medications used to treat high blood pressure) such as enalapril, captopril, or angiotensin receptor antagonists.
• Aliskiren (medication used to treat high blood pressure).
• Potassium supplements, potassium-sparing diuretics such as amiloride or spironolactone.
• Ranitidine (medication used to treat stomach and duodenal ulcers, acidity, and reflux, among others).
• Lithium salts (medication used to treat a type of depression).
• Muscle relaxants of the curare type.
• Theophylline (medication used to treat asthma).
• Risperidone (medication used to treat dementia).
• Cisplatin (medication used to treat some types of cancer).
• Cyclosporin A (medication used to prevent transplant rejection).
• Levothyroxine (medication used to treat thyroid problems).
• Phenytoin (antiepileptic medication).
• Probenecid (medication used to treat gout).
• Methotrexate.
• Antidiabetic medications (metformin, meglitinides, thiazolidinediones, alpha-glucosidase inhibitors) and sympathomimetic medications (epinephrine and norepinephrine): The effect of antidiabetics and sympathomimetics may be reduced.

Large amounts of licorice and prolonged use of laxatives can increase the risk of hypokalemia.

Administration of Salidur with any of these medications may modify the action and/or increase the side effects of Salidur or the other medications.

Never take another medication on your own initiative without your doctor's recommendation, as some combinations should be avoided.

This medication and sucralfate should not be administered together, with an interval of less than 2 hours, as the effect of Salidur may be reduced.

Furosemide may alter HDL cholesterol, LDL cholesterol, and triglyceride values.

Triamterene may change the color of your urine to blue.

Taking Salidur with food and drinks

It is recommended to take this medication on an empty stomach, as its effect may be less than expected in the presence of food.

Pregnancy and breastfeeding

Do not take Salidur if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant. Consult your doctor or pharmacist before using this medication.

Do not take Salidur if you are breastfeeding. If during breastfeeding your doctor considers it essential to take Salidur, your doctor may require you to interrupt breastfeeding, as furosemide passes into breast milk.

Children and adolescents

Salidur should not be used in children.

Use in people over 65 years old

Elderly patients have a higher risk of suffering adverse reactions and dehydration due to the use of this medication, so Salidur should be used with caution in these patients (see section "How to take Salidur").

Use in athletes

Athletes are informed that this medication contains a component that can produce a positive result in doping tests.

Driving and using machines

This medication can cause dizziness or fainting. This may occur more frequently at the start of treatment, so during the first few weeks, it is not advisable to drive or operate machines.

Salidur contains ethanol and sodium

This medication contains 7% ethanol (alcohol), which corresponds to 16 mg per tablet.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Salidur

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

Your doctor will indicate the duration of treatment with Salidur. Do not use it for longer than indicated by your doctor.

This medication is for oral administration. Take your dose with a sufficient amount of water or fruit juice, preferably on an empty stomach (see section "Taking Salidur with food and drinks").

The dose of Salidur should be as indicated by your doctor and at the hours indicated by your doctor, according to your individual needs. It is recommended to administer the lowest dose that is sufficient to produce the desired effect.

In severe cases, the maximum daily dose should not exceed 4 tablets/day.

Treatment of fluid retention (edema): The recommended dose is 1 to 2 tablets per day.

Treatment of high blood pressure (hypertension): The recommended dose is 1 tablet per day or 1 tablet every two days.

Use in people over 65 years old

Your doctor should adjust the dose of Salidur, especially if you are elderly and have kidney disease.

Use in patients with kidney disease

Do not take Salidur if you have severe renal insufficiency, as its use is contraindicated in these cases (see section "Do not take Salidur").

If you have less severe kidney disease, your doctor should adjust the dose of Salidur.

Use in patients with liver disease

Do not take Salidur if you have liver problems that affect the nervous system (hepatic coma), as its use is contraindicated in these cases (see section "Do not take Salidur").

If you have less severe liver disease, your doctor should adjust the dose of Salidur.

If you think the action of Salidur is too strong or too weak, inform your doctor or pharmacist.

If you take more Salidur than you should

If you have taken more Salidur than you should, you may suffer from blood disorders (electrolyte disturbances, metabolic alkalosis, anemia), digestive disorders (vomiting), or skin disorders (rash).

Consult your doctor or pharmacist immediately, indicating the medication and the amount ingested.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately and call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

If you forget to take Salidur

Do not take a double dose to make up for forgotten doses. If you forget to take a dose, take the next dose at the usual time.

If you have forgotten to take several doses, consult your doctor to indicate the dosage schedule to follow until you reach your maintenance dose.

If you stop taking Salidur

Do not stop treatment before your doctor indicates it, as the expected results will not be achieved.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The side effects that have been observed with Salidur are the following:

Very common side effects (may affect more than 1 in 10 people)

• Electrolyte disturbances, dehydration, hypovolemia, hyperkalemia.

Common side effects (may affect up to 1 in 10 people)

• Electrolyte disturbances (decreased potassium, sodium, or chloride in the blood)
• Increased blood viscosity (hemoconcentration)
• Mental disorders in patients with liver problems (hepatic encephalopathy)
• Increased urine volume
• Increased uric acid in the blood, mainly after high-dose or prolonged treatment, and gout attacks.

Uncommon side effects (may affect up to 1 in 100 people)

• Decreased platelet count (thrombocytopenia).
• Increased calcium in urine
• Glucose intolerance due to decreased potassium levels
• Gout
• Headache
• Transient ear disorders, cases of deafness (sometimes irreversible)
• Digestive disorders (nausea, dry mouth)
• Skin disorders (itching, hives, rash, blistering dermatitis, erythema multiforme, exfoliative dermatitis, purpura, photosensitivity reactions, rash)
• Transient kidney failure
• Increased creatinine
• Decreased HDL cholesterol and increased LDL cholesterol in the blood, elevated triglycerides in serum.

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

• Blood disorders (decreased white blood cells and eosinophils)
• Abnormal tingling sensation
• Tinnitus
• Vasculitis
• Vomiting, diarrhea, constipation, anorexia.
• Defect of liver enzymes (pseudoporphyria)
• Kidney inflammation (tubulointerstitial nephritis), kidney stones
• Fever.

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

• Blood and lymphatic system disorders: decreased white blood cells (agranulocytosis), decreased red blood cells (aplastic anemia, hemolytic anemia), vitamin B12 deficiency anemia (megaloblastic anemia), severe decrease in red blood cells, white blood cells, and platelets (pancytopenia)
• Acute pancreatitis
• Cholestasis
• Elevated transaminases.

Side effects of unknown frequency (cannot be estimated from available data)

• Systemic lupus erythematosus (disease that causes joint pain, skin rash, and fever)
• Severe allergic reactions (anaphylactic reactions)
• Decreased calcium levels in the blood (hypocalcemia), decreased magnesium levels in the blood (hypomagnesemia), increased urea in the blood, excessive basicity in tissues or blood (metabolic alkalosis), pseudo-Bartter syndrome (metabolic disorder that can occur due to misuse and/or prolonged use of furosemide)
• Dizziness, fainting, loss of consciousness (caused by symptomatic hypotension)
• Thrombosis
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms)
• Lichenoid reaction (red or purple rash with itching)
• Severe muscle problems (rhabdomyolysis)
• Urinary retention
• In premature babies, nephrocalcinosis (calcium deposits in the kidney) / nephrolithiasis (kidney stones), increased risk of persistent ductus arteriosus (blood vessel that connects the pulmonary artery to the aorta and closes at birth).
• Kidney failure
• Increased sodium and chloride in urine.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Salidur

No special storage conditions are required.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Salidur

• The active ingredients are furosemide (as xantinol) and triamterene. Each tablet contains 77.6 mg of furosemide (as xantinol) and 25 mg of triamterene.
• The other ingredients are microcrystalline cellulose (E-460), hydroxypropylcellulose (E-463), carboxymethyl starch, colloidal silicon dioxide (E-551), sodium stearyl fumarate, and ethanol.

Appearance of the product and packaging contents

Salidur tablets are circular, flat, beveled, with a central score line on the upper surface and are yellow in color.

Salidur is available in packs of 20 or 60 scored tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Almirall, S.L.

General Mitre, 151

08022 Barcelona (Spain)

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca - Barcelona (Spain)

Date of last revision of this package leaflet: April 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/