Package Insert: Information for the User

Salidur 77.6 mg / 25 mg Tablets

furosemide xantinol/triamterene

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.What Salidur is and for what it is used

2.What you need to know before starting to take Salidur

3.How to take Salidur

4.Possible adverse effects

5.Storage of Salidur

6.Contents of the package and additional information

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

It is indicated for:

• those cases in which edemas, i.e., swellingdue to fluid retention,which iscommonly found in the legs.
• the treatment of high blood pressure (hypertension).

Do not take Salidur

-If you are allergic to furosemide (such as xanthinol), triamterene, sulfonamide antibiotics, 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 or are not urinating
• If you have blood abnormalities such as: low sodium, potassium, and/or decreased blood volume with or without hypotension (low blood pressure)
• If you have high potassium levels in the blood with or without hypotension
• If you are breastfeeding a baby (see "Pregnancy and lactation" section).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Salidur.

• If you have hypotension, diabetes (high blood sugar), severe heart failure, hyperuricemia (elevated uric acid), gout, kidney insufficiency associated with severe liver problems, (nephrolithiasis or nephrocalcinosis in premature newborns) or any ear disorder, 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 at any time.

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

During your treatment with this medication, you will usually require regular monitoring of your blood levels of sodium, potassium, and creatinine, and especially if you experience severe fluid loss, vomiting, diarrhea, or intense sweating (dehydration or hypovolemia), your doctor may require you to stop treatment.

If you are receiving a contrast radiological test while taking furosemide, 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 used recently, or may need to use any other medication, and in particular if you are taking:

• Aminoglycoside antibiotics (medications used to treat some infections) such as gentamicin, especially if you are taking high doses of Salidur.

• Nonsteroidal anti-inflammatory drugs (medications used to treat pain and inflammation) such as aspirin, flurbiprofen, indomethacin, naproxen, piroxicam.
• Cephalosporins (medications used to treat some infections) such as cefaloridine, cefalotin.
• Corticosteroids (medications that reduce inflammation and the body's defenses) such as cortisone, hydrocortisone, carbenoxolone.
• Digitals (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 ulcers and duodenal ulcers, acid reflux, and other conditions).
• Lithium salts (medication used to treat a type of depression).
• Curare-type muscle relaxants.
• 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 antidiabetic medications and sympathomimetic medications may be reduced.

Significant amounts of licorice and prolonged use of laxatives may increase the risk of hypokalemia.

The administration of Salidur with any of these medications may modify the action and/or increase the adverse effects of Salidur or the other medications.

You should 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 cholesterol HDL, LDL, 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 lactation

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

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

Children and adolescents

Salidur should not be used in children.

Use in patients over 65 years

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

Use in athletes

It is reported to athletes that this medication contains a component that may produce a positive result in doping control tests.

Driving and operating machinery

This medication may cause dizziness or fainting. This may occur more frequently at the beginning of treatment, so it is not recommended to drive or operate machinery during the first weeks.

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".

Follow exactly the administration instructions of this medication 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 with an empty stomach (see sectionSalidur intake with food and beverages).

The dose ofSalidurmust be the one indicated by your doctor and at the hours he tells you 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 is1 to2 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 patients over 65 years old

Your doctor should adjust the dose ofSalidur, especiallyif you are elderly and have any kidney disease.

Use in patients with any kidney disease

You should not take Salidur if you have severe kidney failure, as its use is contraindicated in these cases (see sectionDo not take Salidur).

If you have less severe kidney disease, your doctor should adjust your dose ofSalidur.

Use in patients with any liver disease

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

If you have less severe liver disease, your doctor should adjust your dose ofSalidur.

If you estimate that 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 experience blood abnormalities (electrolyte disorders, metabolic alkalosis, anemia), digestive abnormalities (vomiting) or skin abnormalities (rashes).

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 Toxicological Information Service, phone915 620 420, indicating the medication and the amount ingested.

If you forget to take Salidur

Do not take a double dose to compensate for the missed 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 interrupt treatment with Salidur

Do not stop treatment before your doctor tells you, as you will not achieve the expected results.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects thathave been observed withSalidurare as follows:

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

• Electrolyte imbalances, dehydration, hypovolemia, hyperkalemia.

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

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

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

• Decreased platelet levels (thrombocytopenia).
• Increased calcium in urine
• Glucose intolerance due to decreased potassium levels
• Gout
• Headache
• Transient ear disorders, cases of deafness (sometimes irreversible)
• Digestive disturbances (nausea, dry mouth)
• Skin alterations (pruritus, urticaria, rashes, dermatitis, erythema multiforme, pemphigoid, dermatitis exfoliativa, purpura, photosensitivity reactions, rash)
• Transient renal insufficiency
• Increased creatinine
• Decreased HDL cholesterol and increased LDL cholesterol and triglycerides in the blood.

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

• Blood alterations (decreased leukocytes and eosinophils)
• Abnormal sensation of tingling
• Abnormal sensation of ringing in the ears
• Vascular inflammation
• Vomiting, diarrhea, constipation, anorexia.
• Liver enzyme defects (pseudoporphyria)
• Renal inflammation (tubulointerstitial nephritis), urinary stones
• Fever.

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

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

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

• Lupus Erythematosus (a 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 alkalinity in tissues or blood (metabolic alkalosis), pseudo-Bartter syndrome (a metabolic disorder that may occur due to misuse or prolonged use of furosemide)
• Dizziness, fainting, loss of consciousness (caused by symptomatic hypotension)
• Thrombosis
• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized acute pustular exanthema, drug-induced rash with eosinophilia and systemic symptoms)
• Lichenoid reaction (red or purple rash with itching)
• Severe muscle problems (rhabdomyolysis)
• Urinary retention
• Calcification in the kidneys (nephrocalcinosis) and kidney stones (nephrolithiasis) in premature babies, increased risk of persistent patent ductus arteriosus (a blood vessel that connects the pulmonary artery to the aorta and closes at birth)
• Renal insufficiency
• Increased sodium and chloride in urine.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This product does not require special conditions for conservation.

Keep this medication out 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.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Salidur

• The active principles are furosemide (as xanthan gum) and triamterene. Each tablet contains 77.6 mg of furosemide (as xanthan gum) and 25 mg of triamterene.
• The other components aremicrocrystalline cellulose(E-460),hydroxypropyl cellulose (E-463), carboxymethyl starch, colloidal silica(E-551),sodium stearoylfumarate and ethanol.

Appearance of the product and content of the packaging

Salidur tablets areround, flat, bisected, with a central groove on the upper face and yellow in color.

Saliduris presentedin packaging of 20 or 60 scored tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Almirall, S.L.

General Mitre, 151

08022 Barcelona (Spain)

Responsible for manufacturing

IndustriasPharmaceuticals Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreudela Barca- Barcelona (Spain)

Last review date of this leaflet: April 2024

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/