Salidur 77.6 mg/25 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Salidur 77.6 mg / 25 mg tablets

xanthinol furosemide/triamterene

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Leaflet contents:

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 adverse effects
5. How to store Salidur
6. Contents of the pack and other information

1. What Salidur is and what it is used for

Salidur is a medicine belonging to the group of diuretics (medicines that promote the elimination of urine) and contains a combination of two active substances (furosemide and triamterene).

It is indicated for:

• cases involving edema, that is, swelling due to fluid retention, which commonly occurs in the legs.
• the treatment of high blood pressure (hypertension).

2. What you need to know before taking Salidur

Do not take Salidur

• If you are allergic to xanthinol furosemide, triamterene, antibiotics of the sulfonamide group, or to any of the other ingredients of this medicine (listed in section 6).
  • If you have liver problems affecting the nervous system (hepatic coma)
  • If you have severe kidney disease (severe renal failure) or are not passing urine
  • If you have blood disorders such as low levels of sodium, potassium, and/or reduced blood volume with or without hypotension (low blood pressure)
  • If you have high levels of potassium in your blood with or without hypotension
  • If you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Salidur.

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

Consult your doctor before taking Salidur, even if any of the above conditions occurred in the past.

• If you have benign prostatic hyperplasia (enlarged prostate) or difficulty urinating. In such cases, this medicine should be used with caution, as it may cause urinary retention.
• If you have any liver or kidney disease, as your doctor may need to adjust your dose.
• If you are elderly, if you are being treated with medicines that may lower blood pressure, or if you have other medical conditions associated with a risk of low blood pressure.
• If you have a condition called systemic lupus erythematosus, as it may become activated or worsen.

During treatment with this medicine, periodic monitoring of blood levels of sodium, potassium, and creatinine is generally required. This is especially important if you experience significant fluid loss due to vomiting, diarrhea, or excessive sweating (dehydration or hypovolemia), in which case your doctor may need to interrupt treatment.

If you are scheduled to undergo a radiographic contrast procedure while being treated with furosemide, consult your doctor, as you may experience worsening of kidney function.

Other medicines and Salidur

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines, and particularly if you are taking:

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

• Non-steroidal anti-inflammatory drugs (medicines used to treat pain and inflammation) such as acetylsalicylic acid, flurbiprofen, indomethacin, naproxen, piroxicam.

• Cephalosporins (medicines used to treat certain infections) such as cephaloridine, cephalothin.

• Corticosteroids (medicines that reduce inflammation and immune system activity) such as cortisone, hydrocortisone, carbenoxolone.

• Digitalis preparations (medicines used to treat certain heart conditions) such as digoxin.

• Angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat high blood pressure) such as enalapril, captopril, or angiotensin receptor antagonists.

• Aliskiren (a medicine used to treat high blood pressure).

• Potassium supplements, potassium-sparing diuretics such as amiloride or spironolactone.

• Ranitidine (a medicine used to treat stomach and duodenal ulcers, acid reflux, and heartburn).

• Lithium salts (a medicine used to treat a type of depression).

• Curare-type muscle relaxants.

• Theophylline (a medicine used to treat asthma).

• Risperidone (a medicine used to treat dementia).

• Cisplatin (a medicine used to treat certain types of cancer).

• Cyclosporine A (a medicine used to prevent transplant rejection).

• Levothyroxine (a medicine used to treat thyroid problems).

• Phenytoin (an antiepileptic medicine).

• Probenecid (a medicine used to treat gout).

• Methotrexate.

• Antidiabetic medicines (metformin, meglitinides, thiazolidinediones, alpha-glucosidase inhibitors) and sympathomimetic medicines (epinephrine and norepinephrine): The effect of antidiabetic and sympathomimetic medicines may be reduced.

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

Taking Salidur together with any of these medicines may alter its effect and/or increase the adverse effects of Salidur or of the other drugs.

You should never take another medicine on your own initiative without your doctor's recommendation, as some combinations should be avoided.

This medicine and sucralfate should not be taken together within less than a 2-hour interval, as the effect of Salidur may be reduced.

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

Triamterene may turn your urine blue.

Taking Salidur with food and drinks

It is recommended to take this medicine on an empty stomach, as its effect may be less than expected when taken with food.

Pregnancy and breastfeeding

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

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

Children and adolescents

Salidur must not be used in children.

Use in patients over 65 years of age

Elderly patients have an increased risk of adverse reactions and dehydration due to the use of this medicine; therefore, Salidur should be used with caution in these patients (see section “How to take Salidur”).

Use in athletes

Athletes are advised that this medicine contains a component that may cause a positive result in doping control tests.

Driving and operating machinery

This medicine may cause dizziness or fainting. This is more likely to occur at the beginning of treatment; therefore, driving or operating machinery is not recommended during the first few weeks.

Salidur contains ethanol and sodium

This medicine contains 7% ethanol (alcohol); this small amount corresponds to 16 mg per tablet.

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

3. How to take Salidur

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

Your doctor will indicate how long your treatment with Salidur should last. Do not use it for longer than indicated by your doctor.

This medicine is for oral use. 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 must be the one prescribed by your doctor and taken at the times indicated by your doctor according to your individual needs. It is recommended to use the lowest dose sufficient to achieve the desired effect.

In severe cases, the maximum daily dose must 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 patients over 65 years of age

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

Use in patients with kidney disease

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

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

Use in patients with liver disease

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

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

If you think that the effect 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 disturbances, metabolic alkalosis, anemia), digestive disturbances (vomiting), or skin reactions (rashes).

Contact your doctor or pharmacist immediately, indicating the medicine and the amount taken.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately and call the Toxicology Information Service at telephone number 915 620 420, stating the medicine and the amount taken.

If you forget to take Salidur

Do not take a double dose to make up for 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 so that they can advise you on the dosing regimen to follow until you reach your maintenance dose.

If you stop taking Salidur

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The adverse effects observed with Salidur are as follows:

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

• Electrolyte disturbances, dehydration, hypovolemia, hyperkalemia.

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

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

Uncommon adverse 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 reactions (pruritus, urticaria, rashes, bullous dermatitis, pemphigoid multiforme erythema, exfoliative dermatitis, purpura, photosensitivity reactions, eruption)
• Transient renal failure
• Increased creatinine
• Decreased HDL cholesterol and increased LDL cholesterol in blood, elevated serum triglycerides.

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

• Blood disorders (decreased leukocytes and eosinophils)
• Abnormal sensation of tingling
• Ringing sensation in the ears (tinnitus)
• Inflammation of blood vessels
• Vomiting, diarrhea, constipation, anorexia
• Liver enzyme deficiency (pseudoporphyria)
• Kidney inflammation (tubulointerstitial nephritis), urinary stones
• Fever

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

• Blood and lymphatic system disorders: decrease in a type of white blood cells (agranulocytosis), decreased number of 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

Adverse effects with unknown frequency (cannot be estimated from available data)

• Lupus Erythematosus (a disease causing joint pain, skin rash, and fever)
• Severe allergic reactions (anaphylactic reactions)
• Decreased calcium levels in blood (hypocalcemia), decreased magnesium levels in blood (hypomagnesemia), increased blood urea, excessive alkalinity in tissues or blood (metabolic alkalosis), pseudo-Bartter syndrome (a metabolic disorder that may result from 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 (reddish or purple rash accompanied by itching)
• Severe muscle problems (rhabdomyolysis)
• Urinary retention
• In premature infants: nephrocalcinosis (calcium deposits in the kidney) / nephrolithiasis (kidney stones), increased risk of patent ductus arteriosus (a blood vessel connecting the pulmonary artery with the aorta in fetuses, which normally closes at birth)
• Renal failure
• Increased sodium and chloride in urine

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Salidur

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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Salidur

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

Appearance of the product and contents of the container

Salidur tablets are circular, flat, bevelled, with a central groove on the upper surface and yellow in colour.

Salidur is available in packs containing 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 the most recent review of this leaflet: April 2024

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