Losazid

Italy
Brand name Losazid
Form tablets, film-coated
Active substance / Dosage
LOSARTAN POTASSICO
HYDROCHLOROTHIAZIDE
Prescription type Prescription only
ATC code
C09DA01
Registration number 031497
Manufacturer ALFASIGMA S.P.A.

Table of Contents

Patient Information Leaflet: Information for the patient

Losazid

losartan potassium/hydrochlorothiazide
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losazid is and what it is used for

Losazid contains the active substances losartan potassium and hydrochlorothiazide.
Losartan belongs to a group of medicines known as angiotensin II receptor antagonists, and
hydrochlorothiazide is a diuretic.
Losazid works by dilating blood vessels, thereby lowering blood pressure.
Hydrochlorothiazide works by increasing the elimination of water and salts through the kidneys, thus helping to reduce blood pressure.
Losazid is indicated for the treatment of high blood pressure (essential hypertension) in patients whose blood pressure is not adequately controlled with losartan or hydrochlorothiazide alone.

2. What you need to know before taking Losazid

Do not take Losazid

  • if you are allergic to losartan, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; ask your doctor if you are unsure)
  • if you have severe impairment of liver function (cholestasis and obstructive biliary disorders)
  • if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected with specific treatment
  • if you have gout
  • if you are pregnant (see section “Pregnancy and breastfeeding”)
  • if you have severe impairment of kidney function
  • if you are not passing urine
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Losazid. Contact your doctor if, after taking
Losazid, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether
treatment should continue. Do not stop taking Losazid on your own.
Inform your doctor before taking Losazid:

  • if you have previously had swelling of the face, lips, throat, and/or tongue (angioedema)
  • if you are taking other medicines or supplements that retain potassium or may increase potassium levels (see section “Other medicines and Losazid”):
    o diuretics (medicines that increase the amount of water and salts excreted by the kidneys), particularly potassium-sparing diuretics, or potassium supplements, or potassium-containing salt substitutes
  • if you are on a low-sodium diet
  • if you have had or currently have severe, recurrent vomiting and/or diarrhoea
  • if you have or have had liver problems (see section 2 “Do not take Losazid”)
  • if you have or have had impaired kidney function (see section 2 “Do not take Losazid”)
  • if you have narrowing or blockage of blood vessels supplying the kidneys (bilateral renal artery stenosis or stenosis of the artery to a single kidney)
  • if you have recently undergone a kidney transplant
  • if you have heart failure
  • if you have a condition caused by reduced blood flow in the blood vessels of the heart (cardiovascular ischemic disease) or a condition caused by reduced blood circulation in the brain (cerebrovascular disease)
  • if you have narrowing of heart valves (mitral or aortic valve stenosis) or a condition causing thickening of the heart muscle (hypertrophic cardiomyopathy)
  • if you have diabetes, as your diabetes medication doses may need adjustment
  • if you have or have had an allergic condition, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus)
  • if you have a syndrome associated with increased secretion of the hormone aldosterone (primary hyperaldosteronism)
  • if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and Losazid”)
  • if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losazid.
  • if you experience vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours or weeks after starting Losazid. If not treated promptly, this condition may lead to permanent vision loss. If you are allergic to penicillin or sulfonamides, you may have a higher risk of developing choroidal effusion.
  • if you are taking any of the following medicines for high blood pressure:
    o an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes, or aliskiren.

Inform your doctor during treatment with Losazid:

  • if you are scheduled for a test to evaluate parathyroid function, as treatment with Losazid must be stopped before this test
  • if you develop allergic reactions, which may manifest as swelling of the face, lips, mouth, or throat.

Your doctor may monitor your kidney function, blood pressure, electrolyte levels (e.g. potassium), and blood levels of triglycerides and cholesterol at regular intervals.
See also the information under “Do not take Losazid.”
If you are of Black ethnicity, it is important to know that medicines such as losartan may be less effective in reducing blood pressure.

Children and adolescents
Do not give Losazid to children and adolescents.

Other medicines and Losazid
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), as combination with Losazid is not recommended.
Inform your doctor if you are taking the following medicines:

  • methyldopa or other blood pressure-lowering medicines, as they may further reduce blood pressure
  • antidepressants
  • medicines used for severe psychiatric disorders (antipsychotics), e.g.
    o thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol
  • barbiturates (medicines for epilepsy)
  • baclofen (a medicine to relax muscles)
  • amifostine (a medicine used to reduce side effects of certain cancer treatments or radiotherapy)
  • narcotics (medicines used to relieve pain)
  • medicines for diabetes, e.g.
    o insulin, metformin, or other oral antidiabetic medicines
  • antifungal medicines, e.g. fluconazole, or intravenous amphotericin B
  • antibiotics:
    o rifampicin, intravenous erythromycin, pentamidine
  • lithium (a medicine for mood disorders)
  • non-steroidal anti-inflammatory drugs (NSAIDs), e.g. acetylsalicylic acid
  • cholestyramine and colestipol (medicines to lower blood cholesterol)
  • corticosteroids, adrenocorticotropic hormone (hormonal medicines)
  • adrenaline
  • muscle relaxants, e.g. tubocurarine
  • medicines for gout, e.g.
    o probenecid, sulfinpyrazone, allopurinol
  • atropine (a medicine used, for example, to dilate the eye pupil)
  • medicines for Parkinson’s disease:
    o biperiden, amantadine
  • anticancer medicines, e.g.
    o cyclophosphamide, methotrexate
  • cyclosporine (a medicine used to prevent transplant rejection)
  • medicines containing salicylates (e.g. acetylsalicylic acid)
  • digitalis glycosides, e.g. digoxin
  • medicines used to treat heart rhythm disorders, e.g.:
    o quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, bepridil, cisapride
  • difemanil (a medicine used to treat excessive sweating)
  • halofantrine (a medicine used to treat malaria)
  • mizolastine, terfenadine (antiallergic medicines)
  • intravenous vincamine (a medicine for cerebral ischemia)
  • calcium supplements
  • carbamazepine (a medicine for epilepsy and mood disorders)
  • laxatives
  • glycyrrhizin, a substance found in liquorice.

Your doctor may consider it necessary to adjust the dose and/or take other precautions:

  • if you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Losazid” and “Warnings and precautions”).

Diagnostic tests
Inform your doctor during treatment with Losazid:

  • if you are scheduled for a test to evaluate parathyroid function, as treatment with Losazid must be stopped before this test
  • if you are scheduled for a radiographic procedure involving iodine-containing contrast agents.

Losazid with food, drinks, and alcohol
Do not drink alcohol while taking Losazid tablets, as this may cause a marked drop in blood pressure, especially when standing up (orthostatic hypotension).
You may take Losazid with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you are pregnant or are planning a pregnancy, as they will prescribe a different medicine instead of Losazid.
Do not take Losazid during pregnancy unless your doctor considers it strictly necessary.
Breastfeeding
Inform your doctor if you are breastfeeding or are about to start breastfeeding. Do not take Losazid during breastfeeding unless your doctor considers it strictly necessary.
If you wish to breastfeed, your doctor may prescribe an alternative treatment to Losazid, particularly if your baby is a newborn or a premature infant.

Driving and using machines
Losazid may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. Therefore, exercise caution if you drive or operate machinery.

Losazid contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

Losazid contains potassium
This medicine contains potassium, less than 1 mmol (39 mg) per tablet, i.e. essentially “potassium-free.”

For those engaged in sports
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take Losazid

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losazid based on your condition and any other
medicines you may be taking.
It is important that you continue taking Losazid for as long as your doctor has instructed, as this will
keep your blood pressure under control.
Adults and Elderly
The recommended dose is 1 tablet of Losazid 50 mg + 12.5 mg daily.
In general, the blood pressure-lowering effect is achieved 3-4 weeks after starting treatment.
If necessary, your doctor may increase the dose to the maximum daily doses you can take:

  • 2 tablets of Losazid 50 mg + 12.5 mg daily, or
  • 1 tablet of Losazid 100 mg + 25 mg daily.

Special populations:
Do not take Losazid if you are undergoing haemodialysis.
How to take the tablets
You may take the tablets with or without food.
The film-coated tablets of Losazid 50 mg + 12.5 mg may have a score line on one
of the two sides of the tablet. The score line is intended to facilitate breaking the tablet if you have
difficulty swallowing it whole.
If you take more Losazid than you should
If you accidentally ingest an excessive dose of Losazid, contact your doctor immediately or go to the
nearest hospital.
Taking too much Losazid may cause:

  • low blood pressure
  • changes in heart rate
  • changes in blood electrolyte levels
  • dehydration due to excessive urine production.

If you forget to take Losazid
Take this medicine as prescribed by your doctor. However, if you miss your daily dose, skip the missed
tablet and take the next tablet at the usual time the following day.
Do not take a double dose to make up for the missed tablet.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you stop taking Losazid
Do not stop treatment with this medicine unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Losazid and consult your doctor immediately or go to the nearest hospital emergency
department if you experience symptoms of a severe allergic reaction, such as:

  • skin rash
  • itching
  • swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing. This is a serious side effect but occurs rarely, affecting up to 1 in 1,000 patients.

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

  • Cough, upper respiratory tract infection, nasal congestion, sinusitis, and other sinus disorders
  • Diarrhea, abdominal pain, nausea, indigestion
  • Muscle pain or cramps, leg pain, back pain
  • Insomnia, headache, dizziness
  • Weakness, fatigue, chest pain
  • Increased potassium levels
  • Decreased levels of blood cells (hematocrit) and hemoglobin levels
  • Impaired kidney function including kidney failure
  • Reduction in blood sugar levels (hypoglycemia).

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

  • Anemia
  • Red or brownish spots on the skin (sometimes mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain)
  • Bruising
  • Destruction of red blood cells in the blood
  • Reduction in white blood cells
  • Reduction in red blood cells in the blood
  • Reduction in the number of platelets in the blood
  • Increased levels of uric acid, gout
  • Increased blood sugar levels
  • Decreased levels of potassium and sodium in the blood
  • Slight increase in blood urea and creatinine levels
  • Loss of appetite, anxiety, nervousness, panic, confusion, depression, abnormal dreams, sleep disorders, insomnia, drowsiness, memory impairment
  • Tingling or "pins and needles" sensation, pain in extremities, tremor, migraine, fainting
  • Blurred vision, burning or pain in the eye, conjunctivitis, worsening of vision, seeing things in yellow
  • Ringing or buzzing in the ears, dizziness
  • Reduction in blood pressure, especially when standing up
  • Pain in the sternum, chest pain (angina pectoris), irregular heartbeat, heart attack, palpitations
  • Stroke (TIA, "mini-stroke")
  • Inflammation of blood vessels, sometimes associated with skin rash (necrotizing vasculitis)
  • Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, respiratory congestion
  • Constipation, persistent constipation, flatulence
  • Discomfort, stomach spasms, vomiting, dry mouth, inflammation of the salivary glands
  • Toothache
  • Yellowing of the skin, mucous membranes and eyes (jaundice), inflammation of the pancreas (pancreatitis)
  • Hives, itching, skin inflammation, skin rash, redness of the skin, photosensitivity, dry skin, sweating
  • Hair loss
  • Pain in arms, shoulders, hips, knees, bone, muscle and joint pain, joint swelling, stiffness, muscle weakness
  • Frequent urination, including at night, impaired kidney function including kidney failure, urinary tract infection, sugar in urine
  • Decreased sexual desire, erectile dysfunction/impotence
  • Facial swelling, localized swelling (edema), fever
  • Sexual dysfunction
  • Arrhythmias or irregular heartbeat
  • Depression
  • Skin rash
  • Blisters or vesicles on the skin (pseudoporphyria)
  • Dry mouth (xerostomia)
  • Pneumonia
  • Low blood pressure (hypotension)
  • Low levels of chloride in the blood (hypochloremia)
  • Low levels of magnesium in the blood (hypomagnesemia)
  • High levels of calcium in the blood (hypercalcemia)
  • Low concentrations of calcium in urine (hypocalciuria)
  • Decreased blood volume in the body (hypovolemia)
  • Dehydration
  • Increase in blood pH (metabolic alkalosis)
  • Inflammatory joint disease (gout)
  • Increased total cholesterol, LDL and VLDL in blood (hypercholesterolemia)
  • Increased triglycerides in blood (hypertriglyceridemia)

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

  • Inflammation of the liver (hepatitis)
  • Increased potassium levels in the blood (hyperkalemia)
  • Increased levels of alanine aminotransferase (ALT) in the blood, indicating liver damage
  • Allergic reactions, including severe reactions involving swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing
  • Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

  • Increased levels of certain liver enzymes indicating liver damage
  • Increased bilirubin levels.

Side effects with unknown frequency (the frequency cannot be determined from available data)

  • Flu-like symptoms
  • Impaired liver function
  • Unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis)
  • General feeling of being unwell (malaise)
  • Cutaneous lupus erythematosus
  • Taste disturbances (dysgeusia)
  • Dose-related effects on blood pressure
  • Reduced sodium levels in the blood (hyponatremia)
  • Skin and lip cancer (non-melanoma skin cancer)
  • Rapid-onset difficulty seeing distant objects (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losazid

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp".
The expiry date refers to the last day of the month.
Store in the original packaging to protect the medicine from light and moisture.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Losazid Contains

  • The active substances are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 50 mg of losartan potassium + 12.5 mg of hydrochlorothiazide or 100 mg of losartan potassium + 25 mg of hydrochlorothiazide.
  • The other components are microcrystalline cellulose (E460), lactose monohydrate, pregelatinized corn starch, magnesium stearate (E572), hydroxypropylcellulose (E463), hypromellose (E464), titanium dioxide (E171), quinoline yellow aluminum lake (E104), and carnauba wax (E903).

Description of the Appearance of Losazid and the Contents of the Package
Losazid 50 mg + 12.5 mg film-coated tablets
Available as yellow, oval, film-coated tablets, marked with "ST" on one side and a break line on the other side.
Losazid is packaged in blisters.
Each package of Losazid 50 mg + 12.5 mg film-coated tablets contains:
14 or 28 film-coated tablets.
Losazid 100 mg + 25 mg film-coated tablets
Available as light yellow, oval, film-coated tablets, marked with "ST" on one side and the other side smooth.
Losazid is packaged in blisters.
Each package of Losazid 100 mg + 25 mg film-coated tablets contains:
14 or 28 film-coated tablets.
Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)
Manufacturers
Doppel Farmaceutici Srl - Via Volturno, 48 - Quinto de’ Stampi - 20089 Rozzano (Milan)
Alfasigma S.p.A. - Via Pontina km 30,400 - 00071 Pomezia (RM)