Patient Information Leaflet

Prectiazide 50 mg + 12.5 mg film-coated tablets, 100 mg + 25 mg film-coated tablets

Losartan potassium and hydrochlorothiazide
Generic medicine
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Prectiazide is and what it is used for
What you need to know before taking Prectiazide
How to take Prectiazide
Possible side effects
How to store Prectiazide
Contents of the pack and other information

1. What Prectiazide is and what it is used for

Prectiazide is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing blood vessel constriction. This leads to an increase in blood pressure. Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure. Hydrochlorothiazide works by increasing the excretion of water and salt through the kidneys. This mechanism also helps reduce blood pressure.
This medicine 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 Prectiazide

Do not take Prectiazide
If you are allergic to losartan and/or hydrochlorothiazide or to any of the other ingredients of this
medicine (listed in section 6);
If you are allergic to other sulfonamide-derived drugs (e.g. other thiazides, certain antibacterial agents such as co-
trimoxazole; consult your doctor if you are unsure);
If you have low levels of potassium or sodium (hypokalaemia/hyponatraemia) or high levels of calcium (hypercalcaemia) that
cannot be corrected with treatment;
If you have severe impairment of liver function and/or suffer from cholestasis (impaired bile flow from the
liver) or obstructive biliary disorders;
If you have high levels of uric acid in the blood (symptomatic hyperuricaemia/gout);
If you have severe impairment of kidney function (i.e. creatinine clearance less than 30
ml/min);
If your kidneys are not producing urine (anuria);
If you have diabetes mellitus or kidney problems (glomerular filtration rate GFR less than 60
ml/min/1.73 m²) and are taking blood pressure-lowering medicines containing
aliskiren (see section “Other medicines and Prectiazide”);
If you are more than 3 months pregnant (Prectiazide should also be avoided during early pregnancy) (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Prectiazide.
Be especially careful with Prectiazide and inform your doctor:
If you have previously experienced swelling of the face, lips, throat, and/or tongue (angioedema),
as you must be closely monitored during treatment with this
medicine.
If you are taking diuretic medicines (to increase urine production), are on a low-salt diet, or have recently experienced severe vomiting or diarrhoea; in such cases you may develop a drop in
blood pressure, especially after the first dose.
If you are being treated with potassium-sparing diuretics (potassium-sparing agents) or with
potassium supplements and potassium-containing salt substitutes, as concomitant use with Prectiazide
is not recommended (see section “Other medicines and Prectiazide”).
If you have low potassium levels, are on a low-potassium diet, or have high calcium levels.
If you have mild to moderate impairment of liver function or have had such impairment in the past.
If you have narrowing of the renal arteries (bilateral renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant.
If you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion
of the hormone aldosterone by the adrenal glands due to an adrenal gland abnormality),
as the use of Prectiazide tablets is not recommended in this case.
If you have coronary heart disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood circulation in the brain), due to the risk of excessive lowering of blood pressure, which may lead to myocardial infarction or stroke.
If you have heart failure, with or without impaired kidney function, due to the risk of severe reduction in blood pressure and kidney impairment (often acute).
If you have arterial narrowing (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
If you have heart valve or heart muscle problems (mitral or aortic valve stenosis, obstructive hypertrophic cardiomyopathy).
If you have diabetes, as treatment with this medicine may alter glucose tolerance. Adjustment of the dosage of antidiabetic medicines, including insulin, may be required. Latent diabetes mellitus may become apparent during treatment with this medicine.
If you have or have had allergic diseases, bronchial asthma, or a disease causing joint pain, skin redness, and fever (systemic lupus erythematosus).
If you have had gout.
If you are of Black race, as this medicine appears to be less effective in reducing blood pressure in Black populations compared to non-Black populations (possibly due to a higher prevalence of low-renin conditions (renin is an enzyme secreted by kidney cells) in Black individuals with high blood pressure).
If you need to undergo tests to monitor parathyroid function (see “Interactions with laboratory tests”).
If you need to take an anaesthetic (even from a dentist) or before undergoing surgery.
If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer).
Protect your skin from exposure to sunlight and UV rays during treatment with Prectiazide.
If you experience vision disturbances or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to weeks after taking
PRECTIAZIDE. If left untreated, these conditions may lead to permanent vision loss. If you previously had an allergic reaction to penicillin or sulfonamides, you may have a higher risk of developing this condition.

if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
- aliskiren
If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide.
If you develop shortness of breath or severe breathing difficulties after taking PRECTIAZIDE, consult a doctor immediately.

Children and adolescents
There is no experience regarding the use of Prectiazide in children and adolescents. Therefore, this
medicine must not be administered to children and adolescents.

Other medicines and Prectiazide
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Prectiazide may interact with other medicines. Be especially cautious when taking concomitantly with:

potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride) or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim), potassium supplements, or potassium-containing salt substitutes: may lead to increased potassium levels in the blood. Concomitant administration with Prectiazide is not recommended.
lithium (used to treat certain psychiatric disorders): concomitant use may increase lithium blood concentrations and cause toxicity. If concomitant administration cannot be avoided, exercise particular caution and undergo frequent monitoring of lithium blood levels.
Non-steroidal anti-inflammatory drugs (NSAIDs), such as selective COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), acetylsalicylic acid (aspirin) at anti-inflammatory doses, and non-selective NSAIDs, as they may reduce the blood pressure-lowering effect of Prectiazide. Concomitant use may lead to an increased risk of worsening kidney function (including possible acute kidney failure and increased blood potassium levels), especially if you have kidney problems. The combination should be administered with caution, particularly in elderly patients. During treatment, you should be adequately hydrated, and your doctor should consider periodic monitoring of kidney function.
other blood pressure-lowering medicines (ACE inhibitors, angiotensin II receptor antagonists, and aliskiren): concomitant use may further reduce blood pressure or cause other disturbances, so your doctor may consider dose adjustments and/or other precautions. Blood pressure may also be lowered by the following medicines/classes of medicines: tricyclic antidepressants (used for depression), antipsychotics (used for psychiatric disorders), baclofen (used to relax muscles), amifostine (used in chemotherapy for cancer treatment).
sedative medicines (barbiturates, narcotics) or medicines for depression (antidepressants): orthostatic hypotension (a drop in blood pressure upon standing from a lying or sitting position) may be enhanced.
medicines for diabetes (oral and insulin): glucose tolerance may be altered, and adjustment of antidiabetic medicine dosage may be required. Metformin should be used with caution due to the risk of lactic acid accumulation in the blood (lactic acidosis).
cholestyramine and colestipol (used to treat high cholesterol);
medicines called vasopressor amines (e.g. adrenaline);
muscle relaxants (e.g. tubocurarine);
medicines used to treat gout (probenecid, sulfinpyrazone, and allopurinol); dosage adjustment of gout medicines may be necessary, as Prectiazide may increase blood uric acid levels. Concomitant administration of Prectiazide may increase the incidence of allergic reactions to allopurinol. Concomitant treatment with cyclosporine may increase the risk of elevated blood uric acid levels and gout-like complications.
anticholinergic agents (e.g. atropine, biperiden);
medicines for cancer treatment (e.g. cyclophosphamide, methotrexate); medicines for arthritis treatment;
salicylates (anti-inflammatory medicines) at high doses: Prectiazide may increase the central nervous system toxic effects of salicylates.
methyldopa (another medicine for treating high blood pressure): risk of haemolytic anaemia (destruction of red blood cells).
digitalis glycosides (heart medicines): reduced potassium or magnesium levels induced by Prectiazide may promote digitalis-induced cardiac arrhythmias.
calcium salts: if calcium supplements are prescribed, blood calcium levels should be monitored and calcium dosage adjusted if necessary.
carbamazepine (a medicine for treating epilepsy): risk of reduced sodium levels in the blood.
iodinated contrast media (used in diagnostic imaging): in case of dehydration induced by Prectiazide, there is an increased risk of acute kidney failure, especially with high doses of iodinated agents. Patients should be rehydrated before administration.
medicines for fungal infections;
opioids such as morphine;
amphotericin B (an antibiotic) administered parenterally, corticosteroids, ACTH (medicines for inflammation), or stimulant laxatives or glycyrrhizin (found in liquorice): increased risk of electrolyte imbalance, particularly reduced potassium levels.

Periodic monitoring of blood potassium levels and ECG is recommended when Prectiazide is
administered with medicines affected by changes in blood potassium (e.g. heart medicines such as digitalis glycosides and antiarrhythmics) and with the following medicines that may induce torsades de pointes (ventricular tachycardia) (including some antiarrhythmics), as hypokalaemia (reduced blood potassium levels) is a predisposing factor for torsades de pointes (ventricular tachycardia):

Class Ia antiarrhythmics (e.g. quinidine, hydroquinidine, disopyramide).
Class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide).
Some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
ciamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).
Others (e.g. bepridil, cisapride, difemanil, intravenous erythromycin, halofantrine, mizolastine, pentamidine, terfenadine, intravenous vincamine).

Interactions with laboratory tests
This medicine may interfere with tests for parathyroid function. Inform your doctor that you are taking Prectiazide, as treatment must be discontinued before undergoing parathyroid function tests.

Prectiazide with food and alcohol
Avoid alcohol during treatment, as it may cause a drop in blood pressure upon standing from a lying or sitting position (orthostatic hypotension) or worsen other side effects. A diet particularly high in salt may counteract the effect of Prectiazide tablets. Prectiazide can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
The use of Prectiazide is not recommended during the first trimester of pregnancy.
Prectiazide is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause severe harm to the unborn child if taken after the third month of pregnancy (see section “Do not take Prectiazide”).
If you are planning a pregnancy, your doctor will advise you to stop treatment with Prectiazide and prescribe an alternative antihypertensive treatment with a well-established safety profile during pregnancy, unless continuation of Prectiazide therapy is considered essential.
If you discover you are pregnant while being treated with Prectiazide, stop taking the medicine immediately and inform your doctor to start an alternative therapy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Prectiazide is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.

Driving and using machines
When starting treatment with this medicine, do not perform activities requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.

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

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

3. How to take Prectiazide

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 Prectiazide based on your condition and any other
medicines you may be taking. Prectiazide must not be used as initial therapy, but only in cases where
blood pressure is not adequately controlled with losartan potassium or hydrochlorothiazide (the two active
substances in Prectiazide) alone. It is important to continue taking Prectiazide for the entire duration of the
prescribed treatment, as this will maintain stable control of high blood pressure.
Prectiazide film-coated tablets are available in 2 strengths: 50 mg + 12.5 mg (losartan 50
mg/hydrochlorothiazide 12.5 mg) and 100 mg + 25 mg (losartan 100 mg/hydrochlorothiazide 25 mg).
Recommended dose: One tablet of 50 mg/12.5 mg once daily.
If an adequate response is not achieved with Prectiazide 50 mg + 12.5 mg, the dose may be increased to the
maximum daily dose: 2 tablets of Prectiazide 50 mg/12.5 mg or 1 tablet of Prectiazide 100 mg + 25 mg, once daily.
In general, the antihypertensive effect is achieved within three to four weeks after starting treatment.
Swallow the tablets whole with a glass of water, with or without food.

Use in specific patient groups:
If you have kidney problems: no initial dose adjustment is necessary if you have moderate renal impairment
(i.e. creatinine clearance 30–50 ml/min).
The use of Prectiazide is not recommended if you are undergoing blood dialysis and is totally contraindicated
if you have severe renal impairment (creatinine clearance less than 30 ml/min) (see “Do not take Prectiazide”).
If you have experienced excessive loss of fluid in the blood vessels or sodium: in this case, your doctor must
correct the volume and/or sodium depletion before administering Prectiazide.
If you have liver problems: do not use Prectiazide if you have severe hepatic impairment (see “Do not take Prectiazide”).
If you are elderly: dose adjustment is usually not necessary.

If you take more Prectiazide than you should
If you take an excessive dose of Prectiazide, contact your doctor immediately or go to the nearest hospital to
receive immediate medical treatment.
Overdose may cause low blood pressure, palpitations, slow pulse rate, disturbances in blood electrolytes, and
dehydration.

If you forget to take Prectiazide
Do not take a double dose to make up for a missed tablet or tablets. Simply take the next dose at the usual time.

If you stop taking Prectiazide
If you wish to stop treatment, always consult your doctor first: you may need to continue therapy even if you feel well.
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 everyone gets them.

If you experience the following side effect, stop taking Prectiazide tablets immediately and contact your doctor or go to the nearest hospital emergency department: a severe allergic reaction (rash, itching, swelling of the face, lips, mouth or throat, which may cause difficulty swallowing or breathing). This is a serious but rare side effect, occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical intervention or hospitalization is required.

The following side effects may occur with Prectiazide:

Common (may affect up to 1 in 10 people)

insomnia
headache, dizziness
cough, upper respiratory tract infections, nasal congestion, sinusitis, nasal sinus disorders
abdominal pain, nausea, diarrhoea, indigestion
muscle pain or cramps, back or leg pain, chest pain
asthenia, fatigue
increased potassium levels (which may cause irregular heart rhythm), slight decrease in haemoglobin levels
impaired renal function, including kidney failure
low blood sugar (hypoglycaemia)

Uncommon (may affect up to 1 in 100 people)

anaemia, bruising, purpura, red or brown spots on the skin (sometimes mainly on the feet, legs, arms and buttocks), with joint pain and swelling of hands and feet and stomach pain (Henoch-Schönlein purpura)
destruction of red blood cells
reduced number of white blood cells (agranulocytosis, leucopenia)
reduced number of platelets (thrombocytopenia), coagulation problems, reduced number of all blood cells (aplastic anaemia)
loss of appetite
increased blood uric acid levels, gout
slight increase in blood urea and creatinine levels
increased blood sugar levels
changes in blood potassium and/or sodium levels
nervousness, anxiety, anxiety-related disorders, panic, confusion, depression, abnormal dreams, sleep disturbances, drowsiness, memory impairment
tingling or similar sensations, pain in extremities, tremor, migraine, fainting
blurred vision, burning or stinging pain in the eye, conjunctivitis, yellow vision (xanthopsia), worsening of vision
ringing, buzzing or other noises in the ears, dizziness
drop in blood pressure, which may be associated with changes in posture (feeling dizzy or weak when standing up)
chest pain (sternalgia, angina pectoris)
abnormal heartbeat, cerebrovascular events, heart attack, palpitations
inflammation of blood vessels, sometimes associated with rash or bruising
sore throat, pharyngitis or laryngitis, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties)
nosebleeds, runny nose, respiratory congestion
constipation, obstinate constipation, intestinal gas, gastritis, gastric spasms, stomach irritation, vomiting
inflammation of the salivary glands, dry mouth, toothache
yellowing of the skin and eyes (jaundice), inflammation of the pancreas (pancreatitis)
hair and scalp hair loss, dermatitis, dry skin, skin redness, light sensitivity, itching, rash, urticaria, sweating
severe, potentially life-threatening skin allergic reaction (toxic epidermal necrolysis)
pain in arms, knees, hips, shoulders or other joints, joint pain, inflammation or swelling, numbness, muscle weakness
frequent need to urinate, including at night, urinary tract infections, abnormal kidney function, including kidney inflammation, reduced kidney function, presence of sugar in urine
decreased sexual desire, impotence
facial swelling, localized swelling (oedema), fever

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

severe, rapidly occurring allergic reactions (anaphylactic reactions), swelling of the skin and mucous membranes (angioedema)
inflammation of the liver (hepatitis), abnormal liver function tests (increased ALT)
high potassium levels in the blood (hyperkalaemia)

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

increased liver enzymes and bilirubin
acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)

Frequency not known (the frequency cannot be determined from the available data)

liver function abnormalities
taste disturbances (dysgeusia)
skin and lip cancer (non-melanoma skin cancer)
sudden-onset difficulty seeing distant objects (acute myopia), decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis)
flu-like symptoms, malaise
decreased sodium levels in the blood
cutaneous lupus erythematosus

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. 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 Prectiazide

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp.”. The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 30°C.
Keep in the original packaging to protect the medicine from moisture.
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 Prectiazide contains
Prectiazide 50 mg + 12.5 mg

The active substances are losartan potassium and hydrochlorothiazide. Each tablet contains 50.00 mg of losartan potassium (equivalent to 45.76 mg of losartan and 4.24 mg of potassium, 0.108 mEq) and 12.50 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, magnesium stearate, macrogol/PEG 4000, hypromellose 3 cP/6 cP, titanium dioxide, yellow iron oxide (E172), indigo carmine (E132).

Prectiazide 100 mg + 25 mg

The active substances are losartan potassium and hydrochlorothiazide. Each tablet contains 100.00 mg of losartan potassium (equivalent to 91.52 mg of losartan and 8.48 mg of potassium, equivalent to 0.216 mEq) and 25.00 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, monohydrate lactose, pregelatinized corn starch, magnesium stearate, macrogol/PEG 4000, hypromellose 3 cP/6 cP, titanium dioxide, yellow iron oxide (E172), indigo carmine (E132).

Description of the appearance of Prectiazide and contents of the pack
Prectiazide is available as film-coated tablets:
Prectiazide 50 mg + 12.5 mg: yellow, round, biconvex film-coated tablets with a score line on one side
Prectiazide 100 mg + 25 mg: yellow, oval, biconvex film-coated tablets with a score line on one side
The tablets are contained in opaque PVC/PE/PVDC and aluminum blisters.
Prectiazide 50 mg + 12.5 mg film-coated tablets pack contains 28 tablets.
Prectiazide 100 mg + 25 mg film-coated tablets pack contains 28 tablets.
Marketing Authorization Holder
I.B.N. Savio s.r.l. – Via del Mare, 36 – Pomezia (RM)
Manufacturer
Special Product’s Line Spa – Via Fratta Rotonda Vado Largo 1 – 03012 Anagni (FR)