PRECTIAZIDE 50 mg /12.5 Mg Film-Coated Tablets

Содержание инструкции

1. Prectiazide 50 mg + 12,5 mg film-coated tablets, 100 mg + 25 mg film-coated tablets
   1. What is Prectiazide and what is it used for
   2. Cosa deve sapere prima di prendere Prectiazide
   3. How to take Prectiazide
   4. Possible side effects
   5. How to store Prectiazide
   6. Package Contents and Other Information

Prectiazide 50 mg + 12,5 mg film-coated tablets, 100 mg + 25 mg film-coated tablets

Losartan potassium and hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Prectiazide and what is it 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 constriction of the blood vessel. This causes an increase in blood pressure. Losartan
prevents angiotensin II from binding to these receptors, causing relaxation of the blood vessels with
consequent lowering of blood pressure. Hydrochlorothiazide works by eliminating more water and salt through
the kidneys. This mechanism also helps to reduce blood pressure.
This medicine is indicated for the treatment of high blood pressure (essential hypertension), in
patients in whom blood pressure is not adequately controlled with losartan or hydrochlorothiazide alone.

2. Cosa deve sapere prima di prendere Prectiazide

Non prenda 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 derivatives (e.g. other thiazides, some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure);
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 a severe impairment of liver function and/or if you suffer from cholestasis (the flow of bile from the liver is impaired) or obstructive biliary disorders;
If you have high levels of uric acid in the blood (symptomatic hyperuricaemia/gout);
If you have a severe impairment of kidney function (i.e. creatinine clearance less than 30 ml/min)
If your kidneys do not produce urine (anuria);
If you suffer from diabetes mellitus or kidney problems (glomerular filtration rate GFR less than 60 ml/min/1.73 m²) and are taking medicines that lower blood pressure containing aliskiren (see section “Other medicines and Prectiazide”);
If you are pregnant for more than 3 months (it is best to avoid Prectiazide even in the early stages of pregnancy) (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Prectiazide.
Pay particular attention with Prectiazide and tell your doctor:
If you have suffered in the past from swelling of the face, lips, throat, and/or tongue (angioedema), as in this case you must be closely monitored during treatment with this medicine.
If you are taking diuretic medicines (to increase urine production), if you are following a low-salt diet or if you have had severe vomiting or diarrhoea; in this case you may experience a drop in blood pressure, especially after the first dose.
If you are being treated with diuretics that retain potassium (potassium-sparing diuretics) or with potassium supplements and salt substitutes containing potassium, as concomitant use with Prectiazide is not recommended (see section “Other medicines and Prectiazide”).
If you have low levels of potassium, if you are following a low-potassium diet or if you have high levels of calcium
If you suffer from or have suffered from mild to moderate liver dysfunction.
If you have a narrowing of the arteries of the kidneys (bilateral renal artery stenosis), if you have a single functioning kidney, or if you have recently had a kidney transplant.
If you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal glands, caused by an abnormality of the glands), as the use of Prectiazide tablets is not recommended in this case.
If you suffer from coronary heart disease (caused by reduced blood flow to the heart vessels) or cerebrovascular disease (caused by reduced blood flow to the brain), due to the risk of excessive lowering of blood pressure which in these cases can cause myocardial infarction or stroke.
If you suffer from 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 a narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
If you have problems with the heart valves or heart muscle (mitral and aortic valve stenosis, obstructive hypertrophic cardiomyopathy).
If you have diabetes, as treatment with this medicine may alter glucose tolerance. It may be necessary to adjust the dosage of antidiabetic medicines, including insulin. Latent diabetes mellitus may become manifest during therapy with this medicine.
If you have or have had an allergic disease, bronchial asthma or a disease that causes 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 the black population, compared to the non-black population (possibly due to a higher prevalence of low renin (an enzyme secreted by the kidney cells) conditions in the black population with high blood pressure).
If you need to undergo tests to check parathyroid function (see “Interactions with laboratory tests”).
If you need to have an anaesthetic (even from the dentist) or before a surgical operation
If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use of high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV radiation while taking Prectiazide
If you have a decrease in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to weeks after taking PRECTIAZIDE. If left untreated, these can lead to permanent vision loss. If you have previously experienced an allergy 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: o o an ACE inhibitor (e.g. enalapril, lisinopril and ramipril) especially if you have kidney problems related to diabetes; o o aliskiren If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing 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 should not be given 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 can interact with other medicines.Pay particular attention to the concomitant administration with:

• potassium-sparing diuretics (e.g. spironolactone, triamterene, amiloride) or other medicines that can increase serum potassium (e.g. medicines containing trimethoprim), potassium supplementsor salt substitutes containing potassium: may lead to an increase in potassium levels in the blood. Concomitant administration with Prectiazide is not recommended.
• lithium(used to treat some mental disorders): concomitant administration may increase lithium concentrations in the blood and cause toxicity. If concomitant administration of the two medicines cannot be avoided, take particular care and have frequent checks of lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs), such as COX-2 selective inhibitors (medicines that reduce inflammation and that can be used to relieve pain), acetylsalicylic acid (aspirin) at anti-inflammatory doses and non-selective NSAIDs, because they can decrease the effect of Prectiazide in reducing blood pressure. Concomitant use may lead to an increased risk of worsening renal function (including possible acute renal failure and an increase in potassium levels in the blood), especially if you have kidney problems. The combination should be administered with caution, especially if you are an elderly patient. During treatment you should be adequately hydrated and your doctor should consider monitoring your kidney function periodically.
• other medicines to lower blood pressure (ACE inhibitors, angiotensin II receptor antagonists and aliskiren): concomitant administration may further reduce blood pressure or cause other disorders, so your doctor may need to adjust the dose and/or take other precautions. Blood pressure may also be lowered by one of the following medicines/classes of medicines: tricyclic antidepressants(used for depression), antipsychotics(used for mental disorders), baclofen(used to relax muscles), amifostine(used in chemotherapy to treat cancer.
• sedative medicines (barbiturates, narcotics) or medicines against depression (antidepressants): potentiation of orthostatic hypotension (lowering of blood pressure that occurs when getting up from a lying or sitting position) may occur.
• medicines for diabetes(oral and insulin): glucose tolerance may be altered and an adjustment of the dosage of the antidiabetic medicine may be required. Metformin should be used with caution due to the risk of lactic acid accumulation in the blood (lactic acidosis).
• cholestyramineand colestipol(used to treat high cholesterol);
• medicines called pressor amines(e.g. adrenaline);
• medicines that relax muscles(e.g. tubocurarine);
• medicines used to treat gout(probenecid, sulfinpyrazone and allopurinol); the dosage of gout medicines may need to be adjusted, as Prectiazide may increase uric acid levels in the blood. Concomitant administration of Prectiazide may increase the incidence of allergic reactions to allopurinol. Concomitant treatment with cyclosporinemay increase the risk of high uric acid levels in the blood and gout-like complications.
• anticholinergic agents (e.g. atropine, biperidene);
• medicines for the treatment of tumors (e.g. cyclophosphamide, methotrexate); medicines for the treatment of arthritis
• salicylates(anti-inflammatory medicines) at high doses: Prectiazide may increase the toxic effect of salicylates on the central nervous system.
• methyldopa(another medicine for the treatment of high blood pressure): risk of hemolytic anemia (destruction of red blood cells).
• digitalis glycosides(medicines for the heart): the reduction in potassium or magnesium levels induced by Prectiazide may favor the onset of heart rhythm abnormalities induced by digitalis.
• calcium salts: if calcium supplements are to be prescribed, calcium levels in the blood should be monitored and the calcium dosage adjusted if necessary.
• carbamazepine(medicine for the treatment of epilepsy): risk of reduction in sodium levels in the blood.
• iodinated contrast media (used for diagnostic tests): in case of dehydration induced by Prectiazide, there is an increased risk of acute renal failure, especially with high doses of iodine-containing product. Patients should be rehydrated before administration.
• medicines for the treatment of fungal infections;
• opioids such as morphine;
• amphotericin Bparenterally, corticosteroids, ACTH(anti-inflammatory medicines) or stimulant laxativesor glycyrrhizin(found in licorice ): increased risk of imbalance of minerals in the body, especially reduction of potassium levels.

Periodic monitoring of blood potassium levels and ECG is recommended when Prectiazide is
administered with medicines affected by alterations in blood potassium levels (e.g. heart medicines
like digitalis glycosidesand antiarrhythmics) and with the following medicines that induce torsades de pointes
(ventricular tachycardia) (including some antiarrhythmics), as hypokalaemia (reduction of potassium levels
in the blood) is a predisposing factor to 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,
clomipramine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).
Others (e.g. bepridil, cisapride, difemanil, erythromycin IV, alofantrine, mizolastine, pentamidine,
terfenadine, vincamine IV).

Interactions with laboratory tests
This medicine may interfere with tests for parathyroid function. Tell your doctor
about taking Prectiazide as treatment needs to be stopped before performing parathyroid function tests.

Prectiazide with food and alcohol
Avoid consuming alcohol during treatment as it may cause a lowering of blood pressure
which manifests when getting up from a lying or sitting position (orthostatic hypotension) or
increase any other effect. A diet particularly rich in salts may counteract the effect of
Prectiazide tablets. Prectiazide can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice 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 pregnant
for more than three months, as it may cause serious harm to the baby if taken after the third month of
pregnancy. (see paragraph “Do not take Prectiazide”).
If you are planning a pregnancy, your doctor will advise you to stop treatment with Prectiazide and will
prescribe alternative antihypertensive treatment, with a proven safety profile for use in
pregnancy, unless it is considered essential to continue therapy with Prectiazide.
If you discover you are pregnant during treatment with Prectiazide, stop treatment and inform
your doctor immediately to start alternative therapy.

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

Driving and operating machinery
When you start treatment with this medicine, you should not undertake activities that require particular
attention (e.g., driving a car or operating dangerous machinery) until you know your
tolerance to the medicine.

For athletes
The use of the medicine without therapeutic need constitutes doping and may still result in positive
anti-doping tests

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

3. How to take Prectiazide

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The doctor will decide the appropriate dose of Prectiazide based on your condition and any concurrent use of
other medicines. Prectiazide should not be used as initial therapy, but only in cases where blood
pressure is not adequately controlled with losartan potassium or with hydrochlorothiazide (the two active ingredients
of Prectiazide) alone. It is important to continue taking Prectiazide for the entire duration of the medical
prescription, this will maintain stable control of high blood pressure.
Prectiazide film-coated tablets are available in 2 dosages: 50 mg + 12.5 mg (losartan 50
mg/hydrochlorothiazide 12.5 mg) and 100 mg + 25 mg (losartan 100 mg/hydrochlorothiazide 25 mg)

The recommended doseis 1 tablet of 50 mg/12.5 mg per day.
If you do not respond adequately to treatment with Prectiazide 50 mg + 12.5 mg, the dosage 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 a day.
In general, the antihypertensive effect is achieved within three to four weeks of starting therapy.
Take the tablets whole with a glass of water, even independently of meals.

Use in particular groups of patients:
If you have kidney problems: no dosage adjustment is necessary if you have a
moderate impairment of renal function (i.e. creatinine clearance 30-50 ml/min).
The use of Prectiazide is not recommended if you are undergoing blood dialysis and is absolutely
contraindicated if you have severe impairment of renal function (creatinine clearance less than
30 ml/min) (see “Do not take Prectiazide”).
If you have suffered excessive fluid loss from the body within the blood vessels or sodium: in
this case, the doctor must correct the volume and/or sodium reduction before administering
Prectiazide.
If you have liver problems: do not use Prectiazide if you have severe impairment of hepatic function (see
“Do not take Prectiazide”).
If you are an elderly person: usually no dosage adjustment is necessary.

If you take more Prectiazide than you should
In case of taking an excessive dose of Prectiazide, immediately inform your doctor or go to the
nearest hospital to receive immediate medical care.
Overdosage may cause a lowering of blood pressure, palpitations, slow pulse rate,
electrolyte imbalances in the blood, and dehydration.

If you forget to take Prectiazide
Do not take a double dose to make up for forgetting one or more 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: it may be necessary that
you continue therapy, even if you feel better.
If you have any doubts about the use of this medicine, ask 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 and contact your doctor
immediately or go to the nearest hospital emergency room: a severe allergic reaction (skin rash, itching,
swelling of the face, lips, mouth or throat that can cause difficulty swallowing or breathing). This is a
serious but rare side effect, occurring in more than 1 in 10,000 patients but in less than 1 in 1,000
patients. Immediate medical attention 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, sinus disorders
• abdominal pain, nausea, diarrhea, indigestion
• muscle pain or cramps, back or leg pain, chest pain
• asthenia, fatigue
• increased potassium levels (which can cause heart rhythm abnormalities), mild reduction in hemoglobin levels
• impaired kidney function, including renal failure
• low blood sugar (hypoglycemia)

Uncommon(may affect up to 1 in 100 people)

• anemia, bruising, purpura, red or brown spots on the skin (sometimes especially on the feet, legs, arms and buttocks), with joint pain and swelling of the hands and feet and stomach pain (Henoch-Schönlein purpura)
• destruction of red blood cells
• reduction in the number of white blood cells (agranulocytosis, leucopenia)
• reduction in the number of platelets (thrombocytopenia), blood clotting problems, reduction in the number of all types of cells (aplastic anemia)
• loss of appetite
• increased uric acid levels in the blood, gout
• mild increase in urea and creatinine levels in the blood
• increased blood sugar levels
• alteration of potassium and/or sodium levels in the blood
• nervousness, anxiety, anxiety-related disorders, panic, confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory impairment
• tingling or similar sensations, pain in the extremities, tremor, migraine, fainting
• blurred vision, burning or stinging in the eye, conjunctivitis, seeing things in yellow, worsening of vision
• ringing/whistling/noise in the ears, vertigo
• low blood pressure, which may be associated with changes in posture (feeling dizzy or weak when getting up)
• chest pain (sternalgia, angina pectoris)
• abnormal heartbeat, cerebrovascular events, heart attack, palpitations
• inflammation of blood vessels, sometimes associated with skin rash or bruising
• sore throat, inflammation of the pharynx or larynx, shortness of breath, bronchitis, pneumonia, water in the lungs (causing difficulty breathing)
• nosebleeds, runny nose, nasal congestion
• constipation, stubborn constipation, gas in the intestines, 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 loss, dermatitis, dry skin, skin redness, sensitivity to light, itching, rash, hives, sweating
• severe allergic skin reaction, potentially fatal (toxic epidermal necrolysis)
• pain in the arms, knees, hips, shoulders or other joints, pain, inflammation or swelling of the joints, numbness, muscle weakness
• frequent need to urinate, even at night, urinary tract infections, abnormal kidney function, including inflammation of the kidneys, reduced kidney function, presence of sugar in the urine
• decreased sexual desire, impotence
• swelling of the face, localized swelling (edema), fever

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

• severe allergic reactions with rapid onset (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 (hyperkalemia)

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(frequency cannot be estimated from available data)

• abnormality of liver function
• alterations in taste (dysgeusia)
• skin and lip cancer (non-melanoma skin cancer)
• Rapid-onset distant vision impairment (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).
• unexplained muscle pain with dark (tea-colored) urine (rhabdomyolysis)
• flu-like symptoms, malaise
• reduction in sodium levels in the blood
• cutaneous lupus erythematosus

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 sight and reach of children.
Do not use this medicine after the expiry date that is stated on the packaging after “Scad.”. The expiry
date refers to the last day of that month.
Store the medicine at a temperature not exceeding 30°C.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine in 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 ingredients 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 ingredients are: microcrystalline cellulose, lactose monohydrate, 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 ingredients 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 ingredients are: microcrystalline cellulose, lactose monohydrate, 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 package contents
Prectiazide is available as film-coated tablets:
Prectiazide 50 mg + 12.5 mg: yellow, round, biconvex film-coated tablets with a bar on one side
Prectiazide 100 mg + 25 mg: yellow, oblong, biconvex film-coated tablets with a bar on one side
The tablets are contained in opaque PVC/PE/PVDC and aluminum blisters.
Prectiazide 50 mg + 12.5 mg film-coated tablets contain 28 tablets.
Prectiazide 100 mg + 25 mg film-coated tablets contain 28 tablets.

Marketing Authorisation 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)