Losartan and hydrochlorothiazide PensA: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

LOSARTAN and HYDROCHLOROTHIAZIDE PENSA 50 mg + 12.5 mg film-coated tablets, 100 mg + 25 mg film-coated tablets

losartan potassium and hydrochlorothiazide

Read 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What LOSARTAN AND HYDROCHLOROTHIAZIDE PENSA is and what it is used for

LOSARTAN AND HYDROCHLOROTHIAZIDE PENSA 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 the blood vessels to narrow. 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 a consequent reduction in blood pressure.
Hydrochlorothiazide works by increasing the amount of water and salt excreted through the kidneys. This mechanism also helps to reduce blood pressure.
LOSARTAN AND HYDROCHLOROTHIAZIDE PENSA is indicated for the treatment of essential hypertension (high blood pressure).

2. What you should know before taking LOSARTAN and HYDROCHLOROTHIAZIDE PENSA

Do not take LOSARTAN and HYDROCHLOROTHIAZIDE PENSA

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 drugs such as co-trimoxazole; ask your doctor if you are unsure);
if you are more than three months pregnant. It is best to avoid LOSARTAN and HYDROCHLOROTHIAZIDE PENSA even in the early stages of pregnancy (see section “Pregnancy”);
if you have severe impairment of liver function;
if you have severe impairment of kidney function or if your kidneys do not produce urine;
if you have low potassium levels, low sodium levels, or high calcium levels that cannot be corrected by treatment;
if you suffer from gout;
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, pharmacist, or nurse before taking Losartan and hydrochlorothiazide Pensa
You must inform your doctor if you think you may be pregnant (or if there is any possibility of becoming pregnant).
LOSARTAN and HYDROCHLOROTHIAZIDE PENSA is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see “Pregnancy”).
It is important to inform your doctor before using LOSARTAN and HYDROCHLOROTHIAZIDE PENSA:

if you have a history of swelling of the face, lips, throat, and/or tongue;
if you are taking diuretics (medicines that help increase urine production);
if you are on a low-salt diet;
if you have or have had severe vomiting and/or diarrhea;
if you have heart failure;
if liver function is impaired (see section 2 “Do not take LOSARTAN and HYDROCHLOROTHIAZIDE PENSA”);
if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant;
if you have narrowed arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
if you have 'mitral or aortic valve stenosis' (narrowing of heart valves) or 'hypertrophic cardiomyopathy' (a condition causing thickening of the heart muscle);
if you have diabetes;
if you have had gout;
if you have had allergic conditions, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus);
if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet;
if you are to receive an anesthetic (even from a dentist) or before surgery, or if you are scheduled for tests assessing parathyroid function, you must inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets;
if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland due to an abnormality of the gland);
if you are taking any of the following medicines used to treat high blood pressure:
- an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
- aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the section "Do not take Losartan and hydrochlorothiazide Pensa".
if you have previously had skin cancer or if you develop unexpected skin lesions 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 exposure to sunlight and UV radiation while taking LOSARTAN and HYDROCHLOROTHIAZIDE PENSA;
if you experience vision changes 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 several weeks after starting Losartan and hydrochlorothiazide Pensa. This may lead to permanent vision impairment if left untreated;
if you have previously experienced respiratory or lung problems (including lung inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking this medicine, consult a doctor immediately.

Other medicines and Losartan and hydrochlorothiazide Pensa
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 medicines, or other medicines that may increase serum potassium levels (e.g., medicines containing trimethoprim), as concomitant use with LOSARTAN and HYDROCHLOROTHIAZIDE PENSA is not recommended.
Your doctor may need to adjust your dose and/or take additional precautions if you are taking an ACE inhibitor or aliskiren (see also sections: "Do not take Losartan and hydrochlorothiazide Pensa" and "Warnings and precautions").
Diuretics such as hydrochlorothiazide contained in LOSARTAN and HYDROCHLOROTHIAZIDE PENSA may interact with other medicines. Lithium-containing preparations must not be taken with LOSARTAN and HYDROCHLOROTHIAZIDE PENSA without close medical supervision. Special precautionary measures (e.g., blood tests) may be necessary if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics (“medicines that increase fluid excretion through the kidneys”), certain laxatives, medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin).
It is also important for your doctor to know if you are taking:

other medicines to lower blood pressure;
steroids;
cancer medicines;
painkillers;
antifungal medicines;
medicines for arthritis;
cholesterol-lowering resins such as cholestyramine;
muscle relaxants, sedatives;
opioids such as morphine;
pressor amines such as adrenaline or similar medicines;
oral antidiabetic medicines or insulin;
medicines for Parkinson’s disease: amantadine.

Inform your doctor that you are taking LOSARTAN and HYDROCHLOROTHIAZIDE PENSA even when planning to use iodinated contrast agents.

Use of LOSARTAN and HYDROCHLOROTHIAZIDE PENSA with food and drinks
You are advised not to drink alcoholic beverages while taking these tablets: alcohol and LOSARTAN and HYDROCHLOROTHIAZIDE PENSA tablets may enhance each other's effects.
A diet particularly rich in salt may counteract the effect of LOSARTAN and HYDROCHLOROTHIAZIDE PENSA tablets.
LOSARTAN and HYDROCHLOROTHIAZIDE PENSA may be taken with or without food.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is any possibility of becoming pregnant). Your doctor will usually advise you to stop taking LOSARTAN and HYDROCHLOROTHIAZIDE PENSA before starting pregnancy or as soon as you find out you are pregnant, and will recommend an alternative medicine. LOSARTAN and HYDROCHLOROTHIAZIDE PENSA is not recommended during pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. LOSARTAN and HYDROCHLOROTHIAZIDE PENSA is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.

Use in children and adolescents
There is no experience with the use of LOSARTAN and HYDROCHLOROTHIAZIDE PENSA in children. Therefore, LOSARTAN and HYDROCHLOROTHIAZIDE PENSA must not be administered to children or adolescents.

Use in elderly patients
LOSARTAN and HYDROCHLOROTHIAZIDE PENSA works in the same way and is equally well tolerated in most elderly and younger adult patients. Most elderly patients require the same dosage as younger patients.

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

Important information on some excipients of LOSARTAN and HYDROCHLOROTHIAZIDE PENSA
LOSARTAN and HYDROCHLOROTHIAZIDE PENSA contains lactose. If your doctor has told you that you have an intolerance to certain sugars, speak with your doctor before taking this medicine.
LOSARTAN and HYDROCHLOROTHIAZIDE PENSA contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially ‘sodium-free’.
For individuals 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 LOSARTAN and HYDROCHLOROTHIAZIDE PENSA

Always take LOSARTAN and HYDROCHLOROTHIAZIDE PENSA exactly as your doctor or pharmacist has instructed. Your doctor will determine the appropriate dose of LOSARTAN and HYDROCHLOROTHIAZIDE PENSA based on your condition and any other medicines you may be taking. It is important to continue taking LOSARTAN and HYDROCHLOROTHIAZIDE PENSA for the entire duration prescribed by your doctor, as this will ensure consistent control of your high blood pressure.

High blood pressure
The usual dose for most patients with high blood pressure is 1 tablet of LOSARTAN and HYDROCHLOROTHIAZIDE PENSA 50 mg + 12.5 mg once daily to maintain blood pressure control over 24 hours. The dose may be increased to 2 tablets of Losartan/Hydrochlorothiazide 50 mg + 12.5 mg film-coated tablets once daily or adjusted to 1 tablet daily of Losartan/Hydrochlorothiazide 100 mg + 25 mg film-coated tablets (a higher strength). The maximum daily dose is 2 tablets of Losartan/Hydrochlorothiazide 50 mg + 12.5 mg film-coated tablets per day or 1 tablet per day of Losartan/Hydrochlorothiazide 100 mg + 25 mg film-coated tablets.

Administration
The tablets should be swallowed whole with a glass of water.

If you take more LOSARTAN and HYDROCHLOROTHIAZIDE PENSA than you should
In case of overdose, contact your doctor immediately to receive prompt medical treatment. Overdose may cause low blood pressure, palpitations, slow pulse rate, disturbances in blood electrolytes, and dehydration.

If you forget to take LOSARTAN and HYDROCHLOROTHIAZIDE PENSA
Try to take LOSARTAN and HYDROCHLOROTHIAZIDE PENSA once daily as prescribed. However, if you miss a dose, do not take a double dose. Skip the missed tablet and take the next tablet at the usual time on the following day.

4. Possible side effects

Like all medicines, LOSARTAN and HYDROCHLOROTHIAZIDE PENSA can cause side effects,
although not everyone gets them.
If you experience the following side effect, stop taking LOSARTAN and HYDROCHLOROTHIAZIDE PENSA tablets and contact your doctor immediately 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 have been reported:

Common (may affect up to 1 in 10 people):

cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal sinus disorders;
diarrhoea, abdominal pain, nausea, indigestion;
muscle pain or cramps, leg pain, back pain;
insomnia, headache, dizziness;
weakness, fatigue, chest pain;
increased potassium levels (which may cause abnormal heart rhythm), decreased haemoglobin levels;
changes in kidney function including renal failure;
low blood sugar (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people):

anaemia, red or brownish spots on the skin (sometimes mainly on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, reduced white blood cells, coagulation problems, reduced platelet count;
loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels;
slight increase in blood urea and serum creatinine levels;
anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, dream abnormalities, sleep disturbances, insomnia, memory impairment;
sensation of pins and needles or similar feeling, pain in extremities, tremor, migraine, fainting;
blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, seeing things in yellow;
sensation of hearing a sound, ringing, buzzing or clicking noises in the ears, dizziness;
low blood pressure (hypotension), which may be associated with postural changes (feeling lightheaded or weak when standing up), angina (chest pain), arrhythmias or irregular heartbeat, cerebrovascular accident (TIA, "mini-stroke"), heart attack, palpitations;
inflammation of blood vessels, often associated with skin rash and bruising;
sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleeds, runny nose, congestion;
constipation, obstinate constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth (dryness of mouth), inflammation of the salivary glands, toothache;
jaundice (yellowing of the eyes and skin), inflammation of the pancreas;
urticaria, itching, skin inflammation, rash, blisters or bullae on the skin (pseudoporphyria), redness of the skin, photosensitivity, dry skin, hot flushes, sweating, hair loss;
pain in arms, shoulders, hips, knees or joints, numbness, muscle weakness;
frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine;
decreased sexual desire, sexual dysfunction;
facial swelling, localized swelling (oedema), fever;
low blood chloride levels (hypochloraemia);
low blood magnesium levels (hypomagnesaemia);
high blood calcium levels (hypercalcaemia);
low calcium concentrations in urine (hypocalciuria);
decreased blood volume in the body (hypovolaemia);
dehydration;
increased blood pH (metabolic alkalosis);
inflammatory joint disease (gout);
increased total cholesterol, LDL and VLDL in blood (hypercholesterolaemia);
increased triglycerides in blood (hypertriglyceridaemia).

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

hepatitis (inflammation of the liver), abnormalities in liver function tests.

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

acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data):

flu-like symptoms;
unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis);
low sodium levels in blood (hyponatraemia);
general feeling of being unwell (malaise);
altered taste (dysgeusia);
skin and lip cancer (non-melanoma skin cancer);
sudden-onset difficulty seeing at a distance (acute myopia), decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)) or acute angle-closure glaucoma;
cutaneous lupus erythematosus (an autoimmune inflammatory disease affecting the skin).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to 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 LOSARTAN AND HYDROCHLOROTHIAZIDE PENSA

Keep out of the sight and reach of children.
Do not use LOSARTAN AND HYDROCHLOROTHIAZIDE PENSA after the expiry date stated on the carton
after EXP. The expiry date refers to the last day of the month.
Store below 25°C. Keep in the original packaging to protect the medicine from light.
Medicines should not be disposed of 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 Losartan Hydrochlorothiazide Pensa contains
The active substances are losartan potassium and hydrochlorothiazide.
Losartan Hydrochlorothiazide Pensa 50 mg/12.5 mg
Each tablet contains 50 mg of losartan potassium, equivalent to 45.8 mg of losartan, and 12.5 mg of
hydrochlorothiazide.
Losartan Hydrochlorothiazide Pensa 100 mg/25 mg
Each tablet contains 100 mg of losartan potassium, equivalent to 91.6 mg of losartan, and 25 mg of
hydrochlorothiazide.
The excipients are: microcrystalline cellulose (E460), lactose monohydrate, pregelatinized corn starch,
sodium glycolate starch Type A, magnesium stearate (E572), hydroxypropylcellulose (E463),
hydroxypropylmethylcellulose 6cP (E464), titanium dioxide (E171).

Description of the appearance of Losartan Hydrochlorothiazide Pensa and package contents
50 mg/12.5 mg: white, oblong, biconvex tablets measuring approximately 13.7 × 6.7 mm, with a break line on both sides.
The score line on the tablet is intended to facilitate swallowing by making the tablet easier to break, and is not intended to divide the tablet into equal doses.
100 mg/25 mg: white, oblong, biconvex tablets measuring approximately 15.3 × 6.7 mm, with a break line on both sides.
The tablet can be divided into two equal halves.
The tablets are available in PVC/PE/PVDC/AL blisters.
Pack sizes: 28 film-coated tablets

Marketing Authorization Holder and Manufacturer:
Marketing Authorization Holder
Towa Pharmaceutical S.p.A.
Via Enrico Tazzoli 6,
20154 – Milan
Italy

Manufacturer:
PharmaPath S.A.
28is Oktovriou 1, Agia Varvara,
123 51, Greece

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Italy: Losartan and Hydrochlorothiazide Pensa 50 mg + 12.5 mg film-coated tablets
Losartan and Hydrochlorothiazide Pensa 100 mg + 25 mg film-coated tablets

This patient information leaflet was last approved on