Alortia

Leaflet accompanying the packaging: patient information

Alortia, 50 mg + 5 mg, film-coated tablets

Alortia, 50 mg + 10 mg, film-coated tablets

Alortia, 100 mg + 5 mg, film-coated tablets

Alortia, 100 mg + 10 mg, film-coated tablets

Losartan potassium + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Alortia and what is it used for
• 2. Important information before taking Alortia
• 3. How to take Alortia
• 4. Possible side effects
• 5. How to store Alortia
• 6. Contents of the packaging and other information

1. What is Alortia and what is it used for

Alortia contains two active substances - losartan and amlodipine. Both substances help control high blood pressure.

• Losartan belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called calcium channel blockers. It blocks the entry of calcium ions into the cells of the blood vessel walls, which counteracts the narrowing of the vessels, and thus lowers blood pressure. The action of both substances prevents the narrowing of blood vessels, as a result of which the vessels relax, and blood pressure decreases.

Alortia is used to treat high blood pressure (hypertension) in patients who are already taking losartan and amlodipine in the same doses as in Alortia, instead of taking two separate medicines.

2. Important information before taking Alortia

When not to take Alortia

• if the patient is allergic to losartan, amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium channel blocker. Allergy may manifest as itching, redness of the skin or difficulty breathing;
• if the patient has very low blood pressure (hypotension);
• if the patient has narrowing of the aortic valve of the heart (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply blood in the amount required by the body);
• if the patient has heart failure after a heart attack;
• if the patient is pregnant over 3 months (it is also recommended to avoid taking Alortia in early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient has severe liver dysfunction;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting Alortia, discuss it with your doctor or pharmacist. Inform your doctor about pregnancy, suspected or planned pregnancy. It is not recommended to take Alortia in early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding"). Before taking Alortia, be sure to inform your doctor:

• if the patient has had angioedema (swelling of the face, lips, throat and/or tongue) in the past;
• if the patient has severe vomiting or diarrhea leading to significant loss of fluids and/or electrolytes;
• if the patient is taking diuretics (medicines that increase the amount of water excreted by the kidneys) or a low-salt diet, which can lead to excessive loss of fluids and electrolytes;
• if the patient has narrowing or blockage of the blood vessels leading to the kidneys or if the patient has recently had a kidney transplant;
• if the patient has liver dysfunction (see section 2 "When not to take Alortia");
• if the patient has heart failure with or without kidney dysfunction or severe, life-threatening heart rhythm disorders - special caution is required when co-administering beta-blockers;
• if the patient has valve diseases or heart muscle diseases;
• if the patient has coronary artery disease (caused by reduced blood flow in the coronary arteries) or cerebrovascular disease (caused by reduced blood flow in the brain);
• if the patient has primary hyperaldosteronism (a disease caused by increased secretion of aldosterone by the adrenal glands, as a result of disorders of these glands);
• if the patient has recently had a heart attack;
• if the patient has a significant increase in blood pressure (hypertensive crisis);
• if there is a need to increase the dose in elderly patients;
• if the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren,
• if the patient is taking other medicines that may increase potassium levels in the blood (see section 2 "Alortia and other medicines"). The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood at regular intervals. See also the information under the heading "When not to take Alortia".

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Alortia, they should discuss it with their doctor. The doctor will decide on further treatment. Do not stop taking Alortia on your own.

Children and adolescents

Alortia is not recommended for children and adolescents under 18 years of age.

Alortia and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. Inform your doctor if the patient is taking potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics (e.g. amiloride, triamterene, spironolactone), or other medicines that may increase potassium levels in the blood (e.g. heparin, trimethoprim-containing medicines), as such a combination with Alortia is not recommended. Be cautious if the patient is taking the following medicines while taking Alortia:

• other blood pressure-lowering medicines, as they may further lower blood pressure. Blood pressure may also be lowered by the following medicines/groups of medicines: tricyclic antidepressants, antipsychotics, baclofen, and amifostine,
• non-steroidal anti-inflammatory drugs, such as indomethacin, including COX-2 inhibitors (medicines that limit inflammation and may be used to relieve pain), as they may weaken the blood pressure-lowering effect of losartan. In the case of kidney problems, taking these medicines together may worsen kidney function.

Alortia may affect the action of other medicines or other medicines may affect the action of Alortia. This applies to the following medicines:

• ketokonazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infections);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's Wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used to treat heart diseases);
• dantrolene (in infusion, administered in case of severe body temperature disorders);
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporine (an immunosuppressive medicine).

Alortia can be taken with lithium-containing medicines only under close medical supervision. Special precautions may be necessary (e.g. blood tests). The doctor may need to change the dose and/or take other precautions:

• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Alortia" and "Warnings and precautions").

Alortia with food and drink

Do not drink grapefruit juice or eat grapefruits while taking Alortia, as grapefruits and grapefruit juice may lead to an increase in the level of the active substance - amlodipine in the blood, which may cause unpredictable intensification of the blood pressure-lowering effect of Alortia. Grapefruit juice may also reduce the therapeutic effect of losartan.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a baby, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy

Inform your doctor about pregnancy, suspected or planned pregnancy. The doctor will usually recommend stopping Alortia before planned pregnancy or immediately after pregnancy is confirmed and recommend taking another medicine. Alortia should not be taken in the first trimester of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the baby if taken during this period.

Breastfeeding

Inform your doctor if the patient is breastfeeding or plans to breastfeed. It has been shown that amlodipine passes into breast milk in small amounts, so Alortia is not recommended during breastfeeding. The doctor may recommend another medicine if the patient wants to continue breastfeeding, especially if the baby is a newborn or premature.

Driving and using machines

Alortia may impair the ability to drive and use machines. If nausea, dizziness, fatigue, or headache occur, do not drive or operate machines and contact your doctor immediately.

Alortia contains lactose and sodium

If the patient has previously been diagnosed with intolerance to some sugars, the patient should contact their doctor before taking the medicine. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Alortia

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. In case of doubts, consult a doctor or pharmacist. The recommended dose of Alortia is one tablet per day. The tablet should be swallowed with water, during or outside of meals. The medicine should be taken every day at the same time. Do not take Alortia with grapefruit juice. It is important to continue taking Alortia for as long as your doctor recommends.

Children and adolescents

Alortia is not recommended for children and adolescents.

Taking a higher dose of Alortia than recommended

In case of taking a higher dose of the medicine than recommended, contact your doctor immediately. Taking too many tablets may cause a decrease in blood pressure, even to dangerously low values. Dizziness, a feeling of "emptiness" in the head, fainting, or weakness may occur. In case of significant blood pressure drop, shock may occur. The patient's skin may become cold and clammy, and the patient may lose consciousness. Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Alortia

In case of missing a daily dose of the medicine, take the next dose at the usual time. Do not take a double dose to make up for the missed tablet.

Stopping Alortia

The doctor will determine how long to take the medicine. If the patient stops taking the medicine earlier than recommended by the doctor, the disease may return. In case of any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Alortia can cause side effects, although not everybody gets them. If the patient experiences any of the following serious side effects, they should contact their doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue or throat causing severe breathing difficulties;
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, abnormal heart rhythm;
• pancreatitis, which may cause severe stomach and back pain, with very poor general condition.

AMLODIPINE
The following common side effectshave been reported. If any of them are troublesome or persist for more than a week, consult a doctor.
Very common (may affect more than 1 in 10 people):

• swelling of the ankles (edema).

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

• headache, dizziness, drowsiness (especially at the beginning of treatment),
• palpitations (awareness of heartbeat), sudden redness of the skin, especially of the face,
• stomach pain, nausea,
• change in bowel movements, diarrhea, constipation, indigestion,
• fatigue, weakness,
• vision disturbances, double vision,
• muscle cramps.

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

• mood changes, anxiety, depression, insomnia,
• tremors, taste disturbances, fainting, weakness,
• numbness or tingling of limbs, loss of pain sensation,
• ringing, buzzing, noise, or hissing in the ears (tinnitus),
• low blood pressure,
• rhinitis (inflammation of the nasal mucosa),
• cough,
• dryness of the mucous membranes of the mouth, vomiting,
• hair loss, increased sweating, itching of the skin, red spots on the skin, skin discoloration,
• urination disorders, increased frequency of urination at night, increased frequency of urination,
• erectile dysfunction, breast discomfort or enlargement in men,
• pain, poor general condition,
• joint or muscle pain, muscle cramps, back pain,
• weight gain or loss,
• chest pain.

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

• confusional states.

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

• decrease in the number of white blood cells, decrease in the number of platelets, which may lead to easy bruising and bleeding,

Decreased blood sugar levels (hypoglycemia),

• nerve disorders that can lead to weakness, numbness, or tingling,
• gum swelling,
• abdominal bloating (gastritis),
• liver dysfunction, hepatitis, jaundice, increased liver enzyme activity, which may affect the results of some medical tests,
• increased muscle tone,
• vasculitis (inflammation of blood vessels), often with accompanying skin rash,
• hypersensitivity to light.

Unknown (frequency cannot be estimated from the available data):

• tremors, stiffness, mask-like face, slow movements, and dragging of the feet while walking, unsteady gait.

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

• dizziness,
• low blood pressure (especially in cases of significant reduction in intravascular volume, e.g. in patients with severe heart failure or treated with high doses of diuretics),
• dose-dependent orthostatic effects, such as a decrease in blood pressure when standing up from a lying or sitting position,
• weakness,
• fatigue,
• decrease in blood sugar levels (hypoglycemia),
• increase in potassium levels in the blood (hyperkalemia),
• kidney function disorders, including kidney failure,
• decrease in the number of red blood cells (anemia),
• increase in urea and creatinine levels in the blood, and potassium levels in the serum in patients with heart failure.

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

• drowsiness,
• headache,
• sleep disturbances,
• awareness of heartbeat (palpitations),
• severe chest pain (angina pectoris),
• shortness of breath (dyspnea),
• stomach pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• local swelling,
• cough.

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

• allergic reactions,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• numbness or tingling (paresthesia),
• fainting,
• very rapid and irregular heart rhythm (atrial fibrillation),
• stroke,
• angioedema of the intestines: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea,
• hepatitis,
• increase in liver enzyme activity, usually resolving after discontinuation of treatment.

Unknown (frequency cannot be estimated from the available data):

• decrease in platelet count,
• migraine,
• liver dysfunction,
• muscle and joint pain,
• flu-like symptoms,
• back and urinary tract pain,
• increased sensitivity to sunlight (hypersensitivity to light),
• muscle pain of unknown origin with accompanying dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• poor general condition,
• ringing, buzzing, noise, or hissing in the ears (tinnitus),
• taste disturbances.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alortia

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month stated. There are no special storage precautions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Alortia contains

• The active substances of Alortia are losartan potassium and amlodipine (in the form of besylate). Alortia, 50 mg + 5 mg, film-coated tablets Each film-coated tablet contains 50 mg of losartan potassium and 6.94 mg of amlodipine besylate, equivalent to 5 mg of amlodipine. Alortia, 50 mg + 10 mg, film-coated tablets Each film-coated tablet contains 50 mg of losartan potassium and 13.88 mg of amlodipine besylate, equivalent to 10 mg of amlodipine. Alortia, 100 mg + 5 mg, film-coated tablets Each film-coated tablet contains 100 mg of losartan potassium and 6.94 mg of amlodipine besylate, equivalent to 5 mg of amlodipine. Alortia, 100 mg + 10 mg, film-coated tablets Each film-coated tablet contains 100 mg of losartan potassium and 13.88 mg of amlodipine besylate, equivalent to 10 mg of amlodipine.
• Other ingredients are: lactose monohydrate, cellulose, powder, corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, sodium carboxymethylcellulose (type A), yellow iron oxide (E 172) in the tablet core and in the tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, red iron oxide (E 172) - only in tablets with a strength of 50 mg + 5 mg, 50 mg + 10 mg, and 100 mg + 5 mg, yellow iron oxide (E 172) - only in tablets with a strength of 50 mg + 5 mg and 100 mg + 10 mg. See section 2 "Alortia contains lactose and sodium".

What Alortia looks like and contents of the pack

Alortia, 50 mg + 5 mg: brown-orange, oval (15 mm x 7 mm), slightly bi-convex film-coated tablets Alortia, 50 mg + 10 mg: reddish-brown, oval (15 mm x 7 mm), slightly bi-convex film-coated tablets Alortia, 100 mg + 5 mg: pink, oval (18 mm x 9 mm), bi-convex film-coated tablets Alortia, 100 mg + 10 mg: light brown-yellow, oval (18 mm x 9 mm), bi-convex film-coated tablets Packaging:10, 28, 30, 56, 60, 84, and 90 film-coated tablets in blisters in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

In order to obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder: KRKA-POLSKA Sp. z o.o. ul. Równoległa 5 02-235 Warsaw Tel. 22 57 37 500

Date of last revision of the leaflet: 11.04.2025