Alortia

Leaflet attached to 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

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 corresponding to the body's needs);
• 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 to take Alortia, you should discuss it with your doctor or pharmacist. You should 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, you must inform your doctor:

• if the patient has had angioedema (swelling of the face, lips, throat and/or tongue) in the past (see section 4);
• 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 cause 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 taking β-adrenolytics concomitantly;
• if the patient has valve diseases or heart muscle diseases;
• if the patient has coronary artery disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood flow in the brain's blood vessels);
• 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 or has had 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 abdominal 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 you are taking now or have taken recently, as well as any medicines you plan to take. Inform your doctor if you are 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 you are 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 you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Tell 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

Tell your doctor if you are breastfeeding or planning 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 baby.

Driving and using machines

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

Alortia contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your 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. If you are unsure, consult your 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

If you have taken more than the recommended dose, you should immediately inform your doctor. 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. Even up to 24-48 hours after taking the medicine, shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Alortia

If you miss a daily dose, 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 you should take the medicine. If you stop taking the medicine earlier than recommended by your doctor, the disease may return. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alortia can cause side effects, although not everybody gets them. If you experience any of the following serious side effects, you should immediately contact your doctor:

• 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 difficulty breathing;
• 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 can cause severe abdominal and back pain, with very poor general condition.

AMLODIPINE
The following common side effectshave been reported. If any of them are troublesome for you or last longer than a week, you should contact your 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 the face,
• abdominal pain, nausea,
• change in bowel habits, 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 in the ears,
• low blood pressure,
• rhinitis (runny nose),
• 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,
• urinary 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 1000 people):

• confusional states.

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

• decrease in white blood cell count, decrease in platelet count, which can lead to easy bruising and bleeding,

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

• tremors, rigidity of posture, mask-like face, slow movements and dragging of the feet when 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 those 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 problems, including kidney failure,
• decrease in red blood cell count (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),
• abdominal pain,
• constipation,
• diarrhea,
• nausea,
• vomiting,
• hives,
• itching (pruritus),
• rash,
• localized swelling,
• cough.

Rare (may affect up to 1 in 1000 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 abdominal pain, nausea, vomiting, and diarrhea,
• hepatitis,
• increase in liver enzyme activity (usually resolving after discontinuation of treatment).

Not known (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 (photosensitivity),
• muscle pain of unknown origin with dark (tea-colored) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in the blood (hyponatremia),
• depression,
• general poor condition,
• ringing, buzzing, noise, or hissing in the ears (tinnitus),
• taste disturbances.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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

The medicine should be stored out of 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 specified month. There are no special precautions for storage. 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 the medicine 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, which corresponds 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, which corresponds 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, which corresponds 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, which corresponds to 10 mg of amlodipine.
• Other ingredients are: lactose monohydrate, cellulose, powder, corn starch, microcrystalline cellulose, silica colloidal anhydrous, magnesium stearate, sodium carboxymethylcellulose (type A), iron oxide yellow (E 172) in the tablet core and in the tablet coating: polyvinyl alcohol, titanium dioxide (E 171), macrogol 3000, talc, iron oxide red (E 172) - only in tablets with a strength of 50 mg + 5 mg, 50 mg + 10 mg, and 100 mg + 5 mg, iron oxide yellow (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 convex on both sides, film-coated tablets Alortia, 50 mg + 10 mg: reddish-brown, oval (15 mm x 7 mm), slightly convex on both sides, film-coated tablets Alortia, 100 mg + 5 mg: pink, oval (18 mm x 9 mm), convex on both sides, film-coated tablets Alortia, 100 mg + 10 mg: light brown-yellow, oval (18 mm x 9 mm), convex on both sides, 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, you should 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