Alortia

Package leaflet: Information for the patient

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
Potassium losartan + Amlodipine
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Alortia is and what it is 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 pack and other information

1. What Alortia is and what it is 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, preventing blood vessel constriction and thereby lowering blood pressure. The action of both substances prevents narrowing of blood vessels, resulting in vessel relaxation and reduction of blood pressure.

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

2. Information before using Alortia

When not to use Alortia

• if the patient is allergic to losartan, amlodipine, or any of the other components of this medicine (listed in section 6), or to any calcium channel blocker. Allergic reactions may manifest as itching, redness of the skin, or difficulty breathing;
• if the patient has very low blood pressure (hypotension);
• if the patient has aortic valve stenosis (narrowing of the heart's aortic valve) or cardiogenic shock (a condition in which the heart is unable to deliver enough blood to meet the body's needs);
• if the patient has heart failure following a heart attack;
• if the patient is more than 3 months pregnant (use of Alortia is also not recommended during early pregnancy – see section "Pregnancy and breastfeeding");
• if the patient has severe liver function impairment;
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Before starting treatment with Alortia, discuss this with your doctor or pharmacist.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Use of Alortia is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if taken during this period (see section "Pregnancy and breastfeeding").
Before taking Alortia, you must inform your doctor:

• if you have previously experienced angioedema (swelling of the face, lips, throat, and/or tongue – see section 4);
• if you are experiencing severe vomiting or diarrhoea, leading to significant fluid and/or salt loss from the body;
• if you are taking diuretics (medicines that increase the amount of water excreted by the kidneys) or are on a low-salt diet, which may lead to excessive loss of fluids and salts;
• if you have narrowing or blockage of the blood vessels supplying the kidneys or if you have recently received a kidney transplant;
• if you have liver function impairment (see section 2 "When not to use Alortia");
• if you have heart failure with or without kidney dysfunction, or severe, life-threatening heart rhythm disorders – particular caution is required if you are also being treated with β-blockers;
• if you have heart valve or heart muscle diseases;
• if you have coronary artery disease (caused by reduced blood flow in the heart's blood vessels) or cerebrovascular disease (caused by reduced blood flow to the brain);
• if you have primary hyperaldosteronism (a condition caused by excessive aldosterone secretion from the adrenal glands due to gland dysfunction);
• if you have recently had a heart attack;
• if you have had or currently have a significant increase in blood pressure (hypertensive crisis);
• if dosage adjustment is required in elderly patients;
• if you are taking any of the following medicines for high blood pressure:
• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes,
• aliskiren,
• if you are taking other medicines that may increase serum potassium levels (see section 2 "Alortia and other medicines"). Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading "When not to use Alortia".

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Alortia,
discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Alortia
on your own initiative.

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

Alortia and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Inform your doctor if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing agents such as certain diuretics (amiloride, triamterene, spironolactone), or other medicines that may increase serum potassium levels (e.g. heparin, medicines containing trimethoprim), as such combinations with Alortia are not recommended.
Exercise particular caution if you are taking the following medicines while using Alortia:

• other medicines that lower blood pressure, as they may additionally reduce blood pressure. The following medicines/groups of medicines may also lower blood pressure: tricyclic antidepressants, antipsychotics, baclofen, and amifostine;
• non-steroidal anti-inflammatory drugs (NSAIDs), such as indomethacin, including COX-2 inhibitors (medicines that reduce inflammation and may be used to relieve pain), as they may reduce the blood pressure-lowering effect of losartan. In patients with kidney dysfunction, concomitant use of these medicines 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:

• ketoconazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (protease inhibitors used in the treatment of HIV infection);
• rifampicin, erythromycin, clarithromycin (antibiotics);
• St. John's wort (Hypericum perforatum);
• verapamil, diltiazem (medicines used for heart conditions);
• dantrolene (administered intravenously in cases 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 may be taken together with lithium-containing medicines only under strict medical supervision. Special precautions (e.g. blood tests) may be necessary.
Your doctor may need to adjust the dose and/or take additional precautions:

• if you are taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Alortia" and "Warnings and precautions").

Alortia with food and drink
Do not drink grapefruit juice or eat grapefruits while taking Alortia, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, potentially causing unpredictable intensification of Alortia's blood pressure-lowering effect. Grapefruit juice may also reduce the therapeutic effect of losartan.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy. Your doctor will usually advise discontinuing Alortia before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Alortia is not recommended during the first trimester of pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if taken during this period.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Amlodipine has been shown to pass into human breast milk in small amounts; therefore, Alortia is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you wish to continue breastfeeding, especially if the infant is a newborn or premature.

Driving and operating machinery
Alortia may impair the ability to drive or operate machinery. If you experience nausea, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Alortia contains lactose and sodium
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is considered "sodium-free".

3. How to use Alortia

This medicine should always be used as directed by a physician or pharmacist.
If in doubt, consult a physician or pharmacist.
The recommended dose of Alortia is one tablet per day.
The tablet should be swallowed with water, during a meal or independently of meals.
The medicine should be taken daily at the same time. Do not take Alortia with grapefruit juice.
It is important to continue using Alortia for as long as your doctor has instructed.

Children and adolescents
Alortia is not recommended for use in children and adolescents.

Taking more Alortia than recommended
If more tablets have been taken than recommended, contact a physician immediately.
Taking too many tablets may cause a drop in blood pressure, even to dangerously low levels.
Dizziness, a sensation of "emptiness" in the head, fainting, or weakness may occur.
In the case of a significant drop in blood pressure, shock may develop.
The patient's skin may become cold and clammy, and the patient may lose consciousness.
Breathlessness due to fluid accumulation in the lungs (pulmonary edema) may occur
up to 24–48 hours after taking the medicine.

Missing a dose of Alortia
If a daily dose is missed, take the next dose at the usual time.
Do not take a double dose to make up for a missed tablet.

Stopping Alortia treatment
Your doctor will determine how long you should take the medicine.
If you stop taking Alortia earlier than instructed by your doctor, your condition may return.

If you have any further questions about the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur after taking this medicine, the patient should seek immediate medical attention:

• sudden wheezing, chest pain, shortness of breath or difficulty breathing;
• swelling of the eyelids, face or lips;
• swelling of the tongue or throat causing significant breathing difficulties;
• severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, abnormal heart function;
• pancreatitis, which may cause severe abdominal and back pain accompanied by a very poor general condition.

AMLODIPINE
The following common adverse reactions have been reported. If any of these are troublesome for the patient or persist for longer than one week, the patient should contact a doctor.
Very common (may occur in more than 1 in 10 patients):

• swelling around the ankles (oedema).

Common (may occur in up to 1 in 10 patients):

• headache, dizziness, drowsiness (especially at the beginning of treatment),
• palpitations (awareness of heartbeat), sudden flushing of the skin, especially the face,
• abdominal pain, nausea,
• changes in bowel habits, diarrhoea, constipation, dyspepsia,
• fatigue, weakness,
• visual disturbances, double vision,
• muscle cramps.

The following other adverse reactions have also been reported. If any of these adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform a doctor or pharmacist.
Uncommon (may occur in up to 1 in 100 patients):

• mood changes, anxiety, depression, insomnia,
• tremor, taste disturbances, fainting, weakness,
• sensation of numbness or tingling in limbs, loss of pain sensation,
• tinnitus,
• low blood pressure,
• sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis),
• cough,
• dryness of the oral mucosa, vomiting,
• hair loss, excessive sweating, skin itching, red skin spots, skin discoloration,
• urinary disorders, increased frequency of urination at night, increased frequency of urination,
• erectile dysfunction, discomfort or enlargement of the breasts in men,
• pain, malaise,
• joint or muscle pain, muscle cramps, back pain,
• weight gain or weight loss,
• chest pain.

Rare (may occur in up to 1 in 1,000 patients):

• confusion.

Very rare (may occur in up to 1 in 10,000 patients):

• decrease in white blood cell count, decrease in platelet count, which may lead to easy bruising and bleeding,
• increased blood glucose levels (hyperglycaemia),
• nerve disorders leading to weakness, tingling or numbness,
• gum swelling,
• abdominal bloating (gastritis),
• liver function disorders, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity, which may affect the results of certain medical tests,
• increased muscle tone,
• vasculitis, often accompanied by skin rash,
• photosensitivity.

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

• tremor, stiffness, mask-like facial expression, slowed movements and shuffling gait, unsteady walking.

LOSARTAN
Common (may occur in up to 1 in 10 patients):

• 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 symptoms such as drop in blood pressure upon standing from lying or sitting position,
• weakness,
• fatigue,
• decreased blood glucose levels (hypoglycaemia),
• increased blood potassium levels (hyperkalaemia),
• kidney function disorders, including kidney failure,
• decreased number of red blood cells (anaemia),
• increased blood urea levels, increased serum creatinine and potassium levels in patients with heart failure.

Uncommon (may occur in up to 1 in 100 patients):

• drowsiness,
• headache,
• sleep disorders,
• sensation of rapid heartbeat (palpitations),
• shortness of breath (dyspnoea),
• abdominal pain,
• constipation,
• diarrhoea,
• nausea,
• vomiting,
• urticaria,
• itching (pruritus),
• rash,
• localised swelling,
• cough.

Rare (may occur in up to 1 in 1,000 patients):

• hypersensitivity,
• angioedema,
• vasculitis (including Henoch-Schönlein purpura),
• sensation of numbness or tingling (paraesthesia),
• fainting,
• very fast and irregular heartbeat (atrial fibrillation),
• stroke,
• intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea,
• hepatitis,
• increased alanine aminotransferase (AlAT) activity, usually resolving after discontinuation of treatment.

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

• decreased platelet count,
• migraine,
• liver function disorders,
• muscle and joint pain,
• influenza-like symptoms,
• back pain and urinary tract infections,
• increased sensitivity to sunlight (photosensitivity),
• muscle pain of unknown origin with accompanying dark (tea-coloured) urine (rhabdomyolysis),
• impotence,
• pancreatitis,
• low sodium levels in blood (hyponatraemia),
• depression,
• general malaise,
• ringing, buzzing, noise or crackling in the ears (tinnitus),
• taste disturbances.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Alortia

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after the abbreviation
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Alortia contains

• The active substances in the medicine are losartan potassium and amlodipine (as 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, powdered cellulose, pregelatinized corn starch, corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, sodium carboxymethyl starch (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 50 mg + 5 mg, 50 mg + 10 mg and 100 mg + 5 mg film-coated tablets, yellow iron oxide (E 172) – only in 50 mg + 5 mg and 100 mg + 10 mg film-coated tablets. See section 2 "Alortia contains lactose and sodium".

What Alortia looks like and contents of the pack
Alortia 50 mg + 5 mg: brownish-orange, oval (15 mm x 7 mm), slightly biconvex film-coated tablets
Alortia 50 mg + 10 mg: reddish-brown, oval (15 mm x 7 mm), slightly biconvex film-coated tablets
Alortia 100 mg + 5 mg: pink, oval (18 mm x 9 mm), biconvex film-coated tablets
Alortia 100 mg + 10 mg: light brownish-yellow, oval (18 mm x 9 mm), biconvex film-coated tablets

Pack sizes: 10, 28, 30, 56, 60, 84 and 90 film-coated tablets in blister packs contained in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names:

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Tel. +48 22 57 37 500