Ilpio

Leaflet accompanying the packaging: patient information

YLPIO, 80 mg + 2.5 mg, tablets

Telmisartan + Indapamide

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 their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is YLPIO and what is it used for

YLPIO is a combination medicine that contains two active substances, telmisartan and indapamide, in one tablet. Both substances help control high blood pressure (hypertension).

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, causing blood vessels to widen and blood pressure to decrease.
• Indapamide belongs to a group of medicines called diuretics. Diuretics reduce blood pressure by two mechanisms of action: they increase the amount of urine produced by the kidneys and cause blood vessels to widen, making it easier for blood to flow through them. Diuretics increase the amount of urine excreted by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine production.

Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney failure, stroke, or vision loss. Most often, before the above complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
YLPIOis used to treat high blood pressure in adults who have achieved blood pressure control while taking telmisartan and indapamide in the same doses as in the combination medicine.

2. Important information before taking YLPIO

When not to take YLPIO

Warnings and precautions

The patient should inform their doctor if they have or have had any of the following conditions or diseases:

• Kidney disease or kidney transplant
• Narrowing of the renal artery (narrowing of the blood vessels of the only functioning kidney or both kidneys)
• Liver disease
• Heart disease
• Increased aldosterone levels (water and salt retention in the body, along with electrolyte imbalance)
• Low blood pressure (hypotension), which is more likely to occur if the patient is dehydrated (excessive water loss from the body) or has a sodium deficiency due to the use of diuretics, a low-salt diet, diarrhea, or vomiting
• High potassium levels in the blood
• Diabetes
• Gout.

Before starting YLPIO, the patient should discuss the following with their doctor:

• angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney disease,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take YLPIO".

The patient should tell their doctor:

Pregnancy
YLPIO should not be used during the first 3 months of pregnancy and should not be used after the 3rd month of pregnancy (from the 4th to the 9th month of pregnancy).
Before planned pregnancy or after becoming pregnant, the medicine should be replaced with another treatment as soon as possible.
Breastfeeding
YLPIO should not be used in breastfeeding mothers, as the active substances of the medicine may pass into breast milk. The doctor may recommend taking another medicine if the patient wants to breastfeed, especially when breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking YLPIO may experience dizziness or fatigue. In such cases, they should not drive vehicles or operate machines.

YLPIO contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take YLPIO

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of YLPIO is one tablet per day. The patient should try to take the tablet at the same time every day. It is essential to take YLPIO every day, unless the doctor recommends otherwise.
In patients with liver function disorders, the doctor will adjust the dose of the medicine.
YLPIO can be taken with or without food. The tablets should be swallowed with a sufficient amount of water or another non-alcoholic liquid. The tablet can be divided into equal doses.
YLPIO should be stored in a sealed blister pack, and the tablets should be removed from the blister pack shortly before administration.

Taking a higher dose of YLPIO than recommended

In case of accidental ingestion of too many tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital. A high dose of YLPIO may cause low blood pressure, rapid heartbeat, slow heartbeat, dizziness, decreased kidney function, including acute kidney failure, nausea, vomiting, cramps, drowsiness, disorientation, and changes in urine production.

Missing a dose of YLPIO

The patient should not worry if they miss a dose. They should take it as soon as they remember, and then continue taking the medicine according to the established schedule. If the tablet is not taken on a given day, the patient should take the usual dose the next day.
The patient should not take a double dose to make up for the missed dose.

Stopping YLPIO treatment

Since the treatment of high blood pressure is usually long-term, the patient should discuss stopping the treatment with their doctor before doing so.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, YLPIO can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking the medicine and contact their doctor immediately:

• Septicemia (often referred to as blood poisoning, a severe infection with an inflammatory response of the entire body), which may be accidental or related to a mechanism that has not yet been identified (rare side effect).
• Sudden swelling of the skin on the limbs or face, swelling of the lips or tongue, swelling of the mucous membranes of the throat or respiratory tract, which causes shortness of breath and difficulty swallowing (angioedema) (rare side effect).
• Severe skin reactions, including severe rash, 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) or other allergic reactions (very rare side effect).
• Pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition (very rare side effect).
• Life-threatening, irregular heart rhythm (frequency not known).
• Brain disease caused by liver disease (hepatic encephalopathy) (frequency not known).
• Hepatitis (frequency not known).

Possible side effects of YLPIO:

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

• allergic skin reactions, such as skin rashes in patients prone to allergies and asthmatic reactions
• red, raised rash

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

• urinary tract infections, upper respiratory tract infections
• decrease in red blood cell count (anemia)
• difficulty falling asleep
• low mood (depression)
• fainting
• feeling of spinning (peripheral vertigo)
• slow heart rate (bradycardia)
• low blood pressure (hypotension), dizziness when standing up (orthostatic hypotension)
• shortness of breath, cough
• abdominal pain, diarrhea, discomfort in the abdominal cavity, bloating, vomiting, red spots on the skin (petechiae), itching, excessive sweating, rash
• back pain, muscle cramps, muscle pain
• kidney function disorders, including acute kidney failure
• chest pain, feeling of weakness
• increased creatinine levels in the blood
• high potassium levels in the blood

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

• septicemia (often referred to as blood poisoning, a severe infection with an inflammatory response of the entire body, which can lead to death)
• increase in the number of certain white blood cells (eosinophilia)
• low platelet count (thrombocytopenia)
• severe allergic reaction (anaphylactic reaction)
• allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face)
• feeling of restlessness
• fatigue, headache, feeling of tingling and numbness (paresthesia)
• drowsiness
• vision disturbances
• rapid heart rate (tachycardia)
• nausea, constipation, dryness of the mucous membranes of the mouth, gastritis, disorders of taste
• liver function disorders (more common in patients of Japanese origin)
• sudden swelling of the skin and mucous membranes, which can lead to death (angioedema, including fatal cases)
• rash, redness of the skin, hives, severe drug rash
• joint pain, limb pain, tendon pain
• flu-like symptoms
• decrease in hemoglobin levels (a protein in the blood)
• increase in uric acid levels, a substance that can cause gout or worsen its symptoms (joint pain)
• increase in liver enzyme activity or creatine phosphokinase in the blood
• low blood sugar levels (in patients with diabetes)

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

• decrease in white blood cell count, which can cause fever, redness of the throat, or other flu-like symptoms (leukopenia)
• heart rhythm disorders (causing palpitations and feeling of heartbeat)
• progressive scarring of lung tissue (interstitial lung disease) has been reported during telmisartan treatment, but it is not known whether telmisartan is the cause
• pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition
• severe skin reactions, including severe rash, 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)
• high calcium levels (hypercalcemia)

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

• myopia, blurred vision
• worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye (choroidal effusion) or acute angle-closure glaucoma)
• abnormal ECG recording
• brain disease caused by liver disease (hepatic encephalopathy)
• angioedema of the intestine - after using similar products, intestinal angioedema occurred with symptoms such as abdominal pain, nausea, vomiting, and diarrhea
• hepatitis (liver inflammation)
• possibility of exacerbating symptoms of systemic lupus erythematosus (a type of collagenosis)
• reactions to sunlight (change in skin appearance) after exposure to sunlight or artificial UV radiation
• low potassium levels in the blood
• low sodium levels in the blood, which can lead to dehydration and low blood pressure
• increased glucose levels in the blood in patients with diabetes

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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 181 C, 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store YLPIO

The medicine should be stored out of sight and reach of children.
Store in the original packaging to protect from light.
Do not use this medicine after the expiry date stated on the carton and blister pack after:
Expiry date (EXP). The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 YLPIO contains

• The active substances of the medicine are telmisartan and indapamide. Each tablet contains 80 mg of telmisartan and 2.5 mg of indapamide.
• The other ingredients are mannitol (E 421), sodium hydroxide, povidone 25, magnesium stearate.

What YLPIO looks like and contents of the pack

Yellowish, round, biconvex tablets with a dividing line on both sides, 9 mm in diameter.
The tablets are provided in OPA/Aluminum/PVC/Aluminum blisters, in a cardboard box.
YLPIO is available in packs containing 30 or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s.
Telčská 377/1
Michle, 140 00 Praha 4
Czech Republic

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

Czech Republic (RMS)
YLPIO
Poland
YLPIO
Romania
YLPIO 80 mg/2.5 mg tablets
Slovakia
YLPIO 80 mg/2.5 mg tablets
Date of last revision of the leaflet:24.01.2025