Presartan H

Leaflet accompanying the packaging: patient information

Presartan H, 50 mg + 12.5 mg, film-coated tablets

Presartan H, 100 mg + 25 mg, film-coated tablets

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Presartan H and what is it used for

Presartan H is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Presartan H is indicated for the treatment of primary hypertension (high blood pressure).

2. Important information before taking Presartan H

When not to take Presartan H

• If you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).
• If you have been diagnosed with hypersensitivity (allergy) to sulfonamide-derived substances (e.g. other thiazide diuretics, certain antibacterial drugs such as co-trimoxazole; if in doubt, consult your doctor).
• After the third month of pregnancy (you should also avoid taking Presartan H during early pregnancy
• see section "Pregnancy and breastfeeding").
• If you have severe liver function disorders.
• If you have severe kidney function disorders or if your kidneys do not produce urine.
• If you have low potassium or sodium levels or high calcium levels that cannot be treated.
• If you have gout.
• If you have diabetes or kidney function disorders and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting to take Presartan H, you should discuss this with your doctor, pharmacist or nurse.

• If you have had breathing or lung problems after taking hydrochlorothiazide in the past (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Presartan H, you should seek medical attention immediately.
• If you have had swelling of the face, lips, throat and/or tongue (see section "Side effects").
• If you are taking diuretics (diuretics).
• If you are taking any of the following medicines for high blood pressure:
• an angiotensin-converting enzyme inhibitor (ACE inhibitor), such as enalapril, lisinopril, ramipril, especially if you have diabetic kidney disease,
• aliskiren.
• If you are on a low-salt diet.
• If you experience stomach pain, nausea, vomiting or diarrhea after taking Presartan H, you should discuss this with your doctor. Your doctor will decide whether to continue treatment. Do not stop taking Presartan H on your own.
• If you have heart failure.
• If you have narrowing of the renal arteries or have only one functioning kidney, or have recently undergone a kidney transplant.
• If you have narrowing of the arteries (arteriosclerosis), angina pectoris (chest pain caused by poor heart function).
• If you have narrowing of the aortic or mitral valve or hypertrophic cardiomyopathy (a disease that causes thickening of the heart muscle).
• If you have diabetes.
• If you have had gout in the past.
• If you have had allergic diseases, asthma or joint pain, skin rash and fever (systemic lupus erythematosus).
• If you have high calcium levels or low potassium levels, or if you are on a potassium-restricted diet.
• If you are going to have anesthesia (even at the dentist) or surgery, or if you are going to have functional tests; you should inform your doctor that you are taking Presartan H.
• If you have had skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Presartan H, you should protect your skin from sunlight and UV radiation.
• If you experience vision loss or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to a week after taking Presartan H. If left untreated, they can lead to permanent vision loss. The risk of these side effects may be higher in patients who have previously been allergic to penicillin or sulfonamides.
• In case of primary hyperaldosteronism (a syndrome caused by increased secretion of aldosterone hormone by the adrenal glands due to abnormalities in these glands).
• You should inform your doctor if you are pregnant, planning to become pregnant or breastfeeding. Presartan H is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy and breastfeeding").

Presartan H should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy and breastfeeding").
Your doctor may recommend regular monitoring of kidney function, blood pressure and electrolyte levels (e.g. potassium).
See also the subsection "When not to take Presartan H".

Presartan H and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Diuretics, such as hydrochlorothiazide contained in Presartan H, may interact with other medicines. You should not take lithium-containing products with Presartan H without close medical supervision.
You should be cautious (e.g. have blood tests) when taking potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines, other diuretics (diuretics), certain laxatives, licorice-containing products, gout medicines or antidiabetic medicines (oral or insulin).
You should also inform your doctor about taking other medicines:

• that lower blood pressure,
• corticosteroids,
• anticancer drugs,
• analgesics,
• antifungal drugs,
• antirheumatic drugs,
• cholesterol-lowering resins, such as cholestyramine,
• muscle relaxants,
• sleeping pills,
• opioid drugs, such as morphine,
• amines that increase blood pressure, such as adrenaline or other medicines from this group.

Your doctor may recommend a change in dose and/or other precautions:

• if you are taking an ACE inhibitor or aliskiren (see also subsections "When not to take Presartan H" and "Warnings and precautions").

You should inform your doctor about taking Presartan H if you are going to receive iodine-containing contrast agents.

Presartan H with food and drink

You should not drink alcohol during treatment with Presartan H: alcohol and Presartan H can enhance each other's effects.
Excessive salt intake in the diet may reduce the effect of Presartan H.
You should be cautious when consuming licorice-containing products during treatment with Presartan H.
Presartan H can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding or think you may be pregnant or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
Pregnancy
You should inform your doctor about suspected (or planned) pregnancy. Your doctor will usually recommend stopping Presartan H before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Presartan H. Presartan H is not recommended during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby.
Breastfeeding
You should inform your doctor about breastfeeding or intending to breastfeed. Presartan H is not recommended during breastfeeding. Your doctor may recommend another medicine.

Using Presartan H in children and adolescents

There is no experience with the use of Presartan H in children and adolescents. Therefore, Presartan H should not be given to children and adolescents.

Using Presartan H in the elderly

Presartan H is just as effective and well-tolerated in most elderly patients as in younger patients. Most elderly patients require the same doses as younger patients.

Driving and using machines

No studies have been conducted on the effects on driving and using machines. At the beginning of treatment, you should not perform activities that require increased attention (such as driving, operating hazardous machinery) until it is known how you tolerate the medicine.

Presartan H contains lactose monohydrate

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Presartan H contains sodium

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

3. How to take Presartan H

This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Your doctor will determine the appropriate dose of Presartan H depending on your condition and the medicines you are taking. You should take Presartan H for as long as your doctor recommends to maintain blood pressure control.
The tablets should be swallowed with a glass of water. The medicine can be taken with or without food.
The tablet can be divided into two equal doses.
Hypertension
The usual dose for most patients with high blood pressure is:
1 tablet of Presartan H 50 mg + 12.5 mg per day. This dose provides 24-hour blood pressure control. The dose can be increased to 2 tablets of Presartan H 50 mg + 12.5 mg once a day or changed to 1 tablet of Presartan H 100 mg + 25 mg (higher dose) per day.
The maximum daily dose is:
2 tablets of Presartan H 50 mg + 12.5 mg or 1 tablet of Presartan H 100 mg + 25 mg.

Using in children and adolescents

There is no experience with the use of Presartan H in children and adolescents. Therefore, Presartan H should not be given to children and adolescents.

Taking a higher dose of Presartan H than recommended

In case of overdose, you should immediately contact your doctor to get prompt medical attention. Overdose may cause low blood pressure, rapid heartbeat, slow heart rate, changes in blood composition, dehydration.

Missing a dose of Presartan H

You should take Presartan H every day at the same time.
You should not take a double dose to make up for a missed dose. You should take the next dose at the usual time.

Stopping treatment with Presartan H

If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should stop taking Presartan H and contact your doctor or go to the emergency department of the nearest hospital immediately:
Severe allergic reaction (rash, itching, swelling of the face, lips, tongue or throat, which can 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. Prompt medical attention or hospitalization may be required.
The following side effects are listed by frequency:

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders,
• diarrhea, stomach pain, nausea, indigestion,
• muscle pain or cramps, leg pain, back pain,
• insomnia, headache, dizziness,
• weakness, fatigue, chest pain,
• increased potassium levels in the blood (which can cause heart rhythm disturbances), decreased hemoglobin levels in the blood.

Frequent:occurring in 1 to 10 people in 100

Uncommon:occurring in 1 to 10 people in 1,000

• anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of the hands and feet and stomach pain), bruising, decreased white blood cell count, blood clotting disorders and easy bruising,
• loss of appetite, increased uric acid or gout, increased blood sugar levels, electrolyte disturbances in the blood,
• anxiety, nervousness, panic attacks (recurring panic attacks), disorientation, depression, unusual dreams, sleep disturbances, drowsiness, memory disorders,
• tingling or numbness or similar disorders, limb pain, tremors, migraine, fainting,
• blurred vision, burning or stinging sensation in the eyes, conjunctivitis, decreased visual acuity, yellow vision,
• ringing, buzzing, tapping in the ears, tinnitus,
• low blood pressure, which may be associated with a change in body position (feeling of "emptiness" in the head or weakness when standing up), angina pectoris (chest pain), heart rhythm disturbances, cerebrovascular incidents ("mini-strokes"), myocardial infarction, palpitations,
• vasculitis, often associated with skin rash or bruising,
• sore throat, shortness of breath, bronchitis, pneumonia, fluid accumulation in the lungs (which can cause breathing difficulties), nosebleeds, rhinitis, congestion,
• constipation, bloating, gastritis, stomach cramps, vomiting, dry mouth, salivary gland inflammation, toothache,
• jaundice (yellowing of the eyes and skin), pancreatitis,
• hives, itching, skin inflammation, rash, redness of the skin, photosensitivity, dry skin, hot flashes with redness, increased sweating, hair loss,
• shoulder, arm, hip, knee or other joint pain, joint swelling, stiffness, muscle weakness,
• frequent urination, also at night, kidney function disorders, including kidney inflammation, urinary tract infections, sugar in the urine,
• decreased libido, impotence,
• facial swelling, fever.

Rare:occurring in 1 to 10 people in 10,000

• hepatitis, abnormal liver function test results
• intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting and diarrhea.

Very rare: occurring in less than 1 person in 10,000

• acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

Frequency not known:

• muscle tissue breakdown,
• malignant skin and lip tumors (non-melanoma skin cancer),
• taste disorders.
• vision loss or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma)

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Presartan H

Store in a temperature below 30°C.
Store in a place out of sight and reach of children.
Do not use Presartan H after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Presartan H contains

The active substances of the medicine are losartan potassium and hydrochlorothiazide.
Presartan H, 50 mg + 12.5 mg
Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
Presartan H, 100 mg + 25 mg
Each tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
The other ingredients are: microcrystalline cellulose, lactose monohydrate, maize starch paste, sodium carboxymethylcellulose (type A), magnesium stearate, Opadry White 20A18334 coating containing:
hydroxypropylcellulose (E463), hypromellose 6cP (E464), titanium dioxide (E171).

What Presartan H looks like and contents of the pack

Presartan H, 50 mg + 12.5 mg is a film-coated tablet, white, oblong, biconvex, 13.7x6.7 mm in size with a dividing line on both sides.
Presartan H, 100 mg + 25 mg is a film-coated tablet, white, oblong, biconvex, 15.3x6.7 mm in size with a dividing line on both sides.
The pack contains 3 PVC/PE/PVDC/Al blisters, each containing 10 film-coated tablets, in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Tel: +48 17 865 51 00

Manufacturer

PharmaPath S.A.
28is Oktovriou 1
Agia Varvara, 123 51, Greece
Bausch Health Poland sp. z o.o.
ul. Przemysłowa 2
35-959 Rzeszów, Poland

Date of last revision of the leaflet: