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
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 specifically for you. 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, 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 cotrimoxazole; 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").
• 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 levels of potassium or sodium or high levels of calcium 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, discuss it 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, seek medical attention immediately.
• If you have had swelling of the face, lips, tongue and/or throat in the past (see section "Side effects").
• If you are taking diuretics (diuretics).
• If you are taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme inhibitor (ACE), such as enalapril, lisinopril, ramipril, especially if you have kidney problems related to diabetes,
• aliskiren.
• If you are on a low-salt diet.
• If you experience stomach pain, nausea, vomiting or diarrhea after taking Presartan H, discuss it with your doctor. Your doctor will decide on further 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 levels of calcium or low levels of potassium, or if you are on a low-potassium diet.
• If you are going to be anesthetized (even by a dentist) or before surgery or if you are going to have functional tests; 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, 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).
• Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.

do not recommend taking Presartan H during early pregnancy and do not take it after the third month of pregnancy, as it may seriously 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

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.
Diuretics, such as hydrochlorothiazide contained in Presartan H, may interact with other medicines. Do not take lithium-containing products with Presartan H without close medical supervision.
Be cautious (e.g. have blood tests) when taking potassium supplements, potassium-containing salt substitutes or potassium-sparing diuretics, other diuretics, certain laxatives, gout medications or antidiabetic medications (oral or insulin).
Also, inform your doctor about taking other medicines:

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

Your doctor may recommend changing the dose and/or taking other precautions:

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

Tell your doctor if you are taking Presartan H when iodine-containing contrast agents are to be administered.

Presartan H with food and drink

Do not consume alcohol during treatment with Presartan H: alcohol and Presartan H may enhance each other's effects.
Excessive salt intake in the diet may reduce the effectiveness of Presartan H.
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 or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant or planning to become pregnant. Your doctor will usually recommend stopping Presartan H before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Presartan H. Do not recommend taking Presartan H during early pregnancy and do not take it after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to breastfeed. Do not recommend taking Presartan H during breastfeeding. Your doctor may recommend taking 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 the elderly 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, do not perform tasks that require increased attention (such as driving or 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, 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

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the appropriate dose of Presartan H based on your condition and other medications you are taking. Take Presartan H for as long as your doctor recommends to maintain blood pressure control.
Swallow the tablets with a glass of water. Presartan H 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, contact your doctor immediately 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

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

Stopping treatment with Presartan H

If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Presartan H can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking Presartan H and contact your doctor or go to the emergency department of your 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. Medical attention or hospitalization may be necessary.
The following side effects are listed by frequency:

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders,
• diarrhea, abdominal 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.

Uncommon:occurring in 1 to 10 users 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 abdominal pain), bruising, decreased white blood cell count, bleeding disorders and easy bruising,
• loss of appetite, increased uric acid or gout, increased blood sugar, 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, rapid heartbeat,
• vasculitis, often associated with skin rash or bruising,
• throat pain, shortness of breath, bronchitis, pneumonia, fluid accumulation in the lungs (which can cause difficulty breathing), 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 users in 10,000

• hepatitis, abnormal liver function tests
• gastrointestinal angioedema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhea.

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

• 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, 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, phone: +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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Presartan H contains

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

Marketing authorisation holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
Phone: +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: