Telmisartan hydrochlorothiazide egis

Package leaflet: Information for the patient

Telmisartan HCT EGIS, 40 mg + 12.5 mg, tablets
Telmisartan HCT EGIS, 80 mg + 12.5 mg, tablets
Telmisartan HCT EGIS, 80 mg + 25 mg, tablets
Telmisartanum + Hydrochlorothiazidum
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 further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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 Telmisartan HCT EGIS is and what it is used for
2. Important information before taking Telmisartan HCT EGIS
3. How to take Telmisartan HCT EGIS
4. Possible side effects
5. How to store Telmisartan HCT EGIS
6. Contents of the pack and other information

1. What Telmisartan HCT EGIS is and what it is used for

Telmisartan HCT EGIS is a combination medicine containing two active substances, telmisartan and hydrochlorothiazide, in a single tablet. Both substances help control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor blockers. 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.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which increase urine production, leading to a reduction in blood pressure.

Untreated high blood pressure may damage blood vessels in organs and, in some cases, may lead to complications such as heart attack, heart or kidney failure, stroke, or vision loss. Often, no symptoms of high blood pressure occur before these complications arise. Therefore, it is important to measure blood pressure regularly to ensure it remains within normal limits.
Telmisartan HCT EGIS is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.

2. Important information before using Telmisartan HCT EGIS

When not to use Telmisartan HCT EGIS:

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to hydrochlorothiazide or sulfonamide derivatives;
• after the third month of pregnancy (Telmisartan HCT EGIS should also be avoided during early pregnancy – see section "Pregnancy");
• if the patient has severe liver disease such as cholestasis or biliary obstruction (impaired bile flow from the liver and gallbladder), or any other severe liver disease;
• if the patient has severe kidney disease or anuria (less than 100 ml of urine per day);
• if the doctor has diagnosed low blood potassium levels or high blood calcium levels that do not improve with treatment;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, inform the doctor or pharmacist
before taking Telmisartan HCT EGIS.
Warnings and precautions
Before starting treatment, discuss with your doctor or pharmacist if the patient
has had or currently has any of the following conditions or diseases:

• if breathing or lung problems (including pneumonia or fluid accumulation in the lungs) occurred in the past after taking hydrochlorothiazide. If severe shortness of breath or difficulty breathing occurs after taking Telmisartan HCT EGIS, seek immediate medical help;
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of body water) or has low sodium levels due to diuretics (water tablets), a low-salt diet, diarrhoea, vomiting, or haemofiltration;
• kidney disease or status post-kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying the only functioning kidney or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• elevated aldosterone levels (water and salt retention in the body together with electrolyte imbalance);
• systemic lupus erythematosus (SLE), also known as lupus, a disease in which the immune system attacks the body itself;
• the active ingredient hydrochlorothiazide may rarely cause reactions leading to vision disturbances and eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid buildup between the choroid and sclera) or increased intraocular pressure. These symptoms may occur from several hours to a week after taking Telmisartan HCT EGIS and, if untreated, may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, they may be at higher risk of developing this condition. Before starting Telmisartan HCT EGIS, discuss this with the doctor:
  • if the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems related to diabetes;
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section "When not to use Telmisartan HCT EGIS".
• if the patient is taking digoxin.

Inform the doctor if the patient is pregnant, suspects (or is planning) pregnancy. Use of
Telmisartan HCT EGIS is not recommended during early pregnancy and must not be taken
after the third month of pregnancy, as it may seriously harm the unborn child (see section
"Pregnancy").
If abdominal pain, nausea, vomiting, or diarrhoea occur after taking Telmisartan HCT EGIS, discuss
this with the doctor. The doctor will decide on further treatment. Do not stop taking
Telmisartan HCT EGIS on your own.
Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body.
Typical symptoms of fluid or electrolyte imbalance include dryness of the mucous membranes in the
mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting,
muscle fatigue, and abnormally rapid heartbeat (faster than 100 beats per minute). If any of these
symptoms occur, inform the doctor.
Also inform the doctor if skin becomes unusually sensitive to sunlight, such as sunburn (e.g. redness,
itching, swelling, blistering) occurring more easily than usual.
Before any planned surgery or anaesthesia, inform the doctor about taking Telmisartan HCT EGIS.
Telmisartan HCT EGIS may be less effective in lowering blood pressure in black patients.
Children and adolescents
Use of Telmisartan HCT EGIS is not recommended in children and adolescents under 18 years of age.
Telmisartan HCT EGIS and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as
any medicines the patient plans to take.
The doctor may decide to adjust the dose of these medicines or take other precautions. In some
cases, discontinuation of one of the medicines may be necessary.
This particularly applies to concomitant use of Telmisartan HCT EGIS with the following medicines:

• lithium preparations used to treat certain types of depression;
• medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics (water tablets), laxatives (e.g. castor oil), corticosteroids (e.g. prednisolone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium penicillin G (an antibiotic), salicylic acid and its derivatives;
• iodine-containing contrast agents used in imaging procedures;
• medicines that may increase blood potassium levels, e.g. potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicinal products such as sodium heparin (an anticoagulant);
• medicines affected by changes in blood potassium levels, such as cardiac glycosides (e.g. digoxin), medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used to treat psychiatric disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g. sparfloxacin, pentamidine), and certain medicines used to treat allergic reactions (e.g. terfenadine);
• medicines used for diabetes (insulin or oral agents such as metformin);
• cholestyramine and colestipol, lipid-lowering medicines;
• medicines that raise blood pressure, such as noradrenaline;
• muscle relaxants such as tubocurarine;
• calcium supplements and/or vitamin D;
• anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as adjuncts during anaesthesia), such as atropine and biperiden;
• amantadine (a medicine used for Parkinson's disease and also for treating or preventing certain viral infections);
• other medicines used to treat high blood pressure, corticosteroids, painkillers (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]), anticancer medicines, gout (e.g. allopurinol), or arthritis;
• ACE inhibitors or aliskiren (see also sections "When not to use Telmisartan HCT EGIS" and "Warnings and precautions");
• digoxin.

If the patient has had skin cancer or if unexpected skin changes occur during treatment. Treatment with hydrochlorothiazide, particularly long-term use of high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). While taking Telmisartan HCT EGIS, protect the skin from exposure to sunlight and UV radiation.

Telmisartan HCT EGIS may enhance the blood pressure-lowering effect of other medicines
used to treat high blood pressure or medicines with blood pressure-lowering properties (e.g.
baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol,
barbiturates, opioids, or antidepressants. Symptoms include dizziness upon standing. If dose
adjustment of another medicine taken during Telmisartan HCT EGIS treatment is needed, consult the
doctor.
The effect of Telmisartan HCT EGIS may be reduced when used concomitantly with NSAIDs (non-
steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen).
Taking Telmisartan HCT EGIS with food and alcohol
Telmisartan HCT EGIS can be taken with or without food. Avoid drinking alcohol until you have spoken
with your doctor. Alcohol may additionally lower blood pressure and/or increase the risk of dizziness
or fainting.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Inform the doctor if pregnancy is suspected (or planned). Usually, the doctor will recommend
stopping Telmisartan HCT EGIS before a planned pregnancy or immediately after confirming
pregnancy and will prescribe an alternative medicine. Use of Telmisartan HCT EGIS is not
recommended during pregnancy and must not be used after the third month of pregnancy, as it
may seriously harm the unborn child if used after 3 months of pregnancy.
Breastfeeding
Inform the doctor if breastfeeding or planning to breastfeed. Telmisartan HCT EGIS is not
recommended for breastfeeding women. The doctor may choose a different treatment if the patient
wishes to breastfeed.
Driving and operating machinery
Some patients taking Telmisartan HCT EGIS may experience dizziness, fainting, or vertigo. If such
side effects occur, do not drive or operate machinery.
Telmisartan HCT EGIS contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Telmisartan HCT EGIS

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
The recommended dose of Telmisartan HCT EGIS is one tablet daily. Try to take the tablet at the
same time each day. Telmisartan HCT EGIS may be taken during or between meals. Swallow the
tablets whole with water or a non-alcoholic drink. It is important to take Telmisartan HCT EGIS every
day, unless otherwise advised by your doctor.
If the patient has impaired liver function, the usual dose should not exceed 40 mg telmisartan and
12.5 mg hydrochlorothiazide per day.
Taking more Telmisartan HCT EGIS than recommended
If too many tablets are accidentally taken, symptoms such as low blood pressure and rapid heartbeat
may occur. Cases of slowed heart rate, dizziness, vomiting, worsening kidney function, including
kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, a marked drop
in blood pressure and low potassium levels in the blood may also occur, which could lead to nausea,
drowsiness, muscle cramps and/or cardiac arrhythmias, especially when used concomitantly with
medicines such as cardiac glycosides or certain antiarrhythmic drugs. Seek immediate medical
attention by contacting your doctor or going to the emergency department of the nearest hospital.
Missing a dose of Telmisartan HCT EGIS
If a dose is missed, take it as soon as remembered, on the same day. If a tablet is not taken on a
given day, take the usual dose the next day. Do not take a double dose to make up for a missed dose.
Stopping Telmisartan HCT EGIS
Do not stop taking Telmisartan HCT EGIS without consulting your doctor. Medicines used to treat
high blood pressure may need to be taken for life. If treatment with Telmisartan HCT EGIS is stopped,
blood pressure will return within a few days to the levels seen before treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and require immediate medical attention:
If any of the following symptoms occur, contact your doctor immediately:
Sepsis* (commonly known as blood poisoning, a severe infection with systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema, including fatal cases), blistering and peeling of the outer layer of skin (toxic epidermal necrolysis). These adverse reactions are rare (may occur in up to 1 in 1,000 patients) or very rare (in the case of toxic epidermal necrolysis, may occur in up to 1 in 10,000 patients), but are extremely serious. In such cases, treatment with this medicine must be discontinued immediately and medical advice must be sought without delay. If left untreated, these symptoms may result in death. An increased incidence of sepsis has been observed in patients receiving telmisartan monotherapy; however, it cannot be excluded in patients treated with Telmisartan HCT EGIS.
Possible adverse reactions of Telmisartan HCT EGIS:
Common adverse reactions (may occur in up to 1 in 10 patients):
Dizziness
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Decreased blood potassium levels, anxiety, fainting, tingling and numbness (paraesthesia), sensation of spinning, rapid heartbeat (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath (dyspnoea), diarrhoea, dryness of oral mucous membranes, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Lung inflammation (bronchitis), sore throat, sinusitis, increased uric acid levels, low sodium levels, feeling of sadness (depression), difficulty falling asleep (insomnia), sleep disturbances, visual disturbances, blurred vision, breathing difficulties, abdominal pain, constipation, bloating (dyspepsia), nausea (vomiting), inflammation of the stomach lining, abnormal liver function (more frequently observed in patients of Japanese origin), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain (leg pain), muscle cramps, activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rashes and fever), influenza-like symptoms, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase levels in blood.
Adverse reactions reported for one of the components may also occur during treatment with Telmisartan HCT EGIS, even if they were not observed in clinical trials of the product.

Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions have been observed:
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), urinary tract infections, cystitis, low red blood cell count (anaemia), high potassium levels, slow heart rate (bradycardia), kidney dysfunction, including acute kidney failure, fatigue, cough.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction), low blood glucose levels (in patients with diabetes), gastritis, skin disorders (including rash, skin eruptions, toxic skin eruptions), joint degeneration, tendon pain (symptoms mimicking tendonitis), decreased haemoglobin concentration (a blood protein), somnolence.
Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive fibrosis of lung alveoli (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from available data):
Intestinal angioedema – following administration of similar products, intestinal swelling has occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
*This phenomenon may be coincidental or related to a mechanism not yet understood.
**Cases of interstitial lung disease temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.

Hydrochlorothiazide
In patients receiving hydrochlorothiazide alone, the following additional adverse reactions have been observed:
Very common adverse reactions (may occur in more than 1 in 10 patients):
Elevated blood lipid levels.
Common adverse reactions (may occur in up to 1 in 10 patients):
Nausea, low blood magnesium levels, decreased appetite.
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
Acute kidney failure.
Rare adverse reactions (may occur in up to 1 in 1,000 patients):
Low platelet count (thrombocytopenia), leading to increased risk of bleeding or bruising (small purple-red spots on the skin or other tissues caused by bleeding), high blood calcium levels, headache, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), elevated bile substances in blood (cholestasis), photosensitivity reactions, uncontrolled blood glucose levels in patients with diagnosed diabetes, presence of sugar in urine (glucosuria).
Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Abnormal breakdown of red blood cells (haemolytic anaemia), inability of bone marrow to function properly, decreased white blood cell count (leukopenia, agranulocytosis), severe allergic reactions (e.g. hypersensitivity), increased pH due to low chloride levels in blood (acid-base imbalance, hypochloremic alkalosis), acute respiratory failure (symptoms include severe shortness of breath, fever, fatigue and confusion), pancreatitis, lupus-like syndrome (a condition mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), vasculitis (necrotizing vasculitis).
Frequency not known (frequency cannot be estimated from available data):
Sialadenitis, skin and lip malignancies (non-melanoma skin cancers), decreased blood cell counts (aplastic anaemia), visual disturbances and eye pain (possibly symptoms of fluid accumulation in the avascular membrane surrounding the eye — excessive accumulation of fluid between choroid and sclera — or acute angle-closure glaucoma), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering on lips, eyes and mouth, skin peeling, fever (possible symptoms of erythema multiforme), fatigue, kidney dysfunction.
In isolated cases, low sodium levels have occurred, accompanied by neurological or brain-related symptoms (nausea, progressive disorientation, lack of interest or energy).

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

5. How to store Telmisartan HCT EGIS

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister pack following EXP.
The expiry date refers to the last day of that month.
Aluminium/Aluminium blister
No special storage conditions required.
PVC/PVDC/Aluminium blister
Do not store above 30°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Telmisartan HCT EGIS contains

• The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The active substances are: telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• Other ingredients: magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium carboxymethyl starch (type A), microcrystalline cellulose, mannitol (E421).

What Telmisartan HCT EGIS looks like and contents of the pack
40 mg + 12.5 mg
White or almost white, oval-shaped, biconvex tablets measuring 6.55 x 13.6 mm,
with the imprint "TH" on one side.
80 mg + 12.5 mg
White or almost white, capsule-shaped tablets measuring 9.0 x 17.0 mm,
with the imprint "TH 12.5" on both sides.
80 mg + 25 mg
White or almost white, oval-shaped, biconvex tablets measuring 9.0 x 17.0 mm,
with the imprint "TH" on one side and "25" on the other side.
Pack sizes:
40 mg + 12.5 mg
14, 28, 30, 56, 84, 98 tablets.
80 mg + 12.5 mg, 80 mg + 25 mg
14, 28, 30, 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Egis Pharmaceuticals PLC
1106 Budapest, Keresztúri út 30-38.
Hungary
Manufacturers
Actavis Ltd.
BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000
Malta
Egis Pharmaceuticals PLC
1165 Budapest, Bökényföldi út 118-120.
Hungary
This medicinal product is authorised in the Member States of the European Economic Area under the following names: