Telmisartan 80mg. / 25 mg. 28 tablets

What is telmisartan / hydrochlorothiazide EGIS and what it is used
Telmisartan / hydrochlorothiazide EGIS is a combination of two active substances in one tablet - telmisartan and hydrochlorothiazide. Both substances help to control high blood pressure.
Telmisartan belongs to a group of medicines called receptor antagonists of angiotensin II. Angiotensin II is a substance produced in your body which causes blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so that the blood vessels relax and blood pressure is lowered;
Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause an increase in urine output, leading to a lowering of your blood pressure.
If left untreated, high blood pressure can damage blood vessels in several organs, which can sometimes lead to heart attacks, heart or kidney failure, stroke and blindness. Symptoms due to high blood pressure are not usually observed before damage occurs. It is therefore important to regularly measure blood pressure to verify if it is within normal limits.
Telmisartan / hydrochlorothiazide EGIS is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not controlled enough when either telmisartan used alone.

2. What you need to know before taking telmisartan / hydrochlorothiazide EGIS
No telmisartan / hydrochlorothiazide EGIS:
if you are allergic to telmisartan or any other ingredients of this medicine (listed in section 6);
if you are allergic to hydrochlorothiazide or other medicines sulfonamide-derived;
if you are pregnant after the third month (better to avoid the use of telmisartan / hydrochlorothiazide EGIS and in early pregnancy - see "Pregnancy");
if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease;
if you suffer from severe kidney disease;
if your doctor determines that you have low potassium levels or high calcium levels in the blood, which do not improve with treatment.
Tell your doctor or pharmacist before taking Telmisartan / hydrochlorothiazide EGIS if any of the above applies to you.

Warnings and Precautions
Talk to your doctor if you suffer or have ever suffered from any of the following conditions or illnesses:
low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy (water tablets), a diet low in salt, diarrhea, vomiting or hemodialysis;
kidney disease or kidney transplant;
renal artery stenosis (narrowing of the blood vessels to one or both kidneys);
liver disease;
heart problems;
diabetes;
gout;
elevated levels of aldosterone (retention of water and salts in the body, accompanied by imbalance of other minerals in the blood);
systemic lupus erythematosus (also known as "lupus" or "(SLE"), a disease in which the immune system attacks its own body.
You should tell your doctor if you think you are (or might become) pregnant.
Telmisartan / hydrochlorothiazide EGIS is not recommended in early pregnancy and must not be taken after the third month of pregnancy because it may cause serious harm to your baby if used at that stage (see "Pregnancy").
Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea (feeling sick), vomiting, muscle fatigue and palpitations (more than 100 beats per minute). You should tell your doctor if you experience any of these symptoms.
You should also tell your doctor if you experience an increased sensitivity of the skin and sun exposure, with symptoms of sunburn (eg. Redness, itching, swelling, rash), which occur more frequently than usual.
In case of surgery or anesthesia, you should tell your doctor that you are taking telmisartan / hydrochlorothiazide ETEC.
Telmisartan / hydrochlorothiazide EGIS may be less effective in lowering blood pressure in black patients.

Children and adolescents
Not recommended the use of telmisartan / hydrochlorothiazide EGIS in children and adolescents up to 18 years.

Other medicines and telmisartan / hydrochlorothiazide EGIS
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. You may need your doctor to change the dose of these other medications or take other precautions. In some cases it may be necessary to stop using any of the drugs. This applies especially to the medicines listed below, when used simultaneously with telmisartan / hydrochlorothiazide EGIS:
medicines containing lithium used to treat certain types of depression;
drugs associated with low blood potassium (hypokalaemia) such as other diuretics (water tablets), laxatives (eg castor oil), corticosteroids (such as prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treatment of mouth ulcers), penicillin G sodium (an antibiotic), salicylic acid and its derivatives;
potassium-sparing diuretics, potassium supplements, potassium containing salt substitutes, ACE inhibitors that may increase the level of potassium in the blood;
heart medicines (eg digoxin) or medicines to control heart rhythm (eg quinidine, disopyramide);
drugs used in mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine);
other drugs used to treat high blood pressure, steroids, painkillers, drugs for treating cancer, arthritis and gout or supplements with vitamin D.
Telmisartan / hydrochlorothiazide EGIS can increase the effect of lowering blood pressure other medicines and you should consult with your doctor if you need to adjust the dose of the other medicine while taking telmisartan / hydrochlorothiazide EGIS.
The effects of telmisartan / hydrochlorothiazide EGIS may be reduced when administered with NSAIDs (nonsteroidal anti-inflammatory drugs such as aspirin or ibuprofen).

Pregnancy and lactation
Pregnancy
You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Telmisartan / hydrochlorothiazide EGIS before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan / hydrochlorothiazide EGIS. Telmisartan / hydrochlorothiazide EGIS is not recommended in early pregnancy and must not be taken if you are pregnant after the third meat because it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Telmisartan / hydrochlorothiazide EGIS is not recommended for use by mothers who are breastfeeding, and your doctor may prescribe another treatment if you want to breast-feed, especially if your baby is newborn, or born prematurely.

Driving and using machines
Some people feel dizzy or tired when taking telmisartan / hydrochlorothiazide EGIS. If you feel dizzy or tired, do not drive or operate machinery.

3. How to take telmisartan / hydrochlorothiazide EGIS
Always take Telmisartan / hydrochlorothiazide EGIS exactly as your doctor has told you.
If you're not sure, ask your doctor or pharmacist.

The recommended dose of telmisartan / hydrochlorothiazide EGIS is one tablet daily. Try to take the tablet at the same time each day. You can take Telmisartan / hydrochlorothiazide EGIS with or without food. The tablets should be swallowed with some water or other soft drink. It is important to take
Telmisartan / hydrochlorothiazide EGIS every day until your doctor tells you otherwise.
If your liver is not working properly, the usual dose should not exceed 40 mg / 12,5 mg once daily.

If you take more dose of telmisartan / hydrochlorothiazide EGIS
If you accidentally take too many tablets contact your doctor, pharmacist or nearest emergency center.

If you forget to take Telmisartan / hydrochlorothiazide EGIS
If you forget to take a dose, do not worry. Take it as soon as you remember and then carry on as before. If you do not take your tablet on one day, take your normal dose the next day. Do not take a double dose to make up the missed dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and require immediate medical attention.
Tell your doctor if you experience any of the following symptoms:
Sepsis * (often called "blood poisoning", is a severe infection with inflammation throughout the body), rapid swelling of the skin and mucosa (angioedema); these side effects are rare (may affect up to 1 in 1000 people) but very serious. Patients should stop taking the drug immediately and consult a doctor. If not treated, these reactions can be fatal. Increased incidence of sepsis was observed with telmisartan only, but can not be excluded in the telmisartan / hydrochlorothiazide EGIS.
Possible side effects to telmisartan / hydrochlorothiazide EGIS:
Common side effects (may affect up to 1 in 10 people):
Dizziness.
Uncommon side effects (may affect up to 1 in 100 people):
decreased levels of potassium in the blood, anxiety, fainting (syncope), sensation of tingling and numbness in the extremities (paraesthesia), dizziness (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when standing, shortness of breath (dyspnoea), diarrhea, dry mouth, flatulence, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain, increased levels of uric acid in the blood .
Rare side effects (may affect up to 1 in 1000 people):
inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks its own body, which causes joint pain, skin rash and fever), sore throat, inflamed sinuses, feeling sad (depression ), insomnia (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), nausea, inflammation of the stomach (gastritis), abnormal liver function (in Japanese patients are more likely to development of this side effect), rapid swelling of the skin and mucous membranes, which can lead to death (angioedema also with fatal outcome), redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like illness, pain, increased levels of uric acid, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Adverse reactions reported for each component may have potential side effects of telmisartan / hydrochlorothiazide EGIS, even if not observed in clinical trials with this product.
Telmisartan
The following additional adverse reactions were reported in patients taking telmisartan alone:
Uncommon side effects (may affect up to 1 in 100 people):
infection of upper respiratory tract infections (eg sore throat, inflamed sinuses, common cold), urinary tract infection, reduced number of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute renal failure, weakness, cough.
Rare side effects (may affect up to 1 in 1000 people):
Sepsis * (often called "blood poisoning" is a severe infection with an inflammatory process in the whole body, which can lead to death), low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), serious allergic reactions (eg hypersensitivity, anaphylactic reaction, drug rash), reduced blood sugar levels (in diabetic patients), upset stomach, skin disorders (including eczema, drug eruption, toxic skin rash), arthrosis, inflammation of the tendons, decreased hemoglobin (a blood protein), somnolence.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissues (interstitial lung disease) **.
* Event may be a chance or could be related to a mechanism currently.
** Cases of progressive scarring of lung tissue have been reported during administration of telmisartan. It is unknown, however, whether the reason is telmisartan.

Hydrochlorothiazide
The following additional adverse reactions were reported in patients receiving hydrochlorothiazide only:
Side effects with unknown frequency (based on available data can not assess the frequency):
Inflammation of the salivary glands, low blood counts, including low red and white blood cells, reduced platelet count (thrombocytopenia); serious allergic reactions (eg hypersensitivity, anaphylactic reaction), changing levels of glucose in the blood, if you suffer from diabetes, decreased or loss of appetite; restlessness, light-headedness, blurred or yellowing of vision, inflammation of the blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition resembling a disease called systemic lupus erythematosus in which the immune system attacks its own body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, or blistering and peeling of the top layer of skin (toxic epidermal necrolysis), weakness, kidney inflammation or impaired kidney function, the presence of glucose in the urine (glycosuria) fever, electrolyte imbalance, elevated cholesterol levels in the blood, decreased blood volume, increased levels of glucose or lipids in the blood.
If you get any side effects, contact your doctor or pharmacist. This includes all listed in this leaflet.

5. How to store telmisartan / hydrochlorothiazide EGIS
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.

For blister Al / Al:
This medicine does not require any special storage conditions.

For blisters Al / PVC / PVDC:
Do not store above 30 ° C.

Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of the drugs they no longer need. These measures will help to protect the environment.

6. Contents of the pack and other information
What telmisartan / hydrochlorothiazide EGIS
The active substances are telmisartan / telmisartan / hydrochlorothiazide / hydrochlorothiazide /. Each tablet contains 40 mg telmisartan and 12,5 mg hydrochlorothiazide;
The active substances are telmisartan / telmisartan / hydrochlorothiazide / hydrochlorothiazide /. Each tablet contains 80 mg telmisartan and 12,5 mg hydrochlorothiazide;
The active substances are telmisartan / telmisartan / hydrochlorothiazide / hydrochlorothiazide /. Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide;
The other ingredients are magnesium stearate (E470b), potassium hydroxide, meglumine, povidone, sodium starch glycolate (type A), microcrystalline cellulose, mannitol (E421).
How does Telmisartan / hydrochlorothiazide EGIS and contents of the pack
Telmisartan / hydrochlorothiazide EGIS 40 mg / 12,5 mg tablets are white or almost white, size 6-55 x 13,6 mm, oval and double-convex shape marked "TH" on one side.
Telmisartan / hydrochlorothiazide EGIS 80 mg / 12,5 mg tablets are white or almost white, size 9,0 x 17,0 mm, capsule-shaped and marked "TN 12.5" on both sides.
Telmisartan / hydrochlorothiazide EGIS the 80 mg / 25 mg tablets are white or almost white, size 9,0 x 17,0 mm, oval and double-convex shape marked "TH" on one side and "25" on the other side .
Packs
Pack sizes: 14, 28, <and> 56, 84 and 98 tablets.