TELMISARTAN 40 mg /12.5 Mg Tablets

Зміст інструкції

1. Telmisartan and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets
   1. What Telmisartan and Hydrochlorothiazide Teva Italia is and what it is used for
   2. What you need to know before taking Telmisartan and Hydrochlorothiazide Teva Italia
   3. How to take Telmisartan and Hydrochlorothiazide Teva Italia
2. Telmisartan and Hydrochlorothiazide Teva Italia with or without food. The tablets must be
3. Telmisartan and Hydrochlorothiazide Teva Italia every day until your doctor tells you otherwise
   1. Possible side effects
   2. How to store Telmisartan and Idroclorotiazide Teva Italia
   3. Contents of the pack and other information
4. Telmisartan and Hydrochlorothiazide Teva Italia 80 mg/25 mg tablets are white or

Telmisartan and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg tablets, 80 mg/12.5 mg tablets, 80 mg/25 mg tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Telmisartan and Hydrochlorothiazide Teva Italia is and what it is used for
• 2. What you need to know before you take Telmisartan and Hydrochlorothiazide Teva Italia
• 3. How to take Telmisartan and Hydrochlorothiazide Teva Italia
• 4. Possible side effects
• 5. How to store Telmisartan and Hydrochlorothiazide Teva Italia
• 6. Contents of the pack and other information

1. What Telmisartan and Hydrochlorothiazide Teva Italia is and what it is used for

Telmisartan and Hydrochlorothiazide Teva Italia is a combination of two active ingredients, telmisartan
and hydrochlorothiazide in a single tablet. Each of these substances helps to control
high blood pressure.

• Telmisartan belongs to a group of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance present in the body that causes the constriction of blood vessels, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, causing a relaxation of the blood vessels and thus reducing blood pressure.
• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics which cause an increase in urine flow, contributing to the reduction of blood pressure.

Hypertension, if left untreated, can damage blood vessels in many organs, which can
sometimes cause heart attack, heart failure or kidney failure, stroke or blindness. Normally
hypertension does not give symptoms before such damage occurs. Therefore, it is important
to have your blood pressure measured regularly to check if it is
within the normal range.
[ For 40 mg/12.5 mg and 80 mg/12.5 mg:]

Telmisartan and Hydrochlorothiazide Teva Italia is used totreat high blood
pressure (essential hypertension) in adults in whom blood pressure is not
sufficiently controlled by telmisartan used alone.
[ For 80 mg/25 mg:]

Telmisartan and Hydrochlorothiazide Teva Italia is used totreat high blood
pressure (essential hypertension) in adults in whom blood pressure is not
adequately controlled by Telmisartan and Hydrochlorothiazide Teva Italia 80/12.5 mg or in
patients whose blood pressure has previously been stabilized by telmisartan and
hydrochlorothiazide administered separately.

2. What you need to know before taking Telmisartan and Hydrochlorothiazide Teva Italia

Do not take Telmisartan and Hydrochlorothiazide Teva Italia

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or any other medicine derived from sulfonamide.
• if you are pregnant for more than 3 months. (It is best to avoid taking Telmisartan and Hydrochlorothiazide Teva Italia even in the early stages of pregnancy - see the pregnancy section).
• if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you have severe kidney disease.
• if your doctor determines that the levels of potassium in your blood are low or the levels of calcium are high and do not improve following treatment.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

If any of these conditions apply to you, tell your doctor or pharmacist before taking
Telmisartan and Hydrochlorothiazide Teva Italia.

Warnings and precautions
Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Teva Italia if you suffer or
have suffered from any of the following conditions or illnesses:

• Low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic therapy (diuretics), a low-salt diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels of one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals in the blood).
• Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease in which the body’s immune system attacks the body itself.
• The active ingredient hydrochlorothiazide can cause an uncommon reaction, resulting in decreased vision and eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and can occur from hours to weeks after taking Telmisartan and Hydrochlorothiazide Teva Italia. This condition can lead to permanent visual impairment if not treated.
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Telmisartan and Hydrochlorothiazide Teva Italia.

Talk to your doctor before taking Telmisartan and Hydrochlorothiazide Teva Italia:

• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the section "Do not take Telmisartan and Hydrochlorothiazide
Teva Italia"

• if you are taking digoxin.

You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). Telmisartan and Hydrochlorothiazide Teva Italia is not recommended
in early pregnancy and must not be taken if you are pregnant for more than 3
months, as it can cause serious harm to the baby if taken during this period (see the
pregnancy section).
Treatment with hydrochlorothiazide can cause an electrolyte imbalance in the 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 an abnormally fast heartbeat (more than 100 beats per minute). If you experience any of these symptoms,
tell your doctor.
You should also tell your doctor if you have noticed an increased sensitivity of the skin to the sun,
which manifests as a more rapid onset than normal of sunburn symptoms (such as
redness, itching, swelling, blistering).
In case of surgery or administration of anesthetics, you must inform your doctor
that you are
taking Telmisartan and Hydrochlorothiazide Teva Italia.
Telmisartan and Hydrochlorothiazide Teva Italia may be less effective in reducing blood
pressure in patients of African ethnicity.
For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in positive doping tests.

Children and adolescents
The use of Telmisartan and Hydrochlorothiazide Teva Italia is not recommended in children and
adolescents up to 18 years of age.

Other medicines and Telmisartan and Hydrochlorothiazide Teva Italia
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicines. Your doctor may decide to change the dose of these
other medicines or take other precautions. In some cases, it may be necessary
to stop taking one of these medicines. This applies especially to the medicines
listed below, taken at the same time as Telmisartan and Hydrochlorothiazide Teva
Italia:

• Medicines containing lithium to treat certain types of depression.
• Medicines associated with low blood potassium levels (hypokalemia) such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (antifungal medicine), carbenoxolone (used for the treatment of mouth ulcers), sodium penicillin G (antibiotic), salicylic acid and its derivatives.
• Medicines that can increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporine (an immunosuppressant drug) and other medicines such as sodium heparin (anticoagulant).
• Medicines that are affected by changes in blood potassium levels such as heart medicines (e.g. digoxin) or medicines to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medicines such as some antibiotics (e.g. sparfloxacin, pentamidine) or some medicines for the treatment of allergic reactions (e.g. terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medicines to lower blood fat levels.
• Medicines to increase blood pressure, such as norepinephrine.
• Muscle relaxant medicines, such as tubocurarine.
• Calcium supplements and/or vitamin D supplements.
• Anticholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease and as an aid to anesthesia) such as atropine and biperiden.
• Amantadine (medicine used for the treatment of Parkinson's disease and also used to treat or prevent certain diseases caused by viruses).
• Other substances used to treat high blood pressure, corticosteroids, pain relievers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for the treatment of cancer, gout or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the section: "Do not take Telmisartan and Hydrochlorothiazide Teva Italia" and "Warnings and precautions”).
• Digoxin.

Telmisartan and Hydrochlorothiazide Teva Italia can increase the effect of other medicines used to
lower blood pressure or medicines that can potentially lower blood
pressure (e.g. baclofen, amifostine). In addition, the lowering of blood
pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may
notice this lowering of blood pressure as dizziness when getting up. Consult your doctor
if you need to change the dose of other medicines while taking Telmisartan and
Hydrochlorothiazide Teva Italia.
The effect of Telmisartan and Hydrochlorothiazide Teva Italia may be reduced when you take
NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin and ibuprofen).

Telmisartan and Hydrochlorothiazide Teva Italia with food and alcohol
You can take Telmisartan and Hydrochlorothiazide Teva Italia with or without food.
Avoid drinking alcohol until you have spoken to your doctor. Alcohol can
further lower blood pressure and/or increase the risk of dizziness or
feeling faint.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of
becoming pregnant). As a rule, your doctor will advise you to stop taking
Telmisartan and Hydrochlorothiazide Teva Italia before becoming pregnant or as soon as you
find out you are pregnant and will advise you to take another
medicine instead of Telmisartan and Hydrochlorothiazide Teva Italia.
Telmisartan and Hydrochlorothiazide Teva Italia is not recommended during pregnancy and
must not be taken if you are pregnant for more than 3 months as it can cause serious
harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Telmisartan and
Hydrochlorothiazide Teva Italia is not recommended for women who are breastfeeding and
your doctor may choose another treatment for you if you want to breastfeed.

Driving and using machines
Some patients may experience dizziness or fatigue when taking Telmisartan and
Hydrochlorothiazide Teva Italia. If you experience these effects, do not drive or use machines.

3. How to take Telmisartan and Hydrochlorothiazide Teva Italia

Take this medicine following the instructions of your doctor exactly. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan and Hydrochlorothiazide Teva Italia is one tablet a
day. Try to take the tablet at the same time each day. You can take

Telmisartan and Hydrochlorothiazide Teva Italia with or without food. The tablets must be

swallowed with some water or other non-alcoholic beverage. It is important to take

Telmisartan and Hydrochlorothiazide Teva Italia every day until your doctor tells you otherwise

Unless your liver is not functioning properly, the usual dose of 40 mg/12.5 mg once a day should not be exceeded.
of
40 mg/12.5 mg once a day.

If you take more Telmisartan and Hydrochlorothiazide Teva Italia than you should
If you have accidentally taken too many tablets, you may experience symptoms such as low
blood pressure and a rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney
function including renal failure have also been reported. Due to the hydrochlorothiazide
component, markedly low blood pressure and low blood potassium levels may also occur,
which can cause nausea, drowsiness and muscle cramps and/or irregular heartbeat
associated with the concomitant use of drugs such as digoxin or certain anti-arrhythmic
treatments. Contact your doctor or pharmacist immediately, or the emergency room of the
nearest hospital.

If you forget to take Telmisartan and Hydrochlorothiazide Teva Italia
If you forget to take the medicine, do not worry. Take it as soon as you remember, then
continue as before. If you miss a dose one day, take the normal dose the next day. Do not
take a double dose to make up for a forgotten dose. If you have any doubts about using this
medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Some side effects may be serious and require immediate medical attention:
You should see a doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood infection") is a serious infection with inflammatory
response of the whole body, rapid swelling of the skin and mucous membranes (angioedema), blisters and
shedding of the upper layer of the skin (toxic epidermal necrolysis); these side
effects are rare (may affect up to 1 in 1,000 people) or with unknown frequency
(toxic epidermal necrolysis), but are extremely serious and patients should
stop taking the medicine and consult a doctor immediately. If
these effects are not treated they can be fatal. An increase in the incidence of sepsis has
been observed with telmisartan alone, however, it cannot be excluded for Telmisartan and
Idroclorotiazide Teva Italia.

Possible side effects of Telmisartan and Idroclorotiazide Teva Italia:
Common side effects (may affect up to 1 in 10 people):
Dizziness
Uncommon side effects (may affect up to 1 in 100 people):
Reduced potassium levels in the blood, anxiety, fainting (syncope), sensation of
numbness, tingling sensation (paresthesia), sensation of spinning (vertigo),
fast heartbeat (tachycardia), heart rhythm disorders, low blood pressure, sudden drop in blood pressure when getting up, shortness of breath (dyspnea),
diarrhea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Inflammation of the lungs (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the immune system attacks the body
itself, causing joint pain, rash and fever), sore throat, sinusitis,
feeling of sadness (depression), difficulty falling asleep (insomnia), altered vision,
difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling of
illness (vomiting), inflammation of the stomach (gastritis), abnormal liver function (patients
of Japanese origin are more likely to experience this side effect),
redness of the skin (erythema), allergic reactions such as itching or rash,
increased sweating, hives, joint pain (arthralgia) and pain in the extremities, muscle cramps,
flu-like illness, pain, low sodium levels, increased creatinine
levels, liver enzymes or creatine phosphokinase present in the blood.
Adverse reactions reported with one of the individual components may be potential
adverse reactions with Telmisartan and Idroclorotiazide Teva Italia, even if not observed in
clinical studies with this product.

Telmisartan
The following additional side effects have been found in patients treated with telmisartan alone:
Uncommon side effects (may affect up to 1 in 100 people):
Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold),
urinary tract infections, reduced red blood cells (anemia), high potassium levels, slowed heartbeat (bradycardia), impaired kidney function including acute renal failure,
feeling of weakness, cough.
Rare side effects (may affect up to 1 in 1,000 people):
Low platelet count (thrombocytopenia), increase in some white blood cells (eosinophilia),
severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), stomach upset, skin disorders (including eczema, drug eruption, toxic epidermal rash), osteoarthritis,
inflammation of the tendons, decreased hemoglobin (a blood protein),
drowsiness.
Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of the lung tissue (interstitial lung disease)**.
*The event may have occurred by chance or may be related to a currently unknown mechanism.
**Cases of progressive scarring of the lung tissue have been reported during
taking telmisartan. However, it is not known whether telmisartan was the cause.

Idroclorotiazide
The following additional side effects have been found in patients treated with hydrochlorothiazide alone:
Common side effects (may affect up to 1 in 10 people):
Feeling unwell (nausea), low magnesium levels in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Reduced platelets in the blood which increases the risk of bleeding or bruising (small reddish-purple spots on the skin or other tissues caused by bleeding), high calcium levels in the
blood, headache.
Very rare side effects (may affect up to 1 in 10,000 people):
Increased pH (disturbed acid-base balance) due to low chloride levels in the
blood.
Side effects of unknown frequency (frequency cannot be estimated based on the
available data):
Inflammation of the salivary glands, skin cancer and lips (non-melanoma skin cancer), decreased number of blood cells, including
decrease in red blood cells and white blood cells, severe allergic reactions (e.g.
hypersensitivity, anaphylactic reaction), irregular blood sugar levels if you suffer from
diabetes, decreased or loss of appetite, restlessness, dizziness, blurred or
yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma
acute), inflammation of blood vessels (necrotizing vasculitis),
inflammation of the pancreas, stomach upset, yellowing of the skin or eyes
(jaundice), lupus-like syndrome (a condition that mimics a disease called systemic lupus erythematosus because the immune system attacks the body itself);
skin disorders such as inflammation of the blood vessels in the skin, increased sensitivity
to sunlight, rash, redness of the skin, appearance of blisters on the lips, eyes or mouth, peeling of the skin, fever (possible sign of erythema
multiforme), feeling of weakness, inflammation of the kidneys or altered kidney function,
glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, reduced blood volume, increased glucose levels in the blood,
difficulty controlling blood/urine glucose levels in patients diagnosed with
diabetes mellitus, or fats in the blood.

Reporting side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects
directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you
can help provide more information on the safety of this medicine.

5. How to store Telmisartan and Idroclorotiazide Teva Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after
“Exp.”. The expiry date refers to the last day of that month.
[ For Al/Al blisters and HDPE tablet containers:]
This medicine does not require special storage conditions.
[ For Tristar Al/PVDC blisters:]
Do not store above 30 °C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Telmisartan and Hydrochlorothiazide Teva Italia contains

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg telmisartan and 12.5 mg of hydrochlorothiazide.
• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
• The active ingredients are telmisartan and 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).

Description of the appearance of Telmisartan and Hydrochlorothiazide Teva Italia
Telmisartan and Hydrochlorothiazide Teva Italia 40 mg/12.5 mg tablets are white or
almost white, oval shaped 6.55 x 13.6 mm and biconvex marked with "TH" on one
side.
Telmisartan and Hydrochlorothiazide Teva Italia 80 mg/12.5 mg tablets are white or
almost white, capsule-shaped, 9.0 x 17.0 mm marked with "TH 12.5" on both
sides.

Telmisartan and Hydrochlorothiazide Teva Italia 80 mg/25 mg tablets are white or

almost white, oval in shape, 9.0 x 17.0 mm, biconvex marked with "TH" on one side
and “25” on the other side.

Pack sizes
Blister packs: 14, 28, and 56, 84 and 98 tablets
Tablet container: 30, 90 and 250 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milano

Manufacturer
Merckle GmbH Ludwig-Merckle-Str. 3, 89143 Blaubeuren Germany
Actavis Ltd .BLB 016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem Netherlands

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Denmark Mogilarta
Germany Telmisartan comp. ratiopharm
Italy Telmisartan and Hydrochlorothiazide Teva Italia
Hungary Telmisartan/HCT-Teva
Czech Republic Telmisartan/hydrochlorothiazid Teva

This leaflet was last updated on