TELMISARTAN 20 mg Tabletka Powlekana

Treść ulotki

1. Telmisartan Sandoz 20 mg tablets, 40 mg tablets, 80 mg tablets
   1. What Telmisartan Sandoz is and what it is used for
   2. What you need to know before taking Telmisartan Sandoz
   3. How to take Telmisartan Sandoz
   4. Possible side effects
   5. How to store Telmisartan Sandoz
   6. Contents of the pack and other information

Telmisartan Sandoz 20 mg tablets, 40 mg tablets, 80 mg tablets

Generic medicine
Read this leaflet carefully before 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 they have the same symptoms as you, as it may 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 Sandoz is and what it is used for
2 What you need to know before you take Telmisartan Sandoz
3 How to take Telmisartan Sandoz
4 Possible side effects
5 How to store Telmisartan Sandoz
6 Contents of the pack and other information

1. What Telmisartan Sandoz is and what it is used for

Telmisartan Sandoz belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced by the body that causes blood vessels to constrict, thereby increasing blood pressure.
Telmisartan Sandoz blocks the effect of angiotensin II, so that blood vessels can
relax, resulting in a decrease in blood pressure.
Telmisartan Sandoz is usedto treat essential hypertension (high blood
pressure) in adults. The term “essential” means that the high blood pressure is not caused by other
conditions.
If left untreated, high blood pressure can damage blood vessels in various organs, which can sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. Typically, no
symptoms of high blood pressure appear before such damage occurs. Therefore, it is
important to measure blood pressure regularly to ensure that it is within normal limits.

Telmisartan Sandoz is also usedto reduce cardiovascular events (for example
heart attack or stroke) in adults at risk due to reduced or blocked blood flow to the heart or legs, or because they have had a stroke or suffer from high-risk diabetes. Your doctor will tell you if you are at high risk for these events.

2. What you need to know before taking Telmisartan Sandoz

DO NOT take Telmisartan Sandoz

• if you are allergicto telmisartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant for more than three months. (It is best to avoid Telmisartan Sandoz even in the early stages of pregnancy - see section Pregnancy)
• 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 suffer from diabetesor your kidney function is impairedand are being treated witha medicine that lowers blood pressure, containing aliskiren

If any of the above conditions apply to you, tell your doctor or pharmacist
before taking Telmisartan Sandoz.

Warnings and precautions
If you suffer from or have suffered in the past from any of the following disorders or diseases, tell your
doctor:

• kidney disease or kidney transplant
• stenosis of the renal artery (narrowing of the blood vessels of one or both kidneys)
• liver disease
• heart problems
• increased levels of aldosterone (retention of water and salt in the body, as well as an imbalance of various minerals in the blood)
• low blood pressure (hypotension), which is more likely to occur in case of dehydration (excessive loss of body fluids), or if you suffer from salt deficiency, due to diuretic therapy, a low-salt diet, diarrhea or vomiting
• high levels of potassium in the blood
• diabetes.

Consult your doctor before taking Telmisartan Sandoz:

• 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
• if you are taking digoxin.

The doctor may check your kidney function, blood pressure and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take Telmisartan Sandoz”.
You must tell your doctor if you think you may be pregnant(or if there is a possibility of starting a pregnancy). Telmisartan Sandoz is not recommended in the early stages of pregnancy and
must not be taken if you are pregnant for more than three months, as it can cause serious
harm to the baby if taken during this period (see section Pregnancy).
If you are to be subjected to surgeryor anesthesia, tell your doctor that you are taking
Telmisartan Sandoz.
Telmisartan Sandoz may be less effective in reducing blood pressure in patients of
color.

Children and adolescents
The use of Telmisartan Sandoz in childrenand adolescents up to 18 years of age is not recommended.

Other medicines and Telmisartan Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
The doctor may need to adjust your dose and/or take other precautions. In some
cases it may be necessary to stop taking one of these medicines, particularly
with regard to the medicines listed below when they are taken in combination with
Telmisartan Sandoz:

• medicines containing lithium, used to treat some types of depression
• medicines that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (such as cyclosporine or tacrolimus) and the antibiotic trimethoprim
• diuretics which, especially if taken at high doses together with Telmisartan Sandoz, can induce excessive loss of body fluids and low blood pressure (hypotension)
• an ACE inhibitor or aliskiren, (see also what is stated in the section “Do not take Telmisartan Sandoz” and “Warnings and precautions”)
• digoxin.

The effect of Telmisartan Sandoz may be reduced when it is taken in combination with
NSAIDs (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid or ibuprofen) or
corticosteroids.
Telmisartan Sandoz can increase the effect of reducing blood pressure of other
medicines used to treat hypertension, or of medicines that lower blood pressure (e.g. baclofen, amifostine). Furthermore, low blood pressure may be aggravated
by alcohol, barbiturates, narcotics or antidepressants. You may notice this in the form of dizziness when
you stand up. You should consult your doctor if you need an adjustment of the dose of another
medicine while taking Telmisartan Sandoz.

Telmisartan Sandoz with food and drink
You can take Telmisartan Sandoz with or without food.

Pregnancy and breastfeeding

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). As a rule, your doctor will advise you to stop taking
Telmisartan Sandoz before becoming pregnant or as soon as you find out you are
pregnant and will advise you to take another medicine instead of Telmisartan
Sandoz.
Telmisartan Sandoz is not recommended in the early stages of pregnancy, and must notbe taken if
you are pregnant for more than three 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 if you are planning to start breastfeeding. Telmisartan Sandoz is not
recommended for mothers who are breastfeeding and your doctor may choose another treatment if
you wish to breastfeed, especially if your baby is newly born or was born prematurely.

Driving and using machines
During treatment with Telmisartan Sandoz, some patients experience dizziness or fatigue. If
you experience dizziness or fatigue, do not drive or operate machinery.

Telmisartan Sandoz contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking
this medicine.
Telmisartan Sandoz contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is
essentially ‘sodium-free’.

3. How to take Telmisartan Sandoz

Take Telmisartan Sandoz following your doctor’s instructions exactly. If you have any doubts
consult your doctor or pharmacist.
The recommended dose of Telmisartan Sandoz is one tablet a day.

• Try to take the tablet each day at the same time.
• You can take Telmisartan Sandoz with or without food.
• The tablets must be swallowed with water or another non-alcoholic beverage.
• It is important that you take Telmisartan Sandoz every day, until your doctor tells you otherwise.
• If you feel that the effects of Telmisartan Sandoz are too strong or too weak, consult your doctor or pharmacist.
• Tablets with a fracture line can be divided into two equal halves.

For the treatment of high blood pressure, the usual dose of Telmisartan Sandoz for
most patients is one 40 mg tablet once a day to control the
blood pressure for a period of 24 hours. Sometimes, however, your doctor may recommend a lower dose (20 mg), or a higher dose (80 mg).
Telmisartan Sandoz can also be used in combination with diuretics such as hydrochlorothiazide, which
has been shown to have an additive effect on lowering blood pressure when
used in combination with Telmisartan Sandoz.
For the reduction of cardiovascular events, the usual dose of Telmisartan Sandoz is one
80 mg tablet once a day. At the beginning of preventive therapy with Telmisartan
Sandoz 80 mg, blood pressure should be checked frequently.

Use in children
The use of Telmisartan Sandoz in childrenand adolescents up to 18 years of age is not recommended.

Use in hepatic impairment
If your liver is not functioning properly, the usual dose should not exceed 40 mg once
a day.

Use in renal impairment
In patients with renal impairment, no dosage adjustment is necessary.
If you suffer from severe renal impairment or are undergoing hemodialysis, your
doctor may prescribe you a lower starting dose (20 mg).

If you take more Telmisartan Sandoz than you should
If you accidentally take an excessive amount of tablets, contact your doctor or pharmacist immediately,
or the emergency room of the nearest hospital.

If you forget to take Telmisartan Sandoz
If you forget to take a dose, do not worry. Take it as soon as you remember, then
continue with your normal dosage. If you miss a tablet one day, take your normal dose the next day. Do nottake a double dose to make up for a missed dose.

If you stop taking Telmisartan Sandoz
If you wish to stop taking this medicinal product, always consult your doctor.
Even if you feel well, you may need to continue taking this medicine.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Sandoz can cause side effects, although not everybody gets them.

Some side effects may worsen and require immediate medical attention:
You should immediately consult a doctor if you experience any of the following symptoms:
Sepsis* (often called “blood poisoning”, is a serious infection with inflammatory response from the whole organism) and rapid swelling of the skin and mucous membranes
(angioedema); these side effects are rare (may affect up to 1 in 1000 patients),
but they are also extremely serious and patients should therefore stop taking the
medicine and consult their doctor immediately. If left untreated, these effects can
be fatal.

Possible side effects
Common side effects(may affect up to 1 in 10 people):

• low blood pressure (hypotension) in patients treated for the reduction of cardiovascular events

Uncommon side effects(may affect up to 1 in 100 people):

• urinary tract infections
• upper respiratory tract infections (such as sore throat, sinusitis, common cold)
• low red blood cell count (anemia)
• high potassium levels
• difficulty sleeping (insomnia)
• feeling of sadness (depression)
• fainting (syncope)
• feeling of dizziness (vertigo)
• slow heartbeat (bradycardia)
• low blood pressure (hypotension) in patients treated for hypertension
• dizziness when getting up (orthostatic hypotension)
• shortness of breath
• cough
• abdominal pain
• diarrhea
• abdominal discomfort
• swelling
• vomiting
• itching
• increased sweating
• drug rash
• back pain
• muscle cramps
• muscle pain (myalgia)
• impaired kidney function, including acute renal failure
• chest pain
• feeling of weakness
• increased creatinine levels in the blood

Rare side effects(may affect up to 1 in 1000 people):

• sepsis* (often called “blood poisoning”, is a serious infection with inflammatory response from the whole organism, which can lead to death)
• increased count of some white blood cells (eosinophilia)
• low platelet count (thrombocytopenia)
• severe allergic reaction (anaphylactic reaction)
• allergic reaction (such as rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure)
• low blood sugar levels (in diabetic patients)
• feeling of anxiety
• drowsiness
• impaired vision
• fast heartbeat (tachycardia)
• dry mouth
• stomach pain
• altered taste (dysgeusia)
• abnormal liver function (effect that is more likely to occur in Japanese patients)
• rapid swelling of the skin and mucous membranes, which can also lead to death (angioedema, also with fatal outcome)
• eczema (a skin condition)
• skin redness
• urticaria
• severe drug rash
• joint pain (arthralgia)
• pain in the extremities
• tendon pain
• flu-like illness
• decrease in hemoglobin (a blood protein)
• increased levels of uric acid, liver enzymes, or creatine phosphokinase in the blood

Very rare side effects(may affect up to 1 in 10,000 people):

• progressive scarring in the lung tissue (interstitial lung disease)**

* The event may be coincidental, or it may be related to a mechanism currently
unknown.
** Cases of progressive scarring in the lung tissue have been reported during the use of telmisartan, however it is not known whether the cause is attributable to telmisartan.

Reporting of 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.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Telmisartan Sandoz

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 carton box and on the
blister after EXP. The expiry date refers to the last day of that month.
Store in the original package, to protect the medicine from moisture.
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 Sandoz contains
The activeingredient is telmisartan. Each tablet contains 20 mg of telmisartan.
The activeingredient is telmisartan. Each tablet contains 40 mg of telmisartan.
The activeingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
The otheringredients are sodium hydroxide, meglumine, povidone K25, lactose monohydrate,
povidone, crospovidone, anhydrous lactose, magnesium stearate.

Description of the appearance of Telmisartan Sandoz and contents of the pack
Telmisartan Sandoz
Smooth, round, white tablet, with “20” inscribed on one side.
The size of the tablet is 6.9-7.2 mm.
Telmisartan Sandoz
Smooth, oblong, white tablet, with a fracture line on one side and the inscription “40” on the other
side.
The tablets are 11.5-11.8 mm long and 6.4-6.8 mm wide.
Telmisartan Sandoz
Smooth, oblong, white tablet, with a fracture line on one side and the inscription “80” on the other
side.
The tablets are 14.7-15.0 mm long and 8.2-8.6 mm wide.
Al/Al blisters containing 14, 28, 56 and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz Spa
Largo U. Boccioni 1
21040 Origgio (VA)

Manufacturers
S.C. Sandoz S.R.L.
7A Livezeni Street,
540472 Targu Mures, Jud. Mures
Romania
LEK S.A.
Ul. Podlipie 16 C, 95 010 Strykow
Poland
Registered office:
Ul. Domaniewska 50 C, 02-672 Warszawa
Poland
Lek pharmaceuticals d.d.
Trimlini 2D, 9220 Lendava
Slovenia
Salutas Pharma GmbH
administrative headquarters:
Otto-von-Guericke-Allee 1 39179, Barleben
Germany
operating site:
Dieselstrasse 5 70839 Gerlingen
Germany
Lek pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia

This medicinal product is authorised in the member states of the EEA under the following
names:
Italy: TELMISARTAN SANDOZ
Netherlands: Telmisartan Sandoz 20 mg, tablets
Telmisartan Sandoz 40 mg, tablets
Telmisartan Sandoz 80 mg, tablets