Telmisartan Sandoz: detailed information

Patient Information Leaflet

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

Generic medicine
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including 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 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

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 narrow, thereby increasing blood pressure. Telmisartan Sandoz blocks the effect of angiotensin II, allowing blood vessels to relax, resulting in a reduction of blood pressure.

Telmisartan Sandoz is used to 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 may sometimes lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure generally does not cause any symptoms before such damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it remains within normal limits.

Telmisartan Sandoz is also used to reduce cardiovascular events (such as heart attack or stroke) in adults who are at risk due to reduced or blocked blood flow to the heart or legs, or who have previously had a stroke or have high-risk diabetes. Your doctor will advise you if you are at high risk for these events.

2. What you should know before taking Telmisartan Sandoz

DO NOT take Telmisartan Sandoz

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6)
if you are more than three months pregnant. (It is also advisable to avoid Telmisartan Sandoz during early pregnancy - see section Pregnancy)
if you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder), or any other serious liver disease
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

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

Warnings and precautions

Tell your doctor if you have or have previously had any of the following conditions or diseases:

kidney disease or kidney transplant
renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
liver disease
heart problems
elevated levels of aldosterone (fluid and salt retention in the body, along with an imbalance of various minerals in the blood)
low blood pressure (hypotension), which is more likely to occur if you are dehydrated (excessive loss of body fluids), or if you have salt deficiency due to diuretic therapy, a low-salt diet, diarrhoea or vomiting
high levels of potassium in the blood
diabetes

Talk to your doctor before taking Telmisartan Sandoz:

if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren
if you are taking digoxin

Your doctor may check your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading "Do not take Telmisartan Sandoz".

You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Telmisartan Sandoz is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if taken during this period (see section Pregnancy).

If you are due to undergo surgery or anaesthesia, inform your doctor that you are taking Telmisartan Sandoz.

Telmisartan Sandoz may be less effective in lowering blood pressure in Black patients.

Children and adolescents

The use of Telmisartan Sandoz in children and adolescents under 18 years of age is not recommended.

Other medicines and Telmisartan Sandoz

Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your 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, especially when the following medicines are taken together with Telmisartan Sandoz:

medicines containing lithium, used to treat certain types of depression
medicines that may 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, may cause excessive loss of body fluids and low blood pressure (hypotension)
an ACE inhibitor or aliskiren (see also information under "Do not take Telmisartan Sandoz" and "Warnings and precautions")
digoxin

The effect of Telmisartan Sandoz may be reduced when taken together with NSAIDs (non-steroidal anti-inflammatory drugs, such as acetylsalicylic acid or ibuprofen) or corticosteroids.

Telmisartan Sandoz may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure, or of medicines that lower blood pressure (e.g. baclofen, amifostine). In addition, low blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may experience this as dizziness when standing up. Consult your doctor if you need a dose adjustment of another medicine while taking Telmisartan Sandoz.

Telmisartan Sandoz with food and drink

You may take Telmisartan Sandoz with or without food.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Telmisartan Sandoz before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Telmisartan Sandoz.

Telmisartan Sandoz is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause severe harm to the unborn baby if taken after the third month of pregnancy.

Breast-feeding

Inform your doctor if you are breast-feeding or intend to breast-feed. Telmisartan Sandoz is not recommended for breastfeeding mothers and your doctor may choose another treatment if you wish to breast-feed, especially if your baby is newborn or was born prematurely.

Driving and using machines

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

Telmisartan Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Telmisartan Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

3. How to take Telmisartan Sandoz

Take Telmisartan Sandoz exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan Sandoz is one tablet per day.

Try to take the tablet at the same time each day.
You may take Telmisartan Sandoz with or without food.
Swallow the tablets with water or another non-alcoholic drink.
It is important that you take Telmisartan Sandoz every day, unless your doctor tells you otherwise.
If you think that the effects of Telmisartan Sandoz are too strong or too weak, consult your doctor or pharmacist.
Tablets with a score 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 daily to control blood pressure over a 24-hour period. However, your doctor may sometimes recommend a lower dose (20 mg) or a higher dose (80 mg).
Telmisartan Sandoz may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive effect in lowering blood pressure when used together with Telmisartan Sandoz.
For reduction of cardiovascular events, the usual dose of Telmisartan Sandoz is one 80 mg tablet once daily. Blood pressure should be monitored frequently at the beginning of preventive treatment with Telmisartan Sandoz 80 mg.
Use in children
The use of Telmisartan Sandoz in children and adolescents under 18 years of age is not recommended.
Use in patients with impaired liver function
If your liver is not functioning properly, the usual dose should not exceed 40 mg once daily.
Use in patients with impaired kidney function
In patients with impaired kidney function, no dose adjustment is necessary.
If you have severely impaired kidney function or are undergoing haemodialysis, your doctor may prescribe you a lower initial dose (20 mg).
If you take more Telmisartan Sandoz than you should
If you accidentally take too many tablets, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department.
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 regular dosing schedule. If you miss a dose during the day, take your next dose at the usual time the following day. Do not take a double dose to make up for the forgotten dose.
If you stop taking Telmisartan Sandoz
If you wish to stop taking this medicine, always consult your doctor first.
Even if you feel well, you may still need to continue taking this medicine.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Sandoz may cause side effects, although not everybody gets them.
Some side effects may worsen and require immediate medical attention:
You must consult your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", a severe infection causing a systemic inflammatory response) and rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people), but are extremely serious, and patients should therefore stop taking the medicine and consult their doctor immediately. If left untreated, these side 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 to reduce 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)
Red blood cell deficiency (anaemia)
High potassium levels
Difficulty falling asleep (insomnia)
Feeling of sadness (depression)
Fainting (syncope)
Dizziness (vertigo)
Slow heart rate (bradycardia)
Low blood pressure (hypotension) in patients treated for hypertension
Dizziness upon standing (orthostatic hypotension)
Shortness of breath
Cough
Abdominal pain
Diarrhoea
Abdominal discomfort
Swelling
Vomiting
Itching
Increased sweating
Drug rash
Back pain
Muscle cramps
Muscle pain (myalgia)
Impaired kidney function, including acute kidney failure
Chest pain
Feeling of weakness
Increased blood creatinine levels

Rare side effects (may affect up to 1 in 1,000 people):

Sepsis* (often called "blood poisoning", a severe infection causing a systemic inflammatory response, which may be fatal)
Increased count of certain white blood cells (eosinophilia)
Low platelet count (thrombocytopenia)
Severe allergic reaction (anaphylactic reaction)
Allergic reaction (such as skin rash, itching, breathing difficulties, wheezing, facial swelling, or low blood pressure)
Low blood sugar levels (in diabetic patients)
Feeling of anxiety
Drowsiness
Visual disturbances
Rapid heartbeat (tachycardia)
Dry mouth
Stomach ache
Taste disturbance (dysgeusia)
Abnormal liver function (an effect more commonly observed in Japanese patients)
Rapid swelling of the skin and mucous membranes, which may be fatal (angioedema, also potentially fatal)
Eczema (a skin disorder)
Skin redness
Hives (urticaria)
Severe drug rash
Joint pain (arthralgia)
Pain in the extremities
Tendon pain
Influenza-like illness
Decreased haemoglobin (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 formation of scar tissue in the lung (interstitial lung disease)**

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 cardboard box and on the
blister after EXP. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Telmisartan Sandoz Contains
The active substance is telmisartan. Each tablet contains 20 mg of telmisartan.
The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
The other components are sodium hydroxide, meglumine, povidone K25, lactose monohydrate,
povidone, crospovidone, anhydrous lactose, magnesium stearate.

Description of the Appearance of Telmisartan Sandoz and Package Contents
Telmisartan Sandoz
Smooth, round, white tablet, engraved with "20" on one side.
The tablet size is 6.9–7.2 mm.

Telmisartan Sandoz
Smooth, oval, white tablet, with a score line on one side and engraved "40" on the other side.
The tablets are 11.5–11.8 mm long and 6.4–6.8 mm wide.

Telmisartan Sandoz
Smooth, oval, white tablet, with a score line on one side and engraved "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 Authorization 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
Operational site:
Ul. Domaniewska 50 C, 02-672 Warszawa
Poland

Lek pharmaceuticals d.d.
Trimlini 2D, 9220 Lendava
Slovenia

Salutas Pharma GmbH
Administrative office:
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany
Operational site:
Dieselstrasse 5, 70839 Gerlingen
Germany

Lek pharmaceuticals d.d.
Verovškova 57, 1526 Ljubljana
Slovenia

This medicinal product has been authorized in the EEA Member States under the following names:
Italy: TELMISARTAN SANDOZ
Netherlands: Telmisartan Sandoz 20 mg, tabletten
Telmisartan Sandoz 40 mg, tabletten
Telmisartan Sandoz 80 mg, tabletten