Package Insert: Information for the Patient

Telmisartán Sandoz 20 mg Tablets EFG

Telmisartán Sandoz 40 mg Tablets EFG

Telmisartán Sandoz 80 mg Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Telmisartán belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes the narrowing of blood vessels, thus increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and blood pressure to decrease.

Telmisartán is used to treat essential hypertension (high blood pressure) in adults. “Essential” means that high blood pressure is not caused by any other underlying condition.

High blood pressure, if left untreated, can damage blood vessels in various organs, which may lead, in some cases, to heart attacks, heart failure, or kidney failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartán is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults at risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not take Telmisartán Sandoz:

• if you areallergicto telmisartán or to any of the other components of this medication (including those listed in section 6),
• if you aremore than 3 months pregnant. (In any case, it is better to avoid taking Telmisartán Sandoz also at the beginning of your pregnancy - see section “Pregnancy”),
• if you havesevere liver problemssuch as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease,
• if you havediabetesorkidney insufficiencyand are being treated with a medication to lower blood pressure that containsaliskirén.

If your case is any of the above, consult your doctor or pharmacist before taking this medication.

Warnings and precautions

Consult your doctor if you are experiencing or have ever experienced any of the following conditions or diseases:

• kidney disease or kidney transplant,
• renal artery stenosis (narrowing of blood vessels to one or both kidneys),
• liver disease,
• heart problems,
• elevated aldosterone levels (water and salt retention in the body along with mineral imbalance in the blood),
• low blood pressure (hypotension) that may occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to diuretic treatment, low-salt diet, diarrhea, or vomiting,
• elevated potassium levels in the blood,
• diabetes.

Consult your doctor before starting to take Telmisartán Sandoz

• If you are taking any of the following medications used to treat high blood pressure:

-ACE inhibitors (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

-aliskirén,

• If you are taking digoxina.

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Telmisartán Sandoz”.

If you arepregnant, if you suspect that you may beor plan to becomepregnant, you must inform your doctor. Telmisartán is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to the baby (see section “Pregnancy”).

In case ofsurgery or anesthesia, inform your doctor that you are taking telmisartán.

Telmisartán may be less effective in lowering blood pressure in patients ofblack race.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking telmisartán. Your doctor will decide whether to continue treatment. Do not stop taking telmisartán on your own.

Children and adolescents

Telmisartán Sandoz is not recommended for use inchildrenand adolescents under 18 years of age.

Taking Telmisartán Sandoz with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Your doctor may need to adjust the dose of these other medications or take other precautions. In some cases, you may need to stop taking one of the medications. This applies especially to the following medications when taken with telmisartán:

• medications containing lithium for treating certain types of depression,
• medications that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (e.g., aspirin or ibuprofen), heparins, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimetoprim,
• diuretics, especially if taken in high doses with telmisartán, may cause excessive water loss from the body and low blood pressure (hypotension),
• an ACE inhibitor or aliskirén(see also the information under the headings “Do not take Telmisartán Sandoz” and “Warnings and precautions”),
• digoxina.

The effect of telmisartán may be reduced when you use NSAIDs (e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartán may increase the hypotensive effect of other medications used to treat high blood pressure or of medications with potential to lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. You may experience dizziness when standing up. Consult your doctor if you need to adjust the dose of another medication while taking telmisartán.

Taking Telmisartán Sandoz with food and beverages

Telmisartán can be taken with or without food.

Pregnancy and lactation

Pregnancy

You must inform your doctor if you suspect that you may be (or plan to become) pregnant. Your doctor will usually advise you to stop taking telmisartán before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Telmisartán is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to the baby (see section “Pregnancy”).

Lactation

Inform your doctor if you plan to initiate or are in the lactation period because Telmisartán Sandoz is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to initiate lactation, especially in newborns or premature infants.

Driving and operating machinery

Some people may feel dizzy or tired when taking Telmisartán Sandoz. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán Sandoz contains lactose.

If your doctor has advised you that you have an intolerance to certain sugars, consult with him before taking this medication.

Telmisartán Sandoz contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Sandoz is one tablet per day.

• Try to take the tablet at the same time every day,
• You can take telmisartán with or without food

• The tablets should be swallowed with a little water or other non-alcoholic beverage,
• It is essential to take telmisartán every day until your doctor tells you otherwise,
• If you estimate that the effect of telmisartán is too strong or weak, inform your doctor or pharmacist,
• Tablets with a breaking line can be divided into two equal halves

For the treatment of high blood pressure, the normal dose of telmisartán for most patients is 40 mg once a day, to control blood pressure over 24 hours. However, your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg at times.

Telmisartán can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additive effect in reducing blood pressure with telmisartán.

For the reduction of cardiovascular events, the usual daily dose of telmisartán is 80 mg. At the beginning of preventive treatment with telmisartán, blood pressure should be controlled frequently.

Use in children

Telmisartán Sandoz is not recommended for use inchildrenand adolescents until the age of 18 years.

Use in patients with liver dysfunction

If your liver does not function correctly, the normal dose should not exceed 40 mg once a day.

Use in patients with renal dysfunction

No dose adjustment is necessary in patients with altered renal function.

If you have severe renal impairment or are undergoing dialysis, your doctor should prescribe a lower dose of less than 20 mg.

If you take more Telmisartán Sandoz than you should

If you have taken more Telmisartán Sandoz than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forget to take Telmisartán Sandoz

If you forget to take a dose, do not worry. Take it as soon as you remember and continue as before. If you miss a dose, take your normal dose the next day.Do not takea double dose to compensate for the missed doses.

If you interrupt treatment with Telmisartán Sandoz

Always consult your doctor if you interrupt treatment with telmisartán. Even if you feel well, you should continue taking this medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

Some side effects can be serious and require immediate medical attention:

Consult your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called "blood poisoning," it is a severe infection with a systemic inflammatory response), rapid swelling of the skin and mucous membranes (angioedema), these side effects are rare (they may affect up to 1 in 1,000 patients) but are extremely serious and patients must stop taking this medication and consult their doctor immediately. If these side effects are not treated immediately, they can be fatal.

Possible side effects:

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

• low blood pressure (hypotension) in patients treated for cardiovascular events.

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

• urinary tract infections,
• upper respiratory tract infections (e.g., sore throat, sinusitis, cold),
• red blood cell deficiency (anemia),
• high potassium levels,
• difficulty falling asleep (insomnia),
• feeling sad (depression),
• syncope (fainting),
• feeling of movement (dizziness),
• slow heart rate (bradycardia),
• low blood pressure (hypotension) in patients with high blood pressure treatment,
• feeling of dizziness when standing up (orthostatic hypotension),
• shortness of breath,
• cough,
• abdominal pain,
• diarrhea,
• abdominal discomfort,
• feeling of fullness,
• vomiting,
• itching,
• increased sweating,
• drug rash,
• back pain,
• muscle cramps,
• muscle pain (myalgia),
• renal insufficiency including acute renal failure,
• chest pain,
• feeling of weakness,
• increased creatinine levels in the blood.

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

• sepsis * (often called "blood poisoning," it is a severe infection with a systemic inflammatory response that can lead to death),

• increased certain white blood cells (eosinophilia),
• low platelet count (thrombocytopenia),
• severe allergic reaction (anaphylactic reaction),
• allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure),
• low blood sugar levels (in diabetic patients),
• feeling of anxiety,
• drowsiness,
• vision problems,
• rapid heart rate (tachycardia),
• dry mouth,
• stomach discomfort,
• alteration of taste (dysgeusia)
• abnormal liver function (Japanese patients are more prone to experiencing this side effect),
• rapid swelling of the skin and mucous membranes that can lead to death (angioedema also with fatal outcome),
• eczema (a skin disease),
• skin redness,
• hives (urticaria),
• severe drug rash,
• joint pain (arthralgia),
• pain in the extremities,
• pain in the tendons,
• flu-like symptoms,
• decreased hemoglobin (a protein in the blood),
• increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood,

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

• progressive scarring of lung tissue (interstitial lung disease)**.

* The reaction may occur by chance or be related to a currently unknown medication.

** Cases of progressive scarring of lung tissue have been detected during the intake of telmisartan. However, it is not known if telmisartan was the cause of this.

Unknown frequency(cannot be estimated from available data)

• Intestinal angioedema: intestinal inflammation has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system: Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Telmisartan Sandoz

- The active ingredient is telmisartan.

Telmisartan Sandoz 20 mg: each tablet contains 20 mg of telmisartan.

Telmisartan Sandoz 40 mg: each tablet contains 40 mg of telmisartan.

Telmisartan Sandoz 80 mg: each tablet contains 80 mg of telmisartan.

- The other components are: sodium hydroxide, meglumine, povidone K25, lactose monohydrate, povidone, crospovidone, and anhydrous lactose, magnesium stearate.

Appearance of the product and contents of the package

Telmisartan Sandoz 20 mg:

White, round, flat tablets, marked with “20” on one side.

The tablet size is 6.9–7.2 mm.

Telmisartan Sandoz 40 mg:

White, oblong, flat tablets, scored on one side and marked with “40” on the other side. The tablets are 11.5-11.8 mm long and 6.4-6.8 mm wide.

Telmisartan Sandoz 80 mg:

White, oblong, flat tablets, scored on one side and marked with “80” on the other side. The tablets are 14.7-15.0 mm long and 8.2-8.6 mm wide.

Aluminum/Aluminum blister pack containing 10, 14, 20, 21, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets.

Aluminum/Aluminum single-dose blister pack containing 28 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible manufacturer

LEK PHARMACEUTICAL COMPANY D.D.

Verovskova, 57 (Ljubljana)

1526 - Slovenia

O

SALUTAS PHARMA GMBH

Otto Von Guericke Alle, 1

(Barleben) - D-39179 – Germany

O

LEK, S.A.

Ul Podlipie, 16

(Strykow) - PL95-010 – Poland

O

LEK, S.A. Ul

Domaniewska 50 C

(Warsaw) - PL02-672 – Poland

O

SANDOZ SRL

Livezeni Street, 7A

(Targu Mures) - - Romania

O

LEK PHARMACEUTICAL COMPANY D.D.

Trimlini 2D

(Lendava) - 9220 - Slovenia

This medicinal product is authorized in the member states of the European Economic Area with the following names:

Austria: Telmisartan Sandoz 40 mg – Tabletten

Telmisartan Sandoz 80 mg – Tabletten

Bélgica: Telmisartan Sandoz 20 mg tabletten

Telmisartan Sandoz 40 mg tabletten

Telmisartan Sandoz 80 mg tabletten

República Checa: Telmisartan Sandoz 80 mg

Chipre: Telmisartan sandoz

Estonia: Telmisartan Sandoz 40 mg

Telmisartan Sandoz 80 mg

Finlandia: Telmisartan Sandoz 40 mg tabletti

Telmisartan Sandoz 80 mg tabletti

Francia: Telmisartan Sandoz 20 mg, comprimé

Telmisartan Sandoz 40 mg, comprimé

Telmisartan Sandoz 80 mg, comprimé

Grecia: Telmisartan/Sandoz, 40 mg, δισκ?α

Telmisartan/Sandoz, 80 mg, δισκ?α

Lituania: Telmisartan Sandoz 40 mg tabletes

Telmisartan Sandoz 80 mg tabletes

Paises Bajos: Telmisartan Sandoz 20 mg, tabletten

Telmisartan Sandoz 40 mg, tabletten

Telmisartan Sandoz 80 mg, tabletten

Polonia: Telmisartan Sandoz

Portugal: Telmisartan Sandoz

República Eslovaca: Telmisartan Sandoz 40 mg tablety

Telmisartan Sandoz 80 mg tablety

Suecia: Telmisartan Sandoz 40 mg tabletter

Telmisartan Sandoz 80 mg tabletter

Reino Unido: Telmisartan 20 mg tablets

Telmisartan 40 mg tablets

Telmisartan 80 mg tablets

Last review date of this leaflet: February 2025

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob .es/