TELMISARTAN SANDOZ 80 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan Sandoz 20 mg tablets EFG

Telmisartan Sandoz 40 mg tablets EFG

Telmisartan Sandoz 80 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Telmisartan belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so that the blood vessels relax and your blood pressure is reduced.

Telmisartan is used to treatessential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

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

Telmisartan is also usedto 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 have suffered a stroke or have a high risk of suffering from diabetes. Your doctor will inform you about whether you have a high risk of suffering these events.

2. What you need to know before you take Telmisartan Sandoz

Do not take Telmisartan Sandoz:

• if you are allergicto telmisartan or any of the other ingredients of this medicine (listed in section 6),
• if you are pregnant more than 3 months. (In any case, it is recommended to avoid taking Telmisartan Sandoz also at the beginning of pregnancy - see section "Pregnancy"),
• if you have severe liver problemssuch as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other severe liver disease,
• if you have diabetesor kidney failureand are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings and precautions

Consult your doctor if you are suffering or have ever suffered from any of the following disorders or diseases:

• kidney disease or kidney transplant,
• renal artery stenosis (narrowing of the blood vessels to one or both kidneys),
• liver disease,
• heart problems,
• high aldosterone levels (water and salt retention in the body along with an imbalance of various minerals 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 treatment with diuretics, low-salt diet, diarrhea, or vomiting,
• high potassium levels in the blood,
• diabetes.

Consult your doctor before starting Telmisartan Sandoz

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

• ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren,
  • if you are taking digoxin.

Your doctor may need to 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".

If you are pregnant, if you suspect that you may be pregnant, or if you plan to become pregnant, you should inform your doctor. Telmisartan is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby (see section "Pregnancy").

In case of surgery or anesthesia, inform your doctor that you are taking telmisartan.

Telmisartan may be less effective in lowering blood pressure in black patients.

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

Children and adolescents

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

Taking Telmisartan Sandoz with other medicines

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

Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the following medicines when taken together with telmisartan:

• medicines containing lithium to treat certain types of depression,
• medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparins, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim,
• diuretics, especially if taken in high doses together with telmisartan, may cause excessive water loss in the body and lower blood pressure (hypotension),
• an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan Sandoz" and "Warnings and precautions"),
• digoxin.

The effect of telmisartan may be reduced when you use NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.

Telmisartan may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines with a potential to lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may feel dizzy when standing up. Consult your doctor if you need to adjust the dose of another medicine while taking telmisartan.

Taking Telmisartan Sandoz with food and drinks

Telmisartan can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you suspect that you may be pregnant (or could become pregnant). Your doctor will normally advise you to stop taking telmisartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure. Telmisartan is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as Telmisartan Sandoz is not recommended for women during this period. Your doctor may decide to prescribe a different treatment if you want to start breastfeeding, especially for newborns or premature babies.

Driving and using machines

Some people feel dizzy or tired when taking Telmisartan Sandoz. If you feel dizzy or tired, do not drive or use machines.

Telmisartan Sandoz contains lactose.

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

Telmisartan Sandoz contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Telmisartan Sandoz

Follow exactly the instructions of your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

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

• the tablets should be swallowed with a little water or other non-alcoholic drink,
• it is important that you take telmisartan every day until your doctor tells you to stop,
• the tablets with a break line can be divided into two equal halves

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

Telmisartan can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with telmisartan.

For the reduction of cardiovascular events, the usual daily dose of telmisartan is 80 mg. At the start of preventive treatment with telmisartan, blood pressure should be frequently monitored.

Use in children

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

Use in patients with impaired liver function

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

Use in patients with impaired kidney function

No dose adjustment is necessary in patients with impaired kidney function.

If you have severe kidney problems or are on dialysis treatment, your doctor should prescribe a lower dose of less than 20 mg.

If you take more Telmisartan Sandoz than you should

If you have taken more Telmisartan Sandoz than you should, contact your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used.

If you forget to take Telmisartan Sandoz

If you forget to take a dose, do not worry. Take it as soon as you remember and continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not takea double dose to make up for forgotten doses.

If you stop taking Telmisartan Sandoz

Always consult your doctor if you stop taking telmisartan. Even if you feel well, you should continue to take this medicine.

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 need immediate medical attention:

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

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

Possible side effects:

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

• low blood pressure (hypotension) in users treated for cardiovascular event reduction.

Uncommon 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 of sadness (depression),
• fainting (syncope),
• feeling of spinning (vertigo),
• slow heart rate (bradycardia),
• low blood pressure (hypotension) in patients treated for high blood pressure,
• 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),
• kidney failure including acute kidney 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", a severe infection with an inflammatory response throughout the body that can lead to death),

• increase in certain white blood cells (eosinophilia),
• low platelet count (thrombocytopenia),
• severe allergic reaction (anaphylactic reaction),
• allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure),
• low blood sugar levels (in diabetic patients),
• feeling of anxiety,
• drowsiness,
• vision problems,
• rapid heart rate (tachycardia),
• dry mouth,
• stomach upset,
• taste disturbance (dysgeusia)
• abnormal liver function (Japanese patients are more likely to experience 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),
• redness of the skin,
• hives (urticaria),
• severe drug rash,
• joint pain (arthralgia),
• limb pain,
• tendon pain,
• flu-like symptoms,
• decrease in hemoglobin (a blood protein),
• increase in uric acid levels, 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 medicine currently not known.

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

Frequency not known(cannot be estimated from the available data)

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 and blister after EXP. The expiry date is the last day of the month shown.

Store in the original package to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Content and Additional Information

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 Container Content

Telmisartan Sandoz 20 mg:

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

The tablet dimension is 6.9–7.2 mm.

Telmisartan Sandoz 40 mg:

White, oblong, flat tablets, scored on one face and marked with "40" on the other face. 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 face and marked with "80" on the other face. The tablets are 14.7-15.0 mm long and 8.2-8.6 mm wide.

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

Al/Al unit-dose blister packs containing 28 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

LEK PHARMACEUTICAL COMPANY D.D.

Verovskova, 57 (Ljubljana)

1526 - Slovenia

Or

SALUTAS PHARMA GMBH

Otto Von Guericke Alle, 1

(Barleben) - D-39179 – Germany

Or

LEK, S.A.

Ul Podlipie, 16

(Strykow) - PL95-010 – Poland

Or

LEK, S.A. Ul

Domaniewska 50 C

(Warsaw) - PL02-672 – Poland

Or

SANDOZ SRL

Livezeni Street, 7A

(Targu Mures) - Romania

Or

LEK PHARMACEUTICAL COMPANY D.D.

Trimlini 2D

(Lendava) - 9220 - Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Telmisartan Sandoz 40 mg – Tablets

Telmisartan Sandoz 80 mg – Tablets

Belgium: Telmisartan Sandoz 20 mg tablets

Telmisartan Sandoz 40 mg tablets

Telmisartan Sandoz 80 mg tablets

Czech Republic: Telmisartan Sandoz 80 mg

Cyprus: Telmisartan sandoz

Estonia: Telmisartan Sandoz 40 mg

Telmisartan Sandoz 80 mg

Finland: Telmisartan Sandoz 40 mg tablets

Telmisartan Sandoz 80 mg tablets

France: Telmisartan Sandoz 20 mg, tablet

Telmisartan Sandoz 40 mg, tablet

Telmisartan Sandoz 80 mg, tablet

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

Telmisartan/Sandoz, 80 mg, δισκ?α

Lithuania: Telmisartan Sandoz 40 mg tablets

Telmisartan Sandoz 80 mg tablets

Netherlands: Telmisartan Sandoz 20 mg, tablets

Telmisartan Sandoz 40 mg, tablets

Telmisartan Sandoz 80 mg, tablets

Poland: Telmisartan Sandoz

Portugal: Telmisartan Sandoz

Slovak Republic: Telmisartan Sandoz 40 mg tablets

Telmisartan Sandoz 80 mg tablets

Sweden: Telmisartan Sandoz 40 mg tablets

Telmisartan Sandoz 80 mg tablets

United Kingdom: Telmisartan 20 mg tablets

Telmisartan 40 mg tablets

Telmisartan 80 mg tablets

Date of the last revision of this leaflet: February 2025

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/