Telmisartan Sandoz 80 mg tablets EFG

Package leaflet: Information for the user

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 the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as 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 other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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 Telmisartán Sandoz is and what it is used for

Telmisartan belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, allowing blood vessels to relax and resulting in lower blood pressure.

Telmisartan is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not due to any other identifiable cause.

If left untreated, high blood pressure can damage blood vessels in various organs, potentially leading in some cases to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not produce symptoms before such damage occurs. Therefore, it is important to regularly monitor blood pressure to ensure it remains within the normal range.

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

2. What you need to know before taking Telmisartan Sandoz

Do not take Telmisartán 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 3 months pregnant. (In any case, it is better to avoid taking Telmisartán Sandoz also during the early months of 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 severe liver disease,
• if you have diabetes or renal insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, consult your doctor or pharmacist before taking this medicine.

Warnings and precautions

Consult your doctor before starting telmisartan if you are suffering from or have ever suffered from 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 (water and salt retention in the body along with imbalance of several blood minerals),
• low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to, for example, diuretic treatment, low-salt diet, diarrhoea or vomiting,
• high levels of potassium in the blood,
• diabetes.

Consult your doctor before starting to take Telmisartán Sandoz

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

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

• aliskiren.

Your doctor may monitor 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 Telmisartán Sandoz”.

• if you are taking digoxin.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. Use of telmisartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards as it may cause serious harm to the baby (see section “Pregnancy”).

If you are undergoing surgery or anaesthesia, you must inform your doctor that you are taking telmisartan.

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

Children and adolescents

Telmisartán Sandoz is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Telmisartán Sandoz

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

Your doctor may need to adjust 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 important for the following medicines when taken together with telmisartan:

• 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, ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen), heparins, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim,
• diuretics, especially if taken at high doses together with telmisartan, which may cause excessive loss of body water and low blood pressure (hypotension),
• if you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings “Do not take Telmisartán Sandoz” and “Warnings and precautions”),
• digoxin.

The effect of telmisartan may be reduced when you take 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 potential to lower blood pressure (e.g., baclofen, amifostine). In addition, 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.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you suspect you may be (or could become) pregnant. Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as you become pregnant and will recommend another antihypertensive medicine instead. Use of telmisartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby from that stage onward.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as Telmisartán Sandoz is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable for you if you plan to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Some people may experience adverse effects such as fainting or dizziness (vertigo) when taking Telmisartán Sandoz. If you experience these adverse effects, do not drive or operate machinery.

Telmisartán Sandoz contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

Telmisartán Sandoz contains sodium

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

3. How to take Telmisartán Sandoz

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Sandoz is one tablet daily.

• Try to take the tablet at the same time every day.
• You may take telmisartan with or without food.
• Tablets should be swallowed with a little water or another non-alcoholic drink.
• It is important that you take telmisartan every day until your doctor tells you otherwise.
• If you think that the effect of telmisartan is too strong or too weak, inform your doctor or pharmacist.
• 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 daily, to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg.

Telmisartan may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert 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 beginning of preventive treatment with telmisartan, blood pressure should be monitored frequently.

If your liver is not functioning properly, the normal dose should not exceed 40 mg once daily.

If you take more Telmisartán Sandoz than you should

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

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 then continue as before. If you miss a dose one day, take your normal dose the next day. Do not take a double dose to make up for missed doses.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects may be serious and require immediate medical attention.

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

Sepsis* (often called “blood infection”) – a serious infection with a systemic inflammatory response throughout the body; rapid swelling of the skin and mucous membranes (angioedema). These adverse effects are rare (may affect up to 1 in 1,000 patients) but are extremely serious, and patients must stop taking this medicine and consult their doctor immediately. If these effects are not treated immediately, they may be fatal.

Possible adverse effects:

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

• Low blood pressure (hypotension) in patients treated for reduction of cardiovascular events.

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

• Urinary tract infections,
• Upper respiratory tract infections (e.g., sore throat, sinusitis, common cold),
• Deficiency in red blood cells (anaemia),
• Elevated potassium levels,
• Difficulty falling asleep (insomnia),
• Feeling of sadness (depression),
• Fainting (syncope),
• Sensation of movement (dizziness),
• Slow heart rate (bradycardia),
• Low blood pressure (hypotension) in patients treated for high blood pressure,
• Dizziness upon standing (orthostatic hypotension),
• Shortness of breath,
• Cough,
• Abdominal pain,
• Diarrhoea,
• Stomach pain,
• Abdominal distension,
• Vomiting,
• Itching,
• Increased sweating,
• Drug rash (skin reaction to medicines),
• Back pain,
• Muscle cramps,
• Muscle pain (myalgia),
• Renal failure (including acute renal failure),
• Chest pain,
• Feeling of weakness,
• Increased blood creatinine levels.

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

• Sepsis* (often called “blood infection” – a serious infection with a systemic inflammatory response throughout the body that may 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, facial swelling or low blood pressure),

• Low blood glucose levels (in diabetic patients),

• Feeling of anxiety,

• Drowsiness,

• Vision problems,

• Rapid heartbeat (tachycardia),

• Dry mouth,

• Abdominal discomfort,

• Taste disturbance (dysgeusia),

• Abnormal liver function (Japanese patients are more likely to experience this adverse effect),

• Rapid swelling of the skin and mucous membranes that may be fatal (angioedema, including fatal outcome),

• Eczema (a skin condition),

• Skin redness,

• Hives (urticaria),

• Severe drug-induced skin rash,

• Joint pain (arthralgia),

• Pain in the limbs,

• Tendon pain,

• Flu-like illness,

• Decreased haemoglobin (a blood protein),

• Increased levels of uric acid, increased liver enzymes or creatine phosphokinase in blood,

• Low sodium levels.

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

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

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

• Intestinal angioedema: intestinal swelling has been reported with similar products, presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

• The reaction may occur by chance or may be related to a medicine not currently known.

** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Telmisartan Sandoz Storage

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

Do not use this medicine after the expiry date stated on the outer packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Sandoz

• The active substance 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, anhydrous lactose and magnesium stearate.

Appearance of the product and contents of the pack

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.

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

Al/Al unit dose blisters containing 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovskova ulica 57

1526 Ljubljana

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

Lek Pharmaceuticals d.d.

Trimlini 2d,

9220 Lendava

Slovenia

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Telmisartan Sandoz 40 mg – Tabletten
Telmisartan Sandoz 80 mg – Tabletten

Belgium: Telmisartan Sandoz 20 mg tabletten
Telmisartan Sandoz 40 mg tabletten
Telmisartan Sandoz 80 mg tabletten

Czech Republic: Telmisartan Sandoz 80 mg tablety

Cyprus: Telmisartan sandoz

Estonia: Telmisartan Sandoz 40 mg
Telmisartan Sandoz 80 mg

Finland: Telmisartan Sandoz 40 mg tabletti
Telmisartan Sandoz 80 mg tabletti

France: Telmisartan Sandoz 20 mg, comprimé
Telmisartan Sandoz 40 mg, comprimé
Telmisartan Sandoz 80 mg, comprimé

Greece: Telmisartan/Sandoz, 40 mg, δισκ?α
Telmisartan/Sandoz, 80 mg, δισκ?α

Lithuania: Telmisartan Sandoz 40 mg tabletes
Telmisartan Sandoz 80 mg tabletes

Netherlands: Telmisartan Sandoz 20 mg, tabletten
Telmisartan Sandoz 40 mg, tabletten
Telmisartan Sandoz 80 mg, tabletten

Poland: Toptelmi

Portugal: Telmisartan Sandoz

Slovak Republic: Telmisartan Sandoz 40 mg tablety
Telmisartan Sandoz 80 mg tablety

Sweden: Telmisartan Sandoz 40 mg tabletter
Telmisartan Sandoz 80 mg tabletter

United Kingdom
(Northern Ireland): Telmisartan 20 mg tablets
Telmisartan 40 mg tablets
Telmisartan 80 mg tablets

Date of the most recent review of this leaflet: October 2025

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