TELMISARTAN STADA 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan STADA 40 mg tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

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

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

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

Telmisartan is used totreat essential hypertension (high blood pressure) in adults. "Essential" means that 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 essential to regularly check your blood pressure to see if it is within the normal range.

Telmisartan is also used toreduce 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 are at high risk of developing diabetes. Your doctor will inform you if you are at high risk of experiencing these events.

2. What you need to know before taking Telmisartan Stada

Do not take Telmisartan Stada

• if you are allergic to telmisartan or any of the other ingredients of this medication (listed in section 6).
• if you are pregnant for more than 3 months (it is also recommended to avoid taking telmisartan at the start 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 kidney failure and are being treated with a blood pressure-lowering medication containing aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking telmisartan.

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), which may occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to treatment with diuretics, a low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

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.

Consult your doctor before taking Telmisartan Stada:

• if you are taking any of the following medications used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Telmisartan Stada".

• if you are taking digoxin.

If you think you may be pregnant (or might become pregnant), inform your doctor. Telmisartan is not recommended during 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 reducing blood pressure in black patients.

Children and adolescents.

Telmisartan is not recommended for use in children and adolescents up to 18 years.

Using Telmisartan Stada with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. Your doctor may need to change the dose of these medications and/or take other precautions. In some cases, you may need to stop taking one of the medications. This is especially applicable to the following medications when taken with telmisartan:

• Medications containing lithium for treating certain types of depression.
• Medications that may increase potassium levels in the blood, such as potassium-salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with telmisartan, can cause excessive water loss from the body and lower blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan Stada" and "Warnings and precautions").
• Digoxin.

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

Telmisartan may increase the blood pressure-lowering effect of other medications used to treat high blood pressure or medications that may potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, the decrease in blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medications while taking telmisartan.

Taking Telmisartan Stada with food and drinks

You can take telmisartan with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you may be pregnant (or might become pregnant). Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as you know you are pregnant, and will recommend taking another medication instead of telmisartan. Telmisartan is not recommended during 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 breastfeeding. Telmisartan is not recommended for women who are breastfeeding, and your doctor may decide to prescribe another treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

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

Telmisartan Stada contains sodium

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

3. How to take Telmisartan Stada

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

The recommended dose of telmisartan is one tablet per day. Try to take the tablet at the same time each day. You can take telmisartan with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential that you take telmisartan every day until your doctor tells you to stop. If you think the effect of telmisartan is too strong or too weak, tell your doctor or pharmacist.

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. Alternatively, telmisartan can 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 one 80 mg tablet. At the start of preventive treatment with telmisartan 80 mg, blood pressure should be frequently monitored.

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

If you take more Telmisartan Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Telmisartan Stada

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 nottake a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

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

If you experience any of the following symptoms, you should see your doctor immediately:

Sepsis* (often called "blood infection", a severe infection that involves an inflammatory reaction of the whole body), 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 stop taking the medication and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan Stada:

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, common cold), decreased red blood cells (anemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of losing balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, symptoms of weakness, and high creatinine levels in the blood.

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

Sepsis* (often called "blood infection", a severe infection that involves an inflammatory reaction of the whole body and can cause 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 anxious, drowsiness, vision changes, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a greater tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, pseudoflu-like illness, decrease in hemoglobin (a blood protein), increased blood levels of uric acid, 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) **.

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

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

• This may have been a chance finding or related to a currently unknown mechanism.

** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is unknown whether telmisartan was the cause.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them to the Spanish Medicines Agency's online reporting system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Telmisartan Stada

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

Do not use this medication after the expiration date stated on the packaging and blister after "EXP". The expiration date is the last day of the month indicated.

Aluminum/Aluminum blister: This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return any unused medication to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Contents of the pack and further information

Composition of Telmisartan Stada

• The active ingredient is telmisartan. One 40 mg tablet of Telmisartan Stada contains 40 mg of telmisartan.
• The other ingredients are povidone (K25) (E1201), meglumine, sodium hydroxide (E524), mannitol (E421), crospovidone (E1202), and magnesium stearate (E470b).

Appearance of the product and pack contents

Telmisartan Stada is available as tablets.

Telmisartan Stada 40 mg: white, oblong tablets with LC engraved on one side.

Telmisartan Stada is available in blister packs containing 14, 28, 30, 56, 84, 90, or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 – Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer:

Laboratorios Liconsa, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

or

HEUMANN PHARMA

GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Date of last revision of this package leaflet: 08/2025

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