TELMISARTAN STADA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan STADA 20 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, as 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, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Telmisartan Stada and what is it used for
2. What you need to know before you take 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 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 your blood vessels relax and your blood pressure is reduced.

Telmisartan is used totreat essential 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 have your blood pressure checked regularly 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 have a high risk of suffering from diabetes. Your doctor will tell you if you have a high risk of suffering from these events.

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

Do not take Telmisartan Stada

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is also better 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 insufficiency and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Tell your doctor 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.
• 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 loss of water 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.

Tell 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.

Tell your doctor before taking Telmisartan Stada:

• if you are taking any of the following medicines 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 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 Stada".

• if you are taking digoxin.

If you think you might be pregnant (or might become pregnant), tell your doctor. Telmisartan is not recommended during the first trimester of pregnancy and must 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, tell 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 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 medicines and/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 at the same time as telmisartan:

• Medicines containing lithium for treating some types of depression.
• Medicines 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 medicines (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, may cause excessive water loss from the body and low 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 non-steroidal anti-inflammatory medicines (e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartan may increase the blood-pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, the decrease in blood pressure may be enhanced 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 medicines while taking telmisartan.

Taking Telmisartan Stada with food and drink

You can take telmisartan with or without food.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you think you might be pregnant (or might 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 instead of telmisartan. Telmisartan is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding. Telmisartan is not recommended for women who are breastfeeding, and your doctor may decide to prescribe a different treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

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

3. How to take Telmisartan Stada

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

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 another non-alcoholic drink. It is important that you take telmisartan every day until your doctor tells you to stop. If you feel that the effect of telmisartan is too strong or too weak, talk to your doctor or pharmacist.

The usual dose of telmisartan for most patients is 40 mg once daily to control blood pressure over a 24-hour period. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, telmisartan may 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 checked frequently.

If your liver is not working properly, 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medicine and the amount taken).

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 then 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 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 require immediate medical attention:

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

Sepsis* (often called "blood infection", a serious 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 medicine 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 serious infection that involves an inflammatory reaction of the whole body and can cause death), increased 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 disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbance (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), pain in the limbs, tendon pain, flu-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 presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported after the use of similar products.

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

** 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 side effects

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

5. Storage of Telmisartan Stada

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 refers to the last day of the month shown.

Aluminum/Aluminum Blister: This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Telmisartan Stada

• The active substance is telmisartan. One 20 mg tablet of Telmisartan Stada contains 20 mg of telmisartan.
• The other ingredients are povidone (K25) (E1201), meglumine, sodium hydroxide (E524), mannitol (E421), crospovidone (E1202), and magnesium stearate (E470b).

Appearance and packaging of the product

Telmisartan Stada is a tablet.

Telmisartan Stada 20 mg: are white, round, beveled 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 leaflet: 08/2025

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