Telmisartan Stada 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartan STADA 40 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Telmisartán Stada is and what it is 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, thereby increasing blood pressure. Telmisartan blocks the effect of angiotensin II, allowing your 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, which may lead in some cases to heart attacks, heart or kidney failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before such damage occurs. Therefore, it is important to measure your blood pressure regularly 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 due to reduced or blocked blood flow to the heart or legs, who have previously had a stroke, or who have a 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 Telmisartán Stada

Do not take Telmisartán Stada

• if you are allergic to telmisartán or to any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant (it is best to avoid taking telmisartán also during early pregnancy – see pregnancy section).
• 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 an antihypertensive medicine containing aliskiren.

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

Warnings and precautions

Consult 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 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 depletion due to diuretic treatment, low-salt diet, diarrhoea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

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

Consult your doctor before taking Telmisartán 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), 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 Stada”.

• if you are taking digoxin.

If you think you are pregnant (or could be), you must inform your doctor. Use of telmisartán 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 (see pregnancy section).

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

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

Children and adolescents

The use of telmisartán is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán Stada with other medicines

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 medicines and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This particularly applies to the following medicines when taken together with telmisartán:

• 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 antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially when taken at high doses together with telmisartán, may cause excessive loss of body water and lead to low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán Stada” and “Warnings and precautions”).
• Digoxin.

The effect of telmisartán may be reduced when used together with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). In addition, the reduction in blood pressure may be aggravated by alcohol, barbiturates, narcotics or antidepressants. You may notice this effect as dizziness when standing up. Consult your doctor if you need to adjust the dose of your other medicines while taking telmisartán.

Taking Telmisartán Stada with food and drink

You may take telmisartán with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually advise you to stop taking telmisartán before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of telmisartán. Use of telmisartán 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 if used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding. Telmisartán is not recommended for breastfeeding women, and your doctor may decide to prescribe an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some people may feel dizzy or tired while being treated with telmisartán. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán 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 Telmisartán Stada

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 telmisartan is one tablet daily. Try to take the tablet at the same time each day. Telmisartan may be taken 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 unless your doctor tells you otherwise. If you think that the effect of telmisartan is too strong or too weak, inform 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 may 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 one 80 mg tablet. At the start of preventive treatment with telmisartan 80 mg, 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 Stada than you should

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

If you forget to take Telmisartán 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 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:

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

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

Possible adverse effects of Telmisartán Stada:

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), reduced red blood cells (anemia), elevated potassium levels, difficulty sleeping, feeling of sadness (depression), fainting (syncope), sensation of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhoea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), renal impairment including acute renal failure, chest pain, symptoms of weakness, and elevated blood creatinine levels.

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

Sepsis* (commonly called “blood infection”, a severe infection involving a systemic inflammatory response that may result in 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 sugar levels (in diabetic patients), feeling of anxiety, drowsiness, visual disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes which may be fatal (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness, decreased hemoglobin (a blood protein), increased blood levels of uric acid, increased blood levels of liver enzymes or creatine phosphokinase.

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

Progressive fibrosis of lung tissue (interstitial lung disease) **.

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them 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. Storage of Telmisartan Stada

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

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Stada

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

Appearance of the product and contents of the pack

Telmisartan Stada are 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.

Only some 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 the most recent review of this leaflet: 08/2025

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