Leaflet: information for the user

Telmisartán STADA 80 mg tablets EFG

Read this leaflet carefully before you start taking this medicinebecause 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 give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist,even if they are not listed in this leaflet. See section 4.

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

2.What you need to knowbefore starting totake Telmisartán Stada

3.How to take Telmisartán Stada

4.Possible side effects

5.Storage of Telmisartán Stada

6.Contents of the pack and additional information

Telmisartán belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and blood pressure to decrease.

Telmisartán is used totreat essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not due to any other cause.

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 renal failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartán 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 developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not take Telmisartán Stada

•If you are allergic to telmisartán or any of the other components of this medication (listed in section 6).

•If you are more than 3 months pregnant (it is best to avoid taking telmisartán at the beginning of your 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 kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.

If your case is any of the above, inform your doctor or pharmacist before taking telmisartán.

Warnings and precautions

Consult your doctor if you are experiencing or have ever experienced any of the following conditions or diseases:

•Kidney disease or kidney transplant.

•Renal artery stenosis (narrowing of blood vessels to one or both kidneys).

•Liver disease.

•Heart problems.

•Elevated aldosterone levels (water and salt retention in the body along with mineral imbalance 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 diuretic treatment, low-salt diet, diarrhea, or vomiting.

•Elevated potassium levels in the blood.

•Diabetes.

Consult your doctor before taking Telmisartán 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), particularly if you have kidney problems related to diabetes.

-Aliskirén

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals.

See also the information under the heading “Do not take Telmisartán Stada”.

•If you are taking digoxina.

If you think you may be pregnant (or could be), inform your doctor. Telmisartán is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby (see pregnancy section).

Inform your doctor if you are undergoing surgery or anesthesia that you are taking telmisartán.

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

Children and adolescents

Telmisartán is not recommended for use in children and adolescents until 18 years old.

Use of Telmisartán Stada with other medications

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

•Medications containing lithium for treating certain types of depression.

•Medications that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. ciclosporina or tacrolimus), and the antibiotic trimetoprim.

•Diuretics, especially if taken in high doses with telmisartán, may cause excessive water loss from the body and lower blood pressure (hypotension).

•ACE inhibitors or aliskirén (see also the information under the headings “Do not take Telmisartán Stada” and “Warnings and precautions”).

•Digoxina.

The effect of telmisartán may be reduced when you use NSAIDs (e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán may increase the hypotensive effect of other medications used to treat high blood pressure or medications that may potentially lower blood pressure (e.g. baclofeno, amifostina). 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 telmisartán.

Taking Telmisartán Stada with food and drinks

You can take telmisartán with or without food.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you think you may be 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 recommend taking another medication instead of telmisartán. Telmisartán is not recommended for use at the beginning of pregnancy, and it should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you are planning to start or are breastfeeding. Telmisartán is not recommended for use in breastfeeding women, and your doctor may decide to administer another treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

Some people may feel dizzy or tired when taking telmisartán. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán Stada contains sodium

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

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

The recommended dose of telmisartan is a daily tablet. 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 beverage. It is essential to take telmisartan every day until your doctor tells you otherwise. If you estimate 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 a day 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 association with diuretics such as hydrochlorothiazide, which has been shown to have an additional blood pressure-reducing effect with telmisartan.

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

If your liver does not function correctly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartán Stada than you should

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

If you forgot to take Telmisartán Stada

If you forget to take a dose, do not worry, take it as soon as you remember and continue as before. If you miss a day, take your normal dose the next day.Do nottake a double dose to compensate for the missed doses.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (can affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartán Stada:

Frequent side effects(can affect up to 1 in 10 people):

Low blood pressure (hypotension) in users treated for cardiovascular events.

Rare side effects(can 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), elevated potassium levels, difficulty falling asleep, feeling of sadness (depression), fainting (syncope), feeling of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, symptoms of weakness, and elevated creatinine levels in blood.

Very rare side effects(can affect up to 1 in 10,000 people):

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

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

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

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and the blister after “CAD”. The expiration date is the last day of the month indicated.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Telmisartan Stada Composition

•The active ingredient is telmisartan. One 80 mg Telmisartan Stada tablet contains 80 mg of telmisartan.

•The other components are povidone (K25) (E1201), meglumine, sodium hydroxide (E524), mannitol (E421), crospovidone (E1202), and magnesium stearate (E470b).

Product appearance and packaging contents

Telmisartan Stada are tablets.

Telmisartan Stada 80 mg: are white, oval-shaped 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 packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

STADA Laboratory, S.L.

Frederic Mompou, 5

08960– Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible manufacturer:

Laboratories Liconsa, S.A.

Avda. Miralcampo, Nº 7, Industrial Park Miralcampo

19200 Azuqueca de Henares (Guadalajara), Spain

or

HEUMANN PHARMA

GmbH & Co. Generica KG

Südwestpark 50

90449 Nürnberg

Last review date of this leaflet:07/2021

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/