Leaflet: information for the user

Telmisartán/HidroclorotiazidaStada80 mg/25 mg EFG tablets

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to otherseven 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

6. Contents of the pack and additional information

Telmisartán/HidroclorotiazidaStadais an association of two active principles, telmisartán and hidroclorotiazida in a tablet. Both active principles help to control high blood pressure.

• Telmisartán belongs to a group of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.
• Hidroclorotiazida belongs to a group of medications known as thiazide diuretics, which increase urine production, resulting in a decrease in blood pressure.
• High blood pressure, if left untreated, can damage blood vessels in various organs, which in some cases can cause a heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is essential to monitor blood pressure periodically to ensure it is within the normal range.

Telmisartán/hidroclorotiazidais used forthe treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not controlled sufficiently when using telmisartán alone.

Do not take Telmisartán/Hidroclorotiazida StadaStada

• if you are allergic to telmisartán or any of the other components of this medication (listed in section 6).
• if you are allergic to hidroclorotiazida or other sulfonamide-derived medications.
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medication also 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 severe kidney disease.
• if your doctor determines that you have low levels of potassium or high levels of calcium in your blood that do not improve with treatment.
• if you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

If any of the above mentioned occur, inform your doctor or pharmacist before using telmisartán/hidroclorotiazida.

Warnings and precautions

Consult your doctor if you have or have had any of the following conditions or diseases:

-Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have a deficiency of salts due to diuretic treatment, low-sodium diet, diarrhea, vomiting, or hemodialysis.

-Kidney disease or kidney transplant

-Renal artery stenosis (narrowing of the blood vessels of one or both kidneys)

-Liver disease

-Heart problems

-Diabetes

-Gout

-High levels of aldosterone (retention of water and salt in the body along with imbalance of various minerals in the blood)

• Lupus erythematosus systemic (also called "lupus" or "LES"), a disease in which the body's immune system attacks the body itself
• The active ingredienthidroclorotiazida may cause a rare reaction, leading to a decrease in vision and eye pain. These symptoms may be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in your eye and may appear between hours and weeks after taking telmisartán/hidroclorotiazida. If not treated, it may lead to permanent vision loss.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly its long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking telmisartán/hidroclorotiazida.

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

Consult your doctor, pharmacist, or nurse before starting to take telmisartán/hidroclorotiazida

•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 renal function, blood pressure, and electrolyte levels in your blood (e.g. potassium) at regular intervals. See also the information under the heading “Do not take Telmisartán/Hidroclorotiazida Stada”.

• if you are taking digoxina
• if you have hadrespiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hidroclorotiazida in the past. If you experience severe shortness of breath or difficulty breathing after taking telmisartán/hidroclorotiazida, seek medical attention immediately.

If you are pregnant (or if you suspect that you may be), you must inform your doctor. Telmisartán/hidroclorotiazida 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 when administered from that point onwards (see Pregnancy section).

The treatment with hidroclorotiazida may cause an electrolyte imbalance in your body. Typical symptoms of an electrolyte imbalance or fluid imbalance include dry mouth, weakness, drowsiness, restlessness, muscle pain or cramps, nausea (feeling of discomfort), vomiting, muscle fatigue, and an abnormally fast heart rate (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You must also inform your doctor if you experience increased skin sensitivity to the sun with symptoms of sunburn (such as redness, itching, swelling, and blistering) that appear more quickly than usual.

If you are to undergo surgery or anesthesia, inform your doctor that you are taking telmisartán/hidroclorotiazida.

Telmisartán/hidroclorotiazidamay be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmisartán/hidroclorotiazidais not recommended for use in children and adolescents up to 18 years of age.

Use in athletes

Warning to athletes: This medication contains a component that may result in a positive analytical result for doping control.

Other medications and Telmisartán/Hidroclorotiazida StadaStada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including over-the-counter medications..You may need to adjust your dose and/or take other precautions. In some cases, you may need to discontinue the use of one of these medications, especially if you are taking it with telmisartán/hidroclorotiazidasome of the medications listed below:

• Medications containing lithium for the treatment of certain types of depression
• Medications associated with low levels of potassium in the blood (hypokalemia) such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medication), carbenoxolone (used in the treatment of mouth ulcers), penicillin G sodium (an antibiotic), and aspirin and derivatives.
• Medications that may increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, ciclosporin (an immunosuppressant), and other medications such as heparin sodium (an anticoagulant).
• Medications affected by changes in potassium levels in the blood such as heart medications (e.g. digoxina) or medications to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medications used to treat mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medications such as certain antibiotics (e.g. ciprofloxacin, pentamidine) or medications to treat allergic reactions (e.g. terfenadine).
• Medications for the treatment of diabetes (insulins or oral agents such as metformin).

• Colestiramina and colestipol, medications to reduce cholesterol levels in the blood.
• Medications to increase blood pressure, such as noradrenaline.
• Relaxant medications, such as tubocurarina.
• Calcium and/or vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of conditions such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid to anesthesia) such as atropine and biperiden.
• Amantadina (a medication used to treat Parkinson's disease and also to treat or prevent certain diseases caused by viruses).
• Other medications used to treat high blood pressure, corticosteroids, analgesics (such as nonsteroidal anti-inflammatory drugs [NSAIDs]), medications for cancer treatment, gout, or arthritis.

• if you are taking an ACE inhibitor or aliskirén (see also the information under the headings “Do not take Telmisartán/Hidroclorotiazida Stada” and “Warnings and precautions”).
• digoxina

Telmisartán/hidroclorotiazidamay increase the effect of other medications to lower 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. Inform your doctor about the need to adjust the dose of your other medications while taking telmisartán/hidroclorotiazida.

The effect of telmisartán/hidroclorotiazida may be reduced when using NSAIDs (nonsteroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen).

Taking Telmisartán/Hidroclorotiazida Stada with food and alcohol

You can take this medication with or without food.

Avoid taking alcohol until you have spoken with your doctor. Alcohol may further reduce your blood pressure and/or increase the risk of feeling dizzy or weak.

Pregnancy and lactation

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect that you may be). Your doctor will usually advise you to stop taking telmisartán/hidroclorotiazidabefore becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Telmisartán/hidroclorotiazidais not recommended for use during pregnancy and 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.

Lactation

Inform your doctor if you are to start or are breastfeeding. Telmisartán/hidroclorotiazidais not recommended for use during this period, so your doctor may decide to administer a more suitable treatment if you want to breastfeed.

Driving and operating machinery

Some patients may feel dizzy or weak when taking telmisartán/hidroclorotiazida. If you feel dizzy or weak, do not drive or operate machinery.

Telmisartán/Hidroclorotiazida Stadacontains lactose and sodium

If your doctor has told you that you have a certain sugar intolerance, consult with him before using this medication.

This medication contains less than 23 mg of sodium (1 mmol); this 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 telmisartán/hidroclorotiazidais one tablet per day. Try to take one tablet every day at the same time. You can take telmisartán/hidroclorotiazidawith or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take telmisartán/hidroclorotiazidaevery day until your doctor tells you otherwise.

If your liver does not function correctly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If You Take More Telmisartán/HidroclorotiazidaStadaThan You Should

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeats. Slow heartbeats, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been described. Due to the hidroclorotiazida component, you may also experience notably low blood pressure and low potassium levels in the blood, which can lead to nausea, drowsiness, and muscle cramps and/or irregular heartbeats associated with the concomitant use of medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist immediately or the nearest hospital emergency service.

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

If You Forget to Take Telmisartán/HidroclorotiazidaStada

If you forget to take the medication, do not worry. Take the dose as soon as you remember and continue as before. If you miss a dose, take your normal dose the next day.Do not takea 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 can cause side effects, although not everyone will experience them.

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

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

Sepsis* (also known as "blood infection"), is a serious infection that involves a systemic inflammatory reaction, rapid skin and mucous membrane swelling (angioedema), blistering and peeling of the skin and mucous membranes (toxic epidermal necrolysis); these side effects are rare (can affect up to 1 in 1,000 people) or of unknown frequency (toxic epidermal necrolysis) 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. An increased incidence of sepsis has been observed with telmisartan alone; however, it cannot be ruled out for telmisartan/hydrochlorothiazide.

Possible side effects of Telmisartan/Hydrochlorothiazide Stada:

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

Dizziness.

Rare side effects (can affect up to 1 in 100 people):

Decreased potassium levels in the blood, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heart rate (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure when standing, shortness of breath (dyspnea), diarrhea, dry mouth, flatulence, back pain, muscle spasms, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, and increased uric acid levels in the blood.

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

Pneumonia (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks the body, causing joint pain, skin rashes, and fever), sore throat, sinusitis, feeling of sadness (depression), insomnia, vision disturbances, difficulty breathing, abdominal pain, constipation, indigestion, general discomfort (vomiting), stomach inflammation (gastritis), liver function disturbances (Japanese patients are more prone to experiencing this side effect), rapid skin and mucous membrane swelling that can be fatal (angioedema including fatal outcome), skin redness (erythema), allergic reactions such as itching or rashes, increased sweating, hives (urticaria), joint pain (arthralgia), and limb pain, muscle cramps, pseudogripal disease, pain, increased uric acid levels, low sodium levels, increased creatinine levels, liver enzymes or creatine phosphokinase in the blood.

Telmisartan

The following additional side effects have been reported in patients taking telmisartan alone:

Rare side effects (can affect up to 1 in 100 people):

Upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, anemia, high potassium levels, slow heart rate (bradycardia), cough, kidney function disturbances including acute kidney failure, weakness.

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

Low platelet count (thrombocytopenia), increased eosinophils, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions, drug eruptions), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), arthritis, tendon inflammation, decreased hemoglobin (a blood protein).

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

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

Unknown frequency (frequency cannot be estimated from available data):

Intestinal angioedema: intestinal inflammation has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

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

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

Hidroclorotiazida

The following additional side effects have been reported in patients taking hydrochlorothiazide alone:

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

Nausea, low magnesium levels in the blood.

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

Low platelet count, which increases the risk of bleeding and hematoma formation (small purple-red marks on the skin or other tissues caused by bleeding), high calcium levels in the blood, headache.

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

Increased pH (alteration of acid-base balance) due to low chloride levels in the blood, acute respiratory distress (signs include severe difficulty breathing, fever, weakness, and confusion).

Unknown frequency (cannot be estimated from available data):

Salivary gland inflammation, skin cancer and lip cancer (non-melanoma skin cancer), decreased number (or even absence) of blood cells, including low red and white blood cell counts, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision, and eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute myopia or acute angle-closure glaucoma), necrotizing vasculitis, pancreatitis, stomach discomfort, yellow skin or eye discoloration (jaundice), pseudolupus syndrome (a condition that mimics a disease called systemic lupus erythematosus in which the body's immune system attacks the body), skin disorders such as vasculitis, increased sensitivity to sunlight, skin rash, redness of the skin, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or function disturbances, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood glucose levels, difficulty controlling blood glucose levels/orine in patients with diabetes mellitus, or blood fat.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this prospectus.

Reporting of side effects

If you experience any 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 the 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 carton after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature. Store in the original packaging to protect it from light and moisture. Remove your telmisartan/hydrochlorothiazide tablet just before taking it.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This way, you will help protect the environment.

Telmisartan/Hydrochlorothiazide Composition Stada

• The active principles are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• The other components are mannitol (E421), povidone (Povidone K 25) (E1201), crospovidone (E1202), magnesium stearate (E572), meglumine, sodium hydroxide (E524), lactose monohydrate, microcrystalline cellulose (E460), hypromellose (hydroxypropylmethylcellulose) (E464), sodium carboxymethylcellulose from potato (Type A), and yellow iron oxide (10E 172).

Appearance of the product and contents of the packaging

Telmisartan/Hydrochlorothiazide Stada 80 mg/25 mg tablets are round, bilayer tablets of white and yellow color.

Telmisartan/Hydrochlorothiazide Stada are presented in blister packs containing 7, 10, 14, 28, 28x1, 30, 30x1, 50, 56, 84, 90, 90x1, 98, 100, 112, 126, 140, 154, 168, 182, or 196 tablets.

You may not have all packaging sizes available in your country.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible Manufacturer

Liconsa, S.A.

Avda. Miralcampo, nº7,

Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)

Spain

or

Medical Valley Invest AB

Bradgardsvagen 28 2 Tr

236 32 Ilollviken

Sweden

Last review date of this leaflet: February 2025

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