Package Insert: Information for the Patient

Telmisartán/Hidroclorotiazida Alter 80 mg/12,5 mg Tablets EFG

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

Telmisartán/Hidroclorotiazida Alter is 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 of various organs, which in some cases can cause a heart attack, heart failure 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/Hidroclorotiazida is used forthe treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not controlled sufficiently when telmisartán is used alone.

Do not take Telmisartán/Hidroclorotiazida Alter

• If you are allergic to telmisartán, hidroclorotiazida, or to any other sulfonamide-derived medications, or to any of the other components of this medication (listed in section 6)

• 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 the 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 aliskiren.

If any of the above-mentioned occur, inform your doctor or pharmacist before using Telmisartán/Hidroclorotiazida Alter.

Warnings and Precautions

Consult your doctor before starting to take this medication if you have or have had any of the following conditions or diseases:

• 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 Alter
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive water loss) or have a salt deficiency 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
• Elevated aldosterone levels (water and salt retention in the body along with blood mineral imbalance)
• SLE (systemic lupus erythematosus), a disease in which the body's immune system attacks the body itself
• The active ingredient hidroclorotiazida may cause a rare reaction, leading to decreased vision and eye pain. These symptoms may be indicative of fluid accumulation in the eye's vascular layer (choroidal effusion) or increased eye pressure and may appear between hours and weeks after taking telmisartán/hidroclorotiazida. If left untreated, it may lead to permanent vision loss.

Consult your doctor before taking this medication:

• If you are taking any of the following medications used to treat high blood pressure (hypertension):

• An ACE inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren

Your doctor may monitor your renal function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also the information under the heading "Do not take Telmisartán/Hidroclorotiazida Alter".

• If you are taking digoxina.
• If you have had respiratory 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 Alter, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartán/Hidroclorotiazida Alter. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán/Hidroclorotiazida Alter in monotherapy.

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Telmisartán/hidroclorotiazida is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all after the third month of pregnancy because it may cause severe harm to your baby, see Pregnancy section.

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

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

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

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

Children and Adolescents

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

Taking Telmisartán/Hidroclorotiazida Alter with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication. Your doctor may need to adjust the dose of those other medications or take other precautions. In some cases, you may need to discontinue the use of one or more of these medications, especially if you are taking telmisartán/hidroclorotiazida with any of the medications listed below:

• Medications containing lithium for the treatment of certain types of depression.
• Medications associated with low potassium levels in the blood (hypokalemia) such as other diuretics, laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (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, cyclosporine (immunosuppressant), and other medications such as heparin sodium (anticoagulant).
• Medications affected by changes in potassium levels in the blood such as heart medications (e.g. digoxin) or medications to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medications used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medications such as certain antibiotics (e.g. ciprofloxacin, pentamidine) or medications for allergic reactions (e.g. terfenadine).
• Medications for the treatment of diabetes (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medications to reduce blood cholesterol levels.
• Medications to increase blood pressure, such as norepinephrine.
• Relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medications (medications used to treat a variety of disorders 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.
• Amantadine (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 aliskiren (see also the information under the headings "Do not take Telmisartán/Hidroclorotiazida Alter" and "Warnings and Precautions").
• Digoxina.

Telmisartán/hidroclorotiazida may increase the potency 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 Alter with food and alcohol

You can take this medication with or without food.

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

Pregnancy and Lactation

If you are pregnant, breastfeeding, suspect you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant. Your doctor will usually advise you to stop taking telmisartán/hidroclorotiazida before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Telmisartán/hidroclorotiazida is not recommended for use during pregnancy and should not be administered at all after the third month of pregnancy because it may cause severe harm to your baby when administered from that point on.

Lactation

Inform your doctor if you plan to start or are breastfeeding, as telmisartán/hidroclorotiazida is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed.

Driving and Operating Machines

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

Telmisartán/Hidroclorotiazida Alter contains sorbitol

This medication contains 42.948 mg of sorbitol in each 56.51 mg/g equivalent tablet.

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 is one tablet per day. Try to take the tablet every day at the same time. You can take telmisartán/hidroclorotiazida with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take telmisartán/hidroclorotiazida every 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/Hidroclorotiazida Alter 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 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 hydrochlorothiazide 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 or the nearest hospital emergency service immediately.

If you forgot to take Telmisartán/Hidroclorotiazida Alter

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 day, take your normal dose the next day. Do not take 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 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 severe infection that involves a systemic inflammatory reaction, rapid skin and mucous membrane swelling (angioedema), blistering and peeling of the skin's outer layer (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:

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

Dizziness.

Infrequent 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 upon 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, paranasal sinus inflammation, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, difficulty breathing, abdominal pain, constipation, indigestion (dyspepsia), general discomfort (vomiting), stomach inflammation (gastritis), liver function disturbances (patients in Japan are more prone to experiencing this side effect), 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, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase in the blood.

Adverse reactions reported for one of the individual components may be potential adverse reactions of telmisartan/hydrochlorothiazide, although they have not been observed in clinical trials with this product.

Telmisartan

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

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

Upper respiratory tract infection (e.g., sore throat, paranasal sinus inflammation, common cold), urinary tract infections, anemia, high potassium levels, slow heart rate (bradycardia), acute kidney failure, weakness, and cough.

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

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

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.

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

Unknown 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.

Hidroclorotiazida

The following additional side effects have been described 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):

Decreased 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 (symptoms include severe difficulty breathing, fever, weakness, and confusion).

Side effects of unknown frequency(cannot be estimated from available data):

Skin cancer and lip cancer (non-melanoma skin cancer), salivary gland inflammation, 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 vitreous layer of the eye (choroidal detachment) 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, lip, eye, or mouth blistering, 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 glucose levels in the blood/or urine in patients with diabetes mellitus, or blood fat.

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 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.

This medication does not require special storage conditions.

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

Medications 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 of 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/Hydrochlorothiazide Alter Composition

• The active principles are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other components are microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol copolymer, polyethylene glycol, sodium starch glycolate, sorbitol (E420), iron oxide red (E172), and magnesium stearate.

Product appearance and packaging contents

Reddish-colored tablets with white specks, oblong, unnotched.

Telmisartan/Hydrochlorothiazide Alter is available in blister packs containing 28 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

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/