TELMISARTAN HYDROCHLOROTHIAZIDE ALTER 80 mg/25 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan/Hydrochlorothiazide Alter 80 mg/25 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, 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. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Telmisartan/Hydrochlorothiazide Alter and what is it used for
2. What you need to know before you take Telmisartan/Hydrochlorothiazide Alter
3. How to take Telmisartan/Hydrochlorothiazide Alter
4. Possible side effects
5. Storage of Telmisartan/Hydrochlorothiazide Alter

Contents of the pack and other information

1. What is Telmisartan/Hydrochlorothiazide Alter and what is it used for

Telmisartan/Hydrochlorothiazide Alter is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet. Both active substances help to control high blood pressure.

• Telmisartan belongs to a group 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.
• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase the amount of urine you produce, thereby reducing your blood pressure.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can sometimes lead to heart attack, heart failure, kidney failure, stroke, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to ensure it is within the normal range.

Telmisartan/Hydrochlorothiazide Alter is used forthe treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with telmisartan/hydrochlorothiazide 80 mg/12.5 mg or in patients who have previously been stabilized with telmisartan and hydrochlorothiazide separately.

2. What you need to know before you take Telmisartan/Hydrochlorothiazide Alter

Do not take Telmisartan/Hydrochlorothiazide Alter

• if you are allergic to telmisartan, hydrochlorothiazide, or other sulfonamide-derived medicines or to any of the other ingredients of this medicine (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the start of your 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 severe kidney disease
• if your doctor determines that you have low potassium or high calcium levels in your blood that do not improve with treatment
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before using Telmisartan/Hydrochlorothiazide Alter.

Warnings and precautions

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

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular its long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV ray exposure while taking Telmisartan/Hydrochlorothiazide Alter
• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have low salt levels due to treatment with diuretics, 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 aldosterone levels (water and salt retention in the body along with imbalance of various blood minerals).
• Systemic lupus erythematosus (also called "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself.
• The active ingredient hydrochlorothiazide may cause a rare reaction, leading to decreased vision and eye pain. These symptoms can be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye and may appear between hours and weeks after taking telmisartan/hydrochlorothiazide. If left untreated, it can lead to permanent vision loss.

Consult your doctor before taking this medicine:

• 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/Hydrochlorothiazide Alter"

• if you are taking digoxin.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Telmisartan/Hydrochlorothiazide Alter, seek medical attention immediately.

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

If you are pregnant, think you may be pregnant, or are planning to become pregnant, inform your doctor. The use of telmisartan/hydrochlorothiazide is not recommended during pregnancy (first 3 months) and should not be taken after the third month of pregnancy as it may cause serious harm to your baby, see section Pregnancy.

Treatment with hydrochlorothiazide may cause an electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, somnolence, restlessness, pain or muscle cramps, nausea, vomiting, muscle fatigue, and an abnormally rapid 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 sensitivity of your skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) that appear more quickly than usual.

If you are going to undergo surgery (including dental surgery) or anesthesia, inform your doctor that you are taking telmisartan/hydrochlorothiazide.

Telmisartan/hydrochlorothiazide may be less effective in lowering blood pressure in black patients.

Children and adolescents

The use of telmisartan/hydrochlorothiazide is not recommended in children and adolescents up to 18 years of age.

Taking Telmisartan/Hydrochlorothiazide Alter with other medicines

Inform 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 those other medicines or take other precautions. In some cases, it may be necessary to stop taking some of these medicines, especially if you are using telmisartan/hydrochlorothiazide with any of the following medicines:

• Medicines containing lithium for the treatment of certain types of depression.
• Medicines 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 (an antifungal medicine), carbenoxolone (used in the treatment of mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and derivatives.
• Medicines that can increase potassium levels in the blood such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors that can increase potassium levels in the blood, cyclosporine (an immunosuppressive medicine), and other medicines like heparin sodium (an anticoagulant).
• Medicines whose effects are influenced by changes in potassium levels in the blood such as heart medicines (e.g., digoxin) or medicines to control your heart rate (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines like certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines for treating allergic reactions (e.g., terfenadine).
• Medicines for the treatment of diabetes (insulins or oral agents like metformin).
• Colestyramine and colestipol, medicines to reduce blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements
• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), medicines for treating cancer, gout, or arthritis.
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan/Hydrochlorothiazide Alter" and "Warnings and precautions").
• Digoxin.

Telmisartan/hydrochlorothiazide may increase the effect of other medicines to lower blood pressure or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine).

Additionally, the reduction in blood pressure may be enhanced by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should inform your doctor about the need to adjust the dose of your other medicines while taking telmisartan/hydrochlorothiazide.

The effect of telmisartan/hydrochlorothiazide may be reduced when using NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen).

Taking Telmisartan/Hydrochlorothiazide Alter with food and alcohol

You can take this medicine with or without food.

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking telmisartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take a different blood pressure-lowering medicine instead. The use of telmisartan/hydrochlorothiazide is not recommended during pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby when administered after this time.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding, as telmisartan/hydrochlorothiazide is not recommended for use in women during this period. Your doctor may decide to prescribe a treatment that is more suitable if you wish to breastfeed.

Driving and using machines

Some patients feel dizzy or tired when taking telmisartan/hydrochlorothiazide. If you feel dizzy or tired, do not drive or use machines.

Telmisartan/Hydrochlorothiazide Alter contains sorbitol

This medicine contains 42.948 mg of sorbitol in each tablet, equivalent to 56.51 mg/g.

3. How to take Telmisartan/Hydrochlorothiazide Alter

Follow exactly the instructions of your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is one tablet per day. Try to take the tablet at the same time each day. You can take telmisartan/hydrochlorothiazide 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/hydrochlorothiazide every day until your doctor tells you to stop.

If your liver is not working properly, the usual dose should not exceed 40 mg/12.5 mg once a day.

If you take more Telmisartan/Hydrochlorothiazide Alter than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service: telephone 91 562 04 20, stating the medicine and the amount taken.

If you accidentally take too many tablets, you may experience symptoms such as low blood pressure and rapid heartbeat. Slow heartbeat, dizziness, vomiting, and reduced kidney function, including kidney failure, have also been reported. Due to the hydrochlorothiazide component, you may also experience significantly low blood pressure and low potassium levels in the blood, which can lead to nausea, somnolence, and muscle cramps and/or irregular heartbeat associated with concomitant use of medicines like digitalis or certain antiarrhythmic treatments. Contact

If you forget to take Telmisartan/Hydrochlorothiazide Alter

If you forget to take your medicine, do not worry. Take the dose as soon as you remember and 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

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

Sepsis* (frequently called "blood infection"), is a serious infection that involves an inflammatory reaction of the entire body, rapid swelling of the skin and mucous membranes (angioedema), blistering and peeling of the outer layer of the skin (toxic epidermal necrolysis); these adverse effects are rare (may 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 adverse 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 Adverse Effects of Telmisartan/Hydrochlorothiazide:

Common Adverse Effects(may affect up to 1 in 10 people):

Dizziness.

Uncommon Adverse Effects(may affect up to 1 in 100 people):

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

Rare Adverse Effects(may affect up to 1 in 1,000 people):

Inflammation of the lungs (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, inflammation of the paranasal sinuses, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbance, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function disorder (Japanese patients show a greater tendency to experience this adverse effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs, muscle cramps, pseudo-influenza syndrome, pain, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase levels in the blood.

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

Telmisartan

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

Uncommon Adverse Effects(may affect up to 1 in 100 people):

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

Rare Adverse Effects(may affect up to 1 in 1,000 people):

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

Very Rare Adverse Effects(may affect up to 1 in 10,000 people):

Progressive lung tissue fibrosis (interstitial lung disease) **

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

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

Frequency Not Known(cannot be estimated from available data):

Intestinal angioedema: inflammation in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported after using similar products.

Hydrochlorothiazide

The following additional adverse effects have been described in patients taking hydrochlorothiazide alone:

Common Adverse Effects (may affect up to 1 in 10 people):

Nausea, low magnesium levels in the blood.

Rare Adverse Effects (may affect up to 1 in 1,000 people):

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

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

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

Adverse Effects of Unknown Frequency(cannot be estimated from available data):

Skin and lip cancer (non-melanoma skin cancer), salivary gland inflammation, decrease in blood cell count, including low red and white blood cell count, severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions), decreased or lost 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 effusion) or acute angle-closure glaucoma), blood vessel inflammation (necrotizing vasculitis), pancreatitis, stomach upset, yellowing of the skin or eyes (jaundice), pseudo-lupus syndrome (a condition that mimics systemic lupus erythematosus, in which the body's immune system attacks the body), skin disorders such as blood vessel inflammation of the skin, increased sensitivity to sunlight, skin rash, skin redness, blistering of the lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or dysfunction, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased glucose levels in the blood/urine in patients with a diagnosis of diabetes mellitus, or fat in the blood.

Reporting 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 can also report them through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Telmisartan/Hydrochlorothiazide Alter

Keep this medicine out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date shown on the blister pack and carton after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's SIGRE Point. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Telmisartan/Hydrochlorothiazide Alter

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
• The other ingredients are microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, polyvinyl alcohol-polyethylene glycol copolymer, sodium starch glycolate, sorbitol (E420), yellow iron oxide (E172), and magnesium stearate.

Appearance of the Product and Package Contents

Yellowish-colored tablets with slight white speckles, oblong, and without scoring.

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

Date of the Last Revision of this Leaflet: February 2025.

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