Telmisartan/hydrochlorothiazide Alter 80 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Telmisartan/Hydrochlorothiazide Alter 80 mg/12.5 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 and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any side effects, talk to your doctor or pharmacist, even if it is a side effect not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Telmisartán/Hidroclorotiazida Alter is and what it is used for

Telmisartán/Hidroclorotiazida Alter is a combination of two active substances, telmisartan and hydrochlorothiazide, in one tablet. Both active substances help 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, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, causing your blood vessels to relax and reducing your blood pressure.
• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase your urine output, resulting in a reduction of your blood pressure.

If left untreated, high blood pressure can damage the blood vessels of various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. Often, there are no symptoms of high blood pressure before such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it remains within the normal range.

Telmisartán/Hidroclorotiazida is used for the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled with telmisartan alone.

2. What you need to know before taking Telmisartán/Hidroclorotiazida Alter

Do not take Telmisartán/Hidroclorotiazida 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 during early pregnancy – see Pregnancy section)
• If you have severe liver problems such as cholestasis or biliary obstruction (impaired bile drainage from the liver and gallbladder) or any other serious liver disease
• If you have severe kidney disease
• If your doctor has diagnosed you with persistently low potassium levels or high calcium levels in the blood that do not improve with treatment
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren

If any of the above apply to you, inform your doctor or pharmacist before using Telmisartán/Hidroclorotiazida Alter.

Warnings and precautions

Talk to your doctor before taking this medicine 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. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Telmisartán/Hidroclorotiazida Alter.
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic treatment, a low-sodium diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or kidney transplant
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
• Liver disease
• Heart problems
• Diabetes
• Gout
• High levels of aldosterone (water and salt retention in the body along with imbalance of several blood minerals)
• Systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the body's immune system attacks its own tissues
• The active ingredient hydrochlorothiazide may cause a rare reaction leading to vision loss and eye pain. These symptoms may indicate fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may appear from hours to weeks after taking telmisartan/hydrochlorothiazide. If left untreated, this may lead to permanent vision impairment.

Consult your doctor before taking this medicine:

• If you are taking any of the following medicines for high blood pressure (hypertension):

• An angiotensin-converting enzyme (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/Hidroclorotiazida Alter”.

• If you are taking digoxin.
• If you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Telmisartán/Hidroclorotiazida Alter, seek medical help immediately.

Contact 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 monotherapy without medical advice.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Telmisartan/hydrochlorothiazide is not recommended during early pregnancy (first three months), and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby. See Pregnancy section.

Treatment with hydrochlorothiazide may cause electrolyte imbalance in your body. Typical symptoms of fluid or electrolyte imbalance include dry mouth, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and abnormally rapid heartbeat (more than 100 beats per minute). If you experience any of these symptoms, inform your doctor.

You should also inform your doctor if you develop increased sensitivity of the skin to sunlight, with symptoms of sunburn (such as redness, itching, swelling, or blistering) appearing more quickly than usual.

If you are scheduled for surgery or anesthesia, inform your doctor that you are taking telmisartan/hydrochlorothiazide.

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

Children and adolescents

Telmisartan/hydrochlorothiazide is not recommended for use in children and adolescents under 18 years of age.

Taking Telmisartán/Hidroclorotiazida Alter 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 other medicines or take other precautions. In some cases, you may need to stop taking one of these medicines, especially if you are using any of the following together with telmisartan/hydrochlorothiazide:

• Medicines containing lithium used to treat certain types of depression.
• Medicines associated with low potassium levels in blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and its derivatives.
• Medicines that may increase potassium levels in blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines such as sodium heparin (an anticoagulant).
• Medicines affected by changes in blood potassium levels, such as heart medicines (e.g., digoxin) or medicines to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), and other medicines such as certain antibiotics (e.g., sparfloxacin, pentamidine) or certain medicines to treat allergic reactions (e.g., terfenadine).
• Medicines for diabetes (insulin or oral agents such as metformin).
• Cholestyramine and colestipol, medicines used to reduce blood fat levels.
• Medicines to increase blood pressure, such as noradrenaline.
• Muscle relaxants, such as tubocurarine.
• Calcium and/or vitamin D supplements.
• Anticholinergic medicines (used to treat various disorders such as gastrointestinal spasms, urinary spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as an aid in anesthesia), such as atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral infections).
• Other medicines used to treat high blood pressure, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs [NSAIDs]), cancer treatments, gout, or arthritis.
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán/Hidroclorotiazida Alter” and “Warnings and precautions”).
• Digoxin.

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

In addition, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness upon standing. Inform your doctor, as dose adjustments of your other medicines may be needed while taking telmisartan/hydrochlorothiazide.

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

Taking Telmisartán/Hidroclorotiazida Alter with food and alcohol

You may take this medicine with or without food.

Avoid alcohol until you have spoken with your doctor. Alcohol may further lower your blood pressure and/or increase the risk of dizziness or weakness.

Pregnancy and breastfeeding

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

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking telmisartan/hydrochlorothiazide before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Telmisartan/hydrochlorothiazide is not recommended during pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when used from this stage.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as telmisartan/hydrochlorothiazida is not recommended for women during this period. Your doctor may choose a treatment more suitable if you intend to breastfeed.

Driving and using machines

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

Telmisartán/Hidroclorotiazida Alter contains sorbitol

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

3. How to take Telmisartán/Hidroclorotiazida Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose is one tablet daily. Try to take the tablet at the same time each day. You may take telmisartan/hydrochlorothiazide with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take telmisartan/hydrochlorothiazide every day until your doctor tells you otherwise. If your liver is not functioning properly, the usual dose should not exceed 40 mg/12.5 mg once daily.

If you take more Telmisartán/Hidroclorotiazida Alter 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, stating the medicine and the amount ingested.

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, markedly low blood pressure and low blood potassium levels may also occur, which could lead to nausea, drowsiness, muscle cramps, and/or irregular heartbeat, particularly when used concomitantly with medications such as digitalis or certain antiarrhythmic treatments. Contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Telmisartán/Hidroclorotiazida Alter

If you forget to take your dose, do not worry. Take it as soon as you remember and then continue as before. If you miss a day, simply take your normal dose the next day. Do not take a double dose to make up for forgotten 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 may cause adverse effects, although not everyone experiences 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”) is a serious infection involving a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema), and blistering and peeling of the outer layer of 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. Patients must stop taking the medicine and see their doctor immediately. If these adverse effects are not treated, they may be fatal.

An increased incidence of sepsis has been observed with telmisartan alone; however, this cannot be ruled out for telmisartan/hydrochlorothiazide.

Possible adverse effects of telmisartán/hydrochlorothiazide:

Frequent adverse effects (may affect up to 1 in 10 people):

Dizziness.

Uncommon adverse effects (may affect up to 1 in 100 people):

Decreased blood potassium levels, anxiety, fainting (syncope), tingling sensation, numbness (paresthesia), dizziness (vertigo), rapid heartbeat (tachycardia), irregular heart rhythm, 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, increased blood uric acid levels, and dizziness.

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

Lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body's immune system attacks its own tissues, causing joint pain, skin rashes, and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function abnormalities (patients of Japanese origin show a higher tendency to experience this adverse effect), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), limb pain, muscle cramps, flu-like illness, pain, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase levels in blood.

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

Telmisartan

The following additional adverse effects have been reported 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, deficiency of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), kidney function impairment including acute renal failure, weakness, cough.

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

Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), severe allergic reactions (e.g., hypersensitivity, anaphylactic reactions, drug rash), low blood sugar levels (in diabetic patients), stomach discomfort, 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 fibrosis of lung tissue (interstitial lung disease) **

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

** Cases of progressive fibrosis of lung tissue 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: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Hydrochlorothiazide

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

Frequent adverse effects (may affect up to 1 in 10 people):

Nausea, low blood magnesium levels.

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

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

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

Increase in pH (acid-base imbalance) due to low blood chloride levels, acute breathing difficulty (signs include severe shortness of breath, 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, 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 or loss of appetite, restlessness, dizziness, blurred or yellowish vision, decreased vision and eye pain (possible signs of fluid accumulation in the uveal layer of the eye (choroidal effusion) or acute angle-closure glaucoma), inflammation of blood vessels (necrotizing vasculitis), pancreatitis, stomach discomfort, yellowing of the skin or eyes (jaundice), pseudolupus syndrome (a condition mimicking systemic lupus erythematosus, in which the body's immune system attacks its own tissues), skin disorders such as inflammation of skin blood vessels, increased sensitivity to sunlight, skin rash, redness of the skin, blistering of lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in urine (glucosuria), fever, electrolyte imbalance, high blood cholesterol levels, decreased blood volume, increased blood/urine glucose levels in patients diagnosed with diabetes mellitus, or fat in the blood.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them through 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/Hydrochlorothiazide Alter

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

This medicine does not require special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Hydrochlorothiazide Alter

• The active substances 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-polyethylene glycol copolymer, sodium starch glycolate from potato, sorbitol (E420), iron oxide red (E172), and magnesium stearate.

Appearance of the product and contents of the pack

Reddish tablets with whitish specks, oblong in shape, unmarked.

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

Marketing Authorisation Holder and Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: March 2026

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