TELMISARTAN/HYDROCHLOROTHIAZIDE STADA 40 mg/12.5 mg TABLETS

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

Do not take Telmisartan/Hydrochlorothiazide Stada

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to hydrochlorothiazide or other sulfonamide-derived medicines.
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking this medicine during 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 serious 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, inform your doctor or pharmacist before using telmisartan/hydrochlorothiazide.

Warnings and precautions

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

• Low blood pressure (hypotension), which can occur if you are dehydrated (excessive loss of body water) or have an electrolyte deficiency due to treatment with diuretics, low-sodium diet, diarrhea, vomiting, or hemodialysis.
• Kidney disease or 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 an imbalance of various minerals in the blood)
• Systemic lupus erythematosus (also known as "lupus" or "SLE"), a disease in which the body's immune system attacks itself.
• The active ingredient hydrochlorothiazide can 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 within hours to weeks after taking telmisartan/hydrochlorothiazide. If left untreated, it can lead to permanent vision loss.

• If you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly 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 exposure and UV rays while taking telmisartan/hydrochlorothiazide.

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

Consult your doctor, pharmacist, or nurse before starting to take telmisartan/hydrochlorothiazide

• 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), particularly 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 Stada".

• if you are taking digoxin
• if you have had respiratory or pulmonary 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, seek medical attention immediately.

If you are pregnant (or think you may be), inform your doctor. 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.

Treatment with hydrochlorothiazide can 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 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 symptoms of sunburn (such as redness, itching, swelling, blistering) that appear more quickly than usual.

If you are going to have 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.

Athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Other medicines and Telmisartan/Hydrochlorothiazide Stada

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those without a prescription. Your doctor may need to modify your dose and/or take other precautions. In some cases, it may be necessary to interrupt the use of 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), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat 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, cyclosporine (an immunosuppressive medicine), and other medicines like sodium heparin (an anticoagulant).
• Medicines that are affected 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 some antibiotics (e.g., sparfloxacin, pentamidine) or some 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.
• Anticholinergic medicines (medicines 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) like atropine and biperiden.
• Amantadine (a medicine used to treat Parkinson's disease and also to treat or prevent certain viral diseases).
• 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 angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also the information under the headings "Do not take Telmisartan/Hydrochlorothiazide Stada" and "Warnings and precautions").
• Digoxin

Telmisartan/hydrochlorothiazide may increase the ability of other medicines to lower blood pressure or medicines that can potentially lower blood pressure (e.g., baclofen, amifostine). Additionally, the decrease 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 non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen).

Taking Telmisartan/Hydrochlorothiazide Stada with food and alcohol

You can take this medicine with or without food.

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

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or think you may be). Your doctor will usually advise you to stop taking telmisartan/hydrochlorothiazide before you become pregnant or as soon as you find out you are pregnant, and recommend that you take another blood pressure-lowering medicine instead. 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.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding. Telmisartan/hydrochlorothiazide is not recommended for use in women during breastfeeding, as your doctor may decide to give you a treatment that is more suitable if you want 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 Stadacontains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before using this medicine.

This medicine contains less than 23 mg of sodium (1 mmol); this is essentially "sodium-free".

3. How to take Telmisartan/Hydrochlorothiazide Stada

Follow exactly the instructions of administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of telmisartan/hydrochlorothiazide is one tablet per day. Try to take one tablet each day at the same time. 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 Stada than you should

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 heartbeats associated with concomitant use of medicines like digitalis or certain antiarrhythmic treatments. Contact your doctor or pharmacist or the nearest hospital emergency department immediately.

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

If you forget to take Telmisartan/Hydrochlorothiazide Stada

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 not takea 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* (often 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 skin and mucous membranes (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 increase in the incidence of sepsis with telmisartan alone has been observed; however, it cannot be ruled out for telmisartan/hydrochlorothiazide.

Possible Adverse Effects of Telmisartan/Hydrochlorothiazide Stada:

Frequent 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):

Lung inflammation (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, sinus inflammation, feeling of sadness (depression), difficulty falling asleep (insomnia), vision disturbances, breathing difficulties, abdominal pain, constipation, abdominal distension (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), alteration in liver function (Japanese patients show a greater tendency to experience this adverse effect), rapid swelling of the skin and mucous membranes that can be life-threatening (angioedema, including fatal outcome), skin redness (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the limbs, muscle cramps, pseudogrippal illness, pain, increased uric acid levels, 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 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, red blood cell deficiency (anemia), high potassium levels, slow heart rate (bradycardia), cough, alteration in kidney function, including acute kidney failure, weakness.

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), drowsiness, stomach discomfort, eczema (a skin disorder), osteoarthritis, tendon inflammation, decrease in hemoglobin (a blood protein).

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

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

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

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

• This may have been a casual finding or be 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.

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 magnesium level in the blood.

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

Decrease in platelet count in the blood, which increases the risk of bleeding and bruising (small purple-red spots on the skin or other tissues caused by bleeding), high calcium level 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 level in the blood, acute respiratory distress (signs include severe respiratory distress, fever, weakness, and confusion).

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

Salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), 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 discomfort, yellowing of the skin or eyes (jaundice), pseudolupus 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 altered function, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased glucose levels in the blood, difficulty controlling blood sugar levels in patients with diabetes mellitus, or fat in the blood.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting Adverse Effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 Stada

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

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

This medicine 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.

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. 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 Stada

• The active ingredients are telmisartan and hydrochlorothiazide. Each tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
• The other ingredients 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 starch glycolate (Type A), and yellow iron oxide (E172).

Appearance and Package Contents

Telmisartan/Hydrochlorothiazide Stada 40 mg/12.5 mg tablets are round, biconvex, white and yellow tablets.

Telmisartan/Hydrochlorothiazide Stada is available 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.

Not all pack sizes may be marketed in your country.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Liconsa, S.A.

Avda. Miralcampo, nº 7,

Polígono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara)

Spain

or

Medical Valley Invest AB

Bradgardsvagen 28 2 Tr

236 32 Höllviken

Sweden

Date of 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/