Label: Information for the User

Telmisartán/Hidroclorotiazida Kern Pharma 80 mg/12,5 mg Tablets EFG

Read this label carefully before starting to take this medicine, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it 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 label. See section 4

Telmisartán/Hidroclorotiazida Kern Pharma is an association of two active principles, telmisartán and hidroclorotiazida in a tablet. Both active principles help 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 or kidney failure, stroke, or blindness.

Usually, there are 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 for the 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 Kern Pharma

• 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 best 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 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, which 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.
• Elevated aldosterone levels (retention of water and salt in the body along with imbalance of various minerals in the blood).
• 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 a decrease in vision or eye pain. These symptoms may be indicative of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure and may occur within a few hours to a week after taking Telmisartán/Hidroclorotiazida Kern Pharma. If left untreated, it may lead to permanent vision loss.
• Skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hidroclorotiazida, particularly 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 Kern Pharma.
• 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 shortness of breath or severe difficulty breathing after taking Telmisartán/Hidroclorotiazida, seek medical attention immediately.

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida Kern Pharma

• 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 Kern Pharma)

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartán/Hidroclorotiazida Kern Pharma. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán/Hidroclorotiazida Kern Pharma 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 after the third month of pregnancy as it may cause serious 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 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 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.

Children and adolescents

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

Taking Telmisartán/Hidroclorotiazida Kern Pharma with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to adjust your dose and/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 using them in combination with Telmisartán/Hidroclorotiazida:

• 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 (adrenocorticotropic hormone), amphotericin (antifungal medication), carbenoxolone (used in the treatment of mouth ulcers), penicillin G sodium (an antibiotic), and aspirin and derivatives.
• Diuretics that conserve potassium, potassium supplements, salt substitutes containing potassium, ACE inhibitors that may increase potassium levels in the blood.
• Medications for the heart (e.g. digoxin) or medications used to control heart rhythm (e.g. quinidine, disopyramide).
• Medications used to treat mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine).
• Other medications used to treat high blood pressure, steroids, analgesics, cancer medications, gout, or arthritis, and vitamin D supplements.
• If you are taking an ACE inhibitor or aliskirén (see also the information under the headings "Do not take Telmisartán/Hidroclorotiazida Kern Pharma" and "Warnings and precautions").

Telmisartán/Hidroclorotiazida may increase the effect of other medications to lower blood pressure and you should 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 nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin or ibuprofen).

Pregnancy and breastfeeding

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, suspect you may be pregnant, or plan to become pregnant. In general, your doctor will 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 after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

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 machinery

Some patients may feel dizzy or tired due to high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Use in athletes

This medication contains hidroclorotiazida, which may produce a positive result in doping control tests.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual dose of Telmisartán/Hidroclorotiazida is one tablet per day. Try to take one 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 that you 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 Kern Pharma 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 forgot to take Telmisartán/Hidroclorotiazida Kern Pharma

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 tablet, 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, Telmisartán/Hidroclorotiazida Kern Pharma may cause side effects, although not everyone will experience them.

Some side effects may 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 severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (they may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they may be fatal. An increased incidence of sepsis with telmisartán alone has been observed; however, it cannot be ruled out for Telmisartán/Hidroclorotiazida.

Possible side effects of Telmisartán/Hidroclorotiazida:

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

Dizziness.

Rare side effects(may 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.

Very rare side effects(may 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), difficulty falling asleep (insomnia), vision disturbances, difficulty breathing, abdominal pain, constipation, abdominal distension (dyspepsia), general feeling of discomfort, stomach inflammation (gastritis), alteration in liver function (Japanese patients are more prone to experiencing this side effect), rapid swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), skin redness (erythema), allergic reactions such as itching or rashes, increased sweating, hives (urticaria), joint pain (arthralgia), and pain in the extremities, muscle cramps, pseudogripal disease, pain, increased uric acid levels, low sodium levels, increased creatinine levels, liver enzymes or creatine phosphokinase in the blood.

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

Telmisartán

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

Rare side effects(may 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), kidney function impairment including acute kidney failure, weakness, cough.

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

Sepsis* (frequently called "blood infection", is a severe infection that involves a systemic inflammatory reaction and may cause death), low platelet count (thrombocytopenia), increased eosinophils, 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.

Extremely rare side effects(may affect up to 1 in 10,000 people):

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

Side effects of 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.

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

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

Hidroclorotiazida

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

Extremely rare side effects(may affect up to 1 in 10,000 people):

Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion).

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

Salivary gland inflammation, decreased blood cell count, including low red and white blood cell counts, low platelet count (thrombocytopenia); severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased or loss of appetite; restlessness, dizziness, decreased vision or eye pain due to high pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or acute angle-closure glaucoma], necrotizing vasculitis, pancreatitis, stomach discomfort, yellowing of the skin or eyes (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 inflammation of blood vessels in the skin, increased sensitivity to sunlight or formation of blisters and peeling on the skin's surface (toxic epidermal necrolysis), weakness, kidney inflammation or impairment, glucose in the urine (glucosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar or fat levels,skin cancer and lip cancer (non-melanoma skin cancer).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, Website: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 packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions. It should store your medication in the original packaging to protect the tablets from moisture.

Medications should not be thrown down the drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy.In case of 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 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 sodium hydroxide, mannitol (E-421), cornstarch, microcrystalline cellulose, calcium carmelose, povidone (K-25), silicon dioxide, and sodium stearoylfumarate.

Appearance of the product and content of the packaging

Oval white or almost white tablets.

Telmisartan/Hydrochlorothiazide Kern Pharma is presented in blister packs containing 28 tablets.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus ,72-Pol. Ind.Colón II

08228 Terrassa -Barcelona

Spain

Responsible for Manufacturing

Kern Pharma, S.L.

Venus,72-Pol. Ind.Colón II

08228 Terrassa -Barcelona

Spain

or

Delorbis Pharmaceuticals Ltd.,17, Athion Street, Ergates Industrial Area,

Cyprus

or

Iberfar – Indústria Farmacêutica, S.A.,

Rua Consiglieri Pedroso, nº 121-123 – Queduz de Baixo,

Barcarena, 2745-557,

Portugal

Last review date of this leaflet: February 2025

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