Telmisartan/hydrochlorothiazide Kern Pharma 80/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Telmisartan/Hydrochlorothiazide Kern Pharma 80 mg/12.5 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

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

Contents of the leaflet:

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

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

Telmisartán/Hidroclorotiazida Kern Pharma 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, allowing your blood vessels to relax and reducing your blood pressure.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase urine elimination, resulting in a reduction of blood pressure.

If left untreated, high blood pressure can damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness.

High blood pressure usually does not cause symptoms before damage occurs. Therefore, it is important to regularly monitor your blood pressure to ensure it remains within the normal range.

Telmisartán/Hidroclorotiazida is used to treat 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 Kern Pharma

Do not take Telmisartán/Hidroclorotiazida Kern Pharma

• if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hydrochlorothiazide or to other sulfonamide-derived medicines
• 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 (problems with bile drainage from the gallbladder) or any other serious liver disease
• if you have severe kidney disease
• if your doctor finds 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 renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor if you have or have previously 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 salt deficiency 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 to one or both kidneys).
• Liver disease.
• Heart problems.
• Diabetes.
• Gout.
• Elevated 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 the body itself.
• The active ingredient hydrochlorothiazide may cause a rare reaction leading to vision loss or eye pain. These symptoms may indicate fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur within hours to one week after taking Telmisartán/Hidroclorotiazida Kern Pharma. If left untreated, this may lead to permanent vision loss.
• 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays while taking Telmisartán/Hidroclorotiazida Kern Pharma.
• If you have previously experienced respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Telmisartán/Hidroclorotiazida, seek immediate medical attention.

Consult your doctor before starting Telmisartán/Hidroclorotiazida Kern Pharma

• 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 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 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 as monotherapy without medical advice.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of Telmisartán/Hidroclorotiazida 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 serious harm to your baby. See Pregnancy section.

Treatment with hydrochlorothiazide may cause an 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 skin sensitivity to sunlight with symptoms of sunburn (such as redness, itching, swelling, or blistering) that appear more quickly than usual.

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

Children and adolescents

Use of Telmisartán/Hidroclorotiazida is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán/Hidroclorotiazida Kern Pharma 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 your dose and/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 Telmisartán/Hidroclorotiazida:

• Medicines containing lithium used to treat certain types of depression.
• Medicines associated with low blood potassium levels (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 its derivatives.
• Potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, which may increase blood potassium levels.
• Medicines for the heart (e.g., digoxin) or medicines used to control your heart rhythm (e.g., quinidine, disopyramide).
• Medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine).
• Other medicines used to treat high blood pressure, steroids, painkillers, cancer treatments, gout or arthritis, and vitamin D supplements.
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Telmisartán/Hidroclorotiazida Kern Pharma” and “Warnings and precautions”).

Telmisartán/Hidroclorotiazida may enhance the blood pressure-lowering effect of other medicines, and you should inform your doctor about the need to adjust the dose of your other medicines while taking Telmisartán/Hidroclorotiazida.

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

Pregnancy and breastfeeding

If you are pregnant or 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. Generally, your doctor will advise you to stop taking Telmisartán/Hidroclorotiazida before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Telmisartán/Hidroclorotiazida is not recommended during pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Telmisartán/Hidroclorotiazida is not recommended for women during this period. Your doctor may decide to prescribe a more suitable treatment if you intend to breastfeed.

Driving and using machines

Some patients feel dizzy or tired when being treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Use in athletes

This medicine contains hydrochlorothiazide, which may produce positive results in doping tests.

3. How to take Telmisartán/Hidroclorotiazida Kern Pharma

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

The usual dose of Telmisartán/Hidroclorotiazida is one tablet daily. Try to take one tablet every day at the same time. You may take Telmisartán/Hidroclorotiazida with or without food. Swallow the tablets with a little water or another non-alcoholic drink. It is important that you take Telmisartán/Hidroclorotiazida 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 Kern Pharma than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Telmisartán/Hidroclorotiazida Kern Pharma

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 dose one day, take your normal dose the next day. Do not take a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Telmisartán/Hidroclorotiazida Kern Pharma may produce 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). These adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious, and 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, it cannot be ruled out for Telmisartán/Hidroclorotiazida.

Possible adverse effects of Telmisartán/Hidroclorotiazida:

Common 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), 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 blood uric acid levels.

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, sinus inflammation, feeling of sadness (depression), difficulty sleeping (insomnia), vision disturbances, breathing difficulty, abdominal pain, constipation, abdominal bloating (dyspepsia), general malaise, stomach inflammation (gastritis), liver function abnormalities (Japanese patients show a higher tendency to experience this adverse effect), rapid swelling of the skin and mucous membranes that may be fatal (angioedema including fatal outcome), 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, increased uric acid levels, low sodium levels, increased creatinine, liver enzymes, or creatine phosphokinase levels in blood.

Adverse reactions reported for either individual component may be potential adverse reactions of Telmisartán/Hidroclorotiazida, 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, sinus inflammation, 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, dizziness.

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

Sepsis* (commonly called “blood infection”, a serious infection involving a systemic inflammatory response that may be fatal), 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), somnolence.

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

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

Adverse effects with unknown frequency (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.

• 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 treatment with telmisartan. However, it is unknown whether telmisartan was the cause.

Hydrochlorothiazide

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

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

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

Adverse effects with unknown frequency (cannot be estimated from available data):

Salivary gland inflammation, decreased blood cell counts, 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 elevated pressure [possible signs of fluid accumulation in the vascular 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, or blistering and peeling of the outer skin layer (toxic epidermal necrolysis), weakness, kidney inflammation or impaired kidney function, glucose in urine (glucosuria), fever, electrolyte imbalance, elevated blood cholesterol levels, decreased blood volume, increased blood sugar or fat levels, skin and lip cancer (non-melanoma skin cancer).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan/Hydrochlorothiazide Kern Pharma

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

Do not use this medicine after the expiry date stated on the packaging after "CAD". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions. Keep your medicine in the original packaging to protect the tablets from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan/Hydrochlorothiazide

• The active substances 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), corn starch, microcrystalline cellulose, calcium carmellose, povidone (K-25), silicon dioxide, sodium stearyl fumarate.

Appearance of the medicine and contents of the pack

White or almost white, oval tablets.

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

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

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

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

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