Telmisartan/hydrochlorothiazide Teva-Ratio 80 mg/12.5 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Telmisartan/Hydrochlorothiazide Teva-ratio 80 mg/12.5 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask 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.

Leaflet contents

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

1. What Telmisartán/Hidroclorotiazida Teva-ratio is and what it is used for

Telmisartán/Hidroclorotiazida Teva-ratio 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 blockers. 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 thereby 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 Teva-ratio 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 Teva-ratio

Do not take Telmisartán/Hidroclorotiazida Teva-ratio

• 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 the early stages of pregnancy—see Pregnancy section).
• 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 or anuria (less than 100 ml of urine per day).
• if your doctor determines that you have low potassium levels or high calcium levels in the blood that do not improve with treatment.
• if you have diabetes or renal insufficiency 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 taking Telmisartán/Hidroclorotiazida.

Warnings and precautions

Talk to your doctor before starting Telmisartán/Hidroclorotiazida 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 salt deficiency due to treatment with diuretics, a low-sodium diet, diarrhea, vomiting, or hemofiltration.
• 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 called "lupus" or "SLE"), a disease in which the body's immune system attacks the body itself
• The active ingredient hydrochlorothiazide may cause an uncommon 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 eye pressure and may appear from hours to weeks after taking Telmisartán/Hidroclorotiazida. If left untreated, this may lead to permanent vision impairment.
• 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 non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking Telmisartán/Hidroclorotiazida.

Talk to your doctor before starting Telmisartán/Hidroclorotiazida:

• 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 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 Teva-ratio".

• If you are taking digoxin.
• 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 Teva-ratio, contact your doctor immediately.

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

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 the first trimester of pregnancy (first 3 months), and it must not be used from the third month of pregnancy onward, 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 experience 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.

Telmisartán/Hidroclorotiazida may be less effective in lowering blood pressure in black patients.

Children and adolescents

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

Use in athletes

This medicine contains hydrochlorothiazide, which may result in a positive doping test.

Other medicines and Telmisartán/Hidroclorotiazida Teva-ratio

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 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 to treat mouth ulcers), sodium penicillin G (an antibiotic), and acetylsalicylic acid and its derivatives.
• Iodinated contrast agents used during imaging procedures.
• Medicines that may increase blood potassium levels, 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 for 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 (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]), medicines for 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 Telmisartán/Hidroclorotiazida Teva-ratio" and "Warnings and precautions").
• Digoxin.

Telmisartán/Hidroclorotiazida 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 necessary while using Telmisartán/Hidroclorotiazida.

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

Taking Telmisartán/Hidroclorotiazida 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

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 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 onward, 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 choose a treatment more suitable for you if you wish to breastfeed.

Driving and using machines

Some patients feel dizzy, faint, or experience a sensation of spinning when taking Telmisartán/Hidroclorotiazida. If you experience any of these effects, do not drive or operate machinery.

Telmisartán/Hidroclorotiazida Teva-ratio contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; therefore, it is essentially "sodium-free".

3. How to take Telmisartan/Hydrochlorothiazide Teva-ratio

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

The recommended dose is one tablet daily. Try to take one tablet each day at the same time. Telmisartán/Hydrochlorothiazide may be taken with or without food. The tablets should be swallowed whole with a little water or another non-alcoholic drink. It is important that you take Telmisartán/Hydrochlorothiazide every day until your doctor tells you otherwise.

If your liver is not functioning properly, the usual dose should not exceed 40 mg of telmisartán once daily.

If you take more Telmisartán/Hydrochlorothiazide Teva-ratio 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, markedly low blood pressure and low blood potassium levels may also occur, which can 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 or pharmacist immediately, or go to the nearest hospital emergency department.

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, stating the medicine and the amount ingested.

If you forget to take Telmisartán/Hydrochlorothiazide Teva-ratio

If you forget to take the medicine, do not worry. Take the dose 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 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 can cause adverse effects, although not everyone will experience 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 referred to as "blood infection")—a serious infection involving a systemic inflammatory response, rapid swelling of the skin and mucous membranes (angioedema, including fatal outcomes), 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 very rare (toxic epidermal necrolysis, may affect up to 1 in 10,000 people), but are extremely serious. Patients must stop taking the medicine and seek immediate medical attention. 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/Hidroclorotiazida Teva-ratio:

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, pins and needles (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), sore throat, sinusitis, elevated uric acid levels, low sodium levels, feeling of sadness (depression), difficulty sleeping (insomnia), sleep disorders, vision disturbances, blurred vision, breathing difficulty, abdominal pain, constipation, abdominal bloating (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function abnormalities (Japanese patients 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 (leg pain), muscle cramps, 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), flu-like illness, pain, increased levels of creatinine, liver enzymes, or creatine phosphokinase in blood.

Adverse reactions reported for either individual component may also be potential adverse reactions of Telmisartán/Hidroclorotiazida, 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, bladder infection, deficiency of red blood cells (anemia), high potassium levels, slow heart rate (bradycardia), cough, kidney function impairment including acute renal failure, weakness, dizziness.

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), low blood sugar levels (in diabetic patients), drowsiness, stomach discomfort, eczema (a skin disorder), drug rash, toxic skin eruption, tendon pain (symptoms of pseudotendinitis), decreased 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 (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 a coincidental finding or related to a currently unknown mechanism.

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

Hydrochlorothiazide

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

Very common adverse effects (may affect up to 1 in 10 people)

Elevated blood lipid levels.

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

Nausea, low blood magnesium levels, decreased appetite.

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

Acute renal failure.

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

Low platelet count (thrombocytopenia), which increases the risk of bleeding and bruising (small red-purple spots on the skin or other tissues caused by bleeding), high blood calcium levels, high blood sugar levels, headache, abdominal discomfort, yellowing of the skin or eyes (jaundice), excess bile substances in the blood (cholestasis), photosensitivity reaction, uncontrolled blood glucose levels in patients diagnosed with diabetes mellitus, glucose in urine (glucosuria).

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

Abnormal breakdown of red blood cells (hemolytic anemia), bone marrow failure to function properly, reduction in white blood cells (leukopenia, agranulocytosis), severe allergic reactions (e.g., hypersensitivity), increased pH due to low chloride levels in blood (acid-base imbalance, hypochloremic alkalosis), acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion), pancreatitis, pseudolupus syndrome (a disorder resembling systemic lupus erythematosus, in which the body's immune system attacks its own tissues), inflammation of blood vessels (necrotizing vasculitis).

Frequency not known (cannot be estimated from available data)

Salivary gland inflammation, skin and lip cancer (non-melanoma skin cancer), blood cell deficiency (aplastic anemia), reduced vision and eye pain (possible signs of fluid accumulation in the vascular layer of the eye [choroidal effusion] or acute angle-closure glaucoma), skin disorders such as inflammation of blood vessels in the skin, increased sensitivity to sunlight, skin rash, skin redness, blistering of lips, eyes, or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney dysfunction.

In isolated cases, low sodium levels may occur accompanied by brain- or nerve-related symptoms (nausea, progressive disorientation, lack of interest or energy).

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via 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 Teva-ratio

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 "EXP". The expiry date is the last day of the month indicated.

For Al/Al blisters:

This medicine does not require any special storage conditions.

For Al/PVC/PVDC blisters:

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your usual pharmacy. Ask your pharmacist how to 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 Teva-ratio

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

The other components are magnesium stearate, meglumine, microcrystalline cellulose, povidone, potassium hydroxide, sodium carboxymethylstarch from potato (type A), and mannitol (E421).

Appearance of the medicine and contents of the pack

Telmisartan/Hydrochlorothiazide Teva-ratio 80 mg/12.5 mg tablets are capsule-shaped tablets, 9.0 x 17.0 mm, with "TH 12.5" engraved on both sides.

Pack sizes

Blister pack: 28 tablets

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer

Actavis ehf.

Reykjavíkurvegur 78

IS220

Hafnarfjördur

Iceland

OR

Actavis Ltd.

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

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

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/79608/P_79608.html

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