Telmisartan/hydrochlorothiazide Ratiogen 80 mg/25 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Telmisartan/Hydrochlorothiazide ratiogen 80 mg/25 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 ratiogen is and what it is used for
2. What you need to know before taking Telmisartan/Hydrochlorothiazide ratiogen
3. How to take Telmisartan/Hydrochlorothiazide ratiogen
4. Possible side effects
5. How to store Telmisartan/Hydrochlorothiazide ratiogen
6. Contents of the pack and other information

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

Telmisartán/Hidroclorotiazida ratiogen is a combination of two active substances, telmisartan and hydrochlorothiazide, in a single 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, allowing your blood vessels to relax and resulting in reduced blood pressure.

• Hydrochlorothiazide belongs to a group of medicines known as thiazide diuretics, which increase your urine output, leading to a reduction in 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 monitor your blood pressure regularly to ensure it remains within the normal range.

Telmisartán/Hidroclorotiazida ratiogen 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 starting to take Telmisartan/Hydrochlorothiazide ratiogen

Do not take Telmisartán/Hidroclorotiazida ratiogen:

• 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 (impaired 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 has determined that you have low potassium levels or high calcium levels in blood that do not improve with treatment.

• if you have diabetes or kidney 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 ratiogen.

Warnings and precautions

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida ratiogen 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 blood vessels to one or both kidneys)
• Liver disease
• Heart problems
• Diabetes
• Gout
• Elevated levels of aldosterone (retention of water and salt 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 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 eye pressure and may appear from hours to weeks after taking Telmisartán/Hidroclorotiazida ratiogen. If 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 exposure and UV radiation while taking Telmisartán/Hidroclorotiazida ratiogen.

Consult your doctor before starting to take Telmisartán/Hidroclorotiazida ratiogen:

• 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 ratiogen".

• 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 ratiogen, seek medical attention immediately.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking telmisartán/hydrochlorothiazide. Your doctor will decide whether to continue treatment. Do not stop taking telmisartán/hydrochlorothiazide without medical advice.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of Telmisartán/Hidroclorotiazida ratiogen is not recommended during early pregnancy (first 3 months), and must not be administered from the third month of pregnancy onward, as it may cause serious 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 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 ratiogen.

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

Children and adolescents

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

Use in athletes

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

Other medicines and Telmisartán/Hidroclorotiazida ratiogen

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 ratiogen:

• 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 (insulins or oral agents such as metformin).
• Cholestyramine and colestipol, medicines used to lower 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 to 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, analgesics (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 ratiogen" and "Warnings and precautions").
• Digoxin.

Telmisartán/Hidroclorotiazida ratiogen may enhance the blood pressure-lowering effect of other medicines or of 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 so that the doses of your other medicines can be adjusted while you are using Telmisartán/Hidroclorotiazida ratiogen.

The effect of Telmisartán/Hidroclorotiazida ratiogen 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 generally advise you to stop taking Telmisartán/Hidroclorotiazida ratiogen before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. The use of Telmisartán/Hidroclorotiazida ratiogen is not recommended during pregnancy, and must not be administered from the third month of pregnancy onward, as it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you are planning to start or are currently breastfeeding, as Telmisartán/Hidroclorotiazida ratiogen 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 may feel dizzy, faint, or experience a sensation of spinning when taking Telmisartán/Hidroclorotiazida ratiogen. If you experience any of these effects, do not drive or operate machinery.

Telmisartán/Hidroclorotiazida ratiogen contains sodium

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

3. How to take Telmisartan/Hydrochlorothiazide ratiopharm

Follow exactly the administration instructions for this medicine as indicated 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. Telmisartan/hydrochlorothiazide can be taken with or without food. The tablets should be swallowed whole with a small amount of 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 of telmisartan once daily.

If you take more Telmisartan/Hydrochlorothiazide ratiogen 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 potassium levels in the blood 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 or pharmacist or the nearest hospital emergency service immediately.

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 Telmisartan/Hydrochlorothiazide ratiogen

If you forget to take your dose, do not worry. Take the missed dose as soon as you remember, and then continue as before. If you miss a tablet 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 visit your doctor immediately:

Sepsis* (commonly called "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 the 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, 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, this cannot be ruled out for Telmisartán/Hidroclorotiazida ratiogen.

Possible adverse effects of Telmisartán/Hidroclorotiazida ratiogen:

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

Dizziness.

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

Low 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), sore throat, sinusitis, elevated uric acid levels, low sodium levels, feeling of sadness (depression), difficulty sleeping (insomnia), sleep disorders, vision disturbances, blurred vision, difficulty breathing, abdominal pain, constipation, abdominal bloating (dyspepsia), general malaise (vomiting), stomach inflammation (gastritis), liver function abnormalities (this adverse effect is more commonly observed in Japanese patients), 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 one of the individual components may also be potential adverse reactions of Telmisartán/Hidroclorotiazida ratiogen, 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, 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), somnolence, 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 swelling has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhea following use of similar products.

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

** 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:

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

Elevated blood fat levels.

Common 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 purple-red 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), inability of bone marrow 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 (signs 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)

Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), deficiency of blood cells (aplastic anemia), decreased 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 skin blood vessels, 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 occur accompanied by symptoms related to the brain or nerves (nausea, progressive disorientation, lack of interest or energy).

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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. Conservation of Telmisartan/Hydrochlorothiazide ratiopharm

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

Do not use this medicine after the expiry date stated on the pack 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 empty containers and unused medicines at the SIGRE point in your usual pharmacy. 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 ratiogen

The active substances are telmisartan and hydrochlorothiazide. Each tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.

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

Appearance of the product and contents of the pack

Telmisartan/Hydrochlorothiazide ratiogen 80 mg/25 mg tablets are oval, concave tablets, 9.0 x 17.0 mm, with "TH" engraved on one side and "25" on the other.

Pack sizes

Blister: 28 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas, Madrid

Spain

Manufacturer

Actavis Ltd.

BLB016

Bulebel Industrial Estate

Zejtun ZTN 3000 Malta

Date of the most recent revision 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/