Losartan/hidroclorotiazida teva-ratio 100/12,5 mg comprimidos recubiertos con pelicula

PROSPECTO: INFORMATION FOR THE USER

Teva-ratio Losartan/Hydrochlorothiazide 100 mg/12.5 mg Film-Coated Tablets

Losartan potassium/hydrochlorothiazide

1. What is Losartan/Hydrochlorothiazide Teva-ratio and for what it is used

2. What you need to know before starting to take Losartan/Hydrochlorothiazide Teva-ratio

3. How to take Losartan/Hydrochlorothiazide Teva-ratio

4. Possible adverse effects

5. Storage of Losartan/Hydrochlorothiazide Teva-ratio

6. Contents of the pack and additional information

Losartán/Hidroclorotiazida Teva-ratio 100 mg/12.5 mg tablets is a combination of an angiotensin II receptor antagonist (losartán) and a diuretic (hidroclorotiazida).

Angiotensin II is a substance produced in the body that binds to receptors in blood vessels causing them to constrict. This results in an increase in blood pressure. Losartán prevents the binding of angiotensin II to these receptors, producing the relaxation of blood vessels that decreases blood pressure. Hidroclorotiazida works by causing the kidneys to pass more water and salt. This also helps to reduce blood pressure.

Losartán/hidroclorotiazida is indicated for the treatment of essential hypertension (high blood pressure).

Do not take Losartán/Hidroclorotiazida Teva-ratio tablets

• if you are allergic to losartan, hidroclorotiazida or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamide-derived substances (for example, other thiazides, some antibacterials such as cotrimoxazol, ask your doctor if you are unsure),
• if you have severe liver failure,
• if you have low levels of potassium or sodium or high levels of calcium that cannot be corrected with treatment,
• if you have gout,
• if you are more than 3 months pregnant (it is best to avoid Losartán/Hidroclorotiazida Teva-ratio during the first months of pregnancy - see "Pregnancy and breastfeeding"),
• if you have severe kidney failure or your kidneys do not produce urine,
• if you have diabetes or kidney failure and are being treated with a blood pressure lowering medicine that contains aliskirén.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Losartán/Hidroclorotiazida Teva-ratio.

If you experience a decrease in vision or eye pain, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal hemorrhage) or an increase in eye pressure and may occur within a few hours to several weeks after taking Losartán/Hidroclorotiazida Teva-ratio. If left untreated, this can lead to permanent loss of vision. You may be at a higher risk of this occurring if you have previously had an allergy to penicillin or sulfonamide.

Inform your doctor if you are pregnant (or if you suspect you may be). Losartán/Hidroclorotiazida Teva-ratio is not recommended for use at the beginning of pregnancy, and it should not be taken if you are more than 3 months pregnant as it may cause serious harm to your baby when administered from that point onwards (see "Pregnancy and breastfeeding").

It is essential that you inform your doctor before taking Losartán/Hidroclorotiazida Teva-ratio:

• if you have previously experienced swelling of the face, lips, tongue or throat,
• if you are taking diuretics (urine tablets),
• if you are following a low-sodium diet,
• if you have had excessive vomiting and/or diarrhea,
• if you have heart failure,
• if you have liver failure (see "Do not take Losartán/Hidroclorotiazida Teva-ratio"),
• if you have narrowed arteries leading to the kidney (renal artery stenosis), or if you only have one functioning kidney or have recently had a kidney transplant,
• if you have atherosclerosis, angina (chest pain due to poor heart function),
• if you have "aortic or mitral valve stenosis" (narrowing of the heart valves) or "hypertrophic cardiomyopathy" (a disease that causes thickening of the heart valves),
• if you are diabetic,
• if you have had gout,
• if you have or have had an allergic reaction, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus),
• if you have high levels of calcium or low levels of potassium or if you are following a low-potassium diet,
• if you need anesthesia (even for dental procedures) or before surgery, or if you are undergoing tests to determine your parathyroid function, inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary aldosteronism (a syndrome associated with an elevated secretion of aldosterone hormone by the adrenal gland due to an alteration of this gland),
• if you are taking any of the following medicines used to treat high blood pressure (hypertension):

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (for example, 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 the blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Losartán/Hidroclorotiazida Teva-ratio".

• if you are taking other medicines that may increase serum potassium (see section 2 "Other medicines and Losartán/Hidroclorotiazida Teva-ratio"),
• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. The treatment with hydrochlorothiazide, 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 exposure to the sun and UV rays while taking Losartán/Hidroclorotiazida Teva-ratio.
• Inform your doctor 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 severe shortness of breath or difficulty breathing after taking Losartán/Hidroclorotiazida Teva-ratio, seek medical attention immediately.

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

Children and adolescents

There is no experience with the use of Losartán/Hidroclorotiazida Teva-ratio in children. Therefore, Losartán/Hidroclorotiazida Teva-ratio should not be administered to children.

Older patients

Losartan potassium and hydrochlorothiazide act with equal efficacy and are equally well tolerated by most elderly and young patients. Most elderly patients require the same dose as younger patients.

Other medicines and Losartán/Hidroclorotiazida Teva-ratio

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medicines or other medicines that may increase serum potassium (e.g. trimetoprim-containing medicines), as it is not recommended to combine these with Losartán/Hidroclorotiazida Teva-ratio.

Diuretics such as hydrochlorothiazide contained in Losartán/Hidroclorotiazida Teva-ratio may interact with other medicines.

Lithium preparations should not be taken with Losartán/Hidroclorotiazida Teva-ratio without your doctor's careful monitoring.

Special precautions may be necessary (e.g. blood tests) if you take other diuretics (urine tablets), some laxatives, glycyrrhizin (found in licorice), medicines for gout, medicines to control heart rhythm or for diabetes (oral antidiabetics or insulin).

It is also essential that your doctor knows if you are taking

• other medicines to lower your blood pressure,
• steroids,
• medicines for cancer,
• pain medicines,
• medicines for fungal infections,
• medicines for arthritis,
• resins used for high cholesterol, such as cholestyramine,
• muscle relaxants,
• sleeping tablets;
• opioid medicines such as morphine,
• "pressor amines" such as adrenaline or other medicines in the same group
• oral medicines for diabetes or insulin.

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskirén (see also the information under the headings "Do not take Losartán/hidroclorotiazida Teva-ratio" and "Warnings and precautions").

Please inform your doctor when you plan to have a contrast agent with iodine.

Taking Losartán/Hidroclorotiazida Teva-ratio with food, drinks and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartán/Hidroclorotiazida Teva-ratio may increase the effects of the other.

Excessive salt in the diet may counteract the effect of Losartán/Hidroclorotiazida Teva-ratio tablets.

Avoid foods and drinks that contain glycyrrhizin, which is found in licorice and may cause abnormal electrolyte levels in the blood.

Losartán/Hidroclorotiazida Teva-ratio may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant (or if you suspect you may be). Your doctor will usually recommend that you stop taking Losartán/Hidroclorotiazida Teva-ratio before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medicine instead of Losartán/Hidroclorotiazida Teva-ratio. Losartán/Hidroclorotiazida Teva-ratio is not recommended for use during pregnancy, and in any case, it should not be administered from the third month of pregnancy onwards as it may cause serious harm to your baby when administered from that point onwards.

Lactation

Inform your doctor if you are breastfeeding or plan to start. Losartán/Hidroclorotiazida Teva-ratio is not recommended for use during breastfeeding, and your doctor will choose another treatment for you if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

When starting treatment with this medicine, you should not perform tasks that may require special attention (e.g. driving a car or using hazardous machinery) until you know how you tolerate your medicine.

Losartán/Hidroclorotiazida Teva-ratio contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Follow the administration instructions for this medication, as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide on the appropriate dose of Losartán/Hidroclorotiazida Teva-ratio, depending on your condition and whether you are taking other medications. It is essential to continue taking Losartán/Hidroclorotiazida Teva-ratio as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is one Losartán/Hidroclorotiazida 50 mg/12.5 mg tablet per day to control blood pressure for 24 hours. The dose may be increased to one Losartán/Hidroclorotiazida 100/12.5 mg tablet per day or two Losartán/Hidroclorotiazida 50 mg/12.5 mg tablets per day, or changed to one Losartán/Hidroclorotiazida 100 mg/25 mg tablet per day. The maximum daily dose is two Losartán/Hidroclorotiazida 50/12.5 mg tablets per day or one Losartán/Hidroclorotiazida 100 mg/25 mg tablet per day.

All mentioned dosages are not possible with this medication.

Administration

The tablets should be swallowed whole with a glass of water.

If you take more Losartán/Hidroclorotiazida Teva-ratio than you should

In case of overdose, consult your doctor immediately for prompt medical attention. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

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

If you forget to take Losartán/Hidroclorotiazida Teva-ratio

Try to take Losartán/Hidroclorotiazida Teva-ratio at the same time each day as prescribed.However, if you miss a dose, do not take an extra dose. Simply return to your regular schedule.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following, stop taking Losartán/Hidroclorotiazida Teva-ratio tablets and inform your doctor immediately or go to the nearest hospital emergency department:

• Severe allergic reaction (skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty breathing or swallowing).
• Acute respiratory distress (symptoms include severe difficulty breathing, fever, weakness, and confusion) (very rare, may affect up to 1 in 10,000 people).

This is a serious but rare side effect that affects more than 1 in 10,000 patients, but less than 1 in 1,000. You may need urgent medical attention or hospitalization.

The following side effects have been reported:

Frequent (may affect up to 1 in 10 people)

• Cough, upper respiratory tract infection, nasal congestion, sinusitis, breast disorders,
• Diarrhea, abdominal pain, nausea, indigestion,
• Muscle pain or cramps, leg pain, back pain,
• Insomnia, headache, dizziness,
• Weakness, fatigue, chest pain,
• Elevated potassium levels (which may cause abnormal heart rhythm), decreased hemoglobin levels,
• Changes in renal function that include kidney insufficiency;
• Low blood sugar (hypoglycemia).

Occasional (may affect up to 1 in 100 people)

• Anemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms, and buttocks, with joint pain, swelling of the hands and feet, and abdominal pain), bruises, reduced white blood cells, coagulation problems,reduced platelet count,
• Loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory alteration,
• Tickling or similar sensations, pain in the extremities, tremors, migraine, fainting,
• Blurred vision, eye irritation or itching, conjunctivitis, worsening vision, seeing things in yellow,
• Ringling, buzzing, or clicking sounds in the ears, vertigo
• Low blood pressure that may be associated with changes in posture (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, transient ischemic attack (mini-stroke), heart attack, palpitations,
• Inflammation of blood vessels that often occurs with a skin rash or hematoma,
• Sore throat, shortness of breath, bronchitis, nasal bleeding, runny nose, congestion,
• Constipation, chronic constipation, gas, stomach disorders, stomach spasms, vomiting, dry mouth, salivary gland inflammation, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), pancreatitis inflammation,
• Hives, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss,
• Pain in the arms, shoulders, hips, knees, or other joints, joint swelling, stiffness, muscle weakness,
• Frequent urination even at night, abnormal renal function including kidney inflammation, urinary tract infection, sugar in the urine
• Decreased libido, impotence,
• Swelling of the face,localized swelling (edema),fever.

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

• Hepatitis (liver inflammation), abnormal liver function tests
• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency unknown (the frequency cannot be estimated from available data)

• Symptoms similar to the flu,
• Muscle pain of unknown origin with dark-colored urine (tea-colored urine) (rhabdomyolysis),
• Low sodium levels in the blood (hyponatremia),
• Generally feeling unwell,
• Altered taste (dysgeusia),
• Rashes and skin lesions (cutaneous lupus erythematosus),
• Skin cancer and lip cancer (non-melanoma skin cancer),
• 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].

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear 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 out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C. Store in the original packaging to protect it from moisture.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Teva-ratio

• The active principles are losartan potassium and hydrochlorothiazide. Each film-coated tablet contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

• The other components (excipients) are: lactose monohydrate, pregelatinized maize starch, microcrystalline cellulose, and magnesium stearate in the tablet core and partially hydrogenated polyvinyl alcohol, titanium dioxide (E-171), macrogol 3350, and talc in the coating.

Appearance of the product and contents of the package

• Film-coated tablet

• Film-coated tablet, white, biconvex, oval-shaped, with "LH" engraved on one face and smooth on the other.
• Available in: blisters of 14, 28, 30, 56, 60, 90, 98, and 100 film-coated tablets. 50x1 unit dose (hospital pack) film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

Spain

Responsible Manufacturer:

Pharmachemie B.V

Swensweg 5, Postbus 552, 2003 RN Haarlem

Netherlands

or

TEVA Pharmaceutical Works Private Limited Company

Pallagi út 13, 4042 Debrecen

Hungary

or

TEVA Pharmaceutical Works Private Limited Company

Tancsics Mihaly út 82, 2100 Gödöllö

Hungary

or

Teva Czech Industries s.r.o.

Ostravská 29, indication number 305, 747 70, Opava - Komárov

Czech Republic

or

MERCKLE GMBH

Ludwig-Merckle-Strasse, 3

D-89143 Blaubeuren, Germany

or

TEVA PHARMA, S.L.U.,

C/ No. 4, Polígono Industrial Malpica,

50016- Zaragoza

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:January 2025

“Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74569/P_74569.html