Losartan/hidroclorotiazida teva-ratio 50/12.5 mg comprimidos recubiertos con pelicula efg

Leaflet: information for the user

Teva-ratio Losartan/Hydrochlorothiazide 50 mg/12.5 mg film-coated tablets

EFG

losartan potassium/

hydrochlorothiazide

Read this 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

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

3. How to take Losartan/Hydrochlorothiazide Teva-ratio

4. Possible side effects

5. Storage of Losartan/Hydrochlorothiazide Teva-ratio

6. Contents of the pack and additional information

Losartán/Hidroclorotiazida Teva-ratio 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 eliminate 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

• if you are allergic to losartan, to hydrochlorothiazide or to 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 cotrimoxazole, ask your doctor if you are unsure)
• if you have severe liver failure
• if you have low levels of potassium, 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 losartan/hydrochlorothiazide during the first months of pregnancy – see section 2: Fertility, pregnancy and lactation),
• 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 medication containing aliskiren

Warnings and precautions

Consult your doctor or pharmacist before starting to take losartan/hydrochlorothiazide tablets:

If you experience a decrease in vision or eye pain, they may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and can occur within a few hours to several weeks after taking losartan/hydrochlorothiazide. If left untreated, this can lead to permanent vision loss. You may be at a higher risk of developing this 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). Losartan/hydrochlorothiazide 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 section “Pregnancy and lactation”).

It is essential that you inform your doctor before taking losartan/hydrochlorothiazide:

• 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 Losartan/Hidroclorotiazida Teva-ratio”),
• if you have narrowed arteries (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant,
• if you have atherosclerosis, angina (chest pain due to heart dysfunction),
• if you have mitral or aortic 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 eruptions and fever (systemic lupus erythematosus),
• if you have high calcium levels or low potassium levels or if you are following a low-potassium diet,
• if you need anesthesia (even at the dentist) 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 a glandular alteration),
• if you are taking any of the following medications 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.
  • Aliskiren

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 medications 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 its 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 losartan/hydrochlorothiazide.
• 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 losartan/hydrochlorothiazide, seek medical attention immediately.

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

Children and adolescents

There is no experience with the use of losartan/hydrochlorothiazide in children. Therefore, losartan/hydrochlorothiazide should not be administered to children.

Older patients

Losartan/hydrochlorothiazide acts with equal efficacy and is 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 medication.

Inform your doctor if you are taking potassium supplements, salt substitutes containing potassium, potassium-sparing medications or other medications that may increase serum potassium (e.g. trimetoprim-containing medications), as the combination with losartan/hydrochlorothiazide is not recommended.

Diuretics such as hydrochlorothiazide in losartan/hydrochlorothiazide tablets may interact with other medications. Preparations containing lithium should not be taken with losartan/hydrochlorothiazide without your doctor's careful monitoring. Special precautions may be necessary (e.g. blood tests) if you are taking diuretics (urine tablets), some laxatives, glycyrrhizin (found in licorice), medications for gout treatment, medications for heart rhythm control or for diabetes (oral antidiabetics or insulin).

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

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

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

If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (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 losartan/hydrochlorothiazide may increase the effects of each other.

Excessive salt in the diet may counteract the effect of losartan/hydrochlorothiazide tablets.

You should avoid eating and drinking foods and beverages that contain glycyrrhizin, found in licorice, as it may cause abnormal electrolyte levels in the blood.

Losartan/hydrochlorothiazide can be taken with or without food.

Fertility, pregnancy, lactation

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 losartan/hydrochlorothiazide before becoming pregnant or as soon as you know you are pregnant and will recommend that you take another medication instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended during pregnancy, and in any case, it should not be administered from the third month of pregnancy 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 breastfeeding. Losartan/hydrochlorothiazide is not recommended for use during lactation, and your doctor will choose another treatment for you if you wish to breastfeed.

Driving and operating machinery

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

Losartán/Hidoclorotiazida Teva-ratio contains lactose

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will decide on the appropriate dose of losartán/hidroclorotiazida, depending on your condition and if you are taking other medications. It is essential to continue taking losartán/hidroclorotiazida as prescribed by your doctor to maintain consistent blood pressure control.

Hypertension

For most patients with high blood pressure, the usual dose is 1 tablet of losartán/hidroclorotiazida 50 mg/12.5 mg per day to control blood pressure for 24 hours. It can be increased to 2 tablets of losartán/hidroclorotiazida 50 mg/12.5 mg per day or changed to 1 tablet of losartán/hidroclorotiazida 100 mg/25 mg (a higher dose) per day. The maximum daily dose is 2 tablets of 50 mg losartán/12.5 mg hidroclorotiazida per day or 1 tablet of 100 mg losartán/25 mg hidroclorotiazida per day.

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 an overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. An overdose can cause a drop in blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

Inform your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915 620 420, indicating the medication and the amount ingested.

If you forgot to take Losartán/Hidroclorotiazida Teva-ratio

Try to take losartán/hidroclorotiazida 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:

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

The following side effects have been reported::

Frequent: may affect up to 1 in 10 people

Coughs, respiratory infections, nasal congestion, sinusitis, breast disorders.

Diarrhea, abdominal pain, nausea, indigestion,

Muscle pain or cramps, leg pain, back pain,

Insomnia, headaches, dizziness.

Weakness, fatigue, chest pain.

Elevated potassium levels (which may cause an abnormal heart rhythm), decreased hemoglobin levels.

• Changes in renal functionthat includerenal insufficiency;
• Low blood sugar (hypoglycemia).

Rare: 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), hematoma, reduced white blood cells, coagulation problems, reduced platelets.
• Loss of appetite, elevated uric acid levels, manifest gout, elevated blood glucose levels, abnormal electrolyte levels in the blood,
• Anxiety, nervousness, panic disorder, (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory alteration,
• Tickling or similar sensations, limb pain, tremors, dizziness, migraines, fainting
• Blurred vision, eye itching or stinging, conjunctivitis, worsening vision, seeing things in yellow,
• Ringing, buzzing, or clicking 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,
• Phlebitis (inflammation of the blood vessels that often occurs with a skin rash or hematoma),
• Throat itching, 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,
• Urticaria, itching, skin inflammation, skin rash, skin redness, light sensitivity, dry skin, flushing, sweating, hair loss,
• Arm, shoulder, hip, knee, or other joint pain, 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.

Very 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 not known: the frequency cannot be estimated from available data

• Symptoms similar to the flu
• Unknown origin muscle pain with dark-colored urine (rhabdomyolysis)
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell (malaise)
• Altered taste (dysgeusia)
• Skin eruptions and lesions (cutaneous lupus erythematosus)
• Skin cancer and lip cancer (non-melanoma skin cancer)
• Decreased vision or eye pain due to increased pressure [possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) 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 the Vigilance of Medicinal Products 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 CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Losartán/Hidroclorotiazida Teva-ratio tablets

?The active ingredients are losartan potassium and hydrochlorothiazide. Each tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.

?The other components are :

Tablet core: lactose monohydrate, microcrystalline cellulose (E460a), pregelatinized cornstarch, magnesium stearate (E572).

Coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b),

yellow iron oxide (E172).

Appearance of Losartán/Hidroclorotiazida Teva-ratio and packaging content

?Losartán/Hidroclorotiazida Teva-ratio 50 mg/12.5 mg film-coated tablets are: yellow, oval, biconvex tablets marked with “5” and “0” on one face and a scored on both faces.

The tablet can be divided intoequal doses.

The 50 mg/12.5 mg tablets are available in pack sizes of 1, 14, 20, 28,30, 56, 60, 84, 90, 98, and 100 tablets, calendar packs of28 tabletsand hospital packs of 50x1 and 280 (10x28) tablets.

HDPE bottles with tamper-evident screw cap: 28, 100, 250, and clinical pack of 500 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11. Edificio Albatros B, 1ª planta.

28108 Alcobendas, Madrid, Spain.

Responsible for Manufacturing:

Pharmachemie B.V.

PO Box 552

2003 RN Haarlem

Netherlands

Teva Pharmaceutical Works Private Limited Company

Pallagi út 13, H-4042 Debrecen

Hungary

Teva Czech Industries s.r.o.

Ostravskà 29, 747 70 Opava-Komarov,

Czech Republic

Teva Pharma, S.L.U

C/ C, nº 4, Polígono Industrial Malpica,

50016 Zaragoza

Spain

This medicinal product is authorized in the Member States under the following names:

Last review date of this leaflet:January 2025

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information about this medicinal product by scanning with your smartphone the QR code included in the packaging. You can also access this information on the following internet address:https://cima.aemps.es/cima/dochtml/p/70595/P_70595.html