Losartan/hidroclorotiazida teva-ratio 100/25 mg comprimidos recubiertos con pelicula efg

Package Leaflet: Information for the User

Teva-ratio Losartan/Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets

losartan potassium/

hydrochlorothiazide

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

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

2. What you need to know before you take 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 medicine that contains 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, these may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in eye pressure and may occur within a few hours to several weeks after taking losartan/hydrochlorothiazide. If left untreated, this can lead to permanent loss of vision. 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 start of pregnancy, and 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 important 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 (arterial 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 poor heart function),
• 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 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 a glandular alteration),
• 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.
  • Aliskiren

Your doctor may monitor your renal function, blood pressure and electrolyte levels in the blood (for example, 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 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 exposure to the sun 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 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 (for example, trimetoprim-containing medicines), as the combination with losartan/hydrochlorothiazide is not recommended.

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

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

• other medicines to lower your blood pressure
• steroids
• medicines for cancer treatment
• medicines for pain
• 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 diabetes or insulin medicines.

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 should 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 and will recommend that you take another medicine instead of losartan/hydrochlorothiazide. Losartan/hydrochlorothiazide is not recommended during pregnancy, and 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 breastfeeding. Losartan/hydrochlorothiazide is not recommended for use during breastfeeding, 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 may require special attention (for example, driving a car or operating hazardous machinery) until you know how you tolerate your medicine.

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 Toxicological 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 emergency department of the nearest hospital:

• 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, and 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, pain in the extremities, tremors, dizziness, migraines, fainting
• Blurred vision, eye irritation or itching, conjunctivitis, worsening of vision, seeing things in yellow,
• Ringling, buzzing, ringing, or crackling 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, inflammation of a salivary gland, tooth pain,
• Jaundice (yellow discoloration of the eyes and skin), inflammation of the pancreas,
• Urticaria, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, 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 (inflammation of the liver), abnormal liver function tests

• Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Unknown frequency: the frequency cannot be estimated from available data

• Flu-like symptoms
• Muscle pain of unknown origin with dark-colored urine (rhabdomyolysis)
• Low sodium levels in the blood (hyponatremia)
• Generally feeling unwell (malaise)
• 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 of 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 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 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 Losartan/Hydrochlorothiazide Teva-ratio tablets

?The active principles are losartan potassium and hydrochlorothiazide. Each tablet contains

100 mg of losartan potassium and 25 mg of hydrochlorothiazide.

?The other components are :

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

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

yellow iron oxide (E172).

Appearance of Losartan/Hydrochlorothiazide Teva-ratio and contents of the package

?Losartan/Hydrochlorothiazide Teva-ratio 100 mg/25 mg film-coated tablets are yellow, oval, biconvex tablets marked with “1” and “00” on one face and a scored on both faces.

The tablet can be divided intoequal doses.

The 100 mg/25 mg tablets are available in package sizes of 1, 7, 14, 20, 28,30, 56, 60, 84, 90, 98, and 100 tablets, calendar packs of 7 and28 tabletsand hospital packs of 50x1 and 280 (10x28) tablets.

HDPE bottles with tamper-evident screw cap: 28, 30 and 100 tablets.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

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, Industrial Estate Malpica,

50016 Zaragoza

Spain

This medicinal product is authorized in the Community under the following names:

Last review date of this leaflet:January 2025

The detailed information on 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 on this medicinal product 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/70597/P_70597.html