LOSARTAN/HYDROCHLOROTHIAZIDE TEVA-RATIO 50/12.5 mg FILM-COATED TABLETS

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

Do not take Losartan/Hydrochlorothiazide Teva

• if you are allergic to losartan, hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to sulphonamide-derived substances (e.g. other thiazides, some antibacterials such as cotrimoxazole; ask your doctor if you are not sure)
• if you have severe hepatic impairment
• if you have low potassium, sodium or high calcium levels that cannot be corrected by treatment
• if you have gout
• if you are more than 3 months pregnant (it is also better to avoid Losartan/Hydrochlorothiazide Teva during the first months of pregnancy – see section 2: Fertility, pregnancy and lactation)
• if you have severe renal impairment or your kidneys are not producing urine
• if you have diabetes or renal impairment 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 Teva tablets.

If you experience a decrease in vision or eye pain, these could 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 a few weeks after taking Losartan/Hydrochlorothiazide Teva. If left untreated, this can lead to permanent vision loss. You may be at greater risk if you have previously had an allergy to penicillin or sulphonamide.

Tell your doctor if you are pregnant (or think you might be). Losartan/Hydrochlorothiazide Teva is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby.

It is essential that you inform your doctor before taking Losartan/Hydrochlorothiazide Teva:

• if you have previously suffered from swelling of the face, lips, tongue or throat,
• if you are taking diuretics (water tablets),
• if you are on a low-salt diet,
• if you have had excessive vomiting and/or diarrhoea,
• if you have heart failure,
• if you have liver impairment (see “Do not take Losartan/Hydrochlorothiazide Teva”),
• if you have narrowings of the arteries that supply the kidneys (renal artery stenosis), if you only have one functioning kidney or if you have recently had a kidney transplant,
• if you have narrowing of the arteries (atherosclerosis), angina pectoris (chest pain due to poor heart function),
• if you have narrowing of the aortic or mitral valve (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 had an allergic disorder, asthma or a condition that causes joint pain, skin rashes and fever (systemic lupus erythematosus),
• if you have high calcium or low potassium levels or if you are on a low-potassium diet,
• if you need to have anaesthesia (even at the dentist) or before surgery, or if you are to have tests to determine your parathyroid function, you must inform your doctor or healthcare professional that you are taking losartan potassium and hydrochlorothiazide tablets,
• if you have primary hyperaldosteronism (a syndrome associated with high secretion of the hormone aldosterone by the adrenal gland due to a disorder 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) (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetic-related kidney problems.
• 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 Losartan/Hydrochlorothiazide Teva”.

• if you are taking other medicines that may increase potassium levels in the blood (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Teva”),

• if you have had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, in particular long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun and UV exposure while taking Losartan/Hydrochlorothiazide Teva

Children and adolescents

There is no experience with the use of Losartan/Hydrochlorothiazide Teva in children. Therefore, Losartan/Hydrochlorothiazide Teva must not be given to children.

Elderly patients

Losartan/Hydrochlorothiazide Teva works as well and is as well tolerated by most elderly patients as by younger patients. Most elderly patients require the same dose as younger patients.

Other medicines and Losartan/Hydrochlorothiazide Teva

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Tell your doctor if you are taking potassium supplements, salt substitutes that contain potassium, potassium-sparing medicines or other medicines that may increase potassium levels in the blood (e.g. trimethoprim-containing medicines), as combination with Losartan/Hydrochlorothiazide Teva is not recommended.

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Teva tablets may interact with other medicines. Preparations containing lithium should not be taken with Losartan/Hydrochlorothiazide Teva without close monitoring by your doctor. Special precautions (e.g. blood tests) may be necessary if you take potassium supplements, salt substitutes that contain potassium or potassium-sparing medicines, diuretics (water tablets), certain laxatives, glycyrrhizin (found in liquorice), medicines for treating gout, medicines for controlling heart rhythm or for diabetes (oral antidiabetics or insulin).

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

• other medicines to reduce your blood pressure,
• corticosteroids, cancer medicines,
• medicines for pain, medicines for treating fungal infections
• medicines for arthritis
• cholesterol-lowering resins such as cholestyramine,
• muscle relaxants,
• sleeping tablets;
• opioid medicines such as morphine,
• “pressor amines” such as adrenaline or other medicines of the same group

• oral antidiabetic medicines or insulins.

.

Your doctor may need to change 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 Losartan/Hydrochlorothiazide Teva” and

“Warnings and precautions”).

Please, when taking Losartan/Hydrochlorothiazide Teva, inform your doctor when you are going to have an iodine-containing contrast medium.

Taking Losartan/Hydrochlorothiazide Teva with food, drinks and alcohol

It is recommended that you do not drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Teva may increase the effects of each other.

Excessive salt in the diet may counteract the effect of Losartan/Hydrochlorothiazide Teva tablets.

You should avoid foods and drinks that contain liquorice, such as glycyrrhizin, which can cause abnormal blood electrolyte levels.

Losartan/Hydrochlorothiazide Teva can be taken with or without food.

Fertility, pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should inform your doctor if you are pregnant (or think you might be). Your doctor will normally advise you to stop taking Losartan/Hydrochlorothiazide Teva before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Losartan/Hydrochlorothiazide Teva. Losartan/Hydrochlorothiazide Teva is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Losartan/Hydrochlorothiazide Teva is not recommended during breast-feeding, and your doctor will choose another treatment for you if you want to breast-feed.

Driving and using machines

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

Losartan/Hydrochlorothiazide Teva contains lactose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Losartan/Hydrochlorothiazide Teva tablets

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are not sure, ask your doctor or pharmacist again. Your doctor will decide the appropriate dose of losartan/hydrochlorothiazide, depending on your condition and whether you are taking other medicines. It is essential to keep taking losartan/hydrochlorothiazide while your doctor prescribes it to maintain constant control of your blood pressure.

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of losartan/hydrochlorothiazide 50 mg/12.5 mg per day to control blood pressure over 24 hours. This may be increased to 2 tablets of Losartan/Hydrochlorothiazide Teva 50 mg/12.5 mg per day or changed to 1 tablet of losartan/hydrochlorothiazide 100 mg/25 mg (a stronger dose) per day. The maximum daily dose is 2 tablets of 50 mg losartan/12.5 mg hydrochlorothiazide per day or 1 tablet of 100 mg losartan/25 mg hydrochlorothiazide per day.

Administration

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

If you take more Losartan/Hydrochlorothiazide Teva than you should

In case of overdose, contact your doctor immediately or go directly to the hospital for immediate medical attention. Overdose may 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, telephone: 915 620 420, stating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Teva

Try to take Losartan/Hydrochlorothiazide Teva at the prescribed time. However, if you miss a dose, do not take an extra dose. Simply return to your usual schedule.

If you have any further questions on 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 all people suffer from them.

If you experience the following, stop taking Losartan/Hydrochlorothiazide Teva 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 can cause difficulty swallowing or breathing).

This is a serious but rare adverse effect, affecting more than 1 patient in 10,000, but less than 1 patient in 1,000. It may require urgent medical attention or hospitalization .

The following adverse effects have been reported:

Frequent: may affect up to 1 in 10 people

? cough, respiratory infection, nasal congestion, sinusitis, sinus disorders.

? diarrhea, abdominal pain, nausea, indigestion,

? muscle pain or cramps, leg pain, back pain,

? insomnia, headache, dizziness.

? weakness, fatigue, chest pain.

? high potassium levels (which can cause an abnormal heart rhythm), decreased hemoglobin levels

• changes in renal function, including renal failure
• low blood sugar (hypoglycemia).

Infrequent: 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 cell count, coagulation problems, reduced platelet count
• loss of appetite, high uric acid levels, or gout, high blood glucose levels, abnormal blood electrolyte levels,
• anxiety, nervousness, panic disorder, (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• tingling or similar sensations, pain in the limbs, tremors, dizziness, migraine, fainting
• blurred vision, itching or burning in the eyes, conjunctivitis, worsening vision, seeing things in yellow,
• ringing, buzzing, noises, or clicking in the ears, vertigo.
• low blood pressure that may be associated with postural changes (feeling dizzy or weak when standing up),
• angina (chest pain), abnormal heartbeats, stroke (transient ischemic attack, "mini-stroke"), heart attack, palpitations,
• inflammation of blood vessels that is often associated with a skin rash or hematoma,
• throat itching, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which can cause difficulty breathing), nosebleeds, runny nose, congestion,
• constipation, chronic constipation, gas, stomach disorder, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• jaundice (yellowing of the eyes and skin), pancreatitis,
• hives, itching, skin inflammation, skin rash, redness of the skin, sensitivity to light, dry skin, flushing, sweating, hair loss,
• pain in the arms, shoulders, hips, knee, 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 sexual appetite, 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

Frequency not known: frequency cannot be estimated from available data

• flu-like symptoms
• muscle pain of unknown origin with dark-colored urine (tea-colored) (rhabdomyolysis)
• low sodium levels in the blood (hyponatremia)
• generally feeling unwell (malaise)
• altered taste (dysgeusia)
• skin eruptions and lesions (cutaneous lupus erythematosus)
• skin 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 effusion) or acute angle-closure glaucoma].

Reporting of Adverse Effects

If you experience any of the adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, Website: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Teva-ratio

Keep out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the pharmacy's SIGRE collection point. In case of doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Losartan/Hydrochlorothiazide 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 ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460a), pregelatinized starch (from corn), magnesium stearate (E572).

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

yellow iron oxide (E172).

Appearance of Losartan/Hydrochlorothiazide Teva-ratio and Package Contents

? Losartan/Hydrochlorothiazide Teva-ratio 50 mg/12.5 mg film-coated tablets are yellow, oval, biconvex tablets marked with "5" and "0" on one side and a score line on both sides.

The tablet can be divided into equal 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 of 28 tablets, and hospital packs of 50x1 and 280 (10x28) tablets.

HDPE bottles with screw caps: 28, 100, 250, and clinical packs of 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

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

28108 Alcobendas. Madrid.

Manufacturer:

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 medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: January 2025

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

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