LOSARTAN/HYDROCHLOROTHIAZIDE TEVA-RATIO 100/12.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Losartan/Hydrochlorothiazide Teva-ratio 100 mg/12.5 mg film-coated tablets

losartan potassium/hydrochlorothiazide

Contents of the pack and other information

1. What is Losartan/Hydrochlorothiazide Teva-ratio and what is it 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. Storing Losartan/Hydrochlorothiazide Teva-ratio
6. Contents of the pack and other information

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

Losartan/Hydrochlorothiazide Teva-ratio 100 mg/12.5 mg tablets are a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).

Angiotensin II is a substance produced in the body which binds to receptors in blood vessels, causing them to constrict. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin II to these receptors, resulting in the relaxation of blood vessels, which lowers blood pressure. Hydrochlorothiazide works by making the kidneys pass more water and salt. This also helps to reduce blood pressure.

Losartan/hydrochlorothiazide is indicated for the treatment of essential hypertension (high blood pressure).

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

Do not take Losartan/Hydrochlorothiazide Teva-ratio tablets

• 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 or low sodium levels or high calcium levels that cannot be corrected by treatment,
• if you have gout,
• if you are more than 3 months pregnant (it is better to avoid Losartan/Hydrochlorothiazide Teva-ratio during the first months of pregnancy - see section Pregnancy and breast-feeding),
• 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 containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Losartan/Hydrochlorothiazide Teva-ratio.

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 hours to weeks after taking Losartan/Hydrochlorothiazide Teva-ratio. If left untreated, this can lead to permanent vision loss. You may have a higher risk of this occurring if you have previously had an allergy to penicillin or sulphonamides.

Tell your doctor if you are pregnant (or think you might be). Losartan/Hydrochlorothiazide Teva-ratio 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 (see section Pregnancy and breast-feeding).

It is important that you inform your doctor before taking Losartan/Hydrochlorothiazide Teva-ratio:

• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking Losartan/Hydrochlorothiazide Teva-ratio, seek medical attention immediately,
• 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 problems (see “Do not take Losartan/Hydrochlorothiazide Teva-ratio”),
• if you have narrowings of the arteries that supply the kidneys (renal artery stenosis), or 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 “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 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 going to have tests to check 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 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) (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetic-related kidney problems.
• Aliskiren

Your doctor may check 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-ratio”.

• if you are taking other medicines that may increase serum potassium levels (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Teva-ratio”),
• 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 some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Losartan/Hydrochlorothiazide Teva-ratio.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea 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 Teva-ratio in children. Therefore, Losartan/Hydrochlorothiazide Teva-ratio should not be given to children.

Elderly patients

Losartan potassium and hydrochlorothiazide 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-ratio

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 serum potassium levels (e.g. trimethoprim-containing medicines), as these should not be taken with Losartan/Hydrochlorothiazide Teva-ratio.

Diuretics like hydrochlorothiazide contained in Losartan/Hydrochlorothiazide Teva-ratio may interact with other medicines.

Preparations that contain lithium should not be taken with Losartan/Hydrochlorothiazide Teva-ratio without your doctor carrying out regular checks.

Special precautions may be necessary (e.g. blood tests) if you are taking other 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,
• medicines to treat cancer,
• medicines for pain relief,
• medicines to treat fungal infections,
• medicines for arthritis,
• cholesterol-lowering medicines such as colestyramine,
• muscle relaxants,
• sleeping tablets;
• opioid medicines such as morphine,
• “pressor amines” such as adrenaline or other medicines of the same group
• oral antidiabetics or insulins.

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

If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Losartan/Hydrochlorothiazide Teva-ratio” and “Warnings and precautions”).

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

Taking Losartan/Hydrochlorothiazide Teva-ratio with food, drinks and alcohol

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

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

Food and drinks that contain glycyrrhizin, which is found in liquorice, should be avoided as it can cause abnormal blood electrolyte levels.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazide.

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

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

When you start treatment with this medicine, do 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-ratio contains lactose

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

3. How to take Losartan/Hydrochlorothiazide Teva-ratio

Follow the instructions for administration of this medicine, as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Losartan/Hydrochlorothiazide Teva-ratio, depending on your condition and whether you are taking other medicines. It is important to keep taking Losartan/Hydrochlorothiazide Teva-ratio while your doctor prescribes it for you to maintain constant control of your blood pressure.

High blood pressure

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

Not all of the above mentioned dosages are possible with this medicine.

Administration

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

If you take more Losartan/Hydrochlorothiazide Teva-ratio than you should

In case of overdose, contact your doctor immediately so that medical attention can be given promptly. Overdose may cause a decrease in blood pressure, palpitations, slow pulse, changes in blood composition and dehydration.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Losartan/Hydrochlorothiazide Teva-ratio

Try to take Losartan/Hydrochlorothiazide Teva-ratio as prescribed. However, if you miss a dose, do not take an extra dose. Simply return to your normal 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 Losartán/Hidroclorotiazida Teva-ratio tablets and inform your doctor immediately or go to the emergency department of your nearest hospital:

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

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.

Other adverse effects that may occur:

Frequent (may affect up to 1 in 10 people)

• cough, upper respiratory tract 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), bruising, 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 disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, somnolence, memory impairment,
• tingling or similar sensations, pain in the limbs, tremors, 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 bruising,
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (which causes difficulty breathing), nosebleeds, runny nose, congestion,
• constipation, chronic constipation, gas, stomach disorders, 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
• intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

Frequency not known (frequency cannot be estimated from the 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 Losartán/Hidroclorotiazida Teva-ratio

Keep out of sight and reach of children.

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

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at the pharmacy. 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 Losartán/Hidroclorotiazida Teva-ratio

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

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

Appearance of the Product and Package Contents

• Film-coated tablet

• White, oval, biconvex film-coated tablet, engraved with "LH" on one side 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 packaging) film-coated 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.

Spain

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/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 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 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