Losartan/hydrochlorothiazide Teva-Ratio 100/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

losartan potassium/hydrochlorothiazide

Package leaflet contents:

1. What Losartán/Hidroclorotiazida Teva-ratio is and what it is used for
2. What you need to know before taking Losartán/Hidroclorotiazida Teva-ratio
3. How to take Losartán/Hidroclorotiazida Teva-ratio
4. Possible side effects
5. How to store Losartán/Hidroclorotiazida Teva-ratio
6. Contents of the pack and other information

1. What Losartán/Hidroclorotiazida Teva-ratio is and what it is used for

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

Angiotensin II is a substance produced in the body that binds to receptors in blood vessels, causing them to constrict. This results in increased blood pressure. Losartan prevents angiotensin II from binding to these receptors, leading to relaxation of the blood vessels and a reduction in blood pressure. Hydrochlorothiazide works by making the kidneys excrete more water and salt. This also helps to lower blood pressure.

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

2. What you need to know before taking 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 sulfonamide-derived substances (e.g., other thiazides, certain antibiotics such as cotrimoxazole; ask your doctor if you are unsure),
• if you have severe liver impairment,
• 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 (Losartan/Hydrochlorothiazide Teva-ratio is best avoided during the first months of pregnancy—see section “Pregnancy and breastfeeding”),
• if you have severe renal impairment or your kidneys are not producing urine,
• if you have diabetes or kidney disease and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

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

If you experience blurred vision or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur within hours to weeks after taking Losartan/Hydrochlorothiazide Teva-ratio. If left untreated, this may lead to permanent vision loss. Your risk may be higher if you have previously had an allergy to penicillin or sulfonamides.

Inform your doctor if you are pregnant (or suspect you may be pregnant). The use of Losartan/Hydrochlorothiazide Teva-ratio is not recommended during early pregnancy, and you must not take it after the third month of pregnancy as it may cause serious harm to your baby from that stage onward (see section “Pregnancy and breastfeeding”).

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

• if you have previously experienced breathing or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe difficulty breathing after taking Losartan/Hydrochlorothiazide Teva-ratio, contact your doctor immediately,

• if you have previously had swelling of the face, lips, tongue, or throat,

• if you are taking diuretics (medicines to increase urine production),

• if you are on a low-salt diet,

• if you have had excessive vomiting and/or diarrhea,

• if you have heart failure,

• if you have liver impairment (see “Do not take Losartan/Hydrochlorothiazide Teva-ratio”),

• if you have narrowing of the arteries supplying the kidneys (renal artery stenosis), or if you have only one functioning kidney or have recently undergone a kidney transplant,

• if you have arterial narrowing (atherosclerosis), angina pectoris (chest pain due to poor heart function),

• if you have “aortic or mitral valve stenosis” (narrowing of heart valves) or “hypertrophic cardiomyopathy” (a condition causing thickening of the heart muscle),

• if you are diabetic,

• if you have had gout,

• if you have or have had an allergic disorder, asthma, or a condition causing joint pain, skin rashes, and fever (systemic lupus erythematosus),

• if you have high calcium levels or low potassium levels, or if you are on a low-potassium diet,

• if you require anesthesia (even at the dentist) or before surgery, or if you are undergoing tests to assess parathyroid function, you must inform your doctor or healthcare provider that you are taking losartan potassium and hydrochlorothiazide tablets,

• if you have primary hyperaldosteronism (a syndrome associated with excessive secretion of the hormone aldosterone by the adrenal gland due to adrenal dysfunction),

• if you are taking any of the following medicines for high blood pressure (hypertension):

• an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes,

• 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-ratio”.

• if you are taking other medicines that may increase serum potassium (see section 2 “Other medicines and Losartan/Hydrochlorothiazide Teva-ratio”),
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Losartan/Hydrochlorothiazide Teva-ratio.

Contact 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 Teva-ratio in children. Therefore, Losartan/Hydrochlorothiazide Teva-ratio should not be given to children.

Elderly patients

Losartan potassium and hydrochlorothiazide are equally effective and well tolerated in most elderly and younger patients. Most elderly patients require the same dosage as younger patients.

Other medicines and Losartan/Hydrochlorothiazide Teva-ratio

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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

Lithium-containing preparations should not be taken with Losartan/Hydrochlorothiazide Teva-ratio unless your doctor performs careful monitoring.

Special precautionary measures (e.g., blood tests) may be appropriate if you are taking other diuretics (water tablets), certain laxatives, glycyrrhizin (found in licorice), medicines for gout, medicines to control heart rhythm, 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,
• corticosteroids,
• cancer treatment medicines,
• pain medicines,
• antifungal medicines,
• arthritis medicines,
• cholesterol-lowering resins 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 additional precautions:

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

Please inform your doctor if you are scheduled to receive an iodinated contrast agent while taking Losartan/Hydrochlorothiazide Teva-ratio.

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

You are advised not to drink alcohol while taking these tablets: alcohol and Losartan/Hydrochlorothiazide Teva-ratio may increase each other's effects.

Excessive dietary salt intake may counteract the effect of Losartan/Hydrochlorothiazide Teva-ratio tablets.

Foods and drinks containing glycyrrhizin, found in licorice, should be avoided, as they may cause abnormal blood electrolyte levels.

Grapefruit juice should be avoided while taking losartan/hydrochlorothiazida.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Inform your doctor if you are pregnant (or suspect you may be pregnant). Your doctor will usually advise you to stop taking Losartan/Hydrochlorothiazide Teva-ratio before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. The use of Losartan/Hydrochlorothiazide Teva-ratio is not recommended during pregnancy, and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that stage onward.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. The use of Losartan/Hydrochlorothiazide Teva-ratio is not recommended during breastfeeding, and your doctor will choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

When starting treatment with this medicine, do not perform tasks that require special attention (e.g., driving a car or operating dangerous machinery) until you know how you react to the medicine.

Losartan/Hydrochlorothiazide Teva-ratio contains lactose

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

3. How to take Losartán/Hidroclorotiazida Teva-ratio

Follow the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

High blood pressure

For most patients with high blood pressure, the usual dose is 1 tablet of Losartán/Hidroclorotiazida 50 mg/12.5 mg once daily to control blood pressure over 24 hours. The dose may be increased to 1 tablet once daily of Losartán/Hidroclorotiazida 100 mg/12.5 mg or 2 tablets of Losartán/Hidroclorotiazida 50 mg/12.5 mg once daily, or switched to 1 tablet of Losartán/Hidroclorotiazida 100 mg/25 mg (a stronger dose) once daily. The maximum daily dose is 2 tablets of Losartán/Hidroclorotiazida 50 mg/12.5 mg per day or 1 tablet of Losartán/Hidroclorotiazida 100 mg/25 mg per day.

Not all dosage regimens mentioned are available with this medicine.

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, contact your doctor immediately so that prompt medical care can be provided. Overdose may cause low blood pressure, palpitations, slow pulse, changes in blood composition, and dehydration.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Losartán/Hidroclorotiazida Teva-ratio

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

If you have any further questions about 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 everyone experiences them.

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

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

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

Other possible adverse effects:

Common (may affect up to 1 in 10 people)

• cough, upper respiratory tract infection, nasal congestion, sinusitis, sinus disorders,
• diarrhoea, 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 haemoglobin levels,
• changes in kidney function including renal failure;
• blood sugar too low (hypoglycaemia).

Uncommon (may affect up to 1 in 100 people)

• anaemia, red or brown spots on the skin (sometimes especially on the feet, legs, arms and buttocks, with joint pain, swelling of hands and feet and abdominal pain), bruising, reduced white blood cells, blood clotting problems, reduced platelet count,
• loss of appetite, elevated uric acid levels or manifest gout, elevated blood glucose levels, abnormal blood electrolyte levels,
• anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory disturbance,
• tingling or similar sensations, limb pain, tremor, migraine, fainting,
• blurred vision, burning or itching in the eyes, conjunctivitis, worsening of vision, seeing things in yellow,
• ringing, buzzing, noises or crackling in the ears, dizziness,
• low blood pressure which may be associated with postural changes (feeling dizzy or weak when standing up), angina (chest pain), abnormal heartbeats, stroke (transient ischaemic attack, “mini-stroke”), heart attack, palpitations,
• inflammation of blood vessels often associated with a skin rash or bruising,
• sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing difficulty breathing), nosebleeds, runny nose, congestion,
• constipation, chronic constipation, flatulence, stomach disorders, stomach spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache,
• jaundice (yellowing of eyes and skin), inflammation of the pancreas,
• urticaria, itching, skin inflammation, rash, redness of the skin, photosensitivity, dry skin, flushing, sweating, hair loss,
• pain in arms, shoulders, hips, knee or other joints, joint swelling, stiffness, muscle weakness,
• frequent urination even at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in the urine,
• decreased sexual appetite, impotence,
• facial swelling, localized swelling (oedema), fever.

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

• hepatitis (liver inflammation), abnormal liver function tests,
• intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be estimated from available data)

• flu-like symptoms,
• unexplained muscle pain with dark-coloured urine (tea-coloured) (rhabdomyolysis),
• low sodium levels in blood (hyponatraemia),
• generally feeling unwell (malaise),
• altered taste (dysgeusia),
• skin rashes and skin lesions (cutaneous lupus erythematosus),
• skin 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 of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Losartan/Hydrochlorothiazide Teva-ratio

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Losartan/Hydrochlorothiazide Teva-ratio

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

• The other components (excipients) are: monohydrate lactose, 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 contents of the container

• Film-coated tablet

• White, biconvex, oval-shaped film-coated tablet, marked with "LH" on one side and plain 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 certain 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, 1st floor.

28108 Alcobendas. Madrid.

Spain

Manufacturer:

Pharmachemie B.V

Swensweg 5, Postbus 552, 2003 RN Haarlem

The 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 Gödöllő

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 European Economic Area member states under the following names:

Date of the most recent review of this leaflet: January 2025

“Detailed information about 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 up-to-date information about this medicine by scanning the QR code on the outer packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74569/P_74569.html