Losartan/hydrochlorothiazide Teva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Losartan/Hydrochlorothiazide Teva 50 mg/12.5 mg film-coated tablets, 100 mg/25 mg film-coated tablets

losartan potassium/hydrochlorothiazide
Generic medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. 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 yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Losartan/Hydrochlorothiazide Teva is and what it is used for
What you need to know before taking Losartan/Hydrochlorothiazide Teva
How to take Losartan/Hydrochlorothiazide Teva
Possible side effects
How to store Losartan/Hydrochlorothiazide Teva
Contents of the pack and other information

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

Losartan/Hydrochlorothiazide Teva is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Losartan/Hydrochlorothiazide Teva is indicated for the treatment of essential hypertension (high blood pressure).

2. What you need to know before taking Losartan/Idroclorotiazide Teva

Do not take Losartan/Idroclorotiazide Teva

if you are allergic to losartan, hydrochlorothiazide, or any of the excipients of this medicine (listed in section 6);
if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial agents such as co-trimoxazole; ask your doctor if you are unsure);
if you have severe impairment of liver function;
if you have severe impairment of kidney function or if your kidneys are not producing urine;
if you have low levels of potassium, low levels of sodium, or high levels of calcium that cannot be corrected by treatment;
if you suffer from gout;
if you are more than three months pregnant. (It is better to avoid Losartan/Idroclorotiazide Teva even in the early stages of pregnancy – see section 2 Pregnancy, breastfeeding and fertility);
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking Losartan/Idroclorotiazide Teva

if you have a history of swelling of the face, lips, throat, and/or tongue;
if you are taking diuretics (medicines that increase urine production);
if you are on a low-salt diet;
if you have had or currently have severe vomiting and/or diarrhoea;
if you have heart failure;
if you have narrowing of the renal arteries (renal artery stenosis), if you have only one functioning kidney, or if you have recently had a kidney transplant;
if you have narrowing of arteries (atherosclerosis), angina pectoris (chest pain due to reduced heart function);
if you have 'mitral valve stenosis' or 'aortic stenosis' (narrowing of heart valves) or 'hypertrophic cardiomyopathy' (a condition causing thickening of the heart muscle);
if you have diabetes;
if you have had gout;
if you have or have had an allergic condition, asthma, or a condition causing joint pain, skin redness, and fever (systemic lupus erythematosus);
if you have previously had skin cancer or are developing unexpected skin lesions 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/Idroclorotiazide Teva;
if you have high levels of calcium or low levels of potassium, or if you are on a low-potassium diet;
if you need to take an anaesthetic (including from a dentist) or before undergoing surgery, or if you are scheduled for tests to assess parathyroid function, you must inform your doctor or medical staff that you are taking losartan potassium and hydrochlorothiazide tablets;
if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland due to an abnormality);
you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Losartan/Idroclorotiazide Teva is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section 2 Pregnancy, breastfeeding and fertility);
if you are taking any of the following medicines used to treat high blood pressure:
an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially 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.
if you experience vision disturbances 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 from a few hours to weeks after taking Losartan/Idroclorotiazide Teva. If left untreated, this condition may lead to permanent loss of vision. If you have previously had allergic reactions to penicillin or sulfonamides, you may be at higher risk of developing this condition.

See also the section "Do not take Losartan/Idroclorotiazide Teva".
Children and adolescents
There is no experience regarding the use of Losartan/Idroclorotiazide Teva in children. Therefore,
Losartan/Idroclorotiazide Teva must not be given to children.
Elderly
Losartan/Idroclorotiazide Teva works in the same way and is equally well tolerated in most elderly patients as in younger adults. Most elderly patients require the same dosage as younger patients.
Other medicines and Losartan/Idroclorotiazide Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Diuretics such as hydrochlorothiazide contained in Losartan/Idroclorotiazide Teva can interact with other medicines. Lithium-containing preparations must not be taken with Losartan/Idroclorotiazide Teva without close medical supervision. Special precautionary measures (e.g. blood tests) may be appropriate if you are taking potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, other diuretics ("medicines that increase urine production"), certain laxatives, glycyrrhizin (found in liquorice), medicines for gout, medicines to control heart rhythm, or medicines for diabetes (oral agents or insulin). It is also important for your doctor to know if you are taking other medicines to lower blood pressure, steroids, cancer treatments, painkillers, antifungal medicines, arthritis medicines, cholesterol-lowering resins such as cholestyramine, muscle relaxants, sleeping pills, opioids such as morphine, or "vasopressor amines" such as adrenaline or other drugs in the same class.
Your doctor may consider it necessary to adjust the dose and/or take other precautions: if you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Losartan/Idroclorotiazide Teva" and "Warnings and precautions").
Inform your doctor that you are taking Losartan/Idroclorotiazide Teva even when you plan to use iodinated contrast agents.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
Losartan/Idroclorotiazide Teva with food, drinks and alcohol
You are advised not to drink alcohol while taking these tablets: alcohol increases the effect of Losartan/Idroclorotiazide Teva and vice versa.
A diet particularly high in salt may counteract the effect of Losartan/Idroclorotiazide Teva tablets.
Foods and drinks containing liquorice, such as glycyrrhizin found in liquorice, should be avoided, as they may cause abnormalities in blood electrolyte levels.
Losartan/Idroclorotiazide Teva may be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Losartan/Idroclorotiazide Teva before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Losartan/Idroclorotiazide Teva is not recommended during pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Losartan/Idroclorotiazide Teva is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.
Driving and using machines
When starting treatment with this medicine, do not perform activities requiring special attention (e.g. driving a car or operating dangerous machinery) until you know how you react to the medicine.
Losartan/Idroclorotiazide Teva contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Losartan/Hydrochlorothiazide Teva

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. Your doctor will determine the appropriate dose of Losartan/Hydrochlorothiazide Teva based on your condition and any other medicines you may be taking. It is important to continue taking Losartan/Hydrochlorothiazide Teva for the entire duration prescribed by your doctor, as this will help maintain stable control of high blood pressure.

High blood pressure
The recommended dose for most patients with high blood pressure is 1 tablet of Losartan/Hydrochlorothiazide Teva 50 mg/12.5 mg once daily to maintain blood pressure control over 24 hours.
The dose may be increased to 2 tablets of Losartan/Hydrochlorothiazide Teva 50 mg/12.5 mg film-coated tablets once daily or adjusted to 1 tablet daily of Losartan/Hydrochlorothiazide Teva 100 mg/25 mg film-coated tablets (a higher strength).
The maximum daily dose is 2 tablets of Losartan/Hydrochlorothiazide Teva 50 mg/12.5 mg film-coated tablets per day or 1 tablet per day of Losartan/Hydrochlorothiazide Teva 100 mg/25 mg film-coated tablets.

If you take more Losartan/Hydrochlorothiazide Teva than you should
In case of overdose, contact your doctor immediately to receive prompt medical treatment.
Overdose may cause low blood pressure, palpitations, slow pulse rate, changes in blood electrolytes, and dehydration.

If you forget to take Losartan/Hydrochlorothiazide Teva
Try to take Losartan/Hydrochlorothiazide Teva once daily as prescribed. Do not take a double dose to make up for a forgotten dose. Skip the missed tablet and take the next dose at the usual time the following day.

If you have any doubts about how to use this medicine, speak to your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get them.

If you experience the following side effect, stop taking Losartan/Hydrochlorothiazide Teva tablets and contact your doctor immediately or go to the nearest hospital Emergency Department:

a severe allergic reaction (reddening, itching, swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing).

This is a serious but rare side effect occurring in more than 1 in 10,000 patients but less than 1 in 1,000 patients. Immediate medical treatment or hospitalisation is required.

The following side effects have been reported:

Common (may affect up to 1 in 10 people)

Cough, upper respiratory tract infection, nasal congestion, sinusitis, bone cavity disorders inside the nose
Diarrhoea, abdominal pain, nausea, indigestion
Muscle pain or cramps, leg pain, back pain
Insomnia, headache, dizziness
Weakness, fatigue, chest pain
Increased potassium levels (which may cause abnormal heart rhythm), decreased haemoglobin levels

Uncommon (may affect up to 1 in 100 people)

Anaemia, red or brownish spots on the skin (sometimes mainly on feet, legs, arms and buttocks, with joint pain, swelling of hands and feet, and stomach pain), bruising, reduced white blood cells, blood clotting problems and bruising
Loss of appetite, increased uric acid levels or clinically evident gout, increased blood sugar levels, abnormal blood electrolyte levels
Anxiety, nervousness, panic disorders (recurrent panic attacks), confusion, depression, nightmares, sleep disorders, somnolence, memory impairment
Tingling sensation, pins and needles, pain in extremities, tremor, migraine, fainting
Blurred vision, burning or painful eyes, conjunctivitis, worsening of vision, yellowing of vision
Sensation of hearing a sound, ringing, buzzing or clicking noises in the ears
Low blood pressure, which may be associated with changes in posture (feeling lightheaded or weak when standing up), angina (chest pain), irregular heartbeat, cerebrovascular accident (TIA, "mini-stroke"), heart attack, palpitations
Inflammation of blood vessels, often associated with skin redness and bruising
Sore throat, shortness of breath, bronchitis, pneumonia, fluid in the lungs (causing breathing difficulties), nosebleed, runny nose, congestion
Constipation, flatulence, stomach discomfort, stomach spasms, vomiting, dry mouth, inflammation of salivary glands, toothache
Jaundice (yellowing of eyes and skin), inflammation of the pancreas
Urticaria, itching, skin inflammation, rash, skin redness, light sensitivity, dry skin, hot flushes, sweating, hair loss
Pain in arms, shoulders, hips, knees and other joints, joint swelling, stiffness, muscle weakness
Frequent urination including at night, abnormal kidney function including kidney inflammation, urinary tract infection, sugar in urine
Decreased sexual desire, impotence
Facial swelling, fever

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

Hepatitis (inflammation of the liver), changes in liver function tests

Not known (frequency cannot be estimated from the available data)

Abnormal breakdown of muscle cells, which may lead to kidney problems
Taste disturbances (dysgeusia)
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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Losartan/Hydrochlorothiazide Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Losartan/Hydrochlorothiazide Teva contains

The active substances are losartan potassium and hydrochlorothiazide. Each tablet contains 50 mg of losartan potassium and 12.5 mg of 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).

Description of the appearance of Losartan/Hydrochlorothiazide Teva and package contents

The film-coated tablets of Losartan/Hydrochlorothiazide Teva 50 mg/12.5 mg are yellow, oval, biconvex, marked with the characters “5” and “0” on one side and a score line on both sides. The tablet can be divided into two equal doses.
- The film-coated tablets of Losartan/Hydrochlorothiazide Teva 100 mg/25 mg are yellow, oval, biconvex, marked with the characters “1” and “00” on one side and a score line on both sides. The tablet can be divided into two equal doses.

The 50 mg/12.5 mg tablets are available in packs of 1, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets, in calendar packs of 28 tablets, and in hospital packs of 50x1 and 280 (10x28) tablets.
HDPE bottles with tamper-evident screw caps: 100 and 250 tablets.

The 100 mg/25 mg tablets are available in packs of 1, 7, 14, 20, 28, 30, 56, 60, 84, 90, 98 and 100 tablets, in calendar packs of 7 and 28 tablets, and in hospital packs of 50x1 and 280 (10x28) tablets.
HDPE bottles with tamper-evident screw caps: 30 and 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Teva Italia S.r.l. – Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy

Manufacturers responsible for batch release

Teva Pharmaceutical Works Private Limited Company - Pallagi st. 13 - H-4042 Debrecen (Hungary)
Teva UK Ltd. - Brampton Road - Hampden Park - BN22 9AG Eastbourne - East Sussex (United Kingdom)
Pharmachemie B.V. - Swensweg 5 - P.O. Box 552 - 2003 RN Haarlem (Netherlands)
Teva Czech Industries s.r.o. - Ostravská 29, č.p. 305, 74770 Opava-Komárov (Czech Republic)
Merckle GmbH Ludwig - Merckle - Straße 3, 89143 Blaubeuren (Germany)