Losartan and hydrochlorothiazide Mylan Generics: detailed information

Package leaflet: Information for the user

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

Losartan potassium and hydrochlorothiazide
Equivalent medicine
Please read all of this leaflet carefully before you start 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Losartan Hydrochlorothiazide Mylan Generics is and what it is used for

Losartan Hydrochlorothiazide Mylan Generics is a combination of an angiotensin II receptor antagonist (losartan) and a diuretic (hydrochlorothiazide).
Angiotensin II is a substance produced by the body that binds to receptors in the blood vessels, causing them to narrow. This leads to an increase in blood pressure.
Losartan prevents angiotensin II from binding to these receptors, resulting in relaxation of the blood vessels and consequently lowering blood pressure.
Hydrochlorothiazide works by increasing the amount of water and salts excreted through the kidneys. This also helps reduce blood pressure.
Losartan Hydrochlorothiazide Mylan Generics is indicated for the treatment of essential hypertension (high blood pressure).

2. What you should know before taking Losartan Hydrochlorothiazide Mylan Generics

Do not take Losartan Hydrochlorothiazide Mylan Generics:

if you are allergic to losartan potassium, hydrochlorothiazide, or any of the other ingredients of this medicine (listed in section 6)
if you are allergic to other sulfonamide-derived substances (e.g. other thiazides, certain antibacterial medicines such as co-trimoxazole; ask your doctor if you are unsure)
if you are more than 3 months pregnant (it is best to avoid the use of Losartan Hydrochlorothiazide Mylan Generics even in early pregnancy – see section “Pregnancy and breastfeeding”)
if you have severe liver dysfunction
if you have bile duct obstruction or reduced bile flow, such as cholestasis (which may be due to liver failure or gallstones), causing jaundice, dark urine, pale stools, and skin itching
if you have severe kidney dysfunction or if your kidneys are not producing urine
if you have low levels of potassium or sodium and high levels of calcium that cannot be corrected with treatment
if you suffer from gout
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 Hydrochlorothiazide Mylan Generics.
You must inform your doctor if you think you are pregnant or could become pregnant. Losartan Hydrochlorothiazide Mylan Generics 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 fetus if used during this period (see section “Pregnancy and breastfeeding”).
If you have previously had skin cancer or develop unexpected skin lesions during treatment: treatment with hydrochlorothiazide, particularly 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 exposure to sunlight and UV radiation while taking Losartan Hydrochlorothiazide Mylan Generics.

It is also important to inform your doctor before taking Losartan Hydrochlorothiazide Mylan Generics:

if you have previously experienced swelling of the face, lips, throat, or tongue
if you are taking diuretics
if you are on a low-salt diet
if you suffer or have suffered from severe vomiting and/or diarrhoea or are dehydrated
if you have heart failure
if you have cerebrovascular disease (disease of blood vessels supplying the brain)
if you have impaired liver function (see section 2 “Do not take Losartan Hydrochlorothiazide Mylan Generics”)
if you have narrowed renal arteries (renal artery stenosis), only one functioning kidney, or have recently undergone a kidney transplant
if you have narrowed arteries (arteriosclerosis) or suffer from angina pectoris (chest pain due to poor heart function)
if you suffer from “mitral or aortic valve stenosis” (narrowing of heart valves) or “hypertrophic cardiomyopathy” (a disease causing thickening of the heart muscle)
if you are diabetic
if you suffer from gout
if you suffer or have suffered from an allergic condition, 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 follow a potassium-poor diet
if you have high blood lipid levels (cholesterol and triglycerides), since the hydrochlorothiazide in this medicine may increase them
if you require anaesthesia (including dental anaesthesia) or before surgery, or if you need a test to check parathyroid gland function, you must inform your doctor or medical staff that you are taking Losartan and Hydrochlorothiazide tablets
if you suffer from primary hypoaldosteronism (a syndrome associated with increased aldosterone hormone secretion from adrenal glands due to glandular abnormalities)
if you are of African or Caribbean origin. This medicine may be less effective for you.
if you are taking any of the following medicines used to treat high blood pressure:
an 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 electrolyte levels (e.g. potassium) at regular intervals.
See also the information under “Do not take Losartan Hydrochlorothiazide Mylan Generics”.

If you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion).

Other medicines and Losartan Hydrochlorothiazide Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Your doctor may need to adjust your dose and/or take additional precautions.
Diuretics such as hydrochlorothiazide contained in Losartan Hydrochlorothiazide Mylan Generics may interact with other medicines.
You must avoid taking Losartan Hydrochlorothiazide Mylan Generics with:

lithium (used to treat depression)
potassium supplements, potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium salts, or other medicines that may increase serum potassium (e.g. medicines containing trimethoprim). It is also important that your doctor knows if you are taking any of the following medicines:
other blood pressure-lowering medicines such as ACE inhibitors (e.g. ramipril), methyldopa
other diuretics
medicines for treating gout (e.g. probenecid, sulfinpyrazone, allopurinol)
medicines for controlling heart rhythm (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide)
steroids or ACTH (also called corticotropin, a synthetic hormone used to regulate adrenal gland function)
medicines for treating cancer (e.g. amifostine, cyclophosphamide, methotrexate)
analgesics such as non-steroidal anti-inflammatory drugs (e.g. ibuprofen) or high-dose salicylates (e.g. aspirin)
antifungal medicines (e.g. fluconazole, intravenous amphotericin B)
medicines for arthritis
resins used for high cholesterol, such as cholestyramine, colestipol
muscle relaxants (e.g. tubocurarine, baclofen)
medicines for treating insomnia
opioids such as morphine
“pressor amines” such as adrenaline or other medicines in the same class
oral diabetes medicines (e.g. metformin) or insulin
medicines for treating neurological disorders such as depression, anxiety, and schizophrenia, including tricyclic antidepressants and neuroleptics (e.g. chlorpromazine, carbamazepine, levomepromazine, thioridazine, trifluoperazine, pimozide, amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol)
medicines that may cause dry mouth or blurred vision (e.g. atropine, biperiden)
medicines for mouth ulcers (e.g. choline salicylate)
immunosuppressants used to treat autoimmune disorders or to prevent transplant rejection (e.g. cyclosporine)
certain laxatives (e.g. senna, bisacodyl)
digoxin or other cardiac glycosides (for treating heart problems)
bepridil (used to treat angina pectoris)
cisapride or difenamil (for treating gastrointestinal disorders)
intravenous erythromycin (an antibiotic)
rifampicin (for treating tuberculosis)
halofantrine (used to treat certain types of malaria)
terfenadine or mizolastine (antihistamines for hay fever or allergies)
pentamidine (used to treat pneumonia)
injectable vincamine (used to treat memory loss in the elderly)
calcium, including calcium supplements
carbamazepine (an antiepileptic)
glycyrrhizin (contained in liquorice and often used in cough medicines when taken in large quantities)

Also inform your doctor if you are taking Losartan Hydrochlorothiazide Mylan Generics and are scheduled for radiographic procedures involving iodinated contrast agents.
Your doctor may need to adjust your dose and/or take additional precautions:

If you are taking an ACE inhibitor or aliskiren (see also “Do not take Losartan Hydrochlorothiazide Mylan Generics” and “Warnings and precautions”).

Specific precautionary measures (e.g. blood tests) may be appropriate.
Losartan Hydrochlorothiazide Mylan Generics with food, drinks, and alcohol
You are advised not to drink alcohol while taking this medicine; alcohol and Losartan Hydrochlorothiazide Mylan Generics may increase each other's effects.
Excessive dietary salt intake may counteract the effect of Losartan Hydrochlorothiazide Mylan Generics. Large amounts of glycyrrhizin, contained in liquorice and some cough medicines, may affect Losartan Hydrochlorothiazide Mylan Generics.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise stopping Losartan Hydrochlorothiazide Mylan Generics before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Losartan Hydrochlorothiazide Mylan Generics is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the fetus if used beyond the third month of pregnancy.
Breastfeeding
If you are breastfeeding or planning to breastfeed, consult your doctor or pharmacist before taking this medicine. Losartan Hydrochlorothiazide Mylan Generics is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
At the beginning of treatment with this medicine, do not perform tasks requiring special attention (e.g. driving a vehicle or operating dangerous machinery) until you know how you react to this medicine. You may experience dizziness and drowsiness, especially at the start of treatment or when your dose is increased.
Losartan Hydrochlorothiazide Mylan Generics contains lactose.
If your doctor has informed you that you have an intolerance to certain sugars, including lactose, contact your doctor before taking this medicine.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.

3. How to take Losartan Hydrochlorothiazide Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Your doctor will determine the appropriate dose of Losartan Hydrochlorothiazide Mylan Generics based on your condition and taking into account any other medications you may be taking. It is important to continue taking this medicine for as long as your doctor prescribes it in order to maintain easy control of your blood pressure.
The recommended dose in most patients with hypertension is one tablet of Losartan Hydrochlorothiazide Mylan Generics 50 mg/12.5 mg once daily to control blood pressure over a 24-hour period. This dose may be increased to two tablets of 50 mg/12.5 mg once daily or changed to one tablet of 100 mg/25 mg once daily. The maximum daily dose is two tablets of 50 mg/12.5 mg per day or one tablet of 100 mg/25 mg per day.

Use in the elderly
Losartan Hydrochlorothiazide Mylan Generics works equally well and is equally well tolerated in most adult patients, both young and elderly. Most elderly patients require the same doses as younger patients.

Use in children and adolescents
There is no experience with the use of Losartan Hydrochlorothiazide Mylan Generics in children; therefore, Losartan Hydrochlorothiazide Mylan Generics must not be administered to children.

Taking the medicine
Losartan Hydrochlorothiazide Mylan Generics tablets must be swallowed whole with a glass of water and may be taken with or without food.

If you take more Losartan Hydrochlorothiazide Mylan Generics than you should
In case of overdose, contact your doctor immediately so that prompt medical assistance can be provided. An overdose may cause a drop in blood pressure, increased heart rate, reduced heart rate, changes in blood composition, and dehydration.

If you forget to take Losartan Hydrochlorothiazide Mylan Generics
Try to take Losartan Hydrochlorothiazide Mylan Generics every day as prescribed. Do not take a double dose to make up for a forgotten dose. Simply resume your regular dosing schedule.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following side effects, stop taking Losartan
Hydrochlorothiazide Mylan Generics tablets and contact your doctor immediately or go
to the nearest hospital Emergency Department:
Common (may affect up to 1 in 10 people):

Kidney problems including kidney inflammation and kidney failure,

Uncommon (may affect up to 1 in 100 people):

angina (chest pain), abnormal heartbeat (fast, slow or irregular), cerebrovascular disorders (transient ischaemic attack (TIA), "mini-stroke"), heart attack,
blood disorders, including:
reduction in white blood cells leading to increased risk of infections,
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 stomach pain), problems with blood clotting and bruising,
jaundice (yellowing of the eyes and skin), inflammation of the pancreas, pneumonia, fluid in the lungs (causing difficulty in breathing),
severe skin rash causing blisters which may affect the mouth, throat, nose, genitals. This is often accompanied by flu-like symptoms (Toxic Epidermal Necrolysis (TEN)).

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

severe allergic reaction (rash, itching, swelling of face, tongue, lips, mouth or throat which may cause difficulty in swallowing or breathing)
hepatitis (inflammation of the liver),

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

unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis);
skin and lip cancer (non-melanoma skin cancer);
loss of vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion)).

Other side effects reported include:
Common (may affect up to 1 in 10 people):

Cough, upper respiratory tract infection, nasal congestion, sinusitis, nasal sinus disorders
Diarrhoea, abdominal pain, nausea, indigestion
Muscle pain or cramps, leg pain, back pain
Insomnia, headache and/or neck pain, dizziness
Weakness, fatigue, chest pain
Increased potassium levels (which may cause heart rhythm abnormalities), decreased haemoglobin levels
Decreased blood sugar levels.

Uncommon (may affect up to 1 in 100 people):

Loss of appetite, increased uric acid or gout, increased blood sugar levels, low blood levels of sodium and potassium, increased blood levels of urea and creatinine
Anxiety, nervousness, panic disorder (recurrent panic attacks), confusion, depression, abnormal dreams, sleep disorders, drowsiness, memory problems
Tingling or similar sensations, pain in extremities, tremors, migraine, fainting
Blurred vision, burning or prickling sensation in the eyes, conjunctivitis, worsening of vision, yellow vision
Ringing, buzzing, noises or crackling in the ears, vertigo
Hypotension, which may be associated with changes in posture (dizziness or weakness when standing), palpitations
Inflammation of blood vessels, often associated with skin rashes or bruising
Sore throat, shortness of breath, bronchitis, nosebleeds, runny nose, nasal congestion
Constipation, gas in the intestine, stomach discomfort, gastric spasms, vomiting, dry mouth, inflammation of a salivary gland, toothache
Hives, itching, skin inflammation, rash, redness of the skin, photosensitivity, dry skin, hot flushes, sweating, hair loss
Pain in arms, shoulders, hips, knees or other joints, joint swelling, stiffness, muscle weakness, widespread pain with an intense and painful response to pressure
Frequent need to urinate, including at night, urinary tract infection, sugar in urine
Decreased sexual desire, impotence
Facial swelling, localized swelling, fever.

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

Abnormal liver function tests.

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

Flu-like symptoms,
General feeling of being unwell.
Taste disturbances (dysgeusia)

Reporting of suspected adverse reactions
If you experience any side effects, 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
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Losartan Hydrochlorothiazide Mylan Generics

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label or packaging following the term "Exp.". The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not dispose of any medicine 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 Mylan Generics Contains
The active substances are losartan potassium and hydrochlorothiazide.
Each film-coated tablet contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide.
Each film-coated tablet contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose, monohydrate lactose (see section 2 “Losartan Hydrochlorothiazide Mylan Generics contains lactose”), pregelatinized corn starch, magnesium stearate, hydroxypropylcellulose, titanium dioxide (E-171), and yellow iron oxide (E-172).

Description of the Appearance of Losartan Hydrochlorothiazide Mylan Generics and Contents of the Package
Losartan Hydrochlorothiazide Mylan Generics 50 mg/12.5 mg are yellow, round, film-coated tablets.
Losartan Hydrochlorothiazide Mylan Generics 100 mg/25 mg are yellow, round, film-coated tablets.
Losartan Hydrochlorothiazide Mylan Generics 50 mg/12.5 mg is available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 98, or 100 film-coated tablets, and in calendar packs containing 28 or 98 film-coated tablets.
Losartan Hydrochlorothiazide Mylan Generics 100 mg/25 mg is available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 98, or 100 film-coated tablets, and in calendar packs containing 28 or 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

Manufacturer Responsible for Batch Release:
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom