Irbesartan and hydrochlorothiazide Mylan: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Irbesartan and Hydrochlorothiazide Mylan 150 mg/12.5 mg tablets, 300 mg/12.5 mg tablets, 300 mg/25 mg tablets

Irbesartan/Hydrochlorothiazide
Generic Medicine
Read this entire 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 their symptoms are the same as yours, as it may 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 Irbesartan and Hydrochlorothiazide Mylan is and what it is used for
What you need to know before taking Irbesartan and Hydrochlorothiazide Mylan
How to take Irbesartan and Hydrochlorothiazide Mylan
Possible side effects
How to store Irbesartan and Hydrochlorothiazide Mylan
Contents of the pack and other information

1. WHAT IS IRBESARTAN AND HYDROCHLOROTHIAZIDE MYLAN AND WHAT IS IT USED FOR

Irbesartan and Hydrochlorothiazide Mylan is a combination of two active substances: irbesartan and
hydrochlorothiazide.
Irbesartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body that binds to its receptors located on blood vessels, causing them to narrow. This leads to an increase in blood pressure. Irbesartan prevents angiotensin-II from binding to these receptors, resulting in relaxation of the blood vessels and a reduction in blood pressure.
Hydrochlorothiazide belongs to a group of medicines (called thiazide diuretics) that increase urine production, leading to a reduction in blood pressure.
The two active ingredients in Irbesartan and Hydrochlorothiazide Mylan work together to lower blood pressure to a greater extent than either medicine alone.
Irbesartan and Hydrochlorothiazide Mylan is used to treat high blood pressure when treatment with irbesartan or hydrochlorothiazide alone has not adequately controlled your blood pressure.

2. WHAT YOU NEED TO KNOW BEFORE TAKING IRBESARTAN AND HYDROCHLOROTHIAZIDE MYLAN

DO NOT TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE MYLAN:

if you are allergic to irbesartan or to any of the other ingredients of this medicine (listed in section 6)
if you are allergic to hydrochlorothiazide or to any sulfonamide-derived medicine
if you are more than 3 months pregnant (it is better to avoid taking Irbesartan and Hydrochlorothiazide Mylan even in early pregnancy - see section on Pregnancy)
if you have severe liver or kidney problems
if your doctor has found that you have persistently high calcium levels or low potassium levels in the blood
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 Irbesartan and Hydrochlorothiazide Mylan if you are in any of the following conditions:

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 exposure to sunlight and UV rays while taking Irbesartan and Hydrochlorothiazide Mylan.
if you experience excessive vomiting or diarrhoea
if you have kidney disorders, including renal artery stenosis, or have had a kidney transplant
if you have heart disorders, including narrowing of heart valves, enlargement or weakness of the heart muscle (heart failure)
if you have narrowing of the heart's blood vessels which may cause chest pain, such as angina
if you have other liver disorders
if you have diabetes
if you have systemic lupus erythematosus (also known as lupus or SLE)
if you have a history of allergies or asthma
if you have primary aldosteronism (a condition associated with excessive production of the hormone aldosterone, leading to sodium retention and subsequently increased blood pressure)
if you are on a low-salt diet
if you are taking diuretics (tablets that increase fluid elimination)
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 check your kidney function, blood pressure, and levels of electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section "Do not take Irbesartan and Hydrochlorothiazide Mylan".
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Irbesartan and Hydrochlorothiazide Mylan is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section on Pregnancy).

During treatment
Also, inform your doctor:

if you have symptoms such as unusual thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an unusually fast heartbeat, which may indicate an excessive effect of hydrochlorothiazide (contained in Irbesartan and Hydrochlorothiazide Mylan)
if you have noticed an increased sensitivity of the skin to sunlight, faster than normal, with symptoms of sunburn (such as redness, itching, swelling, rash)
if you are scheduled for surgery or need to take anaesthetics
if you experience vision loss or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside the eye, which may occur from a few hours to several weeks after taking Irbesartan and Hydrochlorothiazide Mylan. This may lead to permanent vision loss if not treated. If you previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing this condition.
If you are scheduled for a blood test to assess parathyroid function (a gland that helps maintain stable calcium levels), inform your doctor or hospital staff that you are taking this medicine.

The hydrochlorothiazide contained in this medicine may yield positive results in doping tests.

Children and adolescents
Irbesartan and Hydrochlorothiazide Mylan must not be given to children and adolescents (under 18 years of age).

Other medicines and Irbesartan and Hydrochlorothiazide Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Diuretics such as hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Mylan may interact with other medicines.
Medicines containing lithium (used to treat mental disorders) must not be taken together with Irbesartan and Hydrochlorothiazide Mylan unless under strict medical supervision.
Your doctor may consider it necessary to adjust your dose and/or take other precautions:

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

You may require blood tests if you are using:

potassium supplements
potassium-containing salt substitutes
potassium-sparing agents or other diuretics
certain laxatives
medicines for gout, such as probenecid, sulfinpyrazone
therapeutic vitamin D or calcium supplements
medicines to control heart rhythm, such as digoxin
medicines for diabetes (oral antidiabetics or insulin)
carbamazepine (a medicine used to treat epilepsy)
amphotericin (a medicine used to treat fungal infections)
sodium penicillin G (an antibiotic used to treat bacterial infections)
carbenoxolone (used for stomach and mouth ulcers)
medicines that may increase blood potassium levels, such as heparin (used to prevent blood clotting).

It is also important to inform your doctor if you are taking other blood pressure-lowering medicines, steroids, cancer treatments such as cyclophosphamide or methotrexate, painkillers known as NSAIDs or COX-2 inhibitors (e.g., celecoxib or acetylsalicylic acid), amantadine (used to treat Parkinson's disease or influenza), allopurinol for gout, medicines affecting gastric emptying such as atropine, biperiden, or cholestyramine and colestipol, resins used to lower blood cholesterol.

Irbesartan and Hydrochlorothiazide Mylan and alcohol
Due to the hydrochlorothiazide contained in Irbesartan and Hydrochlorothiazide Mylan, drinking alcohol during treatment with this medicine may increase the risk of dizziness, especially when standing up from a sitting position.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Irbesartan and Hydrochlorothiazide Mylan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Irbesartan and Hydrochlorothiazide Mylan is not recommended during pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
Irbesartan and Hydrochlorothiazide Mylan 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
No studies on the ability to drive vehicles or use machines have been conducted. It is unlikely that Irbesartan and Hydrochlorothiazide Mylan will affect your ability to drive or operate machinery. However, dizziness or fatigue may occasionally occur during treatment for high blood pressure. If this happens, discuss it with your doctor before driving or operating machinery.

Irbesartan and Hydrochlorothiazide Mylan contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars (e.g., lactose), contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.

3. HOW TO TAKE IRBESARTAN AND HYDROCHLOROTHIAZIDE MYLAN

Take this medicine exactly as your doctor or pharmacist has told you. If
you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Irbesartan and Hydrochlorothiazide Mylan is 1 tablet daily.
Irbesartan and Hydrochlorothiazide Mylan is generally prescribed by your doctor when your
previous treatment has not sufficiently lowered your blood pressure. Your doctor will instruct you
on how to switch from your previous treatment to Irbesartan and Hydrochlorothiazide Mylan.
Method of administration
Irbesartan and Hydrochlorothiazide Mylan is for oral use. Swallow the tablets with a sufficient
amount of liquid (for example, a glass of water). You may take Irbesartan and Hydrochlorothiazide
Mylan with or without food. Try to take the medicine at the same time every day. It is
important to continue therapy unless otherwise instructed by your doctor.
Maximum blood pressure-lowering effect is achieved within 6–8 weeks after starting treatment.
If you take more Irbesartan and Hydrochlorothiazide Mylan than you should
If you accidentally take too many tablets, contact your doctor immediately. You may
experience dizziness, weakness, a sensation of your heart beating faster or slower, nausea,
drowsiness or lethargy.
Children must not take Irbesartan and Hydrochlorothiazide Mylan
Irbesartan and Hydrochlorothiazide Mylan must not be given to children and adolescents under 18 years of age.
If a child swallows any tablets, contact your doctor immediately.
If you forget to take Irbesartan and Hydrochlorothiazide Mylan
If you accidentally miss a dose, take only the next dose as usual. Do not take a double
dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Some of these effects may be serious and may require immediate medical attention. If you notice any
of the following adverse reactions, stop treatment with Irbesartan/Hydrochlorothiazide Mylan
immediately and contact your doctor immediately or go to the nearest hospital emergency
department:
Uncommon (may affect up to 1 in 100 people):
yellowing of the skin and whites of the eyes.
Not known (frequency cannot be estimated from available data):
rare cases of skin allergic reactions (rash, urticaria), as well as localized swelling of the face, lips and/or tongue and difficulty breathing.
faster or irregular heartbeat or sensation of skipped heartbeats (palpitations), pounding in the chest, feeling faint and dizziness, which may be caused by heart rhythm problems. This may be detected on ECG (an examination to assess your heart function).
increased frequency of infections, such as sore throat, mouth ulcers, pale appearance, feeling tired or breathless, especially after physical exertion, increased risk of bruising or bleeding, which may be due to a reduced number or type of blood cells. This may be caused by a bone marrow problem (where blood cells are produced).
pallor, feeling tired or breathless, which may be due to destruction of red blood cells.
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), severe breathing difficulty, fever, chest pain and cough caused by fluid in the lungs (pulmonary edema).
increased urge to urinate more frequently, increased urine volume which may be pale in colour, difficulty or inability to urinate or decreased urine volume which may be darker in colour or contain blood. This may be due to kidney problems.
severe upper abdominal pain with nausea and malaise, which may be due to liver problems.
skin rash with raised purple spots and flat red areas, caused by inflammation of blood vessels (vasculitis).
a severe skin allergic reaction, including flat red patches, blisters and large scaly areas of peeling skin over the entire body.
cutaneous lupus erythematosus – you may notice a rash on the face, neck and scalp.
increased sensitivity of the skin to sunlight.
inflammation of the pancreas – you may experience severe stomach pain radiating to the back and nausea or malaise.
skin and lip cancer (non-melanoma skin cancer).

Other possible adverse reactions
Adverse reactions reported in clinical studies in patients treated with a combination of irbesartan/hydrochlorothiazide include:
Common (may affect up to 1 in 10 people):

feeling unwell (nausea, vomiting)
feeling tired (fatigue)
dizziness
blood tests may show increased levels of an enzyme that reflects muscle and heart function (creatine kinase) or substances that reflect kidney function (blood urea nitrogen, creatinine).

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

diarrhoea
low blood pressure
fainting
increased heart rate
hot flushes
swelling
sexual dysfunction (problems related to sexual performance)
blood tests may show decreased levels of potassium and sodium in the blood
feeling dizzy when standing up from a lying or sitting position.

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

headache
ringing in the ears
cough
altered taste, indigestion
joint and muscle pain
blood tests showing altered liver function
blood tests showing increased levels of potassium in the blood. As with any combination of two active substances, adverse reactions associated with each individual component cannot be ruled out.

Adverse reactions associated with irbesartan alone
Uncommon (may affect up to 1 in 100 people):

chest pain.

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

increased bruising and bleeding, which may be caused by a reduced number of platelets (blood cells involved in clotting).
severe allergic reactions (anaphylactic shock).

Adverse reactions associated with hydrochlorothiazide alone
Not known (frequency cannot be estimated from available data):

loss of appetite
stomach irritation, stomach cramps, constipation
sleep disturbances
depression
blurred vision, colour vision disturbance causing a yellowish tint (xanthopsia), severe myopia
fever
weakness and muscle cramps, skin sensations of tingling, itching or burning, or "pins and needles" (paresthesia)
restlessness, feeling lightheaded
low blood pressure upon changing body position
swelling of the salivary glands
increased blood sugar levels
sugar in the urine
increased levels of certain types of fats in the blood; increased levels of uric acid in the blood, which may cause gout. It is known that adverse reactions associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this patient information leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE IRBESARTAN AND HYDROCHLOROTHIAZIDE MYLAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, label or blister after EXP. The expiry date refers to the last day of that month.
The in-use stability of the product when stored in bottles is 90 days after first opening.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Irbesartan and Hydrochlorothiazide Mylan contains
The active substances are irbesartan and hydrochlorothiazide.
Each 150 mg/12.5 mg tablet of Irbesartan and Hydrochlorothiazide Mylan contains 150 mg of
irbesartan and 12.5 mg of hydrochlorothiazide.
Each 300 mg/12.5 mg tablet of Irbesartan and Hydrochlorothiazide Mylan contains 300 mg of
irbesartan and 12.5 mg of hydrochlorothiazide.
Each 300 mg/25 mg tablet of Irbesartan and Hydrochlorothiazide Mylan contains 300 mg of
irbesartan and 25 mg of hydrochlorothiazide.
The other components are: microcrystalline cellulose (E460), anhydrous colloidal silica, sodium lauryl
sulfate, pregelatinized maize starch, magnesium stearate (E470b), povidone (K-90), lactose
monohydrate, sodium croscarmellose, quinoline yellow (E104) and red iron oxide (E172). See
section 2 “Irbesartan and Hydrochlorothiazide Mylan contains lactose and sodium”.

Description of the appearance of Irbesartan and Hydrochlorothiazide Mylan and pack contents
Irbesartan and Hydrochlorothiazide Mylan 150 mg/12.5 mg are biconvex, oval, peach-coloured tablets,
with “M” printed on one side and “I33” on the other side of the tablet.
Irbesartan and Hydrochlorothiazide Mylan 300 mg/12.5 mg are biconvex, oval, peach-coloured tablets,
with “M” printed on one side and “I34” on the other side of the tablet.
Irbesartan and Hydrochlorothiazide Mylan 300 mg/25 mg are biconvex, oval, pink tablets, with “M”
printed on one side and “I35” on the other side of the tablet.
Irbesartan and Hydrochlorothiazide Mylan is available in blisters containing 14, 28, 30, 56, 90, 98, 100 tablets, in single-dose blisters of 56 x 1 tablets, in calendar pack blisters of 28 tablets, and in bottles of 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy
Manufacturers
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate,
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary