Olmesartan medoxomil and hydrochlorothiazide Mylan: detailed information

Package leaflet: Information for the patient

Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg film-coated tablets, mg/25 mg film-coated tablets

(olmesartan medoxomil / hydrochlorothiazide)
Generic 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Olmesartan medoxomil and Hydrochlorothiazide Mylan is and what it is used for

Olmesartan medoxomil and Hydrochlorothiazide Mylan contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension).

Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. It lowers blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics”. It reduces blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Olmesartan medoxomil and Hydrochlorothiazide Mylan will be prescribed to you only if olmesartan medoxomil alone has not adequately controlled your blood pressure. When administered together, the two active substances in this medicine help reduce blood pressure more than when used individually. You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan medoxomil and Hydrochlorothiazide Mylan to achieve further reduction.
High blood pressure can be managed with medicines such as Olmesartan medoxomil and Hydrochlorothiazide Mylan tablets. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow your doctor’s advice.

2. What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide Mylan

Do not take Olmesartan medoxomil and Hydrochlorothiazide Mylan

if you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides)
if you are more than three months pregnant (use of Olmesartan medoxomil and Hydrochlorothiazide Mylan is advised against even during the first months of pregnancy – see section “Pregnancy”)
if you have severe kidney problems
if you have low levels of potassium or sodium, or high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve with treatment
if you have severe liver problems, yellowing of the skin or eyes (jaundice), or bile flow problems from the gallbladder (biliary obstruction, for example due to gallstones)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren. If you think any of these conditions apply to you, or are unsure, do not take the tablets. Contact your doctor and follow their advice.

Warnings and precautions
Talk to your doctor before taking Olmesartan medoxomil and Hydrochlorothiazide Mylan if you have any of the following health conditions:

Mild or moderate kidney problems, or if you have recently had a kidney transplant
Liver disease
Heart failure or heart valve or heart muscle problems
Severe or prolonged vomiting (feeling unwell) or diarrhoea lasting several days
Treatment with high doses of diuretics or if you are on a low-salt diet
Adrenal gland problems (e.g. primary aldosteronism)
Diabetes
Lupus erythematosus (an autoimmune disease)
Allergies or asthma
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 Olmesartan medoxomil and Hydrochlorothiazide Mylan”.
Your doctor may wish to monitor you more frequently and perform blood tests if you have any of the conditions listed above.
Olmesartan medoxomil and Hydrochlorothiazide Mylan may increase levels of fats and uric acid (causing gout – painful joint swelling) in the blood. Your doctor may want to carry out periodic blood tests to monitor these conditions.
It may alter levels of certain substances called electrolytes in the blood. Your doctor may want to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, apathetic, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you experience any of these symptoms.
As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
If you are undergoing tests for parathyroid function, you must stop taking Olmesartan medoxomil and Hydrochlorothiazide Mylan before the test.
If you engage in sports, this medicine may affect anti-doping test results, causing a positive outcome.
You must inform your doctor if you think you are pregnant or could become pregnant. Olmesartan medoxomil and Hydrochlorothiazide Mylan 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 child if taken during this period (see section “Pregnancy”).

During treatment
Inform your doctor if any of the following symptoms occur:

Severe and prolonged diarrhoea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this blood pressure treatment.
Vision changes or eye pain. These could be symptoms of increased pressure in your eye and may occur within hours or weeks of taking Olmesartan medoxomil and Hydrochlorothiazide Mylan. If untreated, this increased pressure may lead to permanent vision impairment.

Children and adolescents (under 18 years of age)
Olmesartan medoxomil and Hydrochlorothiazide Mylan is not recommended for children and adolescents under 18 years of age.

Black patients
As with other similar medicines, the blood pressure-lowering effect of this medicine is somewhat reduced in black patients.

Other medicines and Olmesartan medoxomil and Hydrochlorothiazide Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist about the following medicines:

Medicines that may increase potassium levels in the blood when used together with Olmesartan medoxomil and Hydrochlorothiazide Mylan. These include:
potassium supplements (such as potassium-containing salt substitutes)
diuretics
heparin (used to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
amphotericin, a medicine used to treat fungal infections
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
certain painkillers such as aspirin or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olmesartan medoxomil and Hydrochlorothiazide Mylan may increase lithium toxicity. If you are to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines such as ibuprofen, aspirin, and diclofenac), used to reduce pain, swelling, and other inflammatory symptoms, including arthritis, may increase the risk of kidney failure when used with Olmesartan medoxomil and Hydrochlorothiazide Mylan. The effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Mylan may be reduced by NSAIDs.
Other blood pressure-lowering medicines (antihypertensives, such as methyldopa), as the effect of Olmesartan medoxomil and Hydrochlorothiazide Mylan may be enhanced
Sleeping pills, sedatives, and antidepressants, which when used with Olmesartan medoxomil and Hydrochlorothiazide Mylan may cause a sudden drop in blood pressure upon standing
Certain medicines such as baclofen and tubocurarine, used to relax muscles
Amifostine and certain other cancer treatments, such as cyclophosphamide or methotrexate
Cholestyramine and colestipol, medicines used to reduce blood fats
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of Olmesartan medoxomil and Hydrochlorothiazide Mylan. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide Mylan at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines, such as atropine and biperiden, used to treat irritable bowel syndrome, asthma, Parkinson’s disease, or other muscle problems
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric conditions
Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart conditions
Medicines such as bepridil, mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, and vincamine or injectable erythromycin, which may alter heart rhythm
Oral antidiabetic medicines, such as metformin or insulin, used to lower blood sugar levels
Beta-blockers and diazoxide, medicines used to treat high blood pressure and low blood sugar, respectively, as Olmesartan medoxomil and Hydrochlorothiazide Mylan may enhance their hyperglycaemic effect
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate
Difemanil, used to treat slow heart rate or reduce sweating
Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout
Calcium supplements
Amantadine, an antiviral medicine
Cyclosporine, a medicine used to prevent rejection of transplanted organs
Certain antibiotics called tetracyclines or sparfloxacin
Some antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Mylan
Cisapride, used to increase movement of food through the stomach and intestines
Halofantrine, used to treat malaria.

Your doctor may consider adjusting your dose and/or taking other precautions:
If you are taking an ACE inhibitor or aliskiren (see also “Do not take Olmesartan medoxomil and Hydrochlorothiazide Mylan” and “Warnings and precautions”).

Olmesartan medoxomil and Hydrochlorothiazide Mylan with alcohol
Be cautious when consuming alcohol during treatment with Olmesartan medoxomil and Hydrochlorothiazide Mylan, as some people may experience fainting or dizziness. If this happens, avoid alcohol, including wine, beer, and carbonated alcoholic beverages.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Your doctor will usually advise you to stop taking Olmesartan medoxomil and Hydrochlorothiazide Mylan before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan medoxomil and Hydrochlorothiazide Mylan is not recommended during early pregnancy and must not be taken after the first three months of pregnancy, as it may cause serious harm to the unborn child if taken beyond the third month of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan medoxomil and Hydrochlorothiazide Mylan is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

3. How to take Olmesartan medoxomil and Hydrochlorothiazide Mylan

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The recommended dose is one tablet of Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg daily. However, if your blood pressure is not adequately controlled, your doctor may decide to change your dose to one tablet of Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg daily.

Swallow the tablets with a glass of water. Try to take your dose at the same time each day, for example with breakfast.

If you take more Olmesartan medoxomil and Hydrochlorothiazide Mylan than you should
If you take more tablets than prescribed, or if a child accidentally swallows one or more tablets, contact your doctor or go to the nearest emergency room immediately, and bring the medicine pack with you. Signs of overdose may include feeling unwell or drowsy, low blood pressure causing weakness or dizziness, changes in heart rate or rhythm, or excessive thirst.

If you forget to take Olmesartan medoxomil and Hydrochlorothiazide Mylan
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking Olmesartan medoxomil and Hydrochlorothiazide Mylan
It is important to keep taking Olmesartan medoxomil and Hydrochlorothiazide Mylan unless your doctor tells you to stop.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you notice any of the following side effects, stop taking Olmesartan medoxomil and
Hydrochlorothiazide Mylan and contact your doctor or the nearest hospital emergency
department immediately:
Uncommon (may affect up to 1 in 100 people):

Allergic reactions affecting the whole body. Signs include sudden rash or itching, swelling of the face, lips, mouth, tongue and/or vocal cords (larynx), and breathing difficulties.
Sudden pain or a feeling of tightness, heaviness, or pressure in the chest. These may be signs of a heart condition known as angina pectoris.
Severe breathing difficulties, sometimes accompanied by coughing with blood, increased sweating, anxiety, or pale skin. These may be signs of a lung problem such as fluid accumulation or inflammation.

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

Reduced or no urine output, or pain during urination, accompanied by back pain, fever, feeling unwell, drowsiness, shortness of breath, or general malaise. These may be signs of kidney problems.
Swollen and painful salivary glands.
Signs of reduced numbers of various blood cells, which may cause paleness of the skin, feeling tired and breathless and dark urine (reduced red blood cells), frequent infections with fever, chills, sore throat or mouth ulcers (reduced white blood cells), unexpected bleeding or bruising, or bleeding that lasts longer than usual without injury (reduced platelets).
Seizures (convulsions).
Loss and return of consciousness, or fainting.
Breathing difficulties, chest pain, fainting, rapid heartbeat, bluish skin colour, sudden pain in arms, legs or feet (signs of possible blood clot formation).
Severe pain in the upper stomach spreading to the back, sometimes with nausea or feeling unwell. These may be signs of inflammation of the pancreas.
Yellowing of the skin or whites of the eyes (jaundice).
Signs of systemic lupus erythematosus, such as skin rash, joint pain, and cold hands and fingers. You may have had this condition previously, or it may appear for the first time.
Severe skin reactions causing painful red patches with skin peeling and blisters.

Very rare (may affect up to 1 in 10,000 people):

Persistent constipation with abdominal pain and vomiting (feeling unwell), which may be signs of intestinal blockage (paralytic ileus).

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

Decreased vision or eye pain (possible signs of acute angle-closure glaucoma).

Olmesartan medoxomil and Hydrochlorothiazide Mylan may cause excessive lowering of blood
pressure in susceptible individuals or as a result of an allergic reaction. Dizziness or fainting
may occur uncommonly. If this happens, stop taking Olmesartan medoxomil and
Hydrochlorothiazide Mylan, contact your doctor immediately and lie down.
Olmesartan medoxomil and Hydrochlorothiazide Mylan is a combination of two active substances, and
the following information first lists other side effects reported so far with the combination of
olmesartan medoxomil and hydrochlorothiazide (in addition to those already mentioned above), and
then those known for the individual active substances.

Other side effects so far known with olmesartan medoxomil and hydrochlorothiazide taken together:
If these side effects occur, they are often mild and you should not stop treatment.
Common (may affect up to 1 in 10 people):

Dizziness, weakness or fatigue.
Headache.
Chest pain.
Swelling of ankles, feet, legs, hands or arms.

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

Awareness of heartbeat (palpitations).
Skin rash, eczema.
Feeling dizzy (vertigo).
Numbness or drowsiness.
Cough.
Indigestion, abdominal pain, nausea (feeling unwell), vomiting (feeling unwell) or diarrhoea.
Muscle cramps or muscle pain.
Joint pain, pain in arms and legs, back pain.
Difficulty achieving or maintaining an erection.
Blood in the urine. Uncommonly, some laboratory test abnormalities have also been observed, including: increased blood fat levels, increased levels of urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood sugar levels, increased levels of substances indicating liver function. Your doctor will detect these from blood tests and will advise you if any action is needed.

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

General feeling of malaise.
Raised, red, itchy or painful areas of skin (wheals or urticaria). Rarely, some laboratory test abnormalities have also been observed, including: increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will detect these from blood tests and will advise you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used
alone, but not with Olmesartan medoxomil and Hydrochlorothiazide Mylan:
Olmesartan medoxomil:
Common (may affect up to 1 in 10 people):

Bronchitis, causing persistent cough, wheezing and chest tightness.
Runny or stuffy nose, sore throat.
Gastroenteritis, causing watery stools with stomach cramps and sometimes fever.
Joint or bone pain.
Urinary tract infections, causing pain or difficulty during urination.
Flu-like symptoms.
Pain.

Commonly observed laboratory test abnormalities include: increased levels of substances indicating muscle function.

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

Swelling of the face.
Itching.
Sudden widespread skin rash with redness or blisters, known as exanthema.

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

Impaired kidney function.
Lack of energy or enthusiasm.

Very rare (may affect up to 1 in 10,000 people):

Severe persistent diarrhoea and marked weight loss.

Hydrochlorothiazide:
Common (may affect up to 1 in 10 people):

Confusion.
Stomach discomfort, bloating, flatulence, constipation.
Glucose in the urine, which may cause a sweet smell of urine and can be detected in urine tests.

Laboratory test abnormalities observed include: reduced levels of chloride, magnesium or sodium in the blood, increased serum amylase (hyperamylasaemia).

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

Decreased or loss of appetite.
Worsening of pre-existing myopia.
Red spots on the skin (erythema) or skin reactions to light.
Small purple spots or patches under the skin due to minor bleeding (purpura).

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

Restlessness, feeling “low” or depressed, sleep disturbances, lack of interest (apathy).
Tingling and numbness (“pins and needles” sensation).
Seeing yellow objects, blurred vision, dry eyes.
Irregular heartbeat.
Inflammation of blood vessels, causing skin rash and sometimes skin blisters.
Gallbladder infection, causing severe pain and tenderness in the upper abdomen, with fever.
Muscle weakness (sometimes leading to movement limitations).

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil and Hydrochlorothiazide Mylan

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.". The expiry date refers to the last day of that month.
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 Olmesartan medoxomil and Hydrochlorothiazide Mylan contains
The active substances are:
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The other components are:
(core of the tablet) croscarmellose sodium, mannitol, microcrystalline cellulose, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate, sodium lauryl sulphate; and (coating of the tablet) hypromellose, titanium dioxide (E171), macrogol, talc.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg: (coating of the tablet) also contains yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide Mylan and pack contents
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/12.5 mg film-coated tablets are white, film-coated, round, biconvex tablets with bevelled edges, marked with "M" on one side and "H4" on the other.
Olmesartan medoxomil and Hydrochlorothiazide Mylan 20 mg/25 mg film-coated tablets are yellow, film-coated, oval, biconvex tablets with bevelled edges, marked with "M" on one side and "H5" on the other.
Olmesartan medoxomil and Hydrochlorothiazide Mylan film-coated tablets are available in blister packs of 14, 28, 30, 56, 90, 98 tablets and calendar packs of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

Manufacturer
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Greece Olmesartan/HCTZ Mylan 20 mg/12.5 mg, 20 mg/25 mg film-coated tablets
Olmesartan medoxomil/Hydrochlorothiazide 20 mg/12.5 mg, 20 mg/25 mg
Ireland film-coated tablets
Portugal Olmesartan medoxomilo + Hidroclorotiazida Mylan
Olmesartan/Hidroclorotiazida Mylan 20 mg/12.5 mg, 20 mg/25 mg
Spain comprimidos recubiertos con película EFG

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