Patient Information Leaflet: Information for the User

Olmesartan and Hydrochlorothiazide Aurobindo 40 mg/12.5 mg film-coated tablets, mg/25 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before you start taking this medicine, as 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olmesartan and Hydrochlorothiazide Aurobindo is and what it is used for

Olmesartan and Hydrochlorothiazide Aurobindo contains two active substances called 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.

You are being given Olmesartan and Hydrochlorothiazide Aurobindo only if olmesartan medoxomil alone has not adequately controlled your blood pressure. When administered together, the two active substances in Olmesartan and Hydrochlorothiazide Aurobindo help reduce blood pressure more than when given separately.
You may already be taking medicines for high blood pressure, but your doctor may switch you to Olmesartan and Hydrochlorothiazide Aurobindo to achieve further blood pressure reduction.
High blood pressure can be managed with medicines such as Olmesartan and Hydrochlorothiazide Aurobindo tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and decreasing 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 and Hydrochlorothiazide Aurobindo

Do not take Olmesartan and Hydrochlorothiazide Aurobindo:

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 and Hydrochlorothiazide Aurobindo is advised against even during the first months of pregnancy – see section “Pregnancy”).
if you have kidney problems.
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
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 your blood that do not improve with treatment.
if you have moderate or severe liver problems, yellowing of the skin and eyes (jaundice), or bile flow problems from the gallbladder (biliary obstruction, for example due to gallstones).

If you think any of these conditions apply to you, or are unsure, do not take the tablets.
Consult your doctor and follow their advice.
Warnings and precautions
Talk to your doctor before using Olmesartan and Hydrochlorothiazide Aurobindo.
Before taking the tablets, consult your doctor 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 blood electrolyte levels (e.g. potassium) at regular intervals.

See also the information under “Do not take Olmesartan and Hydrochlorothiazide Aurobindo”.
Before taking the tablets, inform your doctor if you have any of the following health conditions:

Kidney transplant
Liver disease
Heart failure or heart valve or heart muscle problems
Severe or prolonged vomiting or diarrhoea
Treatment with high doses of diuretics or following a low-salt diet
Adrenal gland problems (e.g. primary aldosteronism)
Diabetes
Systemic lupus erythematosus (an autoimmune disease)
Allergies or asthma.

Contact your doctor if any of the following symptoms occur:

Severe and prolonged diarrhoea with significant weight loss. Your doctor should evaluate your symptoms and decide how to continue antihypertensive treatment.
Vision loss or eye pain. These may be symptoms of increased eye pressure and can occur within hours or weeks after taking Olmesartan and Hydrochlorothiazide Aurobindo. This may lead to permanent vision loss.

Your doctor may decide to examine you more frequently and perform blood tests if you have any of these conditions.
Olmesartan and Hydrochlorothiazide Aurobindo may increase blood lipid and uric acid levels (which can cause gout – painful joint swelling). Your doctor will likely request periodic blood tests to monitor these conditions.
It may alter blood levels of certain substances called electrolytes. Your doctor will likely request 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), general weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if these symptoms occur.
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 heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
If you need to undergo tests for parathyroid function, you must stop taking Olmesartan and Hydrochlorothiazide Aurobindo before such tests.
Caution for athletes: the active ingredient in this preparation is included in the list of banned substances for doping.
If you are an athlete, using this medicine constitutes doping and may lead to a positive anti-doping test.
Inform your doctor if you suspect (or are planning) a pregnancy. Olmesartan and Hydrochlorothiazide Aurobindo is not recommended in early pregnancy and must not be taken after the third month of pregnancy as it may cause severe harm to the unborn child if used during this period (see section “Pregnancy”).
Children and adolescents
Olmesartan and Hydrochlorothiazide Aurobindo is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan and Hydrochlorothiazide Aurobindo
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 any of the following medicines:

Other medicines that lower blood pressure (antihypertensives), as they may enhance the effect of Olmesartan and Hydrochlorothiazide Aurobindo. 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 “Do not take Olmesartan and Hydrochlorothiazide Aurobindo” and “Warnings and precautions”).
Medicines that may alter potassium levels in the blood when used concomitantly with Olmesartan and Hydrochlorothiazide Aurobindo. These include:
potassium supplements (including potassium-containing salt substitutes)
diuretics
heparin (used to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
some painkillers such as aspirin or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olmesartan and Hydrochlorothiazide Aurobindo may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other inflammation symptoms, including arthritis) used together with Olmesartan and Hydrochlorothiazide Aurobindo may increase the risk of kidney failure. The effectiveness of Olmesartan and Hydrochlorothiazide Aurobindo may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, used together with Olmesartan and Hydrochlorothiazide Aurobindo, 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 treatment medicines such as cyclophosphamide or methotrexate.
Cholestyramine and colestipol, medicines used to reduce blood fats.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Olmesartan and Hydrochlorothiazide Aurobindo. Your doctor may advise you to take Olmesartan and Hydrochlorothiazide Aurobindo at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines such as atropine and biperiden.
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 mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.
Oral antidiabetic medicines such as metformin or insulin, used to reduce blood glucose levels.
Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmesartan and Hydrochlorothiazide Aurobindo may enhance their hyperglycaemic effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Dihexyverine, 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 drug
Cyclosporine, a medicine used to prevent rejection of transplanted organs.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Some antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan and Hydrochlorothiazide Aurobindo.
Cisapride, used to increase gastrointestinal motility.
Halofantrine, used for malaria.

Olmesartan and Hydrochlorothiazide Aurobindo with food and drink
Olmesartan and Hydrochlorothiazide Aurobindo can be taken with or without food.
Be cautious when consuming alcohol during treatment with Olmesartan and Hydrochlorothiazide Aurobindo, as some people may experience fainting or dizziness. If this occurs, do not consume further alcohol, including wine, beer, or carbonated alcoholic drinks.
Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olmesartan and Hydrochlorothiazide Aurobindo may be somewhat reduced in patients of Black ethnicity.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop taking Olmesartan and Hydrochlorothiazide Aurobindo before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan and Hydrochlorothiazide Aurobindo is not recommended during pregnancy and must not be taken after the third month of pregnancy as it may cause severe 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. Olmesartan and Hydrochlorothiazide Aurobindo is not recommended for nursing mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
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.
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.
Olmesartan and Hydrochlorothiazide Aurobindo contains lactose monohydrate
This medicine contains lactose monohydrate (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olmesartan and Hydrochlorothiazide Aurobindo

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet of Olmesartan and Hydrochlorothiazide Aurobindo 40 mg/12.5 mg
once daily. However, if your blood pressure is not controlled, your doctor may decide to change your dose
to one tablet of Olmesartan and Hydrochlorothiazide Aurobindo 40 mg/25 mg once daily.
Swallow the tablets with a little water. If possible, take your dose at the same time each day, for example with breakfast. It is important to continue taking Olmesartan and Hydrochlorothiazide Aurobindo unless your doctor tells you otherwise.
If you take more Olmesartan and Hydrochlorothiazide Aurobindo than you should
If you take more tablets than prescribed, or if a child accidentally swallows one or more tablets, go immediately to a doctor or the nearest emergency department, taking the medicine pack with you.
If you forget to take Olmesartan and Hydrochlorothiazide Aurobindo
If you forget to take a dose, take your usual dose the next day at the usual time. Do not take a double dose to make up for the forgotten dose.
If you stop taking Olmesartan and Hydrochlorothiazide Aurobindo
It is important to continue taking Olmesartan and Hydrochlorothiazide Aurobindo unless your doctor tells you to stop.
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 everybody gets them.
However, the following two side effects can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or the vocal cord area (larynx), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olmesartan and Hydrochlorothiazide Aurobindo and contact your doctor immediately.
Olmesartan and Hydrochlorothiazide Aurobindo may cause excessive lowering of blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur uncommonly. If this happens, stop taking Olmesartan and Hydrochlorothiazide Aurobindo, contact your doctor immediately and lie down. Olmesartan and Hydrochlorothiazide Aurobindo is a combination of two active substances, and the information below first lists other side effects reported so far with the combination Olmesartan and Hydrochlorothiazide Aurobindo (in addition to those already mentioned above), followed by those known for the individual active substances.

These are the other known side effects of Olmesartan and Hydrochlorothiazide Aurobindo so far:
If these side effects occur, they are often mild and treatment does not need to be stopped.
Common (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands or arms.
Uncommon (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.
Uncommonly, some laboratory test abnormalities have also been observed, including:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood glucose, increased liver function test values. Your doctor will become aware of these from blood tests and will tell you if any action is needed.
Rare (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (wheals), acute renal failure.
Rarely, some laboratory test abnormalities have also been observed, including:
Increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will become aware of these from blood tests and will tell you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Olmesartan and Hydrochlorothiazide Aurobindo or with higher frequency:

Olmesartan medoxomil:
Common (may affect up to 1 in 10 people):
Bronchitis, cough, runny or stuffy nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.
Commonly observed laboratory test abnormalities include:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased liver and muscle function test values.
Uncommon (may affect up to 1 in 100 people):
Immediate allergic reactions affecting the whole body, which may cause breathing difficulties or a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, rash, skin blisters (wheals).
Uncommonly, some laboratory test abnormalities have also been observed, including:
Reduction in the number of certain blood cells called platelets (thrombocytopenia).
Rare (may affect up to 1 in 1,000 people):
Impaired kidney function, lack of energy.
Rarely, some laboratory test abnormalities have also been observed, including:
Increased potassium levels in the blood.

Hydrochlorothiazide:
Very common (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of fats and uric acid in the blood.
Common (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose in urine.
Some laboratory test abnormalities have also been observed, including:
Increased levels of creatinine, urea, calcium and glucose in the blood, decreased levels of chloride, potassium, magnesium and sodium in the blood. Increased serum amylase (hyperamylasemia).
Uncommon (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purpuric spots or dots on the skin due to minor haemorrhages (purpura), skin blisters (wheals).
Rare (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disorders, lack of interest (apathy), tingling and numbness, seizures, objects appearing yellow, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, lupus-like symptoms (such as skin rash, joint pain, cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (which may sometimes impair movement).
Very rare (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing abnormally low levels of chloride in the blood (hypochloraemic alkalosis), intestinal obstruction (paralytic ileus).
Not known (frequency cannot be estimated from the available data):
Reduced vision or eye pain (possible signs of acute angle-closure glaucoma).

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 and Hydrochlorothiazide Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month.
Store below 30 °C.
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. Package contents and other information

What Olmesartan and Hydrochlorothiazide Aurobindo contains

The active substances are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other components are: Tablet core: monohydrate lactose, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E171), talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Olmesartan and Hydrochlorothiazide Aurobindo and contents of the
packaging
Film-coated tablets.
Olmesartan and Hydrochlorothiazide Aurobindo 40 mg/12.5 mg:
Yellowish-red, oval, biconvex, film-coated tablets, marked with "K" on one side and "53" on the other.
Olmesartan and Hydrochlorothiazide Aurobindo 40 mg/25 mg:
Pink, oval, biconvex, film-coated tablets, marked with "K" on one side and "54" on the other.
The film-coated tablets of Olmesartan and Hydrochlorothiazide Aurobindo are available in blister packs and in HDPE bottles.
Pack sizes:
Blister packs: 14, 28, 30, 56, 84, 90, 98, 280 and 300 film-coated tablets.
Unit dose blister packs: 10, 50 and 500 film-coated tablets.
HDPE bottles: 30, 100, 250 and 1000 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (VA), Italy

Manufacturer:
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 – Malta
Milpharm Limited - Ares Block, Odyssey Business Park, West End Road, Ruislip HA4 6QD – United Kingdom

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Belgium: Co-Olmesartan AB 40 mg/12.5 mg; 40 mg/25 mg filmomhulde tabletten
Bulgaria: Oлмесартан/ хидрохлортиазид Ауробиндо 40mg/12,5mg; 40mg/25mg Филмирани таблетки
Germany: Olmesartan/ Hydrochlorothiazid Aurobindo 40 mg/12.5 mg; 40 mg/25 mg Filmtabletten
Italy: Olmesartan e Idroclorotiazide Aurobindo
Luxembourg: Co-Olmesartan AB 40 mg/12.5 mg; 40 mg/25 mg comprimés pelliculés / Filmtabletten
Malta: Olmesartan/ Hydrochlorothiazide 40mg/12.5mg; 40mg/25mg film-coated tablets
Netherlands: Olmesartan medoxomil/Hydrochloorthiazide Aurobindo 40mg/12.5mg; 40mg/25mg filmomhulde tabletten
Portugal: Olmesartan medoxomilo + Hidroclorotiazida Aurobindo
Spain: Olmesartán/Hidroclorotiazida Aurobindo 40 mg /12.5 mg; 40 mg /25 mg comprimidos recubiertos con película EFG