Olmesartan medoxomil and hydrochlorothiazide HCS: detailed information

PACKAGE LEAFLET

Package leaflet: information for the patient

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

olmesartan medoxomil/hydrochlorothiazide
Generic medicine
Please 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 their symptoms are the same as yours, as 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 HCS is and what it is used for
What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide HCS
How to take Olmesartan medoxomil and Hydrochlorothiazide HCS
Possible side effects
How to store Olmesartan medoxomil and Hydrochlorothiazide HCS
Package contents and other information

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

Olmesartan medoxomil and Hydrochlorothiazide HCS contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used to treat high blood pressure (hypertension) in adult patients:

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 (“water tablets”). It reduces blood pressure by helping the body get rid of excess fluid, causing the kidneys to produce more urine.

You will be prescribed Olmesartan medoxomil and Hydrochlorothiazide HCS if your blood pressure is not adequately controlled with olmesartan medoxomil alone. When administered together, the two active substances in Olmesartan medoxomil and Hydrochlorothiazide HCS lower blood pressure more effectively than either substance alone.
If you are already taking medicines for high blood pressure, your doctor may decide that you should also take Olmesartan medoxomil and Hydrochlorothiazide HCS to further reduce your blood pressure.
High blood pressure can be managed with medicines such as Olmesartan medoxomil and Hydrochlorothiazide HCS tablets. Your doctor has likely recommended that you make certain lifestyle changes to help lower your blood pressure (e.g. losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also encourage you to engage in regular physical activity, such as walking or swimming. It is important to follow your doctor’s advice.

2. What you should know before taking Olmesartan medoxomil and Hydrochlorothiazide HCS

Do not take Olmesartan medoxomil and Hydrochlorothiazide HCS

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. (It is also advisable to avoid Olmesartan medoxomil and Hydrochlorothiazide HCS in early pregnancy - see section Pregnancy)
if you have severe kidney problems
if you suffer from potassium deficiency, sodium deficiency, high calcium levels, or elevated uric acid levels in the blood (with symptoms of gout or kidney stones) that do not improve with treatment
if you have severe liver problems, jaundice (yellowing of the skin and eyes), or problems with bile drainage from the gallbladder (biliary obstruction, e.g. 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 situations applies to you, or if you are unsure, do not take the tablets.
Inform your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Olmesartan medoxomil and Hydrochlorothiazide HCS.
Before taking the tablets, inform your doctor if you have any of the following health problems:

mild to moderate kidney impairment or if you have recently undergone a kidney transplant
liver disease
heart failure or problems with heart valves or heart muscle
severe or prolonged vomiting (nausea) or diarrhoea
treatment with high doses of diuretic tablets (water tablets) or if you are on a low-salt diet
adrenal gland disorders (e.g. primary aldosteronism)
diabetes
systemic lupus erythematosus (an autoimmune disease)
allergies or asthma
If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with 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 Olmesartan medoxomil and Hydrochlorothiazide HCS.
if you are taking any of the following medicines for high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes associated with kidney problems.
aliskiren. Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the information under “Do not take Olmesartan medoxomil and Hydrochlorothiazide HCS”.

Your doctor may decide to see you frequently and perform tests if you are in any of these
conditions.
Inform your doctor if you experience severe, persistent diarrhoea causing significant weight loss.
Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.
Olmesartan medoxomil and Hydrochlorothiazide HCS may increase levels of fats and uric acid (a cause of gout – joint pain) in your blood. Your doctor will likely perform periodic blood tests to monitor these conditions.
Olmesartan medoxomil and Hydrochlorothiazide HCS may alter levels of certain chemical components in your blood called electrolytes. Your doctor will likely 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, sluggish, tired, sleepy or restless, nausea, vomiting, reduced need to urinate, increased heart rate. Inform your doctor if you notice these symptoms.
As with any other medicine that lowers blood pressure, an excessive drop 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 monitor your blood pressure carefully.
If you are undergoing thyroid function tests, you must stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS before these tests.
For athletes: using the medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Inform your doctor if you think you are (or might become) pregnant. Olmesartan medoxomil and Hydrochlorothiazide HCS 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 baby if taken during this period (see section Pregnancy).
Children and adolescents
Olmesartan medoxomil and Hydrochlorothiazide HCS is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan medoxomil and Hydrochlorothiazide HCS
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:

medicines that may increase potassium levels in the blood when used together with Olmesartan medoxomil and Hydrochlorothiazide HCS. These include:
potassium supplements (as well as salt substitutes containing potassium)
diuretic tablets (water tablets)
heparin (to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also called sodium benzylpenicillin, an antibiotic)
certain painkillers such as aspirin and salicylates.
your doctor may need to adjust the dosage and/or take other precautions
if you are taking an ACE inhibitor or aliskiren (see also the information under “Do not take Olmesartan medoxomil and Hydrochlorothiazide HCS” and “Warnings and precautions”).
lithium (a medicine used to treat mood swings and certain types of depression), which when used together with Olmesartan medoxomil and Hydrochlorothiazide HCS 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 relieve pain, swelling, and other symptoms of inflammation, including arthritis), which when used together with Olmesartan medoxomil and Hydrochlorothiazide HCS may increase the risk of kidney failure and may reduce the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS.
other blood pressure-lowering medicines (antihypertensives), as the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be increased.
sleeping pills, sedatives, and antidepressants, as using these medicines together with Olmesartan medoxomil and Hydrochlorothiazide HCS 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 medicines used to treat cancer, such as cyclophosphamide or methotrexate.
cholestyramine and colestipol, medicines used to lower blood fat levels.
colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be reduced. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide HCS at least 4 hours before.
anticholinergic agents, 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 disorders.
certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
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 lower blood sugar levels.
beta-blockers and diazoxide, medicines used respectively for treating high blood pressure and low blood sugar, as Olmesartan medoxomil and Hydrochlorothiazide HCS may enhance the blood sugar-raising effect.
methyldopa, a medicine used to treat high blood pressure.
medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
difenoxin, used to treat slow heart rate or to 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 organ transplant rejection.
certain antibiotics called tetracyclines or sparfloxacin.
amphotericin, a medicine used to treat fungal infections.
certain antacids used to treat stomach acidity, such as magnesium and aluminium hydroxide, as the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be slightly reduced.
cisapride, used to increase movement of food through the stomach and intestine.
halofantrine, used for malaria.

Olmesartan medoxomil and Hydrochlorothiazide HCS with food, drinks, and alcohol
Olmesartan medoxomil and Hydrochlorothiazide HCS can be taken with or without food.
Be cautious when drinking alcohol while taking Olmesartan medoxomil and Hydrochlorothiazide HCS, as some people may experience weakness and dizziness. If this occurs, do not drink alcohol, including wine, beer, or alcopops.
Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil and Hydrochlorothiazide HCS is generally lower in black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS before becoming pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Olmesartan medoxomil and Hydrochlorothiazide HCS 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 baby if taken beyond three months of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding. Olmesartan medoxomil and Hydrochlorothiazide HCS is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice 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 have resolved. Consult your doctor for advice.

3. How to take Olmesartan medoxomil and Hydrochlorothiazide HCS

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Olmesartan medoxomil and Hydrochlorothiazide HCS 20 mg/12.5 mg is one tablet daily. However, if your blood pressure is not adequately controlled, your doctor may decide to adjust the dosage to one tablet daily of Olmesartan medoxomil and Hydrochlorothiazide HCS 20 mg/25 mg.
Swallow the tablet with water. If possible, take the daily dose at the same time each day, for example with breakfast. It is important to continue treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS until your doctor tells you to stop.

If you take more Olmesartan medoxomil and Hydrochlorothiazide HCS than you should
If you take more tablets than prescribed or if a child accidentally swallows one or more tablets, go immediately to your doctor or the nearest emergency department and bring the medicine pack with you.

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

If you stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS
It is important to continue taking Olmesartan medoxomil and Hydrochlorothiazide HCS until your doctor tells you to stop.

If you have any questions 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 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 larynx (the area containing the vocal cords), together with itching and skin rash, which may occur rarely. If this happens, stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS and contact your doctor immediately.
Olmesartan medoxomil and Hydrochlorothiazide HCS may cause a greater drop in blood pressure in more sensitive individuals or as a result of an allergic reaction. Dizziness or fainting may occur uncommonly. If this happens, stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS, contact your doctor immediately, and lie down.

Olmesartan medoxomil and Hydrochlorothiazide HCS is a combination of two active substances. The following information first lists the other side effects reported so far with the combination Olmesartan medoxomil and Hydrochlorothiazide HCS (in addition to those already mentioned above), and secondly, those known for the individual active substances.

These are the other known side effects with Olmesartan medoxomil and Hydrochlorothiazide HCS so far:
If the following side effects occur, they may be mild and you will not need to stop treatment.

Common side effects (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands or arms.

Uncommon side effects (may affect up to 1 in 100 people):
Changes in 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.
In blood test results, changes have been observed uncommonly, including:
Increased levels of fats in the blood, increased blood urea or uric acid, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood glucose, increased liver function tests.

Your doctor will check for these through a blood test and will inform you if any action is needed.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin swellings (wheals), acute kidney failure.
In blood test results, changes have been observed rarely, including:
Increased blood urea nitrogen (azotemia), decreased haemoglobin and haematocrit values.
Your doctor will check for these through a blood test and will inform you if any action is needed.

Other side effects reported after use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan medoxomil and Hydrochlorothiazide HCS or with higher frequency:

Olmesartan medoxomil:
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, nasal congestion or runny nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infections, flu-like symptoms, pain.
In blood test results, changes have been observed commonly, including:
Increased levels of fats in the blood, increased blood urea or uric acid, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Immediate allergic reactions affecting the whole body, which may cause breathing difficulties, as well as 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 rashes, itching, rash (exanthema), skin swellings (wheals).
In blood test results, changes have been observed uncommonly, including:
Reduced number of certain blood cells known as platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, loss of strength.
In blood test results, changes have been observed rarely, including:
Increased potassium levels in the blood.

Hydrochlorothiazide:
Very common side effects (may affect more than 1 in 10 people):
Changes in blood test results, including:
Increased levels of fats and uric acid in the blood.

Common side effects (may affect up to 1 in 10 people):
Feeling confused, abdominal pain, stomach ache, bloated feeling, diarrhoea, nausea, vomiting, constipation, glucose excretion in urine.
In blood test results, changes have been observed, including:
Increased creatinine, urea, calcium and glucose levels in the blood, decreased chloride, potassium, magnesium and sodium levels, increased serum amylase (hyperamylasemia).

Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purplish spots or skin patches due to small haemorrhages (purpura), skin swellings (wheals).

Rare side effects (may affect up to 1 in 1,000 people):
Swelling and pain of the salivary glands, decreased white blood cell count, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling low or depressed, sleep disturbances, feeling of disinterest (apathy), numbness and tingling, seizures, yellow appearance of objects, 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, symptoms of systemic lupus erythematosus (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 (sometimes due to impaired movement).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte imbalances leading to abnormally low chloride levels in the blood (hypochloraemic alkalosis), intestinal blockage (paralytic ileus).

Not known (frequency cannot be estimated from the available data):
Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
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 Olmesartan medoxomil and Hydrochlorothiazide HCS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil and Hydrochlorothiazide HCS contains

The active substances are olmesartan medoxomil and hydrochlorothiazide.
Olmesartan medoxomil and Hydrochlorothiazide HCS 20 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Olmesartan medoxomil and Hydrochlorothiazide HCS 20 mg/25 mg film-coated tablets
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other components are microcrystalline cellulose, magnesium stearate and low-substituted hydroxypropylcellulose in the tablet core, and titanium dioxide, talc, polyvinyl alcohol and macrogol 3000 in the tablet coating.

Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide HCS and
package contents
Olmesartan medoxomil and Hydrochlorothiazide HCS 20 mg/12.5 mg film-coated tablets are white to off-white, round, biconvex tablets, with the mark "C1" engraved on one side of the tablet; tablet diameter: 9 mm.
Olmesartan medoxomil and Hydrochlorothiazide HCS 20 mg/25 mg film-coated tablets are white to off-white, oval, biconvex tablets, with the mark "C2" engraved on one side of the tablet; dimensions: 12 mm x 6 mm.
The film-coated tablets are available in packs of 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local representative in Italy
KRKA Farmaceutici Milano S.r.l. - Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria	Olmesartan/HCT Krka
Belgium	Olmesartan/HCTZ Krka
Czech Republic	Olimesta Combi
Cyprus	Olmesartan/Hydrochlorothiazide TAD
Germany	Olmecor HCT
Denmark	Olmesartan medoxomil/Hydrochlorothiazide Krka
Spain	Olmesartan/Hydrochlorothiazide Krka
Finland	Olmesartan medoxomil/Hydrochlorothiazide Krka
France	Olmesartan medoxomil/Hydrochlorothiazide HCS
Croatia	Co-Olimestra
Hungary	Co-Olimestra
Ireland	Olmesartan/Hydrochlorothiazide Krka
Italy	Olmesartan medoxomil and Hydrochlorothiazide HCS
Netherlands	Olmesartan medoxomil/Hydrochlorothiazide Krka
Norway	Olmesartan medoxomil/Hydrochlorothiazide Krka
Portugal	Olmesartan medoxomil + Hydrochlorothiazide Krka

Patient Information Leaflet

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

olmesartan medoxomil/hydrochlorothiazide
Equivalent medicine
Please 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 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Olmesartan medoxomil and Hydrochlorothiazide HCS contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used for the treatment of high blood pressure (hypertension) in adult patients:

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 (“water tablets”). It reduces blood pressure by helping the body get rid of excess fluid, causing the kidneys to produce more urine.

You will be prescribed Olmesartan medoxomil and Hydrochlorothiazide HCS if your blood pressure is not adequately controlled with olmesartan medoxomil alone. When administered together, the two active substances in Olmesartan medoxomil and Hydrochlorothiazide HCS contribute to lowering blood pressure more effectively than when given separately.
If you are already taking medicines for the treatment of high blood pressure, your doctor may decide that you should also take Olmesartan medoxomil and Hydrochlorothiazide HCS to further reduce your blood pressure.
High blood pressure can be managed with medications such as Olmesartan medoxomil and Hydrochlorothiazide HCS tablets. Your doctor has likely recommended that you make certain lifestyle changes to help lower your blood pressure (e.g. losing weight, quitting smoking, reducing alcohol intake, and reducing the amount of salt in your diet). Your doctor may also encourage you to engage in regular physical activity, such as walking or swimming. It is important to follow your doctor’s advice.

2. What you should know before taking Olmesartan medoxomil and Hydrochlorothiazide HCS

Do not take Olmesartan medoxomil and Hydrochlorothiazide HCS

if you are allergic to olmesartan medoxomil, hydrochlorothiazide, or 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. (It is best to avoid Olmesartan medoxomil and Hydrochlorothiazide HCS even in early pregnancy – see section Pregnancy)
if you have kidney problems
if you suffer from potassium deficiency, sodium deficiency, high calcium levels, or elevated uric acid levels in the blood (with symptoms of gout or kidney stones) that do not improve with treatment
if you have severe liver problems, jaundice (yellowing of the skin and eyes), or problems with bile drainage from the gallbladder (biliary obstruction, e.g. 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 situations applies to you, or are unsure, do not take the tablets.
Inform your doctor first and follow their advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Olmesartan medoxomil and Hydrochlorothiazide HCS.
Before taking the tablets, inform your doctor if you have any of the following health conditions:

kidney transplant
liver diseases
heart failure or problems with heart valves or heart muscle
severe or prolonged vomiting or diarrhoea
treatment with high doses of diuretic tablets ("water pills") or if you are on a low-salt diet
adrenal gland disorders (e.g. primary aldosteronism)
diabetes
systemic lupus erythematosus (an autoimmune disease)
allergies or asthma
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 radiation
during treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS. If you are taking any
of the following medicines for high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have diabetes with kidney problems.
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 information provided under “Do not take Olmesartan medoxomil and Hydrochlorothiazide
HCS”.
Your doctor may decide to monitor you frequently and perform tests if you have any of these
conditions.
Inform your doctor if you experience severe, persistent diarrhoea that causes significant weight loss.
Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.
Olmesartan medoxomil and Hydrochlorothiazide HCS may increase levels of fats and uric acid in the blood (which can cause gout – joint pain). Your doctor will likely perform periodic blood tests to monitor these conditions.
Olmesartan medoxomil and Hydrochlorothiazide HCS may alter levels of certain chemicals in your blood called electrolytes. Your doctor will likely 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, sluggish, tired, sleepy, or restless, nausea, vomiting, reduced need to urinate, increased heart rate. Inform your doctor if you notice these
symptoms.
As with any other medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.
If you need to undergo tests for thyroid function, you must stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS before undergoing such tests.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
Inform your doctor if you think you are (or might become) pregnant. Olmesartan medoxomil and Hydrochlorothiazide HCS 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 unborn baby if taken during this period (see section Pregnancy).
Children and adolescents
Olmesartan medoxomil and Hydrochlorothiazide HCS is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan medoxomil and Hydrochlorothiazide HCS
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:

medicines that may increase potassium levels in the blood when used together with Olmesartan medoxomil and Hydrochlorothiazide HCS. These include:
potassium supplements (as well as salt substitutes containing potassium)
diuretic tablets ("water pills")
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 and salicylates.
your doctor may need to adjust the dosage and/or take other precautions
if you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Olmesartan medoxomil and Hydrochlorothiazide HCS” and “Warnings and precautions”).
Lithium (a medicine used to treat mood swings and certain types of depression), which when used concomitantly with Olmesartan medoxomil and Hydrochlorothiazide HCS 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 relieve pain, swelling, and other symptoms of inflammation, including arthritis), which when used together with Olmesartan medoxomil and Hydrochlorothiazide HCS may increase the risk of kidney failure, and the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be reduced by NSAIDs.
Other blood pressure-lowering medicines (antihypertensives), as the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be enhanced.
Sleeping pills, sedatives, and antidepressants, as using these medicines together with Olmesartan medoxomil and Hydrochlorothiazide HCS may cause a sudden drop in blood pressure upon standing.
Certain muscle relaxants such as baclofen and tubocurarine.
Amifostine and certain other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be reduced. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide HCS at least 4 hours before.
Anticholinergic agents such as atropine and biperiden.
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, carbamazepine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric disorders.
Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
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 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 HCS may enhance the blood sugar-raising effect.
Methyldopa, a medicine used to treat high blood pressure.
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 organ transplant rejection.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Certain antacids used to treat stomach acidity, such as magnesium and aluminium hydroxide, as the effect of Olmesartan medoxomil and Hydrochlorothiazide HCS may be slightly reduced.
Cisapride, used to increase gastrointestinal motility.
Halofantrine, used to treat malaria.

Olmesartan medoxomil and Hydrochlorothiazide HCS with food, drinks, and alcohol
Olmesartan medoxomil and Hydrochlorothiazide HCS can be taken with or without food.
Be cautious when drinking alcohol while taking Olmesartan medoxomil and Hydrochlorothiazide HCS, as some people may experience weakness and dizziness. If this occurs, avoid alcohol, including wine, beer, or alcopops.
Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil and Hydrochlorothiazide HCS is generally lower in Black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Olmesartan medoxomil and Hydrochlorothiazide HCS is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken beyond three months of gestation.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Olmesartan medoxomil and Hydrochlorothiazide HCS is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, 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.

3. How to take Olmesartan medoxomil and Hydrochlorothiazide HCS

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Olmesartan medoxomil and Hydrochlorothiazide HCS 40 mg/12.5 mg is one tablet daily. However, if your blood pressure is not controlled, your doctor may decide to adjust the dose to one tablet daily of Olmesartan medoxomil and Hydrochlorothiazide HCS 40 mg/25 mg.
Swallow the tablet with water. If possible, take the daily dose at the same time each day, for example with breakfast. It is important to continue treatment with Olmesartan medoxomil and Hydrochlorothiazide HCS until your doctor tells you otherwise.

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

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

If you have any questions 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 experiences them.
However, the following two side effects can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), together with itching and skin rash, which may occur rarely. If this happens, stop taking Olmesartan medoxomil and Hydrochlorothiazide HCS and contact your doctor immediately.
Olmesartan medoxomil and Hydrochlorothiazide HCS may cause a greater drop in blood pressure in particularly sensitive individuals or as a result of an allergic reaction.
Dizziness or fainting may uncommonly occur. If this happens, stop taking Olmesartan medoxomil and Hydrochlorothiazide HCS, contact your doctor immediately, and lie down.

Olmesartan medoxomil and Hydrochlorothiazide HCS is a combination of two active substances, and the following information first lists other side effects reported so far with the combination Olmesartan medoxomil and Hydrochlorothiazide HCS (in addition to those already mentioned above), and secondly, those known for the individual active substances.

These are other known side effects so far with Olmesartan medoxomil and Hydrochlorothiazide HCS:
If you experience the following side effects, they may be mild and you will not need to stop treatment.

Common side effects (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon changes observed in blood test results include:
Increased levels of fats in the blood, increased blood urea or uric acid, increased creatinine, increased or decreased blood potassium levels, increased blood calcium levels, increased blood glucose, increased liver function tests.

Your doctor will check these through a blood test and will inform you if any action is needed.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin swellings (wheals), acute renal failure.

Rare changes observed in blood test results include:
Increased blood urea nitrogen (BUN), decreased haemoglobin and haematocrit values.

Your doctor will check these through a blood test and will inform you if any action is needed.

Other side effects reported after use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan medoxomil and Hydrochlorothiazide HCS or with higher frequency:

Olmesartan medoxomil:

Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, blocked or runny nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infections, flu-like symptoms, pain.

Common changes observed in blood test results include:
Increased levels of fats in the blood, increased blood urea or uric acid, increased liver and muscle function tests.

Uncommon side effects (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing problems and a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), swelling of the face, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rashes, itching, rash (exanthema), skin swellings (wheals).

Uncommon changes observed in blood test results include:
Reduced number of certain blood cells known as platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, loss of strength.

Rare changes observed in blood test results include:
Increased potassium levels in the blood.

Hydrochlorothiazide:

Very common side effects (may affect more than 1 in 10 people):
Changes in blood test results including:
Increased levels of fats and uric acid in the blood.

Common side effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, stomach ache, bloating, diarrhoea, nausea, vomiting, constipation, glucose in urine.

Changes observed in blood test results include:
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 (hyperamylasaemia).

Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-induced skin reactions, itching, purplish spots or skin spots due to small haemorrhages (purpura), skin swellings (wheals).

Rare side effects (may affect up to 1 in 1,000 people):
Swelling and pain of the salivary glands, decreased number of white blood cells, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling low or depressed, sleep disturbances, feeling of disinterest (apathy), numbness and tingling, seizures, yellow appearance of objects viewed, 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, symptoms of systemic lupus erythematosus (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 (sometimes due to impaired movement).

Not known (frequency cannot be estimated from available data):
Skin and lip cancer (non-melanoma skin cancer).

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil and Hydrochlorothiazide HCS

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.
Store in the original packaging to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil and Hydrochlorothiazide HCS contains

The active substances are olmesartan medoxomil and hydrochlorothiazide.
Olmesartan medoxomil and Hydrochlorothiazide HCS 40 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Olmesartan medoxomil and Hydrochlorothiazide HCS 40 mg/25 mg film-coated tablets
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other components are microcrystalline cellulose, magnesium stearate and low-substituted hydroxypropylcellulose in the tablet core, and titanium dioxide, talc, polyvinyl alcohol and macrogol 3000 in the tablet coating.

Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide HCS and contents of the pack

Olmesartan medoxomil and Hydrochlorothiazide HCS 40 mg/12.5 mg film-coated tablets are white to off-white, round, with bevelled edges, marked with the code C3 on one side of the tablet; tablet diameter: 12 mm.
Olmesartan medoxomil and Hydrochlorothiazide HCS 40 mg/25 mg film-coated tablets are white to off-white, oval, biconvex, with scores on both sides; size 15 mm x 8 mm. The score line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.
The film-coated tablets are available in packs containing 10, 14, 28, 30, 56, 60, 84, 90, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
HCS bvba, H Kennisstraat 53, B 2650 Edegem, Belgium

Local representative for Italy
KRKA Farmaceutici Milano S.r.l. - Italy

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area Member States under the following names:

Austria	Olmesartan/HCT Krka
Belgium	Olmesartan/HCTZ Krka
Czech Republic	Olimesta Combi
Cyprus	Olmesartan/Hydrochlorothiazide TAD
Germany	Olmecor HCT
Denmark	Olmesartan medoxomil/Hydrochlorothiazide Krka
Spain	Olmesartan/Hydrochlorothiazide Krka
Finland	Olmesartan medoxomil/Hydrochlorothiazide Krka
France	Olmesartan medoxomil/Hydrochlorothiazide HCS
Croatia	Co-Olimestra
Hungary	Co-Olimestra
Ireland	Olmesartan/Hydrochlorothiazide Krka
Italy	Olmesartan medoxomil and Hydrochlorothiazide HCS
Netherlands	Olmesartan medoxomil/Hydrochlorothiazide Krka
Norway	Olmesartan medoxomil/Hydrochlorothiazide Krka
Portugal	Olmesartan medoxomil + Hydrochlorothiazide Krka