Olmesartan medoxomil and hydrochlorothiazide Pensà: detailed information

PATIENT INFORMATION LEAFLET

Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/12.5 mg, mg/25 mg

film-coated tablets
Equivalent medicine
Please read all of 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 other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olmesartan medoxomil and hydrochlorothiazide Pensa is and what it is used for

Olmesartan medoxomil and hydrochlorothiazide Pensa 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” (water tablets). It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Your doctor will prescribe Olmesartan medoxomil and hydrochlorothiazide Pensa if olmesartan medoxomil alone has not adequately controlled your blood pressure. When given together, the two active substances in Olmesartan medoxomil and hydrochlorothiazide Pensa help reduce blood pressure more than when used alone.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan medoxomil and hydrochlorothiazide Pensa to achieve further reduction.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil and hydrochlorothiazide Pensa 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 the amount of salt in your diet). 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 should know before taking Olmesartan medoxomil and hydrochlorothiazide Pensa

Pensa
Do not take Olmesartan medoxomil and hydrochlorothiazide Pensa

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 advisable to avoid using Olmesartan medoxomil and hydrochlorothiazide Pensa even during the first months of pregnancy – see section “Pregnancy”).
if you have severe 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 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 applies to you, or are unsure, do not take the tablets. Contact your doctor first and follow their advice.

Warnings and precautions
Talk to your doctor before taking Olmesartan medoxomil and hydrochlorothiazide Pensa.

if you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Olmesartan medoxomil and hydrochlorothiazide Pensa.

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), especially if you have kidney problems related to diabetes.
Aliskiren.

Your doctor may monitor 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 Pensa”.
Before taking the tablets, consult your doctor if you have any of the following health conditions:

Mild or moderate kidney problems, or if you have recently undergone a kidney transplant.
Liver disease.
Heart failure or heart valve or heart muscle problems.
Severe or prolonged vomiting (nausea) or diarrhoea lasting several days.
Treatment with high doses of diuretic tablets ("water pills") or if you are on 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, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
Changes in vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur from a few hours to a week after taking Olmesartan medoxomil and hydrochlorothiazide Pensa. This may lead to permanent vision impairment if not treated.

Your doctor may need to examine you more frequently and perform blood tests if you have any of the above conditions.
Olmesartan medoxomil and hydrochlorothiazide Pensa may increase levels of fats and uric acid (a cause of gout – painful joint swelling) in the blood. Your doctor may need to perform periodic blood tests to monitor these conditions.
It may alter levels of certain substances called electrolytes in the blood. Your doctor may need 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), general weakness, lethargy, fatigue, drowsiness or restlessness, 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 lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor must therefore carefully monitor your blood pressure.
If you need to undergo tests for parathyroid function, you must stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa before these 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 pregnant (or could become pregnant). Olmesartan medoxomil and hydrochlorothiazide Pensa is not recommended in early pregnancy and must not be taken if you are more than three months pregnant, 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 Pensa is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan medoxomil and hydrochlorothiazide Pensa
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:

Other medicines that lower blood pressure (antihypertensives), as they may enhance the effect of Olmesartan medoxomil and hydrochlorothiazide Pensa. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also sections “Do not take Olmesartan medoxomil and hydrochlorothiazide Pensa” and “Warnings and precautions”).
Medicines that may affect potassium levels in the blood when used together with Olmesartan medoxomil and hydrochlorothiazide Pensa. These include: potassium supplements (such as potassium-containing salt substitutes), diuretic tablets, heparin (a blood thinner), 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), or 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 Pensa may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs – medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) used together with Olmesartan medoxomil and hydrochlorothiazide Pensa may increase the risk of kidney failure, and the effectiveness of Olmesartan medoxomil and hydrochlorothiazide Pensa may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure when standing up if used together with Olmesartan medoxomil and hydrochlorothiazide Pensa.
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 lower blood fats.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as it may reduce the effect of Olmesartan medoxomil and hydrochlorothiazide Pensa. Your doctor may advise you to take Olmesartan medoxomil and hydrochlorothiazide Pensa 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 intravenous erythromycin, which may affect heart rhythm.
Oral antidiabetic medicines such as metformin, or insulin, used to lower blood glucose levels.
Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmesartan medoxomil and hydrochlorothiazide Pensa 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.
Dihydroergotamine, 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.
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 medoxomil and hydrochlorothiazide Pensa.
Cisapride, used to increase gastrointestinal motility.
Halofantrine, used to treat malaria.

Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil and hydrochlorothiazide Pensa is somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan medoxomil and hydrochlorothiazide Pensa 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 the third month of pregnancy.

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

If you are pregnant, breastfeeding, think 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 resolve. Consult your doctor for advice.

Olmesartan medoxomil and hydrochlorothiazide Pensa contains lactose
This medicine contains lactose (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 medoxomil and hydrochlorothiazide Pensa

Always take this medicine exactly as instructed by your doctor. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of Olmesartan medoxomil and hydrochlorothiazide
Pensa 20 mg/12.5 mg daily. However, if your blood pressure is not controlled, your doctor may
decide to change your prescription to one tablet of Olmesartan medoxomil and
hydrochlorothiazide Pensa 20 mg/25 mg daily.
Swallow the tablet with a little water. If possible, take your daily dose
at the same time each day, for example with breakfast. It is important to continue taking
Olmesartan medoxomil and hydrochlorothiazide Pensa until your doctor tells you
to stop.
If you take more Olmesartan medoxomil and hydrochlorothiazide Pensa than you should
If you take more tablets than prescribed or if a child accidentally ingests one or more tablets,
go immediately to your doctor or the nearest emergency room, taking the medicine package
with you.
If you forget to take Olmesartan medoxomil and hydrochlorothiazide Pensa
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 forgotten dose.
If you stop treatment with Olmesartan medoxomil and hydrochlorothiazide Pensa
It is important to continue taking Olmesartan medoxomil and hydrochlorothiazide Pensa
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
everyone will experience 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 of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa and contact your doctor immediately.
Olmesartan medoxomil and hydrochlorothiazide Pensa 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 Pensa, contact your doctor immediately, and lie down.

Olmesartan medoxomil and hydrochlorothiazide Pensa is a combination of two active substances, and the following information first lists the other side effects reported so far with the combination Olmesartan medoxomil and hydrochlorothiazide Pensa (in addition to those already mentioned above), followed by those known for the individual active substances.
The following side effects are those known so far with Olmesartan medoxomil and hydrochlorothiazide Pensa:
If these side effects occur, they are often mild and it is not necessary to stop treatment with Olmesartan medoxomil and hydrochlorothiazide Pensa.
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 side effects (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle pain and muscle cramps, joint pain, pain in arms and legs, back pain, difficulty with erection 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 tests. Your doctor will become aware of these from blood tests and will tell you if any action is needed.
Rare side effects (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 the use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Olmesartan medoxomil and hydrochlorothiazide Pensa or with greater frequency:
Olmesartan medoxomil
Common side effects (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, flu-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 tests.
Uncommon side effects (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 leading 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 side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.
Rarely, some laboratory test abnormalities have also been observed, including: increased potassium in the blood.
Hydrochlorothiazide
Very common side effects (may affect more than 1 in 10 people):
Laboratory test abnormalities 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, gastric disturbances, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose in the 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 (hyperamylasaemia).
Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, cutaneous anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to light, itching, small purple spots or patches on the skin due to minor bleeding (purpura), skin blisters (wheals).
Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased number of white blood cells, decreased number of platelets, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disorders, lack of interest (apathy), tingling and numbness, seizures, seeing yellow objects, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, inflammation of the pancreas, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing movement limitations).
Very rare side effects (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 due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Cancer of the skin and lips (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 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 Pensa

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Pensa contains

The active substances are:
Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan and 12.5 mg of hydrochlorothiazide.
Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan and 25 mg of hydrochlorothiazide.
The other components are microcrystalline cellulose, lactose monohydrate*, polyvinylpyrrolidone, hypromellose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide, polyethylene glycol 4000), yellow iron oxide, red iron oxide.
*See section “Olmesartan medoxomil and hydrochlorothiazide Pensa contains lactose”.

Description of the appearance of Olmesartan medoxomil and hydrochlorothiazide Pensa and contents of the pack
Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/12.5 mg film-coated tablet, yellow, cylindrical, biconvex, with "D1" engraved on one side.
Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/25 mg film-coated tablet, light pink, cylindrical, biconvex, with "D2" engraved on one side.
Olmesartan medoxomil and hydrochlorothiazide Pensa film-coated tablets are available in packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano, Italy

Manufacturer
LABORATORIOS CINFA, S.A.
Ctra. Olaz Chipi, 10
Pol. Ind. Areta de Huarte
31620 Navarre, Spain

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Portugal – Olmesartan medoxomil + hydrochlorothiazide Lumec
Italy – Olmesartan medoxomil and hydrochlorothiazide Pensa

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/25 mg film-coated tablets
Equivalent medicine
Please read all of 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 Pensa is and what it is used for
What you need to know before taking Olmesartan medoxomil and hydrochlorothiazide Pensa
How to take Olmesartan medoxomil and hydrochlorothiazide Pensa
Possible side effects
How to store Olmesartan medoxomil and hydrochlorothiazide Pensa
Contents of the pack and other information

1. What Olmesartan medoxomil and hydrochlorothiazide Pensa is and what it is used for

Olmesartan medoxomil and hydrochlorothiazide Pensa 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” (water tablets). It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Your doctor will prescribe Olmesartan medoxomil and hydrochlorothiazide Pensa if olmesartan medoxomil alone has not adequately controlled your blood pressure. When taken together, the two active substances in Olmesartan medoxomil and hydrochlorothiazide Pensa help reduce blood pressure more than when taken individually.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan medoxomil and hydrochlorothiazide Pensa to achieve further reduction.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil and hydrochlorothiazide Pensa 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 salt in your diet). 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 should know before taking Olmesartan medoxomil and hydrochlorothiazide

Pensa
Do not take Olmesartan medoxomil and hydrochlorothiazide Pensa

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 advisable to avoid using Olmesartan medoxomil and hydrochlorothiazide Pensa even during the first months of pregnancy – see section “Pregnancy”).
if you have severe 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 problems with bile flow from the gallbladder (biliary obstruction, for example gallstones). If you think any of these conditions apply to you, or are unsure, do not take the tablets. Contact your doctor first and follow their advice.

Warnings and precautions
Talk to your doctor before taking Olmesartan medoxomil and hydrochlorothiazide Pensa.

if you have previously had skin cancer or develop an unexpected skin lesion 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 sun exposure and UV radiation while taking Olmesartan medoxomil and hydrochlorothiazide Pensa.

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 (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
aliskiren

Your doctor may monitor 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 Pensa”
Before taking the tablets, consult 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 (nausea) or diarrhoea lasting several days.
Treatment with high-dose diuretic tablets ("water pills") or if you are on a low-salt diet.
Adrenal gland disorders (e.g. primary aldosteronism).
Diabetes.
Lupus erythematosus (an autoimmune disease).
Allergies or asthma.

Contact your doctor if any of the following symptoms occur:

Severe, persistent diarrhoea causing significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
Vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours to a week after taking Olmesartan medoxomil and hydrochlorothiazide Pensa. This may lead to permanent vision impairment if not treated.

Your doctor may want to examine you more frequently and perform blood tests if you have any of the
above conditions.
Olmesartan medoxomil and hydrochlorothiazide Pensa may increase levels of
fats and uric acid (a cause of gout – painful joint swelling) in the
blood. Your doctor should probably perform periodic blood tests to monitor
these conditions.
It may alter levels of certain substances called electrolytes in the blood. Your doctor should
probably perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), weakness, lethargy, tiredness, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you notice 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 heart attack or stroke. Your doctor should therefore carefully monitor your blood pressure.
If you need to undergo tests for parathyroid function, you must stop taking
Olmesartan medoxomil and hydrochlorothiazide Pensa before these tests.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
You must inform your doctor if you think you are pregnant (or could become pregnant). Olmesartan medoxomil and hydrochlorothiazide Pensa is not recommended in 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”).
Children and adolescents
Olmesartan medoxomil and hydrochlorothiazide Pensa is not recommended for children and
adolescents under 18 years of age.
Other medicines and Olmesartan medoxomil and hydrochlorothiazide Pensa
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:

Other medicines that lower blood pressure (antihypertensives), as they may enhance the effect of Olmesartan medoxomil and hydrochlorothiazide Pensa. Your doctor may need to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Olmesartan medoxomil and hydrochlorothiazide Pensa” and “Warnings and precautions”).
Medicines that may affect potassium levels in the blood when used together with Olmesartan medoxomil and hydrochlorothiazide Pensa. These include: potassium supplements (such as potassium-containing salt substitutes), diuretics, heparin (a blood thinner), 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), or 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 Pensa may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs – medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) used together with Olmesartan medoxomil and hydrochlorothiazide Pensa may increase the risk of kidney failure, and the effectiveness of Olmesartan medoxomil and hydrochlorothiazide Pensa may be reduced by NSAIDs.
Sleeping pills, sedatives, and antidepressants, as they may cause a sudden drop in blood pressure when standing up if used together with Olmesartan medoxomil and hydrochlorothiazide Pensa.
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 lower blood fats.
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Olmesartan medoxomil and hydrochlorothiazide Pensa. Your doctor may advise you to take Olmesartan medoxomil and hydrochlorothiazide Pensa at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines 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 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 intravenous erythromycin, which may affect heart rhythm.
Oral antidiabetic medicines such as metformin, or insulin, used to lower blood glucose levels.
Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmesartan medoxomil and hydrochlorothiazide Pensa 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.
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.
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 medoxomil and hydrochlorothiazide Pensa.
Cisapride, used to increase gastrointestinal motility.
Halofantrine, used to treat malaria.

Olmesartan medoxomil and hydrochlorothiazide Pensa with food, drinks and alcohol
Olmesartan medoxomil and hydrochlorothiazide Pensa can be taken with or without food.
Be cautious about consuming alcohol during treatment with Olmesartan
medoxomil and hydrochlorothiazide Pensa, as some people may feel weak or
dizzy. If this occurs, do not drink any more alcohol, including wine, beer, or flavored alcoholic beverages.
Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of
Olmesartan medoxomil and hydrochlorothiazide Pensa is somewhat reduced in patients of Black ethnicity.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or could become pregnant). Normally, your doctor will advise you to stop taking Olmesartan
medoxomil and hydrochlorothiazide Pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan medoxomil and hydrochlorothiazide
Pensa is not recommended during 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 after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan
medoxomil and hydrochlorothiazide Pensa is not recommended for breastfeeding mothers, and your doctor may choose another treatment if you wish to breastfeed.
If you are pregnant or breastfeeding, think you may be pregnant, suspect you are pregnant, or are planning a pregnancy, 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 for advice.
Olmesartan medoxomil and hydrochlorothiazide Pensa contains lactose
This medicine contains lactose (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 medoxomil and hydrochlorothiazide Pensa

Always take this medicine exactly as instructed by your doctor. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of Olmesartan medoxomil and hydrochlorothiazide
Pensa 40 mg/12.5 mg daily. However, if your blood pressure is not controlled, your doctor may
decide to change your prescription to one tablet of Olmesartan medoxomil and
hydrochlorothiazide Pensa 40 mg/25 mg daily.
Swallow the tablet with a little water. If possible, take your daily dose
at the same time each day, for example with breakfast. It is important to continue taking
Olmesartan medoxomil and hydrochlorothiazide Pensa until your doctor tells you
to stop.
If you take more Olmesartan medoxomil and hydrochlorothiazide Pensa than you should
If you take more tablets than you should, or if a child accidentally swallows one or more tablets,
go immediately to your doctor or nearest emergency room,
taking the medicine pack with you.
If you forget to take Olmesartan medoxomil and hydrochlorothiazide Pensa
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 Pensa
It is important to continue taking Olmesartan medoxomil and hydrochlorothiazide Pensa
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 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 (the area of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa and contact your doctor immediately.
Olmesartan medoxomil and hydrochlorothiazide Pensa may cause excessive lowering of blood pressure in susceptible individuals or as a result of an allergic reaction. Dizziness or fainting may occur not uncommonly. If this happens, stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa, contact your doctor immediately, and lie down.

Olmesartan medoxomil and hydrochlorothiazide Pensa is a combination of two active substances. The information below first lists the other side effects reported so far with the combination Olmesartan medoxomil and hydrochlorothiazide Pensa (in addition to those already mentioned above), followed by those known for each individual active substance.

The following side effects are those currently known with Olmesartan medoxomil and hydrochlorothiazide Pensa:
If these side effects occur, they are often mild and it is not necessary to discontinue treatment with Olmesartan medoxomil and hydrochlorothiazide Pensa.

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 side effects (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle pain and muscle cramps, 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: increase in blood lipid levels, increase in blood urea or uric acid levels, increase in creatinine, increase or decrease in blood potassium levels, increase in blood calcium levels, increase in blood glucose levels, increase in liver function tests. Your doctor will become aware of these from blood tests 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 blisters (wheals), acute renal failure.

Rarely, the following laboratory test abnormalities have also been observed:
increase in blood urea nitrogen, decrease in haemoglobin and haematocrit values.
Your doctor will become aware of these from blood tests and will inform you if any action is needed.

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

Olmesartan medoxomil

Common side effects (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: increase in blood lipid levels, increase in blood urea or uric acid levels, increase in 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 or a rapid drop in blood pressure leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, rash (skin eruption), skin blisters (wheals).

Uncommonly observed laboratory test abnormalities include: reduction in the number of certain blood cells called platelets (thrombocytopenia).

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

Rarely observed laboratory test abnormalities include: increase in blood potassium levels.

Hydrochlorothiazide

Very common side effects (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of lipids and uric acid in the blood.

Common side effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloated feeling, diarrhoea, nausea, vomiting, constipation, glucose excretion in urine.

Laboratory test abnormalities observed 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, cutaneous anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purpuric spots or patches on the skin due to small haemorrhages (purpura), skin blisters (wheals).

Rare side effects (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 disturbances, lack of interest (apathy), tingling and numbness, seizures, yellow vision, 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 lupus erythematosus such as skin rash, joint pain, cold hands and fingers, allergic skin reactions, skin peeling and blistering, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement limitations).

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

Not known (frequency cannot be estimated from the available data):
Vision loss or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
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 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 Pensa

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the packaging 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil and hydrochlorothiazide Pensa contains

The active substances are:
Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan and 12.5 mg of hydrochlorothiazide.
Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan and 25 mg of hydrochlorothiazide.
Other components are: microcrystalline cellulose, lactose monohydrate*, polyvinylpyrrolidone, hydroxypropylcellulose, magnesium stearate, Opadry Y-1-7000 (hypromellose, titanium dioxide, macrogol 4000), yellow iron oxide, red iron oxide.
* See section “Olmesartan medoxomil and hydrochlorothiazide Pensa contains lactose”.

Description of the appearance of Olmesartan medoxomil and hydrochlorothiazide Pensa and contents of the pack
Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/12.5 mg: yellow, oblong, biconvex film-coated tablet, with "D3" imprinted on one side.
Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/25 mg: light pink, oblong, biconvex film-coated tablet, with "D4" imprinted on one side.
Olmesartan medoxomil Pensa film-coated tablets are available in packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini 12
20124 Milano, Italy

Manufacturer
LABORATORIOS CINFA, S.A.
Ctra. Olaz Chipi, 10
Pol. Ind. Areta de Huarte
31620 Navarre, Spain

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Portugal – Olmesartan medoxomil + hydrochlorothiazide Lumec
Italy – Olmesartan medoxomil and hydrochlorothiazide Pensa