OLMESARTAN 20 mg /12.5 Mg Film-Coated Tablets

Зміст інструкції

1. Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/12.5mg, mg/25mg
   1. What Olmesartan medoxomil and hydrochlorothiazide Pensa is and what it is used for
   2. What you need to know before taking Olmesartan medoxomil and hydrochlorothiazide
   3. How to take Olmesartan medoxomil and hydrochlorothiazide Pensa
   4. Possible side effects
   5. How to store Olmesartan medoxomil and hydrochlorothiazide Pensa
   6. Contents of the pack and other information
2. Olmesartan medoxomil Pensa film-coated tablets are available in packs of
3. Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/12.5 mg film-coated tablets
4. Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/25 mg film-coated tablets
   1. What is Olmesartan medoxomil and hydrochlorothiazide Pensa and what it is used for
   2. What you need to know before taking Olmesartan medoxomil and hydrochlorothiazide
5. Olmesartan medoxomil and hydrochlorothiazide Pensa and, in some way, reduced in patients of
   1. How to take Olmesartan medoxomil and hydrochlorothiazide Pensa
   2. Possible side effects
   3. How to store Olmesartan medoxomil and hydrochlorothiazide Pensa
   4. Package Contents and Other Information

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

film-coated tablets
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Olmesartan medoxomil and hydrochlorothiazide Pensa is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil and hydrochlorothiazide Pensa
• 3. How to take Olmesartan medoxomil and hydrochlorothiazide Pensa
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil and hydrochlorothiazide Pensa
• 6. 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 ingredients, olmesartan
medoxomil and hydrochlorothiazide, which are used for the treatment of high blood pressure
(hypertension):

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. It lowers blood pressure by relaxing the blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” (water tablets). It lowers blood pressure by helping the body to eliminate excess fluids by making the kidneys produce more urine.

You will be prescribed Olmesartan medoxomil and hydrochlorothiazide Pensa if olmesartan
medoxomil alone has not adequately controlled your blood pressure. When
taken together, the two active ingredients of Olmesartan medoxomil and
hydrochlorothiazide Pensa help to lower blood pressure more than if they are
taken alone.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe
Olmesartan medoxomil and hydrochlorothiazide Pensa to achieve a further reduction.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil and
hydrochlorothiazide Pensa tablets. Your doctor has probably also recommended that you
make some changes to your lifestyle to help lower your blood pressure (for example losing
weight, stopping smoking, reducing alcohol intake and reducing the amount of salt in your
diet). Your doctor may also have advised you to take regular exercise, such as walking or
swimming. It is important that you follow your doctor’s advice.

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

Think
Do not take Olmesartan medoxomil and hydrochlorothiazide Pensa

• if you are allergic to olmesartan medoxomil or to hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6) or to substances similar to hydrochlorothiazide (sulphonamides).
• if you are pregnant for more than three months (it is advisable to avoid the use of Olmesartan medoxomil and hydrochlorothiazide Pensa also during the first months of pregnancy - see section “Pregnancy”).
• if you have severe kidney problems.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve after treatment.
• if you suffer from severe liver problems or yellowing of the skin and eyes (jaundice) or problems with the flow of bile from the gallbladder (bile obstruction, for example gallstones). If you think any of these conditions apply to you, or are not sure, 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 had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Olmesartan medoxomil and hydrochlorothiazide Pensa.

Before taking the tablets, consult your doctorif 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 suffer from kidney problems related to diabetes.
• Aliskiren.

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in the blood at regular intervals.
See also what is reported under “Do not take Olmesartan medoxomil and
hydrochlorothiazide Pensa”.
Before taking the tablets, consult your doctorif you have any of the following health
problems:

• Mild or moderate kidney problems, or if you have recently had a kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling sick) or severe or prolonged diarrhea.
• Treatment with high doses of water tablets (diuretics) or if you are following a low-salt diet.
• Problems with the adrenal glands (for example primary aldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.

Contact your doctor if you experience any of the following symptoms:

• severe, persistent diarrhea and significant weight loss. The doctor will assess the symptoms and decide whether to continue this antihypertensive treatment.
• decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period of a few hours to a week after taking Olmesartan medoxomil and hydrochlorothiazide Pensa. This can lead to permanent vision impairment if left untreated.

The doctor may want to see you more often and do some tests if you have any of the
previous conditions.
Olmesartan medoxomil and hydrochlorothiazide Pensa may cause an increase in levels of
fats and uric acid (cause of gout - painful swelling of the joints) in the
blood. The doctor will probably need to perform periodic blood tests to assess
these conditions.
It can alter the levels of certain substances, called electrolytes, in the blood. The doctor will probably need to perform periodic blood tests to assess these conditions. The
signs of electrolyte alterations are: thirst, dry mouth, muscle pain or
cramps, muscle fatigue, low blood pressure (hypotension), feeling weak,
apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate,
fast heart rate. Tell your doctor if you notice the appearance of these symptoms.
As with any medicine that lowers blood pressure, an excessive reduction
of pressure in patients with disturbances of blood flow to the heart or brain can
lead to a heart attack or stroke. The doctor must therefore carefully monitor
blood pressure.
If you need to have parathyroid function tests, you should stop taking
Olmesartan medoxomil and hydrochlorothiazide Pensa before performing these tests.
For those who play sports: the use of the drug without therapeutic need constitutes
doping and can still result in a positive doping test.
You should tell your doctor if you think you may be pregnant (or planning to become
pregnant). Olmesartan medoxomil and hydrochlorothiazide Pensa is not recommended at the beginning
of pregnancy and should not be taken if you are pregnant for more than three months as
it can cause serious harm to the baby if taken during that period (see section
“Pregnancy”).

Children and adolescents
Olmesartan medoxomil and hydrochlorothiazide Pensa is not recommended in children and
adolescents under the age of 18 years.

Other medicines and Olmesartan medoxomil and hydrochlorothiazide Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
In particular, tell your doctor or pharmacist about the following medicines:

• Other medicines that lower blood pressure (antihypertensives) as they may increase the effect of Olmesartan medoxomil and hydrochlorothiazide Pensa. The doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also what is reported under “Do not take Olmesartan medoxomil and hydrochlorothiazide Pensa” and “Warnings and precautions”).
• Medicines that can cause changes in potassium levels in the blood when used in conjunction with Olmesartan medoxomil and hydrochlorothiazide Pensa. These include: potassium supplements (such as salt substitutes containing potassium) or water tablets (diuretics) or heparin (to thin the blood) or laxatives or steroids or adrenocorticotropic hormone (ACTH) or carbenoxolone (a medicine used to treat mouth and stomach ulcers) or sodium benzylpenicillin (also called benzylpenicillin sodium, an antibiotic) or some painkillers such as aspirin or salicylates
• Lithium (a medicine used to treat mood swings and some types of depression) used together with Olmesartan medoxomil and hydrochlorothiazide Pensa may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in the blood.
• 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 when used together with Olmesartan medoxomil and hydrochlorothiazide Pensa they may cause a sudden drop in blood pressure when getting up.
• Some medicines such as baclofen and tubocurarine, used to relax muscles
• Amifostine and some other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines to lower blood fats.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as it may decrease 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 biperidene.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat some psychiatric illnesses.
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart conditions.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin by injection, which can alter the 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 increase their hyperglycemic effect.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and slow down the heart rate.
• Difemanil, used to treat a slow heartbeat or reduce sweating.
• Medicines such as probenecid, sulfinpyrazone and allopurinol, used for the treatment of 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, because they may slightly reduce the effectiveness of Olmesartan medoxomil and hydrochlorothiazide Pensa 

• Cisapride, used to increase the movement of food in the stomach and intestines.
• Alofantrine, used for malaria.

Olmesartan medoxomil and hydrochlorothiazide Pensa with food, drinks and alcohol
Olmesartan medoxomil and hydrochlorothiazide Pensa can be taken with or without food.
Be careful to drink alcohol during treatment with Olmesartan
medoxomil and hydrochlorothiazide Pensa, as some people may feel weak or
dizzy. If this happens, do not drink any more alcohol, including wine, beer or flavored alcoholic beverages.

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

Pregnancy and breastfeeding
Pregnancy
You should tell your doctor if you think you may be pregnant (or planning to become
pregnant). As a rule, your doctor will advise you to stop taking Olmesartan
medoxomil and hydrochlorothiazide Pensa before you become pregnant or as soon as
you know you are pregnant and advise you to take another medicine instead of
Olmesartan medoxomil and hydrochlorothiazide Pensa. Olmesartan medoxomil and hydrochlorothiazide
Pensa is not recommended during pregnancy and should not be taken if you are pregnant
for more than three months as it can cause serious harm to the baby if taken after the third month of
pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Olmesartan
medoxomil and hydrochlorothiazide Pensa is not recommended in mothers who are
breastfeeding and the doctor may choose another treatment for you if you want to breastfeed.
If you are pregnant or breastfeeding, if you think, suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this
medicine.

Driving and using machines
You may feel drowsy or dizzy during treatment for high blood pressure. If
this happens, do not drive or use machines until the symptoms have disappeared. 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
an intolerance to some sugars, contact them before taking this medicine.

3. How to take Olmesartan medoxomil and hydrochlorothiazide Pensa

Always take this medicine exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.

The recommended doseis one tablet of Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/12.5 mg per day. 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 per day.
Swallow the tablet with a little water. If possible, take your daily dose

every day at the same time, for example at 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 ingests one or more tablets, go to your doctor or the nearest emergency room immediately, bringing the medicine packaging with you.

If you forget to take Olmesartan medoxomil and hydrochlorothiazide Pensa
If you forget to take a dose, take your normal 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 using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Not all people will experience them.

However, the following two side effects may be serious:

• Allergic reactions that can affect the whole body with swelling of the face, mouth and/or larynx (the site of the vocal cords), associated with itching and skin rash, can occur rarely. If this happens, stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa and contact your doctor immediately.
• Olmesartan medoxomil and hydrochlorothiazide Pensa can cause an excessive reduction in blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur infrequently. 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 ingredients and the
following information first mentions other side effects reported so far with the
combination of Olmesartan medoxomil and hydrochlorothiazide Pensa (in addition to those already
mentioned above) and subsequently those known for the individual active ingredients.

The following side effects are known so far with Olmesartan medoxomil and
hydrochlorothiazide Pensa:
If these side effects occur, they are often mild and it is not necessary to
interrupt 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):
Perception of heartbeat (palpitations), skin rash, eczema, vertigo, cough,
indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle pain and cramps
muscular, joint pain, pain in arms and legs, back pain, difficulty
of erection in men, blood in the urine.
Some changes in laboratory tests have also been observed infrequently
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 glucose in the blood, increased
liver function indices. The doctor will be aware of this from blood tests and
will tell you if you need to do anything.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (urticaria), acute
renal failure.
Rarely, some changes in laboratory tests have also been observed,
including:
increased blood urea nitrogen, decreased hemoglobin and hematocrit values.
The doctor will be aware of this from blood tests and will tell you if you need to
do something.

Further 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,
diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood
in the urine, urinary tract infection, flu-like symptoms, pain.
Some changes in laboratory tests have also been commonly observed
including: increased levels of fats in the blood, increased levels of urea or uric acid
in the blood, increased liver and muscle function indices.

Uncommon side effects (may affect up to 1 in 100 people):
Immediate allergic reactions that can affect the whole body and that can
cause breathing problems or a rapid drop in blood pressure causing
fainting (anaphylactic reactions), swelling of the face, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, rash (skin rash), skin blisters (urticaria).
Some changes in laboratory tests have also been observed infrequently
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 changes in laboratory tests have also been observed,
including: increased potassium in the blood.

Hydrochlorothiazide
Very common side effects (may affect more than 1 in 10 people):
Changes in laboratory tests including: increased levels of fats and uric acid
in the blood.

Common side effects (may affect up to 1 in 10 people):
Feeling of confusion, abdominal pain, stomach upset, feeling of fullness,
diarrhea, nausea, vomiting, constipation, elimination of glucose with the urine.
Some changes in laboratory tests have also been observed, including:
increased levels of creatinine, urea, calcium and glucose in the blood, decreased levels of
chloride, potassium, magnesium and sodium in the blood. Increased serum amylase
(hyperamylasemia).

Uncommon 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,
skin reactions to light, itching, purplish spots on the skin due to small
hemorrhages (purpura), skin blisters (urticaria).

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, anemia, bone marrow damage, restlessness,
feeling of depression, sleep disturbances, lack of interest (apathy), tingling and
numbness, convulsions, vision of 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, infection of the gallbladder, symptoms of lupus erythematosus
such as rash, joint pain and cold hands and fingers, allergic skin reactions,
skin exfoliation and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing an abnormal reduction in chloride levels in the blood
(hypochloremic alkalosis), intestinal blockage (paralytic ileus).

Not known (frequency cannot be estimated based on available data):
Decreased vision or eye pain due to high pressure (possible signs
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Skin and lip cancer (non-melanoma skin cancer).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Contents of the pack and other information

What Olmesartan medoxomil and hydrochlorothiazide Pensa contains

• The active ingredients 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 ingredients 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 paragraph “Olmesartan medoxomil and hydrochlorothiazide Pensa contains lactose”.

Description of the appearance of Olmesartan medoxomil and hydrochlorothiazide Pensa and pack contents
Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/12.5 mg film-coated tablet
yellow, cylindrical, biconvex, with D1 imprinted on one side.
Olmesartan medoxomil and hydrochlorothiazide Pensa 20 mg/25 mg film-coated tablet
light pink, cylindrical, biconvex, with D2 imprinted on one side.

Olmesartan medoxomil 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 Milan

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
with the following names:
Portugal – Olmesartan medoxomil + hydrochlorothiazide Lumec
Italy – Olmesartan medoxomil and hydrochlorothiazide Pensa

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

film-coated

Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/25 mg film-coated tablets

film-coated
Generic medicine

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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Olmesartan medoxomil and hydrochlorothiazide Pensa is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil and hydrochlorothiazide Pensa
• 3. How to take Olmesartan medoxomil and hydrochlorothiazide Pensa
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil and hydrochlorothiazide Pensa
• 6. Contents of the pack and other information

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

Olmesartan medoxomil and hydrochlorothiazide Pensa contains two active ingredients, olmesartan
medoxomil and hydrochlorothiazide, which are used for the treatment of high blood pressure
(hypertension):

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. It lowers blood pressure by relaxing the blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called “thiazide diuretics” (water tablets). It lowers blood pressure by helping the body to get rid of excess fluids, causing the kidneys to produce more urine.

Olmesartan medoxomil and hydrochlorothiazide Pensa will be prescribed to you if olmesartan
medoxomil alone has not adequately controlled your blood pressure. When
taken together, the two active ingredients of Olmesartan medoxomil and
hydrochlorothiazide Pensa help to lower blood pressure more than if they were
taken alone.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe
Olmesartan medoxomil and hydrochlorothiazide Pensa to achieve a further reduction.
High blood pressure can be controlled with medicines such as Olmesartan medoxomil and
hydrochlorothiazide Pensa tablets. Your doctor has probably also recommended that you
make some changes to your lifestyle to help reduce your blood
pressure (for example losing weight, stopping smoking, reducing your intake of
alcohol and reducing the amount of salt in your diet). Your doctor may also have advised you to
take regular exercise, such as walking or swimming. It is important that you follow your
doctor’s advice.

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

Think
Do not take Olmesartan medoxomil and hydrochlorothiazide Think

• 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 (sulphonamides).
• if you are pregnant for more than three months (it is advisable to avoid using Olmesartan medoxomil and hydrochlorothiazide Think also during the first months of pregnancy - see section “Pregnancy”).
• if you have severe kidney problems.
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood that do not improve after treatment.
• if you suffer from moderate or severe liver problems or yellowing of the skin and eyes (jaundice) or problems with the flow of bile from the gallbladder (bile duct 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 Think.

• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, can increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Olmesartan medoxomil and hydrochlorothiazide Think.

Before taking the tablets, consult your doctorif 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 suffer from kidney problems related to diabetes.
• aliskiren

The doctor may check your kidney function, blood pressure, and the amount of
electrolytes (e.g. potassium) in your blood at regular intervals.
See also what is stated in the section “Do not take Olmesartan medoxomil and
hydrochlorothiazide Think”
Before taking the tablets, consult your doctorif you have any of the following health
problems:

• Kidney transplant.
• Liver disease.
• Heart failure or problems with the heart valves or heart muscle.
• Vomiting (feeling unwell) or severe or prolonged diarrhoea.
• Treatment with high doses of water tablets (diuretics) or if you are following a low-salt diet.
• Problems with the adrenal glands (for example primary aldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.

Contact your doctorif any of the following symptoms occur:

• severe, persistent diarrhoea that causes significant weight loss. The doctor will assess the symptoms and decide whether to continue this antihypertensive treatment.
• decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur within a period ranging from a few hours to a week after taking Olmesartan medoxomil and hydrochlorothiazide Think. This can lead to permanent vision impairment if not treated.

The doctor may want to see you more often and do some tests if you have any of the
above conditions.
Olmesartan medoxomil and hydrochlorothiazide Think may cause an increase in levels of
fats and uric acid (cause of gout – painful swelling of the joints) in the
blood. The doctor will probably need to perform periodic blood tests to assess
these conditions.
It can alter the levels of certain substances, called electrolytes, in the blood. The doctor will probably need to perform periodic blood tests to assess these conditions. The
signs of electrolyte alterations are: thirst, dry mouth, muscle pain or
cramps, muscle fatigue, low blood pressure (hypotension), feeling weak,
apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate,
fast heart rate. Tell your doctor if you notice the appearance of these symptoms.
As with any medicine that lowers blood pressure, an excessive reduction in
pressure in patients with disturbances of blood flow to the heart or brain can
lead to a heart attack or stroke. The doctor must therefore carefully monitor
blood pressure.
If you need to have parathyroid function tests, you must stop taking
Olmesartan medoxomil and hydrochlorothiazide Think before performing these tests.
For those who play sports: the use of the drug without a therapeutic need constitutes
doping and may still result in a positive doping test.
You should inform your doctor if you think you may be pregnant (or may become
pregnant). Olmesartan medoxomil and hydrochlorothiazide Think is not recommended in early
pregnancy and must not be taken if you are pregnant for more than three months as
it can cause serious harm to the baby if taken during that period (see section
“Pregnancy”).

Children and adolescents
Olmesartan medoxomil and hydrochlorothiazide Think is not recommended in children and
adolescents under the age of 18 years.

Other medicines and Olmesartan medoxomil and hydrochlorothiazide Think
Tell 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 increase the effect of Olmesartan medoxomil and hydrochlorothiazide Think. The doctor may need to adjust the dose and/or take other precautions:
• If you are taking an ACE inhibitor or aliskiren (see also what is stated in the section “Do not take Olmesartan medoxomil and hydrochlorothiazide Think” and “Warnings and precautions”).
• Medicines that can cause changes in potassium levels in the blood when used with Olmesartan medoxomil and hydrochlorothiazide Think. These include: o potassium supplements (such as salt substitutes containing potassium) o water tablets (diuretics) o heparin (to thin the blood) o laxatives o steroids o adrenocorticotropic hormone (ACTH) o carbenoxolone (a medicine used to treat mouth and stomach ulcers) o sodium benzylpenicillin (also called benzylpenicillin sodium, an antibiotic) o some painkillers such as aspirin or salicylates
• Lithium (a medicine used to treat mood swings and some types of depression) used with Olmesartan medoxomil and hydrochlorothiazide Think may increase lithium toxicity. If you need to take lithium, your doctor will measure your lithium levels in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs - medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) used with Olmesartan medoxomil and hydrochlorothiazide Think may increase the risk of kidney failure and the effectiveness of Olmesartan medoxomil and hydrochlorothiazide Think may be reduced by NSAIDs.
• Sleeping pills, sedatives and antidepressants, as when used with Olmesartan medoxomil and hydrochlorothiazide Think they may cause a sudden drop in blood pressure when getting up.
• Some medicines such as baclofen and tubocurarine, used to relax muscles
• Amifostine and some other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines to reduce blood fats.
• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as it may decrease the effect of Olmesartan medoxomil and hydrochlorothiazide Think. Your doctor may advise you to take Olmesartan medoxomil and hydrochlorothiazide Think at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines, such as atropine and biperidene.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat some psychiatric illnesses.
• Some medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart conditions.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin by injection, which can alter the heart rhythm.
• Oral antidiabetic medicines such as metformin, or insulin, used to reduce blood glucose levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmesartan medoxomil and hydrochlorothiazide Think may increase their hyperglycemic effect.
• Methyldopa, a medicine used to treat high blood pressure.
• Medicines such as noradrenaline, used to increase blood pressure and slow the heart rate.
• Difemanil, used to treat a slow heartbeat 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 heartburn, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan medoxomil and hydrochlorothiazide Think.
• Cisapride, used to increase the movement of food in the stomach and intestines.
• Allofantrine, used for malaria.

Olmesartan medoxomil and hydrochlorothiazide Think with food, drinks and alcohol
Olmesartan medoxomil and hydrochlorothiazide Think can be taken with or without food.
Be careful to drink alcohol while taking Olmesartan
medoxomil and hydrochlorothiazide Think, as some people may feel weak or
dizzy. If this happens, do not drink any more alcohol, including wine, beer or flavored alcoholic beverages.

Black patients
As with other similar medicines, the blood pressure-lowering effect of

Olmesartan medoxomil and hydrochlorothiazide Pensa and, in some way, reduced in patients of

Black ethnicity.

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you may be pregnant (or if you might start to become
pregnant). As a rule, your doctor will advise you to stop taking Olmesartan
medoxomil and hydrochlorothiazide Pensa before you start a pregnancy or as soon as
you know you are pregnant and will advise you to take another medicine instead of
Olmesartan medoxomil and hydrochlorothiazide Pensa. Olmesartan medoxomil and hydrochlorothiazide
Pensa is not recommended during pregnancy and should not be taken if you are pregnant
for more than three months as it can cause serious harm to the baby if taken after the third month of
pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or if you are about to start breastfeeding. Olmesartan
medoxomil and hydrochlorothiazide Pensa is not recommended in mothers who are breastfeeding
and your doctor may choose another treatment for you if you wish to breastfeed.
If you are pregnant or breastfeeding, if you think, suspect or are planning a
pregnancy, 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 happens, do not drive or use machines until the symptoms have disappeared. 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 your doctor has told you. If
you have any doubts, ask your doctor or pharmacist.

The recommended doseis 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

every day at the same time, for example at 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 to your doctor or the nearest emergency room immediately
bringing the medicine packaging 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 questions about using this medicine, ask 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 that can affect the whole body with swelling of the face, mouth and/or larynx (the site 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 can cause an excessive reduction in blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur uncommonly. If this happens, stop taking Olmesartan medoxomil and hydrochlorothiazide Pensa, contact your doctor immediately and lie down.

Olmesartan medoxomil and hydrochlorothiazide Pensa is a combination of two active ingredients and the
following information first mentions other side effects reported so far with the combination Olmesartan medoxomil and hydrochlorothiazide Pensa (in addition to those already
mentioned above) and subsequently those known for the individual active ingredients.

The following side effects are known so far with Olmesartan medoxomil and
hydrochlorothiazide Pensa:
If these side effects occur, they are often mild and it is not necessary to interrupt 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):
Perception of heartbeat (palpitations), skin rash, eczema, vertigo, cough,
indigestion, abdominal pain, nausea, vomiting, diarrhea, muscle pain and cramps
muscular, joint pain, pain in arms and legs, back pain, difficulty
of erection in men, blood in the urine.
Some changes in laboratory tests have also been observed uncommonly
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 glucose in the blood, increased
liver function indices. The doctor will be aware of this from blood tests and
will tell you if you need to do anything.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, loss of consciousness, skin blisters (urticaria), acute
renal failure.
Rarely, some changes in laboratory tests have also been observed,
including:
increased blood urea nitrogen, decreased hemoglobin and hematocrit values.
The doctor will be aware of this from blood tests and will tell you if you need to
do something.

Further side effects reported with the use of olmesartan medoxomil or
hydrochlorothiazide alone, but not with Olmesartan medoxomil and hydrochlorothiazide Pensa or
with a higher frequency:
Olmesartan medoxomil
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, runny nose or nasal congestion, sore throat, abdominal pain, indigestion,
diarrhea, nausea, gastroenteritis, joint or bone pain, back pain, blood
in the urine, urinary tract infection, flu-like symptoms, pain.
Some changes in laboratory tests have also been commonly observed
including: increased levels of fats in the blood, increased levels of urea or uric acid
in the blood, increased liver and muscle function indices.

Uncommon side effects (may affect up to 1 in 100 people):
Immediate allergic reactions that can affect the whole body and can
cause breathing problems or a rapid drop in blood pressure causing
fainting (anaphylactic reactions), swelling of the face, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, rash (skin rash), skin blisters (urticaria).
Some changes in laboratory tests have also been observed uncommonly
including: reduction in the number of some blood cells called platelets
(thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.
Rarely, some changes in laboratory tests have also been observed,
including: increased potassium in the blood.

Hydrochlorothiazide
Very common side effects (may affect more than 1 in 10 people):
Changes in laboratory tests including: increased levels of fats and uric acid
in the blood.

Common side effects (may affect up to 1 in 10 people):
Feeling of confusion, abdominal pain, stomach upset, feeling of fullness,
diarrhea, nausea, vomiting, constipation, elimination of glucose with the urine.
Some changes in laboratory tests have also been observed, including:
increased levels of creatinine, urea, calcium and glucose in the blood, reduced levels of
chloride, potassium, magnesium and sodium in the blood. Increased serum amylase
(hyperamylasemia).

Uncommon side effects (may affect up to 1 in 100 people):
Loss or decrease of appetite, severe breathing difficulties, anaphylactic
skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema,
skin reactions to light, itching, purplish spots on the skin due to small
hemorrhages (purpura), skin blisters (urticaria).

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, anemia, bone marrow damage, restlessness,
feeling of depression, sleep disturbances, lack of interest (apathy), tingling and
numbness, convulsions, vision of 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, infection of the gallbladder, symptoms of lupus erythematosus
such as rash, joint pain and cold hands and fingers, allergic skin reactions,
skin exfoliation and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing an abnormal reduction in chloride levels in the blood
(hypochloremic alkalosis), intestinal blockage (paralytic ileus).

Not known (frequency cannot be estimated based on available data):
Decreased vision or eye pain due to high pressure (possible signs
of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
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, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package after
EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 ingredients 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
• The other ingredients 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 package contents
Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/12.5 mg film-coated tablet
yellow, oblong, biconvex, with D3 imprinted on one side.
Olmesartan medoxomil and hydrochlorothiazide Pensa 40 mg/25 mg film-coated tablet
light pink, oblong, biconvex, with D4 imprinted on one side.
Olmesartan medoxomil 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 Milan

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 medoxomilo + hidroclorotiazida Lumec
Italy – Olmesartan medoxomil e idroclorotiazide Pensa