Olmesartan medoxomil and hydrochlorothiazide Alter: detailed information

Patient Information Leaflet: Information for the User

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

olmesartan medoxomil/hydrochlorothiazide
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4. Contents of this leaflet
1. What Olmesartan medoxomil and Hydrochlorothiazide Alter is and what it is used for
2. What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide Alter
3. How to take Olmesartan medoxomil and Hydrochlorothiazide Alter
4. Possible side effects
5. How to store Olmesartan medoxomil and Hydrochlorothiazide Alter
6. Contents of the pack and other information

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

Olmesartan medoxomil and Hydrochlorothiazide Alter 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 reduces blood pressure by helping the body eliminate excess fluid, increasing urine production by the kidneys.

You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan medoxomil and Hydrochlorothiazide Alter to achieve further blood pressure reduction. High blood pressure can be managed with medicines such as Olmesartan medoxomil and Hydrochlorothiazide Alter 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 reducing dietary salt). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow your doctor's advice.

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

Do not take Olmesartan medoxomil and Hydrochlorothiazide Alter

if you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides)
if you are more than three months pregnant (use of Olmesartan medoxomil and Hydrochlorothiazide Alter is advised against 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 problems with bile flow from the gallbladder (biliary obstruction, e.g. gallstones)
Olmesartan medoxomil and Hydrochlorothiazide Alter contains soya lecithin. If you are allergic to peanuts or soya, do not use this medicine. 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 Alter:

if you have previously had skin cancer or are developing 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 and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays while taking Olmesartan medoxomil and Hydrochlorothiazide Alter.
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, etc.), 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 information under the section “Do not take Olmesartan medoxomil and Hydrochlorothiazide Alter”.

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 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

Inform your doctor if any of the following symptoms occur:

Severe and prolonged diarrhoea with significant weight loss. Your doctor must assess your symptoms and decide how to continue antihypertensive treatment.
Vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure within the eye, which may occur within hours to weeks after taking Olmesartan medoxomil and Hydrochlorothiazide Alter. If untreated, increased eye pressure can lead to permanent vision damage. Your doctor may need to examine you more frequently and perform tests if you have any of the above conditions.

Olmesartan medoxomil and Hydrochlorothiazide Alter may increase levels of fats and uric acid (which causes 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 weakness, low blood pressure (hypotension), feeling weak, apathetic, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if you notice 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 should therefore carefully monitor your blood pressure. If you need tests for parathyroid function, you must stop taking Olmesartan medoxomil and Hydrochlorothiazide Alter before undergoing these tests.

For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

You must inform your doctor if you think you are pregnant (or could become pregnant). Olmesartan medoxomil and Hydrochlorothiazide Alter 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 Alter is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan medoxomil and Hydrochlorothiazide Alter
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 increase the effect of Olmesartan medoxomil and Hydrochlorothiazide Alter. Your doctor may consider it necessary to adjust the dose and/or take other precautions:
If you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Olmesartan medoxomil and Hydrochlorothiazide Alter” and “Warnings and precautions”).
Medicines that may cause changes in potassium levels in the blood when used together with Olmesartan medoxomil and Hydrochlorothiazide Alter. These include:
potassium supplements (such as potassium-containing salt substitutes)
diuretic tablets (water pills)
heparin (used to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as sodium benzylpenicillin, an antibiotic)
certain painkillers such as aspirin or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olmesartan medoxomil and Hydrochlorothiazide Alter may increase lithium toxicity. If you need to take lithium, your doctor will monitor your lithium blood 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 Alter may increase the risk of kidney failure, and the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Alter 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 Alter
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 lowers cholesterol levels in the blood, as it may reduce the effect of Olmesartan medoxomil and Hydrochlorothiazide Alter. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide Alter 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 Alter 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
Difemanyl, used to treat slow heart rate or reduce sweating
Medicines such as probenecid, sulfinpyrazone and allopurinol, used to treat gout
Calcium supplements
Amantadine, an antiviral medicine
Cyclosporine, a medicine used to prevent organ transplant rejection
Certain antibiotics called tetracyclines or sparfloxacin
Amphotericin, a medicine used to treat fungal infections
Certain antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Alter
Cisapride, used to increase movement of food through the stomach and intestine
Halofantrine, used for malaria.

Your doctor may consider it necessary to adjust the dose and/or take other precautions:

If you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Olmesartan medoxomil and Hydrochlorothiazide Alter” and “Warnings and precautions”).

Olmesartan medoxomil and Hydrochlorothiazide Alter with food, drinks and alcohol
Olmesartan medoxomil and Hydrochlorothiazide Alter can be taken with or without food. Be cautious when consuming alcohol during treatment with Olmesartan medoxomil and Hydrochlorothiazide Alter, as some people may experience fainting or dizziness. If this occurs, do not drink any more alcohol, including wine, beer or carbonated alcoholic beverages.

Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil and Hydrochlorothiazide Alter is somewhat reduced in Black patients.

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 Alter before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan medoxomil and Hydrochlorothiazide Alter 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 child if taken beyond the third month of pregnancy.

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
You may feel drowsy or dizzy while being treated 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 Alter 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 Alter

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

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

If you forget to take Olmesartan medoxomil and Hydrochlorothiazide Alter
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 Alter
It is important to continue taking Olmesartan medoxomil and Hydrochlorothiazide Alter 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 gets them. However, the following two side effects can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olmesartan medoxomil and Hydrochlorothiazide Alter and contact your doctor immediately.
Olmesartan medoxomil and Hydrochlorothiazide Alter 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 Alter, contact your doctor immediately and lie down.

Olmesartan medoxomil and Hydrochlorothiazide Alter is a combination of two active substances. The information below first lists the other side effects reported so far with the combination of olmesartan and hydrochlorothiazide (in addition to those already mentioned above), followed by those known for each individual active substance. The following side effects are those known so far with the combination of Olmesartan medoxomil and Hydrochlorothiazide Alter: If these side effects occur, they are often mild and it is not necessary to stop treatment.

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

Uncommon side effects (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine. Uncommonly, the following laboratory test abnormalities have also been observed: 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, increase in liver function tests. Your doctor will become aware of these through 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, 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 through blood tests and will tell you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Olmesartan medoxomil and Hydrochlorothiazide Alter or at a different 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: 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, possibly leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reactions, itching, rash, skin blisters (wheals). Uncommonly, the following laboratory test abnormalities have also been observed: reduction in the number of certain blood cells called platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Renal function impairment, weakness.
Rarely, the following laboratory test abnormalities have also been observed: increase in blood potassium levels.

Hydrochlorothiazide

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

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 urine. Laboratory test abnormalities observed include: increase in blood creatinine, urea, calcium and glucose levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasaemia).

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

Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decrease in white blood cell count, decrease in platelet count, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disturbances, 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, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain, cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing movement limitations).

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

Not known (frequency cannot be estimated from the available data):
Decreased vision or eye pain (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:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil and Hydrochlorothiazide Alter

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 stated on the carton and blister pack after "Exp." The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil and Hydrochlorothiazide Alter contains

The active substances are: Olmesartan medoxomil and Hydrochlorothiazide Alter 20 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 20 mg of olmesartan and 12.5 mg of hydrochlorothiazide. Olmesartan medoxomil and Hydrochlorothiazide Alter 20 mg/25 mg film-coated tablets: Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other components are: monohydrate lactose*, microcrystalline cellulose, low-substituted hydroxypropylcellulose, calcium stearate, modified starch (from maize), talc, mannitol (E421), soybean lecithin (E332), titanium dioxide (E171), yellow iron oxide (E172).
Olmesartan medoxomil and Hydrochlorothiazide Alter 20 mg/25 mg contains red iron oxide (E172).
*See the section above “Olmesartan medoxomil and Hydrochlorothiazide Alter contains lactose”

Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide Alter and the contents of the pack
Olmesartan medoxomil and Hydrochlorothiazide Alter 20 mg/12.5 mg: film-coated tablets, yellow, round, biconvex.
Olmesartan medoxomil and Hydrochlorothiazide Alter 20 mg/25 mg: film-coated tablets, light pink, oval, biconvex.
Available in packs of 14, 28, 30, 56, and 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Laboratori Alter S.r.l.
Via Egadi, 7
20144 Milan, Italy

Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid, Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Spain: Olmesartán/Hidroclorotiazida Alter 20 mg/12.5 mg / 20 mg/25 mg
comprimidos recubiertos con película EFG
Italy: Olmesartan medoxomil and Hydrochlorothiazide Alter
Portugal: Olmesartan medoxomilo + Hidroclorotiazida Alter 20 mg + 12.5 mg / 20 mg + 25 mg comprimidos revestidos por película MG

Package leaflet: Information for the user

Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/12.5 mg film-coated tablets

Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/25 mg film-coated tablets
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
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
7. What Olmesartan medoxomil and Hydrochlorothiazide Alter is and what it is used for
8. What you need to know before taking Olmesartan medoxomil and Hydrochlorothiazide Alter
9. How to take Olmesartan medoxomil and Hydrochlorothiazide Alter
10. Possible side effects
11. How to store Olmesartan medoxomil and Hydrochlorothiazide Alter
12. Contents of the pack and other information

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

Olmesartan medoxomil and Hydrochlorothiazide Alter contains two active substances, 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 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 Alter if olmesartan medoxomil alone has not adequately controlled your blood pressure. When administered together, the two active substances in Olmesartan medoxomil and Hydrochlorothiazide Alter help reduce blood pressure more than when used individually. You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan medoxomil and Hydrochlorothiazide Alter to achieve further reduction. High blood pressure can be managed with medicines such as Olmesartan medoxomil and Hydrochlorothiazide Alter 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 consumption 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 Alter

Do not take Olmesartan medoxomil and Hydrochlorothiazide Alter:

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 Alter 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 problems with bile flow from the gallbladder (biliary obstruction, for example gallstones)
Olmesartan medoxomil and Hydrochlorothiazide Alter contains soybean lecithin. You must not take this medicine if you are allergic to peanuts or soy. 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 Alter:

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 exposure to sunlight and UV rays while taking Olmesartan medoxomil and Hydrochlorothiazide Alter.
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 Alter”.

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 problems with heart valves or heart muscle
severe or prolonged vomiting 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 disorders (e.g., primary aldosteronism)
diabetes
systemic lupus erythematosus (an autoimmune disease)
allergies or asthma

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

severe and prolonged diarrhoea with significant weight loss. Your doctor will need to assess your symptoms and decide how to continue antihypertensive treatment.
changes in vision or eye pain. These could be signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which may occur from a few hours up to weeks after taking Olmesartan medoxomil and Hydrochlorothiazide Alter. If untreated, increased eye pressure can lead to permanent vision damage.

Your doctor may wish to examine you more frequently and perform blood tests if you have any of the above conditions.
Olmesartan medoxomil and Hydrochlorothiazide Alter may increase blood levels of lipids (fats) and uric acid (which can cause gout – painful joint swelling). Your doctor will likely perform periodic blood tests to monitor these conditions. It may also alter levels of certain substances called electrolytes in the blood. Your doctor should probably carry out regular blood tests to assess these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, lethargic, sluggish or restless, 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 Alter before these tests.
For athletes: Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

You must inform your doctor if you think you may be pregnant (or could become pregnant). Olmesartan medoxomil and Hydrochlorothiazide Alter is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy”).

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

Other medicines and Olmesartan medoxomil and Hydrochlorothiazide Alter
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 Alter. 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 Alter” and “Warnings and precautions”).
Medicines that may affect potassium levels in the blood when used together with Olmesartan medoxomil and Hydrochlorothiazide Alter. These include:
- potassium supplements (such as potassium-containing salt substitutes)
- diuretic tablets ("water pills")
- heparin (used to thin the blood)
- laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
certain painkillers such as aspirin or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) – when used together with Olmesartan medoxomil and Hydrochlorothiazide Alter, lithium toxicity may increase. 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) – when used together with Olmesartan medoxomil and Hydrochlorothiazide Alter, they may increase the risk of kidney failure, and the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Alter 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 Alter
Certain muscle relaxants such as baclofen and tubocurarine
Amifostine and certain other cancer treatments such as cyclophosphamide or methotrexate
Cholestyramine and colestipol, medicines used to reduce blood fats
Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as it may reduce the effect of Olmesartan medoxomil and Hydrochlorothiazide Alter. Your doctor may advise you to take Olmesartan medoxomil and Hydrochlorothiazide Alter 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 heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis
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 Alter 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
Certain antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan medoxomil and Hydrochlorothiazide Alter
Cisapride, used to increase movement of food through the stomach and intestines
Halofantrine, used to treat malaria.

Olmesartan medoxomil and Hydrochlorothiazide Alter with food, drinks, and alcohol
Olmesartan medoxomil and Hydrochlorothiazide Alter can be taken with or without food.

Be cautious when consuming alcohol during treatment with Olmesartan medoxomil and Hydrochlorothiazide Alter, as some people may experience fainting or dizziness. If this occurs, do not drink any more alcohol, including wine, beer, or carbonated alcoholic beverages.

Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan medoxomil and Hydrochlorothiazide Alter is somewhat reduced in Black patients.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Olmesartan medoxomil and Hydrochlorothiazide Alter before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan medoxomil and Hydrochlorothiazide Alter 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.

If you are pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

3. How to take Olmesartan medoxomil and Hydrochlorothiazide Alter

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

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

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. However, the following two side effects can be serious:

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (the area containing the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olmesartan medoxomil and Hydrochlorothiazide Alter and contact your doctor immediately.
Olmesartan medoxomil and Hydrochlorothiazide Alter 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 Alter, contact your doctor immediately and lie down.

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

The following side effects are those known so far with the combination of Olmesartan medoxomil and Hydrochlorothiazide Alter:
If these side effects occur, they are often mild and it is not necessary to stop treatment.

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

Uncommon side effects (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps and muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine. Uncommonly, the following laboratory test abnormalities have also been observed: 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 calcium levels in the blood, increased blood glucose, increased liver function tests. Your doctor will detect these from blood tests and will advise 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, the following laboratory test abnormalities have also been observed: increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will detect these from blood tests and will advise you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with Olmesartan medoxomil and Hydrochlorothiazide Alter 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, 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, possibly 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, the following laboratory test abnormalities have also been observed: reduced number of blood platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.
Rarely, the following laboratory test abnormality has also been observed: increased potassium levels 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):
Confusion, abdominal pain, gastric disturbances, bloating, diarrhoea, nausea, vomiting, constipation, glucose 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, skin anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, photosensitivity skin reactions, itching, purpura (small haemorrhages causing red or purple spots on the skin), 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 problems, 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, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus (such as skin rash, joint pain, cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing motor impairment).

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 blockage (paralytic ileus).

Not known (frequency cannot be estimated from the available data):
Vision loss or eye pain (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, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil and Hydrochlorothiazide Alter

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 stated on the carton and blister pack 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 Alter contains

The active substances are: Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide. Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/25 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other components are: monohydrate lactose*, microcrystalline cellulose, low-substituted hydroxypropylcellulose, calcium stearate, modified starch (corn), talc (E553b), mannitol (E421), soybean lecithin (E332), and titanium dioxide (E171). Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/25 mg also contains yellow iron oxide (E 172). Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/25 mg also contains red iron oxide (E172).

*See section above “Olmesartan medoxomil and Hydrochlorothiazide Alter contains
lactose”
Description of the appearance of Olmesartan medoxomil and Hydrochlorothiazide Alter and pack contents
Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/12.5 mg: film-coated tablets,
yellow, oblong, biconvex.
Olmesartan medoxomil and Hydrochlorothiazide Alter 40 mg/25 mg: film-coated tablets, dark pink,
oblong, biconvex.
Available in packs of 14, 28, 30, 56, and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratori Alter S.r.l.
via Egadi, 7
20144 Milan, Italy
Manufacturer
Laboratorios Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid, Spain
This medicinal product is authorized in the European Economic Area countries under the following names:
Spain Olmesartán/Hidroclorotiazida Alter 40 mg/12.5 mg / 40 mg/25 mg
comprimidos recubiertos con película EFG
Italy Olmesartan medoxomil and Hydrochlorothiazide Alter
Portugal Olmesartan medoxomilo + Hidroclorotiazida Alter 40 mg + 12.5 mg / 40 mg +
25 mg comprimidos revestidos por película MG