Olmesartan and hydrochlorothiazide Sandoz: detailed information

Package leaflet: Information for the user

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

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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 “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 and Hydrochlorothiazide Sandoz if olmesartan medoxomil alone has not adequately controlled your blood pressure. When given together, the two active substances in Olmesartan and Hydrochlorothiazide Sandoz 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 and Hydrochlorothiazide Sandoz to achieve further reduction.
High blood pressure can be managed with medicines such as Olmesartan and Hydrochlorothiazide Sandoz 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). 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 and Hydrochlorothiazide Sandoz

Do not take Olmesartan and Hydrochlorothiazide Sandoz

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 the use of Olmesartan and Hydrochlorothiazide Sandoz 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)

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 and Hydrochlorothiazide Sandoz.

Before taking the tablets, consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
Aliskiren. Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Olmesartan and Hydrochlorothiazide Sandoz”.

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 hyperaldosteronism).
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from exposure to sunlight and UV rays during treatment with Olmesartan and Hydrochlorothiazide Sandoz.

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

Severe and prolonged diarrhoea with significant weight loss. Your doctor should assess your symptoms and decide how to proceed with this antihypertensive treatment.
Vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye, which may occur within hours or weeks of taking Olmesartan and Hydrochlorothiazide Sandoz. If left untreated, this increase in pressure can lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.

Your doctor may need to monitor you more frequently and perform blood tests if you have any of the above conditions.

Olmesartan and Hydrochlorothiazide Sandoz may increase blood levels of fats and uric acid (which can cause gout – painful joint swelling). Your doctor may need to perform periodic blood tests to monitor these conditions.

It may alter blood levels of certain substances called electrolytes. Your doctor may need to perform periodic blood tests to monitor these. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), general weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if 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 heart attack or stroke. Your doctor should therefore carefully monitor your blood pressure.

If you need to undergo parathyroid function testing, you must stop taking Olmesartan and Hydrochlorothiazide Sandoz before the test.

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 and Hydrochlorothiazide Sandoz 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 and Hydrochlorothiazide Sandoz is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan and Hydrochlorothiazide Sandoz

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 and Hydrochlorothiazide Sandoz. Your doctor may need to adjust the dose and/or take other precautions:
- if you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Olmesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”).
Medicines that may affect potassium levels in the blood when used together with Olmesartan and Hydrochlorothiazide Sandoz. These include:
- potassium supplements (e.g. potassium-containing salt substitutes), diuretic tablets, heparin (a blood thinner), laxatives, steroids, adrenocorticotropic hormone (ACTH)
- carbenoxolone (a medicine used to treat mouth and stomach ulcers)
- sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
- certain painkillers such as acetylsalicylic acid or salicylates
Lithium (a medicine used to treat mood disorders and certain types of depression): concomitant use with Olmesartan and Hydrochlorothiazide Sandoz may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs – medicines used to reduce pain, swelling, and other signs of inflammation, including arthritis): when used together with Olmesartan and Hydrochlorothiazide Sandoz, they may increase the risk of kidney failure, and the effectiveness of Olmesartan and Hydrochlorothiazide Sandoz 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 and Hydrochlorothiazide Sandoz.
Certain muscle relaxants such as baclofen and tubocurarine.
Amifostine and 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 and Hydrochlorothiazide Sandoz. Your doctor may advise you to take Olmesartan and Hydrochlorothiazide Sandoz 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 medications 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 and low blood sugar, respectively, as Olmesartan and Hydrochlorothiazide Sandoz may enhance their hyperglycaemic effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Dihydroergotamine, used to treat slow heart rate or reduce sweating.
Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
Calcium supplements.
Amantadine, an antiviral medicine.
Cyclosporine, a medicine used to prevent rejection of transplanted organs.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Some antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan and Hydrochlorothiazide Sandoz.
Cisapride, used to increase gastrointestinal motility.
Halofantrine, used to treat malaria.

Olmesartan and Hydrochlorothiazide Sandoz with food, drinks and alcohol

Olmesartan and Hydrochlorothiazide Sandoz can be taken with or without food.

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

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Olmesartan and Hydrochlorothiazide Sandoz before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan and Hydrochlorothiazide Sandoz 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 first trimester.

Breastfeeding

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

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

Driving and using machines

You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

Olmesartan and Hydrochlorothiazide Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olmesartan and Hydrochlorothiazide Sandoz

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose is one tablet of Olmesartan and Hydrochlorothiazide Sandoz 20 mg/12.5 mg daily.
However, if your blood pressure is not controlled, your doctor may decide to change your dose to one tablet of
Olmesartan and Hydrochlorothiazide Sandoz 20 mg/25 mg daily.
Swallow the tablet with some water. Do not chew the tablet. If possible, take your dose at the same time each day, for example with breakfast. It is important to continue taking Olmesartan and Hydrochlorothiazide Sandoz until your doctor tells you otherwise.
If you take more Olmesartan and Hydrochlorothiazide Sandoz than you should
If you take more tablets than prescribed, or if a child accidentally swallows one or more tablets, go immediately to a doctor or the nearest emergency department, taking the medicine pack with you.
If you forget to take Olmesartan and Hydrochlorothiazide Sandoz
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the forgotten dose.
If you stop taking Olmesartan and Hydrochlorothiazide Sandoz
It is important to continue taking Olmesartan and Hydrochlorothiazide Sandoz unless your doctor tells you to stop.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (the area containing the vocal cords), associated with itching and skin rash, may occur rarely. If this happens, stop taking Olmesartan and Hydrochlorothiazide Sandoz and contact your doctor immediately.
Olmesartan and Hydrochlorothiazide Sandoz may cause excessive lowering of blood pressure in susceptible individuals or as a result of an allergic reaction. Dizziness or fainting may occur not uncommonly. If this happens, stop taking Olmesartan and Hydrochlorothiazide Sandoz, contact your doctor immediately and lie down.

Olmesartan and Hydrochlorothiazide Sandoz 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 and hydrochlorothiazide:
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 the 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 detect these from blood tests and will tell you if any action is needed.

Rare side effects (may affect up to 1 in 1,000 people):

feeling unwell
disturbances of consciousness
skin blisters (wheals)
acute renal failure.

Rarely, the following laboratory test abnormalities have also been observed:

increase in blood urea nitrogen
decrease in haemoglobin and haematocrit values. Your doctor will detect these from blood tests and will tell you if any action is needed.

Additional side effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with the
combination of olmesartan and hydrochlorothiazide or with higher frequency:
Olmesartan medoxomil
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, runny or blocked nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea,
gastroenteritis, joint or bone pain, back pain, blood in the 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 reaction, itching, rash, skin blisters (wheals).
Uncommonly observed laboratory test abnormalities include:
reduction in the number of certain blood cells called platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, weakness.
Rarely observed laboratory test abnormalities include:
increase in blood potassium.

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):
Confusion, abdominal pain, gastric disturbances, bloated feeling, diarrhoea, nausea, vomiting, constipation,
glucose excretion in urine.

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

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

Rare side effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disorders, lack of interest (apathy), tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, lupus erythematosus symptoms such as skin rash, joint pain and cold hands and fingers, allergic skin reactions, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes causing movement limitations).

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

Not known (frequency cannot be estimated from the available data):
Vision loss 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, 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 and Hydrochlorothiazide Sandoz

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 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 and Hydrochlorothiazide Sandoz contains
The active substances are:
Olmesartan and Hydrochlorothiazide Sandoz 20 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 20 mg of olmesartan and 12.5 mg of hydrochlorothiazide.
Olmesartan and Hydrochlorothiazide Sandoz 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:
Lactose monohydrate, microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose,
magnesium stearate, polyethylene glycol, hydroxypropylmethylcellulose, titanium dioxide (E 171), iron oxide yellow
(E 172).
Description of the appearance of Olmesartan and Hydrochlorothiazide Sandoz and package contents
Olmesartan and Hydrochlorothiazide Sandoz 20 mg/12.5 mg film-coated tablets:
Yellow, round, biconvex film-coated tablets, marked with '346' on one side and 'L' on the other.
Diameter: 8.6 mm
Olmesartan and Hydrochlorothiazide Sandoz 20 mg/25 mg film-coated tablets:
Yellow, oval, biconvex film-coated tablets, marked with 'L400' on one side and smooth on the other.
Size: 16 mm x 7.5 mm
Olmesartan and Hydrochlorothiazide Sandoz is available in the following pack sizes:
Al//Al blisters: 10, 14, 28, 30, 56, 60, 90 and 98 film-coated tablets
PVC/PVDC//Al blisters: 10, 14, 28, 30, 56, 60, 90 and 98 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana, Slovenia
Austria Olmesartan/HCT Sandoz 20/12.5 mg – Film tablets
Olmesartan/HCT Sandoz 20/25 mg – Film tablets
Belgium Co-Olmesartan Sandoz 20 mg/12.5 mg film-coated tablets
Co-Olmesartan Sandoz 20 mg/25 mg film-coated tablets
Bulgaria Олмесартан Хидрохлоротиазид Сандоз 20/12,5 mg филмирани таблетки
France OLMESARTAN / HYDROCHLOROTHIAZIDE SANDOZ 20 mg/12.5 mg, film-coated tablet
OLMESARTAN / HYDROCHLOROTHIAZIDE SANDOZ 20 mg/25 mg, film-coated tablet
Germany Olmesartan HEXAL comp 20 mg/12.5 mg Film tablets
Olmesartan HEXAL comp 20 mg/25 mg Film tablets
Greece Olmesartan + HCTZ/Sandoz
Ireland Olmesartan Hydrochlorothiazide Rowex 20 mg/12.5 mg, Film-coated tablets
Olmesartan Hydrochlorothiazide Rowex 20 mg/25 mg, Film-coated tablets
Italy Olmesartan and Hydrochlorothiazide Sandoz
Luxembourg Co-Olmesartan Sandoz 20 mg/12.5 mg film-coated tablets
Co-Olmesartan Sandoz 20 mg/25 mg film-coated tablets
Netherlands Olmesartanmedoxomil/Hydrochloorthiazide Sandoz 20 mg/12.5 mg, film-coated tablets
Olmesartanmedoxomil/Hydrochloorthiazide Sandoz 20 mg/25 mg, film-coated tablets
Portugal Olmesartan + Hydrochlorothiazide Sandoz
Spain Olmesartán/Hidroclorotiazida Sandoz 20/12,5 mg comprimidos recubiertos con película
EFG
Olmesartán/Hidroclorotiazida Sandoz 20/25 mg comprimidos recubiertos con película EFG

Package leaflet: information for the user

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

Generic medicine
Please read this entire leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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 “diuretics” (water tablets). It lowers blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

Your doctor has prescribed Olmesartan and Hydrochlorothiazide Sandoz because olmesartan medoxomil alone has not adequately controlled your blood pressure. When taken together, the two active substances in Olmesartan and Hydrochlorothiazide Sandoz help reduce blood pressure more than when either is taken alone.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Olmesartan and Hydrochlorothiazide Sandoz to achieve further blood pressure reduction.
High blood pressure can be managed with medicines such as Olmesartan and Hydrochlorothiazide Sandoz tablets. Your doctor has likely also advised you to make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and decreasing the amount of salt in your diet). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow your doctor’s advice.

2. What you should know before taking Olmesartan and Hydrochlorothiazide Sandoz

Do not take Olmesartan and Hydrochlorothiazide Sandoz

if you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6), or to substances similar to hydrochlorothiazide (sulfonamides).
if you are more than three months pregnant (use of Olmesartan and Hydrochlorothiazide Sandoz is also advised to be avoided during the first months of pregnancy - see section “Pregnancy”)
if you have kidney problems
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
if you have low levels of potassium or sodium, or high levels of calcium or uric acid (with symptoms of gout or kidney stones) in your blood that do not improve with treatment
if you have moderate or severe liver problems, yellowing of the skin and eyes (jaundice), or problems with bile flow from the gallbladder (biliary obstruction, for example gallstones)

If you think any of these conditions apply to you, or are unsure, do not take the tablets. Contact your doctor first and follow their advice.

Warnings and precautions

Talk to your doctor before taking Olmesartan and Hydrochlorothiazide Sandoz.

Before taking the tablets, consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

an ACE inhibitor (for example enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals. See also the section "Do not take Olmesartan and Hydrochlorothiazide Sandoz".

Before taking the tablets, consult your doctor if you have any of the following health conditions:

Kidney transplant.
Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe or prolonged vomiting (nausea) or diarrhoea lasting several days.
Treatment with high doses of diuretic tablets ("water pills") or if you are on a low-salt diet.
Adrenal gland problems (for example primary aldosteronism).
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
If you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Olmesartan and Hydrochlorothiazide Sandoz.

Inform your doctor if any of the following symptoms occur:

Severe and prolonged diarrhoea with significant weight loss. Your doctor should evaluate your symptoms and decide how to proceed with this antihypertensive treatment.
Vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure inside your eye, which may occur within hours or weeks of taking Olmesartan and Hydrochlorothiazide Sandoz. If left untreated, this pressure increase can lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulfonamides, you may be at higher risk of developing these symptoms.

Your doctor may need to monitor you more frequently and perform tests if you have any of the above conditions.

Olmesartan and Hydrochlorothiazide Sandoz may increase levels of fats and uric acid (a cause of gout – painful joint swelling) in the blood. Your doctor may need to perform periodic blood tests to monitor these conditions.

It may alter levels of certain substances called electrolytes in the blood. Your doctor may need to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), feeling weak, listless, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, and rapid heartbeat. Inform your doctor if you notice any of these symptoms.

If you need to undergo tests for parathyroid function, you must stop taking Olmesartan and Hydrochlorothiazide Sandoz before the tests.

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

Inform your doctor if you think you are pregnant (or could become pregnant). Olmesartan and Hydrochlorothiazide Sandoz 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 baby if used during this period (see section “Pregnancy”).

Children and adolescents

Olmesartan and Hydrochlorothiazide Sandoz is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan and Hydrochlorothiazide Sandoz

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 and Hydrochlorothiazide Sandoz. Your doctor may consider it necessary to adjust the dose and/or take additional precautions:
if you are taking an ACE inhibitor or aliskiren (see also the sections “Do not take Olmesartan and Hydrochlorothiazide Sandoz” and “Warnings and precautions”).
Medicines that may alter potassium levels in the blood when used together with Olmesartan and Hydrochlorothiazide Sandoz. 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 acetylsalicylic acid or salicylates
Lithium (a medicine used to treat mood swings and certain types of depression) – when used together with Olmesartan and Hydrochlorothiazide Sandoz, it may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs – medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis) – when used together with Olmesartan and Hydrochlorothiazide Sandoz, they may increase the risk of kidney failure, and the effectiveness of Olmesartan and Hydrochlorothiazide Sandoz 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 and Hydrochlorothiazide Sandoz.
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, which may reduce the effect of Olmesartan and Hydrochlorothiazide Sandoz. Your doctor may advise you to take Olmesartan and Hydrochlorothiazide Sandoz 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 and Hydrochlorothiazide Sandoz may enhance their hyperglycaemic effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Dihydroergotamine, used to treat slow heart rate or reduce sweating.
Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
Calcium supplements.
Amantadine, an antiviral medicine.
Cyclosporine, a medicine used to prevent rejection of transplanted organs.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Certain antacids used for stomach acidity, such as aluminium and magnesium hydroxide, as they may slightly reduce the effectiveness of Olmesartan and Hydrochlorothiazide Sandoz.
Cisapride, used to increase movement of food through the stomach and intestines.
Halofantrine, used to treat malaria.

Olmesartan and Hydrochlorothiazide Sandoz with food, drinks, and alcohol

Olmesartan and Hydrochlorothiazide Sandoz can be taken with or without food.

Black patients

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant (or could become pregnant). Normally, your doctor will advise you to stop taking Olmesartan and Hydrochlorothiazide Sandoz before starting a pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan and Hydrochlorothiazide Sandoz 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 baby if taken after the third month of pregnancy.

Breastfeeding

If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You may experience drowsiness or dizziness 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 and Hydrochlorothiazide Sandoz contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Olmesartan and Hydrochlorothiazide Sandoz

If you take more Olmesartan and Hydrochlorothiazide Sandoz 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 room, taking the medicine pack with you.

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

If you stop taking Olmesartan and Hydrochlorothiazide Sandoz
It is important to keep taking Olmesartan and Hydrochlorothiazide Sandoz unless your doctor tells you to stop.

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

4. Possible adverse effects

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

Allergic reactions affecting the entire body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur rarely. If this occurs, stop taking Olmesartan and Hydrochlorothiazide Sandoz and contact your doctor immediately.
Olmesartan and Hydrochlorothiazide Sandoz may cause excessive lowering of blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur not uncommonly. If this occurs, stop taking Olmesartan and Hydrochlorothiazide Sandoz, contact your doctor immediately, and lie down.

Olmesartan and Hydrochlorothiazide Sandoz is a combination of two active substances. The information below first lists the other adverse 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 adverse effects are those known so far with the combination of olmesartan and hydrochlorothiazide:
If these adverse effects occur, they are often mild and it is not necessary to discontinue treatment.

Common adverse 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 adverse 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, arm and leg pain
back pain
erectile dysfunction in men
blood in the urine.

Some laboratory test abnormalities have also been observed uncommonly, including:

increase in blood lipid levels
increase in blood urea or uric acid levels
increase in creatinine
increase or decrease in blood potassium levels
increase in blood calcium levels
increase in blood glucose
increase in liver function tests. Your doctor may detect these from blood tests and will advise you if any action is needed.

Rare adverse effects (may affect up to 1 in 1,000 people):

feeling unwell
disturbances in consciousness
skin blisters (wheals)
acute renal failure.

Some laboratory test abnormalities have also been observed rarely, including:

increase in blood urea nitrogen
decrease in haemoglobin and haematocrit values. Your doctor may detect these from blood tests and will advise you if any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with the combination of olmesartan and hydrochlorothiazide or with higher frequency:

Olmesartan medoxomil

Common adverse 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 the urine, urinary tract infection, influenza-like symptoms, pain.

Some laboratory test abnormalities have also been observed commonly, including:
increase in blood lipid levels, increase in blood urea or uric acid levels, increase in liver and muscle function tests.

Uncommon adverse effects (may affect up to 1 in 100 people):
Immediate allergic reactions affecting the entire body, which may cause breathing difficulties or a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, rash, skin blisters (wheals).

Some laboratory test abnormalities have also been observed uncommonly, including:
reduction in the number of certain blood cells called platelets (thrombocytopenia).

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

Some laboratory test abnormalities have also been observed rarely, including:
increase in blood potassium levels.

Hydrochlorothiazide

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

Common adverse effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating, diarrhoea, nausea, vomiting, constipation, glucose in the urine.

Some laboratory test abnormalities have also been observed, including:
increase in blood creatinine, urea, calcium and glucose levels, decrease in blood chloride, potassium, magnesium and sodium levels. Increase in serum amylase (hyperamylasaemia).

Uncommon adverse 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 adverse 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 of depression, sleep disturbances, lack of interest (apathy), tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of lupus erythematosus such as skin rash, joint pain and 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 adverse effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances causing abnormally low blood chloride levels (hypochloraemic alkalosis), intestinal obstruction (paralytic ileus).

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

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan and Hydrochlorothiazide Sandoz

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 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 and Hydrochlorothiazide Sandoz contains
The active substances are:
Olmesartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg film-coated tablets
Each film-coated tablet contains 40 mg of olmesartan and 12.5 mg of hydrochlorothiazide.
Olmesartan and Hydrochlorothiazide Sandoz 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, hydroxypropylcellulose,
magnesium stearate, polyethylene glycol, hydroxypropylmethylcellulose, titanium dioxide (E 171), yellow iron oxide (E 172).

Description of the appearance of Olmesartan and Hydrochlorothiazide Sandoz and contents of the pack
Olmesartan and Hydrochlorothiazide Sandoz 40 mg/12.5 mg film-coated tablets:
Yellow, oval-shaped, biconvex film-coated tablets with 'L347' imprinted on one side and smooth on the other side.
Dimensions: 16 mm x 7.5 mm.

Olmesartan and Hydrochlorothiazide Sandoz 40 mg/25 mg film-coated tablets:
Yellow, oval-shaped, biconvex film-coated tablets with 'L348' imprinted on one side and smooth on the other side.
Dimensions: 16 mm x 7.5 mm.

Olmesartan and Hydrochlorothiazide Sandoz is available in the following pack sizes:
Al//Al blisters: 10, 14, 28, 30, 56, 60, 90 and 98 film-coated tablets
PVC/PVDC//Al blisters: 10, 14, 28, 30, 56, 60, 90 and 98 film-coated tablets
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
L.go U. Boccioni 1
21040 Origgio (VA)
Italy

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovskova 57, 1526 Ljubljana, Slovenia

This medicinal product is authorized in the European Economic Area countries under the following names:
Austria Olmesartan/HCT Sandoz 40/12.5 mg - Filmtabletten
Olmesartan/HCT Sandoz 40/25 mg - Filmtabletten

Belgium Co-Olmesartan Sandoz 40mg/12.5 mg filmomhulde tabletten
Co-Olmesartan Sandoz 40mg/25 mg filmomhulde tabletten

Bulgaria Олмесартан Хидрохлоротиазид Сандоз 40/12,5 mg филмирани таблетки

France OLMESARTAN / HYDROCHLOROTHIAZIDE SANDOZ 40 mg/12.5 mg, comprimé pelliculé
OLMESARTAN / HYDROCHLOROTHIAZIDE SANDOZ 40 mg/25 mg, comprimé pelliculé

Germany Olmesartan HEXAL comp 40 mg/12.5 mg Filmtabletten
Olmesartan HEXAL comp 40 mg/25 mg Filmtabletten

Greece Olmesartan + HCTZ/Sandoz

Ireland Olmesartan Hydrochlorothiazide Rowex 40 mg/12.5 mg Film-coated tablets
Olmesartan Hydrochlorothiazide Rowex 40 mg/25 mg Film-coated tablets

Italy Olmesartan e Idroclorotiazide Sandoz

Luxembourg Co-Olmesartan Sandoz 40mg/12.5 mg comprimés pelliculés
Co-Olmesartan Sandoz 40mg/25 mg comprimés pelliculés

Netherlands Olmesartanmedoxomil/Hydrochloorthiazide Sandoz 40 mg/25 mg, filmomhulde tabletten
Olmesartanmedoxomil/Hydrochloorthiazide Sandoz 40 mg/12.5 mg, filmomhulde tabletten

Portugal Olmesartan + Hidroclorotiazida Sandoz

Spain Olmesartán/Hidroclorotiazida Sandoz 40/12,5 mg comprimidos recubiertos con película EFG
Olmesartán/Hidroclorotiazida Sandoz 40/25 mg comprimidos recubiertos con película EFG