Patient Information Leaflet: Information for the User

OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 20 mg/5 mg/12.5 mg
film-coated tablets
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/12.5 mg
film-coated tablets
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/12.5 mg
film-coated tablets
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/25 mg
film-coated tablets
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/25 mg
film-coated tablets
Equivalent medicine
Please read this 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is and what it is used for
What you need to know before taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC
How to take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC
Possible side effects
How to store OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC
Contents of the pack and other information

1. What OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is and what it is used for

OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC contains three active substances: olmesartan medoxomil, amlodipine (as amlodipine besilate), and hydrochlorothiazide. All three substances help control high blood pressure.

Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists", which lower blood pressure by relaxing blood vessels.
Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine also lowers blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of medicines called "thiazide diuretics" (medicines that increase urine production). It lowers blood pressure by helping the body get rid of excess water, by increasing urine output from the kidneys.

The combined action of these substances helps reduce blood pressure.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is used to treat high blood pressure:

in adult patients whose blood pressure is not adequately controlled by a fixed-dose combination of olmesartan medoxomil and amlodipine, or
in patients who are already taking a fixed-dose combination of olmesartan medoxomil and hydrochlorothiazide plus amlodipine as a single tablet, or a fixed-dose combination of olmesartan medoxomil and amlodipine plus hydrochlorothiazide as a single tablet.

2. What you should know before taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC

HYDROCHLOROTHIAZIDE DOC
Do not take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC:

if you are allergic to olmesartan medoxomil, amlodipine, or a specific group of calcium antagonists (dihydropyridines), to hydrochlorothiazide or substances similar to hydrochlorothiazide (called sulfonamides), or to any of the excipients of this medicine (listed in section 6). If you think you may be allergic, speak with your doctor before taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC.
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 are more than three months pregnant (it is best to avoid taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC even in the early stages of pregnancy – see section “Pregnancy and breastfeeding”).
if you have severe liver problems, if bile secretion is impaired or bile flow from the gallbladder is blocked (e.g., due to gallstones), or if you have jaundice (yellowing of the skin and eyes).
if you have poor blood flow to tissues with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, meaning shock due to severe heart problems).
if you have very low blood pressure.
if blood flow from your heart is slow or obstructed. This occurs when blood vessels or heart valves carrying blood out of the heart are narrowed (aortic stenosis).
if you have reduced cardiac output due to a heart attack (acute myocardial infarction). Reduced cardiac output may present as shortness of breath or swelling of feet and ankles.

If you think you are in any of the above conditions, do not take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC.
Warnings and precautions
Talk to your doctor or pharmacist before taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC.
Inform 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/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC”.
Inform your doctor if you also have any of the following health conditions:

Kidney problems or kidney transplant.
Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe vomiting, diarrhea, treatment with high doses of diuretics, or if you are on a low-salt diet.
Elevated potassium levels in the blood.
Problems with adrenal glands (hormone-producing glands located above the kidneys).
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
Skin reactions such as sunburn or rash after exposure to sunlight or sunlamps.
if you have previously had skin cancer or are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use with high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation while taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC.
If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC, consult a doctor immediately.

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

Severe and prolonged diarrhea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
Changes in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which may occur within hours or weeks after taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC. If untreated, this increase may lead to permanent vision impairment.

As with any medicine that lowers blood pressure, excessive reduction in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke.
Your doctor will therefore carefully monitor your blood pressure.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC may increase levels of fats and uric acid (which causes gout – painful joint swelling) in the blood.
Your doctor may want to perform periodic blood tests to monitor these conditions.
Levels of certain substances called electrolytes in the blood may change. Your doctor may want to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalances include: thirst, dry mouth, muscle pain or cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, sluggishness, tiredness, drowsiness or restlessness, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if these symptoms occur.
If you are scheduled for parathyroid function testing, stop taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC before the test is performed.
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 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 taken during this period (see section “Pregnancy and breastfeeding”).
Children and adolescents
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is not recommended for children and adolescents under 18 years of age.
Other medicines and OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

Other medicines that lower blood pressure, as they may enhance the effect of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC. Your doctor may consider adjusting the dose and/or taking other precautions:
if you are taking an ACE inhibitor or aliskiren (see also section “Do not take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC” and “Warnings and precautions”).
Lithium (a medicine used to treat mood swings and certain types of depression) used together with OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC may increase lithium toxicity. If you are taking lithium, your doctor will monitor lithium levels in your blood.
Diltiazem, verapamil, medicines used for heart rhythm problems and high blood pressure.
Rifampicin, erythromycin, clarithromycin, tetracyclines, or sparfloxacin, antibiotics used for tuberculosis and other infections.
St. John’s Wort (Hypericum perforatum), a herbal remedy for depression.
Cisapride, used to speed up food transit in the stomach and intestines.
Difemanil, used to treat slow heart rate or reduce sweating.
Halofantrine, used for malaria.
Intravenous vincamine, used to improve circulation in the nervous system.
Amantadine, used for Parkinson’s disease.
Potassium supplements, potassium-containing salt substitutes, diuretics, heparin (to thin the blood and prevent blood clots [thrombosis]), ACE inhibitors (to lower blood pressure), 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 (aspirin) or salicylates. Taking

these medicines together with OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC may alter potassium levels in the blood.

Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis), used together with OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC may increase the risk of kidney failure. The effect of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC may be reduced by NSAIDs. When high doses of salicylates are taken, central nervous system toxic effects may be increased.
Sleeping pills, sedatives, and antidepressants, used together with OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC, may cause a sudden drop in blood pressure upon standing.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC. Your doctor may advise you to take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion or heartburn) may slightly reduce the effect of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC.
Some muscle relaxants, such as baclofen and tubocurarine.
Anticholinergic drugs, such as atropine and biperiden.
Calcium supplements.
Dantrolene (infusion for severe body temperature alterations).
Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
Medicines used to control your body’s immune response (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine) that allow your body to accept transplanted organs.

In addition, inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines for:

Treating certain mental health conditions such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
Treating hypoglycemia (e.g., diazoxide) or hypertension (beta-blockers, methyldopa), since OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC may affect the action of these medicines.
Treating heart rhythm problems such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin.
Treating HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir).
Treating fungal infections (e.g., ketoconazole, itraconazole, amphotericin).
Treating heart problems such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil, or digitalis.
Treating cancers such as amifostine, cyclophosphamide, or methotrexate.
Increasing blood pressure and slowing heart rate such as noradrenaline.
Treating gout such as probenecid, sulfinpyrazone, and allopurinol.
Reducing plasma lipid levels such as colestyramine and colestipol.
Lowering blood glucose such as metformin or insulin.

Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicine.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC with food and drinks
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC can be taken with or without food.
People taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC should not consume grapefruit or grapefruit juice. Grapefruit and its juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the hypotensive effect of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC.
Be cautious when drinking alcohol while taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC, as some individuals may experience faintness or dizziness. If this happens, do not drink alcohol.
Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase to prevent it from dropping too much.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Usually, your doctor will advise you to stop taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 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.
If you become pregnant while taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC, inform and see your doctor immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. It has been shown that amlodipine and hydrochlorothiazide pass into breast milk in small amounts. OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may experience drowsiness, discomfort, dizziness, or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially “sodium-free”.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
For athletes: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC

DOC
Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is
one tablet daily.
The tablet can be taken with or without food. Swallow the tablet with some liquid
(such as a glass of water). Do not chew the tablets. Do not take it with grapefruit juice.
If possible, take your daily dose at the same time each day, for example with breakfast.

If you take more OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC than you should
If you take more tablets than you should, your blood pressure may drop too low, causing symptoms such as dizziness, rapid or slow heartbeat.
If you take more tablets than prescribed, or if a child accidentally swallows any, contact your doctor or the nearest emergency department immediately. Take the medicine pack or this leaflet with you.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop within 24–48 hours after ingestion.

If you forget to take OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC
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 MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC
It is important to continue taking OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC unless your doctor tells you otherwise.
If you have any questions 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. If they do occur, they are mostly mild and do not require discontinuation of treatment.

Although they do not occur in many people, the following side effects can be serious:

During treatment with OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC, allergic reactions may occur, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and rash (skin eruption). If this happens, stop taking OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC and contact your doctor immediately.
OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC may cause excessive lowering of blood pressure in sensitive individuals. This could lead to severe dizziness or fainting. If this happens, stop taking OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC, contact your doctor immediately and remain lying down.
Frequency not known: If you develop yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to continue treatment for high blood pressure.

OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC is a combination of three active substances. The information below first lists other side effects reported so far with the combination OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC (in addition to those already mentioned above), and secondly, those side effects known for each of the three substances when taken alone or when two substances are administered together.

To give you an idea of how many patients have experienced these side effects, they have been listed as common, uncommon, rare, and very rare.

These are the other known side effects with OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC so far:

If they occur, they are mostly mild and do not require discontinuation of treatment.

Common (may affect up to 1 in 10 people):

upper respiratory tract infection
inflammation of the throat and nose
urinary tract infection
dizziness; headache
awareness of heartbeat (palpitations)
low blood pressure
nausea
diarrhoea
constipation
cramps
joint swelling
feeling of urgency to urinate
weakness
ankle swelling
fatigue
laboratory test abnormalities.

Uncommon (may affect up to 1 in 100 people):

dizziness upon standing
vertigo
rapid heartbeat
feeling faint
facial flushing and sensation of warmth
cough
dry mouth
muscle weakness
inability to achieve or maintain erection.

These are the side effects known for each of the components taken alone or for two components taken together:

They may also be side effects of OLMESARTAN MEDOXOMIL/AMLODIPINA/IDROCLOROTIAZIDE DOC, even if they have not so far been observed with olmesartan medoxomil/amlodipina/hydrochlorothiazide in fixed-dose combination.

Very common (may affect more than 1 in 10 people):

Edema (fluid retention).

Common (may affect up to 1 in 10 people):

bronchitis
gastric and intestinal infection
vomiting; increased blood glucose
glucose in urine
confusion; drowsiness
vision disturbances (including double and blurred vision)
runny or stuffy nose
sore throat
breathing difficulty
cough
abdominal pain
heartburn
stomach discomfort
flatulence
joint or bone pain
back pain
skeletal pain
blood in urine
flu-like symptoms
chest pain
pain.

Uncommon (may affect up to 1 in 100 people):

reduction in a type of blood cell called platelets, which may cause easy bruising or prolonged bleeding time
anaphylactic reactions
abnormal reduction in appetite (anorexia)
sleep problems; irritability
mood changes including anxiety
feeling low or depressed
chills; sleep disturbances
taste disturbances
loss of consciousness
reduced tactile sensitivity
tingling sensations
worsening of myopia
ringing in the ears (tinnitus)
angina (chest pain or discomfort, known as angina pectoris)
irregular heartbeat; rash (skin eruption)
hair loss; allergic skin inflammation
skin redness
purple spots or dots on the skin due to small hemorrhages (purpura)
skin color changes
itchy red welts (urticaria)
excessive sweating
itching
skin rash
skin reactions to light such as sunburn or rash (skin eruption)
muscle pain
difficulty urinating
nocturnal urge to urinate
breast enlargement in men
reduced sexual desire
facial swelling
feeling unwell
weight gain or loss
exhaustion.

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

enlargement and pain of the salivary glands
reduction in the number of white blood cells in the blood, which may increase the risk of infections
low number of red blood cells (anaemia)
bone marrow damage
restlessness
lack of interest (apathy)
seizures
seeing yellow objects
dry eyes
blood clots (thrombosis or embolism)
fluid accumulation in the lungs
pneumonia
inflammation of blood vessels and small skin blood vessels
inflammation of the pancreas
yellowing of the skin and eyes
acute inflammation of the gallbladder
symptoms of lupus erythematosus such as rash (skin eruption), joint pain, and cold fingers and hands
severe skin reactions including intense skin rash (skin eruption), urticaria, redness of the skin over the entire body surface, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.
impaired movement
acute kidney failure
non-infectious inflammation of the kidney
reduced kidney function
fever.

Very rare (may affect up to 1 in 10,000 people):

increased muscle tone
numbness of hands or feet
heart attack
inflammation of the stomach
gum thickening
intestinal obstruction
inflammation of the liver.
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).

Not known (frequency cannot be estimated from the available data):

sudden-onset reduction in distance vision (acute myopia), decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
tremor, rigid posture, mask-like face, slow movements and unbalanced, shuffling gait.
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/AMLODIPINE/HYDROCHLOROTHIAZIDE

DOC
Keep this medicine out of the sight and reach of children.
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.
Store in the original packaging to protect the medicine from light.
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/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC contains
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 20 mg/5 mg/12.5 mg
film-coated tablets
The active substances in OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC are 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/12.5 mg
film-coated tablets
The active substances in OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC are 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/12.5 mg
film-coated tablets
The active substances in OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC are 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/25 mg
film-coated tablets
The active substances in OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC are 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/25 mg
film-coated tablets
The active substances in OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC are 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

The other components are:
Tablet core: Microcrystalline cellulose, Lactose monohydrate, Povidone, Crospovidone, Sodium starch glycolate, Hydrated colloidal silica, Magnesium stearate.
Coating:
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 20 mg/5 mg/12.5 mg:
Opadry II 85F18378 White coating: Partially hydrolysed polyvinyl alcohol (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E553b)
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/12.5 mg and 40 mg/5 mg/25 mg: Opadry II 85F22055 Yellow coating: Partially hydrolysed polyvinyl alcohol (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E553b), Yellow iron oxide (E172)
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/12.5 mg and 40 mg/10 mg/25 mg: Opadry II 85F94526 Pink coating: Partially hydrolysed polyvinyl alcohol (E1203), Titanium dioxide (E171), Macrogol (E1521), Talc (E553b), Red iron oxide (E172)

Description of the appearance of OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC and contents of the pack
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 20 mg/5 mg/12.5 mg:
White, round tablet with bevelled edges, marked with the code “OA” on one side and “05” on the other.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/12.5 mg:
Yellow, round tablet with bevelled edges, marked with the code “OA” on one side and “06” on the other.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/12.5 mg:
Pink, round tablet with bevelled edges, marked with the code “OA” on one side and “03” on the other.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/5 mg/25 mg:
Yellow, oval tablet with bevelled edges, marked with the code “OA” on one side and “04” on the other.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC 40 mg/10 mg/25 mg:
Pink, oval tablet with bevelled edges, marked with the code “OA” on one side and “02” on the other.
OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC is available in blisters of 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturer
Teva Operations Poland Sp. z.o.o
ul. Mogilska 80,
31-546 Kraków - Poland
Balkanpharma - Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa - Bulgaria

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Germany:
Halnigal 20mg/5mg/12.5mg Filmtabletten
Halnigal 40mg/5mg/12.5mg Filmtabletten
Halnigal 40mg/10mg/12.5mg Filmtabletten
Halnigal 40mg/5mg/25mg Filmtabletten
Halnigal 40mg/10mg/25mg Filmtabletten
Italy: OLMESARTAN MEDOXOMIL/AMLODIPINE/HYDROCHLOROTHIAZIDE DOC

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