Package leaflet: Information for the user

Olmitze 20 mg/12.5 mg film-coated tablets, 20 mg/25 mg film-coated tablets, 40 mg/12.5 mg film-coated tablets, 40 mg/25 mg film-coated tablets

Olmesartan medoxomil and hydrochlorothiazide
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 they have the same symptoms as yours, because 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 Olmitze is and what it is used for
What you need to know before taking Olmitze
How to take Olmitze
Possible side effects
How to store Olmitze
Contents of the pack and other information

1. What Olmitze is and what it is used for

Olmitze contains two active substances, olmesartan medoxomil and hydrochlorothiazide, which are used for the treatment of high blood pressure (hypertension) in adults:

Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists. It reduces blood pressure by relaxing blood vessels.
Hydrochlorothiazide belongs to a group of medicines called diuretics (tablets that increase urine production). It reduces blood pressure by helping the body eliminate excess fluid, increasing urine production by the kidneys.

Your doctor will prescribe Olmitze if olmesartan medoxomil alone has not adequately controlled your blood pressure. When administered together, the two active substances in Olmitze 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 Olmitze to achieve further reduction.
High blood pressure can be controlled with medicines such as Olmitze tablets. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing the amount of salt in your diet). Your doctor may also have advised 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 Olmitze

Do not take Olmitze

if you are allergic to olmesartan medoxomil or hydrochlorothiazide, or to any of the other ingredients of this medicine (listed in section 6) or to substances similar to hydrochlorothiazide (sulphonamides).
if you are more than three months pregnant (use of Olmitze is advised against even during the first months of pregnancy – see section “Pregnancy”)
if you have low levels of potassium or sodium, or if you have high levels of calcium or uric acid (with symptoms of gout or kidney stones) in the blood that do not improve with treatment
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren [Applies only to 20 mg/12.5 mg and 20 mg/25 mg]
if you have severe kidney problems
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) [Applies only to 40 mg/12.5 mg and 40 mg/25 mg]
if you have kidney problems
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 Olmitze.

Before taking the tablets, inform 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 information under “Do not take Olmitze”.

Before taking the tablets, inform your doctor if you have any of the following health problems:

Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe or prolonged vomiting (nausea) or diarrhoea.
Treatment with high doses of diuretic tablets ("water pills") or if you are on a low-salt diet.
Problems with the adrenal glands (for example primary aldosteronism).
Diabetes.
Systemic lupus erythematosus (an autoimmune disease).
Allergies or asthma.
If you have previously had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to sunlight and UV rays during treatment with Olmitze.
If you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop severe shortness of breath or difficulty breathing after taking Olmitze, seek immediate medical help. [Applies only to 20 mg/12.5 mg and 20 mg/25 mg]
Mild or moderate kidney problems, or if you have recently undergone kidney transplantation. [Applies only to 40 mg/12.5 mg and 40 mg/25 mg]
Kidney transplantation.

Inform your doctor if any of the following symptoms occur:

Severe and prolonged diarrhoea with significant weight loss. Your doctor must evaluate your symptoms and decide how to proceed with this antihypertensive treatment.
Decreased vision or eye pain. These may 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 of taking Olmitze. If untreated, this increase in pressure may lead to permanent vision impairment. If you have previously had an allergy to penicillin or sulphonamides, you may be at higher risk of developing these symptoms.

Your doctor may want to examine you more frequently and carry out some tests if you have any of the above conditions.

Olmitze may increase levels of fats and uric acid (which causes gout – painful swelling of the joints) 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 will likely 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, apathy, fatigue, drowsiness or restlessness, 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 heart or brain circulation disorders may lead to a heart attack or stroke. Your doctor must therefore carefully monitor your blood pressure.

If you need to undergo tests for parathyroid function, you must stop taking Olmitze before these tests.

You must inform your doctor if you think you are pregnant (or could become pregnant). Olmitze 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”).

Contact your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Olmitze. Your doctor will decide whether to continue treatment. Do not stop taking Olmitze on your own.

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

Children and adolescents

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

Other medicines and Olmitze

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 Olmitze.
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 Olmitze” and “Warnings and precautions”).
Medicines that may affect potassium levels in the blood when used together with Olmitze. 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) used together with Olmitze 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 Olmitze may increase the risk of kidney failure, and the effectiveness of Olmitze 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 Olmitze.
Certain medicines such as baclofen and tubocurarine, used to relax muscles
Amifostine and certain other medicines used in cancer treatment, such as cyclophosphamide or methotrexate
Cholestyramine and colestipol, medicines used to lower blood fats
Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as it may reduce the effect of Olmitze. Your doctor may advise you to take Olmitze at least 4 hours before colesevelam hydrochloride.
Anticholinergic medicines, such as atropine and biperiden
Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, ciamemazine, 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 reduce blood glucose levels
Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Olmitze 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 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 Olmitze
Cisapride, used to increase movement of food through the stomach and intestine
Halofantrine, used for malaria.

Olmitze with food, drinks and alcohol

Olmitze can be taken with or without food.

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

Patients of Black ethnicity

As with other similar medicines, the blood pressure-lowering effect of Olmitze is somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding

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

Pregnancy

You must inform your doctor if you think you are pregnant (or could become pregnant). Your doctor will usually advise you to stop taking Olmitze before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine.

Olmitze is not recommended during pregnancy and must not be taken after the first three months 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. Olmitze is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.

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 have resolved. Consult your doctor for advice.
[Applies only to 20 mg/12.5 mg and 40 mg/12.5 mg]

Olmitze contains lactose and sunset yellow

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

Sunset yellow: may cause allergic reactions.

[Applies only to 20 mg/25 mg and 40 mg/25 mg]

Olmitze contains lactose

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

3. How to take Olmitze

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
[Applies only to 20 mg/12.5 mg and 20 mg/25 mg]
The recommended dose is one tablet of Olmitze 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 Olmitze 20 mg/25 mg daily.
[Applies only to 40 mg/12.5 mg and 40 mg/25 mg]
The recommended dose is one tablet of Olmitze 40 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 Olmitze 40 mg/25 mg daily.
Swallow the tablet with a glass of water. Do not chew, crush or break the tablet. If possible, take your dose at the same time each day, for example with breakfast. It is important to keep taking Olmitze unless your doctor tells you to stop.

If you take more Olmitze 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, and take the medicine pack with you.

If you forget to take Olmitze
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 Olmitze
It is important to continue taking Olmitze 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 may be serious:

Allergic reactions affecting the whole 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 happens, stop taking Olmitze and contact your doctor immediately.
Olmitze may cause an excessive drop in 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 Olmitze, contact your doctor immediately and lie down.
Frequency not known: if you develop yellowing of the whites of the eyes, dark urine, or skin itching, even if you started treatment with Olmitze a long time ago, contact your doctor immediately. Your doctor will assess your symptoms and decide how to proceed with your blood pressure therapy.

Olmitze is a combination of two active substances, and 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.
These are the side effects known so far with Olmitze:
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):
Drowsiness, 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.
Some laboratory test abnormalities have also been observed not uncommonly, including:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased creatinine, increased or decreased levels of potassium in the blood, increased calcium levels in the blood, increased blood glucose, increased 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, intestinal angioedema: swelling of the intestine presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Some laboratory test abnormalities have also been observed rarely, including:
Increased blood urea nitrogen, decreased 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 Olmitze or at different frequencies:
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.
Some laboratory test abnormalities have also been commonly observed, including:
Increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased liver and muscle function 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).
Some laboratory test abnormalities have also been observed not uncommonly, including:
Reduction in the number of certain blood cells called platelets (thrombocytopenia).
Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, lack of energy.
Some laboratory test abnormalities have also been observed rarely, including:
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 sensation, diarrhoea, nausea, vomiting, constipation, glucose in urine.
Some laboratory test abnormalities have also been observed, including:
Increased levels of creatinine, urea, calcium and glucose in the blood, decreased levels of chloride, potassium, magnesium and sodium in the blood. Increased serum amylase (hyperamylasaemia).
Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, cutaneous anaphylactic reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, 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, decreased white blood cell count, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disturbances, lack of interest (apathy), tingling and numbness, seizures, 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 obstruction (paralytic ileus).
Not known (frequency cannot be estimated from available data):
Skin and lip cancer (non-melanoma skin cancer).
Vision loss or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

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 Olmitze

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 or 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Olmitze contains

The active substances are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
The active substances are olmesartan medoxomil and hydrochlorothiazide. Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
Other components are: Tablet core: Monohydrate lactose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, microcrystalline cellulose Type 102, magnesium stearate. Tablet coating: [Applies only to 20 mg/12.5 mg and 40 mg/12.5 mg] Opadry II Orange 33G23991 containing: hypromellose 6cP, titanium dioxide (E171), monohydrate lactose, macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172), sunset yellow FCF aluminium lake (E110). [Applies only to 20 mg/25 mg and 40 mg/25 mg] Opadry II Pink 33G34149 containing: hypromellose 6cP, titanium dioxide (E171), monohydrate lactose, macrogol 3350, triacetin (E1518), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Olmitze and contents of the pack
Olmitze 20 mg/12.5 mg film-coated tablets are orange, round, biconvex, 8.5 mm in diameter, with "OH 21" imprinted on one side.
Olmitze 20 mg/25 mg film-coated tablets are pink, round, biconvex, 8.5 mm in diameter, with "OH 22" imprinted on one side.
Olmitze 40 mg/12.5 mg film-coated tablets are orange, oval, biconvex, 15x7 mm, with "OH 41" imprinted on one side.
Olmitze 40 mg/25 mg film-coated tablets are pink, oval, biconvex, 15x7 mm, with "OH 42" imprinted on one side.
Pack sizes
Aluminium-aluminium blister packs: 28 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Day Zero ehf.
Reykjavíkurvegur 62
Hafnarfjörður 220
Iceland

Manufacturer
Actavis Limited,
Blb 015-016 Bulebel Industrial Estate,
Zejtun, ZTN 3000,
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
EE: Lodamaz
IT: Olmitze
[To be completed with national details]

Olmitez