Presdiur: detailed information

Package leaflet: Information for the patient

Presdiur 20 mg/12.5 mg film-coated tablets, 20 mg/25 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it 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 Presdiur is and what it is used for
What you need to know before taking Presdiur
How to take Presdiur
Possible side effects
How to store Presdiur
Contents of the pack and other information

1. What Presdiur is and what it is used for

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

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

You will be prescribed Presdiur if your blood pressure is not adequately controlled with olmesartan medoxomil alone. When administered together, the two active ingredients in Presdiur contribute to lowering blood pressure more than when each is given alone.
If you are already taking medicines for the treatment of high blood pressure, your doctor may decide that you should also take Presdiur to further reduce your blood pressure.
High blood pressure can be controlled with medicines such as Presdiur tablets. Your doctor has likely recommended that you make certain lifestyle changes to help lower your blood pressure (e.g. losing weight, quitting smoking, reducing alcohol intake, and reducing the amount of salt in your diet). Your doctor may also encourage you to exercise regularly, such as walking or swimming. It is important to follow your doctor's advice.

2. What you should know before taking Presdiur

Do not take Presdiur

if you are allergic to olmesartan medoxomil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6) or substances similar to hydrochlorothiazide (sulfonamides)
if you are more than three months pregnant. (It is also advisable to avoid Presdiur during early pregnancy - see section Pregnancy)
if you have severe kidney problems
if you suffer from potassium deficiency, sodium deficiency, high calcium levels, or elevated uric acid levels in the blood (with symptoms of gout or kidney stones) that do not improve with treatment
if you have severe liver problems, or if you have yellowing of the skin and eyes (jaundice), or have problems with bile drainage from the gallbladder (biliary obstruction, e.g. gallstones)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these situations applies to you, or are unsure, do not take the tablets.
Inform your doctor first and follow their advice.
Warnings and precautions
Talk to your doctor or pharmacist before taking Presdiur.
Before taking the tablets, inform your doctor if you have any of the following health problems:

Mild to 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 (nausea) or diarrhoea lasting several days
Treatment with high doses of diuretic tablets ("water pills") or if you are on a low-salt diet
Problems with your adrenal glands (e.g. 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, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation during treatment with Presdiur.
If you are taking any of the following medicines for high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have diabetes associated with kidney problems
aliskiren
If you have previously experienced respiratory or lung problems (including inflammation or fluid accumulation in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Presdiur, consult a doctor immediately.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also the information provided under “Do not take Presdiur”.
Your doctor may decide to see you frequently and perform tests if you are in any of these
conditions.
Contact your doctor if any of the following symptoms occur:

Severe, persistent diarrhoea causing substantial weight loss. Your doctor may assess your symptoms and decide how to continue your blood pressure treatment.
Vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur hours or weeks after taking Presdiur. This may lead to permanent vision impairment if not treated.

Inform your doctor if you experience severe, persistent diarrhoea causing substantial weight loss.
Your doctor may assess your symptoms and decide how to continue your blood pressure
treatment.
Presdiur may increase levels of fats and uric acid in the blood (which can cause gout – joint pain). Your doctor will likely perform periodic blood tests to monitor these conditions.
Presdiur may alter levels of certain blood chemicals called electrolytes. 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, sluggish, tired, sleepy or restless, nausea, vomiting, reduced need to urinate, increased heart rate. Inform your doctor if you notice these symptoms.
As with any other medicine that lowers blood pressure, a sudden excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore monitor your blood pressure carefully.
If you need to undergo tests for parathyroid function, you must stop taking Presdiur before these tests.
For athletes: using the drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Inform your doctor if you think you are (or might become) pregnant. Presdiur is not recommended during early pregnancy, and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if taken during this period (see section Pregnancy).
Children and adolescents
Presdiur is not recommended for children and adolescents under 18 years of age.
Other medicines and Presdiur
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 any of the following medicines:

Medicines that may increase potassium levels in the blood when used together with Presdiur. These include:
potassium supplements (including potassium-containing salt substitutes)
diuretic tablets ("water pills")
heparin (to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
certain painkillers such as aspirin and salicylates.
Your doctor may need to adjust the dosage and/or take other precautions
if you are taking an ACE inhibitor or aliskiren (see also information under “Do not take Presdiur” and “Warnings and precautions”).
Lithium (a medicine used to treat mood swings and certain types of depression), which when used together with Presdiur may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), which when taken with Presdiur may increase the risk of kidney failure and may reduce the effectiveness of Presdiur.
Other blood pressure-lowering medicines (antihypertensives), as the effect of Presdiur may be enhanced.
Sleeping pills, sedatives, and antidepressants, as using these together with Presdiur may cause a sudden drop in blood pressure upon standing.
Certain muscle relaxants such as baclofen and tubocurarine.
Amifostine and certain other cancer treatments such as cyclophosphamide or methotrexate.
Cholestyramine and colestipol, medicines used to lower blood fat levels.
Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as the effect of Presdiur may be reduced. Your doctor may advise you to take Presdiur at least 4 hours before.
Anticholinergic agents 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 disorders.
Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart problems.
Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or injectable erythromycin, which may alter heart rhythm.
Oral anti-diabetic medicines such as metformin or insulin, used to lower blood sugar levels.
Beta-blockers and diazoxide, medicines used to treat high blood pressure and low blood sugar, respectively, as Presdiur may enhance the blood sugar-raising effect.
Methyldopa, a medicine used to treat high blood pressure.
Medicines such as noradrenaline, used to increase blood pressure and slow heart rate.
Difemanyl, used to treat slow heart rate or reduce sweating.
Medicines such as probenecid, sulfinpyrazone, and allopurinol, used to treat gout.
Calcium supplements.
Amantadine, an antiviral medicine.
Cyclosporine, a medicine used to prevent organ transplant rejection.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Certain antacids used for stomach acidity, such as magnesium and aluminium hydroxide, as the effect of Presdiur may be slightly reduced.
Cisapride, used to increase movement of food in the stomach and intestines.
Halofantrine, used for malaria.

Presdiur with food, drinks and alcohol
Presdiur can be taken with or without food.
Be cautious when drinking alcohol while taking Presdiur, as some people may experience weakness and dizziness. If this occurs, avoid alcohol, including wine, beer, or alcopops.
Black patients
As with other similar medicines, the blood pressure-lowering effect of Presdiur is generally lower in black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Presdiur before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Presdiur is not recommended during pregnancy, and must not be taken after 3 months 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 plan to start breastfeeding. Presdiur is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed.
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 during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

3. How to take Presdiur

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Presdiur 20 mg/12.5 mg is one tablet daily. However, if your blood pressure is not adequately controlled, your doctor may decide to adjust the dosage to one tablet daily of Presdiur 20 mg/25 mg.
Swallow the tablet with water. If possible, take the daily dose at the same time each day, for example with breakfast. It is important to continue treatment with Presdiur until your doctor tells you otherwise.
If you take more Presdiur than you should
If you take more tablets than prescribed or if a child accidentally swallows one or more tablets, go immediately to a doctor or the nearest emergency department and bring the medicine pack with you.
If you forget to take Presdiur
If you forget to take a dose, take your usual dose the next day as normal.
Do not take a double dose to make up for the missed dose.
If you stop taking Presdiur
It is important to continue taking Presdiur until your doctor tells you to stop.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Allergic reactions affecting the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), together with itching and skin rash, which may occur rarely. If this happens, stop treatment with Presdiur and contact your doctor immediately.
Presdiur may cause a greater drop in blood pressure in more sensitive individuals or as a result of an allergic reaction. Dizziness or fainting may occur uncommonly. If this happens, stop treatment with Presdiur, 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 have been taking Presdiur for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment for high blood pressure.

Presdiur is a combination of two active substances, and the following information first provides the other side effects reported so far with the combination Presdiur (in addition to those already mentioned above), and secondly, those known for the individual active substances separately.
These are other side effects known so far with Presdiur:
If you experience the following side effects, they may be mild and you may not need 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):
Changes in 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.
In blood test results, changes have been observed uncommonly and include:
Increase in blood fat levels, increase in blood urea or uric acid, 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 check these through a blood test and will inform you if any action is needed.
Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin swellings (wheals).
In blood test results, changes have been observed rarely and include:
Increase in blood nitrogen (azotemia), decrease in haemoglobin and haematocrit values.
Your doctor will check these through a blood test and will inform you if any action is needed.
Other side effects reported after use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Presdiur or with higher frequency:
Olmesartan medoxomil:
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, blocked or runny nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in the urine, urinary tract infections, flu-like symptoms, pain.
In blood test results, changes have been observed commonly and include:
Increase in blood fat levels, increase in blood urea or uric acid, 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, as well as a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions), swelling of the face, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin rashes, itching, rash, skin swellings (wheals).
In blood test results, changes have been observed uncommonly and include:
Reduced number of certain blood cells known as platelets (thrombocytopenia).
Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, loss of strength.
In blood test results, changes have been observed rarely and include:
Increased potassium in the blood.
Hydrochlorothiazide:
Very common side effects (may affect more than 1 in 10 people):
Changes in blood test results, including:
Increased levels of fats and uric acid in the blood.
Common side effects (may affect up to 1 in 10 people):
Feeling confused, abdominal pain, stomach ache, bloated feeling, diarrhoea, nausea, vomiting, constipation, glucose in the urine.
In blood test results, changes have been observed and include:
Increased levels of creatinine, urea, calcium and sugar in the blood, decreased levels of chloride, potassium, magnesium and sodium in the blood. Increased serum amylase (hyperamylasemia).
Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe breathing difficulties, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-induced skin reactions, itching, purple spots or skin lesions due to small haemorrhages (purpura), skin swellings (wheals).
Rare side effects (may affect up to 1 in 1,000 people):
Swelling and pain of the salivary glands, decreased number of white blood cells, decreased number of blood platelets, anaemia, bone marrow damage, restlessness, feeling low or depressed, sleep disturbances, feeling of disinterest (apathy), numbness and tingling, seizures, yellow appearance of objects, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus (such as skin rash, joint pain, cold hands and fingers), skin allergic reactions, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes caused by impaired movement).
Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte imbalances leading to abnormally low chloride levels in the blood (hypochloremic alkalosis), intestinal blockage (paralytic ileus).
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).
Not known (frequency cannot be estimated from available data):
Sudden-onset reduction in distance vision (acute myopia), decreased 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at http://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 Presdiur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
Do not dispose of this 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 Presdiur contains

The active substances are olmesartan medoxomil and hydrochlorothiazide.
Presdiur 20 mg/12.5 mg film-coated tablets:
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.

Presdiur 20 mg/25 mg film-coated tablets:
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The other excipients are microcrystalline cellulose, magnesium stearate and low-substituted hydroxypropylcellulose in the tablet core; titanium dioxide, talc, polyvinyl alcohol and macrogol 3000 in the tablet coating.

Description of the appearance of Presdiur and contents of the pack
Presdiur 20 mg/12.5 mg film-coated tablets are white to off-white, round, biconvex tablets, with the imprint C1 on one side of the tablet; tablet diameter: 9 mm.
Presdiur 20 mg/25 mg film-coated tablets are white to off-white, oval, biconvex tablets, with the imprint C2 on one side of the tablet; size 12 mm x 6 mm.
The film-coated tablets are available in packs of 28 and 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratorio Farmaceutico CT Srl – Via Dante Alighieri, 71 – 18038 Sanremo (IM)
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany
This Patient Information Leaflet was last revised on:

Patient Information Leaflet

Presdiur 40 mg/12.5 mg film-coated tablets, 40 mg/25 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide
Generic 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 others, 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 Presdiur is and what it is used for
What you need to know before taking Presdiur
How to take Presdiur
Possible side effects
How to store Presdiur
Contents of the pack and other information

1. What Presdiur is and what it is used for

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

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

You will be prescribed Presdiur if your blood pressure is not adequately controlled with olmesartan medoxomil alone. When administered together, the two active substances in Presdiur contribute to lowering blood pressure more than either one given alone.
If you are already taking medicines for the treatment of high blood pressure, your doctor may decide that you should also take Presdiur to further reduce your blood pressure.
High blood pressure can be controlled with medicines such as Presdiur tablets. Your doctor has likely recommended that you make certain lifestyle changes to help lower your blood pressure (e.g. losing weight, quitting smoking, reducing alcohol intake, and reducing the amount of salt in your diet). Your doctor may also encourage you to exercise regularly, such as walking or swimming. It is important to follow your doctor’s advice.

2. What you should know before taking Presdiur

Do not take Presdiur:

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 also advisable to avoid Presdiur during early pregnancy – see section Pregnancy)
if you have severe kidney problems
if you suffer from potassium deficiency, sodium deficiency, high calcium levels, or elevated uric acid levels in the blood (with symptoms of gout or kidney stones) that do not improve with treatment
if you have severe liver problems, jaundice (yellowing of the skin and eyes), or bile drainage problems from the gallbladder (biliary obstruction, e.g. gallstones)
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you think any of these situations applies to you, or if you are unsure, do not take the tablets.
Inform your doctor first and follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Presdiur.
Before taking the tablets, inform 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
Treatment with high doses of diuretic tablets ("water pills") or if you are on a low-salt diet
Adrenal gland problems (e.g. primary aldosteronism)
Diabetes
Systemic lupus erythematosus (an autoimmune disease)
Allergies or asthma
If you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking Presdiur.
If you are taking any of the following medicines for high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have diabetes related to kidney problems
aliskiren
If you have previously experienced breathing or lung problems (including lung inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Presdiur, contact a doctor immediately.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the information under "Do not take Presdiur".
Your doctor may decide to monitor you frequently and perform tests if you are in any of these conditions.
Contact your doctor if you experience the following symptoms:

Severe, persistent diarrhoea causing substantial weight loss. Your doctor will assess your symptoms and decide how to continue your blood pressure treatment.
Vision changes or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure and may occur hours or weeks after taking Presdiur. This may lead to permanent vision impairment if left untreated.

Presdiur may increase levels of fats and uric acid (which can cause gout – joint pain) in your blood. Your doctor will likely perform periodic blood tests to monitor these conditions.
Presdiur may alter levels of certain blood chemicals called electrolytes. 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 fatigue, low blood pressure (hypotension), weakness, sluggishness, tiredness, sleepiness or restlessness, nausea, vomiting, reduced need to urinate, increased heart rate. Inform your doctor if you notice these symptoms.
As with any other medicine that lowers blood pressure, an excessive drop in blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore monitor your blood pressure carefully.
If you need to undergo tests for parathyroid function, you must stop taking Presdiur before the tests.
For athletes: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
You must inform your doctor if you think you are (or might become) pregnant. Presdiur is not recommended during early 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 during this period (see section Pregnancy).
Children and adolescents
Presdiur is not recommended for children and adolescents under 18 years of age.
Other medicines and Presdiur
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 if you are taking any of the following medicines:

Medicines that may increase potassium levels in the blood when used together with Presdiur. These include:
potassium supplements (including potassium-containing salt substitutes)
diuretic tablets ("water pills")
heparin (to thin the blood)
laxatives
steroids
adrenocorticotropic hormone (ACTH)
carbenoxolone (a medicine used to treat mouth and stomach ulcers)
sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
certain painkillers such as aspirin and salicylates.
Your doctor may need 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 Presdiur" and "Warnings and precautions").
Lithium (a medicine used to treat mood swings and certain types of depression), which when used together with Presdiur may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other signs of inflammation, including arthritis), which when taken together with Presdiur may increase the risk of kidney failure, and the effect of Presdiur may be reduced by NSAIDs.
Other blood pressure-lowering medicines (antihypertensives), as the effect of Presdiur may be enhanced.
Sleeping pills, sedatives, and antidepressants, as using these together with Presdiur may cause a sudden drop in blood pressure upon standing.
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 fat levels.
Colesevelam hydrochloride, a medicine that lowers blood cholesterol levels, as the effect of Presdiur may be reduced. Your doctor may advise you to take Presdiur at least 4 hours before.
Anticholinergic agents 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 disorders.
Certain heart medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis.
Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or injectable erythromycin, which may alter heart rhythm.
Oral anti-diabetic medicines such as metformin or insulin, used to lower blood sugar levels.
Beta-blockers and diazoxide, medicines used respectively for treating high blood pressure and low blood sugar, as Presdiur may enhance the blood sugar-raising 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 to reduce sweating.
Medicines such as probenecid, sulfinpyrazone and allopurinol, used to treat gout.
Calcium supplements.
Amantadine, an antiviral medicine.
Cyclosporine, a medicine used to prevent organ transplant rejection.
Certain antibiotics called tetracyclines or sparfloxacin.
Amphotericin, a medicine used to treat fungal infections.
Certain antacids used for stomach acidity, such as magnesium and aluminium hydroxide, as the effect of Presdiur may be slightly reduced.
Cisapride, used to increase movement of food through the stomach and intestine.
Halofantrine, used for malaria.

Presdiur with food, drinks and alcohol
Presdiur can be taken with or without food.
Be cautious when drinking alcohol while taking Presdiur, as some people may experience weakness and dizziness. If this occurs, do not drink alcohol, including wine, beer or alcopops.
Black patients
As with other similar medicines, the blood pressure-lowering effect of Presdiur is generally lower in black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might become) pregnant. Your doctor will usually advise you to stop treatment with Presdiur before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Presdiur 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 three months of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to start breastfeeding. Presdiur 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, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may experience drowsiness or dizziness during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

3. How to take Presdiur

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Presdiur 40 mg/12.5 mg is one tablet daily. However, if your blood pressure is not adequately controlled, your doctor may decide to adjust the dosage to one tablet daily of Presdiur 40 mg/25 mg.
Swallow the tablet with water. If possible, take the daily dose at the same time each day, for example with breakfast. It is important to continue treatment with Presdiur until your doctor tells you otherwise.
If you take more Presdiur than you should
If you take more tablets than prescribed or if a child accidentally ingests one or more tablets, go immediately to your doctor or the nearest emergency department, and bring the medicine pack with you.
If you forget to take Presdiur
If you forget to take a dose, take your next dose at the usual time the following day. Do not take a double dose to make up for the forgotten dose.
If you stop taking Presdiur
It is important to continue taking Presdiur until your doctor tells you to stop.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
However, the following 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), together with itching and skin rash, which may occur rarely. If this happens, stop taking Presdiur and contact your doctor immediately.
Presdiur may cause a greater drop in blood pressure in more sensitive individuals or as a result of an allergic reaction. Dizziness or fainting may occur not uncommonly. If this happens, stop taking Presdiur, contact your doctor immediately and lie down.
Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking Presdiur for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with treatment for high blood pressure.

Presdiur is a combination of two active substances, and the following information first lists other side effects reported so far with the combination Presdiur (in addition to those already mentioned above), and secondly, those known for the individual active substances separately.
These are other side effects known so far with Presdiur:
If you experience the following side effects, they may be mild and you may not need 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):
Changes in 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.
In blood test results, changes have been observed not uncommonly and include:
Increased levels of fats in the blood, increased blood urea or uric acid, increased creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in the blood, increased blood glucose, increased liver function tests.
Your doctor will check these through a blood test and will inform you if any action is needed.
Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin swellings (hives), acute renal failure.
In blood test results, changes have been observed rarely and include:
Increased blood urea nitrogen (BUN), decreased haemoglobin and haematocrit values.
Your doctor will check these through a blood test and will inform you if any action is needed.
Other side effects reported after use of olmesartan medoxomil or hydrochlorothiazide alone, but not with Presdiur or with higher frequency:
Olmesartan medoxomil:
Common side effects (may affect up to 1 in 10 people):
Bronchitis, cough, stuffy or runny nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infections, flu-like symptoms, pain.
In blood test results, changes have been observed commonly and include:
Increased levels of fats in the blood, increased blood urea or uric acid, 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 problems, as well as 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 rashes, itching, exanthema (skin rash), skin swellings (hives).
In blood test results, changes have been observed not uncommonly and include:
Reduced number of certain blood cells known as platelets (thrombocytopenia).
Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, loss of strength.
In blood test results, changes have been observed rarely and include:
Increased potassium in the blood.
Hydrochlorothiazide:
Very common side effects (may affect more than 1 in 10 people):
Changes in blood test results including:
Increased levels of fats and uric acid in the blood.
Common side effects (may affect up to 1 in 10 people):
Feeling confused, abdominal pain, stomach ache, bloated feeling, diarrhoea, nausea, vomiting, constipation, glucose excretion in urine.
In blood test results, changes have been observed and include:
Increased levels of creatinine, urea, calcium and sugar in the blood, decreased chloride, potassium, magnesium and sodium levels 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, anaphylactic skin reactions (hypersensitivity reactions), worsening of pre-existing myopia, erythema, light-induced skin reactions, itching, purplish spots or skin spots due to small haemorrhages (purpura), skin swellings (hives).
Rare side effects (may affect up to 1 in 1,000 people):
Swelling and pain of the salivary glands, decreased number of white blood cells, decreased number of platelets in the blood, anaemia, bone marrow damage, restlessness, feeling low or depressed, sleep disturbances, feeling of disinterest (apathy), numbness and tingling, seizures, yellow appearance of objects viewed, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus (such as skin rash, joint pain, cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious inflammation of the kidney (interstitial nephritis), fever, muscle weakness (sometimes caused by impaired movement).
Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte imbalances leading to abnormally low levels of chloride loss in the blood (hypochloraemic alkalosis), intestinal blockage (paralytic ileus).
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion).
Not known (frequency cannot be estimated from available data):
Sudden-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Skin and lip cancer (non-melanoma skin cancer).
Reporting of side effects
If you experience any side 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 http://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 Presdiur

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The
expiry date refers to the last day of that month.
Store in the original packaging to protect from moisture.
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 Presdiur contains

The active substances are olmesartan medoxomil and hydrochlorothiazide.
Presdiur 40 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
Presdiur 40 mg/25 mg film-coated tablets: Each film-coated tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
The other excipients are microcrystalline cellulose, magnesium stearate and low-substituted hydroxypropylcellulose in the tablet core; titanium dioxide, talc, polyvinyl alcohol and macrogol 3000 in the tablet coating.

Description of the appearance of Presdiur and contents of the pack
Presdiur 40 mg/12.5 mg film-coated tablets are white to off-white, round, bevel-edged tablets, with the mark C3 engraved on one side of the tablet; tablet diameter: 12 mm.
Presdiur 40 mg/25 mg film-coated tablets are white to off-white, oval, biconvex tablets, with notches on both sides; size: 15 mm x 8 mm. The score line is intended only to facilitate swallowing by allowing the tablet to be broken into pieces and is not intended to divide the tablet into equal doses.
The film-coated tablets are available in packs of 28 and 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratorio Farmaceutico CT Srl – Via Dante Alighieri, 71 – 18038 Sanremo (IM)

Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz Lohmann Straße 5, 27472 Cuxhaven, Germany

This Patient Information Leaflet was last revised on: