PRESDIUR 20 mg /12,5 Mg Tabletki Powlekane

Treść ulotki

1. Presdiur 20 mg/12,5 mg film-coated tablets, 20 mg/25 mg film-coated tablets
   1. What is Presdiur and what is it used for
   2. What you need to know before taking Presdiur
   3. How to take Presdiur
   4. Possible side effects
   5. How to store Presdiur
   6. Contents of the pack and other information
2. Presdiur 40 mg/12,5 mg film-coated tablets, 40 mg/25 mg film-coated tablets
   1. What Presdiur is and what it is used for
   2. Cosa deve sapere prima di prendere Presdiur
   3. How to take Presdiur
   4. Possible side effects
   5. How to store Presdiur
   6. Contents of the pack and other information

Presdiur 20 mg/12,5 mg film-coated tablets, 20 mg/25 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Presdiur is and what it is used for
• 2. What you need to know before you take Presdiur
• 3. How to take Presdiur
• 4. Possible side effects
• 5. How to store Presdiur
• 6. Contents of the pack and other information

1. What is Presdiur and what is it used for

Presdiur contains two active ingredients, 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 the blood vessels.
• Hydrochlorothiazide belongs to the group of medicines called thiazide diuretics (“water tablets”). It reduces blood pressure by helping the body to eliminate excess fluids, causing the kidneys to produce more urine.

You will be given Presdiur if your blood pressure is not
adequately controlled with olmesartan medoxomil alone. When administered together, the two active ingredients of Presdiur
help to lower blood pressure more than their
individual administration.
If you are already taking medicines to treat high blood pressure, your doctor may
decide that you also take Presdiur to lower it further.
High blood pressure can be controlled with medications such as Presdiur tablets. Your
doctor has probably recommended that you make some changes to your lifestyle to
help reduce blood pressure (e.g. weight loss, quitting smoking, reducing the
amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also
encourage you to take regular exercise, such as walking or swimming. It is important to follow this
advice from your doctor.

2. What you need to 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 (sulphonamides)
• if you are pregnant for more than three months. (It is best to avoid Presdiur even at the beginning of pregnancy - see section Pregnancy)
• if you have severe kidney problems
• if you suffer from potassium deficiency, sodium deficiency, high amount of calcium or high levels of uric acid in the blood (with symptoms of gout or kidney stones) that do not improve when treated
• if you suffer from severe liver problems or yellowing of the skin and eyes (jaundice) or have problems with drainage of bile from the gallbladder (bile duct obstruction e.g. gallstones)
• if you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure containing aliskiren.

If you think any of these apply to you, or you are not sure, do not take the tablets.
Inform your doctor first and follow the given instructions.

Warnings and precautions
Talk to your doctor or pharmacist before taking Presdiur.
Before taking the tablets, tell your doctorif you have any of the following health problems:

• Mild to moderate kidney problems or if you have recently had a kidney transplant
• Liver disease
• Heart failure or problems with the heart valves or heart muscle
• Vomiting (feeling unwell) or diarrhoea that is severe or has been going on for several days
• Treatment with high doses of water tablets (diuretics) or if you are following a low-salt diet
• Problems with the adrenal glands (e.g. primary aldosteronism)
• Diabetes
• Lupus erythematosus (an autoimmune disease)
• Allergies or asthma
• If you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Presdiur.
• If you are taking any of the following medicines for the treatment of high blood pressure:
• an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you have diabetes related to kidney problems
• aliskiren

If you have had breathing or lung problems (including inflammation or fluid in the lungs) following the intake of hydrochlorothiazide in the past. If shortness of breath or severe difficulty breathing occurs after taking Presdiur, consult a doctor immediately.

Your doctor may check your kidney function, blood pressure and the amount 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 often and perform some tests if you are in one of these
conditions.
Contact your doctor if you experience the following symptoms:

• severe, persistent diarrhoea that causes substantial weight loss. The doctor may evaluate the symptoms and decide how to continue the treatment for blood pressure.
• decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye and can occur after hours or weeks of taking Presdiur. This can lead to permanent vision impairment if not treated.

Tell your doctor if you experience severe, persistent diarrhoea that causes substantial weight loss.
Your doctor may evaluate the symptoms and decide how to continue with the treatment for blood
pressure.
Presdiur may cause an increase in levels of fat and uric acid (cause of gout – joint pain). Your doctor will probably have you undergo blood tests periodically
to check for these conditions.
Presdiur may change the level of some chemical compounds in your blood, called electrolytes. Your
doctor will probably have you undergo blood tests periodically to check for these
conditions. Signs of electrolyte disturbances are: thirst, dry mouth, muscle pain or
cramps, muscle fatigue, low blood pressure (hypotension), feeling weak, slowness,
tiredness, restlessness, nausea, vomiting, decreased need to urinate, increased
heart rate. Tell 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 disorders of blood flow to the heart or brain can
lead to a heart attack or stroke. The doctor will therefore carefully monitor blood
pressure.
If you need to undergo tests for parathyroid function, you must stop treatment with
Presdiur before performing these tests.
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.
You should inform your doctor if you think you are (or may become) pregnant. Presdiur is not
recommended at the beginning of pregnancy, and should not be taken if you are pregnant for more than 3
months, as it can cause serious harm to the baby (see section
Pregnancy).

Children and adolescents
Presdiur is not recommended for children and adolescents under the age of 18 years.

Other medicines and Presdiur
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines:
In particular, tell your doctor or pharmacist about any of the following medicines:

• Medicines that can increase potassium levels in the blood if used at the same time as Presdiur. These include:
• potassium supplements (as well as salt substitutes containing potassium)
• water tablets (diuretics)
• heparin (to thin the blood)
• laxatives
• steroids
• adrenocorticotropic hormone (ACTH)
• carbenoxolone (a medicine used to treat mouth and stomach ulcers)
• sodium benzylpenicillin (also called benzylpenicillin sodium, an antibiotic)
• some painkillers such as aspirin and salicylates.
• Your doctor may need to change the dosage and/or take other precautions
• if you are taking an ACE inhibitor or aliskiren (see also the information provided under “Do not take Presdiur” and “Warnings and precautions”).
• Lithium (a medicine used to treat mood swings and some types of depression) which used at the same time with Presdiur may increase lithium toxicity. If you need to take lithium, your doctor will measure the levels of lithium in your blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) which used in conjunction with Presdiur may increase the risk of kidney failure and the effect of Presdiur may be decreased by NSAIDs.
• Other medicines that lower blood pressure (antihypertensives), as the effect of Presdiur may be increased.
• Sleeping pills, sedatives and antidepressants, as using these medicines in conjunction with Presdiur may cause a sudden increase in blood pressure when standing up.
• Some medicines such as baclofen and tubocurarine, used to relax muscles.
• Amifostine and some other medicines used to treat cancer, such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to lower fat levels in the blood.
• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, as the effect of Presdiur may decrease. Your doctor may advise you to take Presdiur at least 4 hours before.
• Anticholinergic agents, such as atropine and biperidene.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat some psychiatric disorders.
• Some 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 can change the heart rhythm.
• Oral antidiabetic medicines, such as metformin or insulin, used to lower blood sugar levels.

Presdiur with food, drinks and alcohol
Presdiur can be taken with or without food.
Be careful when drinking alcohol while taking Presdiur, as some people may
experience weakness and dizziness. If this happens, do not drink alcohol, including wine, beer or alcopops.

Black patients
As with other similar medicines, the blood pressure lowering effect of Presdiur is rather
lower in black patients.

Pregnancy and breastfeeding

Pregnancy
You should tell your doctor if you think you are (or might become) pregnant. Your doctor will normally
tell you to stop taking Presdiur before becoming pregnant or as soon as you find out you are pregnant and will inform you to take another medicine instead of Presdiur. Presdiur
is not recommended during pregnancy, and should not be taken after more than 3 months of
pregnancy, as it can cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Presdiur is not recommended in
mothers who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed.
If you are pregnant or breastfeeding, if you suspect or are planning a pregnancy, 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
happens, do not drive or use machines until the symptoms have disappeared. Ask your
doctor for advice.

3. How to take Presdiur

Take this medicine following the instructions of your doctor exactly. If you have any doubts
consult your doctor or pharmacist.

The recommended doseof Presdiur 20 mg/12,5 mg is one tablet a day. However, if your blood
pressure is not controlled, your doctor may decide to modify the dosage to one tablet
a day 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 at breakfast time. It is important to continue treatment with Presdiur until
your doctor tells you to stop.

If you take more Presdiur than you should
If you take more tablets than you should, or if a child accidentally swallows one or more, go
immediately to your doctor or the nearest emergency room and bring the package of the
medicine with you.

If you forget to take Presdiur
If you forget to take a dose, take the normal dose the next day as usual.

Do nottake a double dose to make up for a 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 the use of this medicine, ask 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 that may affect the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords) together with itching and skin rash, which may occur rarely. If this happens, stop treatment with Presdiur and contact yourdoctor immediately.
• Presdiurmay cause a greater lowering of blood pressure in more sensitive individuals or as a result of an allergic reaction. Dizziness or fainting may occur infrequently. If this happens, stop treatment with Presdiur, contact yourdoctor immediately and lie down.
• Not known frequency: if you experience yellowing of the whites of your eyes, dark urine, skin itching, even if you have been taking Presdiur for a long time, contact yourdoctor immediatelywho will evaluate the symptoms and decide how to proceed with therapy for the treatment of high blood pressure.

Presdiur is a combination of two active ingredients and the following information provides firstly
other side effects reported so far with the Presdiur combination (in addition to those already mentioned above) and,
secondly, those that are known regarding the separate active ingredients.

These are other side effects known so far with Presdiur:
If you experience the following side effects, these may be mild and you will not need to
interrupt the 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 heart rate (palpitations), skin rash, eczema, vertigo, cough, indigestion,
abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain,
arms and legs, back pain, difficulty of erection in men, blood in the urine.
Changes have been observed non-commonly in blood test results and
include:
Increased levels of fats in the blood, increased urea in the blood or uric acid, increased
creatinine, increase or decrease in potassium levels in the blood, increased levels of calcium in
the blood, increased blood sugar, increased liver function indices.
The doctor will check these with a blood test and tell you if anything needs to be done.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, altered consciousness, skin swelling (hives), acute renal failure.
Changes have been observed rarely in blood test results and include:
Increased azotemia, decreased values of hemoglobin and hematocrit.
The doctor will check these with a blood test and inform you if anything needs to be done.

Other side effects reported after the use of olmesartan medoxomil or hydrochlorothiazide alone, but
not with Presdiur or with greater 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, diarrhea, nausea,
gastroenteritis, joint or bone pain, back pain, blood in the urine, urinary tract infections, flu-like
symptoms, pain.
Changes have been commonly observed in blood test results and include:
Increased levels of fats in the blood, increased urea in the blood or uric acid, increased
liver and muscle function indices.

Uncommon side effects (may affect up to 1 in 100 people):
Immediate allergic reactions that may affect the whole body and may cause breathing problems, as well as a rapid drop in blood pressure which may also lead to fainting
(anaphylactic reactions), swelling of the face, angina (chest pain or discomfort, known as
angina pectoris), feeling unwell, allergic skin reactions, itching, rash (skin eruption), skin swelling (hives).
Changes have been observed non-commonly in blood test results and
include:
Reduced number of some blood cells, known as platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, loss of strength.
Changes have been observed rarely in blood test results 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 of confusion, abdominal pain, stomach pain, feeling of fullness, diarrhea, nausea,
vomiting, constipation, excretion of glucose in the urine.
Changes have been observed in blood test results and include:
Increased levels of creatinine in the blood, urea, calcium and sugar, decreased chloride in
the blood, potassium, magnesium and sodium levels. Increased serum amylase
(hyperamylasemia).

Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions
(hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to
light, itching, purple spots or spots on the skin due to small hemorrhages (purpura),
skin swelling (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, anemia, bone marrow damage, restlessness, feeling down or depressed, sleep disorders, feeling of disinterest (apathy), numbness and tingling, convulsions, yellowish appearance of objects you observe, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, inflammation of the pancreas, jaundice, infection of the
gallbladder, symptoms of systemic lupus erythematosus (such as rash, joint pain and cold hands and
fingers), allergic skin reactions, skin exfoliation and blisters on the skin, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes caused by
impaired movement).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances leading to an abnormal level of chloride loss in the blood (hypochloremic alkalosis),
acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).

Not known (frequency cannot be estimated based on available data):
Rapid onset of distant vision impairment (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).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor or pharmacist. You can also report side effects directly
through 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 package to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Presdiur contains

• The active ingredients 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 and 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, with the C1 mark imprinted 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,
with the C2 mark imprinted on one side of the tablet; dimensions 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 Authorisation 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

Presdiur 40 mg/12,5 mg film-coated tablets, 40 mg/25 mg film-coated tablets

Olmesartan medoxomil/hydrochlorothiazide
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Presdiur is and what it is used for
• 2. What you need to know before you take Presdiur
• 3. How to take Presdiur
• 4. Possible side effects
• 5. How to store Presdiur
• 6. Contents of the pack and other information

1. What Presdiur is and what it is used for

Presdiur contains two active ingredients, 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 the blood vessels.
• Hydrochlorothiazide belongs to the group of medicines called thiazide diuretics (“water tablets”). It reduces blood pressure by helping the body to eliminate excess fluids, causing the kidneys to produce more urine.

You will be given Presdiur if your blood pressure is not
adequately controlled with olmesartan medoxomil alone. When administered together, the two active ingredients of Presdiur
contribute to lowering blood pressure more than their
individual administration.
If you are already taking medicines to treat high blood pressure, your doctor may
decide that you also take Presdiur to lower it further.
High blood pressure can be controlled with medicines such as Presdiur tablets. Your
doctor has probably recommended that you make some changes to your lifestyle to
help reduce blood pressure (e.g. weight loss, quitting smoking, reducing
the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also
encourage you to take regular exercise, such as walking or swimming. It is important to follow this
advice from your doctor.

2. Cosa deve sapere prima di prendere Presdiur

Non prenda Presdiur:

• se è allergico ad olmesartan medoxomil o ad idroclorotiazide o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6) o substances similar to hydrochlorothiazide (sulfonamides)
• se è in gravidanza da più di tre mesi. (Ѐ meglio evitare Presdiur anche all’inizio della gravidanza
• vedere paragrafo Gravidanza)
• se ha gravi problemi renali
• se soffre di carenza di potassio, carenza di sodio, elevata quantità di calcio o alti livelli di acido urico nel sangue (con sintomi di gotta o calcoli renali) che non migliorano quando trattati
• se soffre di problemi al fegato gravi o ingiallimento della pelle e degli occhi (ittero) o ha problemi di drenaggio della bile dalla cistifellea (ostruzione biliare per es. calcoli biliari)
• se ha il diabete o la sua funzione renale è compromessa e viene trattato con un medicinale che abbassa la pressione del sangue contenente aliskiren.

Se pensa che uno di questi casi sia il suo, o non è sicuro, non prenda le compresse.
Informi prima il medico e segua le indicazioni date.
Avvertenze e precauzioni
Si rivolga al medico o al farmacista prima di prendere Presdiur.
Prima di prendere le compresse, informi il medicose ha uno dei seguenti problemi di salute:

• Trapianto di rene
• Malattie del fegato
• Insufficienza cardiaca o problemi alle valvole del cuore o al muscolo cardiaco
• Vomito (malessere) o diarrea che sia grave o che prosegue da diversi giorni
• Trattamento con alte dosi di compresse per urinare (diuretici) o se segue una dieta a basso contenuto di sale
• Problemi alle ghiandole surrenali (per es. aldosteronismo primario)
• Diabete
• Lupus eritematoso (una malattia autoimmune)
• Allergie o asma
• Se ha avuto in passato il cancro della pelle o se sta sviluppando una lesione della pelle imprevista durante il trattamento. Il trattamento con idroclorotiazide, in particolare un utilizzo a lungo termine con dosi elevate può aumentare il rischio di alcuni tipi di cancro della pelle e delle labbra (non-melanoma skin cancer). Protegga la sua pelle dall’esposizione al sole e ai raggi UV durante l’assunzione di Presdiur.
• Se sta prendendo uno dei seguenti medicinali per il trattamento della pressione alta:
• un ACE inibitore (per esempio enalapril, lisinopril, ramipril), in particolare se ha il diabete correlato a problemi renali
• aliskiren
• Se ha avuto problemi respiratori o polmonari (compresa infiammazione o presenza di liquido nei polmoni) in seguito all’assunzione di idroclorotiazide in passato. Se dopo l’assunzione di Presdiur compare respiro affannoso o respirazione difficoltosa grave, consulti immediatamente un medico.

Il suo medico può verificare la funzionalità renale, la pressione del sangue e la quantità di elettroliti
(per es. potassio) nel suo sangue ad intervalli regolari.
Vedere anche le informazioni riportate sotto “Non prenda Presdiur”.
Il suo medico può decidere di vederla spesso ed effettuare qualche test se è in una di queste
condizioni.
Contattare il medico se si verificano i seguenti sintomi:

• diarrea grave, persistente che provoca una perdita di peso sostanziale. Il medico può valutare i sintomi e decidere come continuare il trattamento per la pressione sanguigna.
• diminuzione della vista o dolore agli occhi. Questi potrebbero essere sintomi dell’accumulo di liquido nello strato vascolare dell’occhio (choroidal effusion) o di un aumento della pressione nell'occhio e possono verificarsi dopo ore o settimane dall’assunzione di Presdiur. Questo può portare ad una compromissione permanente della vista, se non trattata.

Presdiur può causare un aumento dei livelli di grasso e di acido urico (causa di gotta – dolore delle
articolazioni). Il suo medico probabilmente la sottoporrà a degli esami del sangue periodicamente
per verificare queste condizioni.
Presdiur può modificare il livello di alcuni composti chimici del suo sangue, chiamati elettroliti. Il suo
medico probabilmente la sottoporrà a degli esami del sangue periodicamente per verificare queste
condizioni. Segni di alterazioni degli elettroliti sono: sete, secchezza della bocca, dolore muscolare o
crampi, stanchezza muscolare, pressione bassa (ipotensione), sensazione di debolezza, lentezza,
stanchezza, sonno o irrequietezza, nausea, vomito, minor necessità di urinare, aumento della
frequenza cardiaca. Informi il medico se nota questi sintomi.
Come con qualsiasi altro medicinale che riduce la pressione sanguigna, un calo eccessivo della
pressione sanguigna nei pazienti con disturbi del flusso sanguigno del cuore o del cervello può
portare ad un attacco di cuore o ictus. Il medico quindi controllerà attentamente la pressione
arteriosa.
Se deve effettuare test per la funzionalità della paratiroide, deve interrompere il trattamento con
Presdiur prima di effettuare tali test.
Per chi svolge attività sportiva: l’uso del farmaco senza necessità terapeutica costituisce doping e può
determinare comunque positività ai test antidoping.
Deve informare il medico se pensa di essere (o potrebbe rimanere) incinta. Presdiur non è
raccomandato all'inizio della gravidanza, e non deve essere assunto se lei è in gravidanza da più di 3
mesi, in quanto può causare gravi danni al bambino se preso in questo periodo (vedere paragrafo
Gravidanza).

Bambini e adolescenti
Presdiur non è raccomandato per i bambini e gli adolescenti al di sotto dei 18 anni di età.

Altri medicinali e Presdiur
Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere
qualsiasi altro medicinale:
In particolare informi il medico o il farmacista su uno qualsiasi dei seguenti medicinali:

• Medicinali che possono aumentare i livelli di potassio nel sangue se utilizzati contemporaneamente a Presdiur. Questi includono:
• integratori di potassio (così come sostituti del sale che contengono potassio)
• compresse per urinare (diuretici)
• eparina (per fluidificare il sangue)
• lassativi
• steroidi
• ormone adrenocorticotropo (ACTH)
• carbenoxolone (un medicinale usato per il trattamento delle ulcere della bocca e dello stomaco)
• penicillina G sodica (anche chiamata benzilpenicillina sodica, un antibiotico)
• alcuni antidolorifici come aspirina e salicilati.
• Il suo medico può avere bisogno di cambiare il dosaggio e/o prendere altre precauzioni
• se sta prendendo un ACE inibitore o aliskiren (vedere anche le informazioni riportate sotto “Non prenda Presdiur” e “Avvertenze e precauzioni”).
• Litio (un medicinale usato per il trattamento degli sbalzi di umore ed alcuni tipi di depressione) che utilizzato contemporaneamente con Presdiur può aumentare la tossicità al litio. Se deve prendere litio, il suo medico misurerà i livelli di litio nel sangue.
• Farmaci anti-infiammatori non steroidei (FANS) (medicinali usati per alleviare il dolore, il gonfiore e altri sintomi di infiammazione, inclusa artrite) che utilizzati in concomitanza con Presdiur possono aumentare il rischio di insufficienza renale e l'effetto di Presdiur può essere diminuito dai FANS.
• Altri medicinali che abbassano la pressione del sangue (antipertensivi), in quanto l’effetto di Presdiur può essere aumentato.
• Sonniferi, sedativi e anti-depressivi, in quanto usando questi medicinali in concomitanza con Presdiur può verificarsi un brusco aumento della pressione quando si sta in piedi.
• Alcuni medicinali come baclofene e tubocurarina, utilizzati per rilassare i muscoli.
• Amifostina e alcuni altri medicinali usati per il trattamento del cancro, come ciclofosfamide o metotressato.
• Colestiramina e colestipolo, medicinali usati per abbassare i livelli di grasso nel sangue.
• Colesevelam cloridrato, un medicinale che abbassa il livello di colesterolo nel sangue, in quanto l'effetto di Presdiur può diminuire. Il suo medico le può consigliare di assumere Presdiur almeno 4 ore prima.
• Agenti anti-colinergici, come atropina e biperidene.
• Medicinali quali tioridazina, clorpromazina, levomepromazina, trifluoperazina, ciamemazina, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidolo o aloperidolo, utilizzati per trattare alcuni disturbi psichiatrici.
• Alcuni medicinali quali chinidina, idrochinidina, disopiramide, amiodarone, sotalolo o digitalici, usati per il trattamento di problemi cardiaci.
• Medicinali quali mizolastina, pentamidina, terfenadina, dofetilide, ibutilide o eritromicina iniettabile, che possono modificare il ritmo cardiaco.
• Medicinali anti-diabetici orali, come metformina o insulina, utilizzati per abbassare il livello di zuccheri nel sangue.
• Beta bloccanti e diazossido, medicinali utilizzati rispettivamente per il trattamento della pressione alta e la carenza di zucchero nel sangue, in quanto Presdiur può aumentare l’effetto di incremento di zucchero nel sangue.
• Metildopa, un medicinale utilizzato per il trattamento della pressione alta.
• Medicinali quali la noradrenalina, utilizzati per aumentare la pressione del sangue e rallentare il ritmo cardiaco.
• Difemanil, utilizzato per trattare il battito cardiaco lento o per diminuire la sudorazione.
• Medicinali quali probenecid, sulfinpirazone e allopurinolo, utilizzati per trattare la gotta.
• Supplementi di calcio.
• Amantadina, un medicinale anti-virale.
• Ciclosporina, un medicinale usato per bloccare il rigetto da trapianto d’organo.
• Alcuni antibiotici chiamati tetracicline o sparfloxacina.
• Amfotericina, un medicinale usato per trattare le infezioni fungine.
• Alcuni anti-acidi, utilizzati per il trattamento dell’acidità di stomaco, come idrossido di magnesio e alluminio , in quanto l'effetto di Presdiur può essere leggermente diminuito.
• Cisapride, utilizzato per aumentare il movimento di cibo nello stomaco e nell’intestino.
• Alofantrina, utilizzato per la malaria.

Presdiur con cibi, bevande e alcol
Presdiur può essere assunto a stomaco pieno o vuoto.
Faccia attenzione nel bere alcol mentre assume Presdiur, in quanto alcune persone possono
manifestare debolezza e capogiri. Se accade questo, non beva alcol, incluso vino, birra o alcopops.

Pazienti neri
Come con altri medicinali simili l'effetto di abbassamento della pressione di Presdiur è piuttosto
inferiore nei pazienti neri.

Gravidanza e allattamento

Gravidanza
Deve informare il medico se pensa di essere (o di poter rimanere) incinta. Il suo medico normalmente
le dirà di interrompere il trattamento con Presdiur prima di rimanere incinta o non appena viene a
sapere di essere incinta e la informerà di prendere un altro medicinale al posto di Presdiur. Presdiur
non è raccomandato durante la gravidanza, e non deve essere preso dopo più di 3 mesi di
gravidanza, in quanto può causare grave danno al bambino se preso dopo i tre mesi di gravidanza.

Allattamento
Informi il medico se sta allattando o dell’inizio dell’allattamento. Presdiur non è raccomandato nelle
madri che stanno allattando, ed il medico può scegliere un altro trattamento, se desidera allattare.
Se è in corso una gravidanza o se sta allattando, se sospetta o sta pianificando una gravidanza, chieda
consiglio al medico o al farmacista prima di prendere questo medicinale.

Guida di veicoli e utilizzo di macchinari
Può avvertire sonnolenza o capogiri durante il trattamento per la pressione sanguigna alta. Se questo
accade, non guidi o utilizzi macchinari fino a quando i sintomi non scompaiono. Chieda consiglio al
medico.

3. How to take Presdiur

Take this medicine following the instructions of your doctor exactly. If you have doubts
consult your doctor or pharmacist.

The recommended doseof Presdiur 40 mg/12,5 mg is one tablet a day. However, if your blood
pressure is not controlled, your doctor may decide to modify the dosage to one tablet
a day 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 at breakfast time. It is important to continue treatment with Presdiur until
your doctor tells you to stop.

If you take more Presdiur than you should
If you take more tablets than you should or if a child accidentally ingests one or more, go
immediately to your doctor or the nearest emergency room and bring with you the packaging of
the medicine.

If you forget to take Presdiur
If you forget to take a dose, take the normal dose the next day as usual.

Do nottake a double dose to make up for a 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 the use of this medicine, ask 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 that may affect the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords) together with itching and skin rash, which may occur rarely. If this happens, stop treatment with Presdiur and contact yourdoctor immediately.
• Presdiur may cause a greater decrease in blood pressure in more sensitive individuals or as a result of an allergic reaction. Dizziness or fainting may occur infrequently. If this happens, stop treatment with Presdiur, contact yourdoctor immediately and lie down.
• Frequency not known: if you experience yellowing of the whites of your eyes, dark urine, skin itching, even if you have been taking Presdiur for a long time, contact yourdoctor immediatelywho will evaluate the symptoms and decide how to proceed with therapy for the treatment of high blood pressure.

Presdiur is a combination of two active ingredients and the following information provides firstly
other side effects reported so far with the combination Presdiur (in addition to those already mentioned above) and,
secondly, those that are known with respect to the individual active ingredients separately.

These are other side effects known so far with Presdiur:
If the following side effects occur, they may be mild and you will not need to
interrupt the 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 heart rate (palpitations), skin rash, eczema, vertigo, cough, indigestion,
abdominal pain, nausea, vomiting, diarrhea, muscle cramps and muscle pain, joint pain,
arms and legs, back pain, difficulty getting an erection in men, blood in the urine.
Changes have been observed non-commonly in blood test results and
include:
Increased levels of fats in the blood, increased urea or uric acid in the blood, increased
creatinine, increased or decreased levels of potassium in the blood, increased levels of calcium in
the blood, increased blood sugar, increased liver function indices.
The doctor will check these with a blood test and tell you if anything needs to be done.

Rare side effects (may affect up to 1 in 1,000 people):
Feeling unwell, altered consciousness, skin swellings (hives), acute renal failure.
Changes have been observed rarely in blood test results and include:
Increased azotemia, decreased values of hemoglobin and hematocrit.
The doctor will check these with a blood test and inform you if anything needs to be done.

Other side effects reported after the use of olmesartan medoxomil or hydrochlorothiazide alone, but
not with Presdiur or with a 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, diarrhea, nausea,
gastroenteritis, joint or bone pain, back pain, blood in the urine, urinary tract infections, flu-like
symptoms, pain.
Changes have been observed commonly in blood test results and include:
Increased levels of fats in the blood, increased urea or uric acid in the blood, increased
liver and muscle function indices.

Uncommon side effects (may affect up to 1 in 100 people):
Immediate allergic reactions that may affect the whole body and may cause breathing problems, as well as a rapid drop in blood pressure that may also 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 eruption), skin swellings (hives).
Changes have been observed non-commonly in blood test results and
include:
Reduced number of some blood cells, known as platelets (thrombocytopenia).

Rare side effects (may affect up to 1 in 1,000 people):
Impaired kidney function, loss of strength.
Changes have been observed rarely in blood test results 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 of confusion, abdominal pain, stomach pain, feeling of fullness, diarrhea, nausea,
vomiting, constipation, excretion of glucose in the urine.
Changes have been observed in blood test results and include:
Increased levels of creatinine in the blood, urea, calcium and sugar, decreased chloride in the
blood, potassium, magnesium and sodium levels. Increased serum amylase
(hyperamylasemia).

Uncommon side effects (may affect up to 1 in 100 people):
Decreased or loss of appetite, severe difficulty breathing, anaphylactic skin reactions
(hypersensitivity reactions), worsening of pre-existing myopia, erythema, skin reactions to
light, itching, purple spots or spots on the skin due to small hemorrhages (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, anemia, bone marrow damage, restlessness, feeling down or depressed, sleep disorders, feeling of disinterest (apathy), numbness and tingling, seizures, yellowish appearance of objects you observe, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, inflammation of the pancreas, jaundice, infection of the
gallbladder, symptoms of systemic lupus erythematosus (such as rash, joint pain and cold hands and
fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes caused by
impaired movements).

Very rare side effects (may affect up to 1 in 10,000 people):
Electrolyte disturbances leading to an abnormal level of chloride loss in the blood (hypochloremic alkalosis),
acute respiratory distress (signs include severe shortness of breath, fever, weakness and
confusion).

Not known (frequency cannot be estimated based on available data):
Rapid onset of distant vision impairment (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).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly
through 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 package to protect from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Presdiur contains

• The active ingredients 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 and 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, with
bevelled edge, with the C3 brand mark imprinted 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,
with markings on both sides; dimensions 15 mm x 8 mm. The score line is only to facilitate
swallowing and not 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 Authorisation 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