PLAUNAZIDE

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

olmesartan medoxomil/hydrochlorothiazide
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 may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT PLAUNAZIDE IS AND WHAT IT IS USED FOR

PLAUNAZIDE contains two substances called olmesartan medoxomil and hydrochlorothiazide. Both
are used to control high blood pressure (hypertension).

• Olmesartan medoxomil belongs to a group of medicines known as “angiotensin II receptor antagonists”. It reduces blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of substances called “thiazide diuretics”. It reduces blood pressure by helping the body get rid of excess fluid, increasing urine production by the kidneys.

You will be given PLAUNAZIDE if PLAUNAC (olmesartan medoxomil) alone has not adequately controlled your blood pressure. When administered together, the two active ingredients in PLAUNAZIDE help reduce blood pressure more than when given separately.
If you are already taking medicines to treat high blood pressure, your doctor may prescribe PLAUNAZIDE to achieve a further reduction.
High blood pressure can be controlled with medicines such as PLAUNAZIDE 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 dietary salt). Your doctor may also have encouraged you to exercise regularly, such as walking or swimming. It is important that you follow these recommendations from your doctor.

2. WHAT YOU SHOULD KNOW BEFORE TAKING PLAUNAZIDE

Do not take PLAUNAZIDE

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

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

Warnings and precautions

Talk to your doctor before taking PLAUNAZIDE.

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

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

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (for example potassium) in your blood at regular intervals.

See also the information under the heading "Do not take PLAUNAZIDE".

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

• Mild or moderate kidney problems, or if you have recently undergone a kidney transplant.
• Liver disease.
• Heart failure or problems with heart valves or heart muscle.
• Severe or prolonged vomiting or diarrhoea lasting several days.
• Treatment with high doses of diuretics or if you are on a low-salt diet.
• Adrenal gland disorders (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 sun exposure and UV radiation during treatment with PLAUNAZIDE.

Inform your doctor if any of the following symptoms occur:

• Severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
• Vision disturbances or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which may occur within hours or weeks of taking PLAUNAZIDE. If untreated, this increase in pressure may lead to permanent vision impairment.

Your doctor may want to examine you more frequently and order blood tests if you have any of the conditions listed above.

PLAUNAZIDE may increase levels of fats and uric acid in the blood (which can cause gout – painful joint swelling). Your doctor may wish to perform periodic blood tests to monitor these conditions.

Levels of certain substances called electrolytes in the blood may become altered. Your doctor may wish to perform periodic blood tests to monitor these conditions. Signs of electrolyte imbalance include: thirst, dry mouth, muscle pain or cramps, muscle weakness, fatigue, low blood pressure (hypotension), feeling weak, lethargic, tired, drowsy or unrested, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if these symptoms occur.

As with any medicine that lowers blood pressure, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.

If you need to undergo tests for parathyroid function, you must stop taking PLAUNAZIDE before the tests.

If you participate in sports, this medicine may affect the results of anti-doping tests, causing a positive result.

Inform your doctor if you think you may be pregnant or plan to become pregnant.

PLAUNAZIDE is not recommended during early pregnancy and must not be taken after the third month of pregnancy as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy and breastfeeding”).

Children and adolescents

PLAUNAZIDE is not recommended for use in children and adolescents under 18 years of age.

Other medicines and PLAUNAZIDE

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) may enhance the effect of PLAUNAZIDE. Your doctor may need to adjust the dose and/or take additional precautions. If you are taking an ACE inhibitor or aliskiren (see also the sections "Do not take PLAUNAZIDE" and "Warnings and precautions").

• Medicines that may alter potassium levels in the blood when used concomitantly with PLAUNAZIDE. These include:

  o potassium supplements (such as salt substitutes containing potassium)
  o diuretics
  o heparin (used to thin the blood)
  o laxatives
  o steroids
  o adrenocorticotropic hormone (ACTH)
  o carbenoxolone (a medicine used to treat mouth and stomach ulcers)
  o sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic)
  o certain painkillers such as aspirin or salicylates

• Lithium (a medicine used to treat mood swings and certain types of depression) used together with PLAUNAZIDE may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.

• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to reduce pain, swelling and other symptoms of inflammation, including arthritis) used together with PLAUNAZIDE may increase the risk of kidney failure. The effectiveness of PLAUNAZIDE may be reduced by NSAIDs.

• Sleeping pills, sedatives and antidepressants, when used together with PLAUNAZIDE, 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 medicines used in cancer treatment, such as cyclophosphamide or methotrexate.

• Cholestyramine and colestipol, medicines used to reduce blood fat levels.

• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of PLAUNAZIDE. Your doctor may advise you to take PLAUNAZIDE at least 4 hours before colesevelam hydrochloride.

• Anticholinergic medicines, such as atropine and biperiden.

• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol, used to treat certain psychiatric conditions.

• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol or digitalis, used to treat heart conditions.

• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or intravenous erythromycin, which may affect heart rhythm.

• Oral antidiabetic medicines, such as metformin, or insulin, used to reduce blood glucose levels.

• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood glucose levels, respectively, as PLAUNAZIDE 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.

• Difemanil, 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 PLAUNAZIDE.

• Cisapride, used to increase the movement of food through the stomach and intestines.

• Halofantrine, used for malaria.

PLAUNAZIDE with food and drinks

PLAUNAZIDE can be taken with or without food. Be cautious when consuming alcohol during treatment with PLAUNAZIDE, as some people may feel weak or dizzy. If this happens, do not drink any more alcohol, including wine, beer or flavoured alcoholic beverages.

Patients of Black ethnicity

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you may be pregnant or if you are planning to become pregnant. Your doctor will usually advise you to stop taking PLAUNAZIDE before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. PLAUNAZIDE is not recommended during pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if taken after this time (see section “Pregnancy and breastfeeding”).

Breastfeeding

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

If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, 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.

PLAUNAZIDE contains lactose

This medicine contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE PLAUNAZIDE

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

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
However, the following two adverse reactions can 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 PLAUNAZIDE and contact your doctor immediately.
• PLAUNAZIDE may cause excessive lowering of blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting are not very common. If this happens, stop taking PLAUNAZIDE, contact your doctor immediately and lie down.

PLAUNAZIDE is a combination of two active substances, and the information below first lists the other adverse reactions reported so far with the combination PLAUNAZIDE (in addition to those already mentioned above), followed by those known for the individual active substances.

Other possible adverse reactions known so far with PLAUNAZIDE:
If these adverse reactions occur, they are often mild and you should not stop treatment with PLAUNAZIDE.

Common adverse reactions (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of ankles, feet, legs, hands or arms.

Uncommon adverse reactions (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle pain and muscle cramps, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine.
Uncommonly, some laboratory test abnormalities have also been observed, including: increased levels of lipids in blood, increased levels of urea or uric acid in blood, increased creatinine, increased or decreased levels of potassium in blood, increased levels of calcium in blood, increased blood glucose, increased liver function tests. Your doctor will detect these from blood tests and will advise you if any action is needed.

Rare adverse reactions (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances of consciousness, skin blisters (wheals), acute renal failure.
Rarely, some laboratory test abnormalities have also been observed, including:
increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will detect these from blood tests and will advise you if any action is needed.

Additional adverse reactions reported with olmesartan medoxomil or hydrochlorothiazide used alone, but not with PLAUNAZIDE or with higher frequency:

Olmesartan medoxomil
Common adverse reactions (may affect up to 1 in 10 people):
Bronchitis, cough, nasal hypersecretion, dry throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.
Commonly observed laboratory test abnormalities include: increased lipid levels in blood, increased urea or uric acid levels in blood, increased liver and muscle function tests.

Uncommon adverse reactions (may affect up to 1 in 100 people):
Rapid allergic reactions affecting the whole body, which may cause breathing difficulties or a sudden drop in blood pressure leading to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, exanthema (skin rash), skin blisters (wheals).
Uncommonly observed laboratory test abnormalities include: reduced number of platelets (thrombocytopenia).

Rare adverse reactions (may affect up to 1 in 1,000 people):
Impaired renal function, weakness.
Rarely, the following laboratory test abnormalities have also been observed:
increased potassium levels in blood.

Hydrochlorothiazide
Very common adverse reactions (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of fats and uric acid in blood.

Common adverse reactions (may affect up to 1 in 10 people):
Feeling confused, abdominal pain, gastric disturbances, bloating sensation, diarrhoea, nausea, vomiting, constipation, glucose excretion in urine.
Laboratory test abnormalities observed include: increased creatinine, urea, calcium and glucose levels in blood, decreased chloride, potassium, magnesium and sodium levels in blood. Increased serum amylase (hyperamylasemia).

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

Rare adverse reactions (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 and cold hands and fingers, allergic skin reactions, skin exfoliation and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).

Very rare adverse reactions (may affect up to 1 in 10,000 people):
Electrolyte imbalances causing abnormally low chloride levels in blood (hypochloremic alkalosis).
Intestinal obstruction (paralytic ileus).

Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):
Decreased vision or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Skin and lip cancer (non-melanoma skin cancer).

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

5. HOW TO STORE PLAUNAZIDE

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What PLAUNAZIDE contains
The active substances are:
PLAUNAZIDE 20 mg/12.5 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 12.5 mg of hydrochlorothiazide.
PLAUNAZIDE 20 mg/25 mg: each film-coated tablet contains 20 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.

The excipients are:
Microcrystalline cellulose, lactose monohydrate*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, hypromellose, iron (III) oxide (E172).
*See the section "PLAUNAZIDE contains lactose" above.

Description of the appearance of PLAUNAZIDE and contents of the pack
PLAUNAZIDE 20 mg/12.5 mg film-coated tablets are reddish-yellow, round, 8.5 mm in diameter, with the code "C22" engraved on one side.
PLAUNAZIDE 20 mg/25 mg film-coated tablets are pink, round, 8.5 mm in diameter, with the code "C24" engraved on one side.

PLAUNAZIDE is available in packs containing 14, 28, 30, 56, 84, 90, 98, and 10x28 film-coated tablets, and in packs containing 10, 50 and 500 film-coated tablets in unit-dose divisible blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 – Luxembourg
under license from Daiichi Sankyo Europe GmbH
Sales concessionaire:
Laboratori Guidotti S.p.A. – Via Livornese 897, La Vettola - Pisa

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
Menarini Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden (Germany)

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Olmes plus
Italy: Plaunazide
Spain: Openvas Plus

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

olmesartan medoxomil/hydrochlorothiazide
Please read this entire 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, consult 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 reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Plaunazide is and what it is used for
2. What you need to know before taking Plaunazide
3. How to take Plaunazide
4. Possible side effects
5. How to store Plaunazide
6. Package contents and other information

1. What PLAUNAZIDE is and what it is used for

Plaunazide contains two active substances called olmesartan medoxomil and hydrochlorothiazide, which are used
for the treatment of high blood pressure (hypertension).

• 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”. It reduces blood pressure by helping the body get rid of excess fluid, by making the kidneys produce more urine.

You will be given Plaunazide if Plaunac (olmesartan medoxomil) alone has not adequately controlled your
blood pressure. When administered together, the two active substances in Plaunazide help reduce blood pressure more than when given separately.
You may already be taking medicines to treat high blood pressure, but your doctor may prescribe Plaunazide to achieve a further reduction.
High blood pressure can be controlled with medicines such as Plaunazide 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 dietary salt). 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 PLAUNAZIDE

Do not take PLAUNAZIDE

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

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

Warnings and precautions

Talk to your doctor before taking Plaunazide.

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

• an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

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 section "Do not take Plaunazide".

Before taking this medicine, consult your doctor if you also 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 or diarrhoea lasting several days.
• Treatment with high doses of diuretics or if you are on a low-salt diet.
• Adrenal gland problems (e.g. primary aldosteronism).
• Diabetes.
• Lupus erythematosus (an autoimmune disease).
• Allergies or asthma.
• If you have previously had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays during treatment with Plaunazide.

Inform your doctor if any of the following symptoms occur:

• Severe and prolonged diarrhoea with significant weight loss. Your doctor will assess your symptoms and decide whether to continue this antihypertensive treatment.
• Vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in your eye, which can occur within hours or weeks of taking Plaunazide. If untreated, this increase can lead to permanent vision impairment.

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

Plaunazide may increase blood levels of fats and uric acid (which causes gout – painful joint swelling). Your doctor will likely perform periodic blood tests to monitor these conditions.

It may alter levels of certain substances called electrolytes in your 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, apathetic, tired, drowsy or restless, nausea, vomiting, reduced need to urinate, rapid heartbeat. Inform your doctor if these symptoms occur.

As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.

If you are undergoing tests for parathyroid function, you must stop taking Plaunazide before the tests.

If you are an athlete, this medicine may affect the results of anti-doping tests, causing a positive result.

Inform your doctor if you think you are pregnant or planning to become pregnant. Plaunazide is not recommended in 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

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

Other medicines and Plaunazide

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) may enhance the effect of Plaunazide. Your doctor may consider adjusting the dose and/or taking other precautions. If you are taking an ACE inhibitor or aliskiren (see also sections "Do not take Plaunazide" and "Warnings and precautions").
• Medicines that may alter potassium levels in the blood when used concomitantly with Plaunazide. These include: potassium supplements (such as potassium-containing salt substitutes), diuretics, heparin (a blood thinner), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (also known as benzylpenicillin sodium, an antibiotic), or certain painkillers such as aspirin or salicylates.
• Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Plaunazide may increase lithium toxicity. If you are taking lithium, your doctor will monitor your blood lithium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis, taken together with Plaunazide may increase the risk of kidney failure. The effectiveness of Plaunazide may be reduced by NSAIDs.
• Sleeping pills, sedatives, and antidepressants, when taken with Plaunazide, 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 treatment medicines such as cyclophosphamide or methotrexate.
• Cholestyramine and colestipol, medicines used to reduce blood fats.
• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may reduce the effect of Plaunazide. Your doctor may advise you to take Plaunazide at least 4 hours before colesevelam hydrochloride.
• Anticholinergic medicines such as atropine and biperiden.
• Medicines such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol, used to treat certain psychiatric conditions.
• Certain medicines such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, or digitalis, used to treat heart conditions.
• Medicines such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin, which may affect heart rhythm.
• Oral antidiabetic medicines such as metformin or insulin, used to lower blood glucose levels.
• Beta-blockers and diazoxide, medicines used to treat high blood pressure or low blood sugar, respectively, as Plaunazide may enhance their hypotensive and hyperglycaemic effects.
• 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 drug.
• 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 Plaunazide.
• Cisapride, used to increase movement of food through the stomach and intestine.
• Halofantrine, used for malaria.

Plaunazide with food and drinks

Plaunazide can be taken with or without food. Be cautious when consuming alcohol during treatment with Plaunazide, as some people may experience fainting or dizziness. If this happens, do not drink any more alcohol, including wine, beer, or carbonated alcoholic beverages.

Patients of Black ethnicity

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

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are pregnant or if you plan to become pregnant. Your doctor will usually advise you to stop taking Plaunazide before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Plaunazide 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 during this period.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed. Plaunazide is not recommended for nursing mothers, and your doctor may choose another treatment if you wish to breastfeed.

If you are pregnant, breastfeeding, suspect 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 antihypertensive treatment. If so, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

Plaunazide contains lactose

This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. How to take PLAUNAZIDE

Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is one tablet of Plaunazide 40 mg/12.5 mg daily. However, if your blood
pressure is not adequately controlled, your doctor may decide to change your prescription to one tablet
of Plaunazide 40 mg/25 mg daily.
Swallow the tablets with a little water. If possible, take your dose at the same time every day, for example
with breakfast. It is important to keep taking Plaunazide for as long as your doctor tells you to.
If you take more Plaunazide 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 room, taking the medicine pack with you.
If you forget to take Plaunazide
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 Plaunazide
It is important to continue taking Plaunazide 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 adverse effects

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

• Allergic reactions affecting the 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 Plaunazide and contact your doctor immediately.
• Plaunazide may cause an excessive reduction in blood pressure in predisposed individuals or as a result of an allergic reaction. Dizziness or fainting may occur not uncommonly. If this happens, stop taking Plaunazide, contact your doctor immediately and lie down.

Plaunazide is a combination of two active substances, and the information below first lists the other adverse effects reported so far with the Plaunazide combination (in addition to those already mentioned above), followed by those known for the individual active substances.
Other adverse effects currently known for Plaunazide:
If these adverse effects occur, they are often mild and treatment with Plaunazide does not need to be discontinued.
Common adverse effects (may affect up to 1 in 10 people):
Dizziness, weakness, headache, fatigue, chest pain, swelling of the ankles, feet, legs, hands or arms.
Uncommon adverse effects (may affect up to 1 in 100 people):
Awareness of heartbeat (palpitations), skin rash, eczema, vertigo, cough, indigestion, abdominal pain, nausea, vomiting, diarrhoea, muscle cramps, muscle pain, joint pain, pain in arms and legs, back pain, erectile dysfunction in men, blood in urine. Uncommonly, some laboratory test abnormalities have also been observed, including: increased levels of fats in the blood, increased levels of urea or uric acid in the blood, increased creatinine, increased or decreased potassium levels in the blood, increased calcium levels in the blood, increased blood glucose, increased liver function tests. Your doctor will become aware of these from blood tests and will inform you if any action is needed.
Rare adverse effects (may affect up to 1 in 1,000 people):
Feeling unwell, disturbances in consciousness, skin blisters (wheals), acute renal failure. Rarely, some laboratory test abnormalities have also been observed, including: increased blood urea nitrogen, decreased haemoglobin and haematocrit values. Your doctor will become aware of these from blood tests and will inform you if any action is needed.

Additional adverse effects reported with olmesartan medoxomil or hydrochlorothiazide used alone,
but not with Plaunazide or with higher frequency:

Olmesartan medoxomil
Common adverse effects (may affect up to 1 in 10 people):
Bronchitis, cough, runny or stuffy nose, sore throat, abdominal pain, indigestion, diarrhoea, nausea, gastroenteritis, joint or bone pain, back pain, blood in urine, urinary tract infection, influenza-like symptoms, pain.
Commonly, some laboratory test abnormalities have also been 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 adverse 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 that may lead to fainting (anaphylactic reactions), facial swelling, angina (chest pain or discomfort, known as angina pectoris), feeling unwell, allergic skin reaction, itching, exanthema (skin rash), skin blisters (wheals).
Uncommonly, some laboratory test abnormalities have also been observed, including: reduced number of certain blood cells called platelets (thrombocytopenia).
Rare adverse effects (may affect up to 1 in 1,000 people):
Impaired renal function, weakness.
Rarely, some laboratory test abnormalities have also been observed, including increased potassium levels in the blood.

Hydrochlorothiazide
Very common adverse effects (may affect more than 1 in 10 people):
Laboratory test abnormalities including: increased levels of fats and uric acid in the blood.
Common adverse effects (may affect up to 1 in 10 people):
Confusion, abdominal pain, gastric disturbances, bloating, diarrhoea, nausea, vomiting, constipation, glucose excretion 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 adverse 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 adverse effects (may affect up to 1 in 1,000 people):
Swollen and painful salivary glands, decreased white blood cell count, decreased platelet count, anaemia, bone marrow damage, restlessness, feeling depressed, sleep disorders, lack of interest (apathy), tingling and numbness, seizures, yellow vision, blurred vision, dry eyes, irregular heartbeat, inflammation of blood vessels, blood clots (thrombosis or embolism), lung inflammation, fluid accumulation in the lungs, pancreatitis, jaundice, gallbladder infection, symptoms of systemic lupus erythematosus (such as skin rash, joint pain, and cold hands and fingers), allergic skin reactions, skin peeling and blisters, non-infectious kidney inflammation (interstitial nephritis), fever, muscle weakness (sometimes causing motor limitations).
Very rare adverse 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).
Adverse effects with unknown frequency (frequency cannot be estimated from the available data):
Vision loss or eye pain (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Skin and lip cancer (non-melanoma skin cancer).

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

5. How to store PLAUNAZIDE

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Plaunazide contains
The active substances are:
Plaunazide 40 mg/12.5 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and
12.5 mg of hydrochlorothiazide.
Plaunazide 40 mg/25 mg: each film-coated tablet contains 40 mg of olmesartan medoxomil and
25 mg of hydrochlorothiazide.
The other components are:
Microcrystalline cellulose, lactose monohydrate*, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate, titanium dioxide (E171), talc, hypromellose, iron (III) oxide (E172).
*See the section “Plaunazide contains lactose” above.

Description of the appearance of Plaunazide and pack contents
Plaunazide 40 mg/12.5 mg, film-coated tablets, oval, 15x7 mm, yellowish-red in colour, with the code “C23” engraved on one side;
Plaunazide 40 mg/25 mg, film-coated tablets, oval, 15x7 mm, pink in colour, with the code “C25” engraved on one side.
Plaunazide is available in packs containing 14, 28, 30, 56, 84, 90, 98, 10x28, 10x30 film-coated tablets, and in packs of 10, 50 and 500 film-coated tablets with pre-scored blisters for single-dose administration.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 – Luxembourg
Sales Licence Holder:
Laboratori Guidotti S.p.A. – Via Livornese 897, 56010 La Vettola – Pisa, Italy

Manufacturer
Daiichi Sankyo Europe GmbH
Luitpoldstrasse, 1
85276 Pfaffenhofen (Germany)
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin (Germany)
Menarini Von Heyden GmbH
Leipziger Strasse 7-13,
01097 Dresden (Germany)

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Olmes Plus
Italy: Plaunazide
Spain: Openvas Plus