Lobidiur: detailed information

Package leaflet: Information for the user

Lobidiur 5 mg/12.5 mg film-coated tablets

Nebivolol / hydrochlorothiazide
Read this entire leaflet carefully before you start using 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 effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:

What Lobidiur is and what it is used for
What you need to know before taking Lobidiur
How to take Lobidiur
Possible side effects
How to store Lobidiur
Contents of the pack and other information

1. WHAT LOBIDIUR IS AND WHAT IT IS USED FOR

Lobidiur contains nebivolol and hydrochlorothiazide as active substances.
Nebivolol is a cardiovascular medicine belonging to the group of selective beta-blocking agents
(i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and controls the force of the heart's pumping action. Additionally, it exerts a dilating effect on blood vessels, helping to lower blood pressure.
Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced by the patient.
Lobidiur combines nebivolol and hydrochlorothiazide in a single tablet. It is used to treat high blood pressure (arterial hypertension). It is used instead of the two separate medicines in patients who are already taking them together.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LOBIDIUR

Do not take Lobidiur:

if you are allergic to nebivolol or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic (hypersensitive) to other sulfonamide-derived substances (such as hydrochlorothiazide, which is a sulfonamide-derived drug);
if you have one or more of the following conditions:
o very slow heart rate (less than 60 beats per minute);
o other serious heart rhythm disorders (e.g. sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block);
o recently developed or recently worsened heart failure, or if you are being treated for circulatory shock due to acute heart failure with intravenous therapy to support heart function;
o low blood pressure;
o severe circulatory problems in the arms or legs;
o untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands);
o severe kidney problems, complete absence of urine (anuria);
o a metabolic disorder (metabolic acidosis), such as diabetic ketoacidosis;
o asthma or breathing difficulties (current or past);
o impaired liver function;
o high levels of calcium in the blood, low levels of potassium and sodium in the blood (persistent and resistant to treatment);
o high levels of uric acid with symptoms of gout;

Warnings and precautions
Talk to your doctor or pharmacist before taking LOBIDIUR.

Inform your doctor if you notice or develop any of the following conditions:
o a type of chest pain caused by spontaneous spasm of blood vessels supplying the heart, known as Prinzmetal's angina;
o first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm);
o abnormally slow heartbeat;
o untreated chronic heart failure;
o lupus erythematosus (a disorder of the immune system, the body's defense system);
o psoriasis (a skin disease causing scaly pink patches), or if you have previously suffered from psoriasis;
o overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat caused by this condition;
o poor circulation in the arms or legs, for example Raynaud's disease or syndrome, cramps when walking;
o allergies: this medicine may intensify your reactions to pollen or other substances you are allergic to;
o prolonged breathing difficulties;
o diabetes: this medicine may mask warning signs of low blood glucose (e.g. palpitations, rapid heartbeat); your doctor will also advise you to monitor your blood glucose more frequently when taking Lobidiur, as it may be necessary to adjust the dose of your antidiabetic medications;
o kidney problems: your doctor will monitor your kidney function to ensure it does not worsen. Do not take Lobidiur if you have severe kidney problems (see section "Do not take Lobidiur");
o if you tend to have low potassium levels in the blood, especially if you have long QT syndrome (a type of electrocardiographic abnormality) or if you are taking digitalis (to support your heart pump); you are more likely to have low potassium levels if you have liver cirrhosis, rapid fluid loss after intensive diuretic therapy, or inadequate potassium intake through food and drinks;
o if you are undergoing surgery, always inform the anaesthetist that you are being treated with Lobidiur before receiving anaesthesia;
o 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 non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV radiation during treatment with Lobidiur.
Lobidiur may increase blood lipid levels and uric acid levels. It may affect levels of certain chemicals in the blood called electrolytes: your doctor will periodically check these with a blood test.
The hydrochlorothiazide contained in Lobidiur may make your skin hypersensitive to sunlight or artificial UV light. Stop taking Lobidiur and contact your doctor if you develop a skin rash, itchy spots, or skin sensitivity during treatment (see also section 4).
Anti-doping tests: Lobidiur may cause a positive result in anti-doping tests.

Children and adolescents
Due to lack of data on the use of the product in children and adolescents, the use of Lobidiur is not recommended for these age groups.

Other medicines and Lobidiur
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Always inform your doctor if you are using or have recently been given any of the following medicines in addition to Lobidiur.

Medicines that, like Lobidiur, may affect blood pressure and/or heart function:
- Medicines for controlling blood pressure or heart problems (e.g. amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecainide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine, mexiletine, methyldopa, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, sotalol, verapamil);
- Sedatives and treatments for psychosis (a mental illness), e.g. amisulpride, barbiturates (also used for epilepsy), chlorpromazine, chlordiazepoxide, droperidol, haloperidol, levomepromazine, narcotics, phenothiazines (also used for nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine;
- Medicines for depression, e.g. amitriptyline, fluoxetine, paroxetine;
- Medicines used for anaesthesia during surgery;
- Medicines for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation (enlargement);
- Baclofen (a muscle relaxant drug);
- Amifostine (a protective agent used during anti-tumor therapy).
Medicines whose effect or toxicity may be increased by Lobidiur:
- Lithium (used as a mood stabilizer);
- Cisapride (used for digestive problems);
- Bepridil (used for angina);
- Difemanil (used for excessive sweating);
- Medicines used for infections: intravenous or injected erythromycin, pentamidine, sparfloxacin, amphotericin, sodium penicillin G, halofantrine (used for malaria);
- Vincamine (used for cerebral circulation disorders);
- Mizolastine and terfenadine (used for allergies);
- Diuretics and laxatives;
- Medicines used to treat acute inflammation: steroids (e.g. cortisone and prednisone), ACTH (adrenocorticotropic hormone), and medicines derived from salicylic acid (e.g. acetylsalicylic acid/aspirin and other salicylates);
- Carbenoxolone (used for heartburn and gastric ulcer);
- Calcium salts (used as supplements for bone health);
- Medicines used to relax muscles (e.g. tubocurarine);
- Diazoxide, used to treat hypoglycemia and hypertension;
- Amantadine, an antiviral drug;
- Cyclosporine, used to suppress the body's immune response;
- Iodinated contrast media, used as contrast agents in X-rays;
- Anti-cancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate).
Medicines whose effect may be reduced by Lobidiur:
- Medicines that lower blood glucose levels (insulin and oral antidiabetics, metformin);
- Medicines for gout (e.g. allopurinol, probenecid, sulfinpyrazone);
- Medicines such as noradrenaline, used to treat low blood pressure or slow heart rate (bradycardia).
Non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation, as these may reduce the blood pressure-lowering effect of Lobidiur.
Medicines for excess stomach acid or ulcers (antacids): you should take Lobidiur with a meal and antacids between meals.

Lobidiur and alcohol
When taking Lobidiur, be careful not to drink alcohol, as you may feel confused or dizzy. If this occurs, do not drink alcohol, including wine, beer, or low-alcohol beverages.

Pregnancy and breastfeeding
You must inform your doctor if you are pregnant or think you may be pregnant. Your doctor will usually advise you to take another medicine instead of LOBIDIUR, as LOBIDIUR is not recommended during pregnancy. This is because the active ingredient hydrochlorothiazide crosses the placenta. The use of LOBIDIUR during pregnancy may cause potentially harmful effects on the fetus and newborn.

Inform your doctor if you are breastfeeding or planning to breastfeed. LOBIDIUR is not recommended for women who are breastfeeding.

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

Driving and using machines
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive and do not operate machinery.

Lobidiur contains lactose and sodium
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE LOBIDIUR

Always take this medicine exactly as directed by your doctor. If you have any doubts, you must consult your doctor.
Take one tablet daily with some water, preferably at the same time each day.
Lobidiur may be taken before, during, or after meals, or alternatively, independently of meals.
Use in children and adolescents
Do not administer Lobidiur to children or adolescents.
The score line is intended only to facilitate breaking the tablet if you have difficulty swallowing it whole.
If you take more Lobidiur than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or pharmacist immediately. The most common symptoms and signs of overdose include very slow heartbeat (bradycardia), low blood pressure with possible fainting, shortness of breath resembling asthma, acute heart failure, excessive urination leading to dehydration, nausea and drowsiness, muscle spasms, and disturbances in heart rhythm (especially if you are also taking digitalis or medicines for heart rhythm disorders).
If you forget to take Lobidiur
If you forget to take a dose of Lobidiur but remember shortly afterwards, you may take the missed dose as usual. However, if a significant amount of time has passed (for example, several hours), such that it is nearly time for the next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose. However, avoid repeatedly missing doses.
If you stop taking Lobidiur
You must always consult your doctor before stopping treatment with Lobidiur.
If you have any questions about the use of this product, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following side effects have been reported with nebivolol:

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

headache
dizziness
fatigue
unusual sensations of burning, tingling, itching, or pins and needles
diarrhoea
constipation
nausea
shortness of breath
swelling of the hands and feet

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

slowed heart rate or other heart disorders
low blood pressure
cramp-like leg pain while walking
abnormal vision
impotence
feeling of depression
difficulty in digestion, stomach or intestinal gas, vomiting
skin rashes, itching
shortness of breath resembling asthma due to sudden cramps in the airway muscles (bronchospasm)
nightmares

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

fainting
worsening of psoriasis (a skin disease causing scaly pink patches)

The following adverse reactions have been reported only in isolated cases:

widespread allergic reactions, including generalized skin rashes (hypersensitivity reactions)
rapidly developing swelling, especially around the lips, eyes, or tongue, possibly with sudden breathing difficulties (angioedema)
a type of skin rash characterized by itchy, raised, light-red wheals, either allergic or non-allergic in nature (urticaria)

With hydrochlorothiazide, the following adverse reactions have been reported:
Frequency “not known”: skin and lip cancer (non-melanoma skin cancer)

Allergic reactions

generalized allergic reaction (anaphylactic reaction)

Heart and circulation

disturbances in heart rhythm, palpitations
changes in the electrocardiogram
sudden fainting upon standing, formation of blood clots in veins (thrombosis) and embolism, circulatory collapse (shock)

Blood

changes in blood cell counts, such as: decreased white blood cells, decreased platelets, decreased red blood cells; reduced production of new blood cells by the bone marrow
altered levels of body fluids (dehydration) and blood electrolytes, particularly decreased potassium, sodium, magnesium, chloride, and increased calcium
increased levels of uric acid, gout, increased blood glucose, diabetes, metabolic alkalosis (a metabolic disorder), increased cholesterol and triglycerides

Stomach and intestine

loss of appetite, dry mouth, nausea, vomiting, stomach discomfort, abdominal pain, diarrhoea, reduced bowel movements (constipation), absence of bowel movements (paralytic ileus), flatulence
inflammation of the glands producing saliva, inflammation of the pancreas, increased levels of blood amylase (a pancreatic enzyme)
yellowing of the skin (jaundice), inflammation of the gallbladder

Chest

breathing difficulties, inflammation of the lungs (pneumonia), formation of fibrous tissue in the lungs (interstitial pneumonitis), accumulation of fluid in the lungs (pulmonary edema)

Nervous system

dizziness (sensation of spinning)
seizures, reduced level of consciousness, coma, headache, dizziness
apathy, confusion, depression, nervousness, restlessness, sleep disturbances
unusual burning, tingling, itching, or pins and needles sensations in the skin
muscle weakness (paresis)

Skin and hair

itching, purple spots or patches on the skin (purpura), urticaria, increased sensitivity of the skin to sunlight, skin rashes, facial rash and/or patchy redness that may cause scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue death (necrotizing vasculitis), exfoliation, redness, looseness, and blistering of the skin (toxic epidermal necrolysis)

Eyes and ears

yellow vision, blurred vision, worsening of myopia, reduced tear production

Muscles and joints

muscle spasm, muscle pain

Urinary system

kidney dysfunction, acute kidney failure (reduced urine production and accumulation of fluids and waste products in the body), inflammation of connective tissue within the kidneys (interstitial nephritis), sugar in the urine

Sexual organs

erectile dysfunction

General/Other

general weakness, fatigue, fever, thirst

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
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 LOBIDIUR

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 no longer required. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Lobidiur contains
The active substances are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol
(as nebivolol hydrochloride: 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol) and 12.5 mg of
hydrochlorothiazide.
The excipients are:

tablet core: monohydrate lactose, polysorbate 80 (E433), hypromellose (E464), maize starch, sodium croscarmellose (E468), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572)
tablet coating: macrogol 40 stearate type I, titanium dioxide (E171), carmine (carminic acid on aluminium lake, E120), hypromellose (E464), microcrystalline cellulose (E460)

Description of the appearance of Lobidiur and pack contents
Lobidiur is available as round, slightly biconvex, pink film-coated tablets, marked “5/12.5” on one side and a division line on the other side, in packs of 7, 14, 28, 30, 56, and 90 film-coated tablets.
The tablets are supplied in blisters (PP/COC/PP/aluminium).
(It is possible that not all pack sizes are marketed)

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare L-1611 Luxembourg
Marketing Authorization Holder for sale:
A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi 3, Florence, Italy

Manufacturer
Berlin-Chemie AG
Glienicker Weg 125, 12489 Berlin, Germany
or
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13, 01097 Dresden, Germany
or
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Sette Santi 3, 50131 Florence, Italy

This medicinal product is authorized in the European Economic Area member states under the following names:
Austria: Nomexor Plus HTC
Belgium: Hyporetic
France: CONEBILOX
Greece: Hypoloc plus
Iceland: Nebilet Comp
Ireland: Nebilet Plus
Italy: Lobidiur
Luxembourg: Hyporetic
Portugal: Hypoloc Plus
Spain: Silostar plus
Netherlands: Hyporetic
United Kingdom: Nebizide

Package leaflet: Information for the user

Lobidiur 5 mg/25 mg film-coated tablets

Nebivolol / hydrochlorothiazide
Please read this leaflet carefully before using 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. Never give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

What Lobidiur is and what it is used for
What you need to know before taking Lobidiur
How to take Lobidiur
Possible side effects
How to store Lobidiur
Contents of the pack and other information

1. WHAT LOBIDIUR IS AND WHAT IT IS USED FOR

Lobidiur contains nebivolol and hydrochlorothiazide as active substances.
Nebivolol is a cardiovascular medicine belonging to the group of selective beta-blocking agents
(i.e. with selective action on the cardiovascular system). It prevents the increase in heart rate and
controls the force of the cardiac pump. Furthermore, it exerts a dilating effect on blood vessels,
contributing to lowering blood pressure.
Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced by the patient.
Lobidiur combines nebivolol and hydrochlorothiazide in a single tablet. It is used to treat elevated
blood pressure (arterial hypertension). It is used instead of the two separate products in patients who
are already taking them concomitantly.

2. WHAT YOU SHOULD KNOW BEFORE TAKING LOBIDIUR

Do not take Lobidiur:

if you are allergic to nebivolol or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6);
if you are allergic (hypersensitive) to other sulfonamide-derived substances (such as hydrochlorothiazide, which is a sulfonamide-derived drug);
if you have one or more of the following conditions:
o very slow heart rate (less than 60 beats per minute);
o other serious heart rhythm disorders (for example, sinoatrial syndrome, sinoatrial block, second- or third-degree atrioventricular block);
o recently developed or recently worsened heart failure, or if you are being treated for circulatory shock due to acute heart failure with intravenous therapy to support heart function;
o low blood pressure;
o severe circulatory problems in arms or legs;
o untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands);
o severe kidney problems, complete absence of urine (anuria);
o a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis;
o asthma or breathing difficulties (current or past);
o impaired liver function;
o high levels of calcium in the blood, low levels of potassium and sodium in the blood (persistent and resistant to treatment);
o high levels of uric acid with symptoms of gout;

Warnings and precautions
Talk to your doctor or pharmacist before taking LOBIDIUR.

Inform your doctor if you notice or develop any of the following conditions:
o a type of chest pain caused by spontaneous spasm of blood vessels supplying the heart, called Prinzmetal's angina;
o first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm);
o abnormally slow heartbeat;
o untreated chronic heart failure;
o lupus erythematosus (an autoimmune disorder, i.e. a disorder of the body's defense system);
o psoriasis (a skin disease causing scaly pink patches), or if you have previously suffered from psoriasis;
o overactive thyroid gland: this medicine may mask the signs of abnormally rapid heartbeat caused by this condition;
o poor circulation in arms or legs, for example Raynaud’s disease or syndrome, cramps when walking;
o allergy: this medicine may intensify your reactions to pollen or other substances you are allergic to;
o prolonged breathing difficulties;
o diabetes: this medicine may mask warning signs of low blood glucose (e.g. palpitations, rapid heartbeat); your doctor will also advise you to monitor your blood glucose levels more frequently when taking Lobidiur, as it may become necessary to adjust the dose of your antidiabetic medications;
o kidney problems: your doctor will monitor your kidney function to ensure it does not worsen. If you have severe kidney problems, do not take Lobidiur (see section "Do not take Lobidiur");
o if you tend to have low potassium levels in the blood, and especially if you have long QT syndrome (a type of electrocardiographic abnormality) or are taking digitalis (to support heart pump function); you are more likely to have low potassium levels if you have liver cirrhosis, rapid fluid loss after intensive diuretic therapy, or inadequate potassium intake through food and drinks;
o if you are undergoing surgery, always inform the anaesthetist that you are being treated with Lobidiur before receiving anaesthesia;
o if you have previously had skin cancer or are developing 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 radiation while taking Lobidiur.
Lobidiur may increase blood lipid levels and uric acid levels. It may affect levels of certain chemicals in the blood called electrolytes: your doctor will periodically check these with a blood test.
The hydrochlorothiazide contained in Lobidiur may make your skin hypersensitive to sunlight or artificial UV light. Stop taking Lobidiur and consult your doctor if you develop a skin rash, itchy spots, or skin sensitivity during treatment (see also section 4).
Anti-doping tests: Lobidiur may cause a positive result in anti-doping tests.

Children and adolescents
Due to lack of data on the use of the product in children and adolescents, the use of Lobidiur is not recommended in these age groups.

Medicines that, like Lobidiur, may affect blood pressure and/or heart function:
- Medicines for controlling blood pressure or heart problems (e.g. amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecainide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine, mexiletine, methyldopa, moxonidine, nicardipine, nifedipine, nimodipine, nitrendipine, propafenone, quinidine, rilmenidine, sotalol, verapamil);
- Sedatives and treatments for psychosis (a mental illness), e.g. amisulpride, barbiturates (also used for epilepsy), chlorpromazine, carbamazepine, droperidol, haloperidol, levomepromazine, narcotics, phenothiazines (also used for nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine;
- Medicines for depression, e.g. amitriptyline, fluoxetine, paroxetine;
- Medicines used for anaesthesia during surgery;
- Medicines for asthma, nasal congestion, or certain eye disorders such as glaucoma (increased eye pressure) or pupil dilation (enlargement);
- Baclofen (a muscle relaxant used for spasticity);
- Amifostine (a protective agent used during anticancer therapy).
Medicines whose effect or toxicity may be increased by Lobidiur:
- Lithium (used as a mood stabilizer);
- Cisapride (used for digestive problems);
- Bepridil (used for angina);
- Difemanil (used for excessive sweating);
- Medicines used for infections: erythromycin administered by infusion or injection, pentamidine, sparfloxacin, amphotericin, sodium penicillin G, halofantrine (used for malaria);
- Vincamine (used for cerebral circulation disorders);
- Mizolastine and terfenadine (used for allergies);
- Diuretics and laxatives;
- Medicines used to treat acute inflammation: corticosteroids (e.g. cortisone and prednisone), ACTH (adrenocorticotropic hormone), and medicines derived from salicylic acid (e.g. acetylsalicylic acid/aspirin and other salicylates);
- Carbenoxolone (used for heartburn and gastric ulcer);
- Calcium salts (used as bone health supplements);
- Medicines used to relax muscles (e.g. tubocurarine);
- Diazoxide, used to treat hypoglycemia and hypertension;
- Amantadine, an antiviral drug;
- Cyclosporine, used to suppress the body's immune response;
- Iodinated contrast agents, used as contrast media in X-rays;
- Anticancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate).
Medicines whose effect may be reduced by Lobidiur:
- Medicines that lower blood glucose levels (insulin and oral antidiabetics, metformin);
- Medicines for gout (e.g. allopurinol, probenecid, sulfinpyrazone);
- Medicines such as noradrenaline, used to treat low blood pressure or slow heart rate (bradycardia).
- Non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation, as these may reduce the blood pressure-lowering effect of Lobidiur.
- Medicines for excess stomach acid or ulcers (antacids): you should take Lobidiur with a meal and antacids between meals.

Pregnancy and breastfeeding
You must inform your doctor if you are or think you may be pregnant. Generally, your doctor will advise you to take another medicine instead of LOBIDIUR, as LOBIDIUR is not recommended during pregnancy. This is because the active ingredient hydrochlorothiazide crosses the placenta. The use of LOBIDIUR during pregnancy may cause potentially harmful effects on the fetus and newborn.
Inform your doctor if you are breastfeeding or planning to breastfeed. LOBIDIUR is not recommended for women who are breastfeeding.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
This medicine may cause dizziness or fatigue. If these symptoms occur, do not drive and do not use machinery.

Lobidiur contains lactose and sodium
This product contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially "sodium-free".

3. HOW TO TAKE LOBIDIUR

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
you must consult your doctor.
Take one tablet daily with some water, preferably at the same time each day.
Lobidiur may be taken before, during, or after meals, or alternatively, independently of meals.
Use in children and adolescents
Do not administer Lobidiur to children or adolescents.
If you take more Lobidiur than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or pharmacist immediately.
The most common symptoms and signs of overdose include very slow heartbeat (bradycardia), low blood pressure with possible fainting, shortness of breath as in asthma, acute heart failure, excessive urination leading to dehydration, nausea and drowsiness, muscle spasms, and disturbances in heart rhythm (especially if you are also taking digitalis or medications for heart rhythm disorders).
If you forget to take Lobidiur
If you forget to take a dose of Lobidiur but remember shortly afterwards, you may take the missed dose as usual. However, if a long time has passed (for example, several hours), such that it is almost time for the next scheduled dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose. However, avoid repeatedly missing doses.
If you stop taking Lobidiur
You must always consult your doctor before stopping treatment with Lobidiur.
If you have any doubts about using this product, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported with nebivolol:

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

headache
dizziness
fatigue
unusual sensations of burning, tingling, itching, or pins and needles
diarrhoea
constipation
nausea
shortness of breath
swelling of the hands and feet

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

slowed heart rate or other heart problems
low blood pressure
cramp-like pain in the legs when walking
abnormal vision
impotence
feeling of depression
indigestion, stomach or intestinal gas, vomiting
skin rash, itching
shortness of breath as in asthma, due to sudden cramping of the airway muscles (bronchospasm)
nightmares

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

fainting
worsening of psoriasis (a skin disease causing scaly pink patches)

The following side effects have been reported only in isolated cases:

generalized allergic reactions, including widespread skin rash (hypersensitivity reactions)
sudden swelling, especially around the lips, eyes, or tongue, possibly with sudden breathing difficulties (angioedema)
a type of skin rash characterized by itchy, raised, pale red welts, either allergic or non-allergic in nature (urticaria)

The following side effects have been reported with hydrochlorothiazide:
Frequency “not known”: skin and lip cancer (non-melanoma skin cancer)

Allergic reactions

generalized allergic reaction (anaphylactic reaction)

Heart and circulation

disturbances in heart rhythm, palpitations
changes in the electrocardiogram
sudden fainting upon standing, formation of blood clots in veins (thrombosis) and embolism, circulatory collapse (shock)

Blood

changes in blood cell counts, such as: decreased white blood cells, decreased platelets, decreased red blood cells; reduced production of new blood cells by the bone marrow
imbalances in body fluids (dehydration) and blood electrolytes, particularly decreased potassium, sodium, magnesium, chloride, and increased calcium
increased uric acid levels, gout, increased blood glucose, diabetes, metabolic alkalosis (a metabolic disorder), increased cholesterol and triglyceride levels

Stomach and intestine

loss of appetite, dry mouth, nausea, vomiting, stomach discomfort, abdominal pain, diarrhoea, reduced bowel movements (constipation), absence of bowel movements (paralytic ileus), flatulence
inflammation of the salivary glands, pancreatitis, increased blood amylase levels (a pancreatic enzyme)
yellowing of the skin (jaundice), inflammation of the gallbladder

Chest

breathing difficulties, lung inflammation (pneumonia), development of fibrous tissue in the lungs (interstitial pneumonitis), fluid accumulation in the lungs (pulmonary oedema)

Nervous system

vertigo (sensation of spinning)
seizures, reduced level of consciousness, coma, headache, dizziness
apathy, confusion, depression, nervousness, restlessness, sleep disturbances
unusual burning, tingling, itching, or pins and needles sensations of the skin
muscle weakness (paresis)

Skin and hair

itching, purple spots or patches on the skin (purpura), urticaria, increased sensitivity of the skin to sunlight, skin rashes, facial rash and/or blotchy redness that may cause scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue death (necrotizing vasculitis), skin peeling, redness, looseness, and blistering of the skin (toxic epidermal necrolysis)

Eyes and ears

yellow vision, blurred vision, worsening of myopia, reduced tear production

Muscles and joints

muscle spasm, muscle pain

Urinary system

kidney dysfunction, acute kidney failure (reduced urine production and accumulation of fluids and waste products in the body), inflammation of the connective tissue within the kidneys (interstitial nephritis), sugar in the urine

Sexual organs

erectile dysfunction

General/Other

general weakness, fatigue, fever, thirst

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

5. HOW TO STORE LOBIDIUR

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 which is stated on the carton and on the 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. PACK CONTENTS AND OTHER INFORMATION

What Lobidiur contains
The active substances are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol
(as nebivolol hydrochloride) (2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol) and 25 mg of
hydrochlorothiazide.
The excipients are:

tablet core: monohydrate lactose, polysorbate 80 (E433), hypromellose (E464), maize starch, sodium croscarmellose (E468), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572)
tablet coating: macrogol 40 stearate type I, titanium dioxide (E171), carmine (carmine acid on aluminium lake, E120), hypromellose (E464), microcrystalline cellulose (E460)

Description of the appearance of Lobidiur and pack contents
Lobidiur is available as round, slightly biconvex, film-coated tablets, violet in colour, engraved with “5/25” on one side, supplied in packs containing 7, 14, 28, 30, 56, or 90 film-coated tablets.
The tablets are provided in blisters (PP/COC/PP/aluminum).
(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
Concessionaire for sale:
A. Menarini Industrie Farmaceutiche Riunite s.r.l., Via Sette Santi 3, Florence
Manufacturer
Berlin-Chemie AG
Glienicker Weg 125, 12489 Berlin, Germany
or
Menarini – Von Heyden GmbH
Leipziger Strasse 7-13, 01097 Dresden, Germany
or
A. Menarini Manufacturing Logistics and Services S.r.l.
Via Sette Santi 3, 50131 Florence, Italy

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Nomexor Plus HTC
Belgium: Hyporetic
France: CONEBILOX
Greece: Hypoloc plus
Iceland: Nebilet Comp
Ireland: Nebilet Plus
Italy: Lobidiur
Luxembourg: Hyporetic
Portugal: Hypoloc Plus
Spain: Silostar plus
Netherlands: Hyporetic
United Kingdom: Nebizide