Aloneb: detailed information

Package leaflet: Information for the user

ALONEB 5 mg/12.5 mg film-coated tablets

Nebivolol / hydrochlorothiazide
Read this entire 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. Do not give it to other people, even if their symptoms
are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor,
pharmacist or nurse. See section 4.
Contents of this leaflet:

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

1. WHAT ALONEB IS AND WHAT IT IS USED FOR

ALONEB 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. Furthermore, 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.
ALONEB 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 ALONEB

Do not take ALONEB:

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);

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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., sinoatrial node 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 (currently or in the 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 ALONEB.

Inform your doctor if you experience 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 immune system disorder, i.e., 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 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 may also advise you to monitor your blood glucose levels more frequently while taking ALONEB, as it may be necessary to adjust the dose of your antidiabetic medications;

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o kidney problems: your doctor will monitor your kidney function to ensure it does not worsen. Do not take ALONEB if you have severe kidney problems (see section "Do not take ALONEB");
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 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 anesthetist that you are being treated with ALONEB before receiving anesthesia;
o if you have previously had skin cancer or if you develop unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking ALONEB.

ALONEB 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 ALONEB may make your skin hypersensitive to sunlight or artificial UV light. Stop taking ALONEB and consult your doctor if you develop a skin rash, itchy spots, or skin sensitivity during treatment (see also section 4).
Anti-doping tests: ALONEB may cause a positive result in anti-doping tests.

Children and adolescents
Due to lack of data on the use of this product in children and adolescents, the use of ALONEB is not recommended in these age groups.
Other medicines and ALONEB
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 taking or have recently been given any of the following medicines in addition to ALONEB.

medicines that, like ALONEB, may affect blood pressure and/or heart function:
Medicines for blood pressure control or heart problems (e.g., amiodarone, amlodipine, cibenzoline, clonidine, digoxin, diltiazem, disopyramide, dofetilide, felodipine, flecainide, guanfacine, hydroquinidine, ibutilide, lacidipine, lidocaine,

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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 anesthesia 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 anticancer therapy).
Medicines whose effect or toxicity may be increased by ALONEB:
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 salicylic acid derivatives (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 media, used as contrast agents in X-rays;
anticancer medicines (e.g., cyclophosphamide, fluorouracil, methotrexate).
Medicines whose effect may be reduced by ALONEB:
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 ALONEB.

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Medicines for excess stomach acid or ulcers (antacids): you should take ALONEB with a meal and antacids between meals.

ALONEB and alcohol
When taking ALONEB, be cautious about drinking 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 or think you may be pregnant. Your doctor will usually advise you to take another medicine instead of ALONEB, as ALONEB is not recommended during pregnancy. This is because the active ingredient hydrochlorothiazide crosses the placenta. The use of ALONEB during pregnancy may cause potentially harmful effects on the fetus and newborn.
Inform your doctor if you are breastfeeding or planning to breastfeed. ALONEB 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 occur, do not drive and do not use machinery.
ALONEB contains lactose
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 ALONEB

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor.
Take one tablet daily with a little water, preferably at the same time each day.
ALONEB may be taken before, during or after meals, or alternatively, independently of meals.
Use in children and adolescents
Do not administer ALONEB to children or adolescents.
The score line is intended only to facilitate breaking the tablet if you have difficulty
swallowing it whole.
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If you take more ALONEB than you should
If you accidentally take an excessive dose of this medicine, inform your doctor or
pharmacist immediately. The most frequent symptoms and signs of overdose are
very slow heartbeat (bradycardia), low blood pressure with possible fainting,
breathing difficulties as in asthma, acute heart failure, excessive urination leading to
dehydration, nausea and drowsiness, muscle spasms, and disturbances in heart rhythm
(particularly if you are also taking digitalis or medicines for heart rhythm problems).
If you forget to take ALONEB
If you forget to take a dose of ALONEB but remember shortly afterwards, you may take
that dose as usual. However, if a long time has passed (for example, several hours) and 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 ALONEB
You must always consult your doctor before stopping treatment with ALONEB.
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 side effects (may affect up to 1 in 10 people):

headache
dizziness
fatigue
unusual sensation of burning, tingling, tickling or prickling
diarrhoea
constipation
nausea
shortness of breath
swelling of the hands and feet

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

slow heart rate or other heart problems
low blood pressure
cramp-like leg pain while walking
abnormal vision
impotence
feeling of depression
difficulty in digestion, stomach or intestinal gas, vomiting

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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 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)

The following adverse reactions 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

heart rhythm disorders, palpitations
changes in 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: reduced white blood cells, reduced platelets, reduced red blood cells; reduced production of new blood cells by the bone marrow
disturbances in 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, infrequent 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

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Chest

difficulty breathing, lung inflammation (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, tickling or prickling 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 lead to 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

renal dysfunction, acute renal 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 urine

Sexual organs

erection disorders

General/Other

general weakness, fatigue, fever, thirst

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. 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 ALONEB

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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 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 ALONEB 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 ALONEB and pack sizes
ALONEB is available as round, slightly biconvex, pinkish film-coated tablets, engraved with “5/12.5” on one side and a division line on the other, in packs of 7, 14, 28, 30, 56, and 90 film-coated tablets.
The tablets are supplied in blisters (PP/COC/PP/aluminium).
(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

Marketing Authorisation Holder in Italy:
Istituto Luso Farmaco d’Italia S.p.A.
Milanofiori – Strada 6 – Edificio L, Rozzano (MI)

Manufacturers
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 medicine is authorised in the European Economic Area member states under the following names:

Austria: Hypoloc plus HCT
Belgium: Nobiretic
Bulgaria: Nebilet Plus
Cyprus: Lobivon plus
Czech Republic: Nebilet Plus H 5 mg/12,5 mg film-coated tablets
Denmark: Hypoloc Comp
Estonia: Nebilet Plus
Finland: Hypoloc Comp
France: TEMERITDUO
Greece: Lobivon-plus
Hungary: Nebilet Plus
Iceland: Hypoloc Comp
Ireland: Hypoloc Plus
Italy: Aloneb
Latvia: Nebilet Plus
Lithuania: Nebilet Plus
Luxembourg: Nobiretic
Malta: Nebilet Plus
Norway: Hypoloc Comp
Poland: Nebilet HCT
Portugal: Nebilet Plus
Romania: Co-Nebilet 5 mg / 12.5 mg
Slovakia: Nebilet HCTZ
Slovenia: Co-Nebilet
Spain: Lobivon plus
Sweden: Hypoloc Comp
Netherlands: Nebiretic
United Kingdom: Nebivolol/ Hydrochlorothiazide

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Package Leaflet: Information for the User

ALONEB 5 mg/25 mg film-coated tablets

Nebivolol / hydrochlorothiazide
Please read this entire leaflet carefully before using this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

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

1. WHAT ALONEB IS AND WHAT IT IS USED FOR

ALONEB contains nebivolol and hydrochlorothiazide as active substances.
Nebivolol is a cardiovascular medicine belonging to the group of selective beta-blockers (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. Furthermore, it exerts a dilating effect on blood vessels, helping to reduce blood pressure.
Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced by the patient.
ALONEB 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 together.

2. WHAT YOU SHOULD KNOW BEFORE TAKING ALONEB

Do not take ALONEB:
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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 (currently or in the 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 ALONEB.

Inform your doctor if you experience or develop any of the following problems: 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 systemic lupus erythematosus (an immune system disorder, i.e. 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 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;

Page 12 of 21
o diabetes: this medicine may mask warning signs of low glucose levels (e.g. palpitations, rapid heartbeat); your doctor will also advise you to monitor your blood sugar more frequently while taking ALONEB, as it may be necessary to adjust the dose of your antidiabetic medications;
o kidney problems: your doctor will check your kidney function to ensure it does not worsen. Do not take ALONEB if you have severe kidney problems (see section "Do not take ALONEB");
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 function); you are more likely to have low potassium levels if you have liver cirrhosis, or have experienced rapid fluid loss after intensive diuretic therapy, or if dietary and beverage intake of potassium is inadequate;
o if you are scheduled for surgery, always inform the anaesthetist that you are being treated with ALONEB before undergoing anaesthesia;
o 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 radiation while taking ALONEB.

ALONEB may increase blood lipid levels and uric acid. It may affect levels of certain chemicals in the blood called electrolytes: your doctor will periodically monitor these through blood tests.
The hydrochlorothiazide contained in ALONEB may make your skin hypersensitive to sunlight or artificial UV light. Stop taking ALONEB and consult your doctor if a skin rash, itchy spots, or skin sensitivity appear during treatment (see also section 4).
Anti-doping tests: ALONEB may cause a positive result in anti-doping tests.

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

Medicines that, like ALONEB, may affect blood pressure and/or heart function:

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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 anti-tumor therapy).
Medicines whose effect or toxicity may be increased by ALONEB:
lithium (used as a mood stabilizer);
cisapride (used for digestive problems);
bepridil (used for angina);
disopyramide (used for excessive sweating);
medicines used for infections: erythromycin administered by infusion or injection, pentamidine and sparfloxacin, amphotericin and 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 stomach burning and gastric ulcers);
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;
anticancer medicines (e.g. cyclophosphamide, fluorouracil, methotrexate).
Medicines whose effect may be reduced by ALONEB:
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).

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Medicines for pain and inflammation (non-steroidal anti-inflammatory drugs), because these may reduce the blood pressure-lowering effect of ALONEB.
Medicines for treating excess stomach acid or ulcers (antacids), for example cimetidine: you should take ALONEB with a meal and the antacid between meals.

ALONEB and alcohol
When taking ALONEB, 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 or think you may be pregnant. Normally, your doctor will advise you to take another medicine instead of ALONEB, as ALONEB is not recommended during pregnancy. This is because the active substance hydrochlorothiazide crosses the placenta. The use of ALONEB during pregnancy may cause potentially harmful effects on the fetus and newborn.
Inform your doctor if you are breastfeeding or planning to start breastfeeding. ALONEB 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 use machinery.
ALONEB contains lactose
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 ALONEB

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor.
Take one tablet daily with some water, preferably at the same time each day.
ALONEB may be taken before, during, or after meals, or alternatively, independently of meals.

Use in children and adolescents
Do not administer ALONEB to children or adolescents.
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If you take more ALONEB 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 are 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 heart rhythm disorders (especially if you are also taking digitalis or medicines for heart rhythm problems).

If you forget to take ALONEB
If you forget to take a dose of ALONEB but remember shortly afterwards, you may take that dose as usual. However, if a long time has passed (for example, several hours), such that it is almost 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 skipping doses.

If you stop taking ALONEB
You must always consult your doctor before stopping treatment with ALONEB.
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 everybody gets them.
The following side effects have been reported with nebivolol:

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

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

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

slow 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
difficulty breathing 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:

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 side effects have been reported:

Frequency not known: skin and lip cancer (non-melanoma skin cancer)

Allergic reactions

generalized allergic reaction (anaphylactic reaction)

Heart and circulation

heart rhythm disorders, palpitations
changes in 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: reduced white blood cells, reduced platelets, reduced red blood cells; decreased 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, lung inflammation (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 prickling 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 lead to 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 cramps, 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 side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the 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.
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5. HOW TO STORE ALONEB

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 pack 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 ALONEB contains
The active substances are nebivolol and hydrochlorothiazide. Each tablet contains 5 mg of nebivolol (as nebivolol hydrochloride) – consisting of 2.5 mg of d-nebivolol and 2.5 mg of l-nebivolol – and 25 mg of hydrochlorothiazide.

The excipients are:

Tablet core: lactose monohydrate, polysorbate 80 (E433), hypromellose (E464), maize starch, sodium croscarmellose (E468), microcrystalline cellulose (E460), colloidal anhydrous 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 ALONEB and pack contents
ALONEB is available as round, slightly biconvex, film-coated tablets, violet in colour, with "5/25" engraved on one side, in packs of 7, 14, 28, 30, 56, and 90 film-coated tablets.
The tablets are supplied in blister packs (PP/COC/PP/aluminium).
(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:
Istituto Luso Farmaco d’Italia S.p.A.
Milanofiori – Strada 6 – Edificio L, Rozzano (MI)

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Manufacturers
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 medicine is authorised in the Member States of the European Economic Area under the following names:

Austria: Hypoloc plus HCT
Belgium: Nobiretic
Bulgaria: Nebilet Plus
Cyprus: Lobivon plus
Czech Republic: Nebilet Plus H 5 mg/25 mg film-coated tablets
Denmark: Hypoloc Comp
Estonia: Nebilet Plus
Finland: Hypoloc Comp
France: TEMERITDUO
Greece: Lobivon-plus
Hungary: Nebilet Plus
Iceland: Hypoloc Comp
Ireland: Hypoloc Plus
Italy: Aloneb
Latvia: Nebilet Plus
Lithuania: Nebilet Plus
Luxembourg: Nobiretic
Malta: Nebilet Plus
Norway: Hypoloc Comp
Poland: Nebilet HCT
Portugal: Nebilet Plus
Romania: Co-Nebilet 5 mg / 25 mg
Slovakia: Nebilet HCTZ
Slovenia: Co-Nebilet
Spain: Lobivon plus
Sweden: Hypoloc Comp
Netherlands: Nebiretic
United Kingdom: Nebivolol/ Hydrochlorothiazide

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