Nebivolol and hydrochlorothiazide Doc Generici

Patient Information Leaflet

NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics 5 mg/12.5 mg film-coated tablets

NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics 5 mg/25 mg film-coated tablets
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics are and what they are used for
2. What you need to know before taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics
3. How to take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics
4. Possible side effects
5. How to store NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics
6. Contents of the pack and other information

1. What NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generici is and what it is used for

NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generici 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 dilates blood vessels, helping to lower blood pressure.
• Hydrochlorothiazide is a diuretic that works by increasing the amount of urine produced.

NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generici combines nebivolol and hydrochlorothiazide in a single tablet and is used to treat high blood pressure (hypertension). It is used instead of the two separate products in patients who are already taking them concomitantly.

2. What you need to know before taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics

Generics
Do not take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics:

• 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 to other sulfonamide-derived substances (such as hydrochlorothiazide, which is a sulfonamide-derived medicine)
• if you have one or more of the following conditions:
• very slow heartbeat (less than 60 beats per minute)
• other serious heart rhythm disorders (for example, sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block)
• recently developed or recently worsened heart failure, or if you are

receiving treatment for circulatory shock due to acute heart failure
via intravenous administration to help the heart function

• low blood pressure
• severe circulation problems in arms or legs
• untreated pheochromocytoma, a tumor located above the kidneys (in the adrenal glands)
• severe kidney problems, complete absence of urine (anuria)
• a metabolic disorder (metabolic acidosis), for example diabetic ketoacidosis
• asthma or breathing difficulties (currently or in the past)
• liver problems
• persistently high levels of calcium in the blood, or persistently low levels of potassium and sodium in the blood that do not respond to treatment
• high levels of uric acid with symptoms of gout

Warnings and precautions
Talk to your doctor or pharmacist before taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics.
Inform your doctor if you have or develop any of the following conditions:

• a type of chest pain caused by spontaneous spasm of the heart, called Prinzmetal's angina
• first-degree heart block (a mild cardiac conduction disorder affecting heart rhythm)
• abnormally slow heartbeat
• untreated chronic heart failure
• lupus erythematosus (an immune system disorder, i.e. the body's defense system)
• psoriasis (a skin disease causing scaly pink patches) or if you have had psoriasis in the past
• overactive thyroid gland: this medicine may mask signs of abnormally rapid heartbeat caused by this condition
• poor circulation in arms or legs, for example Raynaud's disease or syndrome, cramp-like pains when walking
• allergies: this medicine may intensify your reactions to pollen or other substances you are allergic to
• prolonged respiratory problems
• diabetes: this medicine may mask symptoms of low blood glucose (such as palpitations, rapid heartbeat); your doctor will also advise you to monitor your blood sugar levels more frequently when taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics, as it may be necessary to adjust the dose of your diabetes medicines
• kidney problems: your doctor will check your kidney function to ensure it does not worsen. Do not take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics if you have severe kidney problems (see "Do not take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics")
• if you tend to have low potassium levels in the blood, especially if you have long QT syndrome (a type of electrocardiographic abnormality) or are taking digitalis (to support heart pumping); you are more likely to have low potassium levels if you have liver cirrhosis, or have experienced rapid fluid loss after intensive diuretic treatment, or if your dietary intake of potassium is inadequate
• if you are undergoing surgery, always inform the anaesthetist that you are being treated with NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics before receiving anaesthesia
• if you have previously had skin cancer or are developing unexpected skin lesions

during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun exposure and UV radiation while taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics.
During treatment

• NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics may increase blood lipid levels and uric acid.
• NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics may affect levels of certain electrolytes in the blood (such as magnesium, potassium, sodium, and chlorides): your doctor may periodically monitor electrolyte levels. This may cause symptoms such as dry mouth, thirst, weakness, fatigue, muscle weakness, pain or cramps, rapid heartbeat, dizziness, low blood pressure, restlessness, malaise, and reduced urine output. Inform your doctor if you experience any of these symptoms.
• The hydrochlorothiazide contained in NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics may make your skin hypersensitive to sunlight or artificial UV light. Stop taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics and consult your doctor if you develop a rash, itchy spots, or skin sensitivity during treatment (see also section 4).
• Inform your doctor if you notice changes in vision or eye pain while taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics. This may be a sign of developing glaucoma. You must stop treatment with NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics and consult your doctor.

Laboratory tests

• Anti-doping tests: NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics may cause a positive anti-doping test result.
• NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics may alter test results for parathyroid function.
• Inform your doctor or hospital that you are taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics before undergoing these tests.

For athletes: using the medicine without therapeutic need constitutes doping and
may lead to a positive anti-doping test result.
Children and adolescents
Due to lack of data on use in children and adolescents, the use of
NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended in children and
adolescents.
Other medicines and NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics
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 taking any of the following medicines in
addition to NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics:

• Medicines that, like NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics, may affect blood pressure and/or heart function:

  • Medicines for blood pressure control or heart problems (such as 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 antipsychotic therapies (a mental illness), for example 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, for example 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 (an antispastic medicine)
  • Amifostine (a protective agent used during cancer treatment)
  • Cholestyramine or colestipol (medicines used to lower cholesterol)

• Medicines whose effect or toxicity may be increased by NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics:

  • Lithium, used to stabilize mood
  • 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 and sodium penicillin G, halofantrine (used for malaria)
  • Vincamine (used for cerebral circulation problems)
  • Mizolastine and terfenadine (used for allergies)
  • Diuretics and laxatives
  • Medicines used to treat acute inflammation: steroids (for example cortisone and prednisone), ACTH (adrenocorticotropic hormone), and salicylic acid derivatives (e.g. acetylsalicylic acid/aspirin and other salicylates)
  • Carbenoxolone (used for heartburn and stomach ulcers)
  • Calcium salts, used as bone health supplements
  • Medicines used to relax muscles (e.g. tubocurarine)
  • Diazoxide, used to treat low blood sugar and high blood pressure
  • Amantadine, an antiviral medicine
  • 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 NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics:

  • Medicines that lower blood sugar levels (insulin and oral antidiabetic medicines, metformin)
  • Medicines for gout (e.g. allopurinol, probenecid, sulfinpyrazone)
  • Medicines such as noradrenaline, used to treat low blood pressure or slow heartbeat

• Non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation, because these may reduce the blood pressure-lowering effect of NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics.

• Medicines for excess stomach acid or ulcers (antacids), for example cimetidine: you should take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics with a meal and the antacid between meals.

NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics with alcohol
Be cautious when drinking alcohol while taking NEBIVOLOL and
HYDROCHLOROTHIAZIDE DOC Generics, 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 suspect you may be pregnant. Normally, your
doctor will advise you to take another medicine instead of NEBIVOLOL and HYDROCHLOROTHIAZIDE
DOC Generics, as NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics is not
recommended during pregnancy. This is because the active ingredient hydrochlorothiazide crosses
the placenta. Use of NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics during pregnancy may
cause potentially harmful effects to the fetus and newborn.
Inform your doctor if you are breastfeeding or planning to breastfeed.
NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics is not recommended for women who
are breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and use of machinery
This medicine may cause dizziness or fatigue. If these conditions occur, do not drive and do not
use machinery.
NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics contains lactose
This product contains lactose. If your doctor has informed you that you have an intolerance to certain
sugars, contact them before taking this medicine.

3. How to take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet daily with a little water, preferably always at the same time of day.
NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics may be taken before, during or after meals, or independently of meals.
NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics 5 mg/12.5 mg film-coated tablets:
The score line is only intended to assist you in breaking the tablet if you have difficulty swallowing it whole.

Use in children and adolescents
NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics must not be given to children or adolescents.

If you take more NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics than you should
If you accidentally take too much 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 cramps, and disturbances in heart rhythm (especially if you are also taking digitalis or medicines for heart rhythm disorders).

If you forget to take NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics
If you forget to take a dose of NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics but remember shortly afterwards, you may take the missed dose as usual. However, if a long time has passed (e.g. several hours), so 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 to make up for a forgotten dose. However, avoid repeatedly skipping doses.

If you stop taking NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics
Always consult your doctor before stopping treatment with NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generics.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking NEBIVOLOL AND HYDROCHLOROTHIAZIDE DOC Generics and contact your doctor
immediately if you experience any of the following:

• Generalised allergic reaction, with widespread skin rashes (hypersensitivity reactions); sudden swelling, particularly around lips, eyes or tongue, possibly causing sudden difficulty in breathing (angioedema). Frequency is not known (cannot be estimated from the available data)

The following side effects have been reported with nebivolol:
Common (may affect up to 1 in 10 people):

• headache
• dizziness
• tiredness
• unusual sensation of burning, tingling, pricking or numbness (paraesthesia)
• diarrhoea
• constipation
• nausea
• shortness of breath
• swelling of hands and feet.

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

• slow heartbeat or other heart disturbances
• low blood pressure
• cramp-like pain in the legs when walking
• vision disturbances
• impotence
• feeling of depression
• indigestion, gas in the stomach or intestines, vomiting
• skin rashes, itching
• shortness of breath as in asthma, due to sudden cramps in the airway muscles (bronchospasm)
• nightmares.

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

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

Not known (frequency cannot be estimated from the available data)
The following side effects have been reported only in a few isolated cases:

• skin rash with raised, itchy, pale red bumps of allergic or non-allergic origin (urticaria)
• seeing or hearing things that are not there (hallucinations)
• loss of contact with reality (psychosis)
• circulation problems in fingers, toes, arms and legs, which may cause paleness, bluish discoloration or tingling in fingers and toes (Raynaud's syndrome)
• dry eyes, with gritty sensation or thickening of the eyelids or the white part of the eye

The following side effects have been reported with hydrochlorothiazide:

• skin and lip cancer (non-melanoma skin cancer) (frequency not known)

Allergic reactions

• generalised allergic reaction affecting the whole body (anaphylactic reaction)

Heart and circulation

• heart rhythm disorders, palpitations
• changes in the electrocardiogram
• sudden fainting when standing up, 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
• 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 sugar, diabetes, metabolic alkalosis (a metabolic disorder), increased cholesterol and/or triglycerides in the blood

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 amylase in the blood (an enzyme from the pancreas)
• 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 lung disease), accumulation of fluid in the lungs (pulmonary oedema)

Nervous system

• dizziness (sensation of spinning)
• seizures, reduced level of consciousness, coma, headache, dizziness
• apathy, confusion, depression, nervousness, restlessness, sleep disturbances
• burning, tingling, pricking or numbness 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 (including erythema multiforme), facial rash and/or blotchy redness that may lead to scarring (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue death (necrotising 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, reduced vision and eye pain (possible signs of acute myopia or acute angle-closure glaucoma)

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 function

• erectile dysfunction

General/Other

• general weakness, fatigue, fever, thirst

Reporting of side effects
If you get any side effects, including ones 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
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NEBIVOLOL and HYDROCHLOROTHIAZIDE DOC Generici

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. Package contents and other information

What NEBIVOLOLO e IDROCLOROTIAZIDE DOC Generici contains

• The active substances are nebivolol 5 mg (as nebivolol hydrochloride) and hydrochlorothiazide 12.5 mg.
• The active substances are nebivolol 5 mg (as nebivolol hydrochloride) and hydrochlorothiazide 25 mg.

The other components are:

• tablet core: monohydrate lactose, polysorbate 80 (E433), hypromellose (E15), maize starch, microcrystalline cellulose (PH102), citric acid monohydrate, anhydrous colloidal silica (E551), magnesium stearate (E572)
• coating: Opadry white 03A 580004 [only 5 mg/12.5 mg], Opadry yellow 03A520012 [only 5 mg/25 mg], hypromellose (E464), titanium dioxide (E171), polyoxyl (macrogol) stearate, microcrystalline cellulose (E460), yellow iron oxide (E172) [only 5 mg/25 mg].

Description of the appearance of NEBIVOLOLO e IDROCLOROTIAZIDE DOC Generici and
pack contents
NEBIVOLOLO e IDROCLOROTIAZIDE DOC Generici 5 mg/12.5 mg tablets are
film-coated tablets, 9.2 mm in size, white to off-white, round, biconvex, with "515" printed on one side and a break line on the other side.
NEBIVOLOLO e IDROCLOROTIAZIDE DOC Generici 5 mg/25 mg tablets are
film-coated tablets, pale yellow in colour, 9.2 mm in size, round, biconvex, with "525" printed on one side.
Pack sizes:
28 film-coated tablets.
The tablets are supplied in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milan
Italy

Manufacturer
Balkanpharma-Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria
Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano 43
24041 Brembate (BG)
Italy

This medicinal product is authorized in the European Economic Area countries under the
following names:
Italy: NEBIVOLOLO e IDROCLOROTIAZIDE DOC Generici