Lobivon Plus 5 mg/12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

LOBIVON PLUS 5 mg/ 12.5 mg film-coated tablets

Nebivolol / Hydrochlorothiazide

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Lobivon Plus is and what it is used for
2. What you need to know before taking Lobivon Plus
3. How to take Lobivon Plus
4. Possible side effects
5. How to store Lobivon Plus

Pack contents and additional information

1. What Lobivon Plus is and what it is used for

Lobivon Plus contains nebivolol and hydrochlorothiazide as active substances.

• Nebivolol is a cardiovascular medicine belonging to the group of selective beta-blockers (with selective activity in the cardiovascular system). It prevents the increase in heart rate and controls the heart's pumping force. It also works by widening blood vessels, which helps lower blood pressure.
• Hydrochlorothiazide is a diuretic that works by increasing urine production.

Lobivon Plus is a fixed-dose combination of nebivolol and hydrochlorothiazide in one tablet, used for the treatment of high blood pressure (hypertension). It is intended for patients who are already being treated with both components separately.

2. What you need to know before taking Lobivon Plus

Do not take Lobivon Plus

• If you are allergic to nebivolol, or to hydrochlorothiazide, or to any of the other components 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 medicine).

• If you have one or more of the following conditions:

• Very slow heart rate (less than 60 beats per minute).

• Other serious heart rhythm disorders (e.g., sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block).

• Recently experienced a heart failure episode or worsening of heart failure, or are receiving intravenous treatment to support heart function after circulatory collapse due to acute heart failure.

• Low blood pressure.

• Severe circulation problems in arms or legs.

• Pheochromocytoma, a tumor located in the upper part of the kidneys (adrenal glands), which is untreated.

• Severe kidney problems, complete absence of urine (anuria).

• Metabolic disorders characterized by metabolic acidosis (e.g., diabetic ketoacidosis).

• Asthma or difficulty breathing (currently or in the past).

• Liver function disorders.

• Persistently high calcium levels and persistently low potassium and sodium levels in blood that are resistant to treatment.

• High levels of uric acid with symptoms of gout.

Warnings and precautions

Talk to your doctor or pharmacist before you start taking Lobivon Plus.

• 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 arteries, called Prinzmetal's angina.

• First-degree heart block (a mild conduction disorder affecting heart rhythm).

• Abnormally slow heart rate.

• Chronic heart failure that is untreated.

• Lupus erythematosus (an immune system disorder, which is your body’s defense system).

• Psoriasis (a skin disease characterized by scaly pink patches), or if you have ever had psoriasis.

• Overactive thyroid gland: this medicine may mask signs of this condition, such as abnormally fast heart rate.

• Poor circulation in arms or legs, such as Raynaud’s disease or syndrome, or cramp-like pain when walking.

• Allergies: this medicine may intensify your reaction to pollen or other substances you are allergic to.

• Chronic respiratory problems.

• Diabetes: this medicine may mask warning signs of low blood sugar (e.g., palpitations, rapid heartbeat) and may increase the risk of severe hypoglycemia when used with certain antidiabetic medicines called sulfonylureas (e.g., gliquidone, gliclazide, glibenclamide, glipizide, glimepiride, or tolbutamide); your doctor will advise you to monitor your blood sugar more frequently while taking Lobivon Plus, as adjustment of your antidiabetic medication dose may be necessary.

• Kidney problems: your doctor will check your kidney function to ensure it does not worsen. If you have severe kidney problems, do not take Lobivon Plus (see section “Do not take Lobivon Plus”).

• If you tend to have low potassium levels in blood, especially if you have long QT syndrome (a type of ECG abnormality), or if you are taking digitalis (medicines to help the heart beat); you are more likely to have low blood potassium if you have liver cirrhosis, or have experienced excessive fluid loss due to strong diuretic treatment, or if your dietary intake of potassium is inadequate.

• If you are scheduled for surgery, always inform your anesthetist that you are taking Lobivon Plus before receiving anesthesia.

• If you have 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 skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV radiation while taking Lobivon Plus.

• If you experience vision loss or eye pain, these could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to weeks after taking Lobivon Plus. This may lead to permanent vision loss if not treated. If you have previously had an allergy to penicillins or sulfonamides, you may be at higher risk of developing this.

• If you have previously experienced respiratory or pulmonary problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop dyspnea or severe difficulty breathing after taking Lobivon Plus, seek medical attention immediately.

• Lobivon Plus may increase blood lipid and uric acid levels. It may affect levels of certain blood chemicals called electrolytes: your doctor will monitor these periodically through blood tests.

• The hydrochlorothiazide in Lobivon Plus may cause skin hypersensitivity to sunlight or artificial UV light. If you develop a rash, itching, or skin sensitivity during treatment, stop taking Lobivon Plus and inform your doctor (see also Section 4).

• Anti-doping tests: Lobivon Plus may produce a positive analytical result in anti-doping tests.

Children and adolescents

Lobivon Plus is not recommended for use in children and adolescents due to the lack of data on its use in this patient population.

Use of Lobivon Plus with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Always inform your doctor if, in addition to Lobivon Plus, you are taking or receiving any of the following medicines:

• Medicines that, like Lobivon Plus, may affect blood pressure and/or heart function:

• Medicines to control blood pressure or treat 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 medicines for psychosis (a mental illness), for example amisulpride, barbiturates (also used for epilepsy), chlorpromazine, ciamemazine, droperidol, haloperidol, levomepromazine, narcotic derivatives, phenothiazines (also used for nausea and vomiting), pimozide, sulpiride, sultopride, thioridazine, tiapride, trifluoperazine.

• Medicines for depression, for example amitriptyline, paroxetine, fluoxetine.

• Medicines used for anesthesia during surgery.

• Medicines for asthma, nasal congestion, and certain eye conditions such as glaucoma (increased eye pressure) or pupil dilation (widening).

• Medicines for diabetes, such as insulin or oral antidiabetic agents.

• Baclofen (a muscle relaxant and antispasmodic medicine).

• Amifostine (a protective medicine used during cancer treatment).

• Medicines whose effect or toxicity may be increased by Lobivon Plus:

• Lithium (used as a mood stabilizer).

• Cisapride (used for digestive problems).

• Bepridil (used for angina pectoris).

• Difemanil (used to treat excessive sweating).

• Medicines 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 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 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 in X-ray imaging scans.

• Anticancer medicines (e.g., cyclophosphamide, fluorouracil, methotrexate).

• Medicines whose effect may be reduced by Lobivon Plus:

• Medicines that lower blood sugar (insulin and oral antidiabetic medicines, metformin).

• Medicines for gout (e.g., allopurinol, probenecid, sulfinpyrazone).

• Medicines such as noradrenaline, used to treat low blood pressure and slow heart rate.

• Non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation, as they may lower blood pressure and thereby reduce the effectiveness of Lobivon Plus.

• Medicines to treat excess stomach acid or ulcers (antacids): Lobivon Plus should be taken with meals, and antacids should be taken between meals.

Taking Lobivon Plus with alcohol

Be cautious when consuming alcohol while taking Lobivon Plus, as you may feel faint or dizzy. If this occurs, avoid drinking alcohol, including wine, beer, or any alcoholic beverages or soft drinks containing alcohol.

Pregnancy and breastfeeding

You should inform your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you to take an alternative medicine instead of Lobivon Plus, as this medicine is not recommended during pregnancy. This is because the active ingredient hydrochlorothiazide crosses the placenta, and its use after the third month of pregnancy may cause potentially harmful fetal and neonatal effects.

Inform your doctor if you are breastfeeding or planning to start breastfeeding. Lobivon Plus is not recommended for breastfeeding mothers.

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

Driving and use of machines

This medicine may cause dizziness or fatigue. If this occurs, refrain from driving and operating machinery.

Lobivon Plus contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet; hence, it is essentially “sodium-free”.

3. How to take Lobivon Plus

Follow exactly the dosage instructions provided by your doctor. If in doubt, consult your doctor again.

Take one tablet daily with some water, preferably at the same time each day.

Lobivon Plus may be taken before, during, or after meals, or can also be taken independently of meals.

Use in children and adolescents

Do not administer Lobivon Plus to children or adolescents.

The score line is intended only for dividing the tablet if you have difficulty swallowing it whole.

If you take more Lobivon Plus than you should

If you have accidentally taken an overdose of this medicine, consult your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken.

You are advised to bring the medicine's packaging and leaflet to the healthcare professional.

The most frequent symptoms and signs of overdose are very slow heartbeat (bradycardia), low blood pressure with possible fainting, breathing difficulties resembling asthma, acute heart failure, excessive urine production leading to consequent dehydration, nausea and drowsiness, muscle spasms, and disturbances in heart rhythm (especially if you are taking digitalis or medications for heart rhythm disorders).

If you forget to take Lobivon Plus

If you forget to take a dose of Lobivon Plus but remember shortly after the time you were supposed to take it, take the daily dose as usual. However, if a long time has passed (several hours), such that it is almost time for your next scheduled dose, skip the missed dose and take the next dose at the regular time. Do not take a double dose. Nevertheless, you should try to avoid repeatedly forgetting to take your medication.

If treatment with Lobivon Plus is interrupted

Always consult your doctor before stopping treatment with Lobivon Plus.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone experiences them.

• The following adverse effects have been reported with the use of nebivolol:

Frequent adverse effects (may affect up to 1 in 10 people):

• Headache.
• Dizziness.
• Fatigue.
• Unusual sensation of burning, tingling, or prickling on the skin.
• Diarrhea.
• Constipation.
• Nausea.
• Difficulty breathing, sensation of shortness of breath.
• Sweating of hands and feet.

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

• Slow heartbeat or other heart disturbances.
• Low blood pressure.
• Leg pain similar to cramping when walking.
• Abnormal vision.
• Sexual impotence.
• Difficulty digesting, stomach or intestinal gas, vomiting.
• Skin rash, itching.
• Difficulty breathing as in asthma, due to sudden contraction of the muscles around the airways (bronchospasm).
• Nightmares.

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

• Fainting.
• Worsening of psoriasis, a skin disease characterized by scaly pink patches.

The following adverse effects have been reported in only a few isolated cases:

• Systemic allergic reactions, with generalized skin rash (hypersensitivity reactions);

• Sudden swelling, especially around the lips, eyes, or tongue, possibly with acute breathing difficulty (angioedema).

• Skin rash characterized by raised, itchy, pink wheals, due to allergic or non-allergic causes (urticaria).

• The following adverse effects have been reported with the use of hydrochlorothiazide:

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

Allergic reactions

• Systemic allergic reaction (anaphylactic reaction).

Heart and circulation

• Heart rhythm disturbances, 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: decreased white blood cells, decreased platelets, decreased red blood cells; alteration in the production of new blood cells in the bone marrow.
• Disturbances in body fluid levels (dehydration) and in blood chemical levels, particularly decreased levels of potassium, sodium, magnesium, chloride, and increased levels of calcium.
• Increased levels of uric acid, gout, increased blood glucose, diabetes, metabolic alkalosis (a metabolic disorder), increased cholesterol and/or triglycerides in blood.

Stomach and intestine

• Loss of appetite, dry mouth, nausea, vomiting, stomach discomfort, abdominal pain, diarrhea, decreased intestinal movements (constipation), absence of intestinal movements (paralytic ileus), flatulence.
• Inflammation of the salivary glands, inflammation of the pancreas, increased levels of amylase in blood (a pancreatic enzyme).
• Yellowing of the skin (jaundice), inflammation of the gallbladder.

Chest cavity

• Respiratory failure, inflammation of the lungs (pneumonitis), formation of fibrous tissue in the lungs (interstitial lung disease), accumulation of fluid in the lungs (pulmonary edema).
• Very rare frequency: Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion).

Nervous system

• Dizziness (sensation of spinning).
• Seizures, decreased level of consciousness, coma, headache, dizziness.
• Apathy, confusion, depression, nervousness, agitation, sleep disturbances.
• Unusual sensation of burning, tingling, or prickling on the skin.
• Muscle weakness (paresis).

Skin and hair

• Itching, purple spots on the skin (purpura), urticaria, increased skin sensitivity to light, rash, facial rash and/or red patches that may leave scars (cutaneous lupus erythematosus), inflammation of blood vessels leading to tissue death (necrotizing vasculitis), peeling, redness, shedding, and blistering of the skin (toxic epidermal necrolysis).

Eyes and ears

• Yellow vision, blurred vision, worsening of myopia, decreased tear production.
• Decreased vision or eye pain due to elevated pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Joints and muscles

• Muscle spasms, muscle pain.

Urinary system

• Kidney dysfunction, acute kidney failure (decreased urine production and accumulation of fluids and waste in the body), inflammation of the connective tissue of the kidneys (interstitial nephritis), presence of sugar in the urine.

Sexual

• Erectile dysfunction.

General/Other

• General weakness, fatigue, fever, thirst.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lobivon Plus

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 the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point located in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Lobivon Plus

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 other components are:

• Core: lactose monohydrate, polysorbate 80 (E-433), hypromellose (E-464), maize starch, sodium croscarmellose (E-468), microcrystalline cellulose (E-460(i)), colloidal anhydrous silica (E-551), magnesium stearate (E-470b).
• Coating: macrogol stearate type I 40 (E-431), titanium dioxide (E-171), carmines (carmine lake of aluminium acid, E-120), hypromellose (E-464), microcrystalline cellulose (E-460(i)).

Appearance of the product and contents of the pack

Lobivon Plus is presented as film-coated pink tablets, round, slightly biconvex, with the inscription “5/12.5” in relief on one side and a score line on the other side, available in packs of 7, 14, 28, 30, 56 and 90 film-coated tablets.

The tablets are packaged in blisters made of (PP/COC/PP/Aluminium).

Not all pack sizes may be marketed.

Marketing Authorization Holder

Menarini International Operations Luxembourg S.A.,
1, Avenue de la Gare L-1611, Luxembourg

Local representative:

Laboratorios Menarini, S.A.
Alfons XII, 587 - Badalona (Barcelona) Spain

Manufacturer

Berlin-Chemie AG
Glienicker Weg 125 - 12489 Berlin, Germany

or

Menarini - Von Heyden GMBH
Leipziger Strasse 7-13, 01097 – Dresden, Germany

or

• Menarini Manufacturing Logistics and Services S.r.l.
  Via Sette Santi 3, 50131 Florence, Italy

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

Date of the most recent review of this leaflet: April 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/