LODOZ 2.5 mg/6.25 mg Film-coated tablets

Зміст інструкції

1. Lodoz 2.5 mg/6.25 mg, film-coated tablet, 5 mg/6.25 mg, film-coated tablet, 10 mg/6.25 mg, film-coated tablet
   1. What is Lodoz and what is it used for
   2. What you need to know before taking Lodoz
   3. How to take Lodoz
   4. Possible side effects
   5. How to store Lodoz
   6. Package Contents and Other Information

Lodoz 2.5 mg/6.25 mg, film-coated tablet, 5 mg/6.25 mg, film-coated tablet, 10 mg/6.25 mg, film-coated tablet

bisoprolol fumarate and hydrochlorothiazide

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Lodoz and what is it used for

Lodoz contains the active ingredients bisoprolol and hydrochlorothiazide:

• Bisoprolol belongs to a group of medicines called beta-blockers and is used to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It promotes the lowering of blood pressure by increasing urine production.

Lodoz is indicated for the treatment of mild to moderate hypertension.

2. What you need to know before taking Lodoz

Do not take Lodoz if any of the following conditions apply to you:

• allergy (hypersensitivity) to bisoprolol, hydrochlorothiazide, other thiazides, sulfonamides or to any of the excipients (see section 6, "What Lodoz contains")
• severe asthma
• uncontrolled heart failure with therapy or cardiogenic shock (a severe acute heart condition that causes low blood pressure and circulatory failure)
• certain heart rhythm disturbances, in particular slowed heartbeat causing problems, conduction disturbances and a condition called sick sinus syndrome.
• pheochromocytoma (a tumor of the adrenal gland that secretes substances that cause severe high blood pressure) that has not been treated
• severe circulation problems in the limbs (such as, for example, Raynaud's syndrome, which can cause tingling or pale or bluish discoloration of the fingers or toes)
• increased blood acidity (metabolic acidosis) as a result of a serious illness
• severe liver or kidney problems
• low blood potassium levels that do not respond to treatment

Warnings and precautions
Do not suddenly stop treatment, especially if you suffer from certain heart conditions
(ischemic heart disease, such as angina pectoris).
Before taking Lodoz, tell your doctor if you have any of the following conditions:

• any heart disease such as heart failure, arrhythmias or Prinzmetal's angina
• less severe circulation problems in the limbs (especially due to Raynaud's syndrome)
• liver or kidney problems
• pheochromocytoma (adrenal gland tumor)
• chronic lung disease or less severe asthma
• diabetes
• thyroid disorders
• psoriasis
• strict fasting
• history of allergy to penicillins.

In addition, tell your doctor:

• if you have suffered from gout, as Lodoz may increase the risk of gout attacks
• if you are going to have anesthesia (e.g., for a surgical operation) as Lodoz may affect the body's reaction in such circumstances
• if you plan to undergo desensitization therapy, as Lodoz may increase the likelihood of allergic reactions, or such reactions may be more severe
• if you are breastfeeding or intend to breastfeed
• if you intend to be exposed to sunlight or artificial (UV) light, as some patients have developed skin rashes after exposure. In this case, you should protect your skin during treatment with Lodoz if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Lodoz
• if you experience decreased vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye and may occur from a few hours to weeks after taking Lodoz. These symptoms, if left untreated, can lead to permanent vision loss. If you have previously had an allergy to penicillin or sulfonamide, you may be at higher risk of developing these symptoms.

While you are using Lodoz, if you have chronic lung disease or less severe asthma, tell your
doctor immediately if you experience new difficulty breathing, coughing, shortness of breath after exercise
etc.
Additional tests
Hydrochlorothiazide affects the balance of salt and water levels in the body. Your doctor may deem
appropriate to perform sporadic checks of these values. This becomes particularly important in the presence of
additional conditions that could worsen if the electrolyte balance is altered. The
doctor will also perform sporadic checks of blood fat levels, uric acid or glucose
The concomitant use of this medicine is not recommended with lithium, used for the treatment of
some psychiatric disorders, or with medicines used for the treatment of high blood pressure, angina pectoris or
irregular heartbeat (such as verapamil, diltiazem or bepridil) (see section ‘Taking other
medicines’).
For those who play sports: the use of the drug without a therapeutic need constitutes doping and may
still result in positive doping tests.

Other medicines and Lodoz
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Take Lodoz together with one of the following medicines only under the guidance of a doctor, as
the association with such drugs is generally not recommended (see the section above ‘Pay particular
attention with Lodoz’):

• Some medicines used to treat high blood pressure, angina pectoris or irregular heartbeat (such as verapamil, diltiazem or bepridil), which may increase the risk of heart rhythm disturbances.
• Lithium, used for the treatment of some psychiatric disorders.

Pregnancy, breastfeeding and fertility
The use of this medicine is not recommended during pregnancy.
The use of this medicine is not recommended during breastfeeding.

Driving and operating machinery
Generally Lodoz does not impair the ability to drive vehicles or operate machinery. However, the individual
response may affect the ability to concentrate and react. In such circumstances, do not drive and do
not operate machinery.

3. How to take Lodoz

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your doctor or pharmacist.
The initial dose is generally 1 Lodoz 2.5 mg/6.25 mg tablet per day.
If the blood pressure lowering effect obtained with this dose is inadequate, it will be
necessary to increase the dose to 1 Lodoz 5 mg/6.25 mg tablet per day and, if the response remains
inadequate, to 1 Lodoz 10 mg/6.25 mg tablet per day.
Take Lodoz in the morning, with or without food. Swallow the tablet with a liquid and do not chew it.
Never stop therapy suddenly (see section ‘If you stop taking Lodoz’)

Use in children
Experience with Lodoz in pediatric patients is limited, therefore use is not recommended in this
population.

Lodoz with food and drink
Lodoz can be taken with or without food, but must be taken in the morning.

If you take more Lodoz than you should
If you have taken a number of Lodoz tablets higher than prescribed, consult your doctor immediately.
The doctor will establish the necessary countermeasures based on the level of overdose.
Symptoms of overdose may include low blood pressure, slowed heartbeat, sudden heart problems, dizziness, nausea, drowsiness, sudden breathing problems, lowered blood glucose levels.

If you forget to take Lodoz
If you forget to take this medicine, take it as soon as possible. Then take the next dose
at the usual time. However, if it is almost time to take the next dose, skip the dose you forgot.
Do not take a double dose to make up for the missed tablet.

If you stop taking Lodoz
Never stop taking this medicine unless directed by your doctor. Otherwise, your condition could seriously worsen. If you need to stop treatment, the
doctor will advise you to reduce the dose gradually. If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects are listed below according to how frequently they occur:

Common side effects(may affect less than 1 in 10 people):

• feeling of cold or numbness in hands and feet
• tiredness, dizziness, headache. These symptoms mainly occur at the beginning of treatment. The effects are generally mild and usually disappear within 1 or 2 weeks of starting treatment
• stomach or intestinal disorders, such as nausea, vomiting, diarrhoea or constipation.

Uncommon side effects(may affect less than 1 in 100 people):

• muscle weakness, muscle cramps, feeling of weakness
• slowing of the heartbeat, changes in heart rate, worsening of heart failure, drop in blood pressure when getting up or standing
• sleep disturbances, depression, loss of appetite
• breathing problems in patients with asthma or chronic bronchial disease
• increased blood levels of creatinine or urea
• abdominal discomfort
• increased levels of amylase (digestive enzymes)
• imbalance of fluids and electrolytes
• increased blood levels of fats, cholesterol, uric acid or sugar; increased sugar levels in the urine

Rare side effects(may affect less than 1 in 1,000 people):

• nightmares, hallucinations allergic-type reactions, such as itching, sudden flushing of the face or skin rash, even after exposure to sunlight, hives, small reddish-purple spots due to bleeding under the skin (purpura). You should see your doctor immediately if you experience more serious allergic reactions, which may involve swelling of the face, neck, tongue, mouth or throat or difficulty breathing.
• increased levels of certain liver enzymes, liver inflammation, yellowish discoloration of the skin and eyes (jaundice)
• erection problems
• hearing problems
• allergic rhinitis, reduced tear secretion, vision disorders
• reduction in the number of white blood cells (leucopenia) or platelets (thrombocytopenia)
• syncope

Very rare side effects(may affect less than 1 in 10,000 people):

• eye irritation and redness (conjunctivitis), hair loss
• appearance or worsening of pre-existing scaly skin rashes (psoriasis); appearance of thick scaly patches (cutaneous lupus erythematosus)
• chest pain
• severe reduction in the number of white blood cells (agranulocytosis)
• inflammation of the pancreas
• low levels of acids in the blood (metabolic alkalosis)
• allergic (anaphylactic) reactions, severe blistering reactions (Lyell's syndrome).

Side effects with unknown frequency(frequency cannot be estimated from available data):

• skin and lip cancer (non-melanoma skin cancer)
• interstitial lung disease
• transient myopia
• decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at 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 Lodoz

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after Scad.

Storage conditions for PP/Alu and PVC/Alu blisters

• Do not store at temperatures above 30°C.

Storage conditions for Alu/Alu blister

• This medicine does not require any special storage conditions.

Do not dispose of any medicine in 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 Lodoz contains
Lodoz 2.5 mg/6.25 mg

• The active ingredients are bisoprolol fumarate and hydrochlorothiazide. Each film-coated tablet contains 2.5 mg of bisoprolol fumarate and 6.25 mg of hydrochlorothiazide
• The other ingredients are

Tablet core: magnesium stearate, crospovidone, corn starch, pregelatinized corn starch,
microcrystalline cellulose, anhydrous dibasic calcium phosphate.

Tablet coating: polysorbate 80, yellow iron oxide (E 172), macrogol 400, titanium dioxide
(E171), hypromellose.
Lodoz 5 mg/6.25 mg

• The active ingredients are bisoprolol fumarate and hydrochlorothiazide. Each film-coated tablet contains 5 mg of bisoprolol fumarate and 6.25 mg of hydrochlorothiazide.
• The other ingredients are Tablet core: colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, corn starch, anhydrous dibasic calcium phosphate. Tablet coating: yellow iron oxide (E 172), red iron oxide (E 172), polysorbate 80, macrogol 400, titanium dioxide (E171), hypromellose.

Lodoz 10 mg/6.25 mg:

• The active ingredients are bisoprolol fumarate and hydrochlorothiazide. Each film-coated tablet contains 10 mg of bisoprolol fumarate and 6.25 mg of hydrochlorothiazide.
• The other ingredients are Tablet core: colloidal anhydrous silica, magnesium stearate, microcrystalline cellulose, corn starch, anhydrous dibasic calcium phosphate. Tablet coating: polysorbate 80, macrogol 400, hypromellose, titanium dioxide (E171).

Description of the appearance of Lodoz and package contents
Lodoz 2.5 mg/6.25 mg: Yellow, round, biconvex film-coated tablet; heart-shaped relief on the upper side, number “2.5” in relief on the lower side.

Lodoz 5 mg/6.25 mg: Pastel pink, round, biconvex film-coated tablet; heart-shaped relief on the
upper side, number “5” in relief on the lower side.

Lodoz 10 mg/6.25 mg: White, round, biconvex film-coated tablet; heart-shaped relief on the upper side, number “10” in relief on the lower side.
Each pack contains: 30, 50, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Merck Serono S.p.A.
Via Casilina 125
00176 Rome

Manufacturers:
Merck Healthcare KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany
Merck Santé s.a.s., Centre de production de Semoy, 2 rue du Pressoir Vert, 45400 Semoy, France
P&G Health Austria GmbH & Co. OG, Hösslgasse 20 - 9800 Spittal/Drau, Austria
Merck S.L., Poligono Merck, 08100 Mollet del Vallès (Barcelona), Spain