Bisoprolol and hydrochlorothiazide Mylan Generics: detailed information

Patient Information Leaflet

Bisoprolol and Hydrochlorothiazide Mylan Generics 2.5 mg/6.25 mg film-coated tablets, 5 mg/6.25 mg film-coated tablets, 10 mg/6.25 mg film-coated tablets

bisoprolol fumarate
hydrochlorothiazide
Generic medicine
Please read all of this 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. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What is Bisoprolol and Hydrochlorothiazide Mylan Generics and what it is used for

The active substances are bisoprolol and hydrochlorothiazide.
Bisoprolol belongs to a family of medicines called beta-blockers and is used to reduce blood pressure.
Hydrochlorothiazide belongs to a family of medicines called thiazide diuretics. This component helps reduce blood pressure by increasing urine elimination.
The medicine is indicated for the treatment of mild to moderate high blood pressure.

2. What you need to know before taking Bisoprolol and Hydrochlorothiazide Mylan Generics

Do not take Bisoprolol and Hydrochlorothiazide Mylan Generics

If you are allergic to bisoprolol, hydrochlorothiazide, other thiazides, sulfonamides (substances chemically related to hydrochlorothiazide), or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from severe asthma.
If you have uncontrolled heart failure or cardiogenic shock (a serious heart condition causing a drop in blood pressure and circulatory failure).
If you have heart rhythm disorders, particularly a slow heartbeat, conduction disorders, or a condition called sick sinus syndrome.
If you have very low blood pressure.
If you have a tumour of the adrenal medulla (pheochromocytoma) that is not being treated.
If you suffer from severe circulatory problems in the limbs (such as Raynaud's syndrome, which may cause paleness, bluish colouring, or tingling in the fingers or toes).
If you have increased blood acidity (metabolic acidosis) caused by a serious illness.
If you have severe kidney or liver problems.
If you have low potassium levels in the blood that do not respond to treatment (persistent hypokalaemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking Bisoprolol and Hydrochlorothiazide Mylan Generics:

If you have previously experienced respiratory or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If you develop shortness of breath or severe breathing difficulties after taking Bisoprolol and Hydrochlorothiazide Mylan Generics, consult a doctor immediately.
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 and lip cancers. Protect your skin from exposure to sunlight and UV radiation while taking Bisoprolol and Hydrochlorothiazide Mylan Generics.
If you have any heart conditions, such as heart failure, heart rhythm disorders, or Prinzmetal's angina.
If you have circulatory problems in the fingers or toes, arms, or legs (Raynaud's syndrome), or experience cramp-like pains in the calves that occur during exercise or walking. These conditions may worsen, especially at the beginning of treatment.
If you have a tumour of the adrenal medulla (pheochromocytoma) that is being treated. Bisoprolol and Hydrochlorothiazide Mylan Generics should only be used in combination with certain medicines (alpha-blockers).
If you suffer from asthma or any other chronic respiratory disorder that may cause symptoms (bronchospasm). Your treatment may need to be adjusted.
If you have diabetes. Bisoprolol and Hydrochlorothiazide Mylan Generics may mask the symptoms of low blood sugar (hypoglycaemia).
If you have a thyroid disorder, Bisoprolol and Hydrochlorothiazide Mylan Generics may mask symptoms of an overactive thyroid.
If you have or have previously had recurrent skin disorders causing peeling and dryness of the skin (psoriasis).
If you are on a strict diet.
If you have high levels of uric acid in the blood (hyperuricaemia), because Bisoprolol and Hydrochlorothiazide Mylan Generics may increase the risk of gout attacks.
If you are scheduled for surgery. Heart rate and blood pressure may change when an anaesthetic is used together with Bisoprolol and Hydrochlorothiazide Mylan Generics. Inform the anaesthetist that you are taking Bisoprolol and Hydrochlorothiazide Mylan Generics.
If you have reduced blood volume (hypovolaemia).
If you have mild to moderate kidney or liver problems.
If you suffer from high levels of uric acid in the blood (hyperuricaemia), since Bisoprolol and Hydrochlorothiazide Mylan Generics may increase the risk of gout attacks.
If you are elderly.
If you are receiving treatment for allergic reactions. Bisoprolol and Hydrochlorothiazide Mylan Generics may increase the severity of allergic reactions. In addition, your usual treatment may become less effective.
If you plan to be exposed to sunlight or artificial UV radiation, because some patients have developed skin rashes after sun exposure. In such cases, you should protect your skin during treatment with Bisoprolol and Hydrochlorothiazide Mylan Generics.
If you experience a decrease in vision 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 from a few hours to several weeks after taking Bisoprolol and Hydrochlorothiazide Mylan Generics.

Treatment must never be stopped suddenly, especially if you suffer from certain heart conditions (e.g. angina). If you need to stop treatment, your doctor will gradually reduce your dose over several days.
It is not recommended to combine this medicine with lithium, used to treat certain psychiatric disorders, or with medicines used for treating hypertension, angina pectoris, or cardiac arrhythmia (such as verapamil, diltiazem, or bepridil) (see section "Other medicines and Bisoprolol and Hydrochlorothiazide Mylan Generics").

Additional tests
Bisoprolol and Hydrochlorothiazide Mylan Generics affects the body's fluid and electrolyte balance. Your doctor will monitor you regularly. These tests are particularly important if you have other conditions that could worsen if fluid and electrolyte balance is disturbed. Additionally, your doctor may occasionally check levels of lipids, potassium, sodium, calcium, urea, uric acid, or glucose in your blood.

Other medicines and Bisoprolol and Hydrochlorothiazide Mylan Generics
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Bisoprolol and Hydrochlorothiazide Mylan Generics should only be taken with the following medicines if prescribed by your doctor, as they are generally not recommended:

Certain medicines used to treat hypertension, angina, or cardiac arrhythmia (such as verapamil, diltiazem, or bepridil), which may increase the risk of heart rhythm disorders.
Lithium, a medicine used to treat certain psychiatric disorders.

Inform your doctor or pharmacist if you are taking any of the following medicines. Their use with Bisoprolol and Hydrochlorothiazide Mylan Generics should be done with caution:

Certain medicines used to treat hypertension (e.g. clonidine, methyldopa, moxonidine, rilmenidine);
Propafenone, cibenzoline, flecainide, used to treat heart rhythm abnormalities;
Lidocaine, used as an anaesthetic during minor surgical procedures and to treat heart rhythm abnormalities;
Medicines that mimic the action of certain nerves, such as pilocarpine or carbachol (parasympathomimetics);
Medicines for treating diabetes (e.g. insulin, sulfonylureas, glinides). Bisoprolol may increase the risk of severely low blood sugar levels when used with these medicines;
Medicines that may slow the heart rate (e.g. anticholinergic agents, digitalis glycosides, mefloquine);
Medicines that lower blood pressure by dilating blood vessels (ACE inhibitors (e.g. captopril, enalapril, quinapril), sartans (e.g. losartan, irbesartan, valsartan), dihydropyridine calcium antagonists (e.g. nifedipine, amlodipine));
Eye drops for treating glaucoma (topical beta-blockers);
Medicines for treating pain and inflammation (e.g. NSAIDs, acetylsalicylic acid);
Medicines for treating hypertension by increasing urine production (potassium-sparing diuretics);
Medicines that reduce potassium levels in the blood, which may cause excessive potassium loss (hypokalaemic agents, e.g. amphotericin, corticosteroids, tetracosactide, stimulant laxatives);
Medicines that affect or may be affected by blood potassium levels, such as digoxin (a medicine for controlling heart rhythm), and certain antipsychotic medicines;
Carbamazepine, used to treat epilepsy and certain mood disorders;
Medicines used in hospitals to examine blood vessels (iodinated contrast media);
Medicines used to treat gout by reducing uric acid levels in the blood;
Calcium salts, which may increase blood calcium levels to dangerous levels;
Cyclosporine, used after organ transplants and to treat immune disorders such as psoriasis and arthritis;
Medicines that reduce the absorption of hydrochlorothiazide (e.g. cholestyramine, colestipol).

Bisoprolol and Hydrochlorothiazide Mylan Generics with food and drinks
Bisoprolol and Hydrochlorothiazide Mylan Generics tablets should be taken in the morning and may be taken with food. The tablet should be swallowed with liquid and must not be chewed.
It is recommended to maintain adequate fluid intake and to eat more foods rich in potassium while taking this medicine, to prevent potential potassium deficiency, e.g. bananas, vegetables, and nuts. Potassium loss may also be reduced or prevented with potassium-sparing diuretics. Discuss this with your doctor if you are concerned.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine. Your doctor will usually advise you to take another medicine instead of Bisoprolol and Hydrochlorothiazide Mylan Generics, as it is not recommended during pregnancy. This is because both hydrochlorothiazide and bisoprolol cross the placenta, and their use during pregnancy may be harmful to your baby. If Bisoprolol and Hydrochlorothiazide Mylan Generics is used during pregnancy, your baby should be monitored for 5 days after birth.
Inform your doctor if you are breastfeeding or planning to breastfeed. Bisoprolol and Hydrochlorothiazide Mylan Generics is not recommended for breastfeeding mothers. Hydrochlorothiazide may impair milk production.
As with other medicines, Bisoprolol and Hydrochlorothiazide Mylan Generics may rarely affect the ability to achieve an erection.

Sports
For athletes: using this medicine without a therapeutic need constitutes doping and may lead to a positive anti-doping test.

Driving and using machines
Bisoprolol and Hydrochlorothiazide Mylan Generics generally does not affect the ability to drive or operate machinery. However, how you react to the medicine may affect your concentration or reaction time. In such cases, you should not drive or operate machinery.

Bisoprolol and Hydrochlorothiazide Mylan Generics contains lactose, sodium, and macrogol
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially "sodium-free".
This medicine contains macrogol, which may cause stomach discomfort and diarrhoea.

3. How to take Bisoprolol and Hydrochlorothiazide Mylan Generics

Dosage
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is one 2.5 mg/6.25 mg tablet of Bisoprolol and Hydrochlorothiazide Mylan Generics daily.
If blood pressure reduction is insufficient at this dose, the dose may be increased to one 5 mg/6.25 mg tablet of Bisoprolol and Hydrochlorothiazide Mylan Generics daily. If the response is still inadequate, the dose may be further increased to one 10 mg/6.25 mg tablet of Bisoprolol and Hydrochlorothiazide Mylan Generics daily.

Use in children
Bisoprolol and Hydrochlorothiazide Mylan Generics is not recommended for use in children, as there is insufficient experience regarding its use in this population.

Method and route of administration
For oral use.
The tablets should be taken in the morning, with or without food. Swallow the tablets with liquid; do not chew them.

Frequency of administration
The usual frequency is one tablet daily.

Duration of treatment
Treatment with Bisoprolol and Hydrochlorothiazide Mylan Generics is intended for long-term use. Do not stop treatment suddenly, as this may worsen your condition. Discontinuation of treatment should always be discussed with your doctor beforehand.

If you take more Bisoprolol and Hydrochlorothiazide Mylan Generics than you should
If you take more Bisoprolol and Hydrochlorothiazide Mylan Generics than prescribed, contact a doctor or go to the emergency department immediately. Bring the container and any remaining tablets with you. The most common signs of overdose include dizziness, fainting, nausea, vomiting, drowsiness, and slow or irregular heartbeat.

If you forget to take Bisoprolol and Hydrochlorothiazide Mylan Generics
Do not take a double dose to make up for the missed dose. Take the next dose at the usual scheduled time. If you have missed several doses, contact your doctor.

If you stop taking Bisoprolol and Hydrochlorothiazide Mylan Generics
Do not stop taking Bisoprolol and Hydrochlorothiazide Mylan Generics unless instructed by your doctor. Your condition may worsen significantly if you discontinue treatment abruptly. If discontinuation is necessary, your doctor will usually advise you to gradually reduce the dose.

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 everyone will experience them.
If you notice any of the following serious side effects, stop taking this medicine and contact your doctor immediately:

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

Slow heart rate (bradycardia).

Rare (may affect up to 1 in 1,000 people):

Decrease in the number of white blood cells in the blood (leucopenia, agranulocytosis), increasing the risk of infections, causing fever, severe chills, sore throat, or mouth ulcers;
Decrease in the number of platelets in the blood (thrombocytopenia), causing unexpected bruising or bleeding that lasts longer than normal;
Inflammation of the liver (hepatitis), with symptoms including yellowing of the skin and whites of the eyes, abdominal pain, pale stools, and dark urine.

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

Acute breathing difficulty (signs include severe shortness of breath, fever, weakness, and confusion);
A severe allergic (anaphylactic) reaction that may cause difficulty breathing or swallowing;
Severe skin reactions with blistering and widespread peeling (toxic epidermal necrolysis) or appearance of red, scaly patches (cutaneous lupus erythematosus);
Inflammation of the pancreas (pancreatitis) with symptoms including severe pain in the upper abdomen, often accompanied by feeling unwell (nausea) and vomiting.

Not known (frequency cannot be estimated from the available data):

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);
Severe shortness of breath or sudden worsening of breathing difficulties, which could be signs of a lung disorder (interstitial lung disease);
Skin and lip cancer (non-melanoma skin cancer).

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

Cold sensation or numbness in hands and feet;
Feeling of tiredness (fatigue), dizziness, headache. These symptoms occur especially at the beginning of treatment. They are usually mild and typically disappear within 1 or 2 weeks after starting treatment;
Nausea, vomiting, diarrhoea, constipation.

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

Muscle weakness, muscle cramps;
Unusual feeling of tiredness;
Irregular heart rhythm (atrioventricular conduction disorders), worsening of heart failure;
Dizziness or feeling lightheaded when standing;
Sleep disturbances, depression;
Loss of appetite;
Abdominal discomfort;
Breathing problems (difficulty breathing, wheezing, cough), in people with asthma or a history of obstructive airway disease;
Increased levels of serum creatinine, urea, or uric acid in the blood;
Increased amylase levels in the blood;
Increased levels of fats (triglycerides and cholesterol) or sugars (glucose) in the blood;
Increased glucose levels in the urine;
Abnormal levels of body fluids and electrolytes, which may be detected by a blood test.

Rare (may affect up to 1 in 1,000 people):

Nightmares, hallucinations;
Other allergic reactions such as itching, sudden redness of the face, skin rash, swelling of the face, lips, tongue or throat, increased skin sensitivity to sunlight (photosensitivity dermatitis), hives, red spots on the skin due to subcutaneous bleeding (purpura);
Increased levels of liver enzymes in the blood, yellowing of the skin and/or whites of the eyes (jaundice);
Erectile dysfunction;
Hearing problems;
Fainting;
Runny nose;
Reduced tear production (may be a problem if you wear contact lenses);
Vision disturbances.

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

Eye irritation and redness (conjunctivitis);
Hair loss (alopecia);
Onset or worsening of red, itchy, scaly patches (psoriasis);
Chest pain;
Loss of acid from the blood (metabolic alkalosis).

If you experience any of these side effects, consult your doctor or pharmacist. This includes any side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Bisoprolol and Hydrochlorothiazide Mylan Generics

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 packaging after "Exp.". The expiry
date refers to the last day of that month.
Storage conditions
This medicine does not require any special storage conditions.
Do not dispose of 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. Contents of the pack and other information

What Bisoprololo e Idroclorotiazide Mylan Generics 2.5 mg/6.25 mg film-coated tablets contains
The active substances are bisoprolol fumarate and hydrochlorothiazide.
The other components are:
Tablet core
Microcrystalline cellulose (E460), Lactose, Pregelatinized maize starch, Anhydrous colloidal silica (E551), Magnesium stearate, Sodium lauryl sulfate, Sodium croscarmellose (E468), Yellow iron oxide (E172).
See section 2 “Bisoprololo e Idroclorotiazide Mylan Generics contains lactose, sodium and macrogol”.
Film coating
Titanium dioxide (E171), Polydextrose FCC (E1200), Hypromellose (E464), Macrogol, Yellow iron oxide (E172).

What Bisoprololo e Idroclorotiazide Mylan Generics 5 mg/6.25 mg film-coated tablets contains
The active substances are bisoprolol fumarate and hydrochlorothiazide.
The other components are:
Tablet core
Microcrystalline cellulose (E460), Lactose, Pregelatinized maize starch, Anhydrous colloidal silica (E551), Magnesium stearate, Sodium lauryl sulfate, Sodium croscarmellose (E468), Yellow iron oxide (E172).
See section 2 “Bisoprololo e Idroclorotiazide Mylan Generics contains lactose, sodium and macrogol”.
Film coating
Titanium dioxide (E171), Polydextrose FCC (E1200), Hypromellose (E464), Macrogol, Yellow iron oxide (E172), Red iron oxide (E172).

What Bisoprololo e Idroclorotiazide Mylan Generics 10 mg/6.25 mg film-coated tablets contains
The active substances are bisoprolol fumarate and hydrochlorothiazide.
The other components are:
Tablet core
Microcrystalline cellulose (E460), Lactose, Pregelatinized maize starch, Anhydrous colloidal silica (E551), Magnesium stearate, Sodium lauryl sulfate, Sodium croscarmellose (E468).
See section 2 “Bisoprololo e Idroclorotiazide Mylan Generics contains lactose, sodium and macrogol”.
Film coating
Titanium dioxide (E171), Polydextrose FCC (E1200), Hypromellose (E464), Macrogol.

Description of the appearance of Bisoprololo e Idroclorotiazide Mylan Generics and contents of the pack
Bisoprololo e Idroclorotiazide Mylan Generics 2.5 mg/6.25 mg film-coated tablets
Yellow, round, biconvex, film-coated tablets, with “BH1” engraved on one side and “M” on the other side of the tablet.

Bisoprololo e Idroclorotiazide Mylan Generics 5 mg/6.25 mg film-coated tablets
Light pink, round, biconvex, film-coated tablets, with “BH2” engraved on one side and “M” on the other side of the tablet.

Bisoprololo e Idroclorotiazide Mylan Generics 10 mg/6.25 mg film-coated tablets
White, round, biconvex, film-coated tablets, with “BH3” engraved on one side and “M” on the other side of the tablet.

Bisoprololo e Idroclorotiazide Mylan Generics is packaged in boxes containing blisters with 30 film-coated tablets.

Marketing Authorization Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan
Italy

Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
H-2900
Komárom, Mylan utca 1
Hungary

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

Italy

Bisoprolol and Hydrochlorothiazide Mylan Generics