Bisoprololfumaraat/Hydrochloorthiazide Mylan 5/6,25 mg, filmomhulde tabletten

1. What is and what it is used for

The active substances are bisoprolol and hydrochlorothiazide:

Bisoprolol belongs to the family of medicines called beta-blockers and it is used to decrease blood pressure.

Hydrochlorothiazide belongs to the family of medicines called thiazide diuretics (also known as “water tablets”). This product helps to lower blood pressure by increasing the elimination of urine.

This medicine is recommended for the treatment of mild to moderate high blood pressure.

2. What you need to know before you take

Do not take <INVENTED NAME> if you

• are allergic to bisoprolol, hydrochlorothiazide, other thiazides, sulphonamides (substances chemically related to hydrochlorothiazide) or any of the other ingredients of this medicine (listed in section 6).
• suffer from severe forms of asthma or any other breathing problems such as chronic respiratory disorders
• have heart failure which is not controlled by treatment, or cardiogenic shock (a serious cardiac disorder causing a drop in blood pressure and circulatory failure)
• have certain cardiac rhythm disorders, in particular a slow cardiac rhythm, conduction disorders and a disorder called sick sinus syndrome
• have very low blood pressure
• have a tumour of the adrenal medulla (phaeochromocytoma) which is not being treated;
• have severe circulatory disorders affecting the limbs (such as Raynaud’s syndrome that could result in pallor, blueing or tingling of the fingers and toes)
• have an increase in blood acid concentration (metabolic acidosis) due to a serious disease
• have severe kidney or liver disorders
• have low blood potassium levels that do not respond to treatment (persistent hypokalaemia)

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• have very high levels of calcium (hypercalcaemia) in the blood

Warnings and precautions

Talk to your doctor or pharmacist before taking <INVENTED NAME> if you:

• suffer from any cardiopathy such as heart failure, cardiac rhythm disorders or Prinzmetal angina
• suffer from blood circulation problems in the fingers, toes, arms and legs (Raynaud’s syndrome) or a cramp like pain in the calves brought on by exercise or walking. The complaints may be worse, particularly at the beginning of the treatment
• have a tumour of the adrenal medulla (phaeochromocytoma) which is being treated; <INVENTED NAME> must only be used in combination with certain medicinal products (alpha-blockers)
• suffer from asthma or any other chronic respiratory disorders which may cause symptoms (bronchospasms). The treatment you receive may have to be adjusted
• have diabetes, <INVENTED NAME> may hide the symptoms of low blood sugar (hypoglycaemia)
• suffer from a thyroid problem, as <INVENTED NAME> may hide the symptoms of an overactive thyroid
• suffer (or have suffered) from a recurrent skin disorder involving a scaling, dry skin rash (psoriasis)
• follow a strict diet
• suffer from high uric acid levels in your blood (hyperuricaemia), since <INVENTED NAME> has a tendency to increase the risk of gout attacks
• are planning to undergo surgery. Your heart rate and blood pressure can change when anaesthetics are taken together with <INVENTED NAME>. Tell the anaesthetist that you are taking <INVENTED NAME>
• have reduced blood volume (hypovolaemia)
• have mild to moderate kidney or liver problems
• suffer from high uric acid levels in your blood (hyperuricaemia), since <INVENTED NAME> has a tendency to increase the risk of gout attacks
• you are elderly
• are receiving treatment for allergic reactions. <INVENTED NAME> may increase the severity of your allergic reactions. Your normal treatment may also be less effective
• plan to expose yourself to the sun or artificial UV light, given that certain patients have presented a skin rash after sun exposure. In that case, you must protect your skin during treatment with <INVENTED NAME>.

Treatment must never be stopped suddenly, especially if you suffer from certain heart diseases (for example, angina). If you need to stop treatment your doctor will decrease your dosage over several days.

It is not recommended to combine this medicine with lithium used in the treatment of certain psychiatric disorders, or with medicines used in the treatment of hypertension, angina pectoris or cardiac arrhythmia (such as verapamil, diltiazem or bepridil) (see section “Other medicines and <INVENTED NAME>”).

Additional tests

• <INVENTED NAME> acts by influencing the salt-water balance of the body. Your doctor will monitor it regularly. These tests are particularly important if you suffer from other diseases that may be aggravated if the water-electrolyte balance is perturbed. Your doctor may also wish to verify occasionally the lipids, potassium, sodium, calcium, uric acid, urea, uric acid or glucose concentrations in your blood.

Other medicines and <INVENTED NAME>

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Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

<INVENTED NAME> can only be taken with the following medicines if your doctor indicates it, as it is generally inadvisable:

• some medicines used to treat hypertension, angina or cardiac arrhythmia (e.g. verapamil, diltiazem or bepridil) which may increase the risk of cardiac rhythm disorders,
• lithium, medicine used to treat some types of psychiatric illness.

Tell your doctor or pharmacist if you are taking any of the following medicines. Their use with <INVENTED NAME> must be done with caution:

• some medicines to treat high blood pressure (e.g. clonidine, methyldopa, moxonodine, rimenidine),
• propafenone, cibenzoline, flecainide, used to treat abnormal heart beat,
• lidocaine, used to relieve pain during minor surgery and to treat abnormal heart beat,
• - medicines that imitates the action of a kind of nerve such as pilocarpine or carbachol (parasympathomimetics)
• medicines to treat diabetes (e.g. insulin, hypoglycaemic sulphonamides, glinides),
• medicines that can cause a slowing of your heart rate (anticholinergic agents, digitalis glycosides, mefloquine etc.),
• medicines that reduce blood pressure by relaxing your blood vessels (ACE inhibitors (e.g. captopril, enalapril, quinapril), ARBs (e.g. losartan, irbesartan, valsartan), dihydropyridine type calcium antagonists (e.g. nifedipine, amlodipine)),
• eye drops to treat glaucoma (topical beta-blockers),
• medicines to treat pain and inflammation (e.g. NSAIDs, acetylsalicylic acid) ,
• medicines used to treat high blood pressure by increasing urine production (potassium-sparing diuretics),
• medicines to reduce the level of potassium in the blood, they may cause you to loose too much potassium (hypokalaemic agents e.g. amphotericin, corticosteroids, tetracosactide, stimulant laxatives),
• medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines,
• carbamazepine, used to treat epilepsy and some mood disorders,
• medicines used by hospitals to examine your blood vessels (iodinated contrast media),
• medicines used to treat gout by reducing levels of uric acid in the blood,
• calcium salts, they may raise your blood calcium levels to dangerous levels,
• cyclosporine, used following organ transplants, and to treat immune disorders such as psoriasis and arthritis.

<INVENTED NAME>with food and drink

<INVENTED NAME> tablets should be taken in the morning and can be taken with food. They should be swallowed with liquid and should not be chewed.

It is recommended that you maintain an adequate fluid intake and eat more foods that are high in potassium while taking this medicine to avoid potential potassium deficiency e.g. bananas, vegetables and nuts. Loss of potassium can also be reduced or prevented by means of medication (potassium- sparing diuretics). Discuss this with your Doctor if you are concerned.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Usually, your doctor will advise you to take another medicine instead of <INVENTED NAME>, as <INVENTED NAME> is not recommended during pregnancy. This is because both hydrochlorothiazide and bisoprolol cross the

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placenta and their use during pregnancy may harm your baby. If <INVENTED NAME> is used during pregnancy, your baby must be monitored for 5 days after delivery.

Tell your doctor if you are breast-feeding or about to start breast feeding. <INVENTED

NAME> is not recommended for mothers who are breast-feeding. Hydrochlorothiazide may impair your milk production.

As with other drugs, <INVENTED NAME> may rarely affect your ability to have an erection.

Driving and using machines

<INVENTED NAME> normally does not affect the ability to drive or use machines. However, the way you react to your medicine may have an effect on your concentration or your reactions. In that case, do not drive and do not use machines.

<INVENTED NAME> contains lactose

This medicine contains lactose - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects (affecting fewer than 1 in 10 people):

• sensation of cold or numbing in the hands and feet
• fatigue, vertigo sensations, headache. These symptoms appear especially in the beginning of the treatment. They are generally mild in intensity and usually disappear within 1 to 2 weeks after the start of treatment.
• nausea, vomiting, diarrhoea or constipation.

Uncommon side effects (affecting fewer than 1 in 100 people)

• muscle weakness and muscle cramps
• feeling tired or weak
• slow heart beat, abnormal heart rhythm, worsening of heart failure
• feeling dizzy or light headed when you stand up
• sleep disorders, depression
• loss of appetite and weight loss (anorexia)
• respiratory problems in subjects suffering from asthma or chronic bronchopneumopathy
• increase in creatinine or urea levels in blood
• abdominal complaints
• increase in amylases (enzymes involved in digestion)
• increase in lipid, cholesterol, uric acid or glucose levels in blood; increase in glucose levels in urine
• abnormal body fluid and electrolyte levels (hypokalaemia, hypomagnesaemia, hyponatraemia, hypochloraemia, hypercalcaemia)

Rare side effects (affecting fewer than 1 in 1,000 people)

• nightmares, hallucinations
• allergic reactions such as itching, sudden redness in the face or skin rash, sensitisation of the skin to sun, urticaria, red spots on the skin due to bleeding under the skin (purpura)
• increase in certain hepatic enzymes, liver inflammation, yellow skin and eye colour (jaundice)
• potency disorders
• hearing disorders
• runny nose
• reduced tear flow (can be a problem if you wear contact lenses)
• visual disturbance
• decrease in the number of white blood cells (leucocytopenia) or platelets (thrombocytopenia) in the blood.

Very rare side effects (affecting fewer than 1 in 10,000 people):

• irritation and redness of the eyes (conjunctivitis), hair loss

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• appearance or aggravation of pre-existing squamous cutaneous rash (psoriasis); appearance of plaques with crust (cutaneous lupus erythematosus)
• chest pains
• significant decrease in the number of white blood cells (agranulocytosis)
• inflammation of the pancreas
• severe loss of acids in blood (metabolic alkalosis)
• allergic reactions (anaphylactic), severe skin reactions with blisters (Lyell’s syndrome).

If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

What <INVENTED NAME> contains

<INVENTED NAME> 2.5 mg/6.25 mg film-coated tablet

The active substances are bisoprolol fumarate and hydrochlorothiazide.

The other ingredients are:

Tablet core: Cellulose microcrystalline (E460); Lactose anhydrous; Starch, pregelatinised (maize); Silica, colloidal anhydrous (E551); Magnesium stearate; Sodium laurilsulfate; Croscarmellose sodium (E468); Iron oxide yellow (E172).

Film-coating: Titanium dioxide (E171); Polydextrose FCC (E1200); Hypromellose (E464); Macrogol; Iron oxide yellow (E172).

<INVENTED NAME> 5 mg/6.25 mg film-coated tablet

The active substances are bisoprolol fumarate and hydrochlorothiazide.

The other ingredients are:

Tablet core: Cellulose microcrystalline (E460); Lactose anhydrous; Starch, pregelatinised (maize); Silica, colloidal anhydrous (E551); Magnesium stearate; Sodium laurilsulfate; Croscarmellose sodium (E468); Iron oxide yellow (E172).

Film-coating: Titanium dioxide (E171); Polydextrose FCC (E1200); Hypromellose (E464); Macrogol; Iron oxide yellow (E172); Iron oxide red (E172).

<INVENTED NAME> 10 mg/6.25 mg film-coated tablet

The active substances are bisoprolol fumarate and hydrochlorothiazide.

The other ingredients are:

Tablet core: Cellulose microcrystalline (E460); Lactose anhydrous; Starch, pregelatinised (maize); Silica, colloidal anhydrous (E551); Magnesium stearate; Sodium laurilsulfate; Croscarmellose sodium (E468).

Film-coating: Titanium dioxide (E171); Polydextrose FCC (E1200); Hypromellose (E464); Macrogol.

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What <INVENTED NAME> looks like and contents of the pack

<INVENTED NAME> 2.5 mg/6.25 mg film-coated tablet

Film-coated tablet

A yellow, film coated, round, biconvex tablet debossed with ‘BH1’ on one side and ‘M’ on the other side of the tablet.

<INVENTED NAME> 5 mg/6.25 mg film-coated tablet

Film-coated tablet

A light pink, film coated, round, biconvex tablet debossed with ‘BH2’ on one side and ‘M’ on the other side of the tablet.

<INVENTED NAME> 10 mg/6.25 mg film-coated tablet

Film-coated tablet

A white, film coated, round, biconvex tablet debossed with ‘BH3’ on one side and ‘M’ on the other side of the tablet.

<INVENTED NAME> is packed as cardboard cartons containing blister packs of 10, 28, 30, 30 x 1 blister, 50, 56, 84, 90, 90 x 1 blister, 98 or 100 film-coated tablets. <INVENTED NAME> are packed as cardboard cartons containing bottles of 100 or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mylan B.V.

Dieselweg 25

3752 LB Bunschoten

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 authorised in the Member States of the EEA under the following names:

Belgium	Bisocombimyl
France	Bisoprolol	Hydrochlorothiazide Mylan
	Pharma
Luxembourg	Bisocombimyl
Malta	Bisocombimyl
Poland	Bisogen combi
Romania	Biasidral
Slovak	Bisomyl	Combi
Republic
The	Bisoprololfumaraat/Hydrochloorthiazide
Netherlands	Mylan

Deze bijsluiter is voor het laatst goedgekeurd in september 2013.

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