REGIAM 2,5 mg/1,25 mg Hard capsule

Зміст інструкції

1. Regiam 2.5 mg/1.25 mg hard capsules, 2.5 mg/2.5 mg hard capsules, 5 mg/2.5 mg hard capsules, 5 mg/5 mg hard capsules, 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules
   1. What is Regiam and what is it used for
   2. What you need to know before taking Regiam
   3. How to take Regiam
   4. Possible side effects
   5. How to store Regiam
   6. Contents of the pack and other information

Regiam 2.5 mg/1.25 mg hard capsules, 2.5 mg/2.5 mg hard capsules, 5 mg/2.5 mg hard capsules, 5 mg/5 mg hard capsules, 10 mg/5 mg hard capsules, 10 mg/10 mg hard capsules

Ramipril / bisoprolol fumarate

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, pharmacist or nurse.
• 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, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Regiam and what is it used for

Regiam contains two active ingredients, bisoprolol fumarate and ramipril in a capsule:

• Ramipril is an inhibitor of the angiotensin converting enzyme (ACE). This works by dilating blood vessels, making it easier for the heart to pump blood around the body.
• Bisoprolol fumarate belongs to a group of medicines called beta-blockers. Beta-blockers slow down the heartbeat and make the heart more efficient at pumping blood throughout the body.

Regiam is used to treat high blood pressure (hypertension) and/or chronic heart failure
with a dysfunction of the left ventricle of the heart (a condition in which the heart is unable
to pump enough blood to meet the body's needs, resulting in shortness of breath and
swelling) and/or to reduce the risk of cardiac events, such as myocardial infarction, in patients with chronic coronary artery disease
(a condition in which blood supply to the heart is reduced or blocked) and for those who have already had
a myocardial infarction and/or surgery to improve blood supply to the heart by dilating the vessels that
feed it.
Instead of taking bisoprolol fumarate and ramipril in separate capsules, you will take only one Regiam capsule
containing both active ingredients at the same dosage.

2. What you need to know before taking Regiam

Do not take Regiam if:

• you are allergic to bisoprolol or any other beta-blocker, to ramipril or any other ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6);
• you have heart failure that is suddenly getting worse and/or may require hospital treatment,
• you have cardiogenic shock (a severe heart condition caused by very low blood pressure);
• you have a heart condition characterised by a slow or irregular heartbeat (second or third degree atrioventricular block, sinoatrial block, sick sinus syndrome),
• you have a slow heart rate;
• you have very low blood pressure;
• you suffer from severe asthma or a severe chronic lung disease;
• you have severe problems with blood circulation to the limbs (such as Raynaud's syndrome), which can cause tingling in the fingers and toes or make them turn pale or blue;
• you have an untreated pheochromocytoma, a rare tumour of the adrenal gland (medulla);
• you have metabolic acidosis, a condition in which there is an excessive amount of acid in the blood;
• you have experienced symptoms such as difficulty breathing, swelling of the face, tongue or throat, intense itching or severe skin rashes with a previous treatment with ACE inhibitors or if you or a member of your family has had these symptoms in any other circumstance (a condition called angioedema);
• you are pregnant for more than 3 months (it is also better to avoid Regiam in the early stages of pregnancy - see section “Pregnancy”);
• you have diabetes or impaired kidney function and are being treated with a medicine to lower blood pressure containing aliskiren;
• you are undergoing dialysis or any type of blood filtration. Depending on the machinery used, Regiam may not be suitable for you;
• you have kidney problems where the blood supply to the kidneys is reduced (renal artery stenosis);
• you are being treated with sacubitril/valsartan, a medicine for heart failure (see “Warnings and precautions” and “Other medicines and Regiam”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Regiam, if:

• you have diabetes,
• you have kidney problems (including kidney transplant) or if you are on dialysis,
• you have liver problems,
• you have aortic and mitral stenosis (narrowing of the main blood vessel leaving the heart) or hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney),
• you have an abnormally high level of a hormone called aldosterone in your blood (primary aldosteronism),
• you have heart failure or any other heart problems, such as minor disturbances in heart rhythm or severe chest pain at rest (Prinzmetal's angina),
• you suffer from a collagen vascular disease (a connective tissue disease) such as systemic lupus erythematosus or scleroderma,
• you are following a low-salt diet or using salt substitutes that contain potassium (too much potassium in the blood can cause changes in heart rate),
• you have recently suffered from diarrhoea or vomiting, or are dehydrated (Regiam can cause a lowering of blood pressure),
• you are undergoing LDL apheresis (which is the removal of cholesterol from the blood using a machine),
• you are having allergy treatment or are about to undergo desensitisation treatment to reduce the effects of an allergy to bee or wasp stings,
• you are on a strict fast or diet,
• you are about to undergo anaesthesia and/or major surgery,
• you have circulation problems in the limbs,
• you suffer from asthma or a chronic lung disease,
• you have (or have had) psoriasis,
• you have a tumour of the adrenal gland (pheochromocytoma),
• you have thyroid problems (Regiam can mask the symptoms of an overactive thyroid),
• you have angioedema (a severe allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing). This can happen at any time during treatment. If you develop these symptoms, stop taking Regiam and go to your doctor immediately,
• you are of black ethnicity, as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-black patients,
• you are taking any of the following medicines used to treat high blood pressure:
• an "angiotensin II receptor antagonist" (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals. See also the information included under “Do not take Regiam” and “Warnings and precautions”).
• you are taking any of the following medicines, the risk of angioedema is increased:
• racecadotril (used to treat diarrhoea),
• sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTOR inhibitors (used in preventing organ rejection after transplantation),
• sacubitril (available as a fixed combination with valsartan), used to treat chronic heart failure.

Do not stop taking Regiam suddenly as this can cause a serious
worsening of your heart condition. Treatment should not be stopped abruptly,
especially in patients with coronary artery disease.
You should inform your doctor if you think you are (or might be) pregnant. Regiam is not
recommended in the early stages of pregnancy, and should not be taken if you are pregnant for more than 3 months,
as it can cause serious harm to the baby if used during that period (see section “Pregnancy”).

For athletes:the use of the drug without a therapeutic need constitutes doping and may
still result in a positive doping test.

Children and adolescents
Regiam is not recommended for use in children and adolescents under the age of 18 years.

Other medicines and Regiam
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
There are some medicines that can change the effect of Regiam or their effect can be
changed by Regiam. This type of interaction can reduce the effect of one or both medicines.
Or it can increase the risk or severity of side effects.
Make sure you inform your doctor if you are taking any of the following medicines:

• medicines used to control blood pressure or medicines for heart problems (such as amiodarone, amlodipine, clonidine, digitalis glycosides, diltiazem, disopyramide, felodipine, flecainide, lidocaine, methyldopa, moxonidine, procainamide, propafenone, quinidine, rilmenidine, verapamil),
• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also the information under “Do not take Regiam” and “Warnings and precautions”) or diuretics (medicines that increase the amount of urine produced by the kidneys),
• potassium-sparing drugs (e.g. triamterene, amiloride), potassium supplements or salt substitutes containing potassium, other drugs that can increase potassium in the body (such as heparin and co-trimoxazole also known as trimethoprim/sulfamethoxazole),
• potassium-sparing drugs used to treat heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day,
• sympathomimetic agents used to treat clinical shock (adrenaline, noradrenaline, dobutamine, isoprenaline, ephedrine),
• estramustine used in cancer therapy,
• medicines that are often used to treat diarrhoea (racecadotril) or to prevent organ rejection (sirolimus, everolimus, temsirolimus and other drugs belonging to the class of so-called mTOR inhibitors). See section “Warnings and precautions”,
• sacubitril/valsartan (used for the long-term treatment of heart failure). See sections "Do not take Regiam” and “Warnings and precautions”,
• lithium used to treat mania or depression,
• some medicines used to treat depression such as imipramine, amitriptyline, monoamine oxidase inhibitors (MAOIs) (except MAO-B inhibitors),
• some medicines used to treat schizophrenia (antipsychotics),
• some medicines used to treat epilepsy (phenytoin, barbiturates such as phenobarbital),
• anaesthetic medicines used in surgery,
• vasodilators including nitrates (products that widen blood vessels),
• trimethoprim used to treat infections,
• immunosuppressants (medicines that reduce the body's defenses) such as cyclosporine, tacrolimus, used for the treatment of autoimmune disorders or following transplantation,
• allopurinol, used to treat gout,
• parasympathomimetic medicines used to treat conditions such as Alzheimer's disease or glaucoma,
• topical beta-blockers used to treat glaucoma (increased pressure in the eye),
• mefloquine used to prevent or treat malaria,
• baclofen used to treat muscle stiffness in diseases such as multiple sclerosis,
• gold salts, especially with intravenous administration (used to treat the symptoms of rheumatoid arthritis),
• medicines for treating diabetes such as insulin, metformin, linagliptin, saxagliptin, sitagliptin, vildagliptin,
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or diclofenac or high-dose aspirin used to treat arthritis, headache, pain or inflammation.

Regiam with food, drinks and alcohol
It is preferable to take Regiam before a meal.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You should tell your doctor if you think you are pregnant or if there is a possibility of becoming
pregnant. Your doctor will usually advise you to stop taking Regiam before starting a
pregnancy or as soon as you find out you are pregnant and will advise you to take another
medicine instead of Regiam. Regiam is not recommended in the early stages of pregnancy, and should not
be taken after the first 3 months of pregnancy, as it can cause serious harm to your baby if
taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Regiam is not
recommended for mothers who are breastfeeding, and your doctor may
choose another treatment for you if you intend to breastfeed, especially if the baby is newly born or
premature.

Driving and using machines
Regiam generally does not affect alertness and attention (vigilance), but in some
patients dizziness/lightheadedness or weakness may occur due to low blood pressure,
especially at the beginning of treatment or when changing the medicine, as well as in association with
alcohol. If this happens to you, your ability to drive vehicles or use machines may be
impaired.

Lactose
Regiam 2.5 mg / 1.25 mg contains 40.97 mg of lactose (20.49 mg of glucose and 20.49 mg of
galactose) per dose. To be taken into consideration in people affected by diabetes mellitus.
Regiam 2.5 mg / 2.5 mg contains 40.97 mg of lactose (20.49 mg of glucose and 20.49 mg of
galactose) per dose. To be taken into consideration in people affected by diabetes mellitus.
Regiam 5 mg / 2.5 mg contains 81.94 mg of lactose (40.97 mg of glucose and 40.97 mg of galactose)
per dose. To be taken into consideration in people affected by diabetes mellitus.
Regiam 5 mg / 5 mg contains 81.94 mg of lactose (40.97 mg of glucose and 40.97 mg of galactose)
per dose. To be taken into consideration in people affected by diabetes mellitus.
Regiam 10 mg / 5 mg contains 163.88 mg of lactose (81.94 mg of glucose and 81.94 mg of galactose)
per dose. To be taken into consideration in people affected by diabetes mellitus.
Regiam 10 mg / 10 mg contains 163.88 mg of lactose (81.94 mg of glucose and 81.94 mg of
galactose) per dose. To be taken into consideration in people affected by diabetes mellitus.

Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially ‘sodium-free’.

3. How to take Regiam

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose is one capsule once a day. Take the capsule swallowing it with a
glass of water in the morning before a meal.

Patients with kidney disease
If you have moderate kidney disease, your doctor will adjust the dose of Regiam. Regiam is not
recommended if you suffer from severe kidney disease.

Patients with hepatic impairment
The doctor will carefully monitor the start of treatment with Regiam if you suffer from mild to moderate liver disease.

Use in children and adolescents
Use in children and adolescents is not recommended.

If you take more Regiam than you should
If you take more capsules than prescribed, contact your doctor or pharmacist immediately.
The most likely effect in case of overdose is low blood pressure which may make you feel dizzy or faint (if this happens, it may help to lie down with your legs
raised), severe difficulty breathing, tremor (due to decreased blood sugar)
and slow heartbeat.

If you forget to take Regiam
It is important to take the medicine every day as regular treatment is more effective. However,
if you forget to take a dose of Regiam, take the next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.

If you stop taking Regiam
Do not suddenly stop treatment with Regiam or change the dose without consulting your
doctor as this may cause a significant worsening of your heart condition. Treatment
should not be stopped abruptly, especially in patients with coronary artery disease.
If you have any questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop taking Regiam and contact your doctor immediately if you notice any of the following side effects:

• severe dizziness/lightheadedness or fainting due to low blood pressure (common - may affect up to 1 in 10 people),
• worsening of heart failure causing increased difficulty breathing and/or fluid retention (common - may affect up to 1 in 10 people),
• swelling of the face, lips, mouth, tongue or throat, difficulty breathing (angioedema) (uncommon - may affect up to 1 in 100 people),
• sudden difficulty breathing, chest pain, shortness of breath or difficulty breathing (bronchospasm) (uncommon - may affect up to 1 in 100 people),
• unusually slow or irregular heartbeat, chest pain (angina) or heart attack (uncommon - may affect up to 1 in 100 people),
• weakness of arms or legs, or difficulty speaking, which could be a sign of a possible stroke (frequency not known - cannot be estimated on the basis of available data),
• inflamed pancreas that can cause severe abdominal pain and back pain accompanied by a feeling of severe discomfort (very rare - may affect up to 1 in 10,000 people),
• yellowing of the skin or eyes (jaundice) which could be a sign of hepatitis (rare - may affect up to 1 in 1,000 people),
• skin rash that often starts with itchy red spots on the face, arms or legs (erythema multiforme) (frequency not known - cannot be estimated on the basis of available data). Regiam is generally well tolerated but, like any other medicine, people may experience other side effects, especially at the beginning of treatment.

If you notice any of the following side effects mentioned below or that are not listed, inform your doctor or pharmacist immediately:
Very common (may affect more than 1 in 10 people):

• slowed heartbeat.

Common (may affect up to 1 in 10 people):

• headache,
• dizziness,
• fainting, hypotension (abnormally low blood pressure), especially when standing up or getting up quickly,
• numbness of hands or feet,
• feeling of cold hands or feet,
• cough,
• shortness of breath,
• inflammation of the sinuses (sinusitis) or bronchitis,
• chest pain,
• gastrointestinal disorders such as nausea, vomiting, abdominal pain, indigestion or dyspepsia, diarrhea, constipation,
• allergic reactions such as skin rash, itching,
• muscle cramps, muscle pain (myalgia),
• feeling tired,
• fatigue,
• blood tests detecting more potassium than normal in the blood.

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

• dizziness,
• altered taste,
• tingling (paresthesia),
• vision disorders,
• tinnitus (ringing in the ears),
• nasal congestion, difficulty breathing or worsening of asthma,
• rhinitis, nasal congestion,
• hot flushes,
• mood changes,
• sleep disorders,
• depression,
• dry mouth,
• sweating,
• kidney problems,
• producing more urine than normal during the day,
• impotence,
• an excess of eosinophils (a type of white blood cells in the blood),
• drowsiness,
• palpitations,
• tachycardia,
• irregular heartbeat (atrioventricular conduction disturbances),
• muscle weakness,
• arthralgia (joint pain),
• localized swelling (peripheral edema),
• fever,
• loss or decrease of appetite (anorexia),
• changes in laboratory parameters: an increased number of certain white blood cells in the blood (eosinophilia), increased urea in the blood, increased creatinine in the blood, increased liver enzyme levels, elevated levels of bilirubin in the serum,
• increased protein levels in the urine,
• ulcers in the mouth,
• breast enlargement in men.

Rare (may affect up to 1 in 1000):

• nightmares, hallucinations,
• reduced tear production (dry eyes),
• red, itchy, swollen or watery eyes,
• hearing problems,
• inflammation of the liver that can cause yellowing of the skin or whites of the eyes,
• inflammation of blood vessels (vasculitis),
• changes in laboratory parameters: abnormal fat levels, decreased number of red blood cells, white blood cells or platelets or amount of hemoglobin in the blood.

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

• confusion,
• inflammation of the pancreas (which can cause severe abdominal and back pain),
• hair loss,
• appearance or worsening of a scaly skin rash (psoriasis), psoriasis-like rash,
• increased sensitivity of the skin to sunlight (photosensitivity reaction).

Frequency not known (frequency cannot be estimated on the basis of available data):

• change in color, numbness and pain of the fingers of the hands or feet (Raynaud's phenomenon),
• low levels of sodium, very low blood sugar levels (hypoglycemia) in diabetic patients,
• inflammation of the tongue.

With the use of ACE inhibitors, highly concentrated urine (dark in color), a feeling or state of discomfort, muscle cramps, confusion and convulsions may occur, probably due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor immediately

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at the web address:
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 Regiam

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 blister and the packaging after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C. Do not refrigerate or freeze.
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. Contents of the pack and other information

What Regiam contains

• The active ingredients are ramipril and bisoprolol fumarate.
• The other ingredients are: Capsule contents: lactose monohydrate, polyvinyl alcohol, sodium croscarmellose (E468), sodium stearyl fumarate, microcrystalline cellulose, anhydrous dibasic calcium phosphate, crospovidone type A, anhydrous colloidal silica, magnesium stearate.

Film coating- AquaPolish P yellow: hypromellose (E464), hydroxypropylcellulose (E463),
medium chain triglycerides, talc (E553b), titanium dioxide (E171), yellow iron oxide (E172).

Capsule shell: titanium dioxide (E171), gelatin, red iron oxide (E172) [in the capsules
of 10mg/10mg, 10mg/5mg, 5mg/5mg, 5mg/2.5mg], yellow iron oxide (E172) [in the capsules of
10mg/5mg, 5mg/5mg, 5mg/2.5mg, 2.5mg/2.5mg, 2.5mg/1.25mg], quinoline yellow (E104) [in the
capsules of 5mg/2.5mg, 2.5mg/2.5mg, 2.5mg/1.25mg].

Printing ink: shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.

Description of the appearance of Regiam and contents of the pack
Regiam 2.5 mg/1.25 mg hard capsules
The capsule has a yellow cap with ‘2.5 mg’ printed in black and a white body with ‘1.25 mg’ printed
in black.
Regiam 2.5 mg/2.5 mg hard capsules
The capsule has a yellow cap with ‘2.5 mg’ printed in black and a yellow body with ‘2.5 mg’ printed in
black.
Regiam 5 mg/2.5 mg hard capsules
The capsule has an orange cap with ‘5 mg’ printed in black and a yellow body with ‘2.5 mg’ printed
in black.
Regiam 5 mg/5 mg hard capsules
The capsule has an orange cap with ‘5 mg’ printed in black and an orange body with ‘5 mg’
printed in black.
Regiam 10 mg/5 mg hard capsules
The capsule has a brownish-red cap with ‘10 mg’ printed in black and an orange body with ‘5
mg’ printed in black.
Regiam 10 mg/10 mg hard capsules
The capsule has a brownish-red cap with ‘10 mg’ printed in black and a brownish-red body
with ‘10 mg’ printed in black.
Capsule contents: white or almost white powder of ramipril and a round, biconvex, yellow, film-coated bisoprolol fumarate tablet.
Blisters in BOPA/ALU/PVC laminate and aluminum foil.
The capsules are available in packs of 10, 30, 60 or 100 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer
Marketing authorization holder
Bruno Farmaceutici S.P.A.
Via delle Ande, 15
00144 Rome (RM),
Italy

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: