DIHYDROERGOCRISTINE (AS MESYLATE) 0.5 MG + CLOPAMIDE 5 MG + RESERPINE 0.1 MG

The excipients are: stearic acid, povidone, talc, corn starch, lactose monohydrate, cetyl alcohol, hydrogenated peanut oil, stearic acid, polyethylene glycol 6000, povidone, microcrystalline cellulose, colloidal anhydrous silica gel, talc, sucrose, red iron oxide, titanium dioxide

1. WHAT IS BRINERDIN AND WHAT IT IS USED

Your medicine is called Brinerdin and comes in the form of coated tablets. Each tablet contains 0.1 mg of reserpine, 0.5 mg clopamide, 0.5 mg dihydroergocristine. Brinerdin effective antihypertensive drug with good tolerability. The effect of lowering the blood pressure of reserpine component which is significantly more pronounced in patients with normal blood pressure is mainly due to the action of noradrenaline on landfills endings of the peripheral sympathetic nerves.

Clopamide is an active substance - a thiazide diuretic, inducing increased excretion of water and sodium, by inhibition of tubular reabsorption.

Dihydroergocristine reduces arterial tone through a central mechanism of action and causes peripheral vasodilation by alpha-adrenolitichen effect. It also acts as a central inhibits baroreceptor reflexes.

If you have questions concerning the operation of Brinerdin or why you are prescribed this medication, contact your doctor.

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2 BEFORE YOU TAKE BRINERDIN

Follow all instructions of your doctor, even if they differ from the general information in this leaflet.

Do NOT take BRINERDIN if you are hypersensitive to any component of the product and to sulphonamides (clopamide belongs to this group); treatment-resistant hypokalaemia; severe kidney or liver disease; severe coronary insufficiency, recent myocardial infarction, advanced atherosclerosis; history of depression, active peptic ulcer, ulcerative colitis; pregnancy and lactation.

If you have any of these conditions, talk to your doctor and do not take BRINERDIN. Your doctor will decide if this medicine is suitable for you.

Caution should be exercised with BRINERDIN:

if you have diabetes, you may need dosage adjustments of antidiabetic medications.

if you have gout, your doctor

Your doctor may need to monitor potassium levels in your blood. He may recommend a potassium rich foods (fruits, vegetables, fish, low-fat cheese, etc..) During treatment with Brinerdin.

if you have impaired kidney function.

If you have any of the following conditions inform your doctor before you start taking Brinerdin.

Brinerdin and elderly

Elderly patients may be more sensitive to the effects of Brinerdin than other adults. They should especially careful to follow the doctor's instructions.

Brinerdin and children / adolescents

Brinerdin should not be prescribed to children and adolescents.

Pregnancy and lactation

Brinerdin not take if you are pregnant or plan to become pregnant. Brinerdin should not be taken by nursing mothers.

Driving and using machines

In the initial stages of treatment with antihypertensive agents may be monitored fatigue and orthostatic hypotension. Caution should be exercised when driving or operating machinery until the establishment of individual response to treatment.

This product contains lactose, which makes it unsuitable for patients with lactase deficiency, or galactosemia glgokozen / galactose malabsorption.

This medicinal product contains sucrose and peanut butter.

If you are taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Remember drugs that are not prescribed by your doctor.

It is particularly important to tell your doctor if you are taking any of the following medicines:

thiazide diuretics

Corticosteroids and non-steroidal anti-inflammatory drugs used to relieve pain.

Medicines known as MAO inhibitors

Drugs that suppress the central nervous system or alcohol.

Levodopa (product used to treat Parkinson's disease)

3 HOW TO TAKE BRINERDIN?

Carefully follow your doctor's instructions. Do not exceed the recommended dosage and duration of treatment.

The usual doses are:

At the beginning of treatment: 1 tablet daily.

In severe forms of hypertension may take 2 or 3 tablets a day.

Brinerdin may be administered in combination with other antihypertensive agents such as beta-blockers or vasodilators.

When and how to take the tablets?

Brinerdin tablets should be swallowed whole with a glass of water.

How long to take Brinerdin?

Follow the instructions of your doctor.

If you miss a dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed again and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.

If you take more than the required amount Brinerdin

If you take a large amount Brinerdin coated tablets than prescribed, tell your doctor or seek medical attention immediately.

You may need medical attention.

4 POSSIBLE SIDE EFFECTS

Like all medicines, Brinerdin can have side effects, although not all patients they occur.

In the frequency of adverse reactions are classified as follows:

Very common (likely to occur in less than 1/10 patients)

common (likely to occur between 1 in 100 and 1 in 10 patients)

Uncommon (likely to occur between 1 in 1000 and 1 in every 100 patients)

rare (likely to occur between 1 in 10,000 and 1 in 1000 patients),

very rare (likely to occur in less than 1 in 10,000).

Blood and lymphatic system

Very rare: anemia, thrombocytopenia.

Endocrine disorders

Rare: increased secretion of the hormone prolactin, milk secretion, a condition called ginkeomastiya.

Very rare: breast swelling.

Metabolism and nutrition

Common: weight gain.

Long-term use can lead to changes in the levels of certain chemicals in the blood, and more specifically to reduced fields of sodium, magnesium, chlorine and a decrease in serum calcium.

You may experience symptoms of diabetes mellitus.

Psychiatric disorders

Common: depression.

Nervous System Disorders

Common: dizziness, nervousness, nightmares.

Uncommon: headache.

Rare symptoms such as tremors, including parkinsonism, anxiety, impaired concentration, confusion.

Very rare: cerebral edema.

Eye disorders

Common: blurred vision, redness of the conjunctival sac of the eye, tearing.

Ear

Very rare: impaired.

cardiac disorders

Common: slow rhythm, swelling of the legs / arms.

Uncommon: palpitations.

Rare: irregular heartbeat, severe chest pain, abnormal blood pressure on standing, low blood pressure, hot flushes.

Very rare: loss of consciousness, heart failure.

vascular disorders

Very rare: cerebrovascular disorders.

Respiratory system disorders

Common: swelling of the nasal mucosa, difficulty breathing.

Very rare: nosebleeds.

Gastrointestinal disorders

Common: diarrhea, dry mouth, increased secretion of gastric juice, increased salivation.

Uncommon: nausea, vomiting, pain above the stomach, abdominal pain, constipation.

Rare: increased appetite, ulcers ma stomach or duodenum.

Very Rare: gastrointestinal hemorrhage.

Skin and subcutaneous tissue disorders

Rare: eczema, pruritus.

Hypersensitivity including purple rash called purpura, hives (urticaria) and photosensitivity.

Musculo-skeletal system

Uncommon: muscle stiffness or cramps in the calf.

Rare: muscle weakness.

Can be unlocked attacks of gout in predisposed patients.

Renal and urinary disorders

Very Rare: urinary incontinence, inflammatory kidney called glomerulonephritis.

Disorders of the reproductive system

Rare: decreased libido, impaired sexual function and ejaculation.

General disorders

Common: fatigue.

Tell your doctor if you experience any of these side effects.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 HOW TO STORE BRINERDIN?

Do not store above 25 � C.

Do not use after the expiry date stated on the packaging. Store in the original package to protect from moisture. Keep out of reach of children.