Ramizek inda

Patient Information Leaflet: Information for the User

Ramizek Inda, 5 mg + 1.5 mg, modified-release tablets
Ramizek Inda, 10 mg + 1.5 mg, modified-release tablets
Ramiprilum + Indapamidum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

What this leaflet contains

1. What Ramizek Inda is and what it is used for
2. Important information before taking Ramizek Inda
3. How to take Ramizek Inda
4. Possible side effects
5. How to store Ramizek Inda
6. Contents of the pack and other information

1. What Ramizek Inda is and what it is used for

Ramizek Inda contains two active substances: ramipril and indapamide. It is an antihypertensive medicine used to treat high blood pressure (hypertension). Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). These work by widening blood vessels, making it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it causes only a slight increase in urine production. Each of the active ingredients lowers blood pressure, and together they act synergistically to control blood pressure. Ramizek Inda is used to treat essential hypertension (high blood pressure) in adult patients whose blood pressure is adequately controlled with indapamide and ramipril given concomitantly at the same doses as those contained in Ramizek Inda, but administered as separate medicines.

2. Important information before using Ramizek Inda

When not to use Ramizek Inda:

• If the patient is allergic to ramipril, indapamide (active substances), any other ACE inhibitor, or to other sulfonamides, or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include itching, redness of the skin, or difficulty breathing.
• If the patient has ever experienced a severe allergic reaction called "angioedema". Symptoms include: itching, hives, red marks on the palms, soles, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If the patient has taken or is currently taking sacubitril + valsartan, a medicine used to treat chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling under the skin, e.g. in the throat) increases.
• If the patient is undergoing dialysis or any other type of blood filtration. Depending on the type of equipment used, Ramizek Inda may not be suitable.
• If the patient has severe kidney disease or kidney problems with reduced blood flow to the kidneys (renal artery stenosis).
• During the last 6 months of pregnancy (see section below "Pregnancy and breastfeeding").
• If the patient has diabetes or impaired kidney function and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient's blood pressure is very low or unstable – the doctor will recommend frequent blood pressure monitoring.
• If the patient has liver disease or suffers from a condition called hepatic encephalopathy (degenerative brain disease).
• If the patient has low potassium levels in the blood.

If any of the above situations apply, Ramizek Inda must not be used.
If in doubt about using this medicine, consult a doctor before starting to take Ramizek Inda.
Warnings and precautions
Before starting treatment with Ramizek Inda, discuss the following with your doctor or pharmacist:

• If the patient has heart, heart rhythm, liver, or kidney problems.
• If the patient has lost a large amount of salt or body fluids (due to vomiting, diarrhoea, excessive sweating, low-salt diet, prolonged use of diuretics, or dialysis).
• If the patient is to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
• If the patient is to receive medicines used in anaesthesia. These may be used during surgical or dental procedures. It may be necessary to stop taking Ramizek Inda one day before the procedure; if in doubt, contact your doctor.
• If the patient has high potassium levels in the blood (visible in blood test results).
• If the patient has a collagen disease, such as scleroderma or systemic lupus erythematosus.
• If the patient is taking medicines or has conditions that may lower sodium levels in the blood. The doctor may order regular blood tests, especially to check blood sodium levels, particularly in elderly patients.
• If the patient is taking any of the following medicines used to treat high blood pressure:
  • Angiotensin II receptor antagonists (ARBs) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes;
  • Aliskiren.
• Inform the doctor if the patient thinks she is (or may become) pregnant. Use of ramipril is not recommended during the first three months of pregnancy, and after 3 months of pregnancy this medicine may harm the unborn child (see section below "Pregnancy and breastfeeding").
• If the patient has diabetes.
• If the patient has gout.
• If the patient experiences worsening vision or eye pain. These may be symptoms of fluid accumulation in the choroidal layer of the eye (choroidal effusion) or increased intraocular pressure, and may occur within hours or weeks of taking Ramizek Inda. Untreated symptoms may lead to permanent vision loss. If the patient previously had an allergy to penicillin or sulfonamides, the risk of these disorders is higher.
• If the patient has muscle disorders, including muscle pain, tenderness, weakness, or cramps.
• If the patient is scheduled for a test assessing parathyroid function.
• If the patient is taking any of the following medicines, the risk of angioedema may be increased:
  • Neprilysin inhibitors (such as racecadotril), a medicine used to treat diarrhoea;
• Medicines used to prevent organ transplant rejection and to treat tumours, such as mTOR inhibitors (e.g. temsirolimus, sirolimus, everolimus);
• Vildagliptin, a medicine used to treat diabetes;
• Sacubitril + valsartan (see section 2 "When not to use Ramizek Inda").

Inform the doctor if photosensitivity reactions occur.
The doctor may regularly monitor kidney function, blood pressure, and electrolyte levels
(e.g. sodium, potassium, or calcium) in the blood. See also subsection "When not to use Ramizek Inda".
Children and adolescents
Ramizek Inda is not recommended for use in children and adolescents under 18 years of age, as
the safety and efficacy of the combination of ramipril and indapamide in this age group have not yet been established.
Ramizek Inda and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
Do not take Ramizek Inda with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.
Inform the doctor if taking any of the following medicines. They may reduce the effectiveness of Ramizek Inda:

• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and acetylsalicylic acid).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. The doctor will monitor the patient's blood pressure.

Inform the doctor if taking any of the following medicines. They may increase the risk of adverse effects when used together with Ramizek Inda:

• Sacubitril + valsartan – used to treat chronic (long-term) heart failure in adults (see section 2 "When not to use Ramizek Inda").
• Sirolimus, everolimus (to prevent transplant rejection).
• Cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection.
• Medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and acetylsalicylic acid).
• Medicines used to treat cancer (chemotherapy), such as temsirolimus.
• Diuretics (water tablets), such as furosemide.
• Medicines that may increase potassium levels in the blood, such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (used to treat infections), and heparin (a blood thinner used to prevent clots).
• Allopurinol (used to reduce uric acid levels in the blood).
• Procainamide (used for heart rhythm disorders).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhoea).
• Medicines used for heart rhythm disorders (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digitalis glycosides, bretylium).
• Medicines used to treat psychiatric disorders such as depression, anxiety, schizophrenia (e.g. tricyclic antidepressants, antipsychotics, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol).
• Bepridil (used to treat angina pectoris, a condition causing chest pain).
• Cisapride, difemanil (used to treat gastrointestinal disorders).
• Antibiotics used to treat bacterial infections (e.g. sparfloxacin, moxifloxacin, erythromycin by injection).
• Vinpocetine by injection (used to treat symptomatic cognitive disorders in the elderly, including memory loss).
• Halofantrine (an antiparasitic medicine used to treat certain types of malaria).
• Pentamidine (used to treat certain types of pneumonia).
• Antihistamines used to treat allergic reactions, such as hay fever (e.g. mizolastine, astemizole, terfenadine).
• Amphotericin B by injection (an antifungal medicine).
• Oral corticosteroids used to treat various diseases, including inflammatory conditions, severe asthma, and rheumatoid arthritis.
• Laxatives that stimulate intestinal peristalsis.
• Baclofen (used to treat muscle stiffness occurring in diseases such as multiple sclerosis).
• Digitalis preparations (to strengthen the heart and reduce pulse rate).
• Iodinated contrast agents (used in X-ray examinations).
• Calcium-containing tablets or other calcium supplements.
• Tacrolimus (to prevent rejection of transplanted organs).
• Tetracosactide (used to treat Crohn's disease).
• Methadone (used to treat addiction).

The doctor may decide to adjust the dose and/or take other precautions.
If the patient is taking angiotensin II receptor blockers (ARBs) or aliskiren (see also information in subsections "When not to use Ramizek Inda" and "Warnings and precautions").
Inform the doctor if taking any of the following medicines. Their effect may be altered during treatment with Ramizek Inda:

• Antidiabetic medicines, such as oral glucose-lowering agents and insulin. Ramizek Inda may lower blood glucose levels. Blood glucose levels should be monitored regularly during treatment with Ramizek Inda.

If any of the above situations apply (or if the patient is unsure), consult a doctor before taking Ramizek Inda.
Ramizek Inda with food and alcohol
Ramizek Inda may be taken independently of meals.
Drinking alcohol with Ramizek Inda may cause dizziness or drowsiness. If in doubt about the amount of alcohol allowed while taking Ramizek Inda, discuss with the doctor the possibility of additive effects between blood pressure-lowering medicines and alcohol.
Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
The doctor will usually recommend stopping Ramizek Inda before becoming pregnant or immediately after learning of pregnancy and will recommend an alternative medicine instead of Ramizek Inda.
Ramizek Inda is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child when used after the third month.
Breastfeeding
Ramizek Inda is not recommended for breastfeeding mothers, and the doctor may choose an alternative treatment if the patient wishes to breastfeed, especially if the baby is a newborn or premature.
Consult a doctor or pharmacist before taking any medicine.
Driving and using machines
Ramizek Inda may affect the ability to drive and operate machinery. If Ramizek Inda causes nausea, dizziness, or fatigue, do not drive or operate machinery.
Ramizek Inda contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, he or she should contact the doctor before taking this medicine.
Ramizek Inda contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ramizek Inda

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
If you feel that the effect of Ramizek Inda is too strong or too weak, you should contact your doctor or pharmacist.
The recommended dose is one tablet per day. The tablet should preferably be taken in the morning and before a meal. Swallow the whole tablet with a glass of water; do not chew it.
Your doctor may adjust the dose depending on how it affects you.

Use in children and adolescents
Ramizek Inda is not recommended for use in children and adolescents under 18 years of age, as there is no available information regarding this age group.

Taking more Ramizek Inda than recommended
If you take too many tablets, you should contact your doctor immediately or go to the nearest hospital.
The most likely consequence of an overdose is low blood pressure. If marked low blood pressure occurs (associated with nausea, vomiting, cramps, dizziness, drowsiness, confusion, changes in the amount of urine produced by the kidneys), lying down with your legs raised may be helpful.

If you forget to take Ramizek Inda
If you miss a dose, you should skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

Stopping Ramizek Inda
Since treatment for high blood pressure usually lasts a lifetime, you should discuss stopping this medicine with your doctor beforehand.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient notices any of the following severe adverse reactions, treatment with Ramizek Inda must be discontinued and the patient should immediately contact a doctor – urgent medical assistance may be required:

• Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching and rash. This may be a sign of a severe allergic reaction to Ramizek Inda (frequency unknown).
• Angioedema. Angioedema is characterised by swelling of the skin of the limbs or face, swelling of the lips or tongue, or swelling of the mucous membranes of the throat or airways causing breathlessness or difficulty in swallowing. In such a case, contact a doctor immediately (Not common) (may occur in no more than 1 in 100 people).
• Severe skin reactions, including intense skin rash, redness of the skin all over the body, severe itching, blisters, peeling or swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions (Very rare) (may occur in no more than 1 in 10,000 people).
• Life-threatening irregular heartbeat (frequency unknown).
• Pancreatitis, which may cause severe abdominal and back pain, accompanied by a very poor general condition (Very rare) (may occur in no more than 1 in 10,000 people).
• Brain disease caused by liver disease (hepatic encephalopathy) (frequency unknown).
• Inflammation of the liver (hepatitis) (frequency unknown).
• Muscle weakness, cramps, tenderness or pain, particularly if the patient also feels unwell or has a high temperature, which may be due to abnormal muscle breakdown (frequency unknown).

The patient should immediately inform the doctor if any of the following occur:

• Faster, irregular or strong heartbeat (palpitations), chest pain, chest tightness or more serious problems, including myocardial infarction and stroke. These may commonly occur: chest pain, chest tightness, palpitations, or less commonly: rapid heartbeat, myocardial infarction or stroke.
• Breathlessness or cough. These may be symptoms of lung problems. These are common adverse reactions.
• Easy bruising, bleeding that lasts longer than usual, any signs of bleeding (e.g. bleeding gums), purple spots, skin spots or easier than usual infections, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin. These may be symptoms of blood or bone marrow problems (frequency unknown).

Other adverse reactions
Inform the doctor if any of the following symptoms become serious or persist for more than a few days.
Common (may occur in no more than 1 in 10 people):

• Dizziness (especially at the beginning of treatment).
• Headache or feeling of fatigue.
• Fainting, hypotension (low blood pressure), especially when the patient stands up or sits down quickly.
• Dry, persistent cough, sinusitis or bronchitis, breathlessness.
• Abdominal or intestinal pain, diarrhoea, indigestion, nausea or vomiting.
• Skin rash with or without raised areas.
• Allergic reactions, mainly affecting the skin, in people prone to allergic and asthmatic reactions.
• Chest pain.
• Muscle cramps or pain.
• Detection of higher than normal potassium levels in blood tests.
• Low potassium levels in the blood.

Not common (may occur in no more than 1 in 100 people):

• Sleep disturbances.
• Heartburn, constipation or dry mouth.
• Passing more urine than usual during the day.
• Sweating more than usual.
• Sudden redness of the face, neck or upper chest due to increased blood flow.
• Impotence in men (inability to achieve or maintain an erection), reduced sexual desire in men or women.
• Balance problems (dizziness).
• Itching and unusual skin sensations such as numbness, tingling, pricking, burning or crawling sensations on the skin (paraesthesia).
• Blurred vision.
• Loss or change in taste.
• Feeling depressed, anxious, more nervous or restless, especially increased motor restlessness.
• Stuffy nose, difficulty breathing or worsening of asthma.
• Intestinal swelling called "intestinal angioedema" presenting with abdominal pain, vomiting and diarrhoea.
• Loss of or reduced appetite (anorexia).
• Rapid or irregular heartbeat.
• Swollen hands and feet. This may be a sign of increased fluid retention.
• Joint pain.
• Fever.
• Increased number of certain white blood cells (eosinophilia) detected during blood tests.
• Blood tests showing changes in liver, pancreas or kidney function.
• Vomiting.
• Red spots on the skin (petechiae).
• Low sodium levels in the blood, which may lead to dehydration and low blood pressure.

Rare (may occur in no more than 1 in 1,000 people):

• Feeling of uneasiness, confusion, disorientation.
• Red and swollen tongue.
• Excessive skin peeling, itchy, bumpy rash.
• Nail problems (e.g. loosening or separation of the nail from its bed).
• Skin rash or bruising.
• Skin spots and cold extremities.
• Red, itchy, swollen or watery eyes.
• Hearing disturbances and ringing in the ears.
• Weakness.
• Involuntary, rhythmic, trembling movements of a body part (tremor).
• Inadequate blood flow.
• Blood tests showing decreased numbers of red blood cells, white blood cells or platelets (which may lead to unusual bruising or easy bleeding) or levels of haemoglobin.
• Nausea.
• Low chloride levels in the blood.
• Low magnesium levels in the blood.

Very rare (may occur in no more than 1 in 10,000 people):

• Increased sensitivity to sunlight.
• Urticaria (hives).
• High calcium levels in the blood.
• Heart rhythm disorders, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Frequency unknown:

• Fainting.
• In patients with systemic lupus erythematosus (a type of collagenosis), symptoms may worsen.
• Myopia (short-sightedness).
• Blurred vision.
• Worsening of vision or eye pain due to high pressure (possible symptoms of fluid accumulation in the choroid layer of the eye (choroidal effusion) or closed-angle glaucoma).
• Laboratory parameter changes (blood tests) may occur, and the doctor may order blood tests to monitor the patient's condition. The following laboratory changes may occur: increased uric acid levels, a substance that may cause or worsen gout (joint pain, especially in the feet), increased blood glucose levels in patients with diabetes, high calcium levels in the blood, increased liver enzyme activity.
• Abnormal ECG recording of heart function.

Other reported adverse reactions:
Inform the doctor if any of the following symptoms become serious or persist for more than a few days.

• Difficulty concentrating.
• Swollen lips.
• Blood tests showing lower than normal sodium levels in the blood.
• Concentrated (dark-coloured) urine, nausea or vomiting, muscle cramps, confusion and seizures, which may be caused by inappropriate ADH (antidiuretic hormone) secretion. If the patient experiences such symptoms, contact a doctor as soon as possible.
• Colour changes in fingers upon cold exposure and tingling or pain upon warming (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowed or impaired reactions.
• Burning sensation.
• Smell disturbances.
• Hair loss.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ramizek Inda

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after the abbreviation
"EXP" (abbreviation used to describe the expiry date). The expiry date refers to the last day of the
specified month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ramizek Inda contains

• The active substances are ramipril and indapamide: 5 mg + 1.5 mg, modified-release tablet: each tablet contains 5 mg ramipril and 1.5 mg indapamide.

10 mg + 1.5 mg, modified-release tablet: each tablet contains 10 mg ramipril and 1.5 mg indapamide.

• Other ingredients are: lactose monohydrate, povidone K 30, hypromellose, colloidal anhydrous silica, magnesium stearate, sodium croscarmellose, polyvinyl alcohol, sodium stearyl fumarate, polyvinyl alcohol - partially hydrolysed, calcium carbonate, macrogol 4000, talc, yellow iron oxide (E 172) (10 mg + 1.5 mg and 5 mg + 1.5 mg), red iron oxide (E 172) (10 mg + 1.5 mg).

What Ramizek Inda looks like and contents of the pack
Ramizek Inda, 5 mg + 1.5 mg, modified-release tablet:
Yellow or yellowish, film-coated, round, biconvex tablets with a diameter of 9 mm, imprinted with the number "5" on one side.
Ramizek Inda, 10 mg + 1.5 mg, modified-release tablet:
Orange or slightly orange, film-coated, round, biconvex tablets with a diameter of 9 mm, imprinted with the number "10" on one side.
Ramizek Inda is available in blister packs containing 30, 60 or 100 modified-release tablets, packed in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów
tel.: +48 22 732 77 00

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

This medicinal product is authorised for sale in the European Economic Area under the following names:
Poland: Ramizek Inda
Germany: Indiace
Italy: Imbaxir
Spain: Imbarix
Portugal: Imbarix