RAMANDIUR 5 mg/5 mg /12,5 Mg Hard Capsule

Содержание инструкции

1. What is RAMANDIUR and what is it used for
2. What you need to know before taking RAMANDIUR
3. How to take RAMANDIUR
4. Possible side effects
5. How to store RAMANDIUR
6. Package Contents and Other Information

RAMANDIUR
5 mg/5 mg/12.5 mg hard capsules
5 mg/5 mg/25 mg hard capsules
10 mg/5 mg/25 mg hard capsules
10 mg/10 mg/25 mg hard capsules
Ramipril / amlodipine / hydrochlorothiazide
Read this leaflet carefully before 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you because it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is RAMANDIUR and what is it used for

RAMANDIUR contains three different active ingredients called ramipril, amlodipine and hydrochlorothiazide.
Ramipril belongs to a group of medicines called “ACE inhibitors” (Angiotensin Converting Enzyme Inhibitors).
It works by:

• Decreasing the production, by the body, of substances that can cause an increase in blood pressure
• Relaxing and widening its blood vessels
• Making it easier for your heart to pump blood around the body. Amlodipine belongs to a group of medicines called “calcium antagonists”. It works by relaxing the blood vessels, so that blood can flow through them more easily.

Hydrochlorothiazide is a sulfonamide that belongs to a group of medicines called “thiazide diuretics”
or oral diuretics.
It works by increasing the amount of water (urine) produced by the body. This lowers blood
pressure.
RAMANDIUR can be used to treat high blood pressure (hypertension) in patients
adequately controlled with the individual active ingredients given at the same time, at the
same dose levels as RAMANDIUR, but in separate tablets.

2. What you need to know before taking RAMANDIUR

Do not take RAMANDIUR if

• you are allergic to ramipril, amlodipine or hydrochlorothiazide, to any other ACE inhibitor or calcium channel blocker or sulfonamide-derived medicine or to any of the other ingredients of this medicine (listed in section 6);
• you have a severe narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body);
• you have had a severe allergic reaction called “angioedema” in the past. The signs include itching, skin rash (urticaria), red patches on the hands, feet and in the throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing;
• you are undergoing dialysis or are having any other type of blood filtration. Depending on the machinery used, treatment with RAMANDIUR may not be suitable for you;
• you have severe kidney problems;
• you have severe liver problems;
• you have abnormal levels of salts (calcium, potassium, sodium) or high levels of uric acid in the blood;
• you have kidney problems due to insufficient blood supply to the kidney (renal artery stenosis);
• during the last 6 months of pregnancy and during breastfeeding (see section “Pregnancy and breastfeeding”);
• you have abnormally low or unstable blood pressure;
• you suffer from heart failure after a heart attack;
• you have diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• you suffer from high blood pressure and are pregnant;
• you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a long-term (chronic) type of heart failure in adults.

Do not take RAMANDIUR if any of these apply to you. If you are not sure, ask your doctor before
taking RAMANDIUR.

Warnings and precautions
Talk to your doctor or pharmacist before taking RAMANDIUR.
You must tell your doctor if any of the following apply to you:

• you are elderly and your dose may need to be increased;
• you have problems with your heart, liver or kidneys;
• you have a severe increase in blood pressure (hypertensive crisis);
• you have lost a lot of salts or body fluids (due to illness (vomiting), diarrhoea, excessive sweating, or following a low-salt diet, or after taking diuretics for a long time or after dialysis);
• you are about to undergo treatment to reduce your allergy to bee or wasp stings (desensitization);
• you are about to have an anaesthetic which may be given for surgery or dental treatment. It may be necessary to stop taking RAMANDIUR the day before; ask your doctor for advice;
• you have a high amount of potassium in your blood (shown by a blood test);
• you are taking medicines or are in conditions that may cause the levels of sodium in your blood to decrease. Your doctor may prescribe blood tests at regular intervals, especially to check the levels of sodium in your blood, particularly if you are elderly;
• you are taking medicines called mTOR inhibitors (e.g. temsirolimus, everolimus, sirolimus) or vildagliptin or racecadotril, as they may increase the risk of angioedema, a severe allergic reaction;
• you have a connective tissue disease such as scleroderma or systemic lupus erythematosus;
• you have a sudden decrease in vision (acute transient myopia) or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase in pressure in the eye (angle-closure glaucoma) and may occur within a period ranging from a few hours to a week after taking RAMANDIUR. If left untreated, they can lead to permanent vision damage. If in

the past you have had an allergic reaction to penicillin or sulfonamides, you may be more likely to develop these symptoms;

• you experience sensitivity to light (photosensitivity); in this case you should stop taking RAMANDIUR;
• you have diabetes. In this case you may need to adjust your dose of insulin or oral hypoglycemic agents may be needed;
• you are taking one of the following medicines used to treat high blood pressure: an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, or aliskiren”
• you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lip cancer (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV radiation while taking RAMANDIUR;
• you have had breathing or lung problems (including inflammation or fluid in the lungs) following the use of hydrochlorothiazide in the past. If you experience shortness of breath or severe difficulty breathing after taking RAMANDIUR, consult your doctor immediately.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes
in your blood (e.g. potassium) at regular intervals. See also the information in section
“Do not take RAMANDIUR”.
You must tell your doctor if you think you may be pregnant (or might become pregnant). RAMANDIUR is not
recommended during the first three months of pregnancy and can cause serious harm to the baby after
the first three months of pregnancy (see section “Pregnancy and breastfeeding”).

Children and adolescents
The use of RAMANDIUR is not recommended in children and adolescents under 18 years of age
due to a lack of safety and efficacy data.

Other medicines and RAMANDIUR
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including medicines obtained without a prescription.
This is because RAMANDIUR can affect the way some other medicines work.
Also, some medicines can affect the way RAMANDIUR works.
Your doctor may need to change your dose and/or take other precautions if:

• you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also the information in sections “Do not take RAMANDIUR” and “Warnings and precautions”);
• barbiturates or narcotics (sleeping pills).

The following medicines may reduce the effectiveness of RAMANDIUR:

• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and acetylsalicylic acid).
• Medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, noradrenaline and adrenaline. Your doctor will need to monitor your blood pressure.
• Rifampicin (an antibiotic used to treat tuberculosis).
• Hypericum perforatum (St. John's wort - herbal remedy for depression). The following medicines, if taken with RAMANDIUR, may increase the likelihood of adverse effects:
• Sacubitril/valsartan - used to treat a long-term (chronic) type of heart failure in adults (see section 2 “Do not take RAMANDIUR”)
• Medicines used to relieve pain and inflammation (e.g. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) such as ibuprofen or indometacin and acetylsalicylic acid).
• Cancer medicines (chemotherapy).
• Medicines to prevent organ rejection after transplantation such as ciclosporin.
• Medicines that can lower the amount of potassium in the blood. These include medicines for constipation, glucocorticoids, diuretics, amphotericin B (used for fungal infections) and adrenocorticotropic hormone (used to check if your adrenal glands are working properly).
• Desmopressin
• Steroid medicines for inflammation such as prednisolone.
• Medicines that can increase the amount of potassium in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections caused by bacteria) and heparin (to make the blood more fluid).
• Medicines for heart problems, including problems with the heartbeat.
• Calcium and vitamin D supplements.
• Allopurinol (used to lower uric acid levels in the blood).
• Procainamide (for heart rhythm problems).
• Cholestyramine (to reduce the amount of fat in the blood).
• Carbamazepine, oxcarbazepine (for epilepsy).
• Ketoconazole, itraconazole (used to treat fungal infections).
• Erythromycin, clarithromycin (antibiotic agents used to treat some bacterial infections).
• Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat patients infected with HIV).
• Verapamil, diltiazem (for the treatment of some heart diseases and high blood pressure).
• Dantrolene (infusion for severe temperature abnormalities).
• Temsirolimus (for cancer).
• Sirolimus, everolimus (to prevent transplant rejection).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used for diarrhoea)
• Tacrolimus (used to control the body's immune response, allowing the body to accept the transplanted organ).
• Other medicines that lower blood pressure such as phosphodiesterase 5 inhibitors (used for erectile dysfunction), nitrates, alpha-blockers (for urological use, used to reduce tension in the muscles of the prostate and urethra), tricyclic antidepressants and antipsychotics
• Medicines that alter gastrointestinal motility such as anticholinergic agents.
• Amantadine (for influenza)

The following medicines may be affected by RAMANDIUR:

• Medicines for diabetes such as oral hypoglycemic agents and insulin. RAMANDIUR may lower blood sugar levels. Carefully monitor your blood sugar levels when taking RAMANDIUR.
• Lithium (for mental health problems): RAMANDIUR may increase the amount of lithium in the blood. Your doctor should carefully monitor your lithium levels in your blood.
• Simvastatin (cholesterol medicine): amlodipine increases exposure to simvastatin. Your doctor may need to reduce the dose of simvastatin
• Medicines to relax muscles.
• Medicines that contain iodine, these may be used in hospital before an X-ray or scan.
• Medicines that thin the blood taken orally (oral anticoagulants) such as warfarin.

If any of the above occur or if you are unsure, ask your doctor before
taking RAMANDIUR.
Check with your doctor or pharmacist before taking this medicine if:

• you are having a test for parathyroid function. RAMANDIUR may alter the results of the test;
• you are an athlete who needs to undergo doping control. RAMANDIUR may give a positive result.

RAMANDIUR with food, drinks and alcohol

• RAMANDIUR can be taken before and after a meal.
• While taking RAMANDIUR, you should not consume grapefruit juice or grapefruit. This is because both grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which may cause an unpredictable hypotensive effect of RAMANDIUR.
• Drinking alcohol with RAMANDIUR can cause dizziness or drowsiness. If you want to know how much alcohol you can drink while taking RAMANDIUR, discuss this with your doctor as medicines used to lower blood pressure and alcohol can intensify each other's sedative effects.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
You must tell your doctor if you think you may be pregnant (or might become pregnant). You must not take
RAMANDIUR in the first 12 weeks of pregnancy and must not take it at all after the
13th week because it can be harmful to the baby. If you become pregnant during
treatment with RAMANDIUR , inform your doctor immediately. Before planning a
pregnancy you should switch to an alternative medicine more suitable.
Breastfeeding
You must not take RAMANDIUR if you are breastfeeding. Ask your doctor or pharmacist for advice
before taking any medicine.
Fertility
Available data on potential effects on fertility are insufficient.

Driving and operating machinery
RAMANDIUR can affect your ability to drive or operate machinery. If the medicine makes you
feel unwell, dizzy, tired or gives you a headache, do not drive or operate machinery and contact
your doctor immediately.
Caution for those engaged in sports: the medicinal product contains substances prohibited for
doping. Administration different from the prescribed dosage and route of administration is
prohibited.

RAMANDIURcontains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take RAMANDIUR

Take this medicine following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
The recommended dose is 1 capsule of the dosage prescribed by your doctor once a day.
Depending on the effect, your doctor may modify the dose.
The maximum dose is 1 capsule of the 10 mg/10 mg/25 mg dosage once a day.
You must take the medicine by mouth at the same time each day, before or after meals.
Swallow the capsule whole with some liquid.
Do not crush or chew the hard capsules.
Do not take RAMANDIUR with grapefruit juice.
Liver and kidney disease
If you suffer from liver or kidney disease, your doctor may modify your dose.
Elderly
If you are an elderly patient, your doctor will reduce the initial dose and adjust the treatment more slowly.
If you are a very elderly and frail patient, taking RAMANDIUR capsules is not
recommended.

Use in children and adolescents
The use of RAMANDIUR is not recommended in children and adolescents under 18 years of age due to
the lack of safety and efficacy data.

If you take more RAMANDIUR than you should
Taking too many capsules may cause your blood pressure to drop and become even
dangerously low. You may experience dizziness, mental confusion, fainting or weakness. If the drop
in blood pressure is severe enough, it can cause shock. Your skin may become cold
and clammy and you may lose consciousness. Seek immediate medical attention if you take too
many RAMANDIUR capsules. Do not drive to the hospital, have someone accompany you or
call an ambulance. Bring the medicine package with you. This is because the doctor needs to know what
you have taken.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath
which can develop up to 24-48 hours after taking it.

If you forget to take RAMANDIUR
If you forget to take a capsule, do not take that dose. Take the next dose at the correct
time. Do not take a double dose to make up for a missed dose.

If you stop taking RAMANDIUR
Your doctor will advise you how long to take the medicine. If you stop treatment
before your doctor has advised you, your health problem may recur.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Stop taking RAMANDIUR and contact your doctor immediately if you notice the onset of any of the following serious side effects as you may need urgent medical treatment:

• Swelling of the face, lips or throat making it difficult to swallow or breathe, as well as itching or skin rash. This may be a sign of a severe allergic reaction to RAMANDIUR.
• Severe skin reactions including skin rash, mouth sores, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson Syndrome, toxic epidermal necrolysis or multiforme erythema).

Inform your doctor immediately if you experience:

• Increased heart rate, irregular or forceful heartbeat (palpitations), chest pain, feeling of tightness in the chest or more serious problems including heart attack and stroke.
• Shortness of breath or cough. These could be signs of lung problems, including inflammation.
• Easier bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or a tendency to develop infections, sore throat and fever, feeling tired, weak, fainting, dizziness or pale skin. These can be signs of problems with blood circulation or bone marrow.
• Severe stomach pain that may extend to the back. This may be a sign of inflammation of the pancreas (pancreatitis).
• Fever, chills, fatigue, loss of appetite, stomach pain, feeling unwell, yellowing of the skin or eyes (jaundice). These can be signs of liver problems such as liver inflammation (hepatitis) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions becomes severe or lasts for more than a few days.

Very common: may affect more than 1 in 10 people

• Swelling (edema)
• Low potassium levels in the blood (Hypokalemia)
• Increased levels of cholesterol and triglycerides (Hyperlipidemia)

Common: may affect up to 1 in 10 people

• Headache, dizziness, drowsiness associated with feeling sleepy (somnolence; especially at the beginning of treatment), feeling exhausted (fatigue)
• Awareness of your heartbeat (palpitations)
• Swelling of the ankles
• Low blood pressure (hypotension), especially when getting up or sitting quickly (reduced orthostatic blood pressure), weakness (syncope), flushing, redness
• Dry cough, sinus inflammation (sinusitis), bronchitis, shortness of breath (dyspnea)
• Abdominal pain, diarrhea, gastrointestinal inflammation, digestive disorders and abdominal discomfort (including dyspepsia), nausea, vomiting, altered bowel habits (including diarrhea and constipation), loss of appetite (anorexia), spasms
• Skin rash with or without swelling, hives
• Chest pain
• Muscle cramps or pain (myalgia), muscle spasms
• Blood tests showing lower than usual levels of magnesium and sodium
• Feeling weak and lacking energy (asthenia)
• Blood tests showing a higher than usual amount of uric acid or potassium
• Inability to get an erection (impotence)
• Vision problems (including double and blurred vision)
• Increased levels of potassium in the blood (Hyperkalemia)

Uncommon: may affect up to 1 in 100 people

• Increased blood cells called eosinophils (eosinophilia)
• Swelling of the skin, mucous membranes and surrounding tissues (angioedema/Quincke's edema: in very rare cases, airway obstruction caused by angioedema can be fatal)
• Arms and legs swelling (peripheral edema; this may be a sign that your body is retaining more water than usual)
• Swelling of the intestine (angioedema of the small intestine)
• Mood changes, depression, anxiety, nervousness, restlessness, sleep disorders (insomnia)
• Ringing in the ears (tinnitus)
• Sneezing/runny nose (rhinitis), stuffy nose
• Difficulty breathing (bronchospasm) including worsening of asthma
• Dry mouth, pain in the upper abdomen including gastritis, constipation
• Inflamed pancreas (pancreatitis; fatal cases have been reported in very rare cases with ACE inhibitors)
• Kidney impairment, including acute renal failure and nephritis, problems with urination, passing more urine than usual during the day, increased need to urinate at night (nocturia)
• Worsening of pre-existing proteinuria (more protein than usual in the urine)
• Reduced levels of magnesium in the urine (hypomagnesemia)
• Feeling unwell (malaise)
• Weight gain or loss
• Anorexia, decreased appetite
• Vertigo, trembling (tremor)
• Hair loss (alopecia)
• Itching, small spots or areas of bleeding on the skin (purpura), changes in skin color, rash
• Unusual skin sensations such as numbness, tingling, prickling, burning or crawling on the skin (paresthesia), reduced skin sensation (hypoesthesia)
• Loss (ageusia) or altered sense of taste (dysgeusia)
• Sweating more than usual (hyperhidrosis)
• Heart attack (myocardial infarction), heart vessel disease (myocardial ischemia), chest tightness and pain (angina pectoris), increased (tachycardia) or irregular (arrhythmia) heartbeat
• Slow heartbeat (bradycardia), specific heart rhythm disorders (atrial fibrillation, ventricular tachycardia)
• Joint pain (arthralgia), back pain, general pain
• Increased body temperature / fever (pyrexia)
• Decreased sexual desire in men and women, breast enlargement in men (gynecomastia)
• Blood tests showing changes in liver function (increased liver enzymes and/or conjugated bilirubin), pancreas (increased pancreatic enzymes) or kidneys (increased urea, increased creatinine)
• Cough
• Necrotizing vasculitis (vasculitis, cutaneous vasculitis)

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

• Feeling or being confused, balance disorders
• Red and swollen tongue (glossitis)
• Inflammation and peeling of the skin (exfoliative dermatitis)
• Problems with nails e.g. loss or separation of the nail from its bed (onycholysis)
• Redness, itching, swelling or watering of the eyes (conjunctivitis)
• Hearing impairment
• Yellowing of the skin (cholestatic jaundice), hepatocellular damage and intrahepatic cholestasis
• Narrowing of blood vessels (vascular stenosis)
• Disturbed blood flow (hypoperfusion)
• Inflammation of blood vessels (vasculitis)
• Blood tests showing a reduction in the number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leucopenia) or in the amount of hemoglobin
• Blood tests showing a reduction in the number of platelets (thrombocytopenia)
• Blood tests showing a higher than usual amount of sugar in the blood. If you have diabetes, this may worsen your diabetes
• Sensitivity to light or the sun (photosensitivity)
• Increased levels of calcium in the blood (hypercalcemia)
• Hypersensitivity reactions
• Presence of glucose in the urine
• Sleep disorder.

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

• Widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• Liver inflammation (hepatitis, in most cases with cholestasis)
• Allergic reactions
• Rash, which may form blisters, resembling small targets (dark central spots surrounded by a lighter area with a dark ring around the edge) (multiforme erythema)
• Reaction characterized by erythematous skin and mucous membrane manifestations, (similar to lupus erythematosus), reactivation of lupus erythematosus, inflammation of the blood vessel walls (necrotizing vasculitis) and extensive skin rash with a tendency for the skin to detach (toxic epidermal necrolysis).
• Enlargement of the gum tissue (gingival hyperplasia)
• Increased muscle tone (hypertonia)
• Peripheral nervous system disease (peripheral neuropathy)
• Bone marrow depression
• Severe reduction in the number of blood cells called granulocytes (agranulocytosis),
• Blood tests showing too many damaged red blood cells (hemolytic anemia)
• Hypochloremic alkalosis caused by extreme lack or loss of chloride, which can occur with prolonged vomiting
• Breathing problems (including pneumonia and pulmonary edema)
• Increases in blood glucose levels
• Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)

Not known: frequency cannot be estimated from available data
Inform your doctor if any of the following effects becomes severe or lasts for more than a few days.

• Blood tests showing too few red blood cells or white blood cells and platelets (pancytopenia)
• Anaphylactic or anaphylactoid reactions
• Lumpy skin (pemphigus)
• Increased antinuclear antibodies
• Difficulty concentrating (Attention deficit disorder)
• Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
• Reduction in the production of blood cells (aplastic anemia)
• Fingers and toes changing color when you feel cold and then tingling or a stinging sensation when they warm up (Raynaud's phenomenon)
• Cerebral ischemia including ischemic stroke and transient ischemic attack (TIA)
• Impaired psychomotor skills
• Burning sensation
• Alteration of the smell of things (parosmia)
• Acute liver failure, cholestatic and cytolytic hepatitis (fatal outcomes have been reported in very rare cases)
• Inflammation of the skin (psoriasiform dermatitis), acute rash (pemphigoid or lichenoid rash), worsening of scaling or flaking of the skin (psoriasis aggravated), rash of the mucous membranes (enanthema)
• Feeling unwell or sick. Muscle cramps, confusion and convulsions that may be due to inappropriate secretion of ADH (anti-diuretic hormone). If you experiencethese symptoms, contact your doctor as soon as possible.
• Tremor, rigid posture, mask-like face, slow movements and unsteady gait.
• Rapid onset of distant vision impairment (acute myopia), decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).

Liquid)

• Skin cancer and lip cancer (non-melanoma skin cancer)
• Bone marrow failure

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist directly through the national reporting system at
http://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 RAMANDIUR

Store this medicine at a temperature below 30  C
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry
date refers to the last day of that month.
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. Package Contents and Other Information

What RAMANDIUR contains

RAMANDIUR5 mg/5 mg/12.5 mg hard capsules:

• The active ingredients are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate) and 12.5 mg of hydrochlorothiazide.

RAMANDIUR5 mg/5 mg/25 mg hard capsules:

• The active ingredients are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 5 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

RAMANDIUR10 mg/5 mg/25 mg hard capsules

• The active ingredients are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 10 mg of ramipril, 5 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.

RAMANDIUR10 mg/10 mg/25 mg hard capsules

• The active ingredients are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 10 mg of ramipril, 10 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.
• The other ingredients are: Capsule contents:Microcrystalline cellulose, Anhydrous calcium hydrogen phosphate, Pregelatinized corn starch, Sodiumstarch glycolate (type A), Sodiumstearyl fumarate

Capsule shell (5 mg/5 mg/12.5 mg):Red iron oxide (E172), Black iron oxide
(E172), Titanium dioxide (E171), Gelatin

Capsule shell (5 mg/5 mg/25 mg):Red iron oxide (E172), Yellow iron oxide
(E172), Titanium dioxide (E171), Gelatin

Capsule shell (10 mg/5mg/25 mg):Red iron oxide (E172), Iron oxide
yellow (E172), Titanium dioxide (E171), Gelatin

Capsule shell (10 mg/10 mg/25 mg):Red iron oxide (E172), Yellow iron oxide
(E172), Black iron oxide (E172), Titanium dioxide (E171), Gelatin

Description of the appearance of “RAMANDIURand package contents

RAMANDIUR5 mg /5 mg /12.5 mg hard capsules:
Type 3 capsules with an opaque pink cap and an opaque light grey body.

RAMANDIUR5 mg/5 mg/25 mg hard capsules:
Type 1 capsules with an opaque pink cap and an opaque ivory body.

RAMANDIUR10 mg/5 mg/25 mg hard capsules:
Type 1 capsules with a dark opaque pink cap and an opaque yellow body.

RAMANDIUR10 mg/10 mg/25 mg hard capsules:
Type 1 capsules with an opaque brown cap and an opaque caramel body.
Packs of 28 hard capsules in blister packs made of PA-AL-PVC (laminate) and aluminum foil
packaged in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Scharper S.p.A. – Viale Ortles, 12 – 20139 Milan

Manufacturer
Special Products Line S.p.A.
Via Fratta Rotonda Vado Largo 1
03012 Anagni (FR) – Italy
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95 ‐ 200 Pabianice
Poland