Package leaflet: Information for the user

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
Please read this leaflet carefully before taking this medicine because 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. Never give it to other people, even if they have the same symptoms as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What RAMANDIUR is and what it is used for
What you need to know before taking RAMANDIUR
How to take RAMANDIUR
Possible side effects
How to store RAMANDIUR
Contents of the pack and other information

1. What RAMANDIUR is and what it is used for

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

Reducing the body's production of substances that can cause an increase in blood pressure
Relaxing and widening your blood vessels
Helping your heart to pump blood around the body more easily. Amlodipine belongs to a group of medicines known as “calcium antagonists”. It works by relaxing blood vessels, allowing blood to flow through them more easily.

Hydrochlorothiazide is a sulfonamide and belongs to a group of medicines known as “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 who are adequately controlled with the individual active substances administered simultaneously at the same dose levels as in RAMANDIUR, but as separate tablets.

2. What you should know before taking RAMANDIUR

Do not take RAMANDIUR if

you are allergic to ramipril, amlodipine, or hydrochlorothiazide, to any other ACE inhibitor or calcium antagonist, or to any medicine derived from sulfonamides, or to any of the other components of this medicine (listed in section 6);
you have severe narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body);
you have previously had a severe allergic reaction called "angioedema". Signs include itching, skin rash (urticaria), red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing or swallowing;
you are undergoing dialysis or any other type of blood filtration. Depending on the equipment 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 or unstable low blood pressure;
you suffer from heart failure after a heart attack;
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine 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 type of long-term (chronic) heart failure in adults.

Do not take RAMANDIUR if any of these situations apply to you. If you are unsure, consult your doctor before taking RAMANDIUR.

Warnings and precautions

Talk to your doctor or pharmacist before taking RAMANDIUR.

You must inform your doctor if any of the following conditions apply to you:

you are elderly and your dose needs to be increased;
you have heart, liver, or kidney problems;
you have a severe increase in blood pressure (hypertensive crisis);
you have lost significant amounts of salts or body fluids (due to illness (vomiting), diarrhea, excessive sweating, following a low-salt diet, or from long-term use of oral diuretics, or after dialysis);
you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitization);
you are about to undergo anesthesia that may be administered for surgery or dental procedures. It may be necessary to stop treatment with RAMANDIUR the day before; consult your doctor;
you have high levels of potassium in the blood (shown by a blood test);
you are taking medicines or have conditions that may cause low sodium levels in the blood. Your doctor may prescribe regular blood tests, especially to monitor sodium levels, 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 serious allergic reaction;
you have a vascular collagen disease such as scleroderma or systemic lupus erythematosus;
you experience sudden vision changes (acute transient myopia) or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased pressure in the eye (secondary angle-closure glaucoma), which may occur from a few hours to a week after taking RAMANDIUR. If untreated, they may lead to permanent vision damage. If you previously had an allergic reaction to penicillin or sulfonamides, you may be more likely to develop these symptoms;
you develop light sensitivity (photosensitivity); in this case, you should stop taking RAMANDIUR;
you have diabetes. In this case, you may need to adjust your insulin dose or may require oral hypoglycemic agents;
you are taking any of the following medicines for high blood pressure: or an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes, or aliskiren;
you have previously had skin cancer or are developing unexpected skin lesions during treatment. Treatment with hydrochlorothiazide, particularly long-term use at high doses, may increase the risk of certain types of non-melanoma skin and lip cancer. Protect your skin from sun and UV exposure while taking RAMANDIUR;
you have previously experienced breathing or lung problems (including inflammation or fluid in the lungs) after taking hydrochlorothiazide. If shortness of breath or severe breathing difficulty occurs after taking RAMANDIUR, consult a doctor immediately.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information in section “Do not take RAMANDIUR”.

You must inform your doctor if you think you are pregnant (or could become pregnant). RAMANDIUR is not recommended during the first three months of pregnancy and may 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 lack of safety and efficacy data.

Other medicines and RAMANDIUR

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

This is because RAMANDIUR may affect the action of certain other medicines. In addition, some medicines may affect the action of RAMANDIUR.

Your doctor may need to adjust your dose and/or take other precautions if:

you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also information in sections “Do not take RAMANDIUR” and “Warnings and precautions”);
barbiturates or narcotics (medicines for sleep).

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 indomethacin 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 – a herbal treatment for depression).

The following medicines, when taken with RAMANDIUR, may increase the likelihood of adverse effects:

Sacubitril/valsartan – used to treat a type of long-term (chronic) 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 indomethacin and acetylsalicylic acid).
Cancer medicines (chemotherapy).
Medicines to prevent organ rejection after transplantation such as cyclosporine.
Medicines that may lower potassium levels 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 functioning properly).
Desmopressin
Steroid medicines for inflammation such as prednisolone.
Medicines that may increase potassium levels in the blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for bacterial infections), and heparin (to make blood less likely to clot).
Medicines for heart problems, including heart rhythm issues.
Calcium and vitamin D supplements.
Allopurinol (used to lower uric acid levels in the blood).
Procainamide (for heart rhythm problems).
Cholestyramine (to reduce fat levels in the blood).
Carbamazepine, oxcarbazepine (for epilepsy).
Ketoconazole, itraconazole (used to treat fungal infections).
Erythromycin, clarithromycin (antibiotics used to treat certain bacterial infections).
Ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV-infected patients).
Verapamil, diltiazem (for treating certain heart diseases and high blood pressure).
Dantrolene (infusion for serious body temperature abnormalities).
Temsirolimus (for cancer).
Sirolimus, everolimus (to prevent transplant rejection).
Vildagliptin (used to treat type 2 diabetes).
Racecadotril (used for diarrhea).
Tacrolimus (used to control the body’s immune response, allowing acceptance of transplanted organs).
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 of involuntary muscles in the prostate and urethra), tricyclic antidepressants, and neuroleptics.
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 hypoglycemics and insulin. RAMANDIUR may lower blood sugar levels. Monitor your blood sugar levels carefully when taking RAMANDIUR.
Lithium (for mental health conditions): RAMANDIUR may increase lithium levels in the blood. Your doctor must monitor your blood lithium levels carefully.
Simvastatin (a medicine for cholesterol): amlodipine increases exposure to simvastatin. Your doctor will need to reduce the simvastatin dose if you are taking RAMANDIUR.
Medicines used to relax muscles.
Medicines containing iodine, which may be used in hospital before X-ray or scanning procedures.
Medicines that make the blood thinner when taken orally (oral anticoagulants) such as warfarin.

If any of the above conditions occur or if you are unsure, consult your doctor before taking RAMANDIUR.

Check with your doctor or pharmacist before taking this medicine if:

you are undergoing a test for parathyroid function. RAMANDIUR may alter test results;
you are an athlete required to undergo anti-doping testing. RAMANDIUR may produce a positive test result.

RAMANDIUR with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy

You must inform your doctor if you think you are pregnant (or could become pregnant). You must not take RAMANDIUR during the first 12 weeks of pregnancy and must absolutely avoid it after week 13, as it may harm 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 for use during pregnancy.

Breastfeeding

You must not take RAMANDIUR if you are breastfeeding. Consult your doctor or pharmacist before taking any medicine.

Fertility

Available data on potential effects on fertility are insufficient.

Driving and using machines

RAMANDIUR may affect your ability to drive or operate machinery. If the medicine causes discomfort, dizziness, fatigue, or headache, do not drive or operate machinery and contact your doctor immediately.

Attention for athletes: The medicinal product contains substances prohibited in doping. Use different from the dosage regimen and route of administration indicated is prohibited.

RAMANDIUR contains 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 exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule of the dosage prescribed by your doctor once daily.
Depending on the effect, your doctor may adjust the dose.
The maximum dose is 1 capsule of 10 mg/10 mg/25 mg strength once daily.
You must take the medicine orally at the same time every day, either before or after meals.
Swallow the capsule whole with liquid.
Do not crush or chew the hard capsules.
Do not take RAMANDIUR with grapefruit juice.

Liver and kidney disease
If you have liver or kidney disease, your doctor may adjust your dose.

Elderly patients
If you are an elderly patient, your doctor may reduce your starting dose and adjust treatment more gradually.
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 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, possibly to dangerously low levels. You may experience dizziness, mental confusion, fainting, or weakness. If the drop in blood pressure is severe enough, it may lead to 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 yourself to the hospital; have someone drive you or call an ambulance. Bring the medicine pack with you, as the doctor needs to know what you have taken.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.

If you forget to take RAMANDIUR
If you forget to take a capsule, do not take the missed dose. 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 RAMANDIUR
Your doctor will advise you on how long to take this medicine. If you stop treatment earlier than advised by your doctor, your medical condition may return.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop taking RAMANDIUR and contact your doctor immediately if you notice any of the following
serious side effects, as you may require urgent medical treatment:

Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching or skin rash. These may be signs of a serious allergic reaction to RAMANDIUR.
Severe skin reactions including rash, mouth ulcers, worsening of a pre-existing skin condition, redness, blistering and peeling of the skin (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Contact your doctor immediately if you experience:

Rapid or irregular or forceful heartbeat (palpitations), chest pain, tightness in the chest or more serious problems including heart attack and stroke.
Shortness of breath or cough. These may be signs of lung problems, including inflammation.
Easy bruising, bleeding that lasts longer than normal, any sign of bleeding (e.g. bleeding gums), purple spots on the skin or increased susceptibility to infections, sore throat and fever, feeling tired, weak, faint, dizzy or pale appearance. These may be signs of blood or bone marrow problems.
Severe stomach pain that may spread 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 may be signs of liver problems such as inflammation of the liver (hepatitis) or liver damage.

Other side effects include:
Inform your doctor if any of the following conditions become severe or last for more than a few days.
Very common: may affect more than 1 in 10 people

Swelling (oedema)
Low potassium levels in the blood (hypokalaemia)
Increased cholesterol and triglyceride levels (hyperlipidaemia)

Common: may affect up to 1 in 10 people

Headache, dizziness, numbness associated with drowsiness (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 standing up or sitting down quickly (reduced orthostatic blood pressure), weakness (syncope), hot flushes, redness
Dry, non-productive cough, inflammation of the sinuses (sinusitis), bronchitis, shortness of breath (dyspnoea)
Abdominal pain, diarrhoea, gastrointestinal inflammation, digestive disorders and abdominal discomfort (including dyspepsia), nausea, vomiting, altered bowel habits (including diarrhoea and constipation), loss of appetite (anorexia), spasms
Rash with or without swellings, hives
Chest pain
Muscle cramps or pain (myalgia), muscle spasms
Blood tests showing lower than usual levels of magnesium and sodium in the blood
Feeling of weakness and lack of energy (asthenia)
Blood tests showing higher than usual levels of uric acid or potassium in the blood
Inability to achieve an erection (impotence)
Visual disturbances (including double or blurred vision)
Increased potassium levels in the blood (hyperkalaemia)

Uncommon: may affect up to 1 in 100 people

Increase in blood cells called eosinophils (eosinophilia)
Swelling of the skin, mucous membranes and surrounding tissues (angioedema/Quincke's oedema: in very rare cases, airway obstruction due to angioedema may be fatal)
Swollen arms and legs (peripheral oedema; 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 disturbances (insomnia)
Ringing in the ears (tinnitus)
Sneezing/runny nose (rhinitis), stuffy nose
Difficulty breathing (bronchospasm), including worsening of asthma
Dry mouth, upper abdominal pain including gastritis, constipation
Inflamed pancreas (pancreatitis; fatal outcomes have been reported in very rare cases with ACE inhibitors)
Impaired kidney function, including acute kidney failure and nephritis, urinary disorders, increased urine output during the day, increased need to urinate at night (nocturia)
Worsening of pre-existing proteinuria (more protein than usual in the urine)
Reduced magnesium levels in urine (hypomagnesaemia)
Feeling unwell (malaise)
Weight gain or loss
Anorexia, decreased appetite
Dizziness, trembling (tremor)
Hair loss (alopecia)
Itching, small spots or areas of bleeding on the skin (purpura), skin colour changes, rash
Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia), reduced skin sensation (hypoesthesia)
Loss of taste (ageusia) or altered taste (dysgeusia)
Sweating more than usual (hyperhidrosis)
Heart attack (myocardial infarction), heart vessel disease (myocardial ischaemia), chest stiffness 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)
Reduced sexual desire in men and women, breast enlargement in men (gynaecomastia)
Blood tests showing changes in liver function (increased liver enzymes and/or bilirubin conjugates), 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)
Nail problems, e.g. nail 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 haemoglobin
Blood tests showing a reduction in the number of platelets (thrombocytopenia)
Blood tests showing higher than usual blood sugar levels. If you have diabetes, this may worsen your diabetes
Sensitivity to light or sun (photosensitivity)
Increased calcium levels in the blood (hypercalcaemia)
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 of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
Inflammation of the liver (hepatitis, mostly with cholestasis)
Allergic reactions
Skin rash, which may blister, resembling small targets (dark central spots surrounded by a lighter area with a dark ring around the edge) (erythema multiforme)
A reaction characterised by erythematous skin and mucosal manifestations (similar to lupus erythematosus), reactivation of lupus erythematosus, inflammation of blood vessel walls (necrotizing vasculitis) and extensive skin rash with tendency of the skin to detach (toxic epidermal necrolysis)
Enlargement of 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 (haemolytic anaemia)
Hypochloraemic alkalosis caused by severe deficiency or loss of chloride, which may occur with prolonged vomiting
Respiratory problems (including pneumonia and pulmonary oedema)
Increased blood glucose levels
Acute respiratory distress (signs include severe shortness of breath, fever, weakness and confusion)

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

Blood tests showing too few red blood cells, white blood cells or platelets (pancytopenia)
Anaphylactic or anaphylactoid reactions
Lumpy skin (pemphigus)
Increased antinuclear antibodies
Difficulty concentrating (attention disorder)
Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
Reduced production of blood cells (aplastic anaemia)
Fingers of hands and feet changing colour when exposed to cold, followed by tingling or pain when warmed (Raynaud's phenomenon)
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack (TIA)
Impaired psychomotor performance
Burning sensation
Altered sense of smell (parosmia)
Acute liver failure, cholestatic and cytolytic hepatitis (fatal outcomes have been reported in very rare cases)
Inflammation of the skin (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid eruption), worsening of skin peeling or desquamation (worsened psoriasis), mucosal rash (enantema)
Feeling unwell or malaise. Muscle cramps, confusion and seizures which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
Tremor, rigid posture, mask-like face, slow movements and shuffling, unbalanced gait.
Rapid-onset reduction in distance vision (acute myopia), decreased vision or eye pain due to increased intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
Skin and lip cancer (non-melanoma skin cancer)
Bone marrow failure

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website 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

Keep this medicine below 30 °C.
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 packaging after Exp. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What RAMANDIUR contains
RAMANDIUR 5 mg/5 mg/12.5 mg hard capsules:

The active substances 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.

RAMANDIUR 5 mg/5 mg/25 mg hard capsules:

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

RAMANDIUR 10 mg/5 mg/25 mg hard capsules:

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

RAMANDIUR 10 mg/10 mg/25 mg hard capsules:

The active substances are: ramipril, amlodipine and hydrochlorothiazide. One capsule contains 10 mg of ramipril, 10 mg of amlodipine (as amlodipine besilate) and 25 mg of hydrochlorothiazide.
Other components are:
Capsule contents: Microcrystalline cellulose, Anhydrous calcium hydrogen phosphate, Pregelatinized maize starch, Sodium glycolate starch (type A), Sodium stearil fumarate

Capsule shell (5 mg/5 mg/12.5 mg): Iron oxide red (E172), Iron oxide black (E172), Titanium dioxide (E171), Gelatin
Capsule shell (5 mg/5 mg/25 mg): Iron oxide red (E172), Iron oxide yellow (E172), Titanium dioxide (E171), Gelatin
Capsule shell (10 mg/5 mg/25 mg): Iron oxide red (E172), Iron oxide yellow (E172), Titanium dioxide (E171), Gelatin
Capsule shell (10 mg/10 mg/25 mg): Iron oxide red (E172), Iron oxide yellow (E172), Iron oxide black (E172), Titanium dioxide (E171), Gelatin

Description of the appearance of RAMANDIUR and pack contents
RAMANDIUR 5 mg / 5 mg /12.5 mg hard capsules:
Type 3 capsules with opaque pink cap and opaque light grey body.
RAMANDIUR 5 mg/5 mg/25 mg hard capsules:
Type 1 capsules with opaque pink cap and opaque ivory body.
RAMANDIUR 10 mg/5 mg/25 mg hard capsules:
Type 1 capsules with opaque dark pink cap and opaque yellow body.
RAMANDIUR 10 mg/10 mg/25 mg hard capsules:
Type 1 capsules with opaque brown cap and opaque caramel body.

Pack sizes of 28 hard capsules in blister packs made of PA-AL-PVC (laminated) and aluminium foil, packaged in cardboard cartons.
Not all pack sizes may be marketed.

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

Ramandiur