Ramipril and amlodipine Sandoz

Italy
Brand name Ramipril and amlodipine Sandoz
Form capsules, hard gelatin
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 051168
Manufacturer SANDOZ S.P.A.

Package leaflet: Information for the patient

Ramipril and Amlodipine Sandoz 5 mg/5 mg hard capsules, 10 mg/5 mg hard capsules, 5 mg/10 mg hard capsules, 10 mg/10 mg hard capsules

Please read all of 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. Do not give it to other people, even if they have the same symptoms as yours, as it may be harmful to them.
  • 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:

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

1. What Ramipril and Amlodipine Sandoz is and what it is used for

Ramipril and Amlodipine Sandoz contains two active substances called ramipril and amlodipine. Ramipril belongs to a group of medicines known as ACE inhibitors (Angiotensin-Converting Enzyme inhibitors), while amlodipine belongs to a group of medicines known as calcium antagonists.

Ramipril works by:

  • decreasing the body's production of substances that may cause an increase in blood pressure
  • relaxing and widening blood vessels
  • making it easier for the heart to pump blood around the body.

Amlodipine works by:

  • relaxing and widening blood vessels, allowing blood to flow through them more easily.

Ramipril and Amlodipine Sandoz can be used to treat high blood pressure (hypertension) in adult patients whose condition is adequately controlled with the individual active substances administered simultaneously at the same dose levels as in the combination, but taken as separate tablets.

2. What you need to know before taking Ramipril and Amlodipine Sandoz

Do not take Ramipril and Amlodipine Sandoz:

  • if you are allergic to ramipril, amlodipine, any other calcium antagonist or ACE inhibitor, or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction may include rash, difficulty breathing or swallowing, swelling of the lips, face, throat or tongue.
  • if you have heart failure following a heart attack.
  • if you have severe narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body).
  • if 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 and swallowing.
  • if you are on dialysis or undergoing any other type of blood filtration. Depending on the machine used, Ramipril and Amlodipine Sandoz may not be suitable for you.
  • if you have kidney problems where blood supply to the kidneys is reduced (renal artery stenosis).
  • if you have liver problems.
  • if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema is increased (rapid swelling under the skin in areas such as the throat).
  • during the last 6 months of pregnancy (see section below “Pregnancy and breastfeeding”).
  • if you have abnormally or unstable low blood pressure. Your doctor will need to assess this.

Do not take Ramipril and Amlodipine Sandoz if any of these apply to you. If you are unsure, consult your doctor before taking Ramipril and Amlodipine Sandoz.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramipril and Amlodipine Sandoz:

  • if you are elderly.
  • if you have heart or kidney problems.
  • if you are at risk of circulatory disorders affecting the heart or brain in case of acute hypotension.
  • if you have severely high blood pressure.
  • if you have lost significant amounts of salts or body fluids (due to illness (vomiting), diarrhoea, excessive sweating, a low-salt diet, long-term use of oral diuretics, or dialysis).
  • if you are about to undergo treatment to reduce allergy to bee or wasp stings (desensitisation).
  • if you are about to undergo anaesthesia that may be administered for surgery or dental procedures. It may be necessary to stop treatment with Ramipril and Amlodipine Sandoz the day before. Consult your doctor.
  • if you are taking any of the following medicines, as they may increase the risk of angioedema, a serious allergic reaction:
  • racecadotril, a medicine used to treat diarrhoea.
  • medicines used to prevent organ transplant rejection and for cancer (e.g. temsirolimus, sirolimus, everolimus).
  • vildagliptin, a medicine used to treat diabetes.
  • if you have high levels of potassium in your blood (shown by a blood test).
  • if you are taking medicines or have conditions that may cause low sodium levels in your blood. Your doctor may prescribe regular blood tests, particularly to monitor blood sodium levels, especially if you are elderly.
  • if you have a vascular collagen disorder such as scleroderma or systemic lupus erythematosus.
  • if you have dark skin, you have a higher risk of:
  • sudden, often very painful swelling of the deeper layers of the skin, especially in the face (angioedema).
  • reduced effect of ramipril.
  • if you have a cough. Inform your doctor if it worsens.
  • if you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (AIIRA) (also known as sartans – e.g. valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren. Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also information in the section “Do not take Ramipril and Amlodipine Sandoz”.
  • you must inform your doctor if you think you are pregnant (or could become pregnant). Ramipril and Amlodipine Sandoz is not recommended during the first 3 months of pregnancy and may cause severe harm to the unborn baby after the first three months of pregnancy (see section “Pregnancy and breastfeeding”).

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking Ramipril and Amlodipine Sandoz.

Your doctor is recommended to monitor your white blood cell count. More frequent monitoring is advised:

  • at the beginning of treatment.
  • in patients with reduced kidney function or vascular collagen diseases.
  • when medicines that affect blood cell counts are being used.

Children and adolescents

The use of Ramipril and Amlodipine Sandoz is not recommended in children and adolescents under 18 years of age due to lack of safety and efficacy data for this medicine in this population.

Other medicines and Ramipril and Amlodipine Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ramipril and Amlodipine Sandoz may affect how other medicines work. Also, some medicines may affect how Ramipril and Amlodipine Sandoz works.

Inform your doctor if you are taking any of the following medicines. These may make Ramipril and Amlodipine Sandoz less effective:

  • medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs [NSAIDs] such as ibuprofen, indometacin and acetylsalicylic acid).
  • medicines used to treat low blood pressure, shock, heart failure, asthma or allergies such as ephedrine, noradrenaline, adrenaline, isoprenaline, dobutamine or dopamine. Your doctor will need to monitor your blood pressure.
  • rifampicin (an antibiotic used to treat tuberculosis).
  • St. John's wort (herbal remedy for depression).

Inform your doctor if you are taking any of the following medicines. Taking these with Ramipril and Amlodipine Sandoz may increase the likelihood of side effects:

  • medicines used to relieve pain and inflammation (e.g. non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indometacin and acetylsalicylic acid).
  • cancer medicines (chemotherapy).
  • temsirolimus (for cancer).
  • medicines more commonly used to prevent rejection of transplanted organs (sirolimus, everolimus and other medicines belonging to the mTOR inhibitor class). See section “Warnings and precautions”.
  • sacubitril/valsartan (used to treat heart problems).

Do not take Ramipril and Amlodipine Sandoz if you have taken or are currently taking sacubitril/valsartan (see section “Do not take Ramipril and Amlodipine Sandoz”).

  • diuretics (water tablets) such as furosemide.
  • medicines that lower blood pressure. Your doctor may need to adjust the dose and/or take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also section “Do not take Ramipril and Amlodipine Sandoz” and “Warnings and precautions”).
  • erythromycin, clarithromycin (antibiotics).
  • potassium supplements (including salt substitutes), potassium-sparing diuretics (a group of diuretics, e.g. spironolactone, triamterene, amiloride) and other medicines that may increase potassium levels in the blood (e.g. trimethoprim and co-trimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporine and tacrolimus, immunosuppressive medicines used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting). Careful monitoring of blood potassium levels is required when these medicines are used together.
  • steroid medicines for inflammation such as prednisolone.
  • allopurinol (used to lower uric acid in the blood).
  • procainamide (for heart rhythm problems).
  • medicines that may alter blood cell counts.
  • ketoconazole, itraconazole (used to treat fungal infections).
  • ritonavir, indinavir, nelfinavir (used to treat HIV-infected patients).
  • dantrolene (infusion for severe body temperature abnormalities).
  • vildagliptin (used to treat diabetes).
  • racecadotril (used for diarrhoea).
  • verapamil, diltiazem (for treating certain heart conditions and hypertension).

Inform your doctor if you are taking any of the following medicines. The action of these medicines may be affected by Ramipril and Amlodipine Sandoz:

  • medicines for diabetes such as oral hypoglycaemics and insulin. Ramipril and Amlodipine Sandoz may reduce blood sugar levels. Monitor your blood sugar levels carefully while taking Ramipril and Amlodipine Sandoz.
  • lithium (for mental health conditions). Ramipril and Amlodipine Sandoz may increase lithium levels in the blood. Your doctor must closely monitor your lithium levels.
  • simvastatin (a medicine to lower cholesterol). Amlodipine increases exposure to simvastatin. Your doctor must reduce the simvastatin dose if you are taking Ramipril and Amlodipine Sandoz.

If any of the above conditions apply to you (or you are unsure), consult your doctor before taking Ramipril and Amlodipine Sandoz.

Ramipril and Amlodipine Sandoz with food, drinks and alcohol

  • Grapefruit juice or grapefruit must not be consumed by people taking Ramipril and Amlodipine Sandoz. This is because grapefruit or grapefruit juice may increase blood levels of the active substance amlodipine, which could enhance the blood pressure-lowering effect of Ramipril and Amlodipine Sandoz.
  • Drinking alcohol during treatment with Ramipril and Amlodipine Sandoz may cause dizziness or lightheadedness. If you are concerned about how much alcohol you can drink while taking Ramipril and Amlodipine Sandoz, discuss it with your doctor, as medicines used to lower blood pressure and alcohol may intensify each other's sedative effects.

Pregnancy, breastfeeding

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

You should not take Ramipril and Amlodipine Sandoz during the first 12 weeks of pregnancy and must not take it after week 13, as its use during pregnancy may harm the unborn baby. If you become pregnant while taking Ramipril and Amlodipine Sandoz, inform your doctor immediately. A switch to an appropriate alternative treatment should be made before a planned pregnancy.

You must not take Ramipril and Amlodipine Sandoz while breastfeeding.

Driving and using machines

Ramipril and Amlodipine Sandoz may affect your ability to drive or operate machinery. If the medicine causes you discomfort, dizziness, tiredness or headache, do not drive or operate machinery. This may especially occur at the beginning of treatment with Ramipril and Amlodipine Sandoz or when the dose is increased.

3. How to take Ramipril and Amlodipine Sandoz

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Taking this medicine

  • Take this medicine orally at the same time each day, with or without food
  • Swallow the hard capsule whole with liquid.
  • Do not crush or chew the hard capsule.
  • Do not take this medicine with grapefruit juice.

Dosage

  • The recommended dose is 1 capsule daily, at the dosage prescribed by your doctor.
  • Depending on the effect, your doctor may adjust the dose.
  • The maximum dose is 1 capsule once daily of the 10 mg/10 mg strength.

Kidney disease
Your doctor may adjust the dosage if you have kidney problems.
Liver disease
Do not take this medicine if you have liver problems (see section “Do not take Ramipril and
Amlodipine Sandoz”).
Elderly
Your doctor may reduce the initial dose of Ramipril and Amlodipine Sandoz and adjust your
treatment more gradually. In very elderly and frail patients, administration of Ramipril and
Amlodipine Sandoz is not recommended.
Use in children and adolescents
The use of Ramipril and Amlodipine Sandoz is not recommended in children and adolescents under
18 years of age due to lack of safety and efficacy data.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
If you take more Ramipril and Amlodipine Sandoz than you should
Taking too many capsules may cause a drop in blood pressure, which could be dangerous.
You may experience dizziness, lightheadedness, fainting, or feel weak. If the drop in blood pressure is
particularly severe, shock may occur. The skin may become cold and clammy, and you may lose
consciousness. Contact your doctor immediately or go immediately to the nearest hospital.
Do not drive to the hospital; have someone drive you or call an ambulance. Bring the
packaging with you so the doctor knows what you have taken.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which
may develop within 24–48 hours after ingestion.
If you forget to take Ramipril and Amlodipine Sandoz
If you forget to take a capsule, skip that dose completely. Take the next dose at your usual time. Do
not take a double dose to make up for the missed dose.
If you stop taking Ramipril and Amlodipine Sandoz
Do not stop taking this medicine abruptly or change the prescribed dose without consulting your
doctor, as your condition may temporarily worsen in such cases.
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 gets them.

Stop taking Ramipril and Amlodipine Sandoz 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 swallowing or breathing, as well as itching or skin rash. This could be a sign of a serious allergic reaction to this medicine.
  • Severe skin reactions including rash, mouth ulcers, rash with blisters on the lips, eyes and mouth, worsening of a pre-existing skin condition, redness, severe itching, blistering rash, peeling and swelling of the skin, inflammation of mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis or erythema multiforme) or other allergic reactions.

Tell your doctor immediately if you experience:

  • Rapid heartbeat, irregular or forceful heartbeat (palpitations), slow or irregular heartbeat, chest pain, or chest tightness (angina pectoris), or more serious problems including heart attack and stroke.
  • Shortness of breath, difficulty breathing, wheezing or cough. These could be signs of lung problems.
  • Easy bruising, bleeding that lasts longer than normal, any signs of bleeding (e.g. bleeding gums), purple spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling tired, fainting, dizziness or pale appearance. These may be signs of blood circulation or bone marrow problems.
  • Severe stomach pain that may spread to the back. This could be a sign of inflammation of the pancreas (pancreatitis).
  • Fever, chills, tiredness, loss of appetite, stomach pain, feeling unwell, dark urine, yellowing of the skin or eyes (jaundice). These may be signs of liver problems such as inflammation of the liver (hepatitis) or liver damage.
  • Marked reduction in urine output, swelling, loss of appetite, nausea, vomiting, tiredness, difficulty breathing, abnormal heart rhythms. These may be signs of serious kidney problems.

Other side effects
Tell your doctor if you experience any of the following side effects.

Very common: may affect more than 1 in 10 people

  • Edema

Common: may affect up to 1 in 10 people

  • Drowsiness (especially at the beginning of treatment)
  • Palpitations (awareness of a strong heartbeat), hot flushes
  • Swelling of the ankles
  • Headache or feeling tired
  • Dizziness – this may occur especially when starting treatment with Ramipril and Amlodipine Sandoz
  • Fainting (syncope), hypotension (abnormally low blood pressure), particularly when standing up or sitting up too quickly
  • Vision disorders (including double vision)
  • Dry, irritating cough, inflammation of the sinuses (sinusitis) or bronchitis, shortness of breath
  • Stomach or intestinal pain, altered bowel habits (including diarrhoea or constipation), abdominal discomfort, indigestion, feeling sick or being sick
  • Inflammation of the stomach or intestine
  • Rash with or without swelling
  • Chest pain
  • Weakness
  • Muscle cramps or muscle pain
  • Blood tests showing abnormally high levels of potassium in the blood

Uncommon: may affect up to 1 in 100 people

  • Mood changes, feeling depressed, anxiety, increased nervousness or restlessness, sleep problems (difficulty falling asleep)
  • Tremor
  • Vision disorders (including blurred vision)
  • Ringing in the ears
  • Cold/running nose
  • Cough
  • Hair loss
  • Itching, generalized rash, purplish blotchy spots on the skin (purpura), changes in skin colour
  • Problems with urination, increased amount of urine during the day, increased frequency of urination, increased urge to urinate, especially at night
  • Worsening of pre-existing proteinuria (abnormally high levels of protein)
  • Feeling unwell
  • Back pain
  • Weight gain or weight loss
  • Breast enlargement in men
  • Feeling lightheaded
  • Itching and unusual skin sensations such as numbness, tingling, tickling, burning or chills (paraesthesia)
  • Loss of skin sensitivity
  • Loss or change in taste
  • Stuffy nose, difficulty breathing or wheezing, worsening of asthma
  • Intestinal swelling called "intestinal angioedema" presenting with symptoms such as abdominal pain, vomiting and diarrhoea
  • Inflammation of the pancreas (pancreatitis)
  • Dry mouth
  • Stomach pain, nausea (gastritis)
  • Increased sweating
  • Loss or decrease in appetite (anorexia)
  • Swollen arms and legs – this may indicate that your body is retaining more fluid than normal
  • Joint pain
  • Fever
  • Erectile dysfunction in men, reduced sexual desire in men or women
  • Blood tests showing an increase in the number of certain white blood cells (eosinophilia)
  • Blood tests showing changes in liver, pancreas or kidney function
  • Heart attack, heart vessel disease (myocardial ischaemia), chest tightness and pain (angina pectoris), fast, irregular or slow heartbeats
  • Swelling of the face, lips or throat (see warnings at the beginning of section 4)
  • Reduced kidney function including severe kidney disease (see warnings at the beginning of section 4)
  • Pain

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

  • Feeling confused
  • Balance problems
  • Red or swollen tongue
  • Severe peeling or flaking of the skin, itching, rash with swelling
  • Nail problems (e.g. loss or separation of a nail from the nail bed)
  • Rash or bruising
  • Spots on the skin and coldness in the extremities
  • Red, itchy, swollen or watery eyes
  • Hearing disorders
  • Blood tests showing a reduction in the number of red blood cells, white blood cells, platelets or haemoglobin
  • Inflammation of blood vessels
  • Constriction of blood vessels
  • Yellowing of the skin (cholestatic jaundice), damaged liver cells

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

  • Allergic reactions
  • Inflammation of the liver
  • Increased sensitivity to sunlight
  • High blood sugar levels
  • Increased muscle tension
  • Nerve disorder that may cause muscle weakness, tingling or numbness
  • Swelling of the gums
  • Severe allergic reactions (see warnings at the beginning of section 4)

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

  • Difficulty concentrating
  • Inflammation of the oral mucosa with small ulcers
  • Blood tests showing abnormally low levels of blood cells
  • Blood tests showing abnormally low levels of sodium in the blood
  • Fingers of hands and feet changing colour when cold, followed by tingling or painful sensation when warming up (Raynaud's phenomenon)
  • Slowed or altered reactions
  • Burning sensation
  • Changes in the perception of smells
  • Thickened red/silver areas of skin (psoriasis) or silver-coloured rash
  • Rash on mucous membranes (exanthema)
  • Bone marrow failure
  • Severe allergic reactions
  • Circulatory disorders in the brain including stroke
  • Increase in certain antibodies
  • Concentrated urine (dark in colour), feeling unwell or malaise, muscle cramps, confusion and seizures which may be due to inappropriate secretion of ADH (antidiuretic hormone). If you experience these symptoms, contact your doctor as soon as possible.
  • Tremor, rigid posture, expressionless face, slow movements and shuffling gait.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramipril and Amlodipine Sandoz

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 "Exp.". The expiry date refers to the last day of that month.
Store below 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ramipril and Amlodipine Sandoz contains

  • The active substances are ramipril and amlodipine.

Ramipril and Amlodipine Sandoz 5 mg/5 mg hard capsules:
Each hard capsule contains 5 mg of ramipril and 5 mg of amlodipine (as 6.934 mg of amlodipine
besilate).
Ramipril and Amlodipine Sandoz 10 mg/5 mg hard capsules:
Each hard capsule contains 10 mg of ramipril and 5 mg of amlodipine (as 6.934 mg of amlodipine
besilate).
Ramipril and Amlodipine Sandoz 5 mg/10 mg hard capsules:
Each hard capsule contains 5 mg of ramipril and 10 mg of amlodipine (as 13.868 mg of amlodipine
besilate).
Ramipril and Amlodipine Sandoz 10 mg/10 mg hard capsules:
Each hard capsule contains 10 mg of ramipril and 10 mg of amlodipine (as 13.868 mg of amlodipine
besilate).

  • The other components are:

Ramipril and Amlodipine Sandoz 5 mg/5 mg hard capsules
Ramipril and Amlodipine Sandoz 5 mg/10 mg hard capsules
Ramipril and Amlodipine Sandoz 10 mg/10 mg hard capsules
Microcrystalline cellulose, hypromellose, crospovidone type B, glycerol dibehenate, gelatin, titanium
dioxide (E171) and indigo carmine (E132).
Ramipril and Amlodipine Sandoz 10 mg/5 mg hard capsules
Microcrystalline cellulose, hypromellose, crospovidone type B, glycerol dibehenate, gelatin, titanium
dioxide (E171).

Description of the appearance of Ramipril and Amlodipine Sandoz and the contents of the pack
Ramipril and Amlodipine Sandoz 5 mg/5 mg hard capsules
Size 3 capsule, approximately 15.9 mm in length, hard gelatin capsule with a blue body and a blue cap, filled with white or almost white powder or slightly compacted aggregates.
Ramipril and Amlodipine Sandoz 10 mg/5 mg hard capsules
Size 1 capsule, approximately 19.4 mm in length, hard gelatin capsule with a white body and a white cap, filled with white or almost white powder or slightly compacted aggregates.
Ramipril and Amlodipine Sandoz 5 mg/10 mg hard capsules
Size 1 capsule, approximately 19.4 mm in length, hard gelatin capsule with a white body and a blue cap, filled with white or almost white powder or slightly compacted aggregates.
Ramipril and Amlodipine Sandoz 10 mg/10 mg hard capsules
Size 1 capsule, approximately 19.4 mm in length, hard gelatin capsule with a blue body and a blue cap, filled with white or almost white powder or slightly compacted aggregates.
Pack sizes: 20, 28, 30, 50, 60, 90 or 100 hard capsules in ALU//OPA/ALU/PVC blisters inside a carton box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.
Viale Luigi Sturzo, 43
20154 Milan
Italy

Manufacturer
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia
Zakłady Farmaceutyczne Polpharma S.A.
Ul. Pelplinska 19
83-200 Starogard Gdanski, Pomorskie
Poland

This medicinal product is authorised in the European Economic Area Member States under the following names:
Austria Ramipril/Amlodipin 1A Pharma 5 mg/5 mg – Hartkapseln
Ramipril/Amlodipin 1A Pharma 5 mg/10 mg – Hartkapseln
Ramipril/Amlodipin 1A Pharma 10 mg/5 mg – Hartkapseln
Ramipril/Amlodipin 1A Pharma 10 mg/10 mg – Hartkapseln
Croatia Prylar 5 mg/5 mg tvrde kapsule
Prylar 5 mg/10 mg tvrde kapsule
Prylar 10 mg/5 mg tvrde kapsule
Prylar 10 mg/10 mg tvrde kapsule
Estonia Ramipril/Amlodipine Sandoz
Germany Ramipril HEXAL plus Amlodipin 5 mg/5 mg Hartkapseln
Ramipril HEXAL plus Amlodipin 5 mg/10 mg Hartkapseln
Ramipril HEXAL plus Amlodipin 10 mg/5 mg Hartkapseln
Ramipril HEXAL plus Amlodipin 10 mg/10 mg Hartkapseln
Italy Ramipril e Amlodipina Sandoz
Latvia Ramipril/Amlodipine Sandoz 5 mg/5 mg cietās kapsulas
Ramipril/Amlodipine Sandoz 5 mg/10 mg cietās kapsulas
Ramipril/Amlodipine Sandoz 10 mg/5 mg cietās kapsulas
Ramipril/Amlodipine Sandoz 10 mg/10 mg cietās kapsulas
Czech Republic Piramil Combi Neo
Slovakia Ramipril/Amlodipín Sandoz 5 mg/5 mg
Ramipril/Amlodipín Sandoz 5 mg/10 mg
Ramipril/Amlodipín Sandoz 10 mg/5 mg
Ramipril/Amlodipín Sandoz 10 mg/10 mg
Slovenia Ramelso 5 mg/5 mg trde kapsule
Ramelso 5 mg/10 mg trde kapsule
Ramelso 10 mg/5 mg trde kapsule
Ramelso 10 mg/10 mg trde kapsule