Ramlolan

Leaflet included in the packaging: patient information

Ramlolan, 2.5 mg + 5 mg, hard capsules

Ramlolan, 5 mg + 5 mg, hard capsules

Ramlolan, 5 mg + 10 mg, hard capsules

Ramlolan, 10 mg + 5 mg, hard capsules

Ramlolan, 10 mg + 10 mg, hard capsules

Ramipril + Amlodipine
You should carefully read the contents of this leaflet before taking this medicine, as it contains important information for you.

• You should keep this leaflet, so that you can read it again later if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the following symptoms, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Ramlolan and what is it used for

Ramlolan contains two active substances: ramipril and amlodipine. Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). Amlodipine belongs to a group of medicines called calcium antagonists.

Ramipril works by:

• Reducing the production of substances in the body that can increase blood pressure
• Relaxing and dilating blood vessels
• Making it easier for the heart to pump blood to the body

Amlodipine works by:

• Relaxing and dilating blood vessels, making it easier for blood to flow through them.

Ramlolan is used to treat high blood pressure (hypertension) in adult patients whose blood pressure is adequately controlled with ramipril and amlodipine taken separately at the same doses as in Ramlolan.

2. Important information before taking Ramlolan

When not to take Ramlolan:

• If you are allergic to ramipril, amlodipine (the active substances), or any other ACE inhibitor or calcium antagonist, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction can include: itching, redness of the skin or difficulty breathing.
• If you have ever had a severe allergic reaction called angioedema. Its symptoms include: itching, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, difficulty breathing and swallowing.

If any of the above applies to you, do not take Ramlolan. If you are unsure, consult your doctor before taking Ramlolan.

Warnings and precautions:

Before taking Ramlolan, you should discuss it with your doctor, pharmacist, or nurse. You should inform your doctor if any of the following apply to you:

• If you have heart, liver, or kidney disease.
• If you have recently lost a lot of fluid (e.g., due to vomiting, diarrhea, excessive sweating, low-salt diet, or prolonged use of diuretics) or if you are taking diuretics.
• If you are going to undergo desensitization treatment (e.g., for bee or wasp stings).
• If you are going to have surgery (including dental surgery). You may need to stop taking Ramlolan a day before the procedure; consult your doctor for advice.
• If you have high levels of potassium in your blood (as shown by blood tests).
• If you have collagen diseases (such as scleroderma or systemic lupus erythematosus).
• If you are taking any of the following medicines for high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes. Your doctor may monitor your kidney function, blood pressure, and potassium levels in your blood at regular intervals. See also the information under "When not to take Ramlolan" and "Warnings and precautions".
• aliskiren. Your doctor may monitor your kidney function, blood pressure, and potassium levels in your blood at regular intervals.
• If you have a significant increase in blood pressure (hypertensive crisis). If an increase in dose is necessary in elderly patients.
• If you experience a persistent dry cough.
• If your blood pressure does not decrease sufficiently. Medicines in this class may be less effective in black patients.
• If you are taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent rejection of transplanted organs and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin, a medicine used to treat diabetes.

If you experience sudden swelling of the face, lips, tongue, or throat, or difficulty swallowing or breathing, or hives or hoarseness (angioedema), you should inform your doctor immediately. This can be a sign of a severe allergic reaction to Ramlolan.

Children and adolescents

Ramlolan should not be used in children and adolescents under 18 years of age due to a lack of data on this population.

Ramlolan and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or recently, and about any medicines you plan to take.

You should tell your doctor about taking any of the following medicines, as they may reduce the effectiveness of Ramlolan:

• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, or aspirin)
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine. Your doctor will monitor your blood pressure.
• rifampicin, an antibiotic used to treat tuberculosis
• St. John's Wort, used to treat depression

You should tell your doctor about taking any of the following medicines, as they may increase the risk of side effects when taken with Ramlolan:

• erythromycin, clarithromycin (antibiotics)
• temsirolimus (used to treat cancer) and other cancer medicines (chemotherapy)
• medicines used to prevent rejection of transplanted organs (sirolimus, everolimus, and other mTOR inhibitors); see also "When not to take Ramlolan" and "Warnings and precautions"
• tacrolimus (used to control the immune system, allowing the body to accept a transplanted organ)
• medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, indomethacin, or acetylsalicylic acid)
• diuretics (such as furosemide)
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that can increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent rejection of transplanted organs; heparin, a medicine used to thin the blood and prevent clots)
• corticosteroids, such as prednisolone
• allopurinol, a medicine used to reduce uric acid levels in the blood
• procainamide, a medicine used to treat irregular heart rhythms
• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection)
• verapamil, diltiazem (medicines used to treat irregular heart rhythms or high blood pressure)
• dantrolene (a medicine used to treat severe body temperature disorders)

Your doctor may need to change the dose and/or take other precautions if you are taking an angiotensin receptor blocker (ARB) or aliskiren (see also the information under "When not to take Ramlolan" and "Warnings and precautions").

You should tell your doctor about taking any of the following medicines, as Ramlolan may affect their action:

• saxagliptin and other diabetes medicines, such as oral hypoglycemic agents and insulin. Ramlolan may lower blood sugar levels. You should carefully monitor your blood sugar levels while taking Ramlolan.
• lithium (a medicine used to treat mental disorders). Ramlolan may increase lithium levels in the blood. Your doctor will carefully monitor your lithium levels.
• simvastatin (a medicine used to lower cholesterol levels). Ramlolan may increase simvastatin levels in the blood.

If you are taking any of the above medicines (or are unsure), you should consult your doctor before taking Ramlolan.

Taking Ramlolan with food, drink, and alcohol

Ramlolan can be taken with or without food.

Drinking alcohol while taking Ramlolan may cause dizziness or drowsiness. If you are unsure about the amount of alcohol you can consume while taking Ramlolan, consult your doctor, as the effects of blood pressure-lowering medicines and alcohol can add up.

Patients taking Ramlolan should not eat grapefruit or drink grapefruit juice, as grapefruit and grapefruit juice can increase the levels of the active substance amlodipine in the blood, which can lead to unpredictable intensification of the effect of Ramlolan, lowering blood pressure.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, or think you may be pregnant, you should consult your doctor or pharmacist before taking this medicine.

Pregnancy

Ramlolan should not be taken during pregnancy. If you become pregnant while taking Ramlolan, you should inform your doctor immediately. If you are planning to become pregnant, your doctor will switch you to alternative treatment.

Breastfeeding

Ramlolan should not be taken during breastfeeding. Before taking any medicine, you should consult your doctor or pharmacist.

Fertility

There is not enough data on the potential impact of Ramlolan on fertility.

Driving and using machines

Ramlolan may affect your ability to drive or operate machines. If Ramlolan causes drowsiness, dizziness, or fatigue, or if you experience headache, you should not drive or operate machines; consult your doctor immediately. Such symptoms can occur especially at the beginning of treatment or when changing medicines.

Ramlolan contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per capsule, which means it is essentially "sodium-free".

3. How to take Ramlolan

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

If you feel that the effect of Ramlolan is too strong or too weak, you should consult your doctor or pharmacist.

This medicine should be taken orally, once a day, at the same time, before or after a meal.

The capsule should be swallowed whole, with a drink of water.

Do not take Ramlolan with grapefruit juice.

Ramlolan should be taken once a day.

Your doctor may adjust the dose according to your response to the medicine.

The maximum daily dose is one capsule of 10 mg + 10 mg.

Elderly patients

Your doctor will start with a lower dose and increase it more slowly.

Patients with kidney and/or liver problems

If you have liver or kidney problems, the dose may need to be adjusted.

Use in children and adolescents

Ramlolan should not be used in children and adolescents under 18 years of age due to a lack of data on this population.

Overdose

Taking too many capsules can cause a drop in blood pressure, even to dangerously low levels. You may feel dizzy, lightheaded, or weak; you may also faint. If your blood pressure drops too low, you may develop shock, and your skin may become cold and clammy, and you may lose consciousness.

If you have taken too many capsules, you should contact your doctor or go to the emergency department of the nearest hospital immediately. You should not drive to the hospital; ask someone else to drive you or call an ambulance. Take the medicine packaging with you, so the doctor knows what you have taken.

Even 24-48 hours after taking the medicine, you may experience shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema).

Missed dose

If you miss 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 missed dose.

Stopping treatment

Your doctor will tell you how long to take Ramlolan. Stopping treatment without your doctor's advice may cause your condition to worsen.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ramlolan can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Ramlolan and contact your doctor immediately - you may need urgent medical attention:

• Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing, as well as itching and rash. These can be symptoms of a severe allergic reaction to Ramlolan.
• Severe skin reactions, including rash, ulcers in the mouth, worsening of existing skin conditions, redness, blistering of the skin (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme) or other allergic reactions. The frequency of these side effects is unknown (cannot be estimated from the available data).

You should inform your doctor immediately if you experience any of the following symptoms:

• Rapid heartbeat, irregular heartbeat (palpitations), chest pain, or severe cardiovascular disorders, including heart attack and stroke. These side effects are common (chest pain, palpitations) or uncommon (rapid heartbeat, heart attack, or stroke).
• Shortness of breath or cough. These are common side effects that may be symptoms of lung disease.
• Easy bruising, prolonged bleeding time, any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, bruising, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin. These can be symptoms of blood or bone marrow disorders. These are rare side effects.
• Severe abdominal pain that can radiate to the back. This can be a symptom of pancreatitis. This is an uncommon side effect.
• Fever, chills, fatigue, loss of appetite, liver pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These can be symptoms of liver disorders, such as inflammation or liver damage. The frequency of these side effects is unknown (cannot be estimated from the available data).

Other side effects:

You should inform your doctor if any of the following symptoms worsen or persist for more than a few days.

Common side effects (may affect up to 1 in 10 people):

• Drowsiness (especially at the beginning of treatment)
• Palpitations (feeling of heartbeat), flushing (especially of the face)
• Swelling of the ankles
• Headache or feeling tired
• Dizziness; the risk of dizziness is higher at the beginning of treatment with Ramlolan or when the dose is increased
• Fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting up from a lying position
• Dry, persistent cough, sinusitis, or bronchitis, shortness of breath
• Abdominal pain, liver pain, or intestinal pain, diarrhea, nausea, vomiting
• Skin rash, with or without raised patches
• Chest pain
• Muscle cramps or muscle pain
• Increased potassium levels in the blood (as shown by blood tests).

Uncommon side effects (may affect up to 1 in 100 people):

• Heart attack
• Mood changes, insomnia
• Flu-like symptoms, weakness, pain, malaise
• Visual disturbances, double vision, blurred vision, tinnitus
• Rhinitis (runny nose)
• Changes in bowel movements (including diarrhea or constipation), heartburn, dry mouth
• Hair loss, increased sweating, itching, red spots on the skin, skin discoloration
• Urinary disorders, increased need to urinate, especially at night, increased frequency of urination
• Impotence, decreased libido in men and women
• Discomfort or enlargement of the breasts in men
• Joint or muscle pain, muscle cramps, back pain
• Weight gain or loss
• Balance disorders (dizziness)
• Itching or abnormal sensations on the skin, such as tingling, numbness, prickling, or burning (paresthesia), loss of pain sensation
• Loss of taste or taste disturbances
• Sleep disorders
• Depression, anxiety, increased nervousness or anxiety
• Nasal congestion, difficulty breathing, or worsening of asthma
• Intestinal angioedema, characterized by abdominal pain, vomiting, and diarrhea
• Anorexia (loss of appetite) or decreased appetite
• Rapid or irregular heartbeat
• Swelling of the upper and lower limbs, which can be a sign of fluid accumulation in the body
• Fever
• Increased white blood cell count (eosinophilia), as shown by blood tests
• Liver, pancreas, or kidney function disorders, as shown by blood tests

Rare side effects (may affect up to 1 in 1,000 people):

• Feeling of uncertainty or confusion
• Redness and swelling of the tongue
• Severe skin peeling, severe rash with blisters
• Nail diseases (e.g., nail loosening or separation from the nail bed)
• Skin rash or bruising
• Hives
• Red spots on the skin and discoloration
• Redness, itching, swelling, or tearing of the eyes
• Hearing disorders
• Decreased red blood cell, white blood cell, or platelet count, or hemoglobin levels, as shown by blood tests

Very rare side effects (may affect up to 1 in 10,000 people):

• Sensitivity to sunlight
• Increased blood sugar levels (hyperglycemia)
• Tongue swelling
• Abdominal bloating (gastritis)
• Liver function disorders, liver inflammation, or jaundice
• Increased muscle tone
• Vasculitis, often accompanied by a skin rash
• Sensitivity to light
• A disorder characterized by stiffness, tremors, and/or movement disorders

Side effects with unknown frequency (frequency cannot be estimated from the available data):

• Concentrated urine (dark-colored urine), nausea, or vomiting, muscle cramps, feeling of confusion, and seizures, which can be symptoms of inappropriate antidiuretic hormone secretion (SIADH). If you experience any of these symptoms, you should inform your doctor immediately.

• Feeling of uncertainty, stiffness of posture, mask-like face, slow movements, and shuffling gait

Other observed side effects:

You should inform your doctor if any of the following symptoms worsen or persist for more than a few days.

• Difficulty concentrating
• Decreased white blood cell count, as shown by blood tests
• Decreased sodium levels in the blood, as shown by blood tests
• Change in skin color of fingers and toes in response to cold, followed by a feeling of tingling or pain in response to heat (Raynaud's phenomenon)
• Slowed or impaired reactions
• Taste disturbances
• Psoriasis

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, Poland

Phone: +48 22 49 21 301

Fax: +48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ramlolan

Keep this medicine out of the sight and reach of children.

Store in a temperature not exceeding 30°C.

Store in the original packaging to protect from light.

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 the month stated.

Medicines should 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 packaging and other information

What Ramlolan contains

• The active substances of Ramlolan are: 2.5 mg + 5 mg, hard capsules: each capsule contains 2.5 mg of ramipril and 5 mg of amlodipine as amlodipine besylate. 5 mg + 5 mg, hard capsules: each capsule contains 5 mg of ramipril and 5 mg of amlodipine as amlodipine besylate.

5 mg + 10 mg, hard capsules: each capsule contains 5 mg of ramipril and 10 mg of amlodipine as amlodipine besylate.

10 mg + 5 mg, hard capsules: each capsule contains 10 mg of ramipril and 5 mg of amlodipine as amlodipine besylate.

10 mg + 10 mg, hard capsules: each capsule contains 10 mg of ramipril and 10 mg of amlodipine as amlodipine besylate.

• The other ingredients of Ramlolan are: microcrystalline cellulose, calcium hydrogen phosphate, maize starch, sodium carboxymethylcellulose (type A), sodium stearyl fumarate, red iron oxide (E 172), titanium dioxide (E 171), gelatin, and for the 10 mg + 10 mg strength: yellow iron oxide (E 172) and black iron oxide (E 172). Black ink: shellac, black iron oxide (E 172), propylene glycol, and ammonium hydroxide.

What Ramlolan looks like and contents of the pack

Ramlolan, 2.5 mg + 5 mg, hard capsules: Hard gelatin capsules, size 1 (19.1-19.7 mm), cap: opaque, light pink; body: opaque, white with black printing "R 2.5 mg A 5 mg". The contents of the capsules are white or almost white powder.

Ramlolan, 5 mg + 5 mg, hard capsules: Hard gelatin capsules, size 1 (19.1-19.7 mm), cap: opaque, pink; body: opaque, white with black printing "R 5 mg A 5 mg". The contents of the capsules are white or almost white powder.

Ramlolan, 5 mg + 10 mg, hard capsules: Hard gelatin capsules, size 1 (19.1-19.7 mm), cap: opaque, reddish-brown; body: opaque, white with black printing "R 5 mg A 10 mg". The contents of the capsules are white or almost white powder.

Ramlolan, 10 mg + 5 mg, hard capsules: Hard gelatin capsules, size 1 (19.1-19.7 mm), cap: opaque, dark pink; body: opaque, white with black printing "R 10 mg A 5 mg". The contents of the capsules are white or almost white powder.

Ramlolan, 10 mg + 10 mg, hard capsules: Hard gelatin capsules, size 1 (19.1-19.7 mm), cap: opaque, brown; body: opaque, white with black printing "R 10 mg A 10 mg". The contents of the capsules are white or almost white powder.

Ramlolan is available in packs of 28, 30, 32, 56, 60, 90, 91, 96, 98, or 100 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

G.L. Pharma GmbH, Schlossplatz 1, 8502 Lannach, Austria

Manufacturer

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

This medicinal product has been authorized in the EEA member states under the following names:

Austria: Ramlolan 2.5 mg/5 mg Hartkapseln, Ramlolan 5 mg/5 mg Hartkapseln, Ramlolan 5 mg/10 mg Hartkapseln, Ramlolan 10 mg/5 mg Hartkapseln, Ramlolan 10 mg/10 mg Hartkapseln

Poland: Ramlolan

For more information about this medicine, contact the marketing authorization holder:

G.L. PHARMA POLAND Sp. z o.o., Al. Jana Pawła II 61/313, 01-031 Warsaw, Poland, Phone: 022/636 52 23; 636 53 02, [email protected]

Date of last revision of the leaflet: