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 you can read it again 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 side effects, including those not listed in this leaflet, 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 widening blood vessels
• Making it easier for the heart to pump blood to the body

Amlodipine works by:

• Relaxing and widening 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 already 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. Symptoms can 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, talk to your doctor before taking Ramlolan.

Warnings and precautions:

Before taking Ramlolan, talk to your doctor, pharmacist, or nurse. Tell your doctor if any of the following apply to you:

• If you have heart, liver, or kidney problems.
• If you have recently lost a lot of fluid (e.g., due to vomiting, diarrhea, excessive sweating, low-salt diet, or taking diuretics for a long time) or have had dialysis.
• If you are going to have an allergy test to find out if you are allergic to insect stings.
• If you are going to have surgery or anesthesia. You may need to stop taking Ramlolan the 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.
• aliskiren. 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".
• 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 is not adequately controlled. Medicines in this class are 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 your face, lips, tongue, or throat, difficulty swallowing or breathing, hives, or hoarseness (angioedema), tell your doctor immediately.

Children and adolescents

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

Ramlolan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. 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)

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 anticancer medicines (chemotherapy)
• medicines used to prevent rejection of transplanted organs (e.g., 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 (e.g., 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; cyclosporin, an immunosuppressant used to prevent rejection of transplanted organs, and heparin, a medicine used to thin the blood to prevent clots)
• corticosteroids (e.g., prednisolone)
• allopurinol (used to reduce uric acid levels in the blood)
• procainamide (used to treat irregular heartbeat)
• ketoconazole, itraconazole (antifungal medicines)
• ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection)
• verapamil, diltiazem (used to treat irregular heartbeat or high blood pressure)
• dantrolene (given by infusion in cases of severe body temperature disturbances)

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

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

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

If you are taking any of the above medicines (or are unsure), talk to 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 fainting. If you are unsure about the amount of alcohol you can drink while taking Ramlolan, talk to your doctor, as the effects of blood pressure-lowering medicines and alcohol can add up.

People 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 increases in the effects of Ramlolan.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Do not take Ramlolan if you are pregnant. If you become pregnant while taking Ramlolan, tell your doctor immediately. If you are planning to become pregnant, your doctor will switch you to a different medicine.

Breastfeeding

Do not take Ramlolan while breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine.

Fertility

There is not enough information on the potential effects of Ramlolan on fertility.

Driving and using machines

Ramlolan may affect your ability to drive or use machines. If Ramlolan makes you feel dizzy, tired, or causes you to have headaches, do not drive or use machines; consult your doctor immediately. These symptoms can occur especially at the start of treatment or when changing medicines.

Ramlolan contains sodium

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

3. How to take Ramlolan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist.

If you think the effect of Ramlolan is too strong or too weak, talk to your doctor or pharmacist.

Take Ramlolan orally, once a day, at the same time, before or after a meal.

Swallow the capsule whole with a drink of water.

Do not take Ramlolan with grapefruit juice.

Take Ramlolan 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 lack of data on this population.

Overdose of Ramlolan

Taking too many capsules can cause a significant drop in blood pressure, even to dangerously low levels. You may feel dizzy, faint, or weak; you may also experience fainting. In case of a severe drop in blood pressure, shock can develop - the skin becomes cool and clammy, and you may lose consciousness.

If you have taken too many capsules, contact your doctor or go to the emergency department of your nearest hospital immediately. Do 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, shortness of breath due to excess fluid in the lungs (pulmonary edema) can occur.

Missed dose of Ramlolan

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 with Ramlolan

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

If you have any further questions on the use of 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).

Tell your doctor immediately if you experience any of the following symptoms:

• Rapid heartbeat, irregular heartbeat (palpitations), chest pain, tightness in the chest, or more serious heart problems, including heart attack and stroke. These side effects are common (chest pain, tightness in the chest, palpitations) or uncommon (rapid heartbeat, heart attack, or stroke).
• Shortness of breath or cough. These are common side effects that can 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 pale 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, stomach pain, nausea, yellowing of the skin or whites of the eyes (jaundice). These can be symptoms of liver problems, such as inflammation or liver damage. The frequency of these side effects is unknown (cannot be estimated from the available data).

Other side effects:

Tell your doctor if any of the following side effects get worse or persist for more than a few days.

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

• Drowsiness (especially at the start 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 start 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, tickly cough, sinusitis, or bronchitis, shortness of breath
• Abdominal pain, stomach pain, or intestinal pain, diarrhea, nausea, vomiting
• Rash, including 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
• Vision disturbances, double vision, blurred vision, ringing in the ears
• Rhinitis (inflammation of the nasal mucosa)
• Changes in bowel movements (including diarrhea or constipation), heartburn, dry mouth
• Hair loss, increased sweating, itching of the skin, 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 of the skin and abnormal sensations on the skin, such as tingling, pricking, burning, or numbness (paresthesia), loss of pain sensation
• Loss of or altered taste
• Sleep disturbances
• Depression, anxiety, increased nervousness or anxiety
• Nasal congestion, difficulty breathing, or worsening of asthma
• Intestinal angioedema, characterized by abdominal pain, vomiting, and diarrhea
• Loss of or decreased appetite (anorexia)
• Rapid or irregular heartbeat
• Swelling of the upper and lower limbs, which can be a sign of fluid accumulation in the body
• Fever
• Increased levels of a certain type of white blood cell (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 blistering
• Nail disorders (e.g., nail loosening or separation from the nail bed)
• Rash or bruising
• Hives
• Red or purple spots on the skin and discoloration of the skin
• Redness, itching, swelling, or tearing of the eyes
• Hearing disturbances
• Decreased levels of red blood cells, white blood cells, or platelets, or decreased 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 (inflammation of blood vessels), often accompanied by a rash
• Sensitivity to light
• A condition characterized by stiffness, trembling, 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, contact your doctor immediately.

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

Other observed side effects:

Tell your doctor if any of the following side effects get worse or persist for more than a few days.

• Difficulty concentrating
• Decreased blood cell count, as shown by blood tests
• Decreased sodium levels in the blood, as shown by blood tests
• Change in skin color and unusual sensations on the skin, such as tingling, pricking, burning, or numbness (paresthesia)
• Loss of or altered taste
• Sleep disturbances
• Psoriasis

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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

You can also report side effects 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), black iron oxide (E 172). Black ink: shellac, black iron oxide (E 172), propylene glycol, 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

This medicinal product is authorized in the Member States of the EEA 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 on this medicine, contact the representative of 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: