Ramlolan

Leaflet accompanying 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 medication, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult your doctor or pharmacist.
• This medication has been prescribed to you by a doctor for a specific person. Do not give it to others. The medication can harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 medications called ACE inhibitors (angiotensin-converting enzyme inhibitors). Amlodipine belongs to a group of medications called calcium channel blockers.

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 the patient is allergic to ramipril, amlodipine (active substances), other ACE inhibitors, or other calcium channel blockers, or any other component of this medication (listed in section 6). Symptoms of an allergic reaction may include: swelling, redness of the skin, or difficulty breathing.
• If the patient has ever had a severe allergic reaction called "angioedema". Symptoms include: swelling, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, difficulty breathing and swallowing.

If any of the above situations apply to the patient, they should not take Ramlolan. In case of doubt, the patient should consult their doctor before taking Ramlolan.

Warnings and precautions

Before starting to take Ramlolan, the patient should discuss it with their doctor, pharmacist, or nurse. The patient should inform their doctor if any of the following situations apply:

• If the patient has heart, liver, or kidney disease.
• If the patient has recently lost a significant amount of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, low-salt diet, or prolonged use of diuretics).
• If the patient is to undergo desensitization treatment for bee or wasp stings (allergy shots).
• If the patient is to undergo anesthesia. This may be related to surgery or dental procedures. It may be necessary to stop taking Ramlolan the day before the procedure; the patient should consult their doctor for information.
• If the patient has high levels of potassium in the blood (as shown in blood test results).
• If the patient has collagen disease, such as scleroderma or systemic lupus erythematosus.
• If the patient is taking any of the following medications for high blood pressure:
• Angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems related to diabetes.
• Aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals. See also the information under "When not to take Ramlolan" and "Warnings and precautions".
• If the patient has a significant increase in blood pressure (hypertensive crisis). If it is necessary to increase the dose in elderly patients.
• If the patient experiences a persistent dry cough.
• If blood pressure is not sufficiently lowered. Medications in this class may be less effective in black patients.
• If the patient is taking any of the following medications, the risk of angioedema may increase:
• Racecadotril, a medication used to treat diarrhea;
• Medications used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• Sitagliptin, a medication used to treat diabetes.

If the patient experiences sudden swelling of the lips, face, throat, and sometimes also hands and feet, difficulty swallowing or breathing, hives, or hoarseness ("angioedema"). These may be symptoms of a severe allergic reaction. The reaction can occur at any time during treatment, and the risk is higher in black patients. If such symptoms occur, the patient should immediately inform their doctor.

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 medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

The patient should tell their doctor about taking any of the following medications. These medications may reduce the effectiveness of Ramlolan:

• Pain relievers and anti-inflammatory medications (e.g., nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, or aspirin)
• Medications used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine. The doctor will monitor blood pressure.
• Rifampicin (an antibiotic used to treat tuberculosis)
• St. John's Wort (used to treat depression)

The patient should tell their doctor about taking any of the following medications. They may increase the risk of side effects when taken with Ramlolan:

• Erythromycin, clarithromycin (antibiotics)
• Temsirolimus (used to treat cancer) and other cancer medications (chemotherapy)
• Medications used to prevent transplant rejection (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)
• Pain relievers and anti-inflammatory medications (e.g., nonsteroidal 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 medications that increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medication used to prevent transplant rejection; heparin, a medication used to thin the blood and prevent clots)
• Corticosteroids, such as prednisolone
• Allopurinol (a medication used to reduce uric acid levels in the blood)
• Procainamide (a medication used to treat irregular heart rhythms)
• Ketoconazole, itraconazole (antifungal medications)
• Ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection)
• Verapamil, diltiazem (medications used to treat irregular heart rhythms or high blood pressure)
• Dantrolene (a medication used to treat severe body temperature disorders)

The doctor may need to adjust the dose and/or take other precautions:

• If the patient is taking an angiotensin receptor blocker (ARB) or aliskiren (see also "When not to take Ramlolan" and "Warnings and precautions")

The patient should tell their doctor about taking any of the following medications. Ramlolan may affect their action:

• Sitagliptin and other diabetes medications, such as oral antidiabetic medications and insulin. Ramlolan may lower blood sugar levels. The patient should carefully monitor their blood sugar levels while taking Ramlolan.
• Lithium (a medication used to treat mental disorders). Ramlolan may increase lithium levels in the blood. The doctor will carefully monitor lithium levels in the patient.
• Simvastatin (a medication used to lower cholesterol levels). Ramlolan may increase simvastatin levels in the blood.

If the patient is taking any of the above medications (or is unsure), they should consult their 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 the patient has any doubts about the amount of alcohol allowed while taking Ramlolan, they should consult their doctor, as the effects of blood pressure-lowering medications and alcohol can add up.

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

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medication.

Pregnancy

Ramlolan should not be taken during pregnancy. If the patient becomes pregnant while taking Ramlolan, they should immediately inform their doctor. If the patient plans to become pregnant, the doctor will change the medication to an alternative treatment.

Breastfeeding

Ramlolan should not be taken during breastfeeding. Before taking any medication, the patient should consult their doctor or pharmacist.

Fertility

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

Driving and using machines

Ramlolan may affect the patient's ability to drive or operate machines. If Ramlolan causes drowsiness, dizziness, or fatigue, or headache, the patient should not drive or operate machines; they should immediately consult their doctor. Such symptoms may occur especially at the beginning of treatment or when changing medications.

Ramlolan contains sodium

The medication contains less than 1 mmol (23 mg) of sodium per capsule, which means it is considered "sodium-free".

3. How to take Ramlolan

This medication should always be taken as directed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

If the patient feels that the action of Ramlolan is too strong or too weak, they should consult their doctor or pharmacist.

The medication 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.

Ramlolan should not be taken with grapefruit juice.

Ramlolan should be taken once a day.

The doctor may adjust the dose based on the patient's response to the medication.

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

Elderly patients

The doctor will start with a lower dose and adjust it more slowly.

Patients with kidney and/or liver problems

In case of liver or kidney problems, the dose may be modified.

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 of Ramlolan

Taking too many capsules can cause a decrease in blood pressure, even to dangerously low levels. The patient may feel dizzy, lightheaded, or weak; they may also faint. In case of severe low blood pressure, shock may develop - the skin becomes cold and clammy, and the patient may lose consciousness.

If the patient has taken too many capsules, they should immediately consult their doctor or go to the emergency department of the nearest hospital. The patient should not drive to the hospital - they should ask someone else to drive them or call an ambulance. The patient should take the medication packaging with them, so the doctor knows what medication they have taken.

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

Missing a dose of Ramlolan

If the patient misses a capsule, they should not take the missed dose. They should take the next dose at the usual time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ramlolan

The doctor will inform the patient about the duration of treatment. Stopping treatment without the doctor's advice may cause the disease to recur.

If the patient has any further doubts about taking this medication, they should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Ramlolan and immediately consult their doctor - they may need urgent medical attention:

• Swelling of the face, lips, or throat, making it difficult to swallow or breathe, as well as itching and rash. These may 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, or peeling of the skin (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme). The frequency of these side effects is unknown (cannot be estimated from the available data).

The patient should immediately inform their doctor if they experience any of the following symptoms:

• Rapid heartbeat, irregular heartbeat, or stronger heartbeat (palpitations), chest pain, tightness in the chest, or more serious disorders, 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 may be symptoms of lung disease.
• Easy bruising, prolonged bleeding time, or any signs of bleeding (e.g., bleeding from the gums), purple spots on the skin, bruising, or more frequent bruising. These may be symptoms of blood disorders or bone marrow disorders. These are rare side effects.
• Severe abdominal pain, which may radiate to the back. This may be a symptom of pancreatitis. This is an uncommon side effect.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea, vomiting, yellowing of the skin or whites of the eyes (jaundice). These may 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:

The patient should inform their 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 (perceptible heartbeat), sudden flushing (especially of the face)
• Swelling of the ankles
• Headache or fatigue
• 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, stomach 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 in 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
• Sneezing/runny nose caused by sinusitis (rhinitis)
• Changes in bowel movements (including diarrhea or constipation), heartburn, dry mouth
• Hair loss, increased sweating, skin rash, 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 weight loss
• Balance disorders (dizziness)
• Skin rash and abnormal skin sensations, such as tingling, numbness, prickling, burning, or itching (paresthesia), loss of pain sensation
• Loss of or altered sense of taste
• Sleep disorders
• Depression, anxiety, increased nervousness or anxiety
• Nasal congestion, difficulty breathing, or worsening of asthma
• Intestinal edema, 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 may be a sign of fluid accumulation in the body
• Fever
• Increased levels of a certain type of white blood cell (eosinophilia), as shown in blood tests
• Disorders of liver, pancreas, or kidney function, as shown in 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 disorders (e.g., nail separation or nail lifting)
• Skin rash or bruising
• Hives
• Spots on the skin and discoloration of the skin
• Redness, itching, swelling, or tearing of the eyes
• Hearing disorders
• Decreased levels of red blood cells, white blood cells, or platelets, or hemoglobin levels, as shown in 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 disorders, liver inflammation, or jaundice
• Increased muscle tension
• 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), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be due to abnormal antidiuretic hormone (ADH) secretion. If these symptoms occur, the patient should immediately consult their doctor.

• Restlessness, stiffness, mask-like face, slow movements, and shuffling gait

Other observed side effects:

The patient should inform their doctor if any of the following symptoms worsen or persist for more than a few days.

• Difficulty concentrating
• Decreased levels of sodium in the blood, as shown in blood tests
• Change in skin color and unusual sensations on the skin, such as tingling, numbness, prickling, burning, or itching (paresthesia)
• Loss of or altered sense of taste
• Sleep disorders
• Depression, anxiety, increased nervousness or anxiety
• Nasal congestion, difficulty breathing, or worsening of asthma
• Psoriasis

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.

Reporting side effects helps to gather more information on the safety of the medication.

5. How to store Ramlolan

The medication should be stored out of sight and reach of children.

Store at a temperature below 30°C.

Store in the original packaging to protect from light.

Do not use this medication after the expiration date stated on the box and blister pack after "EXP:". The expiration date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications that are no longer needed. 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 in the form of amlodipine besylate. 5 mg + 5 mg, hard capsules: each capsule contains 5 mg of ramipril and 5 mg of amlodipine in the form of amlodipine besylate.

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

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

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

• Other ingredients of the medication 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 packaging

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". Capsule contents: 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". Capsule contents: 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". Capsule contents: 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". Capsule contents: 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". Capsule contents: 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 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 medication, the patient should consult 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: