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
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any undesirable effects, including any undesirable effects not mentioned in this leaflet, they should inform 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 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 into 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 antagonists, or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include: itching, redness of the skin, or difficulty breathing.
• If the patient has ever had a severe allergic reaction called "angioedema". 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 situations apply to the patient, they should not take Ramlolan. In case of doubt, consult a 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 to them:

• 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, a low-salt diet, or taking diuretics for a long time, or dialysis).
• 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 treatment. It may be necessary to stop taking Ramlolan the day before the procedure; the patient should consult their doctor for advice.
• If the patient has high levels of potassium in the blood (as shown in blood tests).
• If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus.
• If the patient is taking any of the following medicines for high blood pressure:
• angiotensin receptor antagonist (ARB) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if the patient has kidney problems due 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 significantly increased blood pressure (hypertensive crisis). If it is necessary to increase the dose in elderly patients.
• If the patient experiences a dry cough that persists for a long time.
• If blood pressure is not sufficiently lowered. Medicines in this group are likely to be less effective in black patients.
• If the patient is taking any of the following medicines, the risk of angioedema may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin, a medicine used to treat diabetes.

If the patient experiences sudden swelling of the lips, face, throat, and sometimes 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 medicines

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

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

• Erythromycin, clarithromycin (antibiotics)
• Temsirolimus (used to treat cancer) and other medicines used to treat cancer (chemotherapy)
• Medicines used to prevent transplant rejection (sirolimus, everolimus, and other medicines in the mTOR inhibitor class); 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 increase potassium levels in the blood (e.g., trimethoprim and co-trimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to 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 given by infusion in cases of severe temperature regulation disorders)

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

• If the patient is taking an angiotensin receptor antagonist (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 medicines. Ramlolan may affect their action:

• Saxagliptin and other medicines used to treat diabetes, such as oral hypoglycemic agents and insulin. Ramlolan may lower blood sugar levels. The patient should carefully monitor their blood sugar levels while taking Ramlolan.
• Lithium (a medicine 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 medicine used to lower cholesterol levels). Ramlolan may increase simvastatin levels in the blood.

If the patient is taking any of the above medicines (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 medicines and alcohol can add up.

Patients taking Ramlolan should not eat grapefruits or drink grapefruit juice. This is because 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 medicine.

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 medicine to an alternative treatment.

Breastfeeding

Ramlolan should not be taken during breastfeeding. Before taking any medicine, 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 ability to drive and use 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 medicines.

Ramlolan contains sodium

The 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 prescribed by the doctor or pharmacist. In case of doubt, the patient 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 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.

Ramlolan should not be taken with grapefruit juice.

Ramlolan should be taken once a day.

The doctor may adjust the dose depending on the patient's response to the medicine.

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

Elderly patients

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

Patients with kidney and/or liver problems

In case of liver or kidney problems, the doses may 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 may cause a decrease in blood pressure, even to dangerously low values. 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.

In case of overdose, the patient 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 medicine packaging with them so that the doctor knows what medicine they have taken.

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

Missed dose

If a capsule is missed, the patient 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 with Ramlolan without the doctor's advice may cause the disease to recur.

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, 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, difficulty swallowing or breathing, 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, exacerbation 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, any signs of bleeding (e.g., bleeding from the gums), purpura, petechiae, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or pallor. These may be symptoms of blood or bone marrow disorders. These are rare side effects.
• Severe abdominal pain that 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, or 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 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, stomach pain, or intestinal pain, diarrhea, nausea, vomiting
• 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 swings, insomnia
• Flu-like symptoms, weakness, pain, or 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, redness, or 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 or altered taste
• 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)
• 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
• Liver, pancreas, or kidney function disorders, 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
• Nail diseases (e.g., nail separation or detachment from the nail bed)
• Rash or bruising
• Hives
• Red spots on the skin and discoloration
• 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 function disorders, liver inflammation, or jaundice
• Increased muscle tone
• Vasculitis, often accompanied by a 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, or burning (paresthesia)
• Loss of or altered 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 those not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported 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.

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

5. How to store Ramlolan

The medicine should be kept out of the sight and reach of children.

Store at a temperature below 30°C.

Keep the medicine in its original packaging to protect it from light.

Do not use this medicine after the expiry date stated on the carton and blister pack 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. The patient should ask their pharmacist how to dispose of medicines 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.

• 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, 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, biuro@gl-pharma.pl

Date of last revision of the leaflet: