Ramidilan Hct

Leaflet included in the packaging: patient information

Ramidilan HCT, 5 mg + 5 mg + 12.5 mg, hard capsules

Ramidilan HCT, 5 mg + 5 mg + 25 mg, hard capsules

Ramidilan HCT, 10 mg + 5 mg + 25 mg, hard capsules

Ramidilan HCT, 10 mg + 10 mg + 25 mg, hard capsules

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

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor for a specific person. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• 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 Ramidilan HCT and what is it used for
• 2. Important information before taking Ramidilan HCT
• 3. How to take Ramidilan HCT
• 4. Possible undesirable effects
• 5. How to store Ramidilan HCT
• 6. Contents of the packaging and other information

1. What is Ramidilan HCT and what is it used for

Ramidilan HCT contains three active substances: ramipril, amlodipine, and hydrochlorothiazide.
Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors) and works by:

• reducing the production of substances in the body that can increase blood pressure,
• reducing tension and dilating blood vessels,
• making it easier for the heart to pump blood to all parts of the body.

Amlodipine belongs to a group of medicines called calcium antagonists and works by:

• reducing tension and dilating blood vessels, making it easier for blood to flow.

Hydrochlorothiazide belongs to a group of so-called thiazide diuretics and works by:

• increasing the amount of urine excreted, which reduces blood pressure.

Ramidilan HCT is used to treat high blood pressure (hypertension) in adult patients who have achieved adequate blood pressure control with the individual active substances at the same doses as in the combination medicine, but in the form of separate tablets.

2. Important information before taking Ramidilan HCT

When not to take Ramidilan HCT

• if the patient is allergic to ramipril, amlodipine, or hydrochlorothiazide (active substances), or to other calcium antagonists, ACE inhibitors, or sulfonamide derivatives, or to any of the excipients of this medicine (listed in section 6),
• if the patient has severe aortic stenosis or is in cardiogenic shock (a condition in which the heart cannot supply enough blood to the body),
• if the patient has ever had a severe allergic reaction called "angioedema" - its symptoms include: swelling, hives, red spots on the hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing,
• if the patient has taken or is currently taking sacubitril/valsartan, a medicine used to treat a certain type of chronic heart failure in adults, as the risk of angioedema increases (rapid swelling of tissues under the skin in areas such as the throat).
• if the patient is undergoing dialysis or blood filtration of another type - regardless of the equipment used, the administration of Ramidilan HCT may not be suitable for the patient,
• if the patient has severe kidney dysfunction,
• if the patient has liver dysfunction,
• if the patient's blood electrolyte levels (calcium, potassium, sodium) are abnormal,
• if the patient has kidney dysfunction with reduced blood flow to the kidney,
• in the last 6 months of pregnancy (see below under "Pregnancy, breastfeeding, and fertility"),
• if the patient's blood pressure is very low or unstable,
• if the patient has heart failure after a heart attack,
• if the patient has diabetes or kidney dysfunction and is taking a blood pressure-lowering medicine containing aliskiren.

Ramidilan HCT should not be taken if any of the above conditions apply to the patient. In case of doubts, before taking Ramidilan HCT, the patient should consult a doctor.

Warnings and precautions

Before taking Ramidilan HCT, the patient should discuss it with their doctor or pharmacist.
The patient should tell their doctor if they have or have had any of the following situations:

• the patient is elderly and needs to increase the dose of the medicine;
• the patient has heart, liver, or kidney dysfunction;
• the patient has very high blood pressure (hypertensive crisis);
• the patient has lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, low-sodium diet, or prolonged use of diuretics or dialysis);
• the patient is breastfeeding;
• the patient is about to undergo desensitization treatment for bee or wasp venom (desensitization);
• the patient is to receive anesthesia, e.g., before surgery or dental procedure - it may be necessary to discontinue Ramidilan HCT for a day before the procedure; the patient should consult their doctor;
• the patient has high potassium levels in the blood, as shown in blood tests;
• the patient is taking medicines or has conditions that may decrease sodium levels in the blood - the doctor may order regular blood tests, especially to measure sodium levels in the blood (especially in elderly 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 rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin, a medicine used to treat type 2 diabetes.
• the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
• the patient has experienced vision loss or eye pain, especially if they are at risk of developing glaucoma or are allergic to penicillin or sulfonamides. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye;

The doctor may order regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also the section "When not to take Ramidilan HCT".
The patient should inform their doctor if they are pregnant, plan to become pregnant, or suspect they are pregnant. Ramidilan HCT is not recommended during the first 3 months of pregnancy, and after the 3rd month of pregnancy, its administration may be very harmful to the fetus (see the section "Pregnancy, breastfeeding, and fertility").

Children and adolescents

Ramidilan HCT is not recommended for children and adolescents under 18 years of age due to the lack of data on safety and efficacy.

Ramidilan HCT 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, including those available without a prescription (including herbal medicines). Ramidilan HCT may affect the action of other medicines, and other medicines may affect the action of Ramidilan HCT.
The doctor may order a change in the dose of the medicine and/or take other precautions:

• if the patient is taking an angiotensin II receptor antagonist or aliskiren (see also the sections "When not to take Ramidilan HCT" and "Warnings and precautions").

The following medicines may reduce the effect of Ramidilan HCT:

• analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid);
• medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, norepinephrine, or epinephrine - the doctor will order regular blood pressure monitoring;
• rifampicin (an antibiotic used to treat tuberculosis);
• St. John's wort (Hypericum perforatum) (a herbal medicine used to treat depression).

The following medicines may increase the risk of undesirable effects if taken with Ramidilan HCT:

• analgesic and anti-inflammatory medicines (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, indomethacin, and acetylsalicylic acid);
• anticancer medicines (used in chemotherapy);
• medicines used to prevent rejection of a transplanted organ, such as cyclosporine;
• medicines that may decrease potassium levels in the blood, such as laxatives, glucocorticoids, tetracosactide, amphotericin B (used to treat fungal infections), and corticotropin (ACTH, used to test adrenal function);
• diuretics, such as furosemide;
• desmopressin;
• corticosteroid anti-inflammatory medicines, such as prednisolone;
• 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 rejection of a transplanted organ, and heparin, a medicine used to thin the blood to prevent clots)
• medicines used to treat heart conditions, including arrhythmias;
• calcium supplements;
• allopurinol (used to reduce uric acid levels in the blood);
• procainamide (used to treat arrhythmias);
• cholestyramine (used to reduce cholesterol levels in the blood);
• carbamazepine, oxcarbazepine (antiepileptic medicines);
• ketoconazole, itraconazole (used to treat fungal infections);
• erythromycin, clarithromycin (antibiotics used to treat certain bacterial infections);
• ritonavir, indinavir, nelfinavir (protease inhibitors used in HIV-infected patients);
• verapamil, diltiazem (used to treat certain heart conditions and high blood pressure);
• dantrolene (given as an infusion in severe body temperature disorders);
• temsirolimus (used to treat cancer);
• sirolimus, everolimus (used to prevent rejection of a transplanted organ);
• saxagliptin (used to treat type 2 diabetes);
• racecadotril (an anti-diarrheal medicine);
• tacrolimus (a medicine that controls the immune system, allowing the body to accept a transplanted organ);
• other blood pressure-lowering medicines, such as phosphodiesterase inhibitors (used to treat erectile dysfunction), nitrates, alpha-adrenergic blockers (used in urology to reduce smooth muscle tension in the prostate and urethra), tricyclic antidepressants, and neuroleptics;
• medicines that affect gastrointestinal motility, such as anticholinergic medicines.

Medicines whose action may be affected by Ramidilan HCT:

• medicines used to treat diabetes (oral hypoglycemic agents and insulin) - Ramidilan HCT may lower blood sugar levels, so blood sugar levels should be closely monitored during its use;
• lithium (used to treat mental illnesses) - Ramidilan HCT may increase lithium levels in the blood, so the doctor will order close monitoring of lithium levels in the blood;
• simvastatin (a medicine used to reduce cholesterol levels) - since amlodipine increases the risk of simvastatin, the doctor will order a reduction in the dose of simvastatin in patients taking Ramidilan HCT;
• quinine (an antimalarial medicine);
• medicines containing iodine (contrast agents used in imaging tests, e.g., radiography);
• penicillin (used to treat infections);
• oral anticoagulants, such as warfarin.

If any of the above situations apply to the patient (or the patient has doubts), they should consult their doctor before taking Ramidilan HCT.
Before taking this medicine, the patient should consult their doctor or pharmacist if:

• the patient is to undergo a parathyroid function test, as ramipril and hydrochlorothiazide may affect the test results,
• the patient is an athlete and is to undergo a doping test, as ramipril and hydrochlorothiazide may cause a positive test result.

Ramidilan HCT with food, drink, and alcohol

• Ramidilan HCT can be taken before or after a meal.
• The patient should not eat grapefruits or drink grapefruit juice while taking Ramidilan HCT, as they may increase the levels of the active substance amlodipine in the blood and, consequently, the unpredictable intensity of the blood pressure-lowering effect of Ramidilan HCT.
• Drinking alcohol while taking Ramidilan HCT may cause dizziness or fainting. If the patient wants to know how much alcohol they can consume during treatment, they should discuss it with their doctor, as the effects of blood pressure-lowering medicines and alcohol may add up.

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
If the patient is pregnant (or may be pregnant), they should tell their doctor. Ramidilan HCT should not be taken during the first 12 weeks of pregnancy. It should not be taken after the 13th week of pregnancy, as the medicine taken at this time may harm the fetus. If the patient becomes pregnant while taking Ramidilan HCT, they should immediately inform their doctor. The doctor will propose a change to another medicine before planned pregnancy.
Breastfeeding
Ramidilan HCT should not be taken during breastfeeding. Before taking any medicine, the patient should consult their doctor or pharmacist.
Fertility
There is insufficient data on the potential impact on fertility.

Driving and using machines

Ramidilan HCT may affect the ability to drive and use machines.
If the patient experiences nausea, dizziness, fatigue, or headaches while taking the medicine, they should not drive or operate machines. They should immediately contact their doctor.

Ramidilan HCT contains sodium

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

3. How to take Ramidilan HCT

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should contact their doctor or pharmacist.
The recommended dose is 1 capsule of Ramidilan HCT at the strength prescribed by the doctor, taken once a day.
Depending on the treatment outcome, the doctor may modify the dose.
The maximum dose is 1 capsule of 10 mg + 10 mg + 25 mg, taken once a day.
The medicine should be taken orally, once a day, at the same time, before or after a meal.
The hard capsules should be swallowed whole, with a drink of water.
The hard capsules should not be crushed or chewed.
The medicine should not be taken with grapefruit juice.
Liver and kidney disease
In patients with liver and kidney disease, the doctor may adjust the dose of the medicine.
Elderly patients
The doctor may reduce the initial dose and gradually increase it.

Use in children and adolescents

Ramidilan HCT is not recommended for children and adolescents under 18 years of age due to the lack of data on efficacy and safety.

Taking a higher dose of Ramidilan HCT than recommended

Taking too many capsules may cause a significant decrease in blood pressure, even to dangerously low values. The patient may experience dizziness, fainting, or weakness. A significant decrease in blood pressure may cause shock. The patient's skin may be cold and wet, and they may lose consciousness. In case of an overdose, the patient should immediately seek medical attention. The patient should not drive themselves but ask someone else to drive them or call an ambulance. The patient should take the medicine packaging with them so that the doctor can see what medicine was taken.

Missing a dose of Ramidilan HCT

If the patient misses a dose, they should skip it and 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 Ramidilan HCT

The doctor will inform the patient how long they should take the medicine. Stopping treatment without prior consultation with the doctor may cause the disease to recur.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, Ramidilan HCT can cause undesirable effects, although not everybody gets them.
If the patient experiences any of the following serious undesirable effects, they should stop taking Ramidilan HCT and immediately contact their doctor - they may need urgent treatment.

• Swelling of the face, lips, or throat, making swallowing or breathing difficult, as well as hives and itching. These may be symptoms of a severe allergic reaction to Ramidilan HCT.
• Severe skin reactions, including rash, ulcers in the mouth, blistering of the skin, and severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and erythema multiforme.

If the patient experiences any of the following symptoms, they should immediately inform their doctor:

• rapid heartbeat, irregular or strong heartbeat (palpitations), chest pain, tightness in the chest, or more severe disorders, including heart attack and stroke;
• shortness of breath or cough: these may indicate lung disease, including pneumonia;
• easy bruising, prolonged bleeding, or any signs of bleeding (e.g., bleeding from the gums), purpura, or increased susceptibility to infections, sore throat, and fever, fatigue, fainting, dizziness, or pallor: these may be symptoms of blood or bone marrow disorders;
• severe abdominal pain, which may radiate to the back: this may be a symptom of pancreatitis;
• fever, chills, fatigue, loss of appetite, abdominal pain, nausea, jaundice (yellowing of the skin and eyes): these may be symptoms of liver disorders, such as hepatitis or liver damage.

Other undesirable effects

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

Very common (may affect up to 1 in 10 people)

• edema
• decreased potassium levels in the blood (hypokalemia)
• increased lipid levels in the blood (hyperlipidemia)

Common (may affect up to 1 in 100 people)

• headache, dizziness, drowsiness (especially at the beginning of treatment), feeling of exhaustion (fatigue)
• feeling of heart activity (palpitations)
• edema of the ankles
• low blood pressure (hypotension), especially when standing up quickly or sitting down (orthostatic hypotension), fainting, sudden flushing of the skin (especially on the face and neck)
• dry, irritating cough, sinusitis, bronchitis, shortness of breath
• abdominal pain, diarrhea, inflammation of the stomach and intestinal mucosa, digestive disorders and discomfort in the abdominal cavity (including nausea), vomiting, changes in bowel habits (including diarrhea and constipation), loss of appetite (anorexia), cramps
• skin rash with or without hives, hives
• chest pain
• muscle cramps or muscle pain (myalgia)
• decreased magnesium and sodium levels in the blood, as shown in blood tests
• feeling of weakness and lack of strength (weakness)
• decreased platelet count (thrombocytopenia), as shown in blood tests
• increased potassium or uric acid levels in the blood, as shown in blood tests
• impotence
• vision disturbances (including double vision and blurred vision)

Uncommon (may affect up to 1 in 1,000 people)

• angioedema (angioedema/quincial edema; in rare cases, respiratory distress due to angioedema may be life-threatening)
• peripheral edema (peripheral edema, which may be a sign of excessive water retention)
• intestinal edema (intestinal angioedema)
• mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
• ringing in the ears (tinnitus)
• sneezing, runny nose (rhinitis), nasal congestion
• breathing difficulties (bronchospasm), including asthma exacerbation
• dryness of the mucous membranes of the mouth, abdominal pain, including stomach inflammation, gastrointestinal disorders and discomfort in the abdominal cavity
• kidney dysfunction, including kidney failure, urinary disorders, and increased urine production at night
• worsening of existing proteinuria (increased protein levels in the urine)
• general malaise
• weight gain or loss
• feeling of spinning (vertigo of peripheral origin), dizziness
• hair loss (alopecia)
• flushing, presence of dark red spots or patches due to blood leakage into the skin (purpura), skin discoloration, rash
• abnormal sensations on the skin, such as tingling, numbness, prickling, burning, or itching (paresthesia), decreased skin sensitivity (hypoesthesia)
• taste disturbances or loss of taste
• excessive sweating
• myocardial infarction, coronary heart disease (myocardial ischemia), chest pain or tightness (angina pectoris), rapid heartbeat (tachycardia) or arrhythmias
• slow heart rate (bradycardia), particularly arrhythmias (atrial fibrillation, ventricular tachycardia)
• joint pain, back pain, generalized pain
• increased body temperature/fever
• decreased libido in men and women, gynecomastia in men (breast enlargement)
• increased levels of certain white blood cells (eosinophilia) in blood tests
• abnormal liver function (increased liver enzyme activity and/or increased bilirubin levels), pancreas (increased pancreatic enzyme activity), or kidney function (increased creatinine levels) in blood tests
• cough
• vasculitis (vasculitis, cutaneous vasculitis)

Rare (may affect up to 1 in 10,000 people)

• feeling of confusion or disorientation, balance disorders
• redness and swelling of the tongue (glossitis)
• skin inflammation and peeling (exfoliative dermatitis)
• nail diseases (e.g., nail loosening or separation from the nail bed)
• redness, itching, swelling, or tearing of the eyes (conjunctivitis)
• hearing disturbances
• jaundice (yellowing of the skin and eyes due to liver dysfunction), liver cell damage
• constriction of blood vessels
• circulatory disorders
• vasculitis
• abnormal blood test results showing decreased red blood cell count, white blood cell count (including neutropenia or agranulocytosis, leukopenia), or hemoglobin levels
• abnormal blood test results showing increased blood sugar levels, worsening of diabetes in diabetic patients
• increased sensitivity to sunlight (phototoxicity)
• hypercalcemia
• allergic reactions

Frequency not known (cannot be estimated from the available data)

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

• abnormal blood test results showing low red blood cell count, white blood cell count, and platelet count (pancytopenia)
• anaphylactic or anaphylactoid reactions
• skin papules (hives)
• increased antibody levels
• attention disorders
• mouth ulcers (aphthous stomatitis)
• aplastic anemia
• change in finger or toe color after cooling and tingling or pain after warming (Raynaud's phenomenon)
• cerebral ischemia, including ischemic stroke and transient ischemic attack
• psychomotor disorders
• burning sensation
• taste disturbances
• acute kidney failure, cholestatic and cytolytic hepatitis (in rare cases, fatal)
• skin diseases (psoriasis-like dermatitis), acute skin rash (pemphigus or psoriatic erythroderma), worsening of psoriasis, skin rash
• dark urine (dark color), nausea or vomiting, muscle cramps, fainting, and seizures, which may be caused by inadequate secretion of antidiuretic hormone (vasopressin) - if such symptoms occur, the patient should immediately consult their doctor
• dizziness, stiff posture, mask-like face, slowed movements, and shuffling gait.
• sudden vision loss at a distance (acute myopia), vision loss, or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera or acute angle-closure glaucoma)
• skin and lip cancer (non-melanoma skin cancer)

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not mentioned in the leaflet, they should inform their doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store Ramidilan HCT

Store at a temperature below 30°C.
Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
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 Ramidilan HCT contains

• The active substances of the medicine are: Ramidilan HCT, 5 mg + 5 mg + 12.5 mg, hard capsules: One hard capsule contains 5 mg of ramipril, 5 mg of amlodipine (as 6.934 mg of amlodipine besylate), and 12.5 mg of hydrochlorothiazide.

Ramidilan HCT, 5 mg + 5 mg + 25 mg, hard capsules
One hard capsule contains 5 mg of ramipril, 5 mg of amlodipine (as 6.934 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.
Ramidilan HCT, 10 mg + 5 mg + 25 mg, hard capsules
One hard capsule contains 10 mg of ramipril, 5 mg of amlodipine (as 6.934 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.
Ramidilan HCT, 10 mg + 10 mg + 25 mg, hard capsules
One hard capsule contains 10 mg of ramipril, 10 mg of amlodipine (as 13.868 mg of amlodipine besylate), and 25 mg of hydrochlorothiazide.

• Other ingredients of the medicine are: Capsule contents:microcrystalline cellulose; calcium hydrogen phosphate; maize starch; sodium carboxymethylcellulose (type A); sodium stearyl fumarate.

Capsule shell(5 mg + 5 mg + 12.5 mg)
Body: black iron oxide (E 172); titanium dioxide (E 171); gelatin;
Capsule cap: red iron oxide (E 172); titanium dioxide (E 171); gelatin
Capsule shell(5 mg + 5 mg + 25 mg)
Body: yellow iron oxide (E 172); titanium dioxide (E 171); gelatin
Capsule cap: red iron oxide (E 172); titanium dioxide (E 171); gelatin
Capsule shell(10 mg + 5 mg + 25 mg)
Body: yellow iron oxide (E 172); titanium dioxide (E 171); gelatin
Capsule cap: red iron oxide (E 172); titanium dioxide (E 171); gelatin;
Capsule shell(10 mg + 10 mg + 25 mg)
Body: red iron oxide (E 172); yellow iron oxide (E 172); titanium dioxide (E 171);
gelatin;
Capsule cap: red iron oxide (E 172); yellow iron oxide (E 172); black iron oxide (E 172); titanium dioxide (E 171); gelatin.

What Ramidilan HCT looks like and contents of the pack

Ramidilan HCT, 5 mg + 5 mg + 12.5 mg, hard capsules
The capsules are pink with a light gray body and a pink cap.
Ramidilan HCT, 5 mg + 5 mg + 25 mg, hard capsules
The capsules are pink with an ivory body and a pink cap.
Ramidilan HCT, 10 mg + 5 mg + 25 mg, hard capsules:
The capsules are dark pink with a yellow body and a dark pink cap.
Ramidilan HCT, 10 mg + 10 mg + 25 mg, hard capsules:
The capsules are brown with a caramel body and a brown cap.
The pack contains 10, 28, 30, 60, or 100 hard capsules in blisters, in a cardboard box.
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 Member States of the EEA under the following names:

Austria Ramlolan-HCT 5 mg/5 mg/12.5 mg-Hartkapseln
Ramlolan-HCT 5 mg/5 mg/25 mg-Hartkapseln
Ramlolan-HCT 10 mg/5 mg/25 mg-Hartkapseln
Ramlolan-HCT 10 mg/10 mg/25 mg-Hartkapseln
Poland Ramidilan HCT

For more detailed information on this medicine, the patient should 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
biuro@gl-pharma.pl

Date of last revision of the leaflet: 24.03.2023