Ramidilan hct

Poland
Brand name Ramidilan hct
Form capsules, hard
Active substance / Dosage
ramipril · 10 mg
amlodipine · 6.934 mg
hydrochlorothiazide · 25 mg
Prescription type Prescription only
ATC code
C09BX03
Registration number 100451463
Manufacturer Adamed Pharma S.A.

Table of Contents

Package leaflet: Information for the patient

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
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

  • Keep this leaflet, as you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
  • If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

1. What Ramidilan HCT is and what it is 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 in the body of a substance that may increase blood pressure,
  • reducing tension and dilating blood vessels,
  • helping the heart 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, thus improving blood flow.

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

  • increasing the volume of urine produced, which leads to a reduction in blood pressure.

Ramidilan HCT is used to treat high blood pressure (hypertension) in adult patients whose blood pressure has been adequately controlled using the same doses of the individual active substances administered separately as monotherapy tablets.

2. Important information before using Ramidilan HCT

When not to use Ramidilan HCT

  • if the patient is allergic to ramipril, amlodipine or hydrochlorothiazide (the active substances), to other calcium channel blockers, ACE inhibitors or sulfonamide derivatives, or to any of the ingredients of this medicine (listed in section 6),
  • if the patient has significant narrowing of the aortic valve (aortic stenosis) or is in cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body),
  • if the patient has ever experienced a severe allergic reaction called "angioedema" – symptoms include: itching, urticaria, red patches on hands, feet and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing,
  • if the patient is taking or currently receiving sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, as this increases the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat),
  • if the patient is undergoing dialysis or other types of blood filtration – depending on the equipment used, administration of Ramidilan HCT may not be suitable for the patient,
  • if the patient has severe kidney function disorders,
  • if the patient has liver function disorders,
  • if the patient has abnormal blood electrolyte levels (calcium, potassium, sodium),
  • if the patient has kidney function disorders with reduced blood flow to the kidneys (renal artery stenosis),
  • during 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 following a heart attack,
  • if the patient has diabetes or kidney function disorders and is receiving a blood pressure-lowering medicine containing aliskiren.

Do not take Ramidilan HCT if any of the above conditions apply to the patient. If in doubt, consult a doctor before taking Ramidilan HCT.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ramidilan HCT. Inform your doctor if any of the following apply to you or have applied in the past:

  • the patient is elderly and dose escalation is required;
  • the patient has heart, liver or kidney function disorders;
  • the patient has very high blood pressure (hypertensive crisis);
  • the patient has lost a large amount of electrolytes or fluids (due to vomiting, diarrhoea, excessive sweating, a low-sodium diet, long-term use of diuretics, or dialysis);
  • the patient is breastfeeding;
  • the patient is undergoing immunotherapy to reduce allergy to bee or wasp venom (desensitisation);
  • the patient is due to receive anaesthesia, e.g. before surgery or a dental procedure – it may be necessary to discontinue Ramidilan HCT one day before the procedure; consult your doctor;
  • the patient has high blood potassium levels, as confirmed by blood tests;
  • the patient is taking medicines or has conditions that may reduce blood sodium levels – your doctor may recommend regular blood tests, especially to monitor blood sodium levels (particularly 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 diarrhoea;
    • medicines used to prevent transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
    • vildagliptin, a medicine used to treat diabetes.
  • the patient has been diagnosed with a collagen disease such as scleroderma or systemic lupus erythematosus;
  • the patient has experienced worsening vision or eye pain, especially if the patient is at risk of developing glaucoma or is allergic to penicillin- or sulfonamide-containing medicines. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure;
  • the patient has experienced photosensitivity reactions – in such cases, discontinue Ramidilan HCT;
  • the patient has diabetes – insulin dosage or oral antidiabetic medicines may need adjustment;
  • the patient is taking any of the following antihypertensive medicines:
    • an angiotensin II receptor antagonist (also known as a sartan, e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney disease due to diabetes,
    • aliskiren;
  • if the patient has previously had skin cancer or develops an unexpected skin lesion – long-term and high-dose use of hydrochlorothiazide may increase the risk of certain types of skin and lip cancers (non-melanoma skin cancer); during treatment with Ramidilan HCT, protect the skin from sunlight and UV radiation;
  • if the patient has previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe breathlessness or difficulty breathing occurs after taking Ramidilan HCT, seek immediate medical attention.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section "When not to use Ramidilan HCT".

Inform your doctor if you are pregnant, planning pregnancy, or suspect you may be pregnant. Ramidilan HCT is not recommended during the first 3 months of pregnancy, and after the 3rd month of pregnancy, administration of this medicine may be very harmful to the unborn child (see section "Pregnancy, breastfeeding and fertility").

Children and adolescents

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

Ramidilan HCT and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including over-the-counter medicines (including herbal medicines). Ramidilan HCT may affect the action of other medicines, and other medicines may affect the action of Ramidilan HCT.

Your doctor may recommend a dose adjustment and/or additional precautions:

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

The following medicines may reduce the effectiveness of Ramidilan HCT:

  • painkillers 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, noradrenaline or adrenaline – your doctor may recommend 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 adverse effects when taken simultaneously with Ramidilan HCT:

  • painkillers 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 transplant rejection, such as cyclosporine;
  • medicines that may reduce blood potassium levels, such as medicines used to treat constipation, glucocorticosteroids, tetracosactide, amphotericin B (used to treat fungal infections) and corticotropin (ACTH, used to assess adrenal gland function);
  • diuretics (water tablets), such as furosemide;
  • desmopressin;
  • steroid anti-inflammatory medicines, such as prednisolone;
  • potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that increase blood potassium levels (e.g. trimethoprim and co-trimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
  • medicines used for heart diseases, including heart rhythm disorders;
  • calcium supplements;
  • allopurinol (used to reduce blood uric acid levels);
  • procainamide (used for heart rhythm disorders);
  • cholestyramine (used to reduce blood lipid levels);
  • 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 diseases and high blood pressure);
  • dantrolene (administered intravenously in severe temperature regulation disorders);
  • temsirolimus (used in cancer treatment);
  • sirolimus, everolimus (used to prevent transplant rejection);
  • vildagliptin (used in type 2 diabetes treatment);
  • racecadotril (an antidiarrhoeal medicine);
  • tacrolimus (a medicine that modulates immune system function, allowing the body to accept a transplanted organ);
  • other medicines that lower blood pressure, such as phosphodiesterase-5 inhibitors (used to treat erectile dysfunction), nitrates, alpha-adrenolytic medicines (used in urology to reduce smooth muscle tension in the prostate and urethra), tricyclic antidepressants and neuroleptics;
  • medicines affecting gastrointestinal motility, such as anticholinergic medicines.

Medicines whose action may be affected by Ramidilan HCT:

  • medicines used to treat diabetes (oral hypoglycaemics and insulin) – Ramidilan HCT may reduce blood glucose levels, so blood glucose levels should be closely monitored during treatment;
  • lithium (used in psychiatric disorders) – Ramidilan HCT may increase blood lithium levels, so your doctor will recommend close monitoring of blood lithium levels;
  • simvastatin (a medicine used to reduce cholesterol levels) – since amlodipine increases exposure to simvastatin, your doctor will recommend reducing the simvastatin dose in patients taking Ramidilan HCT;
  • quinine (an antimalarial medicine);
  • iodine-containing medicines (contrast agents used in imaging procedures, e.g. X-rays);
  • penicillin (used to treat infections);
  • oral anticoagulants, such as warfarin.

If any of the above situations apply to you (or if you have any doubts), consult your doctor before taking Ramidilan HCT.

Before taking this medicine, consult your doctor or pharmacist if:

  • the patient is due to undergo parathyroid function testing, as ramipril and hydrochlorothiazide may affect the test results;
  • the patient is an athlete who will undergo anti-doping testing, 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 meals.
  • Do not eat grapefruit or drink grapefruit juice while taking Ramidilan HCT, as it may increase blood levels of the active substance amlodipine and consequently lead to unpredictable intensification of the blood pressure-lowering effect of Ramidilan HCT.
  • Drinking alcohol while taking Ramidilan HCT may cause dizziness or drowsiness. If the patient wishes to know how much alcohol may be consumed during treatment, this should be discussed with the doctor, as the effects of blood pressure-lowering medicines and alcohol may be additive.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

If the patient is pregnant (or may be pregnant), she should inform her doctor. Ramidilan HCT should not be taken during the first 12 weeks of pregnancy. It must not be used after the 13th week of pregnancy, as the medicine taken at this time may harm the unborn child. If the patient becomes pregnant while being treated with Ramidilan HCT, she should inform her doctor immediately. The doctor will recommend switching to another medicine before a planned pregnancy.

Breastfeeding

Ramidilan HCT should not be used during breastfeeding. Before taking any medicine, consult your doctor or pharmacist.

Fertility

There are insufficient data on the potential effect on fertility.

Driving and operating machinery

Ramidilan HCT may affect the ability to drive or operate machinery. If the patient experiences nausea, dizziness, fatigue or headache while taking the medicine, he or she should not drive or operate machinery and should contact the doctor immediately.

Ramidilan HCT contains sodium.

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

3. How to take Ramidilan HCT

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
you should contact your doctor or pharmacist.

The recommended dose is 1 capsule of Ramidilan HCT, at the strength prescribed by your doctor, taken once daily.

Depending on the treatment response, your doctor may adjust the dose.

The maximum dose is 1 capsule of 10 mg+10 mg+25 mg taken once daily.

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

Hard capsules should be swallowed whole with liquid.

Do not crush or chew the hard capsules.

Do not take this medicine with grapefruit juice.

Liver and kidney disease
In patients with liver or kidney disease, your doctor may adjust the dose of this medicine.

Elderly patients
Your doctor may reduce the initial dose and increase it gradually.

Ramidilan HCT is not recommended for use in very elderly or frail patients.

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

Taking more Ramidilan HCT than recommended
Taking too many capsules may cause a significant drop in blood pressure, even to dangerously low levels.
Dizziness, lightheadedness, fainting, or weakness may occur. A severe drop in blood pressure may lead to shock.
The patient's skin may become cold and clammy, and loss of consciousness is possible. In case of overdose, seek immediate medical help.
The patient should not drive themselves but ask someone else to drive or call an ambulance.
Take the medicine packaging with you so the doctor can see which medicine was taken.

Breathlessness caused by fluid accumulation in the lungs (pulmonary oedema) may occur even up to 24–48 hours after taking the medicine.

If you miss a dose of Ramidilan HCT
If you miss a dose, skip that dose and take the next dose at your usual time.
Do not take a double dose to make up for a missed dose.

Stopping Ramidilan HCT
Your doctor will advise you how long to take this medicine. Stopping treatment without prior consultation with your doctor may cause your condition to return.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
If any of the following serious adverse effects occur in the patient, treatment with Ramidilan HCT should be discontinued and the patient should immediately contact a doctor – prompt treatment may be necessary.

  • Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as rash. These may be symptoms of a severe allergic reaction to Ramidilan HCT.
  • Severe skin reactions, including rash, ulceration of the mucous membranes of the mouth, rash with blister formation around the lips, eyes, or oral cavity, worsening of pre-existing skin disease, redness, intense itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme).

If any of the following symptoms occur, the patient should immediately inform a doctor:

  • Increased heart rate, irregular or forceful heartbeat (palpitations), chest pain, chest tightness, or more severe disturbances, including myocardial infarction and stroke;
  • Shortness of breath or cough: these may indicate lung diseases, including inflammation;
  • Easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purpura (purple spots on the skin), or increased susceptibility to infections, sore throat and fever, fatigue, fainting, dizziness or pale skin: these may be symptoms of blood or bone marrow disorders;
  • Severe abdominal pain radiating to the back: this may be a symptom of pancreatitis;
  • Fever, chills, fatigue, loss of appetite, abdominal pain, nausea, jaundice (yellowing of the skin or eyes): these may be symptoms of liver disorders, such as hepatitis or liver damage.

Other adverse effects
Inform your doctor if any of the following symptoms worsen or persist for more than a few days.

Very common: may affect at least 1 in 10 people

  • Edema (swelling)
  • Decreased potassium concentration in blood (hypokalemia)
  • Increased lipid concentration in blood (hyperlipidemia)

Common (may affect less than 1 in 10 people)

  • Headache, dizziness, drowsiness (especially at the beginning of treatment), feeling of exhaustion (fatigue)
  • Awareness of heartbeat (palpitations)
  • Ankle swelling
  • Low blood pressure (hypotension), especially upon rapid standing or sitting (orthostatic hypotension), fainting, sudden skin redness (especially of the face and neck)
  • Dry, irritating cough, sinusitis, bronchitis, shortness of breath
  • Abdominal pain, diarrhea, inflammation of the stomach and intestinal mucosa, digestive disturbances and discomfort in the abdominal cavity (including indigestion), nausea, vomiting, bowel rhythm disturbances (including diarrhea and constipation), loss of appetite (anorexia), cramps
  • Skin rash with or without raised bumps, urticaria (hives)
  • Chest pain
  • Muscle cramps or pain (myalgia)
  • Decreased magnesium and sodium concentration in blood, detected in blood tests
  • Feeling of weakness and lack of strength (asthenia)
  • Decreased platelet count (thrombocytopenia), detected in blood tests
  • Increased concentration of uric acid or potassium in blood, detected in blood tests
  • Impotence
  • Vision disturbances (including double and blurred vision)

Uncommon (may affect less than 1 in 100 people)

  • Swelling of the skin, mucous membranes and surrounding tissues (angioedema/Quincke's edema; in exceptional cases, airway obstruction due to angioedema may lead to death)
  • Swelling of hands and feet (peripheral edema, which may indicate retention of larger than usual amounts of fluid)
  • Intestinal swelling (angioedema of the small intestine)
  • Mood changes, depression, anxiety, nervousness, restlessness, sleep disturbances (insomnia)
  • Ringing in the ears (tinnitus)
  • Sneezing, runny nose (rhinitis), nasal congestion
  • Breathing difficulties (bronchospasm), including worsening of asthma
  • Dryness of the oral mucosa, epigastric pain, including inflammation of the gastric mucosa
  • Pancreatitis (rare fatal cases have been reported in association with ACE inhibitors)
  • Kidney function disturbances, including renal failure, disturbances in urination, increased urine output during the day, increased nocturnal urination
  • Worsening of existing proteinuria (appearance of larger than usual amounts of protein in urine)
  • General malaise
  • Increase or decrease in body weight
  • Sensation of spinning (peripheral dizziness), tremor
  • Hair loss (alopecia)
  • Itching, presence of small dark red spots or patches caused by bleeding into the skin (purpura), skin discoloration, rash
  • Unusual skin sensations such as tingling, numbness, pricking, burning or tickling (paresthesia), reduced skin sensitivity (hypoesthesia)
  • Loss or disturbances of taste
  • Excessive sweating
  • Myocardial infarction, heart vessel disease (myocardial ischemia), chest tightness and chest pain (angina pectoris), rapid heartbeat (tachycardia) or heart rhythm disturbances
  • Slowed heart rate (bradycardia), specific rhythm disturbances (atrial fibrillation, ventricular extrasystoles)
  • Joint pain, back pain, generalized pain
  • Increased body temperature/fever
  • Decreased libido in men and women, breast enlargement in men (gynecomastia)
  • Increased number of certain white blood cells (eosinophilia) detected in blood tests
  • Liver function abnormalities detected in blood tests (increased liver enzyme activity and/or increased bilirubin concentration), pancreatic abnormalities (increased pancreatic enzyme activity), or kidney abnormalities (increased creatinine concentration)
  • Cough
  • Necrotizing vasculitis (vasculitis, cutaneous vasculitis)

Rare (may affect less than 1 in 1000 people)

  • Feeling or state of confusion, balance disturbances
  • Redness and swelling of the tongue (glossitis)
  • Inflammation and peeling of the skin (exfoliative dermatitis)
  • Nail disorders (e.g. loosening or separation of the nail from the nail bed)
  • Redness, itching, swelling or watering of the eyes (conjunctivitis)
  • Hearing disturbances
  • Jaundice (cholestatic jaundice), liver cell damage
  • Constriction of blood vessels
  • Blood flow disturbances
  • Inflammation of blood vessels (vasculitis)
  • Decreased number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leukopenia), or hemoglobin concentration, detected in blood tests
  • Increased blood glucose concentration detected in blood tests, worsening of diabetes in diabetic patients
  • Skin photosensitivity (photodermatitis)
  • Hypercalcemia
  • Hypersensitivity reactions

Very rare (may affect less than 1 in 10,000 people)

  • Widespread blistering rash with skin peeling, especially in the area of the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)
  • Liver inflammation (in most cases associated with cholestasis)
  • Skin rash that may form blisters and resemble target lesions (dark central spots surrounded by a lighter ring with a dark border) – erythema multiforme
  • Lupus-like reaction, lupus erythematosus flare-up, necrotizing vasculitis, and toxic epidermal necrolysis
  • Gingival hyperplasia
  • Increased muscle tone
  • Peripheral nerve disease (peripheral neuropathy)
  • Bone marrow failure
  • Excessive number of damaged red blood cells visible in blood tests (hemolytic anemia)
  • Allergic reactions
  • Hypochloremic alkalosis
  • Respiratory failure (including pneumonia and pulmonary edema)
  • Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion)

Frequency unknown (cannot be estimated from available data)
Inform your doctor if any of the following symptoms significantly worsen or persist for more than a few days.

  • Low number of red blood cells, white blood cells and platelets in blood tests (pancytopenia)
  • Anaphylactic or anaphylactoid reactions
  • Skin nodules (bullous eruption)
  • Increased antibody titer
  • Attention disturbances
  • Inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
  • Aplastic anemia
  • Discoloration of fingers and toes upon cold exposure, with tingling or pain upon warming (Raynaud's phenomenon)
  • Cerebral ischemia, including ischemic stroke and transient ischemic attack
  • Psychomotor disturbances
  • Burning sensation
  • Smell disturbances
  • Acute liver failure, cholestatic and cytolytic hepatitis (in exceptional cases fatal)
  • Skin inflammation (dermatitis resembling psoriasis), acute skin rash (pemphigoid or lichenoid eruption), increased skin peeling (psoriasis flare-up), mucosal rash
  • Concentrated urine (dark color), nausea or vomiting, muscle cramps, confusion and seizures, which may be caused by inappropriate antidiuretic hormone (vasopressin) secretion – if such symptoms occur, seek medical advice immediately
  • Tremor, rigid posture, mask-like face, slowed movements and shuffling gait
  • Sudden decrease in distance vision (acute myopia), decreased vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive accumulation between choroid and sclera or acute closed-angle glaucoma)
  • Skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw
Tel.: +48 22 4921301
Fax: +48 22 4921309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to collect more information on the safety of the medicine.

5. How to store Ramidilan HCT

Store below 30°C.
Keep in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help
protect the environment.

6. Contents of the pack and other information

What the medicine Ramidilan HCT contains

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

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

  • Other components of the medicine are:
    Capsule contents: microcrystalline cellulose; calcium hydrogen phosphate; maize starch, pregelatinized; sodium carboxymethyl starch (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
    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
    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
    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
    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
Opaque capsule with a pink cap and a light grey body.

Ramidilan HCT, 5 mg + 5 mg + 25 mg, hard capsules
Opaque capsule with a pink cap and an ivory-coloured body.

Ramidilan HCT, 10 mg + 5 mg + 25 mg, hard capsules
Opaque capsule with a dark pink cap and a yellow body.

Ramidilan HCT, 10 mg + 10 mg + 25 mg, hard capsules
Opaque capsule with a brown cap and a caramel-coloured body.

Pack contains 10, 28, 30, 60 or 100 hard capsules in blisters, packed 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
Poland

This medicinal product has been authorised in EEA Member States 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 further information about this medicine, please contact the local representative of the Marketing Authorization Holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
[email protected]