Sumilar hct: detailed information

Package leaflet: Information for the patient

Sumilar HCT, 5 mg + 5 mg + 12.5 mg, hard capsules
Sumilar HCT, 5 mg + 5 mg + 25 mg, hard capsules
Sumilar HCT, 10 mg + 5 mg + 25 mg, hard capsules
Sumilar HCT, 10 mg + 10 mg + 25 mg, hard capsules
Ramipril + Amlodipine + Hydrochlorothiazide
Please read this leaflet carefully before taking this medicine, as 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 a specific individual. Do not pass it on to others.
It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

What Sumilar HCT is and what it is used for
What you need to know before taking Sumilar HCT
How to take Sumilar HCT
Possible side effects
How to store Sumilar HCT
Contents of the pack and other information

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

Sumilar 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 substances that may increase blood pressure,
reducing tension and widening 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 widening blood vessels, thereby improving blood flow.
Hydrochlorothiazide belongs to a group of so-called thiazide diuretics and works by:
increasing the volume of urine produced, which leads to a reduction in blood pressure.
Sumilar HCT is used to treat high blood pressure (hypertension) in adult patients in whom adequate blood pressure control has been achieved using the same doses of the individual active substances administered as separate tablets.

2. Important information before using Sumilar HCT

When not to use Sumilar HCT
if the patient is allergic to ramipril, amlodipine or hydrochlorothiazide (the active substances), to
other calcium antagonists, ACE inhibitors, other thiazide diuretics or sulphonamide derivatives, or to any of the components of this medicine (listed in section 6),
if the patient has significant aortic valve stenosis (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 experienced a severe allergic reaction called "angioedema" – symptoms include: itching, 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 using sacubitril with valsartan, a medicine used to treat certain types of chronic (long-term) heart failure in adults, because the risk of angioedema (rapid swelling of tissues beneath the skin, such as in the throat) increases,
if the patient is undergoing dialysis or other types of blood filtration – depending on the equipment used, administration of Sumilar HCT may not be suitable for the patient,
if the patient has severe kidney function impairment,
if the patient has liver function disorders,
if there are abnormal levels of electrolytes (calcium, potassium, sodium) and uric acid (with symptoms of gout or kidney stones) in the blood,
if the patient has kidney disorders in which blood flow to the kidney is reduced (renal artery stenosis),
during the last 6 months of pregnancy and while breastfeeding (see section "Pregnancy, breastfeeding and effect on fertility" below),
if 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 taking a blood pressure-lowering medicine containing aliskiren.
Do not take Sumilar HCT if any of the above conditions apply to the patient.
If in doubt, consult a doctor before taking Sumilar HCT.

Warnings and precautions
Before using Sumilar HCT, discuss this with your doctor or pharmacist.
Tell your doctor if any of the following apply to the patient:
the patient is elderly and a dose increase 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 due to undergo treatment to reduce sensitivity to bee or wasp venom (desensitisation);
the patient is to receive anaesthesia, e.g. before surgery or a dental procedure – it may be necessary to discontinue Sumilar HCT one day before the procedure; consult your 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 reduce sodium levels in the blood – the doctor may recommend regular blood tests, especially to measure blood sodium levels (particularly in elderly patients);
the patient is taking any of the following medicines, as the risk of angioedema may increase:

mTOR inhibitors, medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, everolimus, sirolimus),
vildagliptin, a medicine used to treat diabetes,
neprilysin inhibitors (NEP), such as racecadotril, a medicine used to treat diarrhoea,
sacubitril with valsartan (see section "When not to use Sumilar HCT");
the patient has been diagnosed with collagenosis, such as scleroderma or systemic lupus erythematosus;
the patient experiences vision deterioration or eye pain. These may be symptoms of fluid accumulation in the uvea (excessive fluid accumulation between the choroid and sclera) or increased intraocular pressure – they may occur from several hours to a week after taking Sumilar HCT, and if untreated, may lead to permanent vision loss. The risk of such disorders may be higher in patients who belong to a risk group for a disease called glaucoma or who previously had an allergy to penicillin- or sulphonamide-containing medicines;

the patient experiences photosensitivity reactions – in such cases, discontinue Sumilar 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 called a sartan, e.g. valsartan, telmisartan, irbesartan), especially if the patient has kidney disease due to diabetes,
aliskiren;
The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also information under the heading "When not to use Sumilar HCT".
if the patient has previously had skin cancer or if unexpected skin changes appear during treatment – use of hydrochlorothiazide, especially long-term and at high doses, may increase the risk of certain types of skin and lip cancer (non-melanoma skin cancer); during treatment with Sumilar HCT, protect the skin from sunlight and UV radiation.
if the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Sumilar HCT, seek immediate medical help.

The doctor may recommend regular monitoring of blood uric acid levels. See also information under the heading "When not to use Sumilar HCT".
Inform the doctor if the patient is pregnant, suspects pregnancy or plans to become pregnant. Use of Sumilar 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 effect on fertility").

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

Sumilar HCT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines (including herbal medicines). Sumilar HCT may affect the action of other medicines, and other medicines may affect the action of Sumilar HCT.
The doctor may recommend a dose adjustment and/or additional precautions:
if the patient is taking a medicine from the angiotensin II receptor antagonist group or aliskiren (see also sections "When not to use Sumilar HCT" and "Warnings and precautions").

The following medicines may weaken the effect of Sumilar 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, bronchial asthma or allergies, such as ephedrine, noradrenaline or adrenaline – the doctor will 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 if taken simultaneously with Sumilar HCT:
a medicine containing sacubitril and valsartan – used to treat chronic heart failure in adults (see section 2, subsection "When not to use Sumilar 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 that may reduce potassium levels in the blood, such as medicines used to treat constipation, glucocorticosteroids, tetracosactide (used to test adrenal gland function), amphotericin B (used to treat fungal infections);
diuretics (diuretics), such as furosemide;
desmopressin (used to treat congenital blood clotting disorders);
steroidal anti-inflammatory medicines, such as prednisolone;
potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that increase potassium levels in the blood (such as spironolactone, triamterene, amiloride, trimethoprim or trimethoprim in combination with sulfamethoxazole [co-trimoxazole], used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
medicines used for heart diseases, including heart rhythm disorders (quinidine, amiodarone);
calcium preparations;
allopurinol (used to reduce uric acid levels in the blood);
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 (so-called protease inhibitors used in HIV patients);
verapamil, diltiazem (used to treat certain heart diseases and high blood pressure);
dantrolene (administered by infusion in severe temperature disorders);
temsirolimus (used to treat cancer);
sirolimus, everolimus (used to prevent organ transplant rejection);
vildagliptin (used to treat type 2 diabetes);
racecadotril (an antidiarrhoeal medicine);
tacrolimus (a medicine that controls immune system function, allowing acceptance of a transplanted organ);
other medicines that lower blood pressure, such as 5-phosphodiesterase inhibitors (used to treat erectile dysfunction), nitrates, alpha-adrenergic blockers (used in urology to reduce smooth muscle tension in the prostate and urethra), methyldopa, certain medicines used for Parkinson's disease, tricyclic antidepressants and neuroleptics, amifostine (used in chemotherapy) and baclofen (a muscle relaxant).

Medicines whose action may be affected by Sumilar HCT:
medicines used to treat diabetes (oral hypoglycaemic agents and insulin) – Sumilar HCT may reduce blood glucose levels, so blood glucose levels should be closely monitored during treatment;
lithium (used for psychiatric disorders) – Sumilar HCT may increase lithium levels in the blood, so the doctor will recommend close monitoring of blood lithium levels;
simvastatin (a medicine used to reduce cholesterol levels) – since amlodipine increases exposure to simvastatin, the doctor will recommend reducing the simvastatin dose in patients taking Sumilar HCT;
medicines containing iodine (contrast agents used during imaging tests, e.g. X-rays);
oral anticoagulants, such as warfarin.

If any of the above conditions apply to the patient (or the patient has doubts), consult a doctor before taking Sumilar HCT.
Consult a doctor or pharmacist before using this medicine if:
the patient is to undergo parathyroid function testing, as ramipril and hydrochlorothiazide may affect the test result,
the patient is an athlete undergoing anti-doping testing, as ramipril and hydrochlorothiazide may cause a positive test result.

Sumilar HCT with food, drink and alcohol
Sumilar HCT can be taken before or after meals.
Do not eat grapefruit or drink grapefruit juice while taking Sumilar HCT, as they may increase the blood concentration of the active substance – amlodipine – and consequently lead to unpredictable intensification of the blood pressure-lowering effect of Sumilar HCT.
Drinking alcohol while taking Sumilar HCT may cause dizziness or drowsiness. If the patient is unsure how much alcohol is acceptable while taking Sumilar HCT, they should consult their doctor, as blood pressure-lowering medicines and alcohol may mutually enhance their sedative effects.

Pregnancy, breastfeeding and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.

Pregnancy
Inform the doctor if the patient is pregnant, suspects pregnancy or plans to become pregnant. Sumilar HCT should not be taken during the first 12 weeks of pregnancy and must not be used from the 13th week of pregnancy, as use during this period may harm the unborn child. If the patient becomes pregnant while being treated with Sumilar HCT, she should inform the doctor immediately. In case of planned pregnancy, the doctor will recommend using another appropriate medicine.

Breastfeeding
Do not use Sumilar HCT during breastfeeding. Before using any medicine, consult a doctor or pharmacist.

Fertility
There is insufficient data on the potential effect on fertility.

Driving and operating machinery
Sumilar HCT may affect the ability to drive or operate machinery. If nausea, dizziness, fatigue or headache occur while taking the medicine, do not drive or operate machinery; contact the doctor immediately.

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

3. How to use Sumilar HCT

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are unsure,
you should contact your doctor or pharmacist.
The recommended dose is 1 capsule of Sumilar 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 strength, taken once daily.
The medicine should be taken orally, at the same time each day, with or without food.
Hard capsules should be swallowed whole with liquid.
Do not crush or chew the capsules.
Do not take this medicine with grapefruit juice.

Renal disease
In patients with kidney disease, your doctor may adjust the dose of this medicine.

Elderly patients
Your doctor may recommend starting with a lower dose and gradually increasing it.
Use of Sumilar HCT is not recommended in very elderly or debilitated patients.

Use in children and adolescents
Sumilar 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 Sumilar HCT than recommended
Taking too many capsules may cause low blood pressure, including a severe drop in blood pressure. Symptoms may include dizziness, lightheadedness, fainting, or weakness. A significant drop in blood pressure may lead to shock. The skin may become cold and clammy, and the patient may lose consciousness.
Breathlessness caused by fluid accumulation in the lungs (pulmonary oedema) may occur even 24–48 hours after taking the medicine.
In case of overdose, seek immediate medical help or go to the nearest hospital emergency department. Do not drive yourself; ask someone else to drive or call an ambulance. Take the medicine packaging with you so the doctor knows which medicine has been taken.

If you forget to take Sumilar HCT
If you miss a dose, do not take the missed capsule. Take the next dose at your usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Sumilar HCT
Your doctor will advise you on 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 reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following serious adverse reactions, treatment with Sumilar HCT must be discontinued and medical advice must be sought immediately – prompt treatment may be necessary.
Swelling of the face, lips or throat causing difficulty in swallowing or breathing, as well as itching and rash.
These may be symptoms of a severe allergic reaction to Sumilar HCT.
Severe skin reactions, including rash, urticaria, oral mucosal ulceration, worsening of pre-existing skin disease, redness, intense itching, blister formation, detachment of the epidermis from the underlying dermis (Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis or erythema multiforme).
Acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).
Immediately inform your doctor if any of the following symptoms occur:
rapid heartbeat, irregular or forceful heartbeats (palpitations), chest pain, chest tightness or more severe disturbances, including myocardial infarction and stroke;
shortness of breath or cough, which may be symptoms of lung disorders, including pneumonia;
easy bruising, prolonged bleeding time, any signs of bleeding (e.g. bleeding gums), purplish spots on the skin, or increased susceptibility to infections, sore throat and fever, feeling of fatigue, fainting, dizziness or pale skin, which may indicate blood or bone marrow disorders;
severe upper abdominal pain, possibly radiating to the back – this may be a symptom of pancreatitis;
fever, chills, fatigue, loss of appetite, stomach pain, nausea, yellowing of the skin or eyes (jaundice) – these may be symptoms of liver disorders such as hepatitis or liver damage;
reduced frequency of urination (low urine output) or increased frequency of urination, possibly accompanied by high body temperature (fever), nausea, fatigue, flank pain, swelling of legs, ankles, feet, face and hands, or presence of blood in urine. These adverse reactions result from severe kidney function disturbances (interstitial nephritis, acute renal failure);
inflammation of blood vessels, often associated with skin rash, purplish-red spots, itching, fever, chills and fatigue.

All adverse reactions listed by frequency of occurrence:
Very common: may affect at least 1 in 10 people
oedema
decreased potassium levels in blood (hypokalaemia)
increased lipid levels in blood (hyperlipidaemia)

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 when standing up or sitting down quickly (orthostatic hypotension), fainting, sudden flushing of the skin (especially face and neck)
dry, irritating cough, sinusitis, bronchitis, shortness of breath
abdominal pain, diarrhoea, inflammation of the stomach and intestinal mucosa, digestive disturbances and discomfort in the abdominal cavity (including dyspepsia), nausea, vomiting, bowel rhythm disturbances (including diarrhoea and constipation), loss of appetite (anorexia), cramps
skin rash with or without raised lumps, urticaria
chest pain
muscle cramps or pain
decreased magnesium and sodium levels in blood, detected in blood tests
feeling of weakness and lack of strength (asthenia)
increased levels 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 skin, mucous membranes and surrounding tissues (angioedema; in exceptional cases, airway obstruction due to angioedema may lead to death)
swelling of hands and feet (peripheral oedema, which may indicate retention of larger than normal amounts of fluid)
intestinal swelling (angioedema of the small intestine)
mood changes, depression, anxiety, nervousness, psychomotor agitation, 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, upper abdominal pain, including inflammation of the stomach mucosa
pancreatitis (isolated fatal cases have been reported with ACE inhibitors)
kidney function disturbances, including interstitial nephritis and renal failure, disturbances in urination, increased daytime urine output, 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 vertigo), tremor
hair loss (alopecia)
itching, presence of purplish dots or spots caused by bleeding into the skin (purpura), skin discoloration, rash
unusual skin sensations such as numbness, tingling, pricking, burning or stinging (paraesthesia), reduced skin sensitivity (hypoesthesia)
loss or disturbances of taste
excessive sweating
myocardial infarction, heart vessel disease (myocardial ischaemia), chest tightness and chest pain (angina pectoris), increased heart rate (tachycardia) or heart rhythm disturbances
slowed heart rate (bradycardia), specific rhythm disturbances (atrial fibrillation, ventricular tachycardia)
joint pain, back pain, generalized pain
increased body temperature/fever
decreased libido in men and women, breast enlargement in men (gynaecomastia)
increased number of certain white blood cells (eosinophilia), detected in blood tests
parameters indicating disturbances in liver function (increased liver enzyme activity and/or increased conjugated bilirubin levels), pancreas (increased pancreatic enzyme activity) or kidneys (increased creatinine levels), detected in blood tests
increased glucose (sugar) in urine, detected in urine tests
cough
inflammation of blood vessels, often with skin rash, purplish-red spots, itching, fever, chills and fatigue (vasculitis)

Rare (may affect less than 1 in 1,000 people)
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
intense skin itching, yellowing of the skin (cholestatic jaundice), dark urine, pale stools due to impaired or obstructed bile flow in the liver, liver cell damage
narrowing of blood vessels
blood flow disturbances (reduced perfusion)
decreased number of red blood cells, white blood cells (including neutropenia or agranulocytosis, leukopenia) or haemoglobin levels, detected in blood tests
decreased platelet count (thrombocytopenia), detected in blood tests
increased blood glucose levels, detected in blood tests, worsening of diabetes in diabetic patients
skin hypersensitivity to artificial or sunlight (photosensitivity)
increased calcium levels in blood (hypercalcaemia)
hypersensitivity reactions

Very rare (may affect less than 1 in 10,000 people)
widespread rash with blister formation and skin peeling, especially around the mouth, nose, eyes and genital organs (Stevens-Johnson syndrome)
liver inflammation (in most cases with cholestasis)
skin rash, possibly with blister formation, appearing as small target-like lesions (dark central spots surrounded by a lighter ring with a dark edge) – erythema multiforme
lupus-like reaction, lupus flare-up, necrotizing vasculitis and toxic epidermal necrolysis
gingival hyperplasia
increased muscle tone
peripheral nerve disease (peripheral neuropathy)
bone marrow failure
large number of damaged red blood cells (haemolytic anaemia), detected in blood tests
allergic reactions
hypochloraemic alkalosis
respiratory failure (including pneumonia and pulmonary oedema)
acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

Frequency not known (cannot be estimated from available data)
low number of red blood cells, white blood cells and platelets (pancytopenia), detected in blood tests
anaphylactic or anaphylactoid reactions
skin nodules (bullous eruption)
increased titre of antinuclear antibodies
attention disturbances
inflammation of the oral mucosa with small ulcers (aphthous stomatitis)
aplastic anaemia
change in colour of fingers and toes after cold exposure, with tingling or pain upon warming (Raynaud's phenomenon)
cerebral ischaemia, including ischaemic stroke and transient ischaemic attack
psychomotor disturbances
burning sensation
smell disturbances
acute liver failure, cholestatic and cytolytic hepatitis (in exceptional cases fatal)
skin inflammation (psoriasiform dermatitis), acute skin rash (pemphigoid or lichenoid eruption), worsening of skin peeling (worsening of psoriasis), mucosal rash
concentrated urine (dark-coloured), nausea or vomiting, muscle cramps, confusion and seizures, which may be caused by inappropriate antidiuretic hormone (vasopressin) secretion – if such symptoms occur, medical advice should be sought as soon as possible
tremor, rigidity, facial masking, bradykinesia and shuffling gait
sudden myopia
visual impairment or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma)
skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sumilar HCT

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

6. Contents of the packaging and other information

What Sumilar HCT contains
The active substances are ramipril, amlodipine, and hydrochlorothiazide.
Sumilar HCT, 5 mg + 5 mg + 12.5 mg
Each hard capsule contains 5 mg ramipril, 5 mg amlodipine (as amlodipine besilate), and 12.5 mg hydrochlorothiazide.
Sumilar HCT, 5 mg + 5 mg + 25 mg
Each hard capsule contains 5 mg ramipril, 5 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide.
Sumilar HCT, 10 mg + 5 mg + 25 mg
Each hard capsule contains 10 mg ramipril, 5 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide.
Sumilar HCT, 10 mg + 10 mg + 25 mg
Each hard capsule contains 10 mg ramipril, 10 mg amlodipine (as amlodipine besilate) and 25 mg hydrochlorothiazide.

The other ingredients are:
Capsule contents: microcrystalline cellulose, calcium hydrogen phosphate anhydrous, pregelatinized starch (maize), sodium carboxymethyl starch (type A), sodium stearyl fumarate
Capsule shell
(5 mg + 5 mg + 12.5 mg)
red iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin
(5 mg + 5 mg + 25 mg) and (10 mg + 5 mg + 25 mg)
red iron oxide (E 172), yellow iron oxide (E 172), titanium dioxide (E 171), gelatin
(10 mg + 10 mg + 25 mg)
red iron oxide (E 172), yellow iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), gelatin

What Sumilar HCT looks like and contents of the pack
Sumilar HCT, 5 mg + 5 mg + 12.5 mg
A capsule with a pink opaque cap and a light grey opaque body.
Sumilar HCT, 5 mg + 5 mg + 25 mg
A capsule with a pink opaque cap and an opaque ivory-coloured body.
Sumilar HCT, 10 mg + 5 mg + 25 mg
A capsule with a dark pink opaque cap and an opaque yellow body.
Sumilar HCT, 10 mg + 10 mg + 25 mg
A capsule with a brown opaque cap and an opaque caramel-coloured body.

The hard capsules are packed in blisters made of PA/Aluminium/PVC/Aluminium foil and placed in a cardboard box.
Pack sizes:
10, 20, 30, 50, 60, 90, 100 hard capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
Lek Pharmaceuticals d.d.
Verovškova 57,
1526 Ljubljana,
Slovenia

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa
tel. 22 209 70 00