Sumilar Duo

Warnings and precautions

Before taking Sumilar Duo, the patient should discuss it with their doctor or pharmacist if:
they are elderly;
they have heart, liver, or kidney problems;
they are at risk of circulation disorders in the heart or brain if their blood pressure drops suddenly;
they have very high blood pressure;
they have lost a lot of electrolytes or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, taking diuretics for a long time, or undergoing dialysis);
they are going to undergo desensitization treatment (e.g., for bee or wasp stings).
The doctor may need to stop Sumilar Duo the day before the procedure, so the patient should consult their doctor about this.
they are going to receive anesthesia (e.g., before surgery or a dental procedure).
It may be necessary to stop Sumilar Duo the day before the procedure, so the patient should consult their doctor about this.
they are taking any of the following medications, as the risk of angioedema (rapid swelling of tissues under the skin in areas such as the throat) or a severe allergic reaction may increase:

• racecadotril, a medication used to treat diarrhea;
• medications used to prevent the rejection of a transplanted organ and to treat cancer (e.g., temsirolimus, sirolimus, everolimus);
• saxagliptin, a medication used to treat diabetes.

If any of these situations apply to the patient or if they have any doubts, they should consult their doctor before taking Sumilar Duo.
The doctor may need to regularly check the patient's blood count, especially to assess their sodium levels (especially in elderly patients).
If the patient has collagenosis, such as scleroderma or systemic lupus erythematosus;
If the patient is black. There is then a greater risk of:
rapid, usually painful, severe swelling of the deep layers of the skin, mainly on the face;
reduced effectiveness of ramipril.
If the patient has a cough. They should inform their doctor if the cough worsens.
If the patient is taking any of the following blood pressure medications:

• angiotensin II receptor antagonist (medications also known as sartans, e.g., valsartan, telmisartan, irbesartan), especially if the patient has diabetic kidney disease;
• aliskiren. The doctor may regularly check the patient's kidney function, blood pressure, and electrolyte levels (e.g., potassium). See also the information in the "When not to take Sumilar Duo" and "Warnings and precautions" sections.

Erythromycin, clarithromycin (antibiotics);
Potassium supplements (including salt substitutes containing potassium), potassium-sparing diuretics (a certain group of diuretics, e.g., spironolactone, triamterene, amiloride), and other medications that may increase potassium levels in the blood, e.g., trimethoprim and co-trimoxazole (also known as trimethoprim with sulfamethoxazole) - medications used to treat bacterial infections; cyclosporine and tacrolimus (medications that suppress the immune system, used to prevent the rejection of a transplanted organ) and heparin (a medication used to thin the blood and prevent the formation of blood clots).
When taken with Sumilar Duo, close monitoring of potassium levels in the blood is necessary.
Corticosteroids, such as prednisolone;
Allopurinol (a medication used to reduce uric acid levels in the blood);
Procainamide (a medication used to treat heart rhythm disorders);
Medications that can change blood cell counts;
Ketoconazole and itraconazole (antifungal medications);
Ritonavir, indinavir, nelfinavir (medications used in HIV-infected patients);
Dantrolene (a medication used in severe body temperature disorders);
Saxagliptin (a medication used to treat diabetes);
Racecadotril (an anti-diarrheal medication);
Verapamil, diltiazem (medications used to treat certain heart conditions and high blood pressure).
If the patient is taking any of these medications, they should inform their doctor, as Sumilar Duo may interfere with their action:
Oral hypoglycemic medications (and insulin).
Sumilar Duo may lower blood sugar levels. When taking Sumilar Duo, the patient should closely monitor their blood sugar levels.
Lithium (used in psychiatric disorders). Sumilar Duo may increase lithium levels in the blood. The doctor will recommend close monitoring of lithium levels in the blood.
Simvastatin (a medication that lowers cholesterol levels). Amlodipine increases simvastatin exposure. In patients taking Sumilar Duo, the doctor may need to reduce the simvastatin dose.
If any of these situations apply to the patient or if they are unsure, they should consult their doctor before taking Sumilar Duo.

Sumilar Duo with food, drink, and alcohol

If the patient is taking Sumilar Duo, they should not eat grapefruits or drink grapefruit juice. They may cause an increase in the level of the active substance (amlodipine) in the blood and, as a result, unpredictable intensification of the blood pressure-lowering effect.
Drinking alcohol while taking Sumilar Duo may cause dizziness or fainting. People interested in the allowed amount of alcohol during treatment should discuss it with their doctor, as the effects of blood pressure medications and alcohol may add up.

Pregnancy and breastfeeding

The patient should inform their doctor if they are pregnant (or may become pregnant).
Sumilar Duo should not be taken during the first 12 weeks of pregnancy. Do not take it after the 13th week of pregnancy, as the medication taken at this time may harm the baby. If the patient becomes pregnant while taking Sumilar Duo, they should immediately inform their doctor. The doctor will propose a change to another medication before planned pregnancy.

• Do not take Sumilar Duo after the 13th week of pregnancy, as the medication taken at this time may harm the baby.

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

Driving and using machines

Sumilar Duo may affect the patient's ability to drive or operate machines.
While taking this medication, the patient may experience nausea, dizziness, fatigue, or headaches, especially at the beginning of treatment or when increasing the dose. In such cases, they should not drive vehicles, operate tools, or machines.

Sumilar Duo contains Allura Red AC (E 129)

Allura Red AC (E 129) may cause allergic reactions.

Sumilar Duo contains sodium

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

3. How to take Sumilar Duo

This medication should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

Taking the medication

The medication should be taken orally, once a day, at the same time, regardless of meals.
The capsules should be swallowed whole, with a liquid.
The capsules should not be crushed or chewed.
The medication should not be taken with grapefruit juice.

How much to take

Usually, one capsule is taken.
Depending on the treatment outcome, the doctor may increase or modify the dose.
The maximum dose is one 10 mg + 10 mg capsule per day.

Elderly patients

The doctor may reduce the initial dose and gradually increase it.
Sumilar Duo should not be taken by elderly patients who are frail.

Use in children and adolescents

Sumilar Duo should not be taken by children and adolescents under 18 years of age due to the lack of available data on the safety and efficacy of this medication in these patients.
If the patient feels that the effect of the medication is too strong or too weak, they should consult their doctor.

Overdose of Sumilar Duo

Taking too many capsules may cause a significant drop in blood pressure, even to dangerously low levels. The patient may experience dizziness, fainting, or weakness. A significant drop in blood pressure may cause shock. The patient's skin may be cold and sweaty, and they may lose consciousness.
Even 24-48 hours after taking the medication, the patient may experience shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema).
In case of overdose, the patient should consult their doctor or go to the emergency department of the nearest hospital immediately. The patient should not drive themselves but ask someone else to drive them or call an ambulance. They should take the medication packaging with them so the doctor can see what medication was taken.

Missing a dose of Sumilar Duo

In case of a missed dose, the patient should take the next dose at the usual time. They should not take a double dose to make up for the missed dose.

Stopping Sumilar Duo treatment

The patient should not suddenly stop taking Sumilar Duo or change the prescribed dose without consulting their doctor first, as this may cause a temporary worsening of the condition.
In case of any further doubts about taking this medication, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medications, Sumilar Duo can cause side effects, although not everybody gets them.
If the patient experiences any of the following serious side effects, they should stop taking Sumilar Duo and contact their doctor immediately - they may need urgent treatment:
swelling of the face, lips, or throat that makes swallowing or breathing difficult, as well as itching and rash: these may be symptoms of a severe allergic reaction to this medication;
severe skin reactions, including rash, ulcers in the mouth, blistering rash on the lips, eyes, mouth, and genital areas, worsening of existing skin conditions, redness, severe itching, blisters, peeling, and swelling of the skin, inflammation of the mucous membranes (such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme) or other allergic reactions.

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

rapid heartbeat, irregular or strong heartbeat (palpitations), irregular or slow heartbeat, chest pain, tightness in the chest (angina pectoris), or more severe disorders, including heart attack and stroke;
shortness of breath, difficulty breathing, or wheezing, which may indicate lung disease;
easy bruising, prolonged bleeding, any signs of bleeding (e.g., bleeding gums), purple spots on the skin, or more frequent infections, sore throat, and fever, feeling tired, fainting, dizziness, or paleness of the skin: these may be symptoms of a blood or bone marrow disorder;
severe stomach pain, which may radiate to the back: this may be a symptom of pancreatitis;
fever, chills, fatigue, loss of appetite, stomach pain, nausea, dark urine, yellowing of the skin or eyes (jaundice): these may be symptoms of liver disorders, such as inflammation or liver damage;
significantly reduced urine output, swelling, loss of appetite, nausea, vomiting, fatigue, difficulty breathing, irregular heartbeat: these may be symptoms of severe kidney disease.

Other side effects

Very common: may affect at least 1 in 10 people
swelling
Common: may affect up to 1 in 10 people
drowsiness (especially at the beginning of treatment)
palpitations (feeling of heartbeat), flushing of the skin (especially on the face and neck)
swelling of the ankles
headache or feeling tired
dizziness: may occur more frequently at the beginning of Sumilar Duo treatment
fainting, low blood pressure (abnormally low blood pressure), especially when standing up quickly or sitting up
visual disturbances (including double vision)
dry, irritating cough, sinusitis or bronchitis, shortness of breath
stomach pain or intestinal pain, diarrhea, indigestion, nausea, or vomiting
gastritis (inflammation of the stomach and/or intestines)
skin rash with raised bumps or without them
chest pain
weakness
muscle cramps or muscle pain
higher than usual potassium levels in the blood, visible in laboratory tests
Uncommon: may affect up to 1 in 100 people
mood changes, feeling depressed, anxious, more nervous than usual, or restless, sleep problems (difficulty falling asleep)
tremors
visual disturbances (including blurred vision)
ringing in the ears
runny nose, sneezing, coughing
hair loss
itching, generalized rash, purple spots on the skin (purpura), skin discoloration
urination disorders, increased urination during the day, frequent urination, increased need to urinate (especially at night)
worsening of existing proteinuria (increased protein in the urine)
general malaise
back pain
weight loss or gain
breast enlargement in men
feeling of spinning (vertigo of peripheral origin)
itching and unusual sensations on the skin, such as numbness, tingling, pricking, burning, or tingling
reduced skin sensitivity
loss or disturbance of taste
feeling of nasal congestion, difficulty breathing, or wheezing, worsening of asthma
intestinal edema (so-called "angioedema of the intestine"), whose symptoms are abdominal pain, vomiting, and diarrhea
pancreatitis (inflammation of the pancreas)
dry mouth
stomach pain, nausea (gastritis)
excessive sweating
loss or decreased appetite (anorexia)
swelling of the hands and feet: may be a sign of retaining more fluid than usual
joint pain
fever
impotence, decreased libido in men and women
increased white blood cell count, visible in blood tests
blood test results indicating liver, pancreas, or kidney function disorders
heart attack, coronary artery disease (myocardial ischemia), chest tightness and pain (angina pectoris), rapid, irregular, or slow heartbeat
swelling of the face, lips, or throat (see warnings at the beginning of section 4)
reduced kidney function, including severe kidney disease (see warnings at the beginning of section 4)
pain
Rare: may affect up to 1 in 1,000 people
feeling confused
balance disorders
redness and swelling of the tongue
severe skin peeling, itchy, bumpy rash
nail disorders (e.g., loosening or separation of the nail from the nail bed)
skin rash or bruising
spots on the skin and discoloration of the extremities
redness, itching, swelling, or tearing of the eyes
hearing disorders
reduced red blood cell, white blood cell, or platelet count, or hemoglobin level, visible in blood tests
vasculitis (inflammation of blood vessels)
vasoconstriction (narrowing of blood vessels)
jaundice (yellowing of the skin), liver cell damage
Very rare: may affect up to 1 in 10,000 people
allergic reactions
hepatitis (inflammation of the liver)
increased sensitivity to sunlight
high blood sugar levels
increased muscle tone
nerve disorders that can cause muscle weakness, tingling, or numbness
gum swelling
severe skin reactions (see warnings at the beginning of section 4)
Side effects with unknown frequency(frequency cannot be estimated from the available data):
The patient should inform their doctor if any of the following symptoms worsen significantly or persist for more than a few days.
difficulty concentrating
mouth ulcers with small ulcers
low blood cell count, visible in blood tests
lower than usual sodium levels in blood tests
change in finger and toe color after cooling and feeling of tingling or pain after warming (Raynaud's phenomenon)
slowed or weakened reactions
feeling of burning
smell disorders
psoriasis (thickened, red, or silvery skin changes) or rash on mucous membranes
bone marrow failure
severe allergic reactions
disorders of cerebral circulation, including stroke
increased levels of certain antibodies
concentrated urine (dark urine), nausea, or vomiting, muscle cramps, confusion, and seizures, which may be caused by inadequate secretion of antidiuretic hormone. If such symptoms occur, the patient should consult their doctor as soon as possible.
tremors, stiff posture, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. 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:
Jerozolimskie Avenue 181C, 02-222 Warsaw
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 can help gather more information on the safety of this medication.

5. How to store Sumilar Duo

Keep out of sight and reach of children.
Do not use this medication after the expiration date stated on the packaging and blister after EXP. The expiration date refers to the last day of the specified month.
There are no special storage instructions for this medication.
Do not use this medication if visible signs of deterioration are observed (e.g., discoloration).
Medications should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medications they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sumilar Duo contains

• The active substances are ramipril and amlodipine. Each hard capsule contains 5 mg of ramipril and 5 mg of amlodipine (in the form of 6.95 mg of amlodipine besylate).
• Other ingredients are: capsule contents: crospovidone, hypromellose, microcrystalline cellulose, glycerol dibehenate, capsule body and cap: brilliant blue FCF (contains sodium) (E 133), Allura Red AC (contains sodium) (E 129), titanium dioxide (E 171), gelatin.

What Sumilar Duo looks like and contents of the pack

Unmarked hard gelatin capsules, Coni-Snap type (size 2), with a non-transparent, purple-violet body and cap, filled with a white or almost white, odorless or almost odorless free-flowing granulate.
Blisters in a cardboard box contain 30, 90, or 100 hard capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturer
Egis Pharmaceuticals PLC
Bökenyföldi ut 118-120
H-1165, Budapest, Hungary
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For more information on this medication and its names in the Member States of the European Economic Area, please contact:

Sandoz Polska Sp. z o.o.
Domaniewska 50 C
02-672 Warsaw
phone: 22 209 70 00
Sandoz logo
Date of last revision of the leaflet:08/2022