DALNEVA 4 мг/5 мг Таблетки

Содержание инструкции

1. Dalneva 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets
   1. What Dalneva is and what it is used for
   2. What you need to know before taking Dalneva
   3. How to take Dalneva
   4. Possible side effects
   5. How to store Dalneva
   6. Package contents and other information

Dalneva 4 mg/5 mg tablets, 4 mg/10 mg tablets, 8 mg/5 mg tablets, 8 mg/10 mg tablets

perindopril tert-butylamine and amlodipine

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Dalneva is and what it is used for
• 2. What you need to know before you take Dalneva
• 3. How to take Dalneva
• 4. Possible side effects
• 5. How to store Dalneva
• 6. Contents of the pack and other information

1. What Dalneva is and what it is used for

Dalneva is prescribed for the treatment of high blood pressure (hypertension) and/or for the treatment
of stable coronary artery disease (a condition in which the blood supplied to the heart is reduced or
blocked). Patients who are already taking perindopril and amlodipine in separate tablets may
take a Dalneva tablet instead, which contains both active ingredients.
Dalneva is a combination of two active ingredients, perindopril and amlodipine. Perindopril is an ACE
inhibitor (angiotensin converting enzyme). Amlodipine is a calcium antagonist (which
belongs to a class of medicines called dihydropyridines). Together they work to widen and
relax the blood vessels, causing a reduction in blood vessels. Blood can flow around the body more
easily and the heart does not have to work so hard.

2. What you need to know before taking Dalneva

Do not take Dalneva

• if you are allergic to perindopril tert-butylamine or to any ACE inhibitor, to amlodipine besylate or to any dihydropyridine, or to any of the excipients of this medicine (listed in section 6),
• if you are pregnant for more than 3 months (it is better to avoid Dalneva even at the beginning of pregnancy - see the section on pregnancy),
• if you have previously experienced symptoms such as breathlessness, swelling of the face or tongue, intense itching or severe skin rashes with a previous treatment with ACE inhibitors or if you or a member of your family has had these symptoms in other circumstances (a condition called angioedema),
• if you suffer from cardiogenic shock (when the heart is unable to provide enough blood to the body), aortic stenosis (narrowing of the major blood vessels leaving the heart) or unstable angina (chest pain that can occur at rest),
• if you suffer from severe low blood pressure (severe hypotension),
• if you suffer from heart failure (the heart is unable to pump blood adequately causing shortness of breath or peripheral edema such as swelling of the legs, hips or feet) after an acute heart attack,
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, Dalneva may not be suitable for you.
• if you have kidney problems where blood flow to the kidneys is reduced (renal artery stenosis).
• if you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Dalneva:

• if you suffer from hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the artery supplying blood to the kidney)
• if you suffer from any other heart problems
• if you suffer from impaired liver function
• if you have kidney problems or if you are on dialysis
• if you have an abnormal increase in the levels of a hormone called aldosterone in the blood (primary aldosteronism)
• if you have a collagen vascular disease (connective tissue disease) such as systemic lupus erythematosus or scleroderma
• if you have diabetes
• if you are following a salt-restricted diet or using salt substitutes that contain potassium (a balanced potassium level in the blood is essential)
• if you are elderly and your dose needs to be increased
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren.
• if you are taking the following medicines, the risk of angioedema is increased:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent rejection of transplanted organs and cancer (e.g. sirolimus, everolimus, temsirolimus and other medicines that belong to the class of so-called mTOR inhibitors,
• vildagliptin, a medicine used to treat diabetes
• if you are of black origin as you may have a higher risk of angioedema and this medicine may be less effective in lowering blood pressure compared to non-black patients.

The doctor may check your kidney function, blood pressure and the amount of electrolytes (such as potassium) in your blood at regular intervals. See also what is stated under “Do not take Dalneva”.
Angioedema
Angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing or breathing) has been reported in patients treated with ACE inhibitors, including perindopril. This can occur at any time during treatment. If such symptoms develop, stop taking Dalneva and consult a doctor immediately.
See also section 4.
You must tell your doctor if you think you might be (or become) pregnant. Dalneva is not recommended at the beginning of pregnancy and must not be taken if you are pregnant for more than 3 months as it can cause serious harm to the baby if used during this phase (see section on pregnancy).
When taking Dalneva, you must inform your doctor or healthcare professional:

• if you are about to undergo general anesthesia and/or major surgery
• if you have recently suffered from diarrhea or vomiting
• if you are to undergo LDL apheresis (removal of cholesterol from your blood through a machine)
• if you are about to undergo a desensitization treatment to reduce the effects of an allergy to bee or wasp stings.

Children and adolescents
Dalneva is not recommended in children and adolescents.

Other medicines and Dalneva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You must avoid Dalneva with:

• lithium (used to treat mania or depression)
• estramustine (used in cancer therapy)
• potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene) and other medicines that can increase the amount of potassium in the blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent the formation of clots)
• potassium-sparing medicines used in the treatment of heart failure: eplerenone and spironolactone at doses between 12.5 mg and 50 mg per day. Treatment with Dalneva may be affected by other medicines. Make sure to inform your doctor if you are taking any of the following medicines as special care may be needed:
• other medicines for high blood pressure, including angiotensin II receptor blockers (ARB), aliskiren (see also information under "Do not take Dalneva" and "Warnings and precautions"), or diuretics (medicines that can increase the amount of urine produced by the kidneys)
• sacubitril/valsartan (used for the treatment of long-term heart failure): See sections "Do not take Dalneva" and "Warnings and precautions",
• non-steroidal anti-inflammatory medicines (e.g. ibuprofen) for pain relief or high-dose acetylsalicylic acid
• medicines for the treatment of diabetes (such as insulin or vildagliptin)
• medicines for the treatment of mental disorders such as depression, anxiety, schizophrenia etc. (e.g. tricyclic antidepressants, antipsychotics, imipramine-like antidepressants, neuroleptics)
• immunosuppressants (medicines that can reduce the body's defense mechanism) used for the treatment of autoimmune diseases or following transplantation (e.g. cyclosporine, tacrolimus),
• trimethoprim and co-trimoxazole (for the treatment of infections),
• allopurinol (for the treatment of gout)
• procainamide (for the treatment of irregular heartbeat)
• vasodilators including nitrates (products that dilate blood vessels)
• ephedrine, norepinephrine or adrenaline (medicine used for the treatment of low blood pressure, shock or asthma)
• baclofen or dantrolene (infusion) both used for the treatment of muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used for the treatment of malignant hyperthermia during anesthesia (symptoms include very high fever and muscle stiffness),
• some antibiotics such as rifampicin, erythromycin
• clarithromycin (for treating bacterial infections)
• antiepileptic agents such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• itraconazole, ketoconazole (medicines used for the treatment of fungal infections)
• alpha-blockers used for the treatment of enlarged prostate such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin
• amifostine (used to prevent or reduce side effects caused by other medicines or radiation therapy used to treat cancer)
• corticosteroids (used to treat various conditions including severe asthma and rheumatoid arthritis)
• gold salts, particularly in intravenous administration (used to treat the symptoms of rheumatoid arthritis),
• simvastatin (a drug to lower cholesterol levels)
• ritonavir, indinavir, nelfinavir (also called protease inhibitors used to treat HIV)
• Hypericum perforatum(St John's Wort)
• verapamil, diltiazem (medicines for the heart)
• medicines, usually used to treat diarrhea (racecadotril) or to prevent rejection of transplanted organs (sirolimus, everolimus, temsirolimus and other medicines belonging to the class of so-called mTOR inhibitors). See the paragraph "Warnings and precautions".

Dalneva may lower blood pressure even if you are already taking other medicines for the treatment of high blood pressure.

Dalneva with food and drink
Dalneva should be taken before a meal.
Grapefruit and grapefruit juice should not be consumed by patients taking Dalneva. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in blood pressure reducing the blood pressure lowering effect of Dalneva.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you might be (or become) pregnant.
Normally your doctor will advise you to stop taking Dalneva before becoming pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Dalneva. Dalneva is not recommended at the beginning of pregnancy, and must not be taken if you are pregnant for more than 3 months as it can cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are about to start breastfeeding. Dalneva is not recommended in breastfeeding mothers and if you wish to breastfeed your doctor may choose another treatment for you, especially if your baby is newborn or premature.
Amlodipine has been shown to pass into breast milk in small amounts.

Driving and operating machinery
Dalneva does not affect alertness but you may experience dizziness or weakness due to low blood pressure which may affect your ability to drive or operate machinery. It is recommended not to drive a car or operate machinery until you know how Dalneva affects you.

Dalneva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say it is essentially ‘sodium-free’.

3. How to take Dalneva

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Swallow the tablet whole with a glass of water, preferably always at the same time of the
day, in the morning, before a meal. The doctor will decide the correct dose for you. This will usually
be one tablet a day. Dalneva is usually prescribed for patients who are already
taking perindopril and amlodipine in separate tablets.

Use in children and adolescents
Use in children and adolescents is not recommended.

If you take more Dalneva than you should
If you take too many tablets, contact the nearest emergency room or inform your
doctor immediately. The most likely symptoms of overdose are low blood pressure which may make you feel
dizzy or give you a feeling of fainting. If this happens, it may help to lie down with your legs
elevated.

If you forget to take Dalneva
It is important that you take your medicine every day as regular treatment works best.
However, if you forget to take a dose of Dalneva, take the next dose at the usual time.
Do not take a double dose to make up for a missed tablet.

If you stop taking Dalneva
Since treatment with Dalneva is usually chronic, you should discuss with your doctor before
stopping taking your tablets.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occur, stop taking the medicine immediately and tell your doctor straight away:

• sudden shortness of breath, chest pain, lack of breath or difficulty breathing,
• swelling of the eyelids, face or lips,
• swelling of the tongue and throat, causing great difficulty in breathing,
• severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions,
• severe dizziness or fainting,
• heart attack, abnormal or unusually fast heartbeat or chest pain.
• inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of unwellness.

The following side effects have been reported as common. If any of these causes problems or if
it lasts for more than one week, you should contact your doctor.

• Very common side effects (may affect more than 1 in 10 people): edema (fluid retention).
• Common side effects (may affect up to 1 in 10 people): headache, dizziness, drowsiness (especially at the beginning of treatment), vertigo, numbness or tingling in the limbs, visual disturbances (including double vision), tinnitus (sensation of noises in the ears), palpitations (awareness of heartbeat), flushing, feeling of emptiness in the head due to low blood pressure, cough, shortness of breath, nausea (feeling sick), vomiting (feeling unwell), abdominal pain, taste disturbances, dyspepsia or difficulty digesting food, altered bowel habits, diarrhoea, constipation, allergic reactions (such as skin rashes, itching), muscle cramps, fatigue, weakness, swelling of the ankle (peripheral edema).

Other side effects have been reported, included in the following list. If any of these worsens or if
you notice any other side effect not listed in this leaflet, inform your doctor or
pharmacist.

• Uncommon side effects (may affect up to 1 in 100 people): mood swings, anxiety, depression, insomnia, sleep disorders, tremor, fainting, loss of pain sensation, irregular heartbeat, rhinitis (blocked or runny nose), hair loss, red spots on the skin, skin discoloration, back pain, arthralgia (joint pain), myalgia (muscle pain), chest pain, urinary passage disorders, increased need to urinate during the night, increased number of times of urination, pain, malaise, bronchospasm (tightness of the chest, wheezing and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), formation of clusters of blisters on the skin, kidney problems, impotence, increased sweating, excess of eosinophils (a type of white blood cells), discomfort or enlargement of the breast in men, weight increase or decrease, tachycardia, vasculitis (inflammation of blood vessels), photosensitivity reaction (increased sensitivity of the skin to the sun), fever, collapse, changes in laboratory parameters: high blood level of potassium reversible upon discontinuation, low sodium level, hypoglycemia (very low blood sugar level) in diabetic patients, increased urea in the blood and increased blood creatinine.
• Rare side effects (may affect up to 1 in 1,000): confusion, worsening of psoriasis, changes in laboratory parameters: increased level of liver enzymes, high level of serum bilirubin.
• Very rare side effects (may affect up to 1 in 10,000): cardiovascular disorders (angina, heart attack and stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of the eyelids, face or lips, swelling of the tongue and throat, causing great difficulty breathing, severe skin reactions including intense rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome), erythema multiforme (a rash that often starts with itchy red spots on the face, arms or legs, light sensitivity, changes in blood values such as a lower number of white blood cells and red blood cells, lower hemoglobin, lower number of platelets, blood disorders, inflamed pancreas which can cause severe abdominal and back pain accompanied by a feeling of very unwellness, acute kidney failure, alteration of liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increase of liver enzymes which can have an effect on some medical examinations, abdominal bloating (gastritis), nerve disorders that can cause weakness, tingling or numbness, increased muscle tension, swelling of the gums, excess sugar in the blood (hyperglycemia).
• Side effects with unknown frequency (frequency cannot be estimated from available data): trembling and rigid posture, mask-like face, slow movements and an unsteady and imbalanced walk, discoloration, numbness and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Dalneva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date
refers to the last day of the month.
Store in the original packaging to protect from light and moisture.
This medicine does not require any special temperature storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Dalneva contains

• The active ingredients are perindopril tert-butylamine and amlodipine. Dalneva 4 mg/5 mg tablets Each tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 5 mg of amlodipine (as besilate). Dalneva 4 mg/10 mg tablets Each tablet contains 4 mg of perindopril tert-butylamine (equivalent to 3.34 mg of perindopril) and 10 mg of amlodipine (as besilate). Dalneva 8 mg/5 mg tablets Each tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.68 mg of perindopril) and 5 mg of amlodipine (as besilate). Dalneva 8 mg/10 mg tablets Each tablet contains 8 mg of perindopril tert-butylamine (equivalent to 6.68 mg of perindopril) and 10 mg of amlodipine (as besilate).
• The excipients are sodium hydrogen carbonate, microcrystalline cellulose (E460), pregelatinized maize starch, sodium starch glycolate (type A), anhydrous colloidal silica and magnesium stearate (E470b). See section 2 "Dalneva contains sodium".

Description of the appearance of Dalneva and contents of the pack
Dalneva 4 mg/5 mg tablets
This medicine is presented as white to almost white, round, slightly
biconvex tablets with bevelled edges, engraved with the mark U 1 on one side of the tablet. Diameter:
approximately 7 mm..
Dalneva 4 mg/10 mg tablets
This medicine is presented as white to almost white, capsule-shaped tablets, biconvex
with a score line on one side. The tablets are engraved with the mark U on one side of the tablet
and the mark 2 on the other side of the score line. Dimensions: approximately 12.5 mm x 5.5
mm. The score line on the tablet is to aid in breaking for easier swallowing and not for dividing
into equal doses.
Dalneva 8 mg/5 mg tablets
This medicine is presented as white to almost white, round, biconvex tablets with the
bevelled edges, engraved with the mark U 3 on one side of the tablet. Diameter: approximately
9 mm.
Dalneva 8 mg/10 mg tablets
This medicine is presented as white to almost white, round, biconvex tablets with the
bevelled edges and a score line on one side. The tablets are engraved with the mark U on one side
of the tablet and the mark 4 on the other side of the score line. Diameter: approximately 9
mm. The tablet can be divided into two equal doses.
The tablets are available in boxes of 5, 7, 10, 14, 20, 28, 30, 50, 60, 90 and 100 tablets in
blisters.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Local Representative for Italy:
KRKA Farmaceutici Milano S.r.l. Viale Achille Papa 30, 20149 Milano, Italy

Manufacturers responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann- Straße.5, 27472 Cuxhaven, Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following names: