ASBIMA 5 mg/80 mg Фильм-Coated Таблетки

Содержание инструкции

1. Asbima 5 mg/80 mg film-coated tablets, 5 mg/160 mg film-coated tablets, 10 mg/160 mg film-coated tablets
   1. What is Asbima and what is it used for
   2. What you need to know before taking Asbima
   3. How to take Asbima
   4. Possible side effects
   5. How to store Asbima
   6. Package Contents and Other Information

Asbima 5 mg/80 mg film-coated tablets, 5 mg/160 mg film-coated tablets, 10 mg/160 mg film-coated tablets

Amlodipine/ Valsartan
Generic medicine

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 they have the same symptoms as you, as it may 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 Asbima is and what it is used for
• 2. What you need to know before you take Asbima
• 3. How to take Asbima
• 4. Possible side effects
• 5. How to store Asbima
• 6. Contents of the pack and other information

1. What is Asbima and what is it used for

Asbima tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels and thus stops the narrowing of blood vessels.
• Valsartan belongs to a group of substances called “angiotensin II receptor blockers”. Angiotensin II is produced by the body and causes the narrowing of blood vessels, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II. This means that both of these substances help to prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.

Asbima is used in the treatment of high blood pressure in adults in whom blood pressure is not sufficiently controlled with amlodipine or valsartan alone.

2. What you need to know before taking Asbima

Do not take Asbima if

• you are allergic to amlodipine or to any other calcium channel blocker. This may involve itching, redness of the skin or difficulty in breathing.
• you are allergic to valsartan or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, speak to your doctor before taking Asbima.
• you have severe liver problems or problems with the flow of bile from the liver such as biliary cirrhosis or cholestasis.
• you are pregnant for more than 3 months (it is best to avoid taking Asbima even in the early stages of pregnancy, see section “Pregnancy, breastfeeding and fertility”).
• you have very low blood pressure (hypotension).
• you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to pump enough blood to the body).
• you suffer from heart failure following a heart attack.
• 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 any of the above applies to you, do not take Asbima and tell your doctor.

Warnings and precautions
Talk to your doctor before taking Asbima if

• you have been sick (vomiting or diarrhoea).
• you have problems with your liver or kidneys.
• you have had a kidney transplant or have been told you have a narrowing of the arteries to your kidneys.
• you suffer from a condition affecting the adrenal glands called “primary hyperaldosteronism”.
• you have had heart failure or a heart attack. Carefully follow your doctor’s instructions regarding the starting dose. Your doctor may also check your kidney function.
• your doctor has told you that you have a narrowing of the heart valves (called “aortic or mitral stenosis”) or that the heart muscle has become abnormally thickened (a condition called “obstructive hypertrophic cardiomyopathy”).
• you have previously experienced swelling, in particular of the face and throat, when taking other medicines (including ACE inhibitors). If you experience these symptoms, stop taking Asbima and contact your doctor immediately. You should never take Asbima again.
• you are taking any of the following medicines used to treat high blood pressure:
• an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the levels of electrolytes (e.g. potassium) in your blood at regular intervals.
Also see section “Do not take Asbima if”.
If any of these conditions apply to you, tell your doctor before taking Asbima.

Children and adolescents
The use of Asbima is not recommended in children and adolescents (under 18 years of age).

Other medicines and Asbima
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to change your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines.
This is particularly important for the medicines listed below:

• ACE inhibitors or aliskiren (see also “Do not take Asbima if” and “Warnings and precautions”);
• diuretics (a type of medicine also called “water tablets” that increases the amount of urine you produce);
• lithium (a medicine used to treat some types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other substances that can increase potassium levels;
• certain types of painkillers known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). Your doctor may also check your kidney function;
• anticonvulsant medicines (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St John’s wort;
• nitroglycerin and other nitrates or other substances called “vasodilators”;
• medicines used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• rifampicin, erythromycin, clarithromycin, telithromycin (antibiotics - for infections caused by bacteria);
• verapamil, diltiazem (medicines for the heart);
• tacrolimus (used to control the body’s immune response, allowing your body to accept a transplanted organ);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (infusion for severe abnormalities of body temperature);
• medicines used to prevent rejection of transplanted organs (cyclosporine).

Asbima with food, beverages and alcohol
Grapefruit and grapefruit juice must not be consumed by people taking Asbima. This is because grapefruit and grapefruit juice can lead to increased levels of amlodipine in the bloodstream, which can cause an unpredictable increase in Asbima’s blood pressure lowering effect.

Pregnancy, breastfeeding and fertility
If you are pregnant, or suspect you may be pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should tell your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Usually, your doctor will advise you to stop taking Asbima before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Asbima. Asbima is not recommended in the first trimester of pregnancy (first 3 months) and must not be taken if you are more than 3 months pregnant as it may cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or planning to start breastfeeding, you should tell your doctor before taking Asbima. Asbima is not recommended for women who are breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and operating machinery
This medicine can cause dizziness. This may affect your ability to concentrate.
Therefore, if you are not sure how this medicine affects you, do not drive, operate machinery and do not perform other activities that require concentration.

Asbima contains sorbitol (E-420) and sodium
Asbima 5 mg/80 mg film-coated tablets: This medicine contains 9.25 mg of sorbitol in each tablet.
Asbima 5 mg/160 mg film-coated tablets and Asbima 10 mg/160 mg film-coated tablets:
This medicine contains 18.5 mg of sorbitol in each tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, that is to say it is essentially “sodium-free”.

3. How to take Asbima

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. This will help you to obtain the best results and to reduce the risk
of undesirable effects.
The recommended dose of Asbima is one tablet a day.

• It is preferable to take the medicine every day at the same time.
• Swallow the tablets with a glass of water.
• Asbima can be taken with or without food. Do not take Asbima with grapefruit or grapefruit juice.

Based on your response to treatment, your doctor may suggest a lower or higher dose. Do not
take more than the prescribed dose.

Asbima and elderly patients (65 years of age and over)
The doctor must exercise caution when increasing the dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you take more Asbima than you should
If you have taken too many tablets of Asbima, or if someone else has taken your tablets, contact
a doctor immediately.

If you forget to take Asbima
If you forget to take this medicine, take it as soon as you remember. Then take the next
dose at the usual time. However, if it is almost time for the next dose, skip the missed dose. Do not
take a double dose to make up for a forgotten tablet.

If you stop taking Asbima
Stopping treatment with Asbima may cause a worsening of your condition. Do not
stop taking your medicine unless you have been told to do so by your doctor.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some side effects may be serious and require immediate medical attention.
Few patients have experienced these serious side effects (they can affect up to 1 in

• 1,000). If you notice any of the following side effects, contact your doctor immediately: Allergic reactions with symptoms such as skin rash, itching, swelling of the face or lips or

of the tongue, difficulty breathing, low blood pressure (feeling of weakness, feeling of
lightheadedness).

Other possible side effects of Asbima
Common (may affect up to 1 in 10 people):
Influenza; nasal congestion, sore throat and difficulty swallowing; headache; swelling of the arms, hands,
legs, ankles or feet; fatigue; asthenia (weakness); redness and feeling of warmth of the face
and/or neck.
Uncommon (may affect up to 1 in 100 people):
Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the
hands or feet; vertigo; fast heartbeat including palpitations; dizziness when getting up;
cough; diarrhea; constipation; skin rashes, skin redness; swelling of the joints, back pain; joint pain.
Rare (may affect up to 1 in 1,000):
Feeling of anxiety; ringing in the ears (tinnitus); fainting; passing more urine than usual or needing to urinate more urgently than usual; inability to achieve or maintain
an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling of
lightheadedness; excessive sweating; skin rashes all over the body; itching; muscle spasm.
If any of these effects occur severely, inform your doctor.
Adverse reactions reported with amlodipine or valsartan alone and not observed with Asbima or observed
with a higher frequency than with Asbima.

Amlodipine
If you notice any of the following very rare and serious side effects after taking this
medicine, consult a doctor immediately:

• Sudden onset of shortness of breath, chest pain, tightness or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat which can cause difficulty breathing.
• Severe skin reactions including intense rash, hives, red 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.
• Myocardial infarction, abnormal heartbeat.
• Inflammation of the pancreas which can cause severe abdominal and back pain accompanied by a feeling of severe discomfort.

The following side effects have been reported. If any of these occurs or persists for more than
one week, contact your doctor.
Common (may affect up to 1 in 10 people):
Dizziness, drowsiness; palpitations (feeling your heartbeat); flushing, swelling of the ankles
(edema); abdominal pain, feeling unwell (nausea).
Uncommon (may affect up to 1 in 100 people):
Mood changes, anxiety, depression, insomnia, tremor, altered taste,
fainting, loss of sensitivity to pain; visual disturbances, impaired vision, ringing in the
ears; low blood pressure; sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (feeling sick); hair loss, increased sweating, itching
skin, change in skin color; urinary disorders, needing to urinate at night, needing to
urinate frequently; inability to achieve an erection, discomfort or enlargement of the breasts in men, pain,
discomfort, muscle pain, muscle cramps; weight gain or loss.
Rare (may affect up to 1 in 1,000): Confusion.
Very rare (may affect up to 1 in 10,000):
Low levels of white blood cells and platelets in the blood which can lead to unusual bruising or a tendency to bleed (damage to red blood cells); high blood sugar levels
(hyperglycemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which
can lead to changes in some clinical tests; increased muscle tension; inflammation of the
blood vessels, often with skin rash, sensitivity to light.
Frequency not known (the frequency cannot be estimated from the available data):

• Tremor, rigidity, mask-like face, slow and uncoordinated movements, unsteady gait.

Valsartan
Frequency not known (the frequency cannot be estimated from the available data):
Decreased red blood cells, fever, sore throat or pain in the mouth caused by infections;
spontaneous bleeding or bruising; high levels of potassium in the blood; abnormal results of liver function tests; decreased kidney function and severe decrease in kidney function;
swelling, especially of the face and throat; muscle pain; skin rash, purplish red spots;
fever; itching; allergic reaction, skin blisters (signs of a condition called bullous dermatitis).
If any of these affects you, tell your doctor immediately.

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 www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Asbima

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 blister and the packaging after
“EXP”. The expiry date refers to the last day of that month.
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.
Store at a temperature below 30°C in the original packaging to protect the medicine
from humidity and light

6. Package Contents and Other Information

What Asbima contains
The active ingredients are amlodipine and valsartan.
Asbima 5 mg/80 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate) and
80 mg of valsartan.
Asbima 5 mg/160 mg film-coated tablets
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate) and
160 mg of valsartan.
Asbima 10 mg/160 mg film-coated tablets
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate) and
160 mg of valsartan.
The other ingredients are: Tablet core: Silicified microcrystalline cellulose (containing
microcrystalline cellulose and anhydrous colloidal silica); Sorbitol (E-420); Magnesium carbonate; Pregelatinized
corn starch; Partially pregelatinized corn starch; Povidone 25; Sodium stearyl fumarate;
Sodium lauryl sulfate; Crospovidone type A; Anhydrous colloidal silica; Microcrystalline cellulose
Tablet coating: Hypromellose 2910/5; Macrogol 6000; Titanium dioxide (E171); Talc;
Yellow iron oxide (E172).

Description of the appearance of Asbima and package contents
Asbima 5 mg/80 mg film-coated tablets: Film-coated tablet of yellow color, round,
with dimensions of approximately 9 mm.
Asbima 5 mg/160 mg film-coated tablets: Film-coated tablet of light yellow color,
oblong, with dimensions of approximately 14 x 7 mm.
Asbima 10 mg/160 mg film-coated tablets: Film-coated tablet of yellow color,
oblong with a fracture line, with dimensions of approximately 14 x 7 mm. The notch is
not intended for breaking the tablet.
7, 14, 28, 30, 56, 90 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milano
Italy

Manufacturer
Zentiva k.s., U kabelovny 130, Dolní Měcholupy, Praha 10, 102 37, Czech Republic

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
United Kingdom, Italy, Poland, Slovakia, Czech Republic, Lithuania, Cyprus, Greece, Bulgaria, Malta:
Asbima