ASBIMA 10 mg/160 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
2. Asbima, 5 mg + 80 mg, film-coated tablets
3. Asbima, 5 mg + 160 mg, film-coated tablets
4. Asbima, 10 mg + 160 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Asbima and what is it used for
6. Important information before taking Asbima
   1. When not to take Asbima:
   2. Warnings and precautions
   3. Children and adolescents
   4. Asbima and other medicines
   5. Asbima with food, drink, and alcohol
   6. Pregnancy, breastfeeding, and fertility
   7. Driving and using machines
   8. Asbima contains sorbitol (E-420) and sodium
7. How to take Asbima
   1. Taking Asbima in elderly patients (65 years of age and older)
   2. Taking more than the recommended dose of Asbima
   3. Missing a dose of Asbima
   4. Stopping treatment with Asbima
8. Possible side effects
   1. Some side effects may be serious and may require immediate medical attention:
   2. Other possible side effects of Asbima:
   3. Amlodipine
   4. Valsartan
   5. Reporting side effects
9. How to store Asbima
10. Contents of the pack and other information
    1. What Asbima contains
    2. What Asbima looks like and contents of the pack
    3. Marketing authorization holder and manufacturer

Leaflet attached to the packaging: patient information

Asbima, 5 mg + 80 mg, film-coated tablets

Asbima, 5 mg + 160 mg, film-coated tablets

Asbima, 10 mg + 160 mg, film-coated tablets

Amlodipine + Valsartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Asbima and what is it used for
• 2. Important information before taking 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 contains two active substances: amlodipine and valsartan. Both substances help control high blood pressure.

• Amlodipine belongs to a group of medicines called calcium channel blockers. It prevents calcium from entering the blood vessel walls, which inhibits the constriction of blood vessels.
• Valsartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is produced in the human body and causes blood vessel constriction, increasing blood pressure. Valsartan works by blocking the action of angiotensin II.

This means that both substances inhibit the constriction of blood vessels. As a result, the blood vessels dilate, and blood pressure decreases. Asbima is used to treat high blood pressure in adult patients who are not adequately controlled by taking only amlodipine or only valsartan.

2. Important information before taking Asbima

When not to take Asbima:

• if the patient is allergic to amlodipine or other calcium channel blockers - may cause itching, redness of the skin, or difficulty breathing,
• if the patient is allergic to valsartan or any of the other ingredients of this medicine (listed in section 6) - if the patient thinks they may be allergic, they should inform their doctor before taking Asbima,
• if the patient has severe liver function disorders or biliary disorders, such as liver cirrhosis or biliary obstruction,
• after the third month of pregnancy (it is also recommended to avoid taking Asbima in early pregnancy, see "Pregnancy, breastfeeding, and fertility"),
• if the patient has very low blood pressure (hypotension),
• if the patient has aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body),
• if the patient has heart failure after a heart attack,
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to the patient, they should not take Asbima and should consult their doctor.

Warnings and precautions

Before starting to take Asbima, the patient should discuss it with their doctor if:

• the patient has gastrointestinal disorders (vomiting, diarrhea),
• the patient has liver or kidney function disorders,
• the patient has had a kidney transplant or has renal artery stenosis,
• the patient has primary hyperaldosteronism (a condition characterized by excessive production of aldosterone),
• the patient has had heart failure or a heart attack - the doctor will closely monitor the patient's condition and may also check their kidney function,
• the patient has aortic stenosis (narrowing of the aortic valve) or hypertrophic cardiomyopathy (thickening of the heart muscle),
• the patient has experienced swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) - if the patient experiences such symptoms, they should stop taking Asbima immediately and consult their doctor, and never take Asbima again,
• the patient is taking any of the following medicines for high blood pressure:
• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if the patient has diabetic kidney problems,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Asbima".

If any of the above conditions apply to the patient, they should inform their doctor before taking Asbima.

Children and adolescents

Asbima is not recommended for children and adolescents (under 18 years of age).

Asbima and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. The doctor may recommend changing the dose and/or taking other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines:

• ACE inhibitors or aliskiren (see also "When not to take Asbima" and "Warnings and precautions"),
• diuretics (also known as water pills, which increase urine production),
• lithium (a medicine used to treat certain types of depression),
• potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels,
• certain painkillers, known as non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors - the doctor may also recommend monitoring the patient's kidney function,
• antiepileptic drugs (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone),
• St. John's Wort,
• nitroglycerin and other nitrates or other 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 used to treat bacterial infections),
• verapamil, diltiazem (medicines used to treat heart conditions),
• tacrolimus (used to control the immune system, allowing the body to accept a transplanted organ),
• simvastatin (a medicine used to lower high cholesterol levels in the blood),
• dantrolene (used in the treatment of severe body temperature disorders),
• medicines used to prevent the rejection of transplanted organs (cyclosporine).

Asbima with food, drink, and alcohol

Patient taking Asbima should not eat grapefruits or drink grapefruit juice, as both grapefruits and grapefruit juice can cause an increase in the levels of the active substance amlodipine in the blood, leading to an unexpected increase in the effect of Asbima, resulting in a decrease in blood pressure.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy The patient should inform their doctor about a suspected or planned pregnancy. The doctor will usually recommend stopping Asbima before a planned pregnancy or as soon as possible after becoming pregnant and will recommend another medicine instead of Asbima. Asbima should not be taken during the first trimester of pregnancy (the first 3 months) and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after the third month of pregnancy. Breastfeeding It has been shown that small amounts of amlodipine pass into human milk. If the patient is breastfeeding or plans to breastfeed, they should tell their doctor before starting to take Asbima. Asbima is not recommended during breastfeeding. The doctor may recommend another treatment if the patient wants to breastfeed, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

This medicine may cause dizziness, which may affect the patient's ability to concentrate. Therefore, the patient should not drive, operate machinery, or perform other activities that require attention until they know how they react to the medicine.

Asbima contains sorbitol (E-420) and sodium

Asbima, 5 mg + 80 mg: This medicinal product contains 9.25 mg of sorbitol in each tablet. Asbima, 5 mg + 160 mg and Asbima, 10 mg + 160 mg: This medicinal product contains 18.5 mg of sorbitol in each tablet. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Asbima

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist. This will help to get the best results from the treatment and reduce the risk of side effects. The recommended dose of Asbima is one tablet per day.

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

Depending on the patient's response to the treatment, the doctor may recommend a higher or lower dose of the medicine. Do not take more than the recommended dose.

Taking Asbima in elderly patients (65 years of age and older)

The doctor will exercise caution when increasing the dose. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

Taking more than the recommended dose of Asbima

If the patient has taken too many Asbima tablets or someone else has taken them by mistake, they should consult their doctor immediately. Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Asbima

If the patient forgets to take a dose, they should take it as soon as possible. The next dose should be taken at the usual time. However, if it is almost time for the next dose, the missed dose should be skipped. Do not take a double dose to make up for a missed dose.

Stopping treatment with Asbima

Stopping treatment with Asbima may worsen the condition. The patient should not stop taking the medicine unless their doctor tells them to. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Asbima can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate medical attention:

Severe side effects have occurred in a small number of patients (may occur in less than 1 in 1000 people). If the patient experiences any of the following symptoms, they should immediately inform their doctor: Allergic reaction with symptoms such as rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling weak, "empty" head).

Other possible side effects of Asbima:

Common (may affect up to 1 in 10 people): Flu; nasal congestion, sore throat, and discomfort when swallowing; headache; swelling of the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and feeling of warmth on the face and (or) neck. Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dryness of the mouth; drowsiness, tingling, or numbness of the hands or feet; vertigo of labyrinthine origin, rapid heart rate, including palpitations; orthostatic hypotension; cough; diarrhea; constipation; skin rash, redness of the skin; joint swelling, back pain; joint pain. Rare (may affect up to 1 in 1000 people): Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased urination or feeling of strong urge to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head; excessive sweating; skin rash all over the body; itching; muscle cramps. If any of these symptoms worsen, the patient should inform their doctor. Side effects reported after taking amlodipine or valsartan alone, which have not been observed after taking Asbima or have been observed more frequently after taking Asbima:

Amlodipine

If the patient experiences any of the following very rare, serious side effects after taking the medicine, they should immediately contact their doctor:

• Sudden onset of wheezing, chest pain, shortness of breath, or difficulty breathing;
• Swelling of the eyelids, face, or lips;
• Swelling of the tongue and throat, causing severe difficulty breathing;
• Severe skin reactions, including intense skin rash, urticaria, redness of the skin all over the body, severe itching, blisters, and peeling of the skin, as well as inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• Heart attack, arrhythmias;
• Pancreatitis, which can cause severe abdominal pain radiating to the back, with very poor general condition.

The following side effects have been reported. If any of these side effects are troublesome or last for more than a week, the patient should consult their doctor. Common (may affect up to 1 in 10 people): Dizziness, drowsiness; palpitations (feeling of heartbeat); sudden flushing; swelling of the ankles (edema); abdominal pain, nausea. Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, insomnia, tremors, taste disturbances, fainting, loss of pain sensation; vision disturbances, worsening of vision, ringing in the ears; low blood pressure; sneezing/ runny nose caused by nasal inflammation (rhinitis); indigestion, vomiting; hair loss, increased sweating, itching of the skin, skin color changes; urinary disorders, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of the breasts in men, pain, poor general condition, muscle pain, muscle cramps; weight gain or weight loss. Rare (may affect up to 1 in 1000 people): Disorientation. Very rare (may affect up to 1 in 10,000 people): Decreased white blood cell count, decreased platelet count, which can lead to unusual bruising or easier bleeding; increased blood glucose levels (hyperglycemia); gum swelling and (or) bleeding, abdominal bloating (gastritis); abnormal liver function, liver inflammation, yellowing of the skin (jaundice), increased liver enzyme activity, as shown in the results of some tests; increased muscle tone; vasculitis, often with skin rash, hypersensitivity to light. Unknown (frequency cannot be estimated from the available data): Tremor, stiffness, mask-like face, slow movements, and shuffling gait.

Valsartan

Unknown (frequency cannot be estimated from the available data): Decreased red blood cell count, fever, sore throat, or mouth ulcers caused by infection; spontaneous bleeding or bruising; high levels of potassium in the blood; abnormal liver function test results; kidney function disorders and kidney failure; swelling, mainly of the face and throat; muscle pain; skin rash, purple spots on the skin; fever; itching; allergic reactions, blistering of the skin (a condition known as pemphigus). If the patient experiences any of these symptoms, they should immediately inform their doctor.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 Al. Jerozolimskie 181C 02-222 Warsaw tel.: +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 or its representative in Poland. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Asbima

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after "Expiry date (EXP)". The expiry date refers to the last day of the month. Store in a temperature below 30°C. Store in the original packaging to protect from moisture and light. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Asbima contains

• The active substances of Asbima are amlodipine and valsartan. Asbima, 5 mg + 80 mg, film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan. Asbima, 5 mg + 160 mg, film-coated tablets Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan. Asbima, 10 mg + 160 mg, film-coated tablets Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate) and 160 mg of valsartan.
• The other ingredients are: Tablet core: microcrystalline cellulose (containing microcrystalline cellulose and colloidal silicon dioxide), sorbitol, magnesium carbonate, maize starch, pregelatinized maize starch, povidone 25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone type A, colloidal silicon dioxide, microcrystalline cellulose. Coating: hypromellose 2910/5, macrogol 6000, titanium dioxide (E171), talc, yellow iron oxide (E172).

What Asbima looks like and contents of the pack

Asbima, 5 mg + 80 mg, film-coated tablets: yellow, round film-coated tablet with a diameter of about 9 mm. Asbima, 5 mg + 160 mg, film-coated tablets: light yellow, oval film-coated tablet with dimensions of about 14 × 7 mm. Asbima, 10 mg + 160 mg, film-coated tablets: yellow, oval film-coated tablet with a score line, with dimensions of about 14 × 7 mm. The score line on the tablet is not intended for breaking the tablet. 7, 14, 28, 30, 56, 90, 98 film-coated tablets Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Manufacturer:
Zentiva k.s.
U kabelovny 130
Dolní Měcholupy
102 37 Prague 10
Czech Republic
Pharmadox Healthcare Ltd.
KW20A Corradino Industrial Estate
Paola PLA 3000
Malta
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00
Date of last revision of the leaflet:August 2022