Asbima

Package leaflet: Information for the patient

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
Please read this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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.

Leaflet contents

1. What Asbima is and what it is 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 Asbima is and what it is 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 walls of blood vessels, which helps prevent blood vessel constriction.
• 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, thereby increasing blood pressure. Valsartan works by blocking the effects of angiotensin II.

This means that both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure is reduced.
Asbima is used to treat high blood pressure in adult patients whose blood pressure is not sufficiently controlled with amlodipine alone or valsartan alone.

2. Important information before using Asbima

When not to use Asbima:

• if the patient is allergic to amlodipine or other calcium channel blockers – itching, skin redness or breathing difficulties may occur,
• 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 impairment or biliary disorders such as primary biliary cirrhosis or biliary obstruction,
• after the third month of pregnancy (Asbima should also be avoided during early pregnancy; see section "Pregnancy, breastfeeding and fertility"),
• if the patient has very low blood pressure (hypotension),
• if the patient has aortic valve stenosis or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body),
• if the patient has heart failure following a heart attack,
• if the patient has diabetes or kidney function impairment and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply, Asbima must not be used and the patient should consult their doctor.
Warnings and precautions
Before starting Asbima, consult your doctor if:

• the patient has gastrointestinal disturbances (vomiting, diarrhoea),
• the patient has impaired liver or kidney function,
• the patient has had a kidney transplant or has renal artery stenosis,
• the patient has adrenal gland disorders known as primary hyperaldosteronism,
• the patient has had heart failure or a previous heart attack – strictly follow the doctor’s advice regarding the initial dose; the doctor may also check kidney function,
• the patient has heart valve narrowing (called aortic or mitral stenosis) or thickening of the heart muscle (hypertrophic cardiomyopathy with outflow tract obstruction),
• the patient has previously experienced swelling, especially of the face and throat, while taking other medicines (including ACE inhibitors) – if such symptoms occur, Asbima must be stopped immediately, the doctor should be contacted, and Asbima must never be used again,
• the patient is taking any of the following medicines for high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems due to diabetes,
  • aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure and blood electrolyte levels (e.g. potassium). See also section "When not to use Asbima".

If any of the above conditions apply, the patient must inform their doctor before taking Asbima.
Children and adolescents
Asbima is not recommended for use in children and adolescents (under 18 years of age).
Asbima with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. The doctor may need to adjust the dose and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This particularly applies to the following medicines:

• ACE inhibitors or aliskiren (see also sections "When not to use Asbima" and "Warnings and precautions"),
• diuretics (also known as water tablets, which increase urine output),
• lithium (a medicine used to treat certain types of depression),
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, 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 kidney function,
• anticonvulsants (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone),
• St. John’s wort (Hypericum perforatum),
• nitroglycerin and other nitrates or other vasodilating substances,
• medicines used in HIV/AIDS treatment (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 for heart conditions),
• tacrolimus (used to suppress the immune response to allow acceptance of a transplanted organ),
• simvastatin (a medicine used to reduce high blood cholesterol levels),
• dantrolene (used intravenously in severe disturbances of body temperature),
• medicines used to prevent organ transplant rejection (cyclosporine).

Asbima with food, drink and alcohol
Patients taking Asbima should not eat grapefruit or drink grapefruit juice, as both grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unexpected intensification of Asbima’s effect, particularly lowering of blood pressure.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you suspect you are pregnant or are planning a pregnancy. Your doctor will usually advise stopping Asbima before planning a pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Asbima is not recommended during early pregnancy (first 3 months) and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used beyond 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 planning to breastfeed, she should inform her doctor before starting Asbima. Asbima is not recommended during breastfeeding. The doctor may choose an alternative treatment if the patient wishes to breastfeed, especially if the infant is a newborn or premature.
Driving and operating machinery
This medicine may cause dizziness, which could impair the ability to concentrate. Therefore, patients should not drive, operate machinery, or perform any other tasks requiring mental alertness until they know how they personally 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 per tablet.
Asbima 5 mg + 160 mg and Asbima 10 mg + 160 mg: This medicinal product contains 18.5 mg of sorbitol per tablet.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Asbima

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist. This will help achieve the best treatment outcomes
and reduce the risk of adverse effects.
The recommended dose of Asbima is 1 tablet per day.

• It is recommended to take the medicine at the same time each day.
• Tablets should be swallowed with a glass of water.
• Asbima may be taken during meals or independently of meals. Do not take Asbima together with grapefruit or grapefruit juice.

Depending on the response to treatment, the doctor may recommend a higher or lower dose of the medicine. Do not take a higher dose than recommended.
Use of Asbima in elderly patients (aged 65 years and above)
The doctor will exercise caution when increasing the dose.
If there are any further doubts regarding the use of this medicine, consult a
doctor or pharmacist.
Taking more Asbima than recommended
If too many Asbima tablets have been taken or if the tablets have been accidentally ingested by another
person, consult a doctor immediately.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary oedema) may occur
within 24 to 48 hours after taking the medicine.
Missed dose of Asbima
If a patient forgets to take the medicine, it should be taken 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 Asbima treatment
Stopping treatment with Asbima may lead to worsening of the disease. Do not discontinue
treatment unless advised by a doctor.
If there are any further doubts regarding the use of this medicine, consult a
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 may require immediate medical attention:
Severe side effects have occurred in a small number of patients (may occur in less than 1 in 1,000 people).
If any of the following symptoms occur, contact your doctor immediately:
Allergic reaction with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling of weakness, "emptiness" in the head).

Other possible side effects of Asbima medicine:
Common (may occur in less than 1 in 10 people):
Flu-like illness; nasal congestion, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); flushing and sensation of warmth in the face and (or) neck.

Uncommon (may occur in less than 1 in 100 people):
Dizziness; nausea and abdominal pain; dryness of the oral mucosa; drowsiness, tingling or numbness in hands or feet; vertigo, rapid heart rate including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; joint pain.

Rare (may occur in less than 1 in 1,000 people):
Feeling of anxiety; ringing in the ears (tinnitus); fainting; passing more urine than usual or feeling a stronger 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; rash over the entire body; itching; muscle cramps.
If any of these symptoms worsen, inform your doctor.

Side effects reported after administration of amlodipine or valsartan alone, which have not been observed after administration of Asbima or which have been observed more frequently with amlodipine or valsartan than with Asbima:

Amlodipine
If any of the following very rare, serious side effects occur after taking the medicine, contact your doctor immediately:

• sudden onset of wheezing, chest pain, shortness of breath or difficulty breathing;
• swelling of eyelids, face or lips;
• swelling of the tongue and throat causing significant breathing difficulties;
• severe skin reactions, including intense skin rash, urticaria, redness of the entire skin surface, severe itching, blisters, skin peeling and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• heart attack, cardiac arrhythmias;
• pancreatitis, which may cause severe upper abdominal pain radiating to the back, accompanied by very poor general condition.

The following side effects have been reported. If any of these side effects are troublesome for the patient or persist for more than one week, contact your doctor.

Common (may occur in less than 1 in 10 people):
Dizziness, drowsiness; palpitations (awareness of heart beating); sudden flushing; swelling around the ankles (oedema); abdominal pain, nausea.

Uncommon (may occur in less than 1 in 100 people):
Mood changes, anxiety, depression, insomnia, tremor, taste disturbances, fainting, lack of pain sensation; visual disturbances, worsening of vision, tinnitus; low blood pressure; sneezing/rhinitis due to inflammation of the nasal mucosa; indigestion, vomiting; hair loss, increased sweating, skin itching, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; erectile dysfunction, discomfort or enlargement of breasts in men, pain, malaise, muscle pain, muscle cramps; increase or decrease in body weight.

Rare (may occur in less than 1 in 1,000 people):
Disorientation.

Very rare (may occur in less than 1 in 10,000 people):
Decreased number of white blood cells, decreased number of platelets, which may lead to unusual bruising or easier bleeding; increased blood glucose levels (hyperglycaemia); gum swelling and (or) bleeding gums, abdominal bloating (dyspepsia); abnormal liver function, hepatitis, yellowing of the skin (jaundice), increased liver enzyme activity detected in certain test results; increased muscle tension; vasculitis, often with skin rash, photosensitivity.

Unknown (frequency cannot be estimated from available data):
Tremor, muscle rigidity, mask-like facial expression, slowed movements and shuffling gait, unsteady gait.

Valsartan
Unknown (frequency cannot be estimated from available data):
Decreased number of red blood cells, fever, sore throat or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; kidney function disorders and kidney failure; oedema, mainly of the face and throat; muscle pain; rash, purple-red spots on the skin; fever; itching; allergic reactions, blister formation on the skin (a symptom of a condition called bullous pemphigoid).
If any of the above symptoms occur, inform your doctor immediately.

Reporting of side effects
If any side effects occur, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 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 authorisation holder or its representative in Poland.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store the medicine Asbima

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after: "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Store below 30°C.
Keep in the original packaging to protect from moisture and light.
Medicines must 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 Asbima contains

• The active substances in the medicine are amlodipine and valsartan.
  Asbima 5 mg + 80 mg, film-coated tablets: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate) and 80 mg valsartan.
  Asbima 5 mg + 160 mg, film-coated tablets: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
  Asbima 10 mg + 160 mg, film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate) and 160 mg valsartan.
• Other ingredients are:
  Tablet core: microcrystalline cellulose silicon dioxide (containing microcrystalline cellulose and colloidal anhydrous silica), sorbitol, magnesium carbonate + pregelatinized starch, maize, partially pregelatinized starch, maize, povidone 25, sodium stearyl fumarate, sodium lauryl sulfate, crospovidone type A, colloidal anhydrous silica, 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 approximately 9 mm.
Asbima 5 mg + 160 mg, film-coated tablets: light yellow, oblong film-coated tablet with dimensions of approximately 14 × 7 mm.
Asbima 10 mg + 160 mg, film-coated tablets: yellow, oblong film-coated tablet with a division line, with dimensions of approximately 14 × 7 mm. The division line on the tablet is not intended for breaking the tablet.
Pack sizes: 7, 14, 28, 30, 56, 90, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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

For further information about this medicine and its trade names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel.: +48 22 375 92 00