Asbima

Patient Information Leaflet: Information for the Patient

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

Amlodipine/Valsartan
Read this entire leaflet carefully before taking this medicine, because 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform 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 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 tablets contain two substances called amlodipine and valsartan. Both of these
substances help control high blood pressure.

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

Asbima is used to treat high blood pressure in adults whose blood pressure is not adequately 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 antagonist. This may cause itching, skin redness, or difficulty 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, consult your doctor before taking Asbima.
• you have severe liver problems or bile-related problems such as biliary cirrhosis or cholestasis.
• you are more than 3 months pregnant (it is better 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 narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to supply enough blood to the body).
• you have heart failure following a heart attack.
• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, do not take Asbima and consult your doctor.
Warnings and precautions
Talk to your doctor before taking Asbima if

• you have felt unwell (vomiting or diarrhoea).
• you have liver or kidney problems.
• you have had a kidney transplant or have been told you have narrowing of the renal arteries.
• you suffer from a condition affecting the adrenal glands called "primary hyperaldosteronism".
• you have had heart failure or a heart attack. Follow your doctor's instructions carefully regarding the initial dosage. Your doctor may also monitor your kidney function.
• your doctor has told you that you have narrowing of the heart valves (called "aortic or mitral stenosis") or that the heart muscle has abnormally thickened (a condition called "obstructive hypertrophic cardiomyopathy").
• you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you experience these symptoms, stop taking Asbima immediately and contact your doctor. You must never take Asbima again.
• you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
• aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section “Do not take Asbima if”.
If any of these conditions apply to you, inform 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 adjust the dose and/or take other precautions. In some cases, it may be necessary to stop taking one of the medicines.
This is particularly important for the following medicines:

• ACE inhibitors or aliskiren (see also the sections: “Do not take Asbima if” and “Warnings and precautions”);
• diuretics (a type of medicine also known as "water tablets" that increases the amount of urine produced);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other substances that may 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 monitor your kidney function;
• anticonvulsant agents (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 (heart medicines);
• tacrolimus (used to control the body's immune response, allowing the body to accept a transplanted organ);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (infusion for severe body temperature abnormalities);
• medicines used to prevent transplant rejection (cyclosporine).

Asbima with food, drinks and alcohol
Grapefruit and grapefruit juice must not be consumed by people taking Asbima. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of Asbima.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Asbima before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Asbima is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or planning to breastfeed, inform your doctor before taking Asbima. Asbima is not recommended for breastfeeding women, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
This medicine may cause dizziness. This may affect your ability to concentrate.
Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activity requiring concentration.
Asbima contains sorbitol (E-420) and sodium
Asbima 5 mg/80 mg film-coated tablets: This medicine contains 9.25 mg of sorbitol per 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 per tablet.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "sodium-free".

3. How to take Asbima

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. This will help you achieve better results and reduce the risk of unwanted side effects.
The recommended dose of Asbima is one tablet daily.

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

Depending on your response to treatment, your doctor may recommend a lower or higher dose. Do not take more than the prescribed dose.
Asbima and elderly patients (65 years of age and older)
Your doctor should exercise caution when increasing the dose.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.
If you take more Asbima than you should
If you have taken too many Asbima tablets, 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 your next dose at the usual time. However, if it is almost time for your 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 your condition to worsen. Do not stop taking your medicine unless instructed by your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical attention.
A small number of patients have experienced these serious side effects (may affect up to 1 in 1,000 people).
If you notice any of the following side effects, consult your doctor immediately:
Allergic reactions with symptoms such as rash, itching, swelling of the face, lips or tongue, difficulty breathing, low blood pressure (feeling of weakness, lightheadedness).

Other possible side effects of Asbima

Common (may affect up to 1 in 10 people):
Influenza-like illness; stuffy nose, sore throat and difficulty swallowing; headache; swelling of arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); redness and feeling of warmth in 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 in hands or feet; vertigo; rapid heartbeat including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rashes, redness of the skin; joint swelling, back pain; joint pain.

Rare (may affect up to 1 in 1,000 people):
Feeling of anxiety; ringing in the ears (tinnitus); fainting; passing a larger amount of urine than usual or increased urgency to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; rashes over the body; itching; muscle spasms.
If any of these effects occur severely, inform your doctor.

Side effects reported with amlodipine or valsartan alone, not observed with Asbima or observed with higher frequency with the individual components 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, breathlessness or difficulty breathing.
• Swelling of the eyelids, face or lips.
• Swelling of the tongue and throat which may cause difficulty breathing.
• Severe skin reactions including severe rash, hives, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
• Myocardial infarction, irregular heartbeat.
• Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of illness.

The following side effects have been reported. If any of these occur, or if they persist for more than one week, consult your doctor.

Common (may affect up to 1 in 10 people):
Dizziness, drowsiness; palpitations (awareness of heartbeat); flushing, swelling of the ankles (oedema); 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, skin itching, skin colour change; urinary disorders, need to urinate at night, frequent need to urinate; inability to achieve an erection, discomfort or breast enlargement in men, discomfort, muscle pain, muscle cramps; weight gain or weight loss.

Rare (may affect up to 1 in 1,000 people): Confusion.

Very rare (may affect up to 1 in 10,000 people):
Low levels of white blood cells and platelets in the blood which may lead to unusual bruising or tendency to bleed (damage to red blood cells); high blood sugar levels (hyperglycaemia); gum swelling, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to abnormalities in certain clinical tests; increased muscle tension; inflammation of blood vessels, often with skin rash, photosensitivity.

Frequency not known (frequency cannot be estimated from the available data):
Tremor, rigid posture, facial masking, slow and uncoordinated movements, unbalanced gait.

Valsartan
Frequency not known (frequency cannot be estimated from the available data):
Reduction in red blood cells, fever, sore throat or mouth pain due to infections; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; reduced kidney function and severe reduction in kidney function; swelling, especially of the face and throat; muscle pain; skin rash, red-purple spots; fever; itching; allergic reaction, skin blisters (signs of a condition called bullous dermatitis).
If you experience any of these side effects, inform your doctor immediately.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the blister and the outer carton following
“EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.
Store below 30°C in the original packaging to protect the medicine from moisture and light.

6. Package contents and other information

What Asbima contains
The active substances 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 components are: Tablet core: Silicified microcrystalline cellulose (containing microcrystalline cellulose and anhydrous colloidal silica); Sorbitol (E-420); Magnesium carbonate; Pregelatinized maize starch; Partially pregelatinized maize 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 contents of the pack
Asbima 5 mg/80 mg film-coated tablets: Yellow, round, film-coated tablet with dimensions of approximately 9 mm.
Asbima 5 mg/160 mg film-coated tablets: Light yellow, oblong, film-coated tablet with dimensions of approximately 14 x 7 mm.
Asbima 10 mg/160 mg film-coated tablets: Yellow, oblong, film-coated tablet with a breakline, with dimensions of approximately 14 x 7 mm. The score line is not intended to divide the tablet into equal parts.
Pack sizes: 7, 14, 28, 30, 56, 90 and 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization 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 authorized in the European Economic Area countries under the following names:
United Kingdom, Italy, Poland, Slovakia, Czech Republic, Lithuania, Cyprus, Greece, Bulgaria, Malta: Asbima