AVIOR 5 mg/80 mg Film-Coated Tablets

Зміст інструкції

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

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

1. What Avior is and what it is used for

Avior tablets contain two active ingredients called amlodipine and valsartan. Both
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 the group of substances called “angiotensin II receptor antagonists”. 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, the blood vessels relax and blood pressure decreases. Avior 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 Avior

Do not take Avior

• if you are allergic to amlodipine or to any other calcium antagonist. This may involve itching, redness of the skin or difficulty in breathing.
• if 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 or pharmacist before taking Avior.
• if you have severe liver problems or problems with bile such as biliary cirrhosis or cholestasis.
• if you are pregnant for more than 3 months (it is best to avoid taking Avior even in the early stages of pregnancy, see the Pregnancy section).
• if you have very low blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to provide enough blood to the body).
• if you suffer from heart failure following a 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 any of these applies to you, do not take Avior and consult your doctor.

Warnings and precautions
Talk to your doctor before taking Avior:

• if you have felt unwell (vomiting or diarrhoea).
• if you have problems with your liver or kidneys.
• if you have had a kidney transplant or if you have been told you have a narrowing of the renal arteries.
• if you suffer from a disease affecting the adrenal glands called “primary hyperaldosteronism”.
• if you have had heart failure or have had a heart attack. Carefully follow your doctor's instructions for the initial dose. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (called “aortic or mitral stenosis”) or that the thickness of the heart muscle has increased abnormally (a condition called “obstructive hypertrophic cardiomyopathy”).
• if you have previously experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme (ACE) inhibitors). If you experience these symptoms, stop taking Avior and contact your doctor immediately. You should never take Avior again.
• if you suffer from kidney problems where blood flow to the kidneys is reduced (renal artery stenosis).
• if you are taking any of the following medicines used to treat high blood pressure:
• an angiotensin converting enzyme (ACE) inhibitor (for example enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes;
• aliskiren.

The doctor may check kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in the blood at regular intervals.
See also the information under “Do not take Avior”.

If any of these conditions applies to you, tell your doctor before taking
Avior.
Children and adolescents
The use of Avior in children and adolescents is not recommended (under 18 years of age).

Other medicines and Avior
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 especially true for the medicines listed below:

• ACE inhibitors or aliskiren (see also the information under: “Do not take Avior” and “Warnings and precautions”);
• diuretics (a type of medicine also called “water tablets” that increase the amount of urine produced);
• 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;
• some 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 agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St John's wort;
• nitroglycerin and other nitrates or other substances called “vasodilators”;
• medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (infusion for severe body temperature abnormalities);
• medicines used to protect against transplant rejection (cyclosporine).

Avior with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are
taking Avior. This is because grapefruit and grapefruit juice can lead to an
increase in the blood levels of the active substance amlodipine, which can cause an
unpredictable increase in the blood pressure lowering effect of Avior.

Pregnancy and breastfeeding
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 Avior
before becoming pregnant or as soon as you find out you are pregnant and
will advise you to take another medicine instead of Avior. Avior is not recommended
in the early stages of pregnancy (first 3 months) and should not be taken if you are pregnant for
more than 3 months as it can cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Amlodipine has been shown to pass into breast milk in small amounts. Avior 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.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
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.

3. How to take Avior

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor. This will help you to obtain better results and to decrease the risk of adverse
effects.
The usual dose of Avior 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.
• Avior can be taken both on a full stomach or an empty stomach. Do not take Avior with grapefruit or grapefruit juice. Based on your response to treatment, your doctor may suggest a lower or higher dosage.

Do not take more than the prescribed dose.

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

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

If you forget to take Avior
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
and do not take a double dose to make up for the forgotten tablet.

If you stop taking Avior
Stopping treatment with Avior may cause a worsening of your condition. Do not
stop taking your medicine unless you have been told to do so by your doctor.

4. Possible side effects

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

Some side effects can be serious and require immediate medical attention:
Few patients have experienced these life-threatening side effects (may

affect up to 1 in 1,000 people). 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, lips or
tongue, difficulty breathing, low blood pressure (feeling of weakness, feeling
of lightheadedness).

Other possible side effects of Avior:

Common(may affect up to 1 in 10 people): Flu; nasal congestion, sore throat and discomfort
during swallowing, headache; swelling of the arms, hands, legs, ankles or feet;
fatigue; asthenia (weakness); redness and/or 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 heart
rate, 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 people): Feeling of anxiety; ringing in the ears
(tinnitus); fainting; passing a larger amount of 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.
Side effects reported with amlodipine or valsartan alone and not observed with Avior or
observed with a higher frequency than with Avior:
Amlodipine

If you notice any of the following very rare and serious side effects, consult
your doctor immediately:
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 which can cause difficulty breathing.
Severe skin reactions including intense rash, hives, skin redness
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.
Heart attack, abnormal heartbeat.
Inflammation of the pancreas which can cause severe abdominal and back pain accompanied
by a feeling of severe malaise.
The following side effects have been reported. If any of these effects occur or persist
for more than a week, contact your doctor.

Common (may affect up to 1 in 10):Dizziness; drowsiness; palpitations (feeling your
own heartbeat); redness, swelling of the ankles (edema); abdominal pain, feeling
sick (nausea).

Uncommon (may affect up to 1 in 100):Changes in mood, anxiety,
depression, insomnia, tremor, altered taste, fainting, loss of
sensitivity to pain; vision 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; change in skin color; difficulty urinating, needing to urinate at
night; needing to urinate frequently; inability to achieve an erection; discomfort or enlargement of
the breast in men; pain; malaise; 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):Reduction in the number 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 blood vessels, often with skin rash, sensitivity to light; disorders
related to stiffness, tremor and/or movement disorders.
Valsartan

Not known (frequency cannot be estimated based on available data):Decrease in
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; formation of blisters on the skin
(sign of a condition called bullous dermatitis).
If you experience any of these effects, inform 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 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 Avior

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 package and on the blister after
“Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Store in the original package to protect the medicine from moisture.
Do not use this medicine if you notice that the package is damaged or shows signs of tampering.

6. Package Contents and Other Information

What Avior Contains

• The active ingredients of Avior are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.
• The active ingredients of Avior are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
• The active ingredients of Avior are amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.
• The other ingredients are microcrystalline cellulose (E460), povidone (E1201), sodium croscarmellose (E468), talc (E553b), magnesium stearate (E570), hypromellose (E464), macrogol (E1521), titanium dioxide (E171); [ only 5 mg/80 mg and 5 mg/160 mg tablets]:iron oxide, yellow (E172).

Description of the Appearance of Avior and Package Contents
Avior 5 mg/80 mg tablets are 8 mm, round, biconvex and yellow with imprinted “I” on
one side and “LD” on the other.
Avior 5 mg/160 mg tablets are 13.5 mm long and 7 mm wide, oval, biconvex and yellow
with imprinted “2” on one side and “LD” on the other side.
Avior 10 mg/160 mg tablets are 13.5 mm long and 7 mm wide, oval, biconvex and
white with imprinted “3” on one side and “LD” on the other side.
Packs: 28 film-coated tablets.
Not all pack sizes may be marketed

Marketing Authorisation Holder
Dymalife Pharmaceutical S.r.l.,
Via Bagnulo, 95,
Piano di Sorrento (Napoli),
80063, Italy

Manufacturer
Balkanpharma Dupnitza AD
3 Samokovsko Shosse Str.,
Dupnitsa
2600, Bulgaria