Amlodipine and valsartan Doc Generici: detailed information

Patient Information Leaflet: Information for the User

AMLODIPINE AND VALSARTAN DOC 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
Please 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What AMLODIPINE AND VALSARTAN DOC is and what it is used for
What you need to know before taking AMLODIPINE AND VALSARTAN DOC
How to take AMLODIPINE AND VALSARTAN DOC
Possible side effects
How to store AMLODIPINE AND VALSARTAN DOC
Contents of the pack and other information

1. What AMLODIPINA E VALSARTAN DOC is and what it is used for

AMLODIPINA E VALSARTAN DOC 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, thereby preventing 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, thus increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both substances help prevent the narrowing of blood vessels. As a result, blood vessels relax and blood pressure decreases.
AMLODIPINA E VALSARTAN DOC is used for the treatment of 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 AMLODIPINE AND VALSARTAN DOC

Do not take AMLODIPINE AND VALSARTAN DOC

if you are allergic to amlodipine or to any other calcium channel blocker. This may cause itching, skin redness or difficulty 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 AMLODIPINE AND VALSARTAN DOC
if you have severe liver problems or bile-related problems such as biliary cirrhosis or cholestasis
if you are more than 3 months pregnant (it is better to avoid taking AMLODIPINE AND VALSARTAN DOC even in the early stages of pregnancy; see section "Pregnancy")
if you have very low blood pressure (hypotension)
if 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)
if you suffer from heart failure following a heart attack
if you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren

If any of these apply to you, do not take AMLODIPINE AND VALSARTAN DOC and consult your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking AMLODIPINE AND VALSARTAN DOC:

if you have been unwell (vomiting or diarrhoea)
if you have liver or kidney problems
if you have had a kidney transplant or if you have been told you have 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 a heart attack. Follow your doctor’s instructions carefully regarding initial dosing. Your doctor may also monitor your kidney function
if your doctor has told you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or that the thickness of your heart muscle has abnormally increased (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 inhibitors). If you experience these symptoms, stop taking AMLODIPINE AND VALSARTAN DOC immediately and contact your doctor right away. You must never take AMLODIPINE AND VALSARTAN DOC again
if 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 AMLODIPINE AND VALSARTAN DOC".
If any of these conditions apply to you, inform your doctor before taking AMLODIPINE AND VALSARTAN DOC.
Children and adolescents
The use of AMLODIPINE AND VALSARTAN DOC is not recommended in children and adolescents (under 18 years of age).
Other medicines and AMLODIPINE AND VALSARTAN DOC
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may consider it necessary 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 AMLODIPINE AND VALSARTAN DOC" and "Warnings and precautions");
diuretics (a type of medicine 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 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);
tacrolimus (used to control the body’s immune response, allowing the body to accept a transplanted organ);
medicines used to treat bacterial infections (antibiotics 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 prevent transplant rejection (cyclosporine).

AMLODIPINE AND VALSARTAN DOC with food and drink
Grapefruit and grapefruit juice must not be consumed by people taking AMLODIPINE AND VALSARTAN DOC. This is because grapefruit and grapefruit juice can lead to increased blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effect of AMLODIPINE AND VALSARTAN DOC.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. Your doctor will normally advise you to stop taking AMLODIPINE AND VALSARTAN DOC before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. AMLODIPINE AND VALSARTAN DOC is not recommended during early pregnancy (first 3 months) and must not be taken after 3 months of pregnancy, as it may cause serious harm to the unborn child if taken beyond 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, you must inform your doctor before taking CANTESIO AMLODIPINE AND VALSARTAN DOC is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
Ask your doctor or pharmacist for advice before taking any medicine.
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 other activities requiring concentration.
AMLODIPINE AND VALSARTAN DOC contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., essentially ‘sodium-free’.

3. How to take AMLODIPINA E VALSARTAN DOC

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
undesirable effects.
The recommended dose is one tablet of AMLODIPINA E VALSARTAN DOC daily.

It is preferable to take the medicine at the same time every day.
Swallow the tablets with a glass of water.
AMLODIPINA E VALSARTAN DOC may be taken with or without food. Do not take AMLODIPINA E VALSARTAN DOC with grapefruit or grapefruit juice.

Depending on your response to treatment, your doctor may suggest a lower or higher dose.
Do not exceed the prescribed dose.
AMLODIPINA E VALSARTAN DOC 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 AMLODIPINA E VALSARTAN DOC than you should
If you have taken too many AMLODIPINA E VALSARTAN DOC tablets, or if someone else has taken your
tablets, contact a doctor immediately.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may
develop within 24–48 hours after ingestion.
If you forget to take AMLODIPINA E VALSARTAN DOC
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 the forgotten tablet.
If you stop taking AMLODIPINA E VALSARTAN DOC
Stopping treatment with AMLODIPINA E VALSARTAN DOC may cause your condition to worsen. Do not stop taking the 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 can 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 experience any of the following side effects, contact 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, sensation of emptiness in the head).

Other possible side effects of AMLODIPINE AND VALSARTAN DOC:
Common (may affect up to 1 in 10 people): flu-like illness; nasal congestion, sore throat and difficulty swallowing, headache; swelling of the arms, hands, legs, ankles or feet; fatigue; asthenia (weakness); flushing and/or 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 the 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; increased amount of urine or more urgent need to urinate, inability to achieve or maintain an erection, feeling of heaviness; low blood pressure with symptoms such as dizziness, sensation of emptiness in the head; excessive sweating; rashes all over the body; itching; muscle spasms.
If any of these side effects become severe, inform your doctor.

Side effects reported with amlodipine or valsartan used alone, not observed with AMLODIPINE AND VALSARTAN DOC or observed with higher frequency than with AMLODIPINE AND VALSARTAN DOC:

Amlodipine
If you notice any of the following very rare and serious side effects, consult your 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 severe breathing difficulties.
Severe skin reactions including severe rash, urticaria, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.
Heart attack, abnormal heartbeat.
Inflammation of the pancreas which may cause severe abdominal and back pain associated with a strong feeling of malaise.

The following side effects have been reported. If you experience any of these side effects or if they persist for more than one week, contact your doctor.
Common (may affect up to 1 in 10 people): dizziness, drowsiness; palpitations (awareness of your heartbeat); flushing, ankle swelling (oedema); abdominal pain, nausea.
Uncommon (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, tremor, altered taste, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis); indigestion, vomiting; hair loss, increased sweating, skin itching, skin discoloration; urinary problems, increased 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): decrease in the number 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, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may lead to changes in certain laboratory tests; increased muscle tension; inflammation of blood vessels, often with rash, photosensitivity; disorders related to stiffness, tremor and/or movement disorders.
Not known (frequency cannot be estimated from the available data): tremor, rigid posture, lack of facial expression, slow and laboured movements, unbalanced gait.

Valsartan
Not known (frequency cannot be estimated from the available data): decrease 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 tests; 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; blistering of the skin (symptom of a condition called bullous dermatitis).
If any of these side effects affect you, 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 the website 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 AMLODIPINE AND VALSARTAN DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.

6. Package contents and other information

What AMLODIPINA E VALSARTAN DOC contains
The active substances in AMLODIPINA E VALSARTAN DOC are amlodipine (as amlodipine besylate) and
valsartan. Each tablet contains 5 mg of amlodipine and 80 mg of valsartan.
The active substances in AMLODIPINA E VALSARTAN DOC are amlodipine (as amlodipine besylate) and
valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
The active substances in AMLODIPINA E VALSARTAN DOC are amlodipine (as amlodipine besylate) and
valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.

Other components: microcrystalline cellulose, povidone, sodium croscarmellose, talc, magnesium stearate, hypromellose, macrogol, titanium dioxide (E171); [only for tablets 5 mg/80 mg and 5 mg/160 mg]: red iron oxide, yellow iron oxide (E172)

Description of the appearance of AMLODIPINA E VALSARTAN DOC and contents of the pack
AMLODIPINA E VALSARTAN DOC 5 mg/80 mg tablets are round, biconvex, yellow, 8 mm in diameter, with "I" engraved on one side and "LD" on the other.
AMLODIPINA E VALSARTAN DOC 5 mg/160 mg tablets are oval, biconvex, yellow, measuring 13.5 mm in length x 7 mm in width, with "2" engraved on one side and "LD" on the other.
AMLODIPINA E VALSARTAN DOC 10 mg/160 mg tablets are oval, biconvex, white, measuring 13.5 mm in length x 7 mm in width, with "3" engraved on one side and "LD" on the other.
AMLODIPINA E VALSARTAN DOC is available in packs of 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milano
Manufacturer
Balkanpharma Dupnitza AD
3 Samokovsko Shosse Str.
Dupnitza 2600
Bulgaria