Amlodipine and valsartan Krka Pharma: detailed information

Patient Information Leaflet: Information for the User

Amlodipine and Valsartan Krka Pharma 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 all of 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amlodipine and Valsartan Krka Pharma is and what it is used for
What you need to know before taking Amlodipine and Valsartan Krka Pharma
How to take Amlodipine and Valsartan Krka Pharma
Possible side effects
How to store Amlodipine and Valsartan Krka Pharma
Contents of the pack and other information

1. What Amlodipine and Valsartan Krka Pharma is and what it is used for

Amlodipine and Valsartan Krka Pharma 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 blocks the flow of calcium into 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, thereby 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 widen and blood pressure is lowered.
Amlodipine and Valsartan Krka Pharma is used for the treatment of high blood pressure in adults whose blood pressure is not sufficiently controlled with amlodipine or valsartan alone.

2. What you need to know before taking Amlodipine and Valsartan Krka Pharma

Do not take Amlodipine and Valsartan Krka Pharma

if you are allergic to amlodipine or any other calcium channel blocker, as 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, ask your doctor before taking Amlodipine and Valsartan Krka Pharma.
if you have severe liver problems or bile-related disorders such as biliary cirrhosis or cholestasis.
if you are more than 3 months pregnant. (It is best to avoid Amlodipine and Valsartan Krka Pharma in early pregnancy; see section "Pregnancy".)
if you have severely low blood pressure (hypotension).
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to meet the body's needs).
if you have heart failure following a heart attack.
if you have high blood sugar and have type 2 diabetes (also known as non-insulin-dependent diabetes mellitus) or impaired kidney function and are being treated with a blood pressure-lowering medicine called aliskiren.

If you think any of the above apply to you, do not take Amlodipine and Valsartan Krka Pharma and inform your doctor.
Warnings and precautions
Talk to your doctor before taking Amlodipine and Valsartan Krka Pharma:

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 have a condition affecting the adrenal glands called "primary hyperaldosteronism".
if you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. Your doctor may also monitor your kidney function.
if your doctor has told you that you have narrowing of heart valves (called "aortic or mitral stenosis") or that the thickness of your heart muscle has abnormally increased (called "obstructive hypertrophic cardiomyopathy").
if you have 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 Krka Pharma immediately and contact your doctor without delay. You must not take Amlodipine and Valsartan Krka Pharma again.
if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly 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 information under the heading “Do not take Amlodipine and Valsartan Krka Pharma”.
If any of these conditions apply to you, inform your doctor before taking Amlodipine and Valsartan Krka Pharma.
Children and adolescents
Amlodipine and Valsartan Krka Pharma is not recommended for use in children and adolescents (under 18 years of age).
Other medicines and Amlodipine and Valsartan Krka Pharma
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 or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important for the following medicines:

other blood pressure-lowering medicines known as ACE inhibitors or aliskiren;
diuretics (medicines that increase urine production);
lithium (a medicine used to treat certain forms of depression);
potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and 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;
anticonvulsants (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 cholesterol levels);
dantrolene (intravenous infusion for serious body temperature abnormalities);
medicines used to prevent transplant rejection (cyclosporine, tacrolimus).

Amlodipine and Valsartan Krka Pharma with food and drink
Grapefruit and grapefruit juice must not be consumed by people taking Amlodipine and Valsartan Krka Pharma. This is because grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable drop in blood pressure and increase the effects of Amlodipine and Valsartan Krka Pharma.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you may be (or could become) pregnant. Your doctor will usually advise you to stop taking Amlodipine and Valsartan Krka Pharma before pregnancy or as soon as you know you are pregnant, and will recommend an alternative medicine.
Amlodipine and Valsartan Krka Pharma is not recommended during early pregnancy (first 3 months), and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Amlodipine and Valsartan Krka Pharma is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a 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 could affect your concentration. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activity requiring concentration.

3. How to take Amlodipine and Valsartan Krka Pharma

Take this medicine exactly as your doctor has told you. If you have
any doubts, consult your doctor. This will help you achieve the best possible result with the lowest risk of
unwanted side effects.
The usual dose of Amlodipine and Valsartan Krka Pharma is one tablet per day.

It is preferable to take the medicine at the same time each day.
Swallow the tablets with a glass of water.
You may take Amlodipine and Valsartan Krka Pharma with or without food. Do not take Amlodipine and Valsartan Krka Pharma with grapefruit or grapefruit juice. Depending on how you respond to treatment, your doctor may recommend a higher or lower dose. Do not exceed the prescribed dose.

Amlodipine and Valsartan Krka Pharma and elderly patients (aged 65 years and over)
Your doctor should be cautious when increasing the dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
If you take more Amlodipine and Valsartan Krka Pharma than you should
If you have taken too many tablets of Amlodipine and Valsartan Krka Pharma, or if someone else has taken the tablets, inform your doctor immediately.
If you forget to take Amlodipine and Valsartan Krka Pharma
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 your next dose, skip the missed dose. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Amlodipine and Valsartan Krka Pharma
Stopping treatment with Amlodipine and Valsartan Krka Pharma may worsen your condition. Do not stop taking this medicine unless your doctor tells you to do so.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 effects, tell your doctor
immediately:
Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips or tongue,
difficulty breathing, low blood pressure (feeling faint, lightheadedness).
Other possible side effects of Amlodipine and Valsartan Krka Pharma:
Common (may affect up to 1 in 10 people): flu-like illness (fever); nasal congestion, sore throat
and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet;
fatigue; asthenia (weakness); facial and/or neck flushing and sensation of warmth.
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 rash, 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 urine production or increased urge to urinate; inability to achieve or
maintain an erection; sensation of heaviness; low blood pressure with symptoms such as
dizziness, lightheadedness; excessive sweating; skin rash over the entire body; itching;
muscle spasms.
If any of the following effects affect you severely, tell your doctor.
Side effects reported with amlodipine and valsartan used alone, not observed with
Amlodipine and Valsartan Krka Pharma or observed with a higher frequency with
Amlodipine and Valsartan Krka Pharma:
Amlodipine
Tell your doctor immediately if you experience any of the following very rare, serious side
effects after taking this medicine:

Sudden shortness of breath, chest pain, difficulty breathing.
Swelling of the eyelids, face or lips.
Swelling of the tongue and throat causing severe breathing difficulties.
Severe skin reactions including intense skin rash, urticaria, widespread redness of the skin, severe itching, blisters, dryness and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions.
Heart attack, abnormal heartbeat.
Inflamed pancreas, which may cause severe abdominal pain and back pain accompanied by malaise.

The following side effects have been reported. If any of these cause you problems or persist for more than one week, you must tell your doctor.
Common (may affect up to 1 in 10 people): dizziness, drowsiness; palpitations (awareness of heartbeat); flushing, ankle swelling (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 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 (feeling sick); hair loss, increased sweating, itching, skin colour changes; urinary disorders, increased need to urinate at night, frequent need to urinate; inability to achieve an erection, discomfort or breast enlargement in men, pain, feeling unwell, 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): Reduction in white blood cell count, decreased platelets in the blood, which may lead to unusual bruising or easy bleeding (damage to red blood cells); high blood sugar (hyperglycaemia); gum swelling, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, photosensitivity;
Not known (frequency cannot be estimated from available data): tremor, rigid posture, mask-like face, slow movements and shuffling gait, unbalanced walking.
Valsartan
Not known (frequency cannot be estimated from available data): Decrease in red blood cells, fever, sore throat or mouth ulcers 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 mainly 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, tell 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/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine and Valsartan Krka Pharma

Keep this medicine out of the sight and reach of children.
Do not use Amlodipine and Valsartan Krka Pharma after the expiry date stated on the
pack and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Amlodipine and Valsartan Krka Pharma contains

The active substances are valsartan and amlodipine.
Amlodipine and valsartan 5 mg/80 mg film-coated tablets: Each 5 mg/80 mg film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate) and 80 mg of valsartan.
Amlodipine and valsartan 5 mg/160 mg film-coated tablets: Each 5 mg/160 mg film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan.
Amlodipine and valsartan 10 mg/160 mg film-coated tablets: Each 10 mg/160 mg film-coated tablet contains 10 mg of amlodipine (as amlodipine besilate) and 160 mg of valsartan.
The other ingredients are microcrystalline cellulose, magnesium stearate, croscarmellose sodium, povidone K25, sodium lauryl sulfate, mannitol and anhydrous colloidal silica in the tablet core; and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, yellow iron oxide (E172), red iron oxide (E172) – only in the coating of 5 mg/320 mg tablets.

Description of the appearance of Amlodipine and Valsartan Krka Pharma and contents of the pack
Amlodipine and Valsartan Krka Pharma 5 mg/80 mg film-coated tablets (tablets):
This medicinal product is a yellowish-brown, round, slightly biconvex tablet with bevelled edges and possible dark specks (tablet diameter: 8 mm, thickness: 3.0 mm – 4.3 mm).
Amlodipine and Valsartan Krka Pharma 5 mg/160 mg film-coated tablets (tablets):
This medicinal product is a yellowish-brown, oval, biconvex tablet with bevelled edges and possible dark specks (tablet dimensions: 13 mm x 8 mm, thickness: 3.8 mm – 5.4 mm).
Amlodipine and Valsartan Krka Pharma 10 mg/160 mg film-coated tablets (tablets):
This medicinal product is a pale yellowish-brown, oval, biconvex tablet (tablet dimensions: 13 mm x 8 mm, thickness: 3.8 mm – 5.4 mm).

Blister (OPA/Al/PVC-Al foil): 28 tablets in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA D.D. NOVO MESTO, SMARJESKA CESTA 6, 8501 - NOVO MESTO, SLOVENIA

Manufacturer responsible for batch release
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Krka-farma d.o.o., V. Holjevca 20/E, 10 450 Jastrebarsko, Croatia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

This medicinal product is authorized in the European Economic Area countries under the following names:

Member State Name	Medicinal Product Name
Hungary	Amlodipin/Valsartan Krka Pharma
Italy	Amlodipine and Valsartan Krka Pharma

Patient Information Leaflet: Information for the User

Amlodipine and Valsartan Krka Pharma 5 mg/320 mg film-coated tablets, 10 mg/320 mg film-coated tablets

Amlodipine/Valsartan
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Amlodipine and Valsartan Krka Pharma is and what it is used for
What you need to know before taking Amlodipine and Valsartan Krka Pharma
How to take Amlodipine and Valsartan Krka Pharma
Possible side effects
How to store Amlodipine and Valsartan Krka Pharma
Contents of the pack and other information

1. What Amlodipine and Valsartan Krka Pharma is and what it is used for

Amlodipine and Valsartan Krka Pharma is used for the treatment of high blood pressure in patients who are already taking amlodipine and valsartan at these doses, instead of taking these two medicines separately.
Amlodipine and Valsartan Krka Pharma tablets contain two substances called amlodipine and valsartan. Both of these substances help control high blood pressure.

Amlodipine belongs to a group of substances called “calcium channel blockers”. Amlodipine blocks the influx of calcium into the walls of blood vessels, thereby preventing the narrowing of blood vessels.
Valsartan belongs to a group of substances called “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 widen and blood pressure is lowered.

2. What you should know before taking Amlodipine and Valsartan Krka Pharma

Do not take Amlodipine and Valsartan Krka Pharma

if you are allergic to amlodipine or any other calcium channel blocker, as 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 before taking Amlodipine and Valsartan Krka Pharma.
if you have severe liver problems or bile-related disorders such as biliary cirrhosis or cholestasis.
if you are more than 3 months pregnant (it is better to avoid Amlodipine and Valsartan Krka Pharma during early pregnancy; see section "Pregnancy").
if you have severely low blood pressure (hypotension).
if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart cannot pump enough blood to the body).
if you have heart failure following a heart attack.
if you have high blood sugar and have type 2 diabetes (also known as non-insulin-dependent diabetes mellitus), or impaired kidney function and are being treated with a blood pressure-lowering medicine called aliskiren.

If you think any of the above conditions apply to you, do not take Amlodipine and Valsartan Krka Pharma and inform your doctor.
Warnings and precautions
Talk to your doctor before taking Amlodipine and Valsartan Krka Pharma:

if you have recently been unwell (with 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 have a condition affecting the adrenal glands called "primary hyperaldosteronism".
if you have had heart failure or a heart attack. Follow your doctor's instructions carefully when starting treatment. 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 (called "obstructive hypertrophic cardiomyopathy").
if you have 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 Krka Pharma immediately and contact your doctor without delay. You must not take Amlodipine and Valsartan Krka Pharma 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 Krka Pharma”.
If any of these conditions apply to you, inform your doctor before taking Amlodipine and Valsartan Krka Pharma.
Children and adolescents
The use of Amlodipine and Valsartan Krka Pharma is not recommended in children and adolescents (under 18 years of age).
Other medicines and Amlodipine and Valsartan Krka Pharma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to adjust your dose or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important for the following medicines:

other medicines used to lower blood pressure, called ACE inhibitors or aliskiren;
diuretics (a type of medicine that increases the amount of urine produced);
lithium (a medicine used to treat certain forms of depression);
potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, and 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;
anticonvulsants (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 cholesterol levels);
dantrolene (infusion for severe body temperature abnormalities);
medicines used to prevent transplant rejection (cyclosporine, tacrolimus).

Amlodipine and Valsartan Krka Pharma with food and drink
Grapefruit and grapefruit juice must not be consumed by people taking Amlodipine and Valsartan Krka Pharma. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may lead to an unpredictable increase in blood pressure and reduce the effectiveness of Amlodipine and Valsartan Krka Pharma.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you think you are (or might be) pregnant. Your doctor will usually advise you to stop taking Amlodipine and Valsartan Krka Pharma before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine.
Amlodipine and Valsartan Krka Pharma 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 baby if taken beyond the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Amlodipine and Valsartan Krka Pharma is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a 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 concentration. Therefore, if you are unsure how this medicine affects you, do not drive, operate machinery, or perform any activities requiring concentration.

3. How to take Amlodipine and Valsartan Krka Pharma

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor.
Following these instructions will help you achieve the best results with the lowest risk of side effects.
The usual dose of Amlodipine and Valsartan Krka Pharma is one tablet per day.

It is preferable to take the medicine at the same time each day.
Swallow the tablets with a glass of water.
You may take Amlodipine and Valsartan Krka Pharma with or without food. Do not take Amlodipine and Valsartan Krka Pharma with grapefruit or grapefruit juice.

Depending on how you respond to treatment, your doctor may recommend a higher or lower dose.
Do not exceed the prescribed dose.
Amlodipine and Valsartan Krka Pharma and elderly patients (aged 65 years and over)
Your doctor should be cautious when increasing the dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you take more Amlodipine and Valsartan Krka Pharma than you should
If you have taken too many tablets of Amlodipine and Valsartan Krka Pharma, or if someone else has taken them, inform your doctor immediately.
If you forget to take Amlodipine and Valsartan Krka Pharma
If you forget to take your dose, take it as soon as you remember. Then take the next dose at your 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 the forgotten tablet.
If you stop taking Amlodipine and Valsartan Krka Pharma
Stopping treatment with Amlodipine and Valsartan Krka Pharma may worsen your condition. Do not stop taking this medicine unless your doctor tells you to do so.
If you have any doubts 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 experience any of the following, inform your doctor immediately:
Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue,
difficulty breathing, low blood pressure (feeling faint, lightheadedness).

Other possible side effects of Amlodipine and Valsartan Krka Pharma:
Common (may affect up to 1 in 10 people): flu-like symptoms (fever); 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 affect up to 1 in 100 people): dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness in hands or feet; vertigo; increased heart rate, including palpitations; dizziness upon standing; cough; diarrhoea; constipation; skin rash, 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 urine production or increased urge to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; rash over the entire body; itching; muscle spasms.

If any of the following side effects affect you severely, inform your doctor.
Side effects reported with amlodipine and valsartan used alone, not observed with Amlodipine and Valsartan Krka Pharma or observed with a higher frequency with Amlodipine and Valsartan Krka Pharma:

Amlodipine
Inform your doctor immediately if you experience any of the following very rare, serious side effects after taking this medicine:

Sudden shortness of breath, chest pain, difficulty breathing.
Swelling of the eyelids, face or lips.
Swelling of the tongue and throat causing severe breathing difficulties.
Severe skin reactions including intense skin rash, urticaria, widespread skin redness, severe itching, blisters, dryness and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome) or other allergic reactions.
Heart attack, abnormal heart rhythm.
Inflamed pancreas, which may cause severe abdominal pain and back pain accompanied by a general feeling of illness.

The following side effects have been reported. If any of these cause you problems or persist for more than one week, you must inform 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, tremors, 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 (feeling sick); hair loss, increased sweating, itching, skin colour changes; urinary disorders, increased need to urinate at night, frequent need to urinate; inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, 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): Decreased white blood cell count, reduced platelet count in the blood, which may lead to unusual bruising or easy bleeding (damage to red blood cells); high blood sugar (hyperglycaemia); gum swelling, abdominal swelling (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests; increased muscle tension; inflammation of blood vessels, often with skin rash, photosensitivity.
Not known (frequency cannot be estimated from the available data): tremor, rigid posture, mask-like face, slow movements and shuffling gait, unbalanced walking.

Valsartan
Not known (frequency cannot be estimated from the available data): Decreased red blood cell count, fever, sore throat or mouth ulcers 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 mainly 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/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine and Valsartan Krka Pharma

Keep this medicine out of the sight and reach of children.
Do not use Amlodipine and Valsartan Krka Pharma after the expiry date which is stated on the
carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amlodipine and Valsartan Krka Pharma contains

The active substances are valsartan and amlodipine. 5 mg/320 mg film-coated tablets:

Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besilate)
and 320 mg of valsartan.
10 mg/320 mg film-coated tablets:
Each film-coated tablet contains 10 mg of amlodipine (as amlodipine
besilate) and 320 mg of valsartan.

The other components are microcrystalline cellulose, magnesium stearate, sodium croscarmellose, povidone K25, sodium lauryl sulfate, mannitol and anhydrous colloidal silicon dioxide in the tablet core, and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc, yellow iron oxide (E172), red iron oxide (E172) – only in the 5 mg/320 mg tablets in the coating.

Description of the appearance of Amlodipine and Valsartan Krka Pharma and contents of the
package
Amlodipine and Valsartan Krka Pharma 5 mg/320 mg film-coated tablet (tablets):
this medicine is presented as capsule-shaped, brown, biconvex film-coated tablets
(tablet dimensions 16 mm x 8.5 mm, thickness: 5.5 mm – 7.5 mm).
Amlodipine and Valsartan Krka Pharma 10 mg/320 mg film-coated tablet
(tablets): this medicine is presented as capsule-shaped, yellowish-brown, biconvex film-coated tablets with possible dark specks (tablet dimensions 16 mm x 8.5 mm, thickness: 5.8 mm – 7.8 mm).
Blister (OPA/Al/PVC-Al foil): 28 tablets, in a box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
KRKA D.D. NOVO MESTO, SMARJESKA CESTA 6 8501 - NOVO MESTO SLOVENIA

This medicinal product is authorized in the European Economic Area countries under the
following
names:

Member State Name	Medicinal Product Name
Hungary	Amlodipin/Valsartan Krka Pharma
Italy	Amlodipine and Valsartan Krka Pharma