VALSARTAN 40 mg Film-Coated Tablets

Зміст інструкції

1. Valsartan Almus 40 mg Film-coated Tablets, 80 mg Film-coated Tablets, 160 mg Film-coated Tablets
   1. WHAT IS VALSARTAN ALMUS AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING VALSARTAN ALMUS
   3. HOW TO TAKE VALSARTAN ALMUS
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE VALSARTAN ALMUS
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Valsartan Almus 40 mg Film-coated Tablets, 80 mg Film-coated Tablets, 160 mg Film-coated Tablets

Generic medicine

Read this leaflet carefully before you start 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, 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 may 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 Valsartan Almus is and what it is used for
• 2. What you need to know before you take Valsartan Almus
• 3. How to take Valsartan Almus
• 4. Possible side effects
• 5. How to store Valsartan Almus
• 6. Contents of the pack and other information

1. WHAT IS VALSARTAN ALMUS AND WHAT IS IT USED FOR

Valsartan Almus belongs to a class of medicines known as angiotensin II receptor antagonists, which help to control high blood pressure. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Valsartan Almus works by blocking the effect of angiotensin II. The result is that blood vessels relax and blood pressure decreases.

Valsartan Almus 40 mg film-coated tablets can be used to treat three different conditions:

• in the treatment of high blood pressure in children and adolescents aged between 6 and 18 years.When blood pressure is high, the workload on the heart and arteries increases. If left untreated, this can damage the blood vessels of the brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these diseases.
• in the treatment of adult patients who have recently had a heart attack(myocardial infarction).“Recently” means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adult patients.Valsartan Almus is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used or can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This happens when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body. Valsartan Almus 80 mg film-coated tablets can be used to treat threedifferent conditions:
• in the treatment of high blood pressure in adults and in children and adolescents aged between 6 and 18 years.When blood pressure is high, the workload on the heart and arteries increases. If left untreated, this can damage the blood vessels of

brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these conditions.

• in the treatment of adult patients who have recently had a heart attack(myocardial infarction)."Recently" means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adult patients.Valsartan Almus is used when a group of medicines called angiotensin-converting enzyme (ACE) inhibitors (medicines used to treat heart failure) cannot be used or can be used in addition to ACE inhibitors when other medicines to treat heart failure cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This happens when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body. Valsartan Almus 160 mg film-coated tablets can be used to treat threedifferent conditions:
• in the treatment of high blood pressure in adults and in children and adolescents aged between 6 and 18 years.When blood pressure is high, the workload on the heart and arteries increases. If left untreated, this can damage the blood vessels of brain, heart and kidneys and can lead to stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attack. Bringing blood pressure back to normal values reduces the risk of developing these conditions.
• in the treatment of adult patients who have recently had a heart attack(myocardial infarction). "Recently" means from 12 hours to 10 days.
• in the treatment of symptomatic heart failure in adult patients.Valsartan Almus is used when angiotensin-converting enzyme (ACE) inhibitors (medicines for the treatment of heart failure) cannot be used or can be used in addition to ACE inhibitors when beta-blockers (other medicines for the treatment of heart failure) cannot be used. Symptoms of heart failure include shortness of breath and swelling of the feet and legs due to fluid accumulation. This happens when the heart muscle fails to pump blood forcefully enough to supply all the blood needed to every part of the body.

2. WHAT YOU NEED TO KNOW BEFORE TAKING VALSARTAN ALMUS

Do not take Valsartan Almus:

• if you are allergic(hypersensitive) to valsartan or to any of the other ingredients of this medicine (listed in section 6).
• if you suffer from a severe liver disease.
• if you are pregnant for more than 3 months(it is best to avoid taking Valsartan Almus in the early stages of pregnancy - see the Pregnancy section).
• 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 conditions apply to you, do not take Valsartan Almus.
Warnings and precautions
Talk to your doctor or pharmacist before taking Valsartan Almus.

• if you have liver diseases.
• if you have severe kidney diseases or if you are undergoing dialysis .
• if you suffer from a narrowing of the renal artery.
• if you have recently undergone a kidney transplant (received a new kidney).
• if you are being treated after a heart attack or for heart failure, your doctor may check your kidney function.
• if you have serious heart problems that are not heart failure or a heart attack.
• if you have already experienced swelling of the tongue and face caused by an allergic reaction called

angioedema when taking another medicine (including ACE inhibitors), talk to your doctor.
If these symptoms occur while you are taking Valsartan Almus, stop taking it immediately
and never take it again. See also section 4 Possible side effects.

• if you are taking medicines used to treat high blood pressure such as angiotensin receptor blockers, including Valsartan Almus, or ACE inhibitors and aliskiren.
• if you are taking medicines that increase potassium levels in the blood. These include potassium supplements or salt substitutes containing potassium or potassium-sparing drugs and heparin. It may be necessary to check your blood potassium level at regular intervals.
• if you are under 18 years of age and are taking Valsartan Almus in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor will check your kidney function and your blood potassium levels at regular intervals.
• if you suffer from aldosteronism, a condition in which the adrenal glands produce too much aldosterone hormone. In this case, the use of Valsartan Almus is not recommended.
• if you have experienced fluid loss (dehydration) caused by diarrhea, vomiting or high doses of diuretics.
• you must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Valsartan Almus is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken during that period (see the Pregnancy section).
• if you are taking any of the following medicines used to treat high blood pressure: or an “ACE inhibitor” (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes or aliskiren
• if you are being treated with an ACE inhibitor together with other medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol). Your doctor may check your kidney function, blood pressure and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also what is stated under “Do not take Valsartan Almus”.

If any of these conditions apply to you, inform your doctor before taking
Valsartan Almus.
Other medicines and Valsartan Almus
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The effect of the treatment may be affected if Valsartan Almus is taken with certain types of medicine.
It may be necessary to change the dosage, take other precautions or, in some cases, stop
taking one of the medicines. This applies to any medicine, even those available without a prescription,
especially:

• other medicines that lower blood pressure, especially those that increase the elimination of fluids (diuretics).
• medicines that increase potassium levelsin the blood such as potassium supplements, salt substitutes containing potassium, potassium-sparing drugs and heparin.
• some types of pain relieverscalled non-steroidal anti-inflammatory drugs (NSAIDs).
• some antibiotics(rifamycin group), a medicine used in organ transplants to prevent rejection (cyclosporine) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines can increase the effect of Valsartan Almus.
• medicines used to treat high blood pressuresuch as angiotensin receptor blockers, including Valsartan Almus, or ACE inhibitors and aliskiren.
• lithium, a medicine used in the treatment of some psychiatric illnesses.
• The doctor may need to adjust the dose and/or take other precautions:

or if you are taking an ACE inhibitor or aliskiren (see also what is stated under:
“Do not take Valsartan Almus” and “Warnings and precautions”);
or if you are being treated with an ACE inhibitor together with other medicines used to treat
heart failure, known as mineralocorticoid receptor antagonists (MRA)
(for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

In addition:

• if you are being treated after a heart attack, the combination with ACE inhibitors(medicines for the treatment of a heart attack) is not recommended.
• if you are being treated for heart failure, the triple combination with ACE inhibitors and beta-blockers(medicines for the treatment of heart failure) is not recommended. In addition:
• if you are being treated after a heart attack, the combination with ACE inhibitors(medicines for the treatment of a heart attack) is not recommended.
• if you are being treated for symptomatic heart failure, the triple combination with ACE inhibitors and beta-blockers(medicines for the treatment of heart failure) is not recommended.

Valsartan Almus with food and drink
Valsartan Almus can be taken with or without food.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.

• You must inform your doctor if you think you may be pregnant(or if there is a possibility ofbecoming pregnant).As a rule, your doctor will advise you to stop taking Valsartan Almus before you become pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Valsartan Almus. Valsartan Almus is not recommended in early pregnancy and should not be taken after the third month of pregnancy as it can cause serious harm to the baby if taken after the third month of pregnancy.
• Inform your doctorif you are breastfeeding, or are about to start breastfeeding.Valsartan Almus is not recommended during breastfeeding and your doctor may choose another treatment for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Before driving a vehicle, using machines or performing other activities that require concentration, it
is advisable to know your reaction to Valsartan Almus. Like many other medicines used in the treatment
of high blood pressure, Valsartan Almus can rarely cause dizziness and affect your ability
to concentrate.

Valsartan Almus contains lactose
This medicine contains lactose. If your doctor has diagnosed you with intolerance to certain sugars,
contact him before taking this medicine.

3. HOW TO TAKE VALSARTAN ALMUS

Take this medicine always exactly as your doctor has instructed, in order to obtain the best results and reduce the risk of side effects. If you have any doubts, consult your doctor or pharmacist.
Those who suffer from high blood pressure often do not notice any signs of this problem and many feel as well as usual. For this reason, it is very important that you keep regular appointments with your doctor, even when you feel well.

Children and adolescents (aged between 6 and 18 years) with high blood pressure:
In patients weighing less than 35 kg the usual dose is 40 mg of valsartan once a day.
In patients weighing 35 kg or more the usual dose is 80 mg of valsartan once a day.
In some cases the doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack:treatment is generally started as soon as possible after 12 hours from the infarction, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose over a few weeks, up to a maximum of 160 mg twice a day. The final dose depends on the dose that you tolerate individually.
Valsartan Almus can be administered together with other treatments for heart attack and the doctor will decide which treatment is most suitable for you.

Adult patients with heart failure:treatment is generally started with 40 mg twice a day. The doctor will gradually increase this dose over a few weeks, up to a maximum of 160 mg twice a day. The final dose depends on the dose that you tolerate individually.
Valsartan Almus can be administered together with other treatments for heart failure and the doctor will decide which treatment is most suitable for you.

Adult patients with high blood pressure:the usual dose is 80 mg once a day. In some cases the doctor may prescribe a higher dose (e.g. 160 mg or 320 mg) or associate it with another medicine (e.g. a diuretic).

Children and adolescents (aged between 6 and 18 years) with high blood pressure
In patients weighing less than 35 kg the usual dose is 40 mg of valsartan once a day.
In patients weighing 35 kg or more the usual dose is 80 mg of valsartan once a day.
In some cases the doctor may prescribe higher doses (the dose may be increased to 160 mg and up to a maximum of 320 mg).

Adult patients after a recent heart attack:treatment is generally started as soon as possible after 12 hours from the infarction, usually with a low dose of 20 mg twice a day. The 20 mg dose is obtained by dividing the 40 mg tablet. The doctor will gradually increase this dose over a few weeks, up to a maximum of 160 mg twice a day. The final dose depends on the dose that you tolerate individually.
Valsartan Almus can be administered together with other treatments for heart attack and the doctor will decide which treatment is most suitable for you.

Adult patients with heart failure:treatment is generally started with 40 mg twice a day. The doctor will gradually increase this dose over a few weeks, up to a maximum of 160 mg twice a day. The final dose depends on the dose that you tolerate individually.
Valsartan Almus can be administered together with other treatments for heart failure and the doctor will decide which treatment is most suitable for you.
You can take Valsartan Almus with or without food. The tablet must be swallowed with a glass of water. Take Valsartan Almus at about the same time each day.

If you take more Valsartan Almus than you should
In case of severe dizziness and/or fainting, contact your doctor immediately and lie down. If you have inadvertently taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Valsartan Almus
If you forget to take a dose, take it as soon as you remember. 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 missed dose.

If you stop taking Valsartan Almus
Stopping treatment with Valsartan Almus may cause your condition to worsen. Do not stop using the medicine unless you have been told to do so by your doctor.
If you have any doubts 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 everybody gets them.
These side effects can occur with certain frequencies, defined as follows:

• very common: affects more than 1 in 10 people
• common: affects 1 to 10 people in 100
• uncommon: affects 1 to 10 people in 1,000
• rare: affects 1 to 10 people in 10,000
• very rare: affects less than 1 in 10,000 people
• not known: the frequency cannot be estimated from the available data.

Some symptoms require immediate medical attention:
Consult a doctor immediately if you have symptoms of angioedema (a particular allergic reaction),
such as:

• swelling of the face, lips, tongue or throat
• difficulty breathing or swallowing
• urticaria, itching If you experience any of these symptoms, stop taking Valsartan Almus and contact yourdoctor immediately (see also section 2 Warnings and precautions).

The side effects are:
Common:

• dizziness
• low blood pressure accompanied or not by symptoms such as dizziness and fainting when getting up
• reduced values of kidney function tests (sign of kidney dysfunction)

Uncommon:

• angioedema (see the section “Some symptoms require immediate medical attention”)
• sudden loss of consciousness (syncope)
• feeling of dizziness (vertigo)
• severely reduced kidney function (sign of acute renal failure)
• muscle spasms, irregular heartbeat (signs of high potassium levels in the blood)
• shortness of breath, difficulty breathing when lying down, swelling of the feet or legs (signs of heart failure)
• headache
• cough
• abdominal pain
• nausea
• diarrhoea
• fatigue
• weakness

Not known:

• blisters on the skin (sign of a condition called bullous dermatitis)
• allergic reactions such as skin rashes, itching and urticaria, feverish symptoms, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness)
• red papules, fever, itching (signs of inflammation of the vessels also known as vasculitis)
• unusual bleeding or bruising (signs of thrombocytopenia)
• muscle pain (myalgia)
• fever, sore throat or ulcers in the mouth due to infections (symptoms of a deficiency of white blood cells, also called neutropenia)
• decreased levels of hemoglobin and decreased percentage of red blood cells in the blood (which can lead to anemia in severe cases)
• increased levels of potassium in the blood (which can cause muscle cramps and heart rhythm abnormalities in severe cases)
• increased liver function values (which may be an indication of liver damage) including increased levels of bilirubin in the blood (which can cause a yellowish pigmentation of the skin and eyes in severe cases)
• increased levels of azotemia and serum creatinine levels (which may indicate a kidney function abnormality)
• low levels of sodium in the blood (which can cause fatigue, confusion, muscle contraction and/or seizures in severe cases)

The frequency of some of the side effects may vary depending on your condition. For example,
effects such as dizziness and decreased kidney function values have been observed less
frequently in adult patients treated for high blood pressure compared to adult patients treated
for heart failure or after a recent heart attack.
In children and adolescents, side effects are similar to those in adults.

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
http://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 VALSARTAN ALMUS

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the packaging after Expiry:. The expiry date refers to the last day of the month.
• Do not store at a temperature above 30°C.
• Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
• Do not dispose of any medicine in 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 Valsartan Almus contains
The active ingredient is valsartan.
Valsartan Almus 40 mg film-coated tablets: each film-coated tablet contains 40 mg of
valsartan.
Valsartan Almus 80 mg film-coated tablets: each film-coated tablet contains 80 mg of
valsartan.
Valsartan Almus 160 mg film-coated tablets: each film-coated tablet contains 160 mg
of valsartan.
The excipients are:

Tablet core:
anhydrous lactose, lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, colloidal
silicon dioxide and magnesium stearate.

Tablet film coating:
hypromellose, macrogol 8000, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide
(E 172)
Valsartan Almus 40 mg also contains black iron oxide.
Valsartan Almus 160 mg also contains black iron oxide.

Description of Valsartan Almus and package contents
Valsartan Almus 40 mg film-coated tablets are presented as a film-coated core.
Valsartan Almus 80 mg film-coated tablets are presented as a film-coated core.
Valsartan Almus 160 mg film-coated tablets are presented as a film-coated core.
Valsartan Almus 40 mg tablets are yellow, oblong and biconvex. They have a score line on one side.
They can be divided into two equal halves.
Valsartan Almus 80 mg tablets are pink, round and biconvex. They have a score line on one side.
They can be divided into two equal halves.
Valsartan Almus 160 mg tablets are dark yellow, oblong and biconvex. They have a score line on one
side. They can be divided into two equal halves.
Valsartan Almus is available in the following packs:
Valsartan Almus 40 mg:
PVC/PVDC/aluminium blisters with 14, 28, 56 or 98 film-coated tablets.
Valsartan Almus 80 mg:
PVC/PVDC/aluminium blisters with 14, 28, 56 or 98 film-coated tablets.
Valsartan Almus 160 mg:
PVC/PVDC/aluminium blisters with 14, 28, 56 or 98 film-coated tablets.
Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder and Manufacturer responsible for batch release
Marketing Authorisation Holder
Almus S.r.l. - Via Cesarea, 11/10 - 16121 Genoa - Italy

Manufacturer responsible for batch release
Special Product's Line S.p.A - Via Fratta Rotonda Vado Largo, 1 - 03012 Anagni (FR) - Italy
For further information on this medicinal product, contact the marketing authorisation holder.