Vilantal comp 80 mg/12,5 mg Filmdragerad tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

22-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

22-04-2018

Aktiva substanser:
hydroklortiazid; valsartan
Tillgänglig från:
Sandoz A/S,
ATC-kod:
C09DA03
INN (International namn):
hydrochlorothiazide; valsartan
Dos:
80 mg/12,5 mg
Läkemedelsform:
Filmdragerad tablett
Sammansättning:
valsartan 80 mg Aktiv substans; hydroklortiazid 12,5 mg Aktiv substans
Klass:
Apotek
Receptbelagda typ:
Receptbelagt
Terapiområde:
Valsartan och diuretika
Produktsammanfattning:
Förpacknings: Blister, 7 tabletter (plast/Al); Blister, 7 tabletter (Al); Blister, 10 tabletter (Al); Blister, 14 tabletter (Al); Blister, 15 tabletter (Al); Blister, 20 tabletter (Al); Blister, 28 tabletter (Al); Blister, 30 tabletter (Al); Blister, 50 tabletter (Al); Blister, 56 tabletter (Al); Blister, 60 tabletter (Al); Blister, 84 tabletter (Al); Blister, 90 tabletter (Al); Blister, 98 tabletter (Al); Blister, 100 tabletter (Al); Blister, 280 tabletter (Al); Blister, 10 tabletter (plast/Al); Blister, 14 tabletter (plast/Al); Blister, 15 tabletter (plast/Al); Blister, 20 tabletter (plast/Al); Blister, 28 tabletter (plast/Al); Blister, 30 tabletter (plast/Al); Blister, 50 tabletter (plast/Al); Blister, 56 tabletter (plast/Al); Blister, 60 tabletter (plast/Al); Blister, 84 tabletter (plast/Al); Blister, 90 tabletter (plast/Al); Blister, 98 tabletter (plast/Al); Blister, 100 tabletter (plast/Al); Blister, 280 tabletter (plast/Al); Blister, 50 x 1 tabletter, endos (Al); Blister, 50 x 1 tabletter, endos (plast/Al)
Bemyndigande status:
Godkänd
Godkännandenummer:
42507
Tillstånd datum:
2011-04-15

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

16-01-2019

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16-01-2019

Offentlig bedömningsrapport Offentlig bedömningsrapport - engelska

21-02-2013

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Package leaflet: Information for the user

Vilantal comp 80 mg /12.5 mg film-coated tablets

Vilantal comp 160 mg /12.5 mg film-coated tablets

Vilantal comp 160 mg /25 mg film-coated tablets

Vilantal comp 320 mg /12.5 mg film-coated tablets

Vilantal comp 320 mg /25 mg film-coated tablets

Valsartan/hydrochlorothiazide

Read all of this leaflet carefully before you start taking this medicine because it contains important

information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if

their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not

listed in this leaflet. See section 4.

What is in this leaflet

What Vilantal comp is and what it is used for

What you need to know before you take Vilantal comp

How to take Vilantal comp

Possible side effects

How to store Vilantal comp

Contents of the pack and other information

1.

What Vilantal comp is and what it is used for

Vilantal comp film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both

of these substances help to control high blood pressure (hypertension).

Valsartan 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 vessels to tighten, thus

causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a

result, blood vessels relax and blood pressure is lowered.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water

tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Vilantal comp is used to treat high blood pressure which is not adequately controlled by a single substance alone.

High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood

vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure or kidney failure. High blood

pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of

developing these disorders.

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2.

What you need to know before you take Vilantal comp

Do not take Vilantal comp

if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically

related to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6).

if you are more than 3 months pregnant (it is also better to avoid Vilantal comp in early pregnancy - see

pregnancy section).

if you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis)

leading to the build up of bile in the liver (cholestasis).

if you have severe kidney disease.

if you are unable to produce urine (anuria).

if you are treated with an artificial kidney.

if the level of potassium or sodium in your blood is lower than normal, or if the level of calcium in your

blood is higher than normal despite treatment.

if you have gout.

if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering

medicine containing aliskiren.

If any of the above apply to you, do not take this medicine and speak to your doctor.

Warnings and precautions

Talk to your doctor before taking Vilantal comp

if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing

potassium or other medicines that increase the amount of potassium in your blood such as heparin. Your

doctor may need to check the amount of potassium in your blood regularly.

if you have low levels of potassium in your blood.

if you have diarrhoea or severe vomiting.

if you are taking high doses of water tablets (diuretics).

if you have severe heart disease.

if you are suffering from heart failure or have experienced a heart attack. Follow your doctor’s instruction

for the starting dose carefully. Your doctor may also check your kidney function.

if you suffer from a narrowing of the kidney artery.

if you have recently received a new kidney.

if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands make too much of

the hormone aldosterone. If this applies to you, the use of Vilantal comp is not recommended.

if you have liver or kidney disease.

if you have ever experienced swelling of the tongue and face caused by an allergic reaction called

angioedema when taking another medicine (including ACE-inhibitors), tell your doctor. If these

symptoms occur when you are taking Vilantal comp, stop taking Vilantal comp immediately and never

take it again. See also section 4, “Possible side effects”.

if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-

called autoimmune disease).

if you have diabetes, gout, high levels of cholesterol or triglycerides in your blood.

if you have had allergic reactions with the use of other blood pressure-lowering agents of this class

(angiotensin II receptor antagonists) or if you have allergy or asthma.

if you experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in

your eye and can happen within hours to a week of taking Vilantal comp. This can lead to permanent

vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy you can be at higher

risk of developing this.

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it may cause increased sensitivity of the skin to sun.

if you are taking any of the following medicines used to treat high blood pressure:

- an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related

kidney problems.

- aliskiren.

If any of these apply to you, talk to your doctor.

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 information under the heading “Do not take Vilantal comp”

You must tell your doctor if you think you are (or might become) pregnant. Vilantal comp is not recommended

in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm

to your baby if used at that stage (see pregnancy section).

Children and adolescents

The use of Vilantal comp in children and adolescents (below the age of 18 years) is not recommended.

Other medicines and Vilantal comp

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

The effect of the treatment can be influenced if Vilantal comp is taken together with certain other medicines.

Your doctor may need to change your dose and/or take other precautions, or in some cases to stop taking one of

the medicines. This especially applies to the following medicines:

lithium, a medicine used to treat some types of psychiatric diseases

medicines or substances that may increase the amount of potassium in your blood. These include

potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.

medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets),

corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G

some antibiotics (rifamycin group), a medicine used to protect against transplant rejection (ciclosporin) or

an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the

effect of Vilantal comp.

medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines

used to treat heart problems) and some antipsychotics

medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics,

antiepileptics

medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone

therapeutic vitamin D and calcium supplements

medicines for the treatment of diabetes (oral agents such as metformin or insulins)

other medicines to lower your blood pressure including methyldopa, ACE-inhibitors (such as enalapril,

lisinopril, etc.) or aliskiren (see also information under the headings “Do not take Vilantal comp” and

“Warnings and precautions”)

medicines to increase blood pressure, such as noradrenaline or adrenaline

digoxin or other digitalis glycosides (medicines used to treat heart problems)

medicines that may increase blood sugar levels, such as diazoxide or beta blockers

cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide

pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective

cyclooxygenase-2 inhibitors (Cox-2 inhibitors) and more than 3 grams of acetylsalicylic acid per day

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muscle relaxing medicines, such as tubocurarine

anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps,

urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to

anaesthesia)

amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain illnesses

caused by viruses)

cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood)

ciclosporin, a medicine used for organ transplant to avoid organ rejection

alcohol, sleeping pills and anaesthetics (medicines with sleeping or painkilling effect used for example

during surgery)

iodine contrast media (agents used for imaging examinations).

Vilantal comp with food, drink and alcohol

You can take Vilantal comp with or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more

and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor

or pharmacist for advice before taking this medicine.

You must tell your doctor if you think that you are (or might become) pregnant

Your doctor will normally advise you to stop taking Vilantal comp before you become pregnant or as soon as

you know you are pregnant, and will advise you to take another medicine instead of Vilantal comp. Vilantal

comp is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it

may cause serious harm to your baby if it is used after the third month of pregnancy.

Tell your doctor if you are breast-feeding or about to start breast-feeding

Vilantal comp is not recommended for mothers who are breast-feeding, and your doctor may choose another

treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Before you drive a vehicle, use tools or operate machines or carry out other activities that require concentration,

make sure you know how Vilantal comp affects you. Like many other medicines used to treat high blood

pressure, Vilantal comp may occasionally cause dizziness and affect the ability to concentrate.

3.

How to take Vilantal comp

Always take this medicine exactly as your doctor has told you. This will help you to get the best results and

lower the risk of side effects. Check with your doctor or pharmacist if you are not sure.

People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This

makes it all the more important for you to keep your appointments with your doctor even if you are feeling well.

Your doctor will tell you exactly how many tablets of Vilantal comp to take. Depending on how you respond to

the treatment, your doctor may suggest a higher or lower dose.

The recommended dose of Vilantal comp is one tablet per day

Do not change the dose or stop taking the tablets without consulting your doctor

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The medicine should be taken at the same time each day, usually in the morning

You can take Vilantal comp with or without food

Swallow the tablet with a glass of water.

If you take more Vilantal comp than you should

If you experience severe dizziness and/or fainting, lay down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Vilantal comp

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose,

skip the dose you missed.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Vilantal comp

Stopping your treatment with Vilantal comp may cause your high blood pressure to get worse. Do not stop

taking your medicine unless your doctor tells you to.

If you have any further questions on the use of this medicine, ask 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 need immediate medical attention:

You should see your doctor immediately if you experience symptoms of angioedema, such as:

swollen face, tongue or pharynx

difficulty in swallowing

hives and difficulties in breathing

If you get any of these symptoms, stop taking Vilantal comp and contact your doctor straight away (see

also section 2 “Warnings and precautions”).

Other side effects include:

Uncommon, affects 1 to 10 per 1,000 users

cough

low blood pressure

light-headedness

dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry

skin)

muscle pain

tiredness

tingling or numbness

blurred vision

noises (e.g. hissing, buzzing) in ears

Very rare, affects less than 1 per 10,000 users

dizziness

diarrhoea

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joint pain

Frequency not known, according to the available data

breathing difficulty

severely decreased urine output

low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or

convulsions in severe cases)

low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart

rhythm)

low level of white cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth

ulcers due to infections, weakness)

the level of bilirubin increased in blood (which can, in severe cases, trigger yellow skin and eyes)

the level of blood urea nitrogen and creatinine increased in blood (which can indicate abnormal kidney

function)

the level of uric acid in blood increased (which can, in severe cases, trigger gout)

syncope (fainting)

The following side effects have been reported with products containing valsartan or hydrochlorothiazide

alone:

Valsartan

Uncommon, affects 1 to 10 per 1,000 users

spinning sensation

abdominal pain

Frequency not known, according to the available data

blistering skin (sign of dermatitis bullous)

skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain,

muscle pain, swollen lymph nodes and/or flu-like symptoms

rash, purplished-red spots, fever, itching (symptoms of inflammation of blood vessels)

low level of blood platelets (sometimes with unusual bleeding or bruising)

high level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)

allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing,

dizziness)

swelling mainly of the face and throat; rash; itching

elevation of liver function values

the level of haemoglobin decreased and the percentage of red cells decreased in the blood (which both

can, in severe cases, trigger an anaemia).

kidney failure

low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or

convulsions in severe cases)

Hydrochlorothiazide

Very common, affects more than 1 per 10 users

low level of potassium in the blood

increase of lipids in the blood

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Common, affects 1 to 10 per 100 users

low level of sodium in the blood

low level of magnesium in the blood

high level of uric acid in the blood

itchy rash and other types of rash

reduced appetite

mild nausea and vomiting

dizziness, fainting on standing up

inability to achieve or maintain erection

Rare, affects 1 to 10 per 10,000 users

swelling and blistering of the skin (due to increased sensitivity to sun)

high level of calcium in the blood

high level of sugar in the blood

sugar in the urine

worsening of diabetic metabolic state

constipation, diarrhoea, discomfort of the stomach or bowels, liver disorders which can occur together

with yellow skin and eyes

irregular heart beat

headache

sleep disturbances

sad mood (depression)

low level of blood platelets (sometimes with bleeding or bruising underneath the skin)

dizziness

tingling or numbness

vision disorder

Very rare, affects less than 1 per 10,000 users

inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis)

rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)

severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever

(toxic epidermal necrolysis)

facial rash, joint pain, muscle disorder, fever (lupus erythematosus)

severe upper stomach pain (pancreatitis)

difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including

pneumonitis and pulmonary oedema)

fever, sore throat, more frequent infections (agranulocytosis)

pale skin, tiredness, breathlessness, dark urine (haemolytic anaemia)

fever, sore throat or mouth ulcers due to infections (leucopenia)

confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis)

Frequency not known, according to the available data

weakness, bruising and frequent infections (aplastic anemia)

severely decreased urine output (possible signs of renal disorder or renal failure)

decrease in vision or pain in your eyes due to high pressure (possible signs of acute angle-closure

glaucoma)

rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema

multiforme)

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muscle spasm

fever (pyrexia)

weakness (asthenia)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not

listed in this leaflet. You can also report side effects directly via [the national reporting system; to be completed

nationally]. By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Vilantal comp

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 blister and carton. The expiry date

refers to the last day of that month.

Do not store above 30 °C. Store in the original package in order to protect from moisture.

Do not use any Vilantal comp pack that is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you

no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Vilantal comp contains

The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide

Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide

Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide

Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.

The other ingredients are:

Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide.

Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172).

Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide

(E172), black iron oxide (E172).

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Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide

(E172).

Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).

What Vilantal comp looks like and contents of the pack

Vilantal comp 80 mg/12.5 mg film-coated tablets

Film-coated tablet, light orange, ovaloid, slightly convex faces, imprinted (debossed) with “HGH” on one side

and “CG" on the reverse side

Vilantal comp 160 mg/12.5 mg film-coated tablets

Film-coated tablet, dark red, ovaloid, slightly convex faces, imprinted (debossed) with “HHH” on one side and

“CG" on the reverse side.

Vilantal comp 160 mg/25 mg film-coated tablets

Film-coated tablet, brown orange, ovaloid, slightly convex faces, imprinted (debossed) with “HXH” on one side

and “NVR" on the reverse side

Vilantal comp 320 mg/12.5 mg film-coated tablets

Film-coated tablet , pink, ovaloid shaped, beveled edge, imprinted (debossed) with “NVR” on one side and

“HIL” on the reverse side

Vilantal comp 320 mg/25 mg film-coated tablets

Yellow, ovaloid shaped, beveled edge, film coated tablet, imprinted (debossed) with “NVR” on one side and

“CTI” on the reverse side

Pack sizes: one pack contains 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 280 film-coated

tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in 2015-02-12

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