Angiosan Comp 80 mg/12,5 mg Filmdragerad tablett

Sverige - svenska - Läkemedelsverket (Medical Products Agency)

Bipacksedel Bipacksedel (PIL)

20-04-2018

Produktens egenskaper Produktens egenskaper (SPC)

01-06-2018

Aktiva substanser:
hydroklortiazid; valsartan
Tillgänglig från:
Novartis Sverige AB
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, 14 tabletter; Blister, 28 tabletter (kalenderförpackning); Blister, 56 tabletter; Blister, 98 tabletter (kalenderförpackning); Blister, 280 x 1 tabletter (endos); Blister, 280 tabletter; Blister, 56 x 1 tabletter (endos); Blister, 98 x 1 tabletter (endos)
Bemyndigande status:
Godkänd
Godkännandenummer:
22457
Tillstånd datum:
2005-11-18

Dokument på andra språk

Bipacksedel Bipacksedel - engelska

31-08-2020

Produktens egenskaper Produktens egenskaper - engelska

31-08-2020

Läs hela dokumentet

Package leaflet: Information for the user

Angiosan Comp 80 mg/12.5 mg film-coated tablets

Angiosan Comp 160 mg/12.5 mg film-coated tablets

Angiosan Comp 160 mg/25 mg film-coated tablets

Angiosan Comp 320 mg/12.5 mg film-coated tablets

Angiosan 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 pharmacistThis includes any possible side

effects not listed in this leaflet See section 4.

What is in this leaflet:

What Angiosan Comp is and what it is used for

What you need to know before you take Angiosan Comp

How to take Angiosan Comp

Possible side effects

How to store Angiosan Comp

Contents of the pack and other information

What Angiosan Comp is and what it is used for

Angiosan 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.

Angiosan 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.

2.

What you need to know before you take Diovan Comp

Do not take Angiosan Comp:

if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives

(substances chemically related to hydrochlorothiazide) or to any of the other ingredients of this

medicine.(listed in section6)

if you are more than 3 months pregnant (it is also better to avoid Angiosan 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, tell your doctor and do not take Angiosan Comp.

Warnings and precautions

Talk to your doctor

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 Angiosan 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 drug (including ACE inhibitors), tell your doctor. If

these symptoms occur when you are taking Angiosan Comp, stop taking Angiosan 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 Angiosan 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.

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

an ACE inhibitors (for example enalapril, lisinopril, ramipril), in particular if you have

diabetes-related kidney problems.

aliskiren.

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 Angiosan Comp”

Angiosan Comp may cause increased sensitivity of the skin to sun.

The use of Angiosan Comp in children and adolescents (below the age of 18 years) is not

recommended.

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

Other medicines and Angiosan 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 Angiosan Comp is taken together with certain other

medicines. It may be necessary to change the dose, to 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 drug used to protect against transplant rejection

(ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs

may increase the effect of Angiosan 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

Angiosan 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 acetylsalicylic acid > 3 g

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)

Angiosan Comp with food, drink and alcohol

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

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

Your doctor will normally advise you to stop taking Angiosan Comp before you become pregnant or

as soon as you know you are pregnant, and will advise you to take another medicine instead of

Angiosan Comp. Angiosan 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

Angiosan 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 Angiosan Comp affects you. Like many other medicines used

to treat high blood pressure, Angiosan Comp may occasionally cause dizziness and affect the ability to

concentrate.

3.

How to take Angiosan 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 Angiosan Comp to take. Depending on how you

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

The recommended dose of Angiosan Comp is one tablet per day.

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

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

You can take Angiosan Comp with or without food.

Swallow the tablet with a glass of water.

If you take more Angiosan 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 Angiosan 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 Angiosan Comp

Stopping your treatment with Angiosan 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

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

fever (toxic epidermal necrolysis)

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

closure glaucoma)

Fever, sore throat, more frequent infections (agranulocytosis)

These side effects are very rare or of frequency not known.

If you get any of these symptoms, stop taking Angiosan Comp and contact your doctor straight

away (see also section 2 “Warnings and precautions”).

Other side effects include:

Uncommon (may affect up to 1 in 100 people):

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 (may affect up to 1 in 10,000 people):

dizziness

diarrhoea

joint pain

Not known (frequency cannot be estimated from 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 (may affect up to 1 in 100 people):

spinning sensation

abdominal pain

Not known (frequency cannot be estimated from 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 (may affect more than 1 in 10 people):

low level of potassium in the blood

increase of lipids in the blood

Common (may affect up to 1 in 10 people):

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 (may affect up to 1 in 1,000 people):

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 (may affect up to 1 in 10,000 people):

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

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

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)

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)

Not known (frequency cannot be estimated from the available data):

weakness, bruising and frequent infections (aplastic anemia)

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

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

erythema multiforme)

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

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Angiosan 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 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 this medicine if you notice that the pack is damaged or shows signs of tampering.

Do not throw away any medicines via wastewater or household waste. 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 Angiosan Comp contains

The active substance is valsartan and hydrochlorothiazide. Each tablet contains 80 mg, 160 mg

or 320 mg valsartan, respectively and 12.5 mg or25 mg hydrochlorothiazide, respectively.

The tablet core contains microcrystalline cellulose, crospovidone, silica, colloidal anhydrous,

magnesium stearate.

The tablet coating contains hypromellose, macrogol 8000 (only 80 mg/12.5 mg and

160 mg/12.5 mg), macrogol 4000 (only 160 mg/25 mg, 320 mg/12.5 mg and 320 mg/25 mg),

talc, red iron oxide (E 172, not 320 mg/25 mg), yellow iron oxide (E 172, only 80 mg/12.5 mg,

160 mg/25 mg and 320 mg/25 mg), black iron oxide (E 172, only 160 mg/25 mg and

320 mg/12.5 mg), titanium dioxide (E 171).

What Angiosan Comp looks like and contents of the pack

Angiosan Comp 80 mg/12.5 mg film-coated tablets are light orange, ovaloid tablets imprinted with

HGH on one side and CG on the other side.

Angiosan Comp 160 mg/12.5 mg film-coated tablets are dark red, ovaloid tablets imprinted with HHH

on one side and CG on the other side.

Angiosan Comp 160 mg/25 mg film-coated tablets are brown, ovaloid tablets imprinted with HXH on

one side and NVR on the other side.

Angiosan Comp 320 mg/12.5 mg film-coated tablets are pink, ovaloid shaped, beveled edge tablets,

imprinted with NVR on one side and HIL on the other side.

Angiosan Comp 320 mg/25 mg film-coated tablets are yellow, ovaloid shaped, beveled edge tablet,

imprinted with NVR on one side and CTI on the other side.

The tablets are supplied in blister packs of 7 tablets (only for Angiosan Comp 320 mg/12.5 mg and

320 mg/25 mg), 14 tablets, 28 tablets as calendar pack, 30 tablets (only for Angiosan Comp

80 mg/12.5 mg), 56 tablets, 98 tablets as calendar pack or 280 tablets. Perforated unit dose blister

packs of 56x1, 98x1 or 280x1 tablets are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

<[To be completed nationally]>

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

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

names:

Sweden

Angiosan Comp

Austria, Portugal, Spain

Co-Angiosan

Austria, Portugal, Spain

Co-Angiosan forte

Austria,

Co-Angiosan fortissimum

Germany

Cordinate plus

Germany

Cordinate plus forte

Greece

Co-Dalzad

This leaflet was last revised in 2015-04-09

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