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Tekturna (aliskiren) – Package leaflet - C09XA02

Updated on site: 10-Oct-2017

Medication nameTekturna
ATC CodeC09XA02
Substancealiskiren
ManufacturerNovartis Europharm Ltd.

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

 

Tekturna 150 mg film-coated tablets

 

 

Aliskiren

 

Read all of this leaflet carefully before you start taking this medicine.

 

-

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. Do not pass it on to others. It may harm them, even

 

if their symptoms are the same as yours.

 

 

-

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

 

authorised

In this leaflet:

 

1.

What Tekturna is and what it is used for

 

2.

Before you take Tekturna

 

3.

How to take Tekturna

 

4.

Possible side effects

 

5.

How to store Tekturna

 

6.

Further information

 

 

 

 

1.

WHAT TEKTURNA IS AND WHAT IT IS USED FOR

 

 

 

longer

 

Tekturna belongs to a new class of medicines called renin inhibitors. Tekturna helps to lower high

 

no

 

 

blood pressure. Renin inhibitors reduce the amount f angiotensin II the body can produce. Angiotensin II causes blood vessels to tighte , which increases the blood pressure. Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.

High blood pressure increasesproductthe workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart

failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk of developing these disorders.

2. BEFORE YOU TAKE TEKTURNA Do not take Tektur

-if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Tekturna. If you th nk you may be allergic, ask your doctor for advice.

-f you have already experienced angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) when taking aliskiren.

-during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and br astfeeding.

-if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis) or verapamil (a medicine used

to lower blood pressure, to correct hearth rhythm or to treat angina pectoris) or quinidine (a medicine used to correct heart rhythm).Medicinal

Take special care with Tekturna

-if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).

-if you have impaired kidney function.

-if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).

Driving and using machines

If any of these apply to you, tell your doctor before you take Tekturna.

The use of Tekturna in children and adolescents is not recommended.

There are no special dose recommendations for patients aged 65 years or older.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor may need to change your dose and/or to take other precautions if you are taking one of

the following medicines:

authorised

-

medicines that increase the amount of potassium in your blood. These include potassium-

 

sparing diuretics, potassium supplements.

 

-

furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, wh ch is

 

used to increase the amount of urine you produce.

 

-

ketoconazole, a medicine used to treat fungal infections.

 

-

certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).

Taking Tekturna with food and drink

You should take Tekturna with a light meal once a day, preferably at the s me time each day. You should not take Tekturna together with grapefruit juice.

Pregnancy and breast-feeding

Do not take Tekturna if you are pregnant. It is important to talk to your doctor immediately if you

think you may be pregnant or are planning to become preg a t. Do not breast-feed if you are taking

Tekturna.

 

 

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

 

no

longer

 

 

how you react to the effects of Tekt rna.

You may feel dizzy and thisproductcan affect your ability to concentrate. Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know

3. HOW TO TAKE TEKTURNA

Always take Tekturna exactly as your doctor has told you. You should check with your doctor or MedicinalPeople who have high blood pressure often do not notice any signs of the problem. Many may feel

pharmacist if you re not sure.

quite normal. It s very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appointments with the doctor even if you are feeling well.

The usual starting dose is one 150 mg tablet once daily.

Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily. Your doctor may prescribe Tekturna together with other medicines used to treat high blood pressure.

Method of administration

It is recommended that you take the tablets with some water. You should take Tekturna with a light meal once a day, preferably at the same time each day. You should not take Tekturna together with grapefruit juice.

If you take more Tekturna than you should

If you have accidentally taken too many Tekturna tablets, consult a doctor immediately. You may require medical attention.

If you forget to take Tekturna

If you forget to take a dose of Tekturna, take it as soon as you remember and then take the next dose at its usual time. However, if it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

tell your doctor or pharmacist.

authorised

Like all medicines, Tekturna can cause side effects, although not everybody gets them.

Common (affecting less than 1 in 10 patients): Diarrhoea. Uncommon (affecting less than 1 in 100 patients): Skin rash.

Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, r swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

5. HOW TO STORE TEKTURNA

Keep out of the reach and sight of children.

no

longer

 

Do not use Tekturna after the expiry date which is stated on the carton and blister. The expiry date

refers to the last day of that month.

 

 

Do not store above 30°C.

 

 

 

product

 

 

Store in the original package in order to pro ect from moisture.

6.

FURTHER INFORMATION

 

 

What Tekturna contains

 

 

-

The active substance is aliskiren (as hemifumarate) 150 mg.

-

The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,

Medicinal

 

 

 

microcryst lline ce ulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),

black iron oxide (E 172), red iron oxide (E 172).

What Tekturna looks like and contents of the pack

Tekturna 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.

T kturna is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito 131

I-80058 Torre Annunziata/NA

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

България

Novartis Pharma Services Inc. Тел.: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Eesti

product

Novartis Pharma Services Inc.

Tel: +372 60 62 400

Ελλάδα

Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12

MedicinalEspaña

Novartis Farmacéutic , S.A.

Tel: +34 93 306 42 00

France

Novart s Pharma S.A.S.

Tél: +33 1 55 47 66 00

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Ísland

Vistor hf.

Sími: +354 535 7000

Luxembourg/Luxemburg

Novartis Pharma GmbH

Nederland

authorised

Tél/Tel: +49 911 273 0

Magyarország

Novartis Hungária Kft. Pharma

Tel.: +36 1 457 65 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2298 3217

NovartislongerPharma B.V.

Tel: +31 26 37 82 111

N rge

N vartis Norge AS noTlf: +47 23 05 20 00

Österreich

Novartis Pharma GmbH Tel: +43 1 86 6570

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 550 8888

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

România

Novartis Pharma Services Inc.

Tel: +40 21 31299 01

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 77

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Κύπρος

Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690

Latvija

Novartis Pharma Services Inc.

Tel: +371 7 887 070

Lietuva

Novartis Pharma Services Inc.

Tel: +370 5 269 16 50

This leaflet was last approved in

Medicinal

product

 

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 9 61 33 22 11

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

United Kingdom

authorised

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

no

longer

 

 

 

 

PACKAGE LEAFLET: INFORMATION FOR THE USER

 

Tekturna 300 mg film-coated tablets

 

 

Aliskiren

 

Read all of this leaflet carefully before you start taking this medicine.

 

-

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. Do not pass it on to others. It may harm them, even

 

if their symptoms are the same as yours.

 

 

-

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

 

please tell your doctor or pharmacist.

 

authorised

In this leaflet:

 

1.

What Tekturna is and what it is used for

 

2.

Before you take Tekturna

 

3.

How to take Tekturna

 

4.

Possible side effects

 

5.

How to store Tekturna

 

6.

Further information

 

 

 

 

1.

WHAT TEKTURNA IS AND WHAT IT IS USED FOR

 

 

 

longer

 

Tekturna belongs to a new class of medicines called renin inhibitors. Tekturna helps to lower high

 

no

 

 

blood pressure. Renin inhibitors reduce the amount f angiotensin II the body can produce. Angiotensin II causes blood vessels to tighte , which increases the blood pressure. Reducing the amount of angiotensin II allows the blood vessels to relax, which lowers blood pressure.

High blood pressure increasesproductthe workload of the heart and arteries. If this continues for a long time, it can damage the blood vessels of the brain, heart and kidneys, and may result in a stroke, heart

failure, heart attack or kidney failure. Lowering the blood pressure to a normal level reduces the risk of developing these disorders.

2. BEFORE YOU TAKE TEKTURNA Do not take Tektur

-if you are allergic (hypersensitive) to aliskiren or any of the other ingredients of Tekturna. If you th nk you may be allergic, ask your doctor for advice.

-f you have already experienced angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue) when taking aliskiren.

-during the last 6 months of pregnancy or if you are breast-feeding, see section Pregnancy and br astfeeding.

-if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis) or verapamil (a medicine used

to lower blood pressure, to correct hearth rhythm or to treat angina pectoris) or quinidine (a medicine used to correct heart rhythm).Medicinal

Take special care with Tekturna

-if you are taking a diuretic (a type of medicine also known as “water” tablets which increases the amount of urine you produce).

-if you have impaired kidney function.

-if you experience angioedema (difficulties in breathing, or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).

Driving and using machines

If any of these apply to you, tell your doctor before you take Tekturna.

The use of Tekturna in children and adolescents is not recommended.

There are no special dose recommendations for patients aged 65 years or older.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Your doctor may need to change your dose and/or to take other precautions if you are taking one of

the following medicines:

authorised

-

medicines that increase the amount of potassium in your blood. These include potassium-

 

sparing diuretics, potassium supplements.

 

-

furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, wh ch is

 

used to increase the amount of urine you produce.

 

-

ketoconazole, a medicine used to treat fungal infections.

 

-

certain types of pain killers called non-steroidal anti-inflammatory medicines (NSAIDs).

Taking Tekturna with food and drink

You should take Tekturna with a light meal once a day, preferably at the s me time each day. You should not take Tekturna together with grapefruit juice.

Pregnancy and breast-feeding

Do not take Tekturna if you are pregnant. It is important to talk to your doctor immediately if you

think you may be pregnant or are planning to become preg a t. Do not breast-feed if you are taking

Tekturna.

 

 

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

 

no

longer

 

 

how you react to the effects of Tekt rna.

You may feel dizzy and thisproductcan affect your ability to concentrate. Before you drive a vehicle, use machinery, or carry out other activities that require concentration, you should make sure you know

3. HOW TO TAKE TEKTURNA

Always take Tekturna exactly as your doctor has told you. You should check with your doctor or MedicinalPeople who have high blood pressure often do not notice any signs of the problem. Many may feel

pharmacist if you re not sure.

quite normal. It s very important that you take this medicine exactly as your doctor tells you to get the best results and reduce the risk of side effects. Keep your appointments with the doctor even if you are feeling well.

The usual starting dose is one 150 mg tablet once daily.

Depending on how you respond to the treatment your doctor may prescribe a higher dose of one 300 mg tablet once daily. Your doctor may prescribe Tekturna together with other medicines used to treat high blood pressure.

Method of administration

It is recommended that you take the tablets with some water. You should take Tekturna with a light meal once a day, preferably at the same time each day. You should not take Tekturna together with grapefruit juice.

If you take more Tekturna than you should

If you have accidentally taken too many Tekturna tablets, consult a doctor immediately. You may require medical attention.

If you forget to take Tekturna

If you forget to take a dose of Tekturna, take it as soon as you remember and then take the next dose at its usual time. However, if it is almost time for your next dose you should simply take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

tell your doctor or pharmacist.

authorised

Like all medicines, Tekturna can cause side effects, although not everybody gets them.

Common (affecting less than 1 in 10 patients): Diarrhoea. Uncommon (affecting less than 1 in 100 patients): Skin rash.

Rare (affecting less than 1 in 1,000 patients): Angioedema (difficulties in breathing, r swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).

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

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please

5. HOW TO STORE TEKTURNA

Keep out of the reach and sight of children.

no

longer

 

Do not use Tekturna after the expiry date which is stated on the carton and blister. The expiry date

refers to the last day of that month.

 

 

Do not store above 30°C.

 

 

 

product

 

 

Store in the original package in order to pro ect from moisture.

6.

FURTHER INFORMATION

 

 

What Tekturna contains

 

 

-

The active substance is aliskiren (as hemifumarate) 300 mg.

-

The other ingredients are crospovidone, hypromellose, magnesium stearate, macrogol,

Medicinal

 

 

 

microcryst lline ce ulose, povidone, colloidal anhydrous silica, talc, titanium dioxide (E 171),

black iron oxide (E 172), red iron oxide (E 172).

What Tekturna looks like and contents of the pack

Tekturna 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.

T kturna is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets. Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

Novartis Europharm Limited

Wimblehurst Road

Horsham

West Sussex, RH12 5AB

United Kingdom

Manufacturer

Novartis Farma S.p.A.

Via Provinciale Schito 131

I-80058 Torre Annunziata/NA

Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Novartis Pharma N.V.

Tél/Tel: +32 2 246 16 11

България

Novartis Pharma Services Inc. Тел.: +359 2 489 98 28

Česká republika

Novartis s.r.o.

Tel: +420 225 775 111

Danmark

Novartis Healthcare A/S

Tlf: +45 39 16 84 00

Deutschland

Novartis Pharma GmbH

Tel: +49 911 273 0

Eesti

product

Novartis Pharma Services Inc.

Tel: +372 60 62 400

Ελλάδα

Novartis (Hellas) A.E.B.E. Τηλ: +30 210 281 17 12

MedicinalEspaña

Novartis Farmacéutic , S.A.

Tel: +34 93 306 42 00

France

Novart s Pharma S.A.S.

Tél: +33 1 55 47 66 00

Ireland

Novartis Ireland Limited

Tel: +353 1 260 12 55

Ísland

Vistor hf.

Sími: +354 535 7000

Luxembourg/Luxemburg

Novartis Pharma GmbH

Nederland

authorised

Tél/Tel: +49 911 273 0

Magyarország

Novartis Hungária Kft. Pharma

Tel.: +36 1 457 65 00

Malta

Novartis Pharma Services Inc.

Tel: +356 2298 3217

NovartislongerPharma B.V.

Tel: +31 26 37 82 111

N rge

N vartis Norge AS noTlf: +47 23 05 20 00

Österreich

Novartis Pharma GmbH Tel: +43 1 86 6570

Polska

Novartis Poland Sp. z o.o.

Tel.: +48 22 550 8888

Portugal

Novartis Farma - Produtos Farmacêuticos, S.A.

Tel: +351 21 000 8600

România

Novartis Pharma Services Inc.

Tel: +40 21 31299 01

Slovenija

Novartis Pharma Services Inc.

Tel: +386 1 300 75 77

Slovenská republika

Novartis Slovakia s.r.o.

Tel: +421 2 5542 5439

Italia

Novartis Farma S.p.A.

Tel: +39 02 96 54 1

Κύπρος

Δημητριάδης και Παπαέλληνας Λτδ Τηλ: +357 22 690 690

Latvija

Novartis Pharma Services Inc.

Tel: +371 7 887 070

Lietuva

Novartis Pharma Services Inc.

Tel: +370 5 269 16 50

This leaflet was last approved in

Medicinal

product

 

Suomi/Finland

Novartis Finland Oy

Puh/Tel: +358 9 61 33 22 11

Sverige

Novartis Sverige AB

Tel: +46 8 732 32 00

United Kingdom

authorised

Novartis Pharmaceuticals UK Ltd.

Tel: +44 1276 698370

no

longer

 

 

 

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