TENIF

Active substance: NIFEDIPINE

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P036591

PACKAGE LEAFLET: INFORMATION FOR THE USER

Tenif ® 50 mg/20 mg Capsules
atenolol 50 mg, nifedipine 20 mg

Read all of this leaflet carefully before you
start taking this medicine.
•  eep this leaflet. You may need to read it again.
K
• f you have any further questions, ask your
I
doctor or pharmacist.
•  his medicine has been prescribed for you. Do
T
not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
• f any of the side effects get serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1.  hat Tenif is and what it is used for
W
2.  efore you take Tenif
B
3.  ow to take Tenif
H
4.  ossible side effects
P
5.  ow to store Tenif
H
6.  urther information
F
1.  hat Tenif is and what it is used for
W
The name of your medicine is Tenif. It contains
atenolol and nifedipine. Each of these works in
a different way.
•  tenolol belongs to a group of medicines
A
called beta-blockers. It works by making your
heart beat more slowly and with less force.
This helps to prevent chest pain.
•  ifedipine belongs to a group of medicines
N
called dihydropyridines. Dihydropyridines are
a type of calcium channel blocker. They work
by making your blood vessels widen. This
helps to prevent chest pain and lowers your
blood pressure.
Tenif is used to treat high blood pressure
(hypertension) or to prevent chest pain (angina).
2.  efore you take Tenif
B
Do not take Tenif if:
•  ou are having an angina attack (sudden
Y
chest pain). Tenif cannot treat an angina
attack, but it can help you get fewer attacks if
you take it regularly.
•  ou are allergic (hypersensitive) to Tenif,
Y
Tenormin, atenolol, nifedipine, or anything
else in this medicine (see Section 6: Further
information).
•  ou are allergic (hypersensitive) to other
Y
dihydropyridines such as amlodipine or
felodipine.
•  ou have any of the following heart problems:
Y
h
-- ­ eart failure which is not under control (this

usually makes you breathless and causes
your ankles or legs to swell)
-- ­ econd- or third-degree heart block

s
(a condition which may be treated with
a pacemaker)
-- ­ very slow or very uneven heart beat, very
a

low blood pressure or very poor circulation
-- ­ heart attack within the last month
a

a
-- ­ heart condition called sick sinus

syndrome, or unstable angina, or aortic
stenosis
-- a condition where the heart is unable

­
to supply enough blood to the body
(cardiogenic shock).
w
-- ­ ithin one month of a heart condition (e.g.

chest pain, angina, heart attack).
•  ou have problems with your kidneys.
Y
•  ou have a tumour called phaeochromocytoma
Y
that is not being treated. This is usually near
your kidney and can cause high blood pressure.
•  our doctor has told you that you have higher
Y
than normal levels of acid in your blood
(metabolic acidosis).
•  ou have not been eating much recently.
Y
•  ou are taking a medicine called rifampicin.
Y
•  ou are taking a medicine that is a certain type
Y
of calcium channel blocker such as verapamil
or diltiazem.
•  ou are a woman at an age where you
Y
could get pregnant, or you are pregnant or
breast‑feeding (see the section on “Pregnancy
and breast-feeding” below).
Y
•  ou have severe liver failure.
If you are not sure if any of the above apply to
you, talk to your doctor or pharmacist before
taking Tenif.
Take special care with Tenif
Before you take Tenif, tell your doctor if:
•  ou have asthma, wheezing or similar
Y
breathing problems, or you get allergic
reactions, such as to insect stings. If you
have ever had asthma or wheezing, do not
take this medicine without first checking
with your doctor.
Y
•  ou have a type of chest pain (angina) called
Prinzmetal’s angina.
•  ou have poor blood circulation or controlled
Y
heart failure.
•  ou have first-degree heart block (a condition
Y
which may be treated by a pacemaker).
•  ou have liver problems. Your doctor may need
Y
to do tests during your treatment with Tenif to
check how well your liver is working.
•  ou have diabetes. Your medicine may change
Y
how you respond to having low blood sugar.
You may feel your heart beating faster. Your
medicine may hide the symptoms of low blood
sugar.
•  ou suffer from treated phaeochromocytoma
Y
(high blood pressure due to a tumour near your
kidney). Your blood pressure will be monitored
closely by your doctor.
•  ou have thyrotoxicosis (a condition caused
Y
by an overactive thyroid gland). Your medicine
may hide the symptoms of thyrotoxicosis.
•  ou are to be given an anaesthetic agent.
Y
•  ou are giving a urine sample for a doping
Y
test. Tenif may cause a positive result.
•  ou are a man whose female partner is having
Y
IVF (in-vitro fertilisation treatment). This is
because Tenif can affect your sperm.
If you give a urine sample, it is important to tell your
doctor that you are taking Tenif. This is because
Tenif may interfere with the urine test results.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking, or have recently taken, any other medicines.
This includes herbal medicines and medicines that
you buy without a prescription. Tenif can affect the
way that some other medicines work and some
medicines can have an effect on Tenif.
You must not take Tenif if you are taking any of
the following medicines:
•  ifampicin (for tuberculosis).
R
•  ther dihydropyridines such as amlodipine or
O
felodipine (for high blood pressure or heart
problems).
•  ertain calcium channel blockers such as
C
verapamil or diltiazem (for high blood pressure
or chest pain).
Tell your doctor or pharmacist if you are taking
any of the following medicines:
•  ther medicines to treat high blood pressure.
O
•  aclofen (a medicine used for muscle relaxation).
B
•  AO Inhibitors e.g. moclobemide (medicines
M
used for the treatment of depression).
•  acrolide antibiotics e.g. erythromycin
M
(antibiotics used to treat bacterial infections).
•  nti-HIV protease inhibitors e.g. ritonavir (used
A
to treat HIV).
•  etoconazole, itraconazole or fluconazole
K
(anti-fungal medicines).
•  luoxetine or nefazodone (to treat depression).
F
•  uinupristin/dalfopristin (a combination antibiotic).
Q
•  henytoin, carbamazepine, phenobarbitone or
P
valproic acid (to treat epilepsy).
•  isapride (used to treat heart burn).
C
•  lonidine (for high blood pressure or migraine).
C
If you are taking clonidine and Tenif together,
do not stop taking clonidine unless your doctor
tells you to do so. If you have to stop taking
clonidine, your doctor will tell you how to do it.
•  isopyramide, quinidine or amiodarone (for an
D
uneven heart beat).
•  igoxin or digitoxin (for heart problems).
D
•  acrolimus (to prevent the rejection of
T
transplanted organs).
•  drenaline, also known as epinephrine
A
(a medicine that stimulates the heart).
• buprofen or indometacin (for pain and
I
inflammation).
• nsulin or medicines that you take by mouth for
I
diabetes.
•  edicines to treat nose and sinus congestion
M
or other cold remedies (including those you
buy in the pharmacy).
•  imetidine (for stomach problems).
C
If you go into hospital to have an operation, tell
the anaesthetist or doctor that you are taking
Tenif. This is because you can get low blood
pressure (hypotension) if you are given certain
anaesthetics while you are taking Tenif.
Pregnancy and breast-feeding
•  o not take Tenif if you are pregnant or at
D
an age where you could get pregnant. This is
because Tenif can harm your unborn baby.
•  o not take Tenif if you are breast-feeding.
D
Driving and using machines
•  our medicine is not likely to affect driving or
Y
using tools or machines. However, it is best
to wait to see how your medicine affects you
before trying these activities.
• f you feel dizzy or tired when taking this
I
medicine, ask your doctor for advice.
Taking Tenif with food and drink
Do not drink grapefruit juice throughout the whole
period of time you take Tenif. This is because
your blood pressure may be reduced too much,
which may make you feel dizzy.
Important information about some of the
ingredients of Tenif
Tenif contains lactose which is a type of sugar.
If you have been told by your doctor that you
cannot tolerate or digest some sugars (have
an intolerance to some sugars), talk to your doctor
before taking this medicine.
3.  ow to take Tenif
H
Always use your medicine exactly as your doctor
has told you. You should check with your doctor
or pharmacist if you are not sure.
•  wallow the capsules with a drink of water.
S
•  our doctor will tell you how many capsules
Y
to take each day and when to take them. Also
read the label on the carton.
Adults with high blood pressure
(hypertension)
The usual dose is one capsule each day.
Adults with chest pain (angina)
The usual dose is one capsule every 12 hours.
Older people (aged over 65 years)
High blood pressure (hypertension): The dose
should not be more than one capsule each day.
Chest pain (angina): The dose should not be more
than one capsule every 12 hours.
People with liver problems
The dose should not be more than one capsule
each day.
Children
Your medicine must never be given to children.
If you take more Tenif than you should
If you have taken more of your medicine than
prescribed by your doctor, tell your doctor or go to
the nearest hospital casualty department straight
away. Take the medicine packaging with you.
If you forget to take Tenif
If you forget to take a dose, take it as soon as
you remember. If it is almost time to take the next
dose, wait until then. Do not take a double dose.
If you stop taking Tenif
Do not stop taking your medicine without first
talking to your doctor. In some cases, you may
need to stop taking it gradually.

Font information
Font family: Nimbus Sans
Body text size: 9 pt

214643
UK
01
16 August 2013
P036591
630170L4
Pharma Code:

379
Tenif Leaflet

13:59

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4.  ossible side effects
P
Like all medicines, Tenif can cause side effects,
although not everybody gets them.
Important side effects to look out for:
Stop taking Tenif and seek medical help
immediately if you have any of the following:
•  aised lumps on your skin (weals) or
R
swelling of your face, lips, mouth, tongue
or throat. This means that you are having
an allergic reaction.
•  ain in your chest when you start taking
P
Tenif.
Other side effects include:
Common (affects less than 1 in 10 people)
•  eadache**
H
•  low heart beat*
S
•  old hands and feet*
C
•  elaxation of blood vessels, possibly leading to
R
flushing**
•  pset stomach or gut such as stomach pains,
U
diarrhoea, heartburn and feeling sick*
•  onstipation**
C
•  eeling tired*
F
•  eeling unwell**
F
•  welling, particularly of the ankles and legs.**
S
Uncommon (affects less than 1 in 100 people)
•  llergic reactions (raised lumps on your skin
A
(weals) or swelling of your face, lips, mouth,
tongue or throat)**
•  welling of eyes & lips resulting in painful
S
responses with attempts to speak**
•  leep disturbances such as difficulty sleeping*
S
•  nxiety or nervousness**
A
•  leep disorders**
S
•  pinning feeling (vertigo)**
S
•  igraine**
M
•  izziness**
D
•  haking (tremor)**
S
•  ainting**
F
•  isturbances of vision**
D
•  ast heartbeat**
F
• rregular heartbeats (palpitations)**
I
•  ow blood pressure**
L
•  ose bleeds**
N
•  locked nose**
B
•  tomach pain**
S
•  eeling sick (nausea)**
F
• ndigestion**
I
•  ind (flatulence)**
W
•  ry mouth**
D
• ncreased levels of liver enzymes**
I
•  welling of the face, lips, mouth, tongue and/
S
or throat**
•  kin rash or redness of skin**
S
•  uscle cramps**
M
•  welling of your joints**
S
• ncrease in the need to pass water (urinate)**
I
•  ifficulty in passing water**
D
• nability to achieve or maintain an erection**
I
•  nspecific pains**
U
•  hills**
C
• ncreased levels of liver transaminases
I
(enzymes).*
Rare (affects less than 1 in 1,000 people)
•  educed number of platelets in your blood
R
which may make you bleed more easily*
•  ood changes (including depression)*
M
•  ightmares*
N
•  onfusion*
C
•  hanges in personality (psychoses) or
C
hallucinations*
•  izziness*
D
•  eadache*
H
•  ingling feeling such as ‘pins and needles’*
T
•  oss of sense of touch**
L
•  ry eyes*
D
•  isturbances of vision*
D
•  orsening of heart failure*
W
• ncreased heart block (which can cause
I
an abnormal heart beat, dizziness, tiredness or
fainting)*
•  eeling faint (especially when standing up)*
F
•  umbness and spasm in your fingers which
N
is followed by warmth and pain (Raynaud’s
disease)*
•  uddenly feeling wheezy or short of breath
S
(bronchospasm)*
•  nlarged gums**
E
•  ry mouth*
D
•  iver problems including inflammation of liver
L
and jaundice (yellowing of the skin or the
whites of your eyes)*
•  air loss (alopecia)*
H
•  soriasis-like rash (a skin condition)*
P
•  orsening of psoriasis (a skin condition)*
W
•  kin rash*
S
• tching**
I
• tchy rash**
I
•  ash**
R
•  eing unable to get an erection.*
B
Very rare (affects less than 1 in 10,000 people)
• ncrease in Antinuclear Antibodies (ANA).*
I
Not known (cannot be estimated from
available data)
•  evere decrease of the blood cells
S
(agranulocytosis). You may notice tiredness,
an infection or easy bruising**
•  ecrease in the number of white blood cells
D
(leucopenia), increasing the chances of
an infection**
•  urplish marks on your skin
P
•  evere allergic reactions**
S
• ncrease in the amount of sugar (glucose) in
I
your blood**
•  educed feeling in the skin**
R
•  eeling sleepy**
F
•  izziness
D
•  eadache
H
•  ye pain**
E
•  hest pain or tightness in the chest (angina
C
pectoris)**
•  lushing of the skin
F
•  welling caused by a build up of fluid. This is
S
also known as ‘oedema’
•  ifficulty breathing**
D
•  eing sick (vomiting)**
B
•  eartburn or indigestion (gastro-oesophageal
H
sphincter insufficiency)**
•  onstipation*
C

•  pset stomach or gut such as stomach pains,
U
diarrhoea, heartburn and feeling sick
•  ellowing of your skin or whites of your eye
Y
(jaundice)**
•  evere rash, that develops quickly, with
S
blistering or peeling of the skin and possibly
blistering in the mouth**
•  ensitivity to light (photosensitivity allergic
S
reaction)**
•  mall, raised areas of bleeding in the skin
S
(palpable purpura)**
•  caling of the skin (exfoliative dermatitis)**
S
•  oint pains (arthralgia)**
J
•  uscle pain (myalgia)**
M
•  eing unable to get an erection.
B
•  nlarged breasts, particularly in older men.
E
•  urning pain, warmth and redness of the
B
hands and feet.
* Frequency for side effect for atenolol
** Frequency for side effect for nifedipine
Conditions that may get worse
If you have any of the following conditions, they
may get worse when you start to take your
medicine:
•  soriasis (a skin condition), rarely.
P
•  eing short of breath or having swollen ankles
B
(if you have heart failure), rarely.
•  sthma or breathing problems, rarely.
A
•  oor blood circulation, rarely.
P
Do not be concerned by this list of possible side
effects. You may not get any of them. If any of the
side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
5.  ow to store Tenif
H
•  eep out of the reach and sight of children.
K
•  o not store this medicine above 30oC.
D
•  tore in the original package. Keep the blister
S
pack in the outer carton. This will protect your
medicine from light and moisture.
•  o not use your medicine after the expiry date
D
that is stated on the packaging. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.
6. Further information
What Tenif Capsules contain
•  he active ingredients are 50 mg atenolol and
T
20 mg nifedipine per capsule.
•  he other ingredients are gelatin, iron
T
oxide (E172), lactose, macrogol, magnesium
carbonate, magnesium stearate, maize starch,
hypromellose, microcrystalline cellulose,
polysorbate, sodium lauryl sulphate, titanium
dioxide (E171) and printing ink (ink 1 – titanium
dioxide (E171), shellac or ink 2 – titanium
dioxide (E171), shellac and povidone).
What Tenif Capsules look like and contents of
the pack
Tenif Capsules are a reddish-brown colour
printed with ‘Tenif’ and the logo ‘S’ on one side
in white. They come in a blister pack containing
28 capsules.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation for Tenif Capsules
is held by AstraZeneca UK Ltd.,
600 Capability Green, Luton, LU1 3LU, UK.
Tenif Capsules are manufactured by AstraZeneca
UK Ltd., Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.

To listen to or request
a copy of this leaflet in
Braille, large print or audio
please call, free of charge:
0800 198 5000 (UK only)
Please be ready to give
the following information:
Product name
Tenif Capsules
Reference number
17901/0047
This is a service provided
by the Royal National
Institute of Blind People.

Leaflet prepared: February 2013.
© AstraZeneca 2013
Tenif is a trade mark of the AstraZeneca group of
companies.
CV 12 0146a

P036591

Font information
Font family: Nimbus Sans
Body text size: 9 pt

214643
UK
01
16 August 2013
P036591
630170L4
Pharma Code:

379
Tenif Leaflet

13:59

Black

Profile

Technical

Info

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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