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TENIF

Active substance(s): ATENOLOL / NIFEDIPINE / ATENOLOL / NIFEDIPINE

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P043340

Package leaflet: Information for the patient

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

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 you doctor
or pharmacist. This includes any possible
side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Tenif is and what it is used for
2. What you need to know before you
take Tenif
3. How to take Tenif
4. Possible side effects
5. How to store Tenif
6. Contents of the pack and other information
1. What Tenif is and what it is used for
Tenif contains the active substances atenolol
and nifedipine. Each of these works in a
different way.
• Atenolol belongs to a group of medicines
called beta-blockers. It works by making
your heart beat more slowly and with less
force. This helps to prevent chest pain.
• Nifedipine belongs to a group of medicines
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. What you need to know before you
take Tenif
Do not take Tenif:
• If you are allergic to atenolol, nifedipine,
or any of the other ingredients of this
medicine (listed in section 6).
• If you are having an angina attack
(sudden chest pain). Tenif cannot treat an
angina attack, but it can help you get fewer
attacks if you take it regularly.
• If you are allergic (hypersensitive) to other
dihydropyridines such as amlodipine or
felodipine.
• If you have any of the following heart
problems:
- heart failure which is not under control
(this usually makes you breathless and
causes your ankles or legs to swell)
- second- or third-degree heart block
(a condition which may be treated with
a pacemaker)
- a very slow or very uneven heart beat,
very low blood pressure or very poor
circulation
- a heart attack within the last month
- 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).
- within one month of a heart condition
(e.g. chest pain, angina, heart attack).
• If you have problems with your kidneys.
• If you have a tumour called
phaeochromocytoma that is not being
treated. This is usually near your kidney and
can cause high blood pressure.
• If your doctor has told you that you have
higher than normal levels of acid in your
blood (metabolic acidosis).
• If you have not been eating much recently.
• If you are taking a medicine called rifampicin.
• If you are taking a medicine that is a certain
type of calcium channel blocker such as
verapamil or diltiazem.
• If you are a woman at an age where you
could get pregnant, or you are pregnant
or breast‑feeding (see the section
on “Pregnancy, breast‑feeding and
fertility” below).
• If you 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.
Warnings and precautions
Talk to your doctor or pharmacist before
taking Tenif:
• If you have asthma, wheezing or similar
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.
• If you have a type of chest pain (angina)
called Prinzmetal’s angina.
• If you have poor blood circulation or
controlled heart failure.
• If you have first-degree heart block
(a condition which may be treated by a
pacemaker).
• If you have liver problems. Your doctor may
need to do tests during your treatment with
Tenif to check how well your liver is working.
• If you have diabetes. Your medicine may
change 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.
• If you suffer from treated
phaeochromocytoma (high blood pressure
due to a tumour near your kidney). Your
blood pressure will be monitored closely by
your doctor.
• If you have thyrotoxicosis (a condition
caused by an overactive thyroid gland).
Your medicine may hide the symptoms of
thyrotoxicosis.
• If you are to be given an anaesthetic agent.
• If you are giving a urine sample for a doping
test. Tenif may cause a positive result.
• If you are a man whose female partner is
having 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.
Other medicines and Tenif
Tell your doctor or pharmacist if you are taking,
have recently taken or might take 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:
• Rifampicin (for tuberculosis).
• Other dihydropyridines such as amlodipine
or felodipine (for high blood pressure or
heart problems).
• Certain calcium channel blockers such
as verapamil or diltiazem (for high blood
pressure or chest pain).
Tell your doctor or pharmacist if you are taking
any of the following medicines:
• Other medicines to treat high blood pressure.
• Baclofen (a medicine used for muscle
relaxation).
• MAO Inhibitors e.g. moclobemide (medicines
used for the treatment of depression).
• Macrolide antibiotics e.g. erythromycin
(antibiotics used to treat bacterial infections).
• Anti-HIV protease inhibitors e.g. ritonavir
(used to treat HIV).
• Ketoconazole, itraconazole or fluconazole
(anti-fungal medicines).
• Fluoxetine or nefazodone (to treat depression).
• Quinupristin/dalfopristin (a combination
antibiotic).
• Phenytoin, carbamazepine, phenobarbitone
or valproic acid (to treat epilepsy).
• Cisapride (used to treat heart burn).
• Clonidine (for high blood pressure or
migraine). 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.
• Disopyramide, quinidine or amiodarone
(for an uneven heart beat).
• Digoxin or digitoxin (for heart problems).
• Tacrolimus (to prevent the rejection of
transplanted organs).
• Adrenaline, also known as epinephrine
(a medicine that stimulates the heart).
• Ibuprofen or indometacin (for pain and
inflammation).
• Insulin or medicines that you take by mouth
for diabetes.
• Medicines to treat nose and sinus
congestion or other cold remedies
(including those you buy in the pharmacy).
• Cimetidine (for stomach problems).
Operations
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.
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.
Pregnancy, breast‑feeding and fertility
• 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.
• Do not take Tenif if you are pregnant or at an
age where you could get pregnant. This is
because Tenif can harm your unborn baby.
• Do not take Tenif if you are breast‑feeding.
Driving and using machines
• Your medicine is not likely to affect driving
or using tools or machines. However, it is
best to wait to see how this medicine affects
you before trying these activities.
• If you feel dizzy or tired when taking this
medicine, ask your doctor or pharmacist for
advice.
Tenif contains lactose
Tenif contains lactose which is a type of sugar.
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicine.
3. How to take Tenif
Always take this medicine exactly as your
doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.



Swallow the capsules with a drink of water.
Your doctor or pharmacist will tell you how
many capsules to take each day and when
to take them. Also read the label on the
carton.

Adults with high blood pressure
(hypertension)
The recommended dose is one capsule
each day.
Adults with chest pain (angina)
The recommended dose is one capsule every
12 hours.
Elderly (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.
Use in children
This 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.

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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 to make up for the forgotten dose.
If you stop taking Tenif
Do not stop taking this medicine without first
talking to your doctor. In some cases, you may
need to stop taking it gradually.
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.
Important side effects to look out for:
Stop taking Tenif and seek medical help
immediately if you have any of the following:
• Raised lumps on your skin (weals)
or swelling of your face, lips, mouth,
tongue or throat. This means that you
are having an allergic reaction.
• Pain in your chest when you start
taking Tenif.
Other possible side effects:
Common (may affect up to 1 in 10 people)
• Headache**
• Slow heart beat*
• Cold hands and feet*
• Relaxation of blood vessels, possibly
leading to flushing**
• Upset stomach or gut such as stomach
pains, diarrhoea, heartburn and feeling sick*
• Constipation**
• Feeling tired*
• Feeling unwell**
• Swelling, particularly of the ankles and legs.**
Uncommon (may affect up to 1 in
100 people)
• Allergic reactions (raised lumps on your skin
(weals) or swelling of your face, lips, mouth,
tongue or throat)**
• Swelling of eyes & lips resulting in painful
responses with attempts to speak**
• Sleep disturbances such as difficulty
sleeping*
• Anxiety or nervousness**
• Sleep disorders**
• Spinning feeling (vertigo)**
• Migraine**
• Dizziness**
• Shaking (tremor)**
• Fainting**
• Disturbances of vision**
• Fast heartbeat**
• Irregular heartbeats (palpitations)**
• Low blood pressure**
• Nose bleeds**
• Blocked nose**
• Stomach pain**
• Feeling sick (nausea)**
• Indigestion**
• Wind (flatulence)**
• Dry mouth**
• Increased levels of liver enzymes**
• Swelling of the face, lips, mouth, tongue
and/or throat**
• Skin rash or redness of skin**
• Muscle cramps**
• Swelling of your joints**
• Increase in the need to pass water (urinate)**
• Difficulty in passing water**
• Inability to achieve or maintain an erection**
• Unspecific pains**
• Chills**
• Increased levels of liver transaminases
(enzymes).*
Rare (may affect up to 1 in 1,000 people)
• Reduced number of platelets in your blood
which may make you bleed more easily*
• Mood changes (including depression)*
• Nightmares*
• Confusion*
• Changes in personality (psychoses) or
hallucinations*
• Dizziness*
• Headache*
• Tingling feeling such as ‘pins and needles’*
• Loss of sense of touch**
• Dry eyes*
• Disturbances of vision*
• Worsening of heart failure*
• Increased heart block (which can cause an
abnormal heart beat, dizziness, tiredness or
fainting)*
• Feeling faint (especially when standing up)*
• Numbness and spasm in your fingers which
is followed by warmth and pain (Raynaud’s
disease)*
• Suddenly feeling wheezy or short of breath
(bronchospasm)*
• Enlarged gums**
• Dry mouth*
• Liver problems including inflammation of
liver and jaundice (yellowing of the skin or
the whites of your eyes)*
• Hair loss (alopecia)*
• Psoriasis-like rash (a skin condition)*
• Worsening of psoriasis (a skin condition)*
• Skin rash*
• Itching**
• Itchy rash**
• Rash**
• Being unable to get an erection.*
Very rare (may affect up to 1 in
10,000 people)
• Increase in Antinuclear Antibodies (ANA).*
Not known (frequency cannot be estimated
from the available data)
• Severe decrease of the blood cells
(agranulocytosis). You may notice tiredness,
an infection or easy bruising**
• Decrease in the number of white blood cells
(leucopenia), increasing the chances of an
infection**
• Purplish marks on your skin
• Severe allergic reactions**
• Increase in the amount of sugar (glucose) in
your blood**
• Reduced feeling in the skin**
• Feeling sleepy**
• Dizziness
• Headache
• Eye pain**
• Chest pain or tightness in the chest
(angina pectoris)**
• Flushing of the skin
• Swelling caused by a build up of fluid. This
is also known as ‘oedema’
• Difficulty breathing**




Being sick (vomiting)**
Heartburn or indigestion (gastrooesophageal sphincter insufficiency)**
• Constipation*
• Upset stomach or gut such as stomach
pains, diarrhoea, heartburn and feeling sick
• Yellowing of your skin or whites of your eye
(jaundice)**
• Severe rash, that develops quickly, with
blistering or peeling of the skin and possibly
blistering in the mouth**
• Sensitivity to light (photosensitivity allergic
reaction)**
• Small, raised areas of bleeding in the skin
(palpable purpura)**
• Scaling of the skin (exfoliative dermatitis)**
• Joint pains (arthralgia)**
• Muscle pain (myalgia)**
• Being unable to get an erection.
• Enlarged breasts, particularly in older men.
• Burning pain, warmth and redness of the
hands and feet.
• Lupus-like syndrome (a disease where the
immune system produces antibodies that
attacks mainly skin and joints).
* 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:
• Psoriasis (a skin condition), rarely (may
affect up to 1 in 1,000 people).
• Being short of breath or having swollen
ankles (if you have heart failure), rarely
(may affect up to 1 in 1,000 people).
• Asthma or breathing problems, rarely
(may affect up to 1 in 1,000 people).
• Poor blood circulation, rarely (may affect up
to 1 in 1,000 people).
Do not be concerned by this list of possible
side effects. You may not get any of them.
Reporting of side effects
If you get any side effects, talk to you doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card
Scheme. Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Tenif








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 packaging.
The expiry date refers to the last day of
that month.
Do not store this medicine above 30oC.
Store in the original package. Keep the blister
pack in the outer carton. This will protect your
medicine from light and moisture.
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 Tenif contains
• The active substances are 50 mg atenolol
and 20 mg nifedipine per capsule.
• The other ingredients are gelatin,
iron 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 looks 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.
This leaflet was last revised in
November 2016.
© AstraZeneca 2016
Tenif is a trade mark of the AstraZeneca group
of companies.
CV 16 0106

P043340

549721-A01
24-11-16
P043340
630170L4

Black

Technical Info

502

Profile

Tenif 20mg Leaflet: Patient GB
GP

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Smallest text size

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6.0 pt

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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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