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TENIF 50 MG/20 MG CAPSULES

Active substance(s): ATENOLOL / NIFEDIPINE

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P041300

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.

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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.
• S
 wallow 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.
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.
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.
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.

JL

UK
01
28 October 2015

14:14

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1282

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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 (gastro-oesophageal
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)**

• S
 evere 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
• K
 eep 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 October 2015.
© AstraZeneca 2015
Tenif is a trade mark of the AstraZeneca group of
companies.
CV 15 0078

P041300

265383

JL

UK
01
28 October 2015

14:14

Black

Profile

P041300
630170L4
Pack Line Code Data:

1282

Technical
Info

Tenif leaflet

Font family: Nimbus Sans
9 pt
N

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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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