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TENIF CAPSULES

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

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PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT

Tenif® Capsules
(atenolol/nifedipine)

Your medicine is available using the name Tenif Capsules but
will be referred to as Tenif throughout this leaflet.

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.
2.
3.
4.
5.
6.

What Tenif is and what it is used for
What you need to know before you take Tenif
How to take Tenif
Possible side effects
How to store Tenif
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 heartburn).

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).

Page 1 of 2

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.

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 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.

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.

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.

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 heart beat**
Irregular heart beats (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.*

5. How to store Tenif






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)**
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 your 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.

Page 2 of 2




Do not store above 25°C. Protect from light and
moisture.
KEEP ALL MEDICINES OUT OF THE SIGHT AND
REACH OF CHILDREN.
Do not use after the expiry date printed on the carton
label or blister strip. The expiry date refers to the last
day of that month.
If your doctor tells you to stop taking the capsules,
please take them back to the pharmacist for safe
disposal. Only keep the capsules if your doctor tells you
to.
If the capsules become discoloured or show signs of any
deterioration, you should seek the advice of your
pharmacist.
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. Contents of the pack and other
information
What Tenif contains



Each capsule contains 20mg nifedipine in a slow release
formulation and 50mg atenolol.
Tenif also contains the following ingredients:
magnesium carbonate, maize starch,
sodium lauryl sulphate, magnesium stearate,
microcrystalline cellulose, lactose, polysorbate 80,
hypromellose 2910, macrogol 4000, titanium dioxide
(E171), red iron oxide (E172) and gelatin

What Tenif looks like and contents of the pack

The capsules are reddish-brown and marked 'Tenif' in white.
Tenif is available as calendar blister packs of 28 capsules.

Manufacturer

This product is manufactured by: AstraZeneca GmbH,
Plankstadt, Germany.
Or
AstraZeneca UK Ltd., Silk Road Business Park, Macclesfield,
Cheshire, SK10 2NA, UK.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall Industrial Estate, Doncaster, DN3 1QR.
PL No: 04423/0325

POM

If you wish to receive this leaflet in Braille, large font or audio
format please contact 01302 365000 and ask for the
Regulatory Department.
Please be ready to give the following information:
Product name:
Tenif Capsules
Reference number:
04423/0325
Leaflet revision and issue date (Ref.): 04.03.16
Tenif® is a registered trademark of AstraZeneca group of
companies.

Expand Transcript

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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