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TENIF

Active substance(s): ATENOLOL / NIFEDIPINE

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Previously assessed against UK
®
PIL
December
2014 mg Capsules
Tenif
50 mg/20

2599
08.12.15[4]

(atenolol 50 mg, nifedipine 20 mg)
PATIENT INFORMATION 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.
Your medicine is available as the above name but will be referred to as
Tenif throughout this leaflet.
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).

Leaflet updated to

Tell your doctor or pharmacist if you are taking any of the following
amend the active
medicines:
- Other medicines to treat high blood pressure.
statement
- 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.
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 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)**
- 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.
* 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 at:
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 out of the sight and reach of children
Do not store above 30°C. Protect from light and moisture.
Store in the original package. Keep the container in the outer carton.
Do not use your medicine after the expiry date that is stated on the
packaging. The expiry date refers to the last day of that month.
If the capsules become discoloured or show any other sign of deterioration,
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 contain
- Each capsule contains 20mg nifedipine in a slow release formulation and
50mg atenolol.
- The other ingredients are gelatin, red iron oxide (E172), lactose,
macrogol 4000, magnesium carbonate, magnesium stearate, maize
starch, hypromellose 2910, microcrystalline cellulose, polysorbate,
sodium lauryl sulphate, titanium dioxide (E171)
What Tenif look like and contents of the pack
Tenif Capsules are reddish brown gelatin hard capsules printed with 'Tenif'
in white on one side.
They come in a blister pack containing 28 capsules.
Manufacturer and Product Licence Holder
Manufactured by AstraZeneca UK Ltd, Silk Road Business Park,
Macclesfield, Cheshire, SK10 2NA, UK.
Procured from within the EU by Product Licence holder
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex,
HA1 1XD. Repackaged by Servipharm Ltd.
POM

PL 20636/2599

Leaflet revision and issue date: 08.12.15[4]
Tenif is a trademark of AstraZeneca UK Limited.

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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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