Tenif
5. How to store Tenif
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store your tablets above 25°C.
• Store in the original package. Protect from light and moisture.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
6. Contents of the pack and other information
What Tenif contains
• The active substances in Tenif are atenolol and nifedipine.
Each hard capsule contains 20mg nifedipine in a slow release formulation and 50mg atenolol.
• The other ingredients are: gelatin, red iron oxide (E172), lactose, macrogol, magnesium carbonate, magnesium stearate, maize starch, hypromellose, microcrystalline cellulose, polysorbate 80, sodium lauryl sulphate and titanium dioxide (E171).
What Tenif looks like and contents of the pack
Tenif capsules are red-brown capsules marked ‘TENIF’ in white on the cap containing a white powder and a small round pinkish tablet with a yellow core.
Tenif Capsules are available as blister packs of 28 tablets.
Product Licence holder
Procured from within the ELI and repackaged by the Product Licence holder: S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley, Middlesex HAO 1DX.
Manufacturer
This product is manufactured by
• Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany.
• AstraZeneca UK Limited, Silk Road, Business Park, Macclesfield, Cheshire, SK10 2NA, UK.
|POMl PL: 19488/0131
Leaflet revision date: 10 March 2016
Tenif is a registered trademark of AstraZeneca UK Ltd UK.
S131 LEAFLET Tenif 20160310
S131 LEAFLET Tenif 20160310
PACKAGE LEAFLET: INFORMATION FOR THE USER TENIF® 50mg/20mg CAPSULES (atenolol / nifedipine)
Your medicine is known as Tenif 50mg/20mg Capsules but will be referred to as Tenif throughout the following 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 your 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.
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.**
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.
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*
• Fleadache*
• 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.
• 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 at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.