Active substance: NIFEDIPINE

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Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1. What VALNI XL is and what it is used for
2. Before you take VALNI XL
3. How to take VALNI XL
4. Possible side effects
5. How to store VALNI XL
6. Further information
VALNI XL Prolonged Release Tablets contain nifedipine which belongs to a group of medicines called
calcium-channel blockers that act on the cardiovascular system (the heart and blood vessels). VALNI XL
has been prescribed by your doctor to treat your high blood pressure or to reduce the frequency of your
anginal attacks. They are called prolonged release tablets because they are manufactured in a way that
allows the nifedipine to be released and slowly absorbed by your body over a period of several hours.
In high blood pressure, nifedipine works by widening the blood vessels. This creates less resistance to
the blood flow, and results in lower blood pressure, which in turn reduces the strain on your heart.
In angina, nifedipine works by opening up the arteries supplying the heart muscle and this allows more
blood and oxygen to reach the muscle, decreasing the chances of angina (chest pains) occuring when
extra strain is placed upon the heart.
Do not take VALNI XL:
• if you are allergic to nifedipine, other calcium-channel blockers (e.g verapamil, diltiazem or felodipine)
or any of the other ingredients of VALNI XL
• if you are pregnant, likely to become pregnant or are breast-feeding
• if you have been told that you have a narrowing (stenosis) of the aortic valve in your heart
• if you have experienced a collapse which was caused by a heart problem (cardiogenic shock)
• if the severity or frequency of your angina has rapidly worsened over a matter of hours or days
• to treat an angina attack as it occurs, but rather to reduce the frequency of the angina you experience
over time
• if you suffer from inflammation of the bowel or intestines (such as Crohn’s disease), oesophageal
(gullet) obstruction or have in the past had an obstruction or narrowing of the intestine
• if you have a liver disease
• if you have had a heart attack during the last month or to treat a heart attack
• if you are taking the antibiotic rifampicin (used to treat tuberculosis)
• if your blood pressure continues to rise despite treatment (malignant hypertension)
Take special care with VALNI XL:
It is important that you tell your doctor if any of the following applies to you.
• if you suffer from low blood pressure
• if you experience chest pains when you first start taking VALNI XL, contact your doctor immediately
• if you are diabetic, the treatment for your diabetes may need to be adjusted
• if you are receiving kidney dialysis and have very high blood pressure with low blood volume
• if you are taking other drugs to treat high blood pressure (e.g. beta-blockers). If you are changing
from a beta-blocker to nifedipine, you should gradually reduce your beta-blocker after discussion
with your doctor
• if you have a Kock pouch (a type of ileostomy)
• if you have to give a urine sample, have an x-ray or undergo surgery
Your doctor may, under certain conditions, think it necessary to keep you on VALNI XL whilst you are
pregnant. If this is the case particular care must be taken if you are also receiving magnesium sulphate
Taking other medicines:
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
In particular, tell your doctor if you are taking:
• other drugs to treat high blood pressure
• cimetidine, to treat stomach ulcers
• the medicines digoxin, diltiazem, quinidine, or beta-blockers, used to treat heart conditions
• the anti-epileptic drug phenytoin
• the antibiotic rifampicin and combination treatment quinupristin/dalfopristin
• cisapride, a drug used to treat reduced movements of the gullet and stomach
The effect of the following drugs on VALNI XL is uncertain. Therefore, as a additional precaution,
please tell your doctor if you are taking:
• the antibiotics erythromycin, ketoconazole, itraconazole or fluconazole
• the HIV protease inhibitors indinavir, nelfinavir, ritonavir or saquinavir
• the antidepressant drugs fluoxetine and nefazodone
• tacrolimus, an immunosuppressant used to prevent the rejection of transplant organs
• carbamazepine and valproic acid, used for the treatment of epilepsy
• the barbiturate phenobarbital, used primarily to treat insomnia and anxiety
The following drugs do not interact with VALNI XL: aspirin, benazepril, candesartan cilexetil, orlistat,
debrisoquine, doxazosin, irbesartan, omeprazole, pantoprazole, ranitidine, rosiglitazone and
triamterene hydrochlorothiazide.
Taking VALNI XL with food and drink:
Do not drink grapefruit juice at the same time or soon after taking VALNI XL because grapefruit juice
can increase the blood levels of nifedipine.
Pregnancy and breast-feeding:
Do not take VALNI XL if you are pregnant, trying to become pregnant or are breast-feeding.
Drugs like VALNI XL have been shown in laboratory experiments to impair sperm function. If you are
male and have been unsuccessful in fathering a child please consult your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines:
It is possible that you may react to VALNI XL. Reactions can vary in intensity from individual to individual
and may affect your concentration. If you are unable to concentrate or remain alert after taking VALNI XL,
then do not drive or operate machinery or perform any activity for which you need to be attentive. This
applies particularly at the start of treatment, on changing medication or in combination with alcohol.
Important information about some of the ingredients of VALNI XL:
VALNI XL contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicinal product.

Always take VALNI XL exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
VALNI XL is specially formulated so that you only have to take your tablets once a day, preferably in the
morning. Your tablet must be swallowed whole with a glass of water and not with grapefruit juice. Do not
break or chew your tablets.
The usual adult dose for treating high blood pressure or preventing angina is 30mg or 60mg once a day.
Your doctor may decide to increase your dose to a maximum of 90mg of nifedipine once a day.
If you are elderly, lower doses of this medicine may be prescribed by your doctor.
Do not stop taking your medicine until your doctor tells you.
Children must not take this medicine.
If you take more VALNI XL than you should:
If you take more VALNI XL than you should, immediately contact your doctor or pharmacist. Elimination
of the product and the restoration of stable cardiovascular conditions may be needed. If you take too
much nifedipine low blood pressure (hypotension) can occur, which can be recognised from symptoms
like dizziness, nausea, vomiting, drowsiness, confusion, lethargy, flushing, a lack of oxygen (hypoxia),
headache or red spots on the face. Eventually, unconsiousness can occur. Increased or decreased
heart rates are also a symptom of overdose. In the event of overdose it is recommended to lay the
patient down with elevated legs, for instance by using some pillows.
If you forget to take VALNI XL:
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking VALNI XL:
If you suddenly stop using this medicine, the symptoms that you had before you started taking this
medicine can come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, VALNI XL can cause side effects, although not everyone gets them. If you do
experience any of these effects they will usually go away when treatment is stopped.
If you experience chest pains when you first start taking VALNI XL, contact your doctor immediately.
The most common side effects that may affect 1 person in 10 are: headache, an irregular heartbeat
(palpitations), flushing, general weakness or loss of strength and energy, constipation, dizziness and
swelling particularly of the ankles and legs.
Less common side effects which may affect less than 1 person in 100 are: pain particularly in the stomach
area (abdomen), chest and legs, general feeling of being unwell, a low blood pressure when rising to the
standing position (hypotension), fainting, a fast heart beat (tachycardia), diarrhoea, a dry mouth, indigestion,
wind (flatulence), feeling sick, leg cramps, sleep disorders, nervousness, pins and needles, dizziness
(vertigo), difficulty in breathing, itching, rash, an increase in the need to pass water and bed wetting.
Rare side effects which may affect less than 1 person in 1,000 are: allergic reactions which may appear as a
yellowing of the skin (jaundice), chills, swelling of the face, fever, problems with your circulatory system, loss
of appetite (anorexia), belching, problems with your gut, inflammation of the gums, tender or swollen gums
which may bleed, an increase in gamma glutamyl-transferase (an enzyme that occurs naturally in the body),
liver function abnormalities, vomiting, problems with your joints that may be painful, muscle pain, increased
sensitivity particularly in the skin, trembling, mood changes, nose bleeds, hives that appear on the body, lips,
eyes, or tongue, sweating, problems with the eyes that may be painful or cause blurred vision, difficulty in
passing water that may be painful and a failure to achieve or maintain an erection (impotence).
Very rare side effects which may affect approximately 1 person in 10,000 are: an allergic reaction that
may become severe, a mass of foreign material found in the stomach which may require surgery for
removal, difficulty in swallowing, inflammation of the gullet, problems with the gums, obstruction of the
gut, ulcers in the gut, jaundice, an increase in serum glutamate pyruvate transaminase (an enzyme that
occurs naturally in the body), a reduction in the number of white blood cells, weight loss, muscle cramps
and blistering of the skin when exposed to sunlight. Too much glucose in the blood (hyperglycaemia)
may also occur. Symptoms of hyperglycaemia include thirst, resulting in need to pass water more
frequently, weight loss and tiredness.
A slight development in breast tissue has also been reported in older men on long term therapy.
As with similar drugs which act on blood vessels, chest (anginal) pain may occur rarely at the start of
treatment with VALNI XL.
Because of the nature of coronary artery disease, heart attacks have occurred in patients treated with
the active ingredient, nifedipine. It has not been shown that these heart attacks were due to treatment
with nifedipine.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Keep out of the reach and sight of children.
Do not store above 25°C. Keep the blister in the outer carton.
Do not use VALNI XL after the expiry date which is stated on the blister and carton.
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 protect the environment.

What VALNI XL contains:
• The active substance is nifedipine.
• The other ingredients are povidone K30, lactose monohydrate, talc, hypromellose (E464),
magnesium stearate, carbomer 974P, colloidal anhydrous silica, macrogol 4000, dimethylaminoethyl
methacrylate-butyl methacrylate-methyl methacrylate copolymer, red iron oxide (E172) and titanium
dioixide (E171).
What VALNI XL look like and the contents of the pack:
Valni XL 30mg and 60 mg Prolonged Release Tablets are pale red with a round and biconvex shape, marked
on one side with “30” or “60” respectively. They are available in calendar blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer.
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
This leaflet was last revised in October 2011
'Zentiva' is a registered trademark. © 2011 Zentiva.


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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.