Active ingredient
- nifedipine
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL 17780/0317, PL 17780/0318.
Valni XL 30mg, 60mg Prolonged Release Tablets
PATIENT INFORMATION LEAFLET
VALNI XL 30MG & 60MG PROLONGED RELEASE TABLETS
Nifedipine
Read all of this leaflet carefully before you start taking this medicine.
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. Contents of the pack and other information
1. WHAT VALNI XL IS AND WHAT IT IS USED FOR
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) occurring when extra strain is placed upon the heart.
2. BEFORE YOU TAKE VALNI XL
Do not take VALNI XL:
Take special care with VALNI XL:
It is important that you tell your doctor if any of the following applies to you.
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 sulfate injections.
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:
The effect of the following drugs on VALNI XL is uncertain. Therefore, as an additional precaution, please tell your doctor if you are taking:
The following drugs do not interact with VALNI XL: aspirin, benazepril, candesartan cilexetil, orlistat, debrisoquine, doxazosin, irbesartan, omeprazole, pantoprazole, ranitidine, rosiglitazone and triamterene hydrochlorothiazide.
VALNI XL with food and drink:
Do not drink grapefruit juice or eat grapefruit whilst taking VALNI XL because grapefruit juice can increase the blood levels of nifedipine.
Do not start taking VALNI XL within 3 days of drinking grapefruit juice or eating grapefruit. The effects of this can last for at least 3 days so it is important to tell your doctor if you have had grapefruit juice or ate grapefruit during this time.
Pregnancy and breast-feeding:
Tell your doctor if you are pregnant, think you might be pregnant or are planning a family.
You may be able to use VALNI XL, but only after special consideration and agreement by your doctor.
Do not take VALNI XL if you are breast feeding. If you need to take VALNI XL, you should stop breastfeeding before you start taking the tablets.
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. VALNI XL may make you feel dizzy, faint, extremely tired or have visual disturbances. 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.
3. HOW TO TAKE VALNI XL
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, bite or chew your tablets. VALNI XL may be taken with or without food.
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 and adolescents under 18 years of age 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, unconsciousness 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.
Take your normal dose immediately and continue taking your tablets at the usual time of day, waiting at least 12 hours before taking the next 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.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VALNI XL can cause side effects, although not everyone gets them. If you experience any of the following side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department:
Apart from the side effects listed above, these are the other side effects of VALNI XL, starting with the more common ones:
Common side effects – these may affect up to 1 in 10 people
Uncommon side effects – these may affect up to 1 in 100 people
Rare side effects – these may affect up to 1 in 1,000 people
Other side effects – frequency unknown
A slight development in breast tissue has also been reported in older men on long term therapy. 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.
All of these symptoms usually go away when treatment with VALNI XL is stopped.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE VALNI XL
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What VALNI XL contains:
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.
The Marketing Authorisation Holder is:
The Manufacturer is:
This leaflet was last revised in September 2019
'Zentiva' is a registered trademark. © 2019
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