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VALNI 20 RETARD

Active substance(s): NIFEDIPINE

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PATIENT INFORMATION LEAFLET

Valni 20 Retard
(Nifedipine 20mg Modified Release Tablets)
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
2
3

1

4

What Valni is and what it is used for
What you need to know before you take Valni
How to take Valni

5
6

Possible side effects
How to store Valni
Contents of the pack and other information

medicines obtained without a prescription. This includes
herbal medicines.

What Valni is and what it
is used for

Valni must not be taken with the following:
 Rifampicin, used to treat bacterial infections
Medicines which may interact with or be affected by Valni:
 Medicines used as a muscle relaxant during surgery
e.g. tubocurarine (anaesthetic). If you are due to have
Valni (Nifedipine 20mg modified release tablets referred to
an operation, you should make sure that your
as Valni throughout this leaflet) is used:
anaesthetist knows you are taking Valni

To treat high blood pressure (hypertension)
 Medicines used to treat bacterial infections e.g.

To prevent attacks of chest pain (angina) diagnosed by
erythromycin, azithromycin (macrolide antibiotics) and
your doctor as chronic stable angina
quinupristin/dalfopristin (combination antibiotic)
Angina is caused by a narrowing of the arteries in the heart
 Medicines used to treat HIV e.g. ritonavir (protease
muscle. Chronic stable angina is a pattern of attacks of chest
inhibitors)
pain that are predicable and happen under certain conditions 
Medicines used to treat fungal infections e.g.
such as after exercise, stress or in cold weather.
ketoconazole
 Medicines used to treat depression e.g. fluoxetine and
nefazodone
What you need to know before
 Medicines used to treat convulsions and epilepsy e.g.
you take Valni
phenytoin, valproic acid and carbamazepine
 Medicines used to treat and prevent the recurrence of
Do not take Valni if:
ulcers e.g. Cimetidine
 You are allergic (hypersensitive) to Nifedipine or any of
Medicines used to treat heart burn e.g. cisapride
the other ingredients of this medicine (See Section 6
 Medicines used to treat insomnia or anxiety e.g.
Contents of the pack and other information")
phenobarbital
 You are allergic (hypersensitive) to other similar
 Medicines used to treat high blood pressure e.g.
medicines (known as dihydropydridine) such as
atenolol (beta−blockers), diltiazem (calcium channel
Nicardipine, Amlodipine, Felodipine, Isradipine,
blocker), lisinopril (ACE inhibitors), indapamide
Lacidipine or Nimodipine
(diuretics),tadalafil (PDE5 inhibitors), methyldopa
 You suffer from narrowing of the valve in your heart
(alpha−adrenergic agonists), losartan (angiotensin
(aortic stenosis)
receptor antagonists)
 You have a sudden attack of chest pain (angina) or
 Medicines used to treat an irregularity in the heartbeat
chest pain even at rest, which increases in severity
e.g. quinidine (arrhythmias)
(unstable angina)
 Medicines used to prevent the rejection of transplanted
 You have suffered a heart attack within the last month
organs e.g. tacrolimus(immunosuppressants)
(acute myocardial infarction)
 Medicines used to treat heart problems such as heart
 You have a history of heart attacks (myocardial
failure e.g. digoxin
infarction)
 Medicines used to treat asthma, bronchitis, emphysema
 Your heart is damaged so that it is unable to supply
and other lung and airway related problems e.g.
sufficient blood to the body (cardiogenic shock)
theophylline (xanthine−derivative bronchodilators)
 You are taking Rifampicin, medicine used to treat
 If you are given magnesium sulphate injections and
bacterial infections (See "Other medicines and Valni"
you are pregnant (may cause a severe fall in blood
section)
pressure)
 Your blood pressure continues to rise despite treatment  Urine tests: Valni may interfere with the results of certain
(malignant hypertension)
urine tests
 You suffer from a liver disease that prevents your liver
from working properly
Valni with food and drink
 You currently have or have had an obstruction or
Do not drink grapefruit juice or eat grapefruit whilst being
narrowing in your intestines
treated with this medicine. Grapefruit juice can increase the
 You have ever had an obstruction in the gullet (the
amount of Nifedipine (the active ingredient in Valni) in the
oesophagus − the tube connecting the throat to the
blood. This effect can last at least 3 days after having
stomach)
grapefruit juice.
 You have a Kock pouch (ileostomy after
Valni and alcohol
proctocolectomy)
 You suffer from inflammation of the bowel or intestines, During treatment with Valni, it is advisable not to drink
alcohol as this may cause you to feel sick, dizzy, extremely
such as Crohn’s disease
tired or suffer headaches (see "Driving and using machines"
Warnings and precautions
section).
Talk to your doctor before taking Valni:
Pregnancy, breast−feeding and fertility
 If you suffer from low blood pressure. Your blood
If you are pregnant or breast−feeding, think you may be
pressure may be decreased further by this treatment
pregnant or are planning to have a baby, ask your doctor for
 If you have a heart condition where your heart cannot
advice before taking this medicine.
cope with increased strain (poor cardiac reserve)
 If you are taking other medicine to treat high blood
Pregnancy
pressure, such as beta−blockers (See "Other
If you are pregnant you should not take Valni. Valni should
medicines and Valni" section)
 If you experience chest pains when you first (within 1−4 only be taken by pregnant women suffering from severely
high blood pressure where standard treatment has failed.
hours) start taking Valni, contact your doctor
immediately
Breast−feeding
 If you are given magnesium sulphate injections and you If you are breast−feeding, you must not take Valni. You
are pregnant [may cause a severe fall in blood pressure] should stop breast−feeding before taking this medicine.
(See "Other medicines and Valni" section)
Nifedipine (the active ingredient in Valni) has been reported
 If you are diabetic. The treatment for your diabetes may to be excreted in human milk and the effects are not known
need to be adjusted
 If you are on kidney dialysis and you have very high
Fertility
blood pressure or have problems with your circulation. A In vitro fertilisation:
significant decrease in blood pressure could occur
If you are a man and have been repeatedly unable to father
 If you are taking the following medicines as your blood
a child by in vitro fertilisation (IVF), and no other explanation
pressure should be monitored and a reduction of Valni
has been found, it is possible that your sperm function may
may need to be considered: (see "Other medicines and be affected by medicines such as Valni.
Valni" section)
Driving and using machines
o Erythromycin, quinupristin,dalfopristin (used to treat
Valni may make you feel sick, dizzy, extremely tired or suffer
bacterial infections)
headaches. If any of these symptoms are experienced, do
o Ritonavir (used to treat HIV)
not drive or operate machinery or pursue any activity in
o Ketoconazole (used to treat fungal infections)
which full attention is required.
o Fluoxetine and Nefazodone (used to treat
These symptoms are more likely to occur when you first start
depression)
o Valproic acid (used to treat convulsions and epilepsy) treatment, change tablets or if you have drunk alcohol (see
"Valni and alcohol" section).
o Cimetidine (used to treat stomach ulcers)
 If you are pregnant or breast feeding. (See "Pregnancy
Valni contains lactose
and breast−feeding" section)
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
Other medicines and Valni
taking this medicine.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines, including
The active ingredient in Valni is Nifedipine which is one of a
group of medicines known as calcium channel blockers.
These work by opening up the blood vessels and increasing
the flow of blood to them.

2

continued....

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Phone

0800 970 6115

for help
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3

How to take Valni

Always take this medicine as your doctor has told you.
Check with your doctor or pharmacist if you are not
sure.




These tablets should be swallowed whole (not broken,
chewed or crushed) with sufficient fluid (e.g. water)
Do not drink grapefruit juice or eat grapefruit whilst
being treated with this medicine (see "Valni with food
and drink" section)

The recommended dose is:
Adults
The recommended starting dose is one tablet (20mg) every
12 hours. Your doctor may increase the dose to two tablets
(40mg) every 12 hours.
Patients with liver problems
If you suffer from any liver problems, your doctor may need
to adjust the dose and should monitor you carefully whilst
you are being treated with Valni.
Elderly patients:
The dose may need to be adjusted (lowered)
Use in children
Valni is not recommended for use in children and
adolescents below 18 years of age, because the safety and
efficacy of Nifedipine (the active ingredient in Valni) has not
been established.
If you take more Valni than you should
If you accidentally take too many tablets, contact your
doctor or nearest hospital emergency department
immediately for advice. Remember to take this leaflet or
any remaining tablets with you. The symptoms of
overdose include: very low blood pressure, fast/slow heart
beat, increased blood sugar level, increased acidity in the
blood, high/low levels of potassium in the blood, heart
problems, drowsiness, dizziness, confusion, feeling or
being sick, lack of energy (lethargy), flushing, low blood
oxygen levels, a lack of consciousness to point of coma
and excess collection of watery fluid in the lungs.
If you forget to take Valni
Take it as soon as you remember, unless it is nearly time
for your next dose. If you miss a dose do not take a double
dose to make up for a forgotten dose.
If you stop taking Valni
Treatment with Valni should not be suddenly stopped.
It is important that you keep on taking Valni for as long as
your doctor has told you to. Do not stop taking the tablets
even though you may feel better. Do not stop or change
your treatment before talking to your doctor.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4






Rare side effects (may affect up to 1 in 1,000 people)
Tingling or numbness in the hands or feet
(paraesthesia) or abnormal sense of touch
(dysaesthesia)
 Lack of energy (lethargy)
 Swelling of the gums (gingivitis/gingival hyperplasia)
[reversible following withdrawal of this medicine]
 Itching (pruritus)
 Skin rashes with the formation of wheals (urticaria)
 Rashes
 Increased need to pass urine



Not known (frequency cannot be estimated from the
available data)
 More prone to infections. This may be due to a severe
reduction in number of white blood cells
(agranulocytosis, leucopoenia)
 Increase in blood sugar levels (hyperglycaemia)
 Decreased skin sensitivity to pain or touch
(hypoaesthesia)
 Feeling sleepy or drowsy (somnolence)
 Eye pain
 Chest pain (angina)
 Breathlessness
 A solid mass of indigestible material that collects in
your digestive tract, sometimes causing a blockage
(bezoar)
 Difficulty swallowing (dysphagia)
 Abdominal pain caused by obstruction of the gut or
ulcers in the gut
 Heartburn caused by stomach acid coming up from the
stomach into the gullet (gastroesophageal sphincter
insufficiency)
 Being sick (vomiting)
 Yellowing of the skin or whites of the eyes (jaundice)
 Abnormal sensitivity of the skin to sunlight
(photosensitivity)
 Skin rash caused by small blood vessels bleeding into
the skin (palpable purpura)
 Muscle pain (myalgia), joint pain (arthralgia)
 Excessive development of the male breast in older
men (gynecomastia) [reversible following withdrawal of
this medicine]
 Build up of bile acids in the bloodstream causing
persistent itch (cholestasis) [reversible following
withdrawal of this medicine]
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
internet at (www.mhra.gov.uk/yellowcard). By reporting side
effects you can help provide more information on the safety
of this medicine.

5

Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Valni and seek medical advice immediately
if you develop the following symptoms:
 Chest pain or worsening of existing chest pain (angina
pectoris) within 1 − 4 hours of taking your first dose of
this medicine
 Allergic reactions: swelling of the face, throat or
tongue, fever, difficulty in breathing, dizzin
 Swelling of the deeper layers of the skin caused by a
build−up of fluid (angioedema)
 Severe blistering of the skin, mouth, eyes and genitals
(Toxic Epidermal Necrolysis) [TEN]
Common side effects (may affect up to 1 in 10 people)
Headache
Swelling of parts of the body, particularly the ankles
(oedema)
 Constipation
 Widening of blood vessels (vasodilatation). (A distinct
fall in blood pressure can occur in dialysis patients with
malignant hypertension [very high blood pressure that
comes on suddenly and quickly] and hypovolaemia
[severe blood and fluid loss making the heart unable to
pump enough blood to the body] as a result of
vasodilation)
 Reddening of the face (flushing)
 Feeling unwell




Uncommon side effects (may affect up to 1 in 100 people)
 Anxiety
 Sleep disorders
 Feeling of dizziness or "spinning" (vertigo)
 Severe headache (migraine)
 Shaking (tremors)
 Sight disturbances
 Faster heartbeat (tachycardia)
 Feeling your heartbeat (palpitations)
 Low blood pressure (hypotension)
 Fainting (syncope)
 Blocked nose
 Nose bleed
 Stomach and abdominal pain
 Indigestion
 Feeling bloated/wind (flatulence)
 Dry mouth
 Feeling sick (nausea)
 Temporary increase in liver enzymes (detected through
blood test)
 Flushing of the skin
 Muscle cramps
 Swelling of the joints
 Increased production of urine (polyuria)

Hard to Read?
Product Name
Strength / Form
Type
Dimensions
Typefaces
Rev #
Last updated
No. of Colours

Painful or difficult urination (dysuria)
Difficulty achieving or maintaining an erection
Unspecific pain
Chills




How to store Valni

Keep out of the sight and reach of children.
Store below 25°C . Store in the original package in
order to protect from light.
Do not use this medicine after the expiry date which is
stated on the carton/blister after "EXP". The expiry
date refers to the last day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.
If you should notice any defects with these tablets such
as discolouration and chipping you must take them to
your pharmacist for advice before taking them.






6

Contents of the pack and other
information

What Valni contains:
Each modified released tablet contains 20mg of Nifedipine.
The other ingredients are: microcrystalline cellulose,
lactose, corn starch, talc, hydroxypropylmethyl cellulose,
magnesium stearate, polysorbate 80, polyethylene glycol
4000, iron oxide (E172) and titanium dioxide (E171).
What Valni looks like and contents of the pack:
Valni Tablets are pale red, round, biconvex tablets with the
marking NIF20 on one side.
Valni is available in:
Valni Tablets are available in packs of 28, 30, 56, 60, 84,
100, 250, 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd
3 Howard Road
Eaton Socon
St Neots
Cambridgeshire
PE19 8ET
United Kingdom
Product Licence Number:
PL 11311/0458.

Date of last revision: February 2014

Phone

0800 970 6115

Valni 20 Retard
Tabs
PIL
175 x 420 mm
Font SansSerif − Min. Text 8pt
Till−Ver.5s
06/02/2014
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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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