Adalat LA 30 tablets

United Kingdom - English - eMC (Electronic Medicines Compendium)

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Active ingredient:
Nifedipine
Available from:
CST Pharma Ltd
ATC code:
C08CA05
INN (International Name):
Nifedipine
Dosage:
30mg
Pharmaceutical form:
Modified-release tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Caution - AMP level prescribing advised
Product summary:
BNF: 02060200; GTIN: 5055946802299

C324 LEAFLET Adalat LA 20200219

PACKAGE LEAFLET: INFORMATION FOR USER

Adalat

®

LA 30 Tablets

(nifedipine)

Your medicine is known as Adalat LA 30 Tablets but will be referred

to as Adalat LA 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 Adalat LA is and what it is used for

2.

What you need to know before you take Adalat LA

3.

How to take Adalat LA

4.

Possible side effects

5.

How to store Adalat LA

6.

Contents of the pack and other information

1. What Adalat LA is and what it is used for

Adalat LA contains nifedipine, which belongs to a group of

medicines called calcium antagonists.

Adalat LA is used to treat high blood pressure or angina (chest

pain).

For high blood pressure: Adalat LA works by relaxing and

expanding the blood vessels. This makes the blood flow more

easily and lowers blood pressure. Lower blood pressure reduces

the strain on your heart.

For angina: Adalat LA works by relaxing and expanding the arteries

supplying the heart. This allows more blood and oxygen to reach

the heart and decreases the strain on it. Your angina attacks will be

less severe and less frequent if there is less strain on the heart.

2. What you need to know before you take Adalat LA

Do not take Adalat LA:

If you have had a heart attack within the last month.

If you get a sudden angina attack. Adalat LA will not help

relieve symptoms of angina quickly.

If you have unstable angina.

If you are allergic to nifedipine, any other similar medicines

(known as dihydropyridines) or any of the other ingredients

this medicine (listed in section 6).

If you are taking rifampicin, an antibiotic.

If you have a liver disease that prevents your liver from

working properly.

If you have inflammation of the bowel or intestines, such as

Crohn’s disease.

If you have an obstruction or narrowing in your intestines,

or have had this in the past.

If you have ever had an obstruction in the gullet (the

oesophagus - the tube connecting the throat to the stomach).

If you have been told that you have a narrowing of the

aortic heart valve (stenosis).

If you have ever had a collapse caused by a heart problem

(cardiogenic shock), during which you became breathless, pale

and had a cold sweat and dry mouth.

If you have a “Kock pouch” (a surgically constructed intestinal

reservoir with an opening through the abdominal wall) in your

gut.

If your blood pressure continues to rise despite treatment

(malignant hypertension).

Tell your doctor and do not take Adalat LA if any of these

apply to you.

Warnings and precautions

Talk to your doctor before taking Adalat LA

If you have low blood pressure and you were prescribed

Adalat LA for your angina. Your blood pressure may be

decreased further by this treatment.

If you have a heart condition where your heart cannot cope

with increased strain (poor cardiac reserve).

If you are pregnant.

If you are breast-feeding. If you need to take Adalat LA, you

should stop breast-feeding before you start to take this

medicine.

If you are a diabetic. The treatment for your diabetes may

need to be adjusted. If you have any questions about this, ask

your doctor.

If you are on kidney dialysis. If you have a very high blood

pressure and a low blood volume, you might experience a

sudden drop in blood pressure when you take Adalat LA.

If your liver is not working properly. Your doctor may need to

do some blood tests. You may also be given a lower dose of

Adalat LA.

Talk to your doctor before you take Adalat LA if any of

these apply to you.

Tell your doctor:

If your chest pain (angina) gets worse (comes on more often

or more severely) over a matter of hours or days. You may be

advised not to take Adalat LA.

If you have chest pains after taking your first dose of Adalat

LA. Your doctor may wish to change your treatment.

If you notice increased breathlessness.

If you notice swelling of the ankles.

Tell your doctor before you take the next dose if any of

these apply to you.

Also tell your doctor:

If you are giving a urine sample. Adalat LA may interfere with

the results of certain urine tests.

If you are to have a barium contrast x-ray (barium meal).

These tablets may affect the results of the test.

If you are a man who has been unable to father a child by in

vitro fertilisation. Drugs like Adalat LA have been shown to

impair sperm function.

Other medicines and Adalat LA

Tell your doctor if you are taking, have recently taken or might

take any other medicines.

Some medicines may affect the way Adalat LA works. Tell your

doctor if you are taking:

Other medicines to treat high blood pressure.

Rifampicin (an antibiotic).

Cimetidine (to treat stomach ulcers).

Digoxin, diltiazem, quinidine or beta-blockers (to treat heart

conditions).

Quinupristin/dalfopristin (a combination antibiotic).

Phenytoin, carbamazepine or valproic acid (to treat

epilepsy).

Cisapride (to treat reduced movements of the gullet and

stomach).

Magnesium sulphate injections during pregnancy (may

cause a severe fall in blood pressure).

Erythromycin (an antibiotic).

Ketoconazole, itraconazole or fluconazole (anti-fungal

medicines).

Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to

treat HIV).

Fluoxetine or nefazodone (to treat depression).

Tacrolimus (to prevent the rejection of transplanted organs).

Phenobarbital (usually used to treat insomnia or anxiety).

Adalat LA with food and drink

You can take Adalat LA with or without food.

Do not drink grapefruit juice or eat grapefruit while taking

Adalat LA.

Do not start taking Adalat LA within 3 days of drinking grapefruit

juice or eating grapefruit. Tell your doctor if you have had grapefruit

or grapefruit juice in this time. Also, do not drink grapefruit juice or

eat grapefruit whilst taking Adalat LA. Grapefruit juice is known to

increase the blood levels of the active ingredient, nifedipine. This

effect can last for at least 3 days.

This medicine contains less than 1mmol sodium (23mg) per tablet,

that is to say essentially 'sodium free'.

Tell your doctor if you are on a low-salt diet.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to

have a baby, ask your doctor for advice before taking this

medicine.

You may be able to use Adalat LA but only after special

consideration and agreement by your doctor.

Do not take Adalat LA if you are breast-feeding. If you need to

take Adalat LA, you should stop breast-feeding before you start

taking this medicine.

Driving and using machines

Adalat LA may make you feel dizzy, faint, extremely tired or have

visual disturbances. Do not drive or operate machinery if you are

affected in this way.

This may be more likely when you first start treatment, if you

change tablets, or if you have drunk alcohol.

3. How to take Adalat LA

Adalat LA is specially formulated so that you only have to take one

dose each day.

Always take this medicine exactly as your doctor has told you.

Check with your doctor if you are not sure.

Dose for high blood pressure: the usual dose is 1 tablet, once

a day.

Dose for angina: the dose depends on your individual

requirements. Your doctor will decide how much you should

take.

Swallow the tablets whole. Do not bite, chew or break them

– if you do they will not work properly. If you have difficulty

swallowing tablets, consult your doctor as he or she may wish

to change your medicine.

Continue to take these tablets for as long as your doctor has

told you to.

Take your dose at the same time each day, preferably in the

morning.

Take your tablets with a glass of water. Do not take them with

grapefruit juice.

You can take Adalat LA with or without food.

You may see what looks like a complete tablet in the toilet or in your

stools. This is normal – it’s the outer shell of the tablet which is not

digested by the body.

Use in children and adolescents: Adalat LA is not recommended

for use in children and adolescents below 18 years of age, because

there are only limited data on the safety and efficacy in this

population.

If you take more Adalat LA than you should

Get medical help immediately. If possible, take your tablets or

the box with you to show the doctor.

Taking too many tablets may cause your blood pressure to become

too low and your heartbeats to speed up or slow down. It may also

lead to an increase in your blood sugar level or an increase in the

acidity of your blood, swelling in the lungs, low blood oxygen levels

and disturbances in consciousness, possibly leading to

unconsciousness.

If you forget to take Adalat LA

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.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask

your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although

not everybody gets them.

Serious side effects

If you notice:

Severe, sudden generalised allergic reaction including very

rarely life-threatening shock (e.g. difficulty in breathing, drop of

blood pressure, fast pulse), swelling (including potentially life-

threatening swelling of the airway)

other allergic reactions causing swelling under the skin

(possibly severe and including swelling of the larynx that may

result in a life-threatening outcome)

fast heart beat (tachycardia)

shortness of breath (frequency not known) or difficulty breathing

mild to moderate allergic reactions

itching (possibly severe), a rash or hives

Contact your doctor immediately and do not take the next

dose as these may be the first signs of allergic reaction which

may become severe.

If you develop:

a skin reaction or blistering/peeling of the skin and/or mucosal

reactions (in the mouth/nose or at the penis/vagina) (Toxic

Epidermal Necrolysis)

Contact your doctor immediately before you continue

treatment as these may be signs of a severe reaction.

Less serious side effects

Apart from the side effects listed above, these are the other side

effects of Adalat LA, starting with the more common ones:

Common side effects

(These may affect up to 1 in 10 people)

headache

flushing

general feeling of being unwell

constipation

swelling, particularly of the ankles and legs

Uncommon side effects

(These may affect up to 1 in 100 people)

stomach pain (abdominal pain)

unspecific pain

chills

low blood pressure when standing up (symptoms include

fainting, dizziness, light headedness, occasional palpitations,

blurred vision and sometimes confusion)

fainting

irregular heartbeat (palpitations)

dry mouth

indigestion or upset stomach

wind (flatulence)

feeling sick (nausea)

muscle cramps

joint swelling

sleep disorders

anxiety or nervousness

reddening of the skin

nose bleeds

nasal congestion

sensation of spinning or whirling motion (vertigo)

migraine

dizziness

trembling

increase in the need to pass water (urinate)

painful or difficult urination

inability to achieve or maintain an erection (impotence)

blurred vision

temporary increase in certain liver enzymes

Rare side effects

(These may affect up to 1 in 1,000 people)

pins and needles

inflammation of the gums, tender or swollen gums, bleeding

gums

Other side effects

(Frequency not known: frequency cannot be estimated from the

available data)

stomach pain or distress caused by a mass of foreign material

found in the stomach which may require surgery for removal

difficulty swallowing

abdominal pain, caused by obstruction of the gut or ulcers in

the gut

vomiting

a reduction in the number of white blood cells (leucopenia)

a more severe decrease in a specific class of white blood cell

(agranulocytosis)

increased blood sugar (hyperglycaemia)

decreased skin sensitivity (hypoaesthesia)

drowsiness (somnolence)

eye pain

chest pain (angina pectoris)

heartburn or indigestion (gastroesophageal sphincter

insufficiency)

yellowing of the whites of the eyes or skin (jaundice)

sensitivity to light (photosensitivity allergic reaction)

small, raised areas of bleeding in the skin (palpable purpura)

joint pain

muscle pain

All of these symptoms usually go away when treatment with Adalat

LA 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 Adalat LA

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

Adalat LA Tablets should be stored below 25°C in the

manufacturer’s original container and protected from strong

light. Only remove a tablet from the box or blister strip when you

are about to take it.

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 Adalat LA contains

Each Adalat LA contains 30mg of the active ingredient,

nifedipine, in a modified release formulation.

Adalat LA Tablets also contain the following: polyethylene

oxide, magnesium stearate, red iron oxide (E172), cellulose

acetate, polyethylene glycol, hydroxypropylmethyl cellulose,

titanium dioxide (E171), propylene glycol, hydroxypropyl

cellulose and black printing ink.

What Adalat LA looks like and contents of the pack

Adalat LA is round, pink, biconvex tablet marked ‘Adalat 30’ on

one side.

Adalat LA Tablets are available as calendar blister packs of 28

tablets. Each tablet has the day of the week printed next to it to

remind you when to take it.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,

Wembley, Middlesex, HA0 1DX, England.

Manufacturer

This product is manufactured by Bayer AG, Leverkusen, Germany.

PL: 08747/0324

Leaflet revision date: 19 February 2020

Blind or partially sighted? Is

this leaflet hard to see or read?

Call 02087997607 to obtain the

leaflet in large print, tape, CD

or Braille.

Adalat

®

LA is a registered trademark of Bayer Intellectual Property

GmbH, Germany.

C324 LEAFLET Adalat LA 20200219

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