Adalat LA 30 mg prolonged-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. 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

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 of 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.

Adalat LA 30 contains 9.4 mg of sodium (main component of cooking/table salt). This is less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. Increasing the daily dose to 90 mg nifedipine results in an intake of 28.2 mg sodium. This is equivalent to 1.41 % of the recommended maximum daily dietary intake of sodium for an adult. 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.

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.

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Malta

What Adalat LA contains

Adalat LA tablets contain the active ingredient, nifedipine.

Adalat LA tablets also contain propylene glycol, cellulose acetate, hypromellose, hydroxypropylcellulose, polyethylene oxide, macrogol, magnesium stearate, black printing ink Opacode (containing iron oxide black (E172) and shellac), titanium dioxide (E171), iron oxide (E172) and sodium chloride (see section 2).

What Adalat LA looks like and contents of the pack

Each prolonged-release tablet contains 30 mg of nifedipine. Each tablet is pink and round with a laser hole on one side and marked ‘Adalat 30’.

Each pack contains 28 tablets. Each tablet has the day of the week printed next to it to remind you when to take it.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Manufacturer: