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Adalat La 30 Tablets

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S0082-28-RM-PIL-06.02.2014

Package leaflet - information for the user

Adalat® LA 30 Tablets

Nifedipine

Read all of this leaflet carefully before you start taking this medicine.

The name of your medicine is Adalat LA 30 Tablets but will be referred to as Adalat La throughout the remainder of this leaflet.

   Keep this leaflet. You may need to read it again.

   If you have more 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet

1.    What Adalat LA is

2.    Before you take Adalat LA

3.    How to take Adalat LA

4.    Possible side effects

5.    How to store Adalat LA

6.    Further information

1.    WHAT ADALAT LA IS

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.    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 the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Adalat LA are 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.

Your doctor will take special care:

   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 breastfeeding. If you need to take Adalat LA, you should stop breastfeeding 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 about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.

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).

Food and drink with Adalat LA

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.

One tablet of Adalat LA 30 contains 24mg salt (sodium chloride).

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

Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Adalat LA.

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 breastfeeding. If you need to take Adalat LA, you should stop breastfeeding before you start taking the tablets.

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.

Take the tablets as prescribed by your doctor.

   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: Adalat LA 30 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.

POM


If you take too many tablets

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 the tablets

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 the missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Adalat LA can have 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 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 unknown)

   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.

If you get side effects

Tell your doctor if any side effect gets serious, or if you get

any effects not listed in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.

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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.    HOW TO STORE ADALAT LA

Keep this medicine out of the sight and reach of children.

Store your medicine in its original container.

Protect from strong light and only remove the tablet from the blister strip when you are about to take it. Do not store above 30°C.

Do not use after the expiry date which is marked on both the outer carton and on each blister strip of tablets.

Do not dispose of medicines in household rubbish. Any unused Adalat LA tablets should be returned to a pharmacist (chemist) who will dispose of them properly. This helps the environment.

6.    FURTHER INFORMATION What Adalat LA 30 contains

Each Adalat LA tablet contains 30mg of active ingredient, nifedipine.

Each Adalat LA tablet also contains: magnesium stearate, hypromellose (5 cP), hypromellose (3 cP), polyethylene oxide, red iron oxide (E172), sodium chloride, cellulose acetate, macrogol 3350, hydroxypropylcellulose, titanium dioxide (E171), propylene glycol and black printing ink - Opacode S-1-17823 (shellac, black iron oxide E172, propylene glycol and ammonium hydroxide 28%).

Each tablet also contains 24mg of sodium chloride (salt) to be taken into consideration by patients on a controlled sodium diet.

What's in the pack

Each prolonged release film-coated tablet contains 30 mg of nifedipine.

Each tablet is pink, circular and marked ‘Adalat 30' on one side in black.

Each pack contains 28 tablets.

Manufacturer: Bayer Pharma AG, Bayerwerk, D-51368, Leverkusen, Germany.

Procured from within the EU and repackaged by: Amimed Direct Ltd, Hendon, London, NW9 6AQ.

Product Licence Holder: Sam Pharma Ltd, Unit 20 Garrick Industrial Estate, Irving Way, Hendon, London, NW9 6AQ.

PL No: 33902/0082

This leaflet was last revised: 06.02.2014

Adalat® is a registered trademark of Bayer AG Germany

S0082-28-RM-PI L-06.02.2014