Adalat Retard 20mg Tablets
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S. Gonzalez, s. I.
drtes giaficds
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) *T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
cn
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Prueba N.°: 6
Fecha: 20.4.2012
Cliente: BOTICALIA Codigo: ADAR20 [0178]
Edicion: 18.04.2012 Prospecto:
ADALAT RETARD 20MG TABLETS
Tamano: 150 x 540 mm
Plegado: 150 x 33,75 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
Your medicine will be referred to as Adalat Retard Tablets throughout this leaflet.
Read all of this leaflet carefully before you start taking this medicine.
• 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 Retard Tablets are
2 Before you take Adalat Retard Tablets
3 How to take Adalat Retard Tablets
4 Possible side effects
5 How to store Adalat Retard Tablets
6 Further information
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MEDIDA FINAL PLEGADO
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Adalat Retard Tablets contain nifedipine, which belongs to a group of medicines called calcium antagonists.
Adalat Retard Tablets are used to treat high blood pressure or angina (chest pain).
For high blood pressure: Adalat Retard Tablets 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 Retard Tablets 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.
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Do not take Adalat Retard Tablets:
• If you have had a heart attack within the last month.
• If you get a sudden angina attack. Adalat Retard Tablets 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 Retard Tablets are listed in section 6.
• If you are pregnant.
• If you are breastfeeding. If you need to take Adalat Retard Tablets, you should stop breastfeeding before you start to take this medicine.
• If you are taking rifampicin, an antibiotic.
• 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 your blood pressure continues to rise despite treatment (malignant hypertension).
• If you have been told to avoid lactose, that you have a hereditary condition called Lapp
lactase deficiency or glucose-galactose malabsorption
Tell your doctor and do not take Adalat Retard Tablets if any of these apply to you.
Your doctor will take special care:
• If you have low blood pressure and you were prescribed Adalat Retard Tablets 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 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 Retard Tablets.
• 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 Retard Tablets.
Talk to your doctor before you take Adalat Retard Tablets 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 Retard Tablets.
• If you have chest pains after taking your first dose of Adalat Retard Tablets. 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 Retard Tablets may interfere with the results of certain urine tests.
• If you are a man who has been unable to father a child by in vitro fertilisation. Drugs like Adalat Retard Tablets have been shown to impair sperm function.
Other medicines and Adalat Retard Tablets
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 Retard Tablets work. 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 Retard Tablets
You can take Adalat Retard Tablets either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat Retard Tablets.
Do not start taking Adalat Retard Tablets 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 Retard Tablets. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days. Pregnancy and breastfeeding
Do not take Adalat Retard Tablets if you are pregnant. If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Adalat Retard Tablets You may be able to use Adalat Retard Tablets after week 20 of your pregnancy, but only after special consideration and agreement by your doctor
Do not take Adalat Retard Tablets if you are breastfeeding. If you need to take Adalat Retard Tablets, you should stop breastfeeding before you start taking the tablets.
Driving and using machines
Adalat Retard Tablets 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.
Take the tablets as prescribed by your doctor.
• To start with, you may be given a lower strength (10mg) tablet called Adalat Retard 10mg. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.
• The usual maintenance dose of Adalat Retard (20mg strength) is 1 tablet, every 12 hours (i.e. twice per day), but your doctor may increase or decrease the dose depending on how well your blood pressure or angina is being controlled. The maximum dose is 2 tablets (40 mg) every 12 hours.
o • Lower doses may be prescribed for elderly patients.
§ • If you have problems with your liver you are likely to be given Adalat Retard 10mg, at least to begin with.
S. Gonzalez, s. I.
drtes giaficds
Mercurio 13 - Pol. Ind. "Coherman" 28970 Humanes (Madrid) *T. 91 697 65 02 - F. 91 697 18 03 artesgraficas@s-gonzalezsl.com
Prueba N.°: 6
Fecha: 20.4.2012
Cliente: BOTICALIA Codigo: ADAR20 [0178]
Edicion: 18.04.2012 Prospecto:
ADALAT RETARD 20MG TABLETS
Tamano: 150 x 540 mm
Plegado: 150 x 33,75 mm
N° de Colores: 1/1
Color: Negro
Cod. Barras: ---
Papel: Offset blanco 50 g/m2
• Swallow the tablets whole with a little water.
• Continue to take the tablets for as long as your doctor has told you to.
Do not take them with grapefruit juice.
You can take Adalat Retard Tablets either with or without food.
Use in children: Adalat Retard Tablets are 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 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 as prescribed, waiting 12 hours before taking your next dose.
Do not take a double dose to make up for the missed dose.
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Helvetica Condensed Tamano: 9,5 pt.
Correcciones □ Aprobado □
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Like all medicines, Adalat Retard Tablets 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 Retard Tablets, 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)
• 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 or bleeding in the skin (palpable purpura)
• joint pain
• muscle pain
All of these symptoms usually go away when treatment with Adalat Retard Tablets 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.
• Keep this medicine out of the reach and sight of children.
• Do not store above 25°C. Store in the original package. Protect from light.
• Only remove a tablet from the box or blister strip when you are about to take it.
• Do not use this medicine after the expiry date which is printed on both the carton label and blister.
• If your doctor tells you to stop taking this medicine, return any unused medicine to your pharmacist for safe disposal. Only keep this medicine, if your doctor tells you to.
• If your tablets show signs of deterioration or discolouration, you should seek the advice of your pharmacist who will tell you what to do.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Each film-coated tablet contains 20mg of the active ingredient nifedipine.
Each tablets also contains microcrystalline cellulose, maize starch, lactose, polysorbate 80, magnesium stearate, hypromellose, macrogol 4000, titanium dioxide (E171) and red iron oxide (E172) What Adalat Retard Tablets look like and contents of the pack
Each round, pink, film coated tablet is marked 'A20'on one side, ‘BAYER' cross on the other side. Adalat Retard 20mg Tablets are available as blister packs of 60 tablets.
Who manufactured your medicine
Manufactured by Bayer Healthcare AG, D-51368 Leverkusen, Germany and are within the EU and repackaged by Product Licence Holder Boticalia Ltd, 27 Acton London W3 7QE.
procured from Park, The Vale,
Adalat Retard 20mg Tablets PL 23038/0178
Leaflet Date: 18.04.2012
POM
ADAR20
Adalat Retard is a registered trademark of Bayer Schering Pharma AG, Leverkusen, Germany