Fortipine La 40mg Modified-Release Tablets
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MercuryPharma
PATIENT INFORMATION LEAFLET
Fortipine® LA 40mg Modified Release Tablets
Nifedipine
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 any further 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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Fortipine LA 40mg Modified Release Tablets are and what they are used for
2. Before you take Fortipine LA 40mg Modified Release Tablets
3. How to take Fortipine LA 40mg Modified Release Tablets
4. Possible side effects
5. How to store Fortipine LA 40mg Modified Release Tablets
6. Further information
1. What Fortipine LA 40mg Modified Release Tablets are and what they are used for
Fortipine LA 40mg Modified Release Tablets contain the active substance Nifedipine. This belongs to a group of medicines known as calcium antagonists. These work by opening up the blood vessels and increasing the flow of blood through them.
Fortipine LA 40mg Modified Release Tablets are used:
• To stop the symptoms of angina. Angina is a chest pain caused by a narrowing of the arteries in the heart muscle.
• For the treatment of mild to moderate high blood pressure (hypertension).
2. Before you take Fortipine LA 40mg Modified Release Tablets
DO NOT take Fortipine LA 40mg Modified Release Tablets if:
• You know that you are allergic to nifedipine or any of the other ingredients of Fortipine LA 40mg Modified Release Tablets (listed at the end of this leaflet).
• You have a severe problem with your heart which causes collapse and a sudden fall in your blood pressure
• You have a severe constriction of the main blood vessel from the heart called aortic stenosis.
• You suffer from a blood disease called porphyria.
• You have suffered a heart attack in the last one month
Fortipine LA 40mg Modified Release Tablets should not be given to children.
Take special care with Fortipine LA 40mg Modified Release Tablets and check with your doctor or pharmacist before taking your medicine if:
• You have any liver or kidney problems
• You have heart problems which cause you to get breathless even with the slightest exercise
• You suffer from low blood pressure causing dizziness or fainting on standing up
• You are diabetic
• You suffer from a severe form of increased blood pressure (hypertensive crisis)
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The effects of these medicines may change, especially if you are taking:
• Other medications for chest pains and/or high blood pressure
• Any other drug for the treatment of heart problems (especially Digoxin and Quinidine)
• Any drugs containing cimetidine (for the reduction of stomach acidity and treatment of ulcers)
• Medicines for treatment of tuberculosis (rifampicin)
• Anti psychotic drugs for treating mental disorders
• Muscle relaxants
• Medicines used in the treatment of epilepsy (Carbamezipine, phenytoin)
• Medicines to treat diabetes
• Cyclosporine used in organ transplantation Pregnancy and breast feeding:
Ask your doctor or pharmacist for advice before taking any medicine.
Fortipine LA 40mg Modified Release Tablets should not be taken if you are pregnant, think you are pregnant or are planning to become pregnant, or if you are breast feeding.
Driving and using machines:
Fortipine LA 40mg Modified Release Tablets may cause headaches, dizziness, tiredness and you may feel sick. If this occurs, do not drive or use machines.
Taking with food and drink:
The tablets should be swallowed whole with a glass of water after eating. Do not break or chew the tablet.
Fortipine LA 40mg Modified Release Tablets should not be taken with grapefruit juice.
Important information about some of the ingredients of Fortipine LA 40mg Modified Release Tablets:
This medicine also contains lactose which is a form of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Fortipine LA 40mg Modified Release Tablets
Fortipine LA 40mg Modified Release Tablets are specially designed to release the active ingredient slowly. Always take Fortipine LA 40mg Modified Release Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual dose is:
• one tablet (40mg) daily. However, your doctor may increase your dose to 2 tablets (80mg) once daily or 1 tablet (40mg) twice daily depending on your response.
The tablets should be swallowed whole with a glass of water after eating. Do not break or chew the tablet. Children
Fortipine LA 40mg Modified Release 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 more Fortipine LA 40mg Modified Release Tablets than you should:
Taking too many Fortipine LA 40mg Modified Release Tablets can cause a severe drop in blood pressure, a slow heart rate and unconsciousness. If you take more tablets than you should, contact your doctor or hospital immediately. Take any remaining tablets or this leaflet with you so the medical staff know exactly what you have taken.
If you forget to take your Fortipine LA 40mg Modified Release Tablets:
If you forget to take a tablet, take it if you remember within 12 hours of your usual time. If more than 12 hours have passed, you should not take the missed tablet but should take your next tablet at the normal time when it is due.
If you stop taking Fortipine LA 40mg Modified Release Tablets:
Do not stop taking your tablets suddenly as your condition may get worse. Consult your doctor first.
4. Possible side effects
Like all medicines Fortipine LA 40mg Modified Release Tablets can sometimes cause side-effects, although not everybody gets them.
Stop taking Fortipine LA 40mg Modified Release Tablets and tell your doctor immediately if you experience:
• Signs of an allergic reaction such as skin rash, itching, swollen lips, difficulties in breathing
• Chest pain occurring within 1 to 4 hours of taking the first dose of these tablets
• Other side effects may include:
Common side effects (probably occurring in less than 1 in 10 people) are
• Headache
• Dizziness
• Feeling sick
• Reduced blood pressure (you may feel faint)
• Numbness and tingling sensations in fingers
• Redness of skin (flushing)
• Swelling of the hands and feet.
Uncommon side effects (probably occurring in less than 1 in 100 people) are
• Rash
• Lethargy (general weakness and loss of strength and energy)
• Increased frequency of passing water
• Skin rash caused by sunlight
• Tremors or shaking of the limbs.
Rare cases (probably occurring in less than 1 in 1000 people) of jaundice (yellowing of the skin and eyes from liver damage), and swelling of the gums have been reported.
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.
5. How to store Fortipine LA 40mg Modified Release Tablets
Keep this medicine out of the sight and reach of children.
Do not use Fortipine LA 40mg Modified Release Tablets after the expiry date which is stated on the pack. The expiry refers to the last day of that month.
• Store in a dry place in the original package in order to protect from light. The tablet must not be removed from its blister until it is about to be taken.
• Do not store above 25°C.
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 protect the environment.
6. Further information
The active substance is nifedipine. Each tablet contains 40mg nifedipine.
The other ingredients are microcrystalline cellulose, hypromellose, lactose monohydrate, magnesium stearate, colloidal anhydrous silica, polyethylene glycol 400, polyethylene glycol 6000, red iron oxide (E172), titanium dioxide (E171), talc.
What Fortipine LA 40mg Modified Release Tablets look like and contents of the pack:
Fortipine LA 40mg Modified Release Tablets are red brownish modified release tablets. Fortipine LA 40mg Modified Release Tablets come in blister strips which are in cartons of 30 tablets.
Marketing Authorisation Holder and Company responsible for manufacture:
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK
This leaflet was last revised in December 2013. 100026/LF/4
Fortipine is a registered trademark of Mercury Pharmaceuticals Ltd.
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Date of Approval: N/A |
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MercuryPharma |
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N/A |
06/12/2013 | ||
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Product Description: |
Originated by Date: |
Tech Approved |
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Fortipine LA 40mg MR Tabs |
JH 28/03/2012 |
Yes |
10/04/2012 |
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Leaflet |
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100026/LF/4 | |
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Siegfried |
100026LF Fortipine LA Tabs v4_1 |
AMCo.CRF. 133.2013 | | |
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UK |
Quark Xpress 9 |
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8pt Swiss 721BT |
148 x 270mm |
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