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FORTIPINE LA 40MG MODIFIED-RELEASE TABLETS

Active substance(s): NIFEDIPINE

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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)
• You are pregnant/breast feeding
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.

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 cause side-effects, although not everybody gets them.
Stop taking Fortipine LA 40mg Modified Release Tablets and tell your doctor immediately if you
experience:
• 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 before you continue treatment 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) as
these may be signs of a severe reaction (Toxic Epidermal Necrolysis)
Other side effects may include:
Common side effects
• Headache
• Redness of skin (flushing)
• General feeling of being unwell
• Swelling of ankles and legs
• Constipation
Uncommon side effects
• Increase in the need to pass water (urinate)
• Bleeding from nose
• Painful or difficult urination
• Nose block
• Trembling
• Pain in abdomen
• Low blood pressure when standing up (symptoms include fainting, • Indigestion or upset stomach
dizziness, light headedness, occasional palpitations, blurred vision • Wind (flatulence)
and sometimes confusion)
• Dry mouth
• Anxiety or nervousness
• Feeling sick (nausea)
• Erythema (localized redness of skin)
• Temporary increase in liver enzymes
• Fainting
• Muscle cramps
• Giddiness or sensation of spinning (vertigo)
• Joint swelling
• Dizziness
• Inability to achieve or maintain an erection
• Sleep disorders
(impotence)
• Migraine
• Unspecific pain
• Blurred vision
• Chills
• Feeling that the heart is pounding (palpations)
Rare cases
• Numbness and tingling sensations in fingers (pins and needles),
• Inflammation of the gums, tender or swollen gums, bleeding gums.
Frequency not known
• Being sick (vomiting)
• A reduction in the number of white blood cells (leucopenia)
• Yellowing of the whites of the eyes or skin
• A more severe decrease in a specific class of
(jaundice)
white blood cell (agranulocytosis)
• Small, raised areas of bleeding in the skin
• Increased glucose in blood (hypoglycemia)
(palpable purpura)
• Decreased skin sensitivity (hypoaesthesia)
• Pain in joints
• Drowsiness (somnolence)
• Muscle pain
• Eye pain
• Skin rash on exposure to light
• Stomach pain or distress caused by a mass of
• Ulcers in gut
foreign material found in the stomach which may
• Difficulty in breathing
require surgery for removal
• Chest pain
• Difficulty in swallowing
• Heartburn or indigestion (gastroesophageal
• Obstruction of gut
sphincter insufficiency).
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 Fortipine LA 40mg Modified Release Tablets

3. How to take 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.

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

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 July 2015
Fortipine is a registered trademark of Mercury Pharmaceuticals Ltd.
100026/LF/015/05

6. Further information

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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