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

^a 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

•    General feeling of being unwell

•    Constipation Uncommon side effects

•    Increase in the need to pass water (urinate)

•    Painful or difficult urination

•    Trembling

•    Low blood pressure when standing up (symptoms include fainting, dizziness, light headedness, occasional palpitations, blurred vision and sometimes confusion)

•    Anxiety or nervousness

•    Erythema (localized redness of skin)

•    Fainting

•    Giddiness or sensation of spinning (vertigo)

•    Dizziness

•    Sleep disorders

•    Migraine

•    Blurred vision

•    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

•    A reduction in the number of white blood cells (leucopenia)

•    A more severe decrease in a specific class of white blood cell (agranulocytosis)

•    Increased glucose in blood (hyperglycemia)

•    Decreased skin sensitivity (hypoaesthesia)

•    Drowsiness (somnolence)

•    Eye pain

•    Stomach pain or distress caused by a mass of foreign material found in the stomach which may require surgery for removal

•    Difficulty in swallowing

•    Obstruction of gut ^a Being sick (vomiting)

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.

Redness of skin (flushing) Swelling of ankles and legs

Bleeding from nose Nose block Pain in abdomen Indigestion or upset stomach Wind (flatulence)

Dry mouth

Feeling sick (nausea)

Temporary increase in liver enzymes Muscle cramps Joint swelling

Inability to achieve or maintain an erection (impotence)

Unspecific pain Chills

Yellowing of the whites of the eyes or skin (jaundice)

Small, raised areas of bleeding in the skin (palpable purpura)

Pain in joints Muscle pain

Skin rash on exposure to light Ulcers in gut Difficulty in breathing Chest pain

Heartburn or indigestion (gastroesophageal sphincter insufficiency)

Shortness of breath.

5. How to store Fortipine l_A 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 06/2016 Fortipine is a registered trademark of Mercury Pharmaceuticals Ltd.

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