NIFEDIPINE CAPSULES 10 MG - patient leaflet, side effects, dosage

NIFEDIPINE CAPSULES 5mg AND 10mg

J..... „......

Read all of this leaflet carefully before you start taking this medicine because it contains important information foryou

• Keep this leaflet. You may need to read it again
• If you have further questions, ask your doctor, । pharmacist or nurse

L This medicine has been prescribed for you only.

• Do not pass it on to others. It may harm them, I even if their signs of illness are the same as yours If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible । side effects not listed in this leaflet. See section 4. Wh?.t.jsi.n.th­.is'eafleti

|1. What Nifedipine Capsules are and what they are used for

2. What you need to know before you take Nifedipine Capsules

• 3. Howtotake Nifedipine Capsules

4. Possible side effects

|5 Howtostore Nifedipine Capsules

6. Contents of the pack and other information.

• 1. WHAT NIFEDIPINE CAPSULES ARE AND WHATTHEY ARE USED FOR

Nifedipine Capsules contain nifedipine. This belongs to a group of medicines called calcium antagonists. Nifedipine works by relaxing and expanding blood Vessels allowing blood to flow more easily.

Nifedipine is used in the treatment of high blood pressure and Raynaud's phe­nomenon (a condition where spasm of the blood vessels in the fingers causes them to go white, with numbness and discomfort). It is also used for the prevention of chronic stable angina pectoris.

Nifedipine Capsules should not be used for the treatment of acute attacks of angina.

2. what you need to know before you take nifedipine capsules

Do not take Nifedipine Capsules if:

• you are allergic to nifedipine, any other dihydropyridine drugs, or any of the ingredients in this medicine (listed in section 6)

L you are suffering from shock induced by heart circulatory collapse or have ever had a collapse caused by a heart problem (cardiogenic shock), during which you became breathless, pale and i had a cold sweat and dry mouth

• you have aortic stenosis (narrowing of the i opening ofthe aortic heart valve)
• you suffer with unstable angina
• you are having, or have had a heart attack in the

। last month

• you are taking rifampicin (see other medicines

I section)

• if you get a sudden angina attack. Nifedipine

I capsules will not help relieve symptoms of

, angina quickly

• if your blood pressure continues to rise despite

। treatment (malignant hypertension).

Warnings and precautions:

Talk to your doctor, pharmacist or nurse before taking this medicine:

• If you have low blood pressure. 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 i high blood pressure and a low blood volume, you might experience a sudden drop in blood i pressure when you take Nifedipine Capsules
• If your liver is not working properly your

। doctor may need to do some blood tests. You

1 may also be given a lower dose of this medicine

• 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

I Nifedipine Capsules

• If you are taking other medications (see other

I medicines section)

• If you are giving a urine sample. Nifedipine

Capsules 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

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. I

Some medicines may affect the way Nifedipinel Capsules work. Tell your doctor if you are taking:

• Other medicines to treat high blood pressure |
• Rifampicin (an antibiotic)

• Digoxin, diltiazem, quinidine or beta-blockers

• Magnesium sulphate injections during1

pregnancy (may cause a severe fall in blood pressure)

• Ketoconazole, itraconazole or fluconazole

• Indinavir, nelfinavir, ritonavir, saquinavir or

• Fluoxetine or nefazodone (to treat depression) ।
• Tacrolimus (to prevent the rejection of

This medicine can be taken with or without food.

Alcohol can increase the effect of Nifedipine, this may be dangerous. Ask your doctor or pharmacist for| advice if you wish to drink alcohol while taking this medicine. I

Do not drink grapefruit juice or eat grapefruit] while taking Nifedipine Capsules.

Do not start taking Nifedipine Capsules 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 takingi Nifedipine Capsules. Grapefruitjuice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.

You may be able to use Nifedipine Capsules but only after special consideration and agreement by your doctor.

Breast-feeding:

You should not take Nifedipine Capsules whilel breast-feeding. If you are unsure you should talk to yourdoctor. |

Driving and using machines: |

Side effects such as feeling faint, extremely tired, dizziness and visual disturbances may affect your| ability to drive or operate machinery. You should avoid driving or operating machinery if you suffer] from any such side effects.

• 3. HOWTO TAKE NIFEDIPINE CAPSULES

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if youi are not sure.

Adults:

Patients with kidney problems will be given the| normaLrecommen­deddosage_ _ _ _ _

— — — — — — — — — —

Elderly patients:

Lower maintenance doses of nifedipine may be Required.

Use in children and adolescents:

Nifedipine Capsules 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 experience any unexpected anginal pain soon after taking nifedipine, stop taking the medicine and tell yourdoctor immediately.

'if you take more Nifedipine Capsules than you Should:

If you take too many capsules you should contact your nearest hospital casualty department immediately. Take the remaining capsules and box with you. Taking too many capsules may cause your blood pressure to become too low and your heartbeat 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.

|f you forget to take Nifedipine Capsules:

If you have missed a dose, take the missed dose as soon as you remember unless your next dose is due within 2 hours. Do not take double the dose next ^ime. If you are concerned consult your doctor.

If you stop taking Nifedipine Capsules:

Consult your doctor before you stop taking nifedipine as your original symptoms may return if you stop taking it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Nifedipine Capsules can have bide effects, although not everybody gets them.

Serious side effects:

If you notice any of the following, contact your doctor immediately and do not take the next dose as these may be the first signs of an allergic reaction which may become severe:

• severe, sudden generalised allergic reaction । including very rarely life-threatening shock (e.g. I difficulty in breathing, drop of blood pressure, fast pulse) or swelling (including potentially life-

I 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 heartbeat (tachycardia)
• shortness of breath or difficulty breathing
• mild to moderate allergic reactions
• itching (possibly severe), a rash or hives.

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

I continue treatment as these may be signs of a severe reaction.

Other side effects which may occur:

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
• tiredness and lack of energy (lethargy)
• swelling or enlargement of breasts in male (gynaecomastia).

Uncommon side effects

(These may affect up to 1 in 100 people)

• stomach pain (abdominalpain)
• 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 ofspinnlngor-whlfling-motien (vertigo)

• dizziness

• increase in the need to pass water1

• inability to achieve or maintain an.

• blurred vision
• temporary increase in certain liver

enzymes.

L

Rare side effects (These may affect up to 1 in 1,000 people)

• pinsand needles
• inflammation of the gums, tender or swollen-gums, bleeding gums.

Other side effects (Frequency not known: frequency cannot bq estimated from the available data)

• a more severe decrease in a specific class of

• decreased skin sensitivity (hypoaesthesia)

• eye pain

• heartburn or indigestion (gastroesophageal

• yellowing of the whites of the eyes or

• sensitivity to light (photosensitivity allergic

• small, raised areas of bleeding in the

• muscle pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

• 5. HOWTOSTORE NIFEDIPINE CAPSULES

6. contents of the pack and other information

Nifedipine Capsules 5mg contain the active

Nifedipine Capsules 10mg contain the active

What Nifedipine Capsules look like and contents) of the pack:

Ennogen Pharma Limited

UnitG4, Riverside Industrial Estate, Riverside Way |

Dartford, DA1 5BS, United Kingdom

Manufacturer:

RP Scherer SPA |

Viale Europa 3,20075 Lodi, Milan, Italy ।

This leaflet was last revised in January 2018