5 mg and 10 mg tablets
amlodipine
What Norvasc is and what it is used for
Norvasc contains the active substance amlodipine which belongs to a group of medicines called calcium channel blockers.
Norvasc is used to treat high blood pressure ( hypertension ) or a special type of chest pain called angina. A rare form of this is Prinzmetal’s angina or variant angina.
In patients with high blood pressure, the drug reduces the resistance in the blood vessels, so that the blood can pass more easily. In patients with angina, Norvasc works by increasing blood flow to the heart muscle, which then receives more oxygen. That way, chest pain is prevented. The drug does not provide immediate relief of chest pain in angina.
What you need to know before using Norvasc
Do not take Norvasc
- if you are allergic (hypersensitive) to amlodipine or any of the other ingredients of this medicine (listed in section 6), or to any other calcium channel blocker. Symptoms may include itching , redness of the skin or difficulty breathing
- if you have very low blood pressure ( hypotension )
- if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply the body with sufficient amounts of blood)
- if you have heart failure after a heart attack.
Warnings and cautions
Talk to your doctor or pharmacist before taking Norvasc.
Tell your doctor if you have or have had any of the following:
- recent heart attack
- heart failure
- very high blood pressure (hypertensive crisis)
- liver disease
- if you are older and your dose needs to be increased
Children and young people
Norvasc has not been studied in children under 6 years of age. Norvasc should only be used to treat hypertension in children and adolescents between 6 and 17 years of age (see section 3).
For more information, talk to your doctor.
Other medicines and Norvasc
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Norvasc may affect or be affected by other medicines, including:
- ketoconazole , itraconazole (antifungal)
- ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV )
- rifampicin, erythromycin, clarithromycin ( antibiotics )
- Hypericum perforatum ( St. John’s wort )
- verapamil, diltiazem (heart medicine)
- dantrolene ( infusion for severe disorders of body temperature)
- tacrolimus, sirolimus, temsirolimus and everolimus (medicines used to change the way the immune system works)
- simvastatin (cholesterol lowering drug)
- ciclosporin (medicines that suppress the immune system)
Norvasc may lower your blood pressure further if you are already taking other medicines for high blood pressure.
Norvasc with food, drink and alcohol
If you are taking Norvasc, do not eat grapefruit or drink grapefruit juice. Grapefruit and grapefruit juice can lead to an increase in the amount of the active substance amlodipine in the blood, which can lead to an unpredictable increase in Norvasc’s blood pressure-lowering effect.
Pregnancy, breastfeeding and fertility
Pregnancy
The safety of amlodipine during pregnancy has not been established. If you think you are pregnant or planning to become pregnant, tell your doctor before taking Norvasc.
Breast-feeding
Amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, tell your doctor before taking Norvasc.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Norvasc may affect your ability to drive or use machines. If you feel unwell, dizzy or tired, or have headaches from the tablets, do not drive or use machines. Contact your doctor immediately.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Norvasc contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
How to use Norvasc
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended starting dose is 5 mg Norvasc once daily. Dose one can be increased to 10 mg Norvasc once daily.
You can take the medicine before or after food or drink. You should take the medicine at the same time each day with a glass of water. Do not take Norvasc with grapefruit juice.
Use for children and adolescents
The recommended starting dose for children and adolescents (6-17 years) is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Norvasc 5 mg tablets can be divided into halves to obtain a dose of 2.5 mg.
You must take the tablets at all times. Do not wait until the tablets run out before going to the doctor.
If you use more Norvasc than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you take too many tablets, your blood pressure may be low or even dangerously low. You may feel dizzy, unsteady, faint, or weak. If the blood pressure drops low enough, you can experience shock. The skin then feels cold and moist and you can become unconscious. Seek immediate care if you have taken too many Norvasc tablets.
If you forget to use Norvasc
Do not worry. If you forget to take a tablet, just ignore that dose. Take the next dose at the right time.
Do not take a double dose to make up for a forgotten dose.
If you stop using Norvasc
Your doctor will tell you how long to take this medicine. Your illness may return if you stop taking the medicine earlier.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
See your doctor immediately if you get any of the following side effects after taking this medicine.
- sudden wheezing, chest pain, shortness of breath or difficulty breathing
- swelling of the eyelids, face or lips
- swelling of the tongue and throat that makes it very difficult to breathe
- severe skin reactions such as severe rash, hives , redness all over the body, severe itching , blisters, skin flaking and swelling, inflamed mucous membranes ( Stevens-Johnson syndrome , toxic epidermal necrolysis ) or other allergic reactions
- heart attack, abnormal heart rate ( pulse )
- inflammation of the pancreas, which can cause severe abdominal and back pain and a strong feeling of illness
The following very common side effects have been reported. If any of these cause you any problems or if they last for more than a week, consult your doctor.
Very common side effects: may affect more than 1 user in 10
- edema (swelling due to fluid)
The following common side effects have been reported. If any of these cause you any problems or if they last for more than a week, consult your doctor.
Common side effects: may affect up to 1 in 10 people
- headache, dizziness, drowsiness (especially at the beginning of treatment)
- palpitations (you feel the heartbeat), hot flashes
- abdominal pain, nausea
- altered bowel habits, diarrhea, constipation, indigestion
- fatigue, weakness
- visual disturbances, double vision
- muscle cramps
- swollen ankles
Other side effects reported are listed below. 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.
Uncommon side effects: may affect up to 1 in 100 people
- mood swings, anxiety, depression, insomnia
- tremors, taste change, fainting
- numbness or tingling in the arms and legs, inability to feel pain
- earrings
- low blood pressure
- sneezing / runny nose due to inflammation of the nasal mucosa ( rhinitis )
- cough
- dry mouth , vomiting
- hair loss, increased sweating, itchy skin, red spots on the skin, skin discoloration
- urination problems, increased need to urinate at night, increased urination frequency
- impotence , discomfort from or enlarged breasts in men
- pain, feeling sick
- joint or muscle pain, back pain
- weight gain or weight loss
Rare side effects: may affect up to 1 in 1,000 people :
- confusion
Very rare side effects: may affect up to 1 in 10,000 people
- decreased number of white blood cells , decreased number of platelets that can lead to bruising or bleeding easily
- elevated blood sugar ( hyperglycaemia )
- a nerve disorder that can cause muscular weakness, tingling or numbness
- swollen gums, bleeding gums
- swollen abdomen ( gastritis )
- abnormal liver function, inflammation of the liver ( hepatitis ), yellow skin (jaundice), elevated liver enzymes that may affect certain medical tests
- increased muscle tone (muscle tension)
- inflammation of the blood vessels, often with rash
- photosensitivity
- diseases that combine rigidity , tremor , and / or movement disorders
Has been reported: (occurs in an unknown number of users)
- tremors, stiff posture, worm-like face, slow movements and sluggish, unbalanced gait
How to store Norvasc
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiration date is the last day of the specified month.
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 to protect the environment.
Contents of the pack and other information
Content declaration
The active substance in Norvasc 5 mg tablets is amlodipine (in the form of besylate).
The active substance in Norvasc 10 mg tablets is amlodipine (in the form of besylate).
The other ingredients are anhydrous calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose, and type A sodium starch glycolate.
What the medicine looks like and contents of the pack
5 mg tablets: White to off-white, octagonal tablets imprinted with AML 5 and a score line on one side and the Pfizer logo on the other side.
10 mg tablets: White to off-white, octagonal tablets debossed with AML 10 on one side and Pfizer logo on the other side.
Norvasc 5 mg tablets are available in blisters of 4, 10, 14, 20, 28, 30, 50, 60, 98, 100, 300, 500 tablets, in calendar packs of 28 or 98 tablets and in single-dose blisters of 50×1 and 500×1 tablets.
Norvasc 10 mg tablets are available in blisters of 4, 10, 14, 20, 28, 30, 50, 60, 90, 98, 100, 300, 500 tablets, in calendar packs of 28 or 98 tablets and in single-dose blisters of 50×1 and 500×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
Netherlands
Local representative
Pfizer AB
191 90 Sollentuna
Tel: 08-550 520 00
Email: eumedinfo@pfizer.com
Manufacturer
R-Pharm Germany GmbH
Heinrich-Mack-Str. 35
89257 Illertissen
Germany
or
Pfizer Manufacturing Deutschland GmbH
Operating office Freiburg
Mooswaldallee 1
79090 Freiburg
Germany