Norvas 10 mg tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Norvas 10 mg tablets
amlodipine
Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.
Leaflet Contents
- What Norvas is and what it is used for
- What you need to know before taking Norvas
- How to take Norvas
- Possible side effects
- How to store Norvas
- Contents of the pack and other information
1. What Norvas is and what it is used for
Norvas contains the active substance amlodipine, which belongs to a group of medicines known as calcium antagonists.
Norvas is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, including a less common type known as Prinzmetal's angina or variant angina.
In patients with high blood pressure, this medicine works by relaxing blood vessels, allowing blood to flow through them more easily. In patients with angina, Norvas improves blood flow to the heart muscle, thereby increasing oxygen supply and preventing chest pain. This medicine does not provide immediate relief of angina-related chest pain.
2. What you need to know before taking Norvas
Do not take Norvas
- If you are allergic (hypersensitive) to amlodipine, or to any of the other components of this medicine (listed in section 6), or to any other calcium antagonist. This may cause itching, skin redness, or difficulty breathing.
- If you have very low blood pressure (hypotension).
- If you have aortic valve stenosis (narrowing of the aortic valve in the heart) or cardiogenic shock (a condition in which the heart is unable to pump enough blood to the body).
- If you suffer from heart failure following a heart attack.
Warnings and precautions
Talk to your doctor or pharmacist before you start taking Norvas.
You should inform your doctor if you have or have had any of the following conditions:
- Recent heart attack
- Heart failure
- Severe increase in blood pressure (hypertensive crisis)
- Liver disease
- You are elderly and your dose needs to be increased
Children and adolescents
Norvas has not been studied in children under 6 years of age. Norvas should only be used to treat high blood pressure in children and adolescents aged 6 to 17 years (see section 3).
For more information, consult your doctor.
Use of Norvas with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Norvas may affect, or be affected by, other medicines such as:
- ketoconazole, itraconazole (antifungal medicines)
- ritonavir, indinavir, nelfinavir (also known as protease inhibitors used to treat AIDS)
- rifampicin, erythromycin, clarithromycin (antibiotics)
- Hypericum perforatum (St. John's Wort)
- verapamil, diltiazem (heart medicines)
- dantrolene (by infusion for serious body temperature abnormalities)
- tacrolimus, sirolimus, temsirolimus, and everolimus (medicines used to modify the function of the immune system)
- simvastatin (a cholesterol-lowering medicine)
- cyclosporine (an immunosuppressant)
If you are already taking other medicines to treat high blood pressure, Norvas may lower your blood pressure even further.
Taking Norvas with food and drinks
People taking Norvas must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable increase in the blood pressure-lowering effect of Norvas.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine during pregnancy has not been established. If you think you may be pregnant, or are planning to become pregnant, you must inform your doctor before taking Norvas.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. If you are breastfeeding or about to start breastfeeding, you must inform your doctor before taking Norvas.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines
Norvas may affect your ability to drive or use machines. If the tablets make you feel unwell, dizzy, tired, or cause you to have a headache, do not drive or operate machinery and consult your doctor immediately.
Norvas contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".
3. How to take Norvas
Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended starting dose is 5 mg of Norvas once daily. The dose may be increased to 10 mg of Norvas once daily.
You may take this medicine before or after meals. Take it at the same time each day, with a glass of water. Do not take Norvas with grapefruit juice.
Use in children and adolescents
For children and adolescents (between 6–17 years of age), the usual recommended starting dose is 2.5 mg daily. The maximum recommended dose is 5 mg daily. Norvas 5 mg tablets may be divided into equal parts to provide a 2.5 mg dose.
It is important not to interrupt tablet administration. Do not wait until you run out of tablets before seeing your doctor.
If you take more Norvas than you should
Taking too many tablets may cause a drop in blood pressure or even a dangerous drop. You may feel dizzy, lightheaded, experience postural dizziness upon standing, or weakness. If the drop in blood pressure is severe enough, shock may occur. You may feel cold and clammy skin and could lose consciousness. If you take too many Norvas tablets, contact your doctor immediately or call the Toxicology Information Service at 91 562 04 20.
Excess fluid may accumulate in the lungs (pulmonary edema), causing difficulty breathing, which may develop within 24–48 hours after ingestion.
If you forget to take Norvas
Do not worry. If you forget to take a tablet, do not take that dose. Take the next dose at the correct time. Do not take a double dose to make up for forgotten doses.
If you stop taking Norvas
Your doctor will advise you on how long you should take this medicine. Your condition may return if you stop taking this medicine before your doctor advises you to do so.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Seek immediate medical attention if you experience any of the following adverse 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 causing severe difficulty breathing
- Severe skin reactions including severe rash, hives, widespread redness of the skin, severe itching, blistering, peeling and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
- Heart attack, irregular heartbeat
- Inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by severe malaise
The following very common adverse effect has been reported. If this causes problems or lasts longer than one week, consult your doctor.
Very common: may affect more than 1 in 10 people
- Edema (fluid retention)
The following common adverse effects have been reported. If any of these cause problems or last longer than one week, consult your doctor.
Common: may affect up to 1 in 10 people
- Headache, dizziness, drowsiness (especially at the beginning of treatment)
- Palpitations (awareness of heartbeat), hot flush
- Abdominal pain, feeling unwell (nausea)
- Changes in bowel habits, diarrhoea, constipation, indigestion
- Tiredness, weakness
- Visual disturbances, double vision
- Muscle cramps
- Swelling of ankles
Other adverse effects have been reported and are listed below. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people
- Mood changes, anxiety, depression, insomnia
- Tremor, taste disturbances, fainting
- Numbness or tingling sensation in the limbs, loss of pain sensation
- Ringing in the ears (tinnitus)
- Decrease in blood pressure
- Sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
- Cough
- Dry mouth, vomiting (feeling unwell)
- Hair loss, increased sweating, skin itching, red spots on the skin, skin discoloration
- Urinary disorders, increased need to urinate at night, increased frequency of urination
- Inability to achieve an erection, discomfort or enlargement of the breasts in men
- Pain, feeling unwell
- Muscle or joint pain, back pain
- Weight gain or weight loss
Rare: may affect up to 1 in 1,000 people
- Confusion
Very rare: may affect up to 1 in 10,000 people
- Decrease in white blood cell count, decrease in blood platelets which may cause easy bleeding or unusual bruising
- High blood sugar (hyperglycaemia)
- A nerve disorder which may cause muscle weakness, tingling or numbness
- Inflammation of the gums, bleeding gums
- Abdominal swelling (gastritis)
- Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), increased liver enzymes which may affect certain medical tests
- Increased muscle tension
- Inflammation of blood vessels, often with skin rashes
- Light sensitivity
- Disorders combining rigidity, tremor and/or movement disorders
Frequency not known: cannot be estimated from available data
- Tremor, rigid posture, mask-like facial expression, slow movements, and a shuffling, unbalanced gait
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Norvas
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.
6. Contents of the pack and other information
Composition of Norvas
The active substance in Norvas 10 mg tablets is amlodipine (as besylate).
The other components are anhydrous calcium hydrogen phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate from potato Type A.
Appearance of the product and contents of the pack
White to off-white diamond-shaped tablets, marked with AML-10 on one side and VLE on the other.
Norvas 10 mg tablets are available in blisters containing 4, 10, 14, 20, 28, 30, 50, 60, 90, 98, 100, 300, 500 tablets, calendar packs with 28 and 98 tablets, and unit-dose blisters containing 50x1 and 500x1 tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland
Manufacturer
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Prumyslová 961/16
747 23 Bolatice
Czech Republic
or
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
Germany
or
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 Madrid
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Tablets:
Austria, Bulgaria, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Sweden: Norvasc
Czech Republic: Zorem
Ireland, Malta, United Kingdom: Istin
Ireland: Amlodipine Pfizer 5 mg tablets, Amlodipine Pfizer 10 mg tablets
Italy: Amlodipina Pfizer Italia
Spain: Norvas 5 mg tablets, Norvas 10 mg tablets
United Kingdom: Amlodipine 5 mg tablets, Amlodipine 10 mg tablets
Date of the most recent review of this leaflet: July 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS): http://www.aemps.gob.es/