Patient Information Leaflet: Information for the User

Amlodipine Accord 5 mg tablets, 10 mg tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Amlodipine Accord is and what it is used for
What you need to know before taking Amlodipine Accord
How to take Amlodipine Accord
Possible side effects
How to store Amlodipine Accord
Contents of the pack and other information

1. What Amlodipine Accord is and what it is used for

Amlodipine Accord contains the active substance amlodipine, which belongs to a group of medicines called calcium channel blockers.
Amlodipine Accord is used to treat high blood pressure (hypertension) or a type of chest pain known as angina, including a rare form called Prinzmetal's angina or variant angina.
In patients with high blood pressure, this medicine works by relaxing the blood vessels, allowing blood to flow more easily. In patients with angina, Amlodipine Accord improves blood flow to the heart muscle, thereby increasing oxygen supply and helping to prevent chest pain. This medicine does not provide immediate relief of angina-related pain.

2. What you need to know before taking Amlodipine Accord

Do not take Amlodipine Accord

If you are allergic to amlodipine or to any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. The reaction may include itching, skin redness, or difficulty breathing.
If you have severe low blood pressure (hypotension).
If you have narrowing of the heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition in which the heart is unable to supply sufficient blood to the body).
If you suffer from heart failure following a heart attack.

Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine Accord. You must inform your doctor if you have or have had any of the following conditions:

Recent heart attack
Heart failure
Severe high blood pressure (hypertensive crisis)
Liver disease
You are elderly and your dose needs to be increased

Children and adolescents
Amlodipine Accord has not been studied in children under 6 years of age. Amlodipine Accord should only be used for hypertension in children and adolescents aged 6 to 17 years (see section 3).
For further information, consult your doctor.
Other medicines and Amlodipine Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Amlodipine Accord may affect or be affected by other medicines, such as:

ketoconazole, itraconazole (antifungal medicines)
ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV)
rifampicin, erythromycin, clarithromycin (antibiotics)
Hypericum perforatum (St. John's wort)
verapamil, diltiazem (heart medicines)
dantrolene (infusion for severe disturbances in body temperature)
tacrolimus (a medicine used to modify the way the immune system works)
simvastatin (a medicine used to lower cholesterol)
ciclosporin (immunosuppressant)

Amlodipine Accord may lower your blood pressure even more if you are already taking other medicines for high blood pressure.
Amlodipine Accord with food and drink
People taking Amlodipine Accord should not consume grapefruit or grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active substance amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Amlodipine Accord.
Pregnancy and breastfeeding
Pregnancy
The safety of amlodipine in pregnant women has not been established. If you think you might be pregnant or if you are planning a pregnancy, inform your doctor before taking Amlodipine Accord.
Breastfeeding
It has been shown that amlodipine passes into breast milk. If you are breastfeeding or planning to breastfeed, you must inform your doctor before taking Amlodipine Accord.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amlodipine Accord may affect your ability to drive or use machinery. If the tablets cause you to feel unwell, dizzy or tired, or give you headaches, avoid driving or using machinery and contact your doctor immediately.

3. How to take Amlodipine Accord

Take this medicine exactly as your doctor or pharmacist has told you. If
you have any doubts, please consult your doctor or pharmacist.
The recommended starting dose is 5 mg once daily. The dose may be increased to 10 mg
once daily.
This medicine can be taken before or after food and drink. Take this medicine
every day at the same time with a glass of water. Do not take Amlodipine Accord with
grapefruit juice.
Use in children and adolescents
For children and adolescents (aged 6 to 17 years), the usual recommended starting dose is 2.5
mg once daily. The maximum recommended dose is 5 mg once daily. Amlodipine 2.5 mg is not
currently available, and the 2.5 mg dose cannot be obtained with Amlodipine Accord 5 mg tablets,
because these tablets are not designed to be divided into two equal halves.
It is important that you continue taking the tablets. Do not wait until your tablets are finished before
seeing your doctor.
If you take more Amlodipine Accord than you should
If you take too many tablets, your blood pressure could drop too much, which could be dangerous.
You may feel dizzy, lightheaded, weak, or faint. The drop in blood pressure could be so severe that it
causes shock. Your skin may become cold and clammy, and you may lose consciousness. If you have
taken too many Amlodipine Accord tablets, contact your doctor immediately.
If you forget to take Amlodipine Accord
Don’t worry. If you forget to take a tablet, skip the missed dose completely.
Take your next dose at the usual time.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Amlodipine Accord
Your doctor will tell you how long to take this medicine. Your condition may return if you stop
treatment before you are advised to do so.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If, after taking this medicine, you notice any of the following side effects, consult your doctor
immediately:

Sudden onset of breathlessness, chest pain, shortness of breath, or difficulty breathing
Swelling of the eyelids, face, or lips
Swelling of the tongue and throat that may cause difficulty breathing
Severe skin reactions including severe rash, hives, redness of the skin all over the body, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson syndrome), or other allergic reactions
Myocardial infarction, irregular heart rhythm
Inflammation of the pancreas that may cause severe abdominal and back pain associated with a general feeling of severe illness

The following very common side effects have been reported. If they cause you problems or if they last longer than one week, consult your doctor.

Very common: may affect more than 1 in 10 people

Edema (fluid retention)

The following common side effects have also been reported. If they cause you problems or if they persist for more 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), flushing
Abdominal pain, nausea
Altered bowel habits, diarrhoea, constipation, indigestion
Fatigue, weakness
Visual disturbances, double vision
Muscle cramps
Swelling of the ankles

In addition, the following side effects have been reported. If any of these side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Uncommon: may affect up to 1 in 100 people

Mood changes, anxiety, depression, insomnia
Tremor, altered taste, fainting
Numbness or tingling sensation in the limbs; loss of pain sensation
Ringing in the ears
Low blood pressure
Sneezing/runny nose due to inflammation of the nasal mucosa (rhinitis)
Cough
Dry mouth, vomiting
Hair loss, increased sweating, skin itching, red patches on the skin, skin discoloration
Urinary disorders, increased need to urinate at night, frequent need to urinate
Inability to achieve an erection; discomfort or breast enlargement in men
Pain, malaise
Joint or muscle 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 the number of white blood cells, decrease in blood platelets that may lead to unusual bruising or tendency to bleed
Excess sugar in the blood (hyperglycaemia)
A nerve disorder that may cause muscle weakness, tingling, or numbness
Swollen gums
Abdominal swelling (gastritis)
Liver dysfunction, 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 rash
Light sensitivity
Disorders related to stiffness, tremor, and/or movement disturbances

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlodipine Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "Exp." The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Amlodipine Accord contains
Amlodipine Accord 5 mg tablets:
The active substance is amlodipine. Each tablet contains 5 mg of amlodipine (as besilate).
The other components are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium hydrogen citrate, crospovidone, sodium croscarmellose.
Amlodipine Accord 10 mg tablets:
The active substance is amlodipine. Each tablet contains 10 mg of amlodipine (as besilate).
The other components are: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, disodium hydrogen citrate, crospovidone, sodium croscarmellose.

Description of the appearance of Amlodipine Accord and contents of the pack
Amlodipine Accord 5 mg tablets:
White, round, biconvex tablets, 6.6 mm in diameter.
Amlodipine Accord 10 mg tablets:
White, round, biconvex tablets, 8.5 mm in diameter.

Pack sizes
Blister packs:
5 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets
10 mg: 10, 14, 20, 28, 30, 50, 60, 90, 98 and 100 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, HA1 4HF
Middlesex
United Kingdom

This medicinal product is authorised in the European Economic Area Member States under the following names:

| Member State | Medicinal Product Name | |------------------|----------------------------| | Austria | Amlodipin Accord 5/10 mg Tabletten | | Belgium | Amlodipine Accord Healthcare 5/10 mg Comprimés/ Tabletten | | Czech Republic | Amlodipin Accord 5/10 mg Tablety | | Germany | Amlodipin Accord 5/10 mg Tabletten | | Denmark | Amlodipin Accord 5/10 mg Tabletter | | Estonia | Amlodipine Accord 5/10 mg | | Greece | Amlodipine Accord 5/10 mg δισκία | | Italy | AMLODIPINA ACCORD 5 /10 MG COMPRESSE | | Lithuania | Amlodipine Accord 5/10 mg tabletės | | Latvia | Amlodipine Accord 5/10 mg tablets | | Netherlands | Amlodipine (as besilate) Accord 5/10 mg tablets | | Poland | Amlodipine Accord | | Portugal | Amlodipina Accord | | Romania | Amlodipina Accord 5/10 mg comprimate | | Sweden | Amlodipin Accord 5/10 mg tabletter |