Amlodipine CT 5 mg, tabletten

Amlodipine tablets contain the active substance amlodipine which belongs to a group of medicines called calcium antagonists.

Amlodipine tablets are used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.

In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine tablets work by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina.

Do not take Amlodipine tablets:

• If you are allergic to amlodipine, or any of the other ingredients of this medicine (listed in section 6), or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing
• If you have severe low blood pressure (hypotension)
• If you have narrowing of the aortic heart valve (aortic stenosis) or cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)

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• If you suffer from heart failure after a heart attack.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amlodipine tablets.

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

Amlodipine has not been studied in children under the age of 6 years. Amlodipine tablets should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).

For more information, talk to your doctor.

Other medicines and Amlodipine tablets

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

Amlodipine tablets may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (anti-fungal 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 body temperature abnormalities)
• simvastatin (medicine used to lower elevated blood lipid levels).

Amlodipine tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Amlodipine tablets with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine tablets. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine tablets.

It is not known whether amlodipine is passed into breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine tablets.

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Driving and using machines

Amlodipine tablets may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired, or give you a headache, do not drive or use machines and contact your doctor immediately.

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

Dosage

Amlodipine tablets 5 mg

Amlodipine (as besilate) ratiopharm 5 mg, Tablets

The recommended initial dose is 1 tablet (corresponding to 5 mg amlodipine) once daily. The dose can be increased to 2 tablets (corresponding to 10 mg amlodipine) once daily.

Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not take Amlodipine tablets with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.

The 2.5 mg dose cannot be obtained with Amlodipine tablets 5 mg as these tablets are not manufactured to break into two equal halves.

Amlodipine tablets 10 mg

Amlodipine (as besilate) ratiopharm 10 mg, Tablets

The recommended initial dose is ½ tablet (corresponding to 5 mg amlodipine) once daily. The dose can be increased to 1 tablet (corresponding to 10 mg amlodipine) once daily.

Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a drink of water. Do not take Amlodipine tablets with grapefruit juice.

Use in children and adolescents

For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day.

The 2.5 mg dose cannot be obtained with Amlodipine tablets 10 mg.

It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Amlodipine tablets than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipine tablets.

If you forget to take Amlodipine tablets

Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

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If you stop taking Amlodipine tablets

Your doctor will advise you how long to take your medicine. Your condition may return if you stop using your medicine before you are advised.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine.

• Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing
• Swelling of eyelids, face or lips
• Swelling of the tongue and throat which causes great difficulty breathing
• Severe skin reactions including intense skin rash, hives, reddening of the skin over your whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens Johnson Syndrome) or other allergic reactions
• Heart attack, abnormal heart beat
• Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

The following common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.

Common: affects 1 to 10 users in 100

• Headache, dizziness, sleepiness (especially at the beginning of treatment)
• Palpitations (awareness of your heart beat), flushing
• Abdominal pain, feeling sick (nausea)
• Ankle swelling (oedema), tiredness

Other side-effects that have been reported include the following list. If any of these get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

Uncommon: affects 1 to 10 users in 1,000

• Mood changes, anxiety, depression, sleeplessness
• Trembling, taste abnormalities, fainting, weakness
• Numbness or tingling sensation in your limbs; loss of pain sensation
• Visual disturbances, double vision, ringing in the ears
• Low blood pressure
• Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)
• Altered bowel habits, diarrhoea, constipation, indigestion, dry mouth, vomiting (being sick)
• Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration
• Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine
• Inability to obtain an erection; discomfort or enlargement of the breasts in men
• Weakness, pain, feeling unwell
• Joint or muscle pain, muscle cramps, back pain
• Weight increase or decrease

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Rare: affects 1 to 10 users in 10,000

• Confusion

Very rare: affects less than 1 user in 10,000

• Decreased numbers of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage)
• Excess sugar in blood (hyperglycaemia)
• A disorder of the nerves which can cause weakness, tingling or numbness
• Cough, swelling of the gums
• Abdominal bloating (gastritis)
• Abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests
• Increased muscle tension
• Inflammation of blood vessels, often with skin rash
• Sensitivity to light
• Disorders combining rigidity, tremor, and/or movement disorders

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Do not store above 30 °C.

Store in the original package in order to protect from light.

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. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Amlodipine tablets contains

• The active substance is amlodipine. Amlodipine tablets 5 mgAmlodipine (as besilate) ratiopharm 5 mg, Tablets Each tablet contains 5 mg amlodipine (as besilate) Amlodipine tablets 10 mgAmlodipine (as besilate) ratiopharm 10 mg, Tablets Each tablet contains 10 mg amlodipine (as besilate)
• The other ingredients are microcrystalline cellulose (E460), calcium hydrogen phosphate (E341), sodium starch glycolate (Type A), magnesium stearate (E470b). <[To be completed nationally]>

What Amlodipine tablets looks like and contents of the pack

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Amlodipine tablets 5 mg

Amlodipine (as besilate) ratiopharm 5 mg, Tablets

White to off-white, round, one sided convex tablets, with “A” and “5” embossed on break line side.

Amlodipine tablets 10 mg

Amlodipine (as besilate) ratiopharm 10 mg, Tablets

White to off-white, round, one sided convex tablets, with “A” and “10” embossed on break line side.

The tablet can be divided into equal halves.

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They are available in PVC/PVDC/Al blister packs with 10, 14, 20, 28, 30, 30x1, 50, 50x1, 56, 60, 90, 98, 100, 100x1, 200, 250 tablets.

They are available in HDPE bottles with 100 and 250 tablets. <[To be completed nationally]>

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They are available in PVC/PVDC/Al blister packs with 10, 14, 20, 28, 30, 30x1, 50, 50x1, 56, 60, 90, 98, 100, 100x1, 200, 250 tablets.

They are available in HDPE bottles with 100 tablets. <[To be completed nationally]>

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma B.V.

Computerweg 10

3542 DR Utrecht

Nederland

Manufacturer

Merckle GmbH

Ludwig-Merckle Strasse 3

89143 Blaubeuren-Weiler

Duitsland

TEVA Pharmaceutical Works Ltd

Pallagi Ut 13

4042 Debrecen

Hongarije

Teva Pharma S.L.U.

C/C, n. 4, Poligono Industrial Malpica 50016 Zaragoza

Spanje

Dit geneesmiddel is geregistreerd onder

Amlodipine CT 5 mg, tabletten	RVG 31809
Amlodipine CT 10 mg, tabletten	RVG 31810

Dit geneesmiddel is geregistreerd in lidstaten van de EEA onder de volgende namen:

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Duitsland: Amlodipin-CT 5, 10 mg N Tabletten

Nederland: Amlodipine CT 5, 10 mg, tabletten

This leaflet was last revised in {MM/YYYY}.